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AEOD Office for Analysis and Evaluation of Operational Data 1988 Annual Report.Nonreactors
	ML20247D683
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Issue date:	06/30/1989
From:	; NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
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References
	NUREG-1272, NUREG-1272-V03-N02, NUREG-1272-V3-N2, NUDOCS 8907250276
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7 AVAILABILITY NOTICE j Availability of Reference Materials Cited in NRC Publications Most documents cited in NRC publications will be available from one of the following sources: 1. The NRC Public Document Room, 2120 L Street, NW, Lower Level, Washington, DC 20555 2. The Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, j Washington, DC 20013-7082 i 3. The National Technical information Service, Springfield, VA 22161 Although the listing that follows represents the majority of documents cited in NRC publica-tions, it is not intended to be exhaustive. Referenced documents available for inspection and copying for a fee from the NHC Public Document Room include NRC correspondence and internal NRC memoranda; NRC Office of Ir.nection and Enforcement bulletins, circulars, information notices, inspection and investi-gation notices; Licensee Event Reports; vendor reports and correspondence; Commission papers; and applicant and licensee documents and correspondence. The following documents in the NUREG series are available for purchase from the GPO Sales Program: formal NRC staff and contractor reports, NRC-sponsored conference proceed-ings, and NRC booklets and brochures. Also available are Regulatory Guides, NRC regula-tions in the Code of Federal Regulations, and Nuclear Regulatory Commission issuances. Documents available from the National Technical information Service include NUREG series reports and technical reports prepared by other federal agencies and reports prepared by the Atomic Energy Commission, forerunner agency to the Nuclear Regulatory Commission. Documents available from public and special technical libraries include all open literature items, such as books, Journal and periodical articles, and transactions. Federal Register notices, federal and state legislation, and congressional reports can usually be obtained from these libraries. Documents such as theses, dissertations, foreign reports and translations, and non-NRC conference proceedings are available for purchase from the organization sponsoring the publication cited Single copies of NRC draft reports are available free, to the extent of supply, upon written request to the ~ Office of Information Resources Management, Distribution Section, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Copies of industry codes and standards used in a substantive manrier in the NRC regulatory process are maintained at the NRC Library, 7920 Norfolk Avenue, Bethesda, Maryland, and are available there for reference use by the public. Codes and standards are usually copy-righted and may be purchased from the originating organization or, if they are American National Standards, from the American National Standards Institute,1430 Broadway, New York, NY 10018.

NUREG-1272 Vol. 3, No. 2 AEOD OFFICE FOR ANALYSIS AND EVALUATION OF OPERATIONAL DATA l 1988 ANNUAL REPORT l NONREACTORS l JUNE 1989 1

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Previous Reports in Series The following semiannual or annual reports have been prepared by the Office for Analysis and Evaluation of Opera-tional Data (AEOD): Semiannual Report, January-June 1984, AEOD/S405, September 1984 + Semiannual Report, July-December 1984, AEOD/S502, April 1985 Annual Report 1985, AEOD/S601, April 1986 Report to the U.S. Nuclear Regulatory Commission on Analysis and Evaluation of Operationa! Data-1986, NUREG-1272, AEOD/S701, May 1989 - Report to the U.S. Nuclear Regulatory Commission on Analysis and Evaluation of Operational Data-1987, Power Reactors NUREG-1272, AEOD/S804, Vol. 2, No.1, October 1983 Report to the U.S. Nuclear Regulatory Commission on Analysis and Evaluation of Operational Data-1987, Non-reactors, NUREG-1272, AEOD/S804, Vol. 2, No. 2, October 1988 4

Abstract 'Ihe annual report of the U.S. Nuclear Regulatory findings and issues identified in AEOD studies over the Commission's Office for Analysis and Evaluation of past year and summarizes information from Licensee Operational Data (AEOD)is devoted to the activities Event Reports, Diagnostic Evaluations, and reports to performed during 1988. The report is published in two the NRC's Operations Center. NUREG-1272, Vol. 3, separate parts. NUREG-1272, Vol. 3. No.1, covers No. 2, covers Nonreactors and presents a review of th: Power Reactors and presents an overview of the oper-nonreactor events and misadministration that were ating experience of the raclear power industry, includ-reported in 1988 and a brief synopsis of AEOD studies ing comments about th .nds of some key perform-published in 1988. Each volume contains a list of the ance measures. The njrt also includes the principal AEOD reports issued for 1980-1988. l i iii NUREG-1272

