Numerous Correspondences and a Report Pertaining to the Investigation of Iodine-131 Misadministration Occurring September 4, 1973 (Redacted)

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ATOMIC ENERGY COMMISSION OAK RIDGE OPERATIONS Martin B. Biles, Director, Division of Operational Safety, HQ LNVESTIGA!L'ION OF ORAU IODINE - 131 MISADMINISTRATION OCCURRING Enclosed are copies of the draft report of the OR investigation of the The basic cause of the misadministration of Iodine-131 to the patients was technician error and the absence of an independent dose verification procedure which would fiave detected the error and prevented the misprocedures ina fhrther effort to preclude undetected human error in in detail as apart of the followup o f ORAU implementation o f ORAU i s being instructed t o implement Recommendations No. 1-4. result of No. 4, ORAU will bring its policy on communication of errors to patients inline with 10 CFR 35 requirements in this regard. reference t o Recommendation No. 5, t h e ORAU Unusual Occurrences Reporting Program as well as Manual Chapter 0502 ( i n those portions regarding items with possible public relations aspects) required reporting of this instance of misadministration. i n AEC manual chapters for specific reporting of misadministrations such of formal requirements for reporting incidents of this type i n an appropriate manual chapter so as t o be consistent with 10 CFli 35. There is also enclosed a memorandum from the Chief Counsel concerning the possibility of claims arising out of this matter. As a result of this incident, we have reviewed the question of whether ORAU Medical should continue t o provide nuclear medicine services tothe Oak Ridge ORAU i s revising its dose verification and check OR will review these revised procedures However, there is no formal requirement Recommend Headquarters consider publication Hospital. A copy of t h

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1. Draft Report of Investigation 2 . Memo, Hill to Hart,dtd 11/5/73 3 . Memo, Lenhard to Hill,dtd 9/24/73

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ATOMIC ENERGY COMMISSION OAK RIDGE OPERATIONS OAK RIDGE, TENNESSEE 37830 AEC INVESTIGATIVE REPORT OF IODINE-1 31 MISADMINISTRATION AT ORAU ON This isto advise that this office has reviewed the subject investigative report f o r the purpose of evaluating the possibility of claims against While we see no reasonable probability of any claims being asserted against the United States in connection with the misadministration of the drug Iodine-131, we cannot eliminate the possibility t h a t a claim or claims might be asserted against ORAU and/or the ORAU physician and technician involved i n the misadministration. We do not, however, believe that there i s any high probability of any claim being asserted. Our reason for being unable t o rule out the possibility of a claim or claims is that the report clearly reflects that the two patients involved were administered a dosage approximately ten times the dose prescribed and intended t o be given. Itis also clear that the two patients are aware of the misadministration. While the knowledgeable medical personnel do not believe that the dosage administered could or will cause any deleterious effect t o the patients, the patients themselves, if their physical condition deteriorates, may believe that the misadministration has a causal connection with their physical condition. Again, we emphasize, however, that we believe the probability of any claims i s Should a claim be asserted against ORAU, and/or i t s medical personnel, we could only speculate as t o the amount of damages which might be alleged and sought. be extremely difficult to show any causal relation between any injury alleged and the doses administered by virtue of the fact that we believe Iodine-131 dosage i n this range was used for a number of years f o r thyroid uptake and scanning studies without any evidence of injury to any patient, and secondly, that while the dose administered is larger than that now considered necessary, itisa very small dosage i f compared with that used for therapeutic purposes. I t would be our opinion, however, that it would

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James ti. Hill, Assistant tfanager for Operations ORAU NUCLEAR HE DIC I HE SERVICES TO ORHHC As you requested, we have reviewed t h e question o f whether ORAU tkdical should continue t o provide nuclear medicine services t o Oak Ridge Hospital Based on our revielcl we believe that these services areof significant benefit t o the AEC prograrn a t ORAU Medical and rec mend that they be The agrement under which OWU provides nuclear medicine services t o ORHHC began i n August 7970. o r registered a t Oak Ridge Hospital and referred by its Radiolcgy Departrent to the OW ifedfcal Division for specific diagnostic procedures. They are seen by a physician on the :k!dical Divisicn s t a f f who approvss the zd a in is t ration of the radioisotope. interpreted by thz ORkU s t a f f physician and reported to the Hospital's Under this agreetwnt, patients are ??;nittee The 0Et;::C reimburses OWU fcr services rendered in accordane w l t h an estzblished schedule o f fixed charges. This fee schedule i s based on Knoxvi Ile hospital charges for the same servi ces. During FY 1973, OPAU received $3,362 for performin? 7 3 diagnostfc prothe rest being tt;yroid, llver,lung, spleen and bone. Approxiaatcly 5011 o f these procedures wrc brain scaris wl t h Our review has considered three a1 ternatives: 1. OMli continues t o provide nuclear medicine services t o ORHYC, 2. ORAD r;.ould no longer provide t h i s servfce and patients would be 3. * OLW would no lonser provide t h i s service and Oi7iE.?C would develop I t s own nuclear medicine capability. of the serious impact alternative 2 or 3 would have on the AEC