Contents Abstract...................................iii 2.1.2 Medical Misadministration.............. 5 Abbrevia tions............................... vii 2.1.2.1 Misadministntions Reported during 1988. 6 Executive Summary..................... .. ix 2.1.2.1.1 Therapy Mt 1 ministrations........... 6 1 Introduction.............................. 1 2.1.2.1.2 Diagnostic Misadministration......... 7 2 Feedback from Nonreactor Licensee 2.1.2.1.3 Diagnostic Misadministration of Iodine. 7 Operational Experience................. 3 2.i.2.2 Misadministration Reported for 2.1 Overview of Operating E,xperience......... 3 1981-1988........................... 7 2.1.1 Nonreactor Events...................... 3 2.2 Reporting of Abnormal Occurrences....... 8 2.1.1.1 Events Reported during 1988.......... 3 2.3 Results of Selected AEOD Studies.......... 9 2.1.1.2 Radiation Overexposure Events........ 4 2.4 Selected Ongoing Technical Studies........ 9 2.1.1.3 Other 'lypes of Events.............. 5 3 S u mma ry.............................. 11 Appendices A Report on 1988 Nonreactor Events D Reports Issued from 1981 through 1988 11 Medical Misadministration Report E Status of AEOD Recommendations C Summary of 1988 Abnormal Occurrences Tables 1 'lypes of Licensees that Submitted 3 Error Rate for Misadministration (Based on honreactor Reports during 1988......... 3 aggregated eight-year data)......... '..... 6 2 Categorization of Reports of Nonreactor Events that Were Reported during 1988...... 4 4 Misadministration Reports for 1981-1988... 8 1 1 I I y NUREG-1272

Abbreviations AO abnormal occurrence IND investigational exemption for a new drug AEOD NRC's Office for Analysis and Evaluation of MPC maximum permissible concentration Operational Data 3M Minnesota Mining and Manufacturing ACC As.hland Chemical Company Company CAL Confirmatory Action 1.xtter NRC U.S. Nuclear Regulatory Commission DOE Department of Energy NRER Nonreactor Event Report FDA U.S. Food and Drug Administration SNM special nuclear material GA General Atomics WESF Waste Encapsulation Storage Facility vii NUREG-1272

Executive Summary One of the activities of the Office for Analysis and The first nonreactor event involved a leaking Evaluation of Operational Data (AEOD)is the review polonium-210 source in a static elimination device that and evaluation of operating experience of nonreactor resulted in some product contamination. Investigation programs invohing the use of materials licensed by the of the event involved all regions of the NRC, U.S. Nuclear Regulatory Commission (NRC), such as Agreement States and Non-Agreement States, and the source material, natural and enriched uranium, and Food and Drug Administration. No contamination of byproduct materials.The AEOD review and evaluation any food, pharmaceutical, or cosmetic product was identifies safety significant events and concerns, their found during the investigation. As a result of this causes, and the trends indicated by the events. When investigation, essentially all devices similar to the one AEOD identifies a safety concern, the AEOD staff that was found to be leaking were withdrawn from use. recommends agency actions to resolve the problem underlying the safety concern. The second nonreactor event occurred in June 1988. A cesium-137 source capsule leased from the Department Approximately 8,000 licensees are authorized by NRC of Energy (DOE) for use in an irradiator in Georgia, an to possess and use licensed materials outside of Agreement State, was found to be leaking. As a result reactors. The majority of licensees (more than 5,000) of the leak, an irradia!2r in Ohio, licensed by the NRC, are authorized to use byproduct materials for such has removed all similar cesium capsules from use and is applications as radiography, gauges, and well logging. in the process of returning them to DOE. Approximately 2,400 licensees are authorized to administer byproduct materials or radiation from The remaining nonreactor events reported to NRC did byproduct materials to individuals for medical diagnosis n t have any reported effect on the public health and or therapy. safety. NRC received reports of 12 therapy misadministration The dominant health concern associated with the use of in 1988. Five of the misadministration involved licensed materials is the possible damage that can occur teletherapy, five involved brachytherapy, and two from overexposure to radiation. In 1988,16 nonreactor involved radiopharmaceutical therapy, Of the total of events were reported to NRC in which 17 individuals 405 reports received during 1988, which involved 470 received exposures that were greater than those patients,393 reports concerned diagnostic permitted by NRC regulations. All of the individuals misadministration. In addition, there were seven were employees of licensees. misadministration of iodine-131 in 1988, but none of these involved millicurie dosages. ne error rate for Two nonreactor events reported to NRC in 1988 therapy and diagnostic misadministration reported for affected industry, although neither event had any 1988 is about 0.0001 per patient, the same as in the known significant effect on public health and safety. previous seven years. l 1 l [ ix NUREG-1272

1 Introduction NRC's Office for Analysis and Evaluation of Opera-received annually, or about 4 events per 100 licensees. l l tional Data (AEOD) was established in 1979, as one of Similarly, the 2,400 medical licensees report about 400 l the Comniission's earliest major steps toward improving misadministration annually or about 16 events per 100 l the use of licensee operating experience to identify and licensees. Oenerally, these licensed programs have resolve problems with potential safety-related implica-little impact on public health and safety. tions. AEOD, which reports directly to the Executive Director for Operations, is dedicated to the collection Role of AEOD and assessment of operational data and its feedback to licensees, regulators, and the public. The focus and role of AEOu in the regulatory p vcess is to provide a capability for the timely analysis of 'I he NRC licenses the use of reactor-produced iso-operating experience, independent of the routine topes, milling of uranium, and subsequent processing of regulatory activities associated with licensing, inspec-either natural or enriched uranium and special nuclear tion, or enforcement, and to feed back the lessons material (SNM). Certain states, referred to as Agree, learned to the appropriate offices of the NRC, the ment States, have the authority to regulate the posses, affected portions of the,ndustry, and the pubhc. i sion and use of these materials, except for the posses. AEOD accomplishes this through the analysis and sion and use of large amounts of enriched uranium or evaluation of opc"sonal safety data assouated with SNM. the use of radioactive materials m nonreactor applica-tions. AEOD publishes studies of specific operational events and, as appropriate, recommends agency actions The NRC has approximately 8,000 licensees authorized to reduce the probability of the recurrence or occur-to possess and use natural uranium and SNM (predomi-rence of the event, nantly in support of the reactor fuel cycle) and byproduct materials of SNM. Of these licensees, about AEOD tracks the recommendations contained in its 3,000 are authorized to use byproduct materials for studies until they are resolved. The recommendations such applications as radiography, gauges, and well are for internal action by the appropriate NRC pro-logging. About 2,400 medical licensees are authorized gram office or regional office. The office to which the to admmister byproduct materials or radiatton from recommendation is addressed is responsible for review-these materials to individuals for medical diagnosis or ing and implementing the recommendation as therapy. A relatively small number of licensees use appropriate. uranium or SNM in fuel cycle operations. AEOD stays aware of studies undertaken by other NRC nonreactor licensees are required to report organizations within NRC and normally will not dupli-events such as an event in which there is a personnel cate a study unless a particular need or special circum-overexposure (10 CFR 20.405(a)), a leaking or contami-stance exists.Thus, the nonreactor staff of AEOD does nated source (10 CFR 34.25,10 CFR 35.14); release of not review in depth all events or operating problems. material (10 CFR 20.405(a)); lost or stolen materials (10 CFR 20.402); or abandoned well logging sources AEOD also coordinates the overall.NRC operational (10 CFR 39.77). Events may also be reported as re-data program and serves as the focal point for interac-quired by a license condition or may be included in an tion with outside and foreign organizations performing inspection report. About 200 reports of such events are similar work. i NUREG-127,2, Section 1

2 Feedback from Nonreactor Licensee Operational Experience i 1 During 1988, the NRC received reports of a large num. ment system provides for input, storage, retrieval, and ber of events that involved NRC and Agreement computer-assisted analyses of operational event data; States. This section provides an overview and summary the system may be used to identify trends in opera-of reported events involving nonreactor facilities and tional safety events that may signal a need for remedial medical misadministration that were received in 1988. actions by the NRC, licensees, or both. Generally, events reported by Agreement State licen-sees are not included in this report unless the event has 2.1.1.1 Events Reported during 1988 been published in a Preliminary Notice of Occurrence The NRER database m. eludes 199 records of events by one of the NRC's regional offices. A report on the events reported by Agreement States will be published that were entered during 1988. Information on these separately. events was contamed in reports submitted by NRC h-censees to the regional offices or m other documents, 2.1 Overview of O EratinE primarily repons of inspections conducted by NRC. E .The NRER database does not mclude mformation from Fxperience reports of medical misadministration. See Section 2.1.2, " Medical Misadministration." for a discussion of 2.1.1 Nonreactor Events these data for 1988. The AEOD Nonte tetor Event Report (NRER) data. Table 1 provides information on the types of licensees base contains information on licensed nuclear materials for which information was entered into the database, and fuel cycle operational events and on personnct ra-Tat 9 3 "r idr 'nformation on how the reports for diation exposure events. 'lhe NRER database manage-nonreactos mnts were categorized. Table 1 Types of Licensees that Submitted Nonreactor Reports during 1988 No.of Reports Type of Licensee Received

Acad e m ic...........................................

3 M ed ical............................................. 34 Commercial and industrial measuring system................ 57 We ll-logging.................................... 26 Other measuring system.......................... 31 Manufacturing and distribution (excluding medical).......... " 11 Industrial radiography 11 Fixed sit e...................................... 1 M ultiple h> cations (field)......................... 10 Irradiator............................................. 5 Research and development....... 23 Sou rce ma t e rials " *..................................... 5 Mills.......................................... O U Fo facilit ies.........................,......... 2 Ottter......................................... 3 Special nuclear material (including plutonium).............. 20 Agreem en t Stat e....................................... 4 Other............................................... . "2f2 Total........................................... 199

Medical misadministration reports are not included.

"nese numbers represent reports that were received by NRC; these numbers would be significantly higher if all lost