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As you know, OR!W has been a major contributor t o the development o f d i agnos tic radi oi solopes for nuclear medi ci ne. role p1 ayzd by OPJJ Ysdi cal In develop1 ng d i agnos t i c radi oisotoDes and the instrumntati.on development by the AEC programs a t UCLA and Donner Lab, the field of nuclear md icl ne Is today accepted as a separate The AEC program o f developing new and better radioisotopes f o r diagnosis a t OPAU benefits directly from the association with ORf!tIC. By retaining fan i liar it y with the types of clinical problems encountered i n the more usual practlce o f nuclear medicine, the 02AU staff is able to fl nd better ways o f transferring research findings t o practical clinical applications. They also see needs for further practical develommts and can bring their special exner ti seto bear on these problem. ORAU Hedical staff does not "got their hands dirty " with actual routine tech ni qu s they are ata disadvantage in attempting t o Improve these Nedical Hospital does n o t provide this opportunity. We believe therefore that alt tr natives2 and 3 are unacceptable since they both reinove the opportuni ty for OUi U I-??dlcals taff to be involved f n routine diagnostic I t should be noted that the patient load atOFW ' He have found t h a t the association betwen ORAU staff and ORHIK has continued to irr,prove and that th z OR HX staff is, on occasion, referring research patients to ORAU qul t e apart fro3 the dlagnosti c service. . t4oreover, certain patients fotlnd by the diagnostic service which are of special research interest have, with the approval of the referrfng physi ci an, been transferred toOXU !!edi cal. provltiing the dfagnostic servic9 to O!W-;C, this source o f patient materizl would be lost as wc!11 as the spirit of cooperation v:hic!! has tsken years Should OR4U Fkdi cal cease Additionally, since the diagnostic service saw 73 patients ir: FY 1973, itis unreasonable t o expect OKL ; ' Xto add a nuclear medicdne facility costins $1OOi: o r more. Since OXU uses the Oi WtC for radiology, itIs hoped that rather than duplicating a facility which exists at 0V.U the hospital would use i ts limited resources t o upgrade i t s X-ray faci 1i ties. Such an arrangezcnt would allo:.~ORAU patients t o receive the latest in radiologic procedures, just as the ORX today receives the latest nuclear mpdicino procedures. a radiologist for OZ iU on the basis of ti-ic shared servlces arrangement Itis worth noting that DEER has not approved

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Finally, from a comnunl t y and hospltal relatlons standpolnt, dtscontin u ing our servtc2 would have a drastically negative lnoact. patlents for the hospital would have t o travel t o Knoxville for this service which i s neither as convenient nor as prompt. I n our hospital relatlons, It is qu lte possible ORAU may be requesting additlonal sew1 ces f roc1 the hospi tal. o r assumption of pat imt care ser vlc es by the hosoital to relieve our ORAU h i g h in-pattent cost problem. Denial of the subject services by ORAU would be astep backward I n our cooperative programs. Conceivably this could i nclude c0;nbi natlon I n conclusion, we feel ORAU services t o the Oak Ridge Hospl tal are hl gh ly beneficial t o our AEC and NCI program activity and should be continued. We understand the hospf t a l 4s developlng a renewal agreement, and we plan t o endorse It, unless you advise t o the contrary. Research and Technical Support Division

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ATOM I C ENERGY COMM I SSlON OAK RIDGE OPERATIONS Oak Ridge Associated Universities Post Office Box 117 Oak Ridge, Tennessee INVESTIGATION OF l3II INCIDENT OF SEPTEMBER 4, 1973 The subdect incident involving the administration t o two patients of l3lI i n excess of prescribed quantities for diagnostic purposes points out a need for reevaluation of ORALJ'S internal procedures and controls i n such matters. Hence, we have determined that a ford investigation should be undertaken t o obtain pertinent infornation which may be instrumental inthe prevention of future occurrences of this nature. The following individuals a r e hereby appointed t o serve on the investiga tion committee: Mr. Kenneth D. McCasland of our Chief Counsel's o f f i c e has been assigned toact as legal advisor tothe committee. The committee shall follow the guidance of AEC and OR Manual Chapters 0502 in investigating t h i s incident, A report of findings and recommendations i s expected by October 30, 1973. Your cooperation in this investigation wi.U be appreciated.

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AEC INVESTIGATION OF IODINE-131 MISADMINISTRATION MEDICAL DIVISION, O A K RIDGE ASSOCIATED UNIVERSITIES

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Introduction and Summary .............1 General Descri pti on ...............1 Discussion o f the Incident ............2 Chronology of Events ..............2 Signatures o f the Investigating Committee ....6

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Introduction and Sumnary On September 4 , 1973, two female patients inadvertently received 284 micro curies of iodine-131 for thyroid uptake and scan studies at the Medi cal Division, Oak R i dge Associ ated Uni versi ti es. iodine-131 i s approximately ten times the currently used dose (30 micro curies)given for thyroid studies at ORAU. was discovered on September 5, and the patients and their private physicians were informed of the occurrence on September 6. The ORAU physician advised the patients that the radiation received from this dose does not pose any risk of demonstrable injury or illness. mis administration resulted from an arithmetic error made by a technician in calculating the volumes of the liquid doses. The patients were referred to the Medical Division, ORAU, by the Oak Ridge Hospital of the Methodist Church, with which the ORAU has cooperative arrangements to pro vi de nuclear medi c i ne servi ces . The mis administration Following a preliminary investigation of the facts,the Assistant Manager for Operations, Oak Ridge Operations Office, appointed a committee t o conduct a formal investigation of the incident. The members of the commi ttee are: This document presents the formal report of the committee. The Medical Division, Oak Ridge Associated Universities (MD-ORAU), occupies AEC-owned faci 1it ies in Oak Ridge, Tennessee, under Contract No. AT-(40-l)-Gen-33 with the AEC, t o perform basic and clinical research in nuclear medi cine. Hospital of the Methodist Church (ORHMC), approved by the AEC, the MD-ORAU performs various nuclear medicine services on a full cost recovery basis when s o requested by the ORHMC. Under cooperative arrangements with the Oak Ridge The ORHMC referred two patients to the MD-ORAU on September 4 , 1973, and requested that thyroid uptake and scan studies be performed. administration of iodine - 131for thyroid uptake and scanning is along standing fully established procedure in clinical nuclear medicine. Such studies have been performed atthe MD-ORAU since the early 1950's.

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In brief,routi ne io d i ne- 131 thyroid uptake and scan studies conducted atthe MD-ORAU consist of the following procedures: 1. Oral administration of iodine - 131in liquid or capsule form. 2.Radioactivity counts over the thyroid gland at4, 24, and 4 8 hours f ol 1owi ng admi nist rat i on of the i odi ne- 131 t o determi ne the percent of administered dose of iodine - 131 taken up by the thyroid. 3. Radioactivity scanning over the thyroid gland at24 hours following administration of the iodine - 131.This provides a visual printout (picture)of the radioactivity contained i n the thyroid. 4. Following completion o f these procedures, the results are compiled and given to a qualified physician for interpretation. The physician interviews and examines the patient and provides a written report of the test results and his interpretation to the referring physician Discussion of the Incident 1. Events Preceding September 4, 1973 Telephone comnuni cations between the Radiology Department ofthe ORHMC and the Clinical Research and Nuclear Medicine Section of the MD-ORAU were made to request the thyroid uptake and scan studies on the two patients and toset up mutually acceptable appointments. These actions were followed up with a written the ORHMC and forwarded t o MD-ORAU. an MD-ORAU physician reviews the request and prescribes the radio i sotopes ,activity, and r e 1ated procedures in dic a ted,via a "Dose Information Form", which is sent to the radio pharmaceutical secti on. This section prepares the radioisotopes as prescribed and coordinates with the nursing staff and other support staff t o accomplish the requested tests. Upon receipt of this request, In this case, the MD-ORAU physician prescribed the standard dose of iodine - 131 (30 micro curies)for a routine thyroid uptake and scan study for each of the two female patients given appointments

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2. Events on September 4, 1973 Patients One and Two arrived a t the MD-ORAU around 8:OO a.m. for the scheduled thyroid tests. Employee A prepared the iodine-131 solutions for the two patients. The iodine-131 doses are usually administered t o the patients in the form o f precalibrated capsules. On this occasion there were no 1 3 1 1 capsules available i n the MD-ORAU, so Employee A proceeded t o prepare the two doses and a third dose for use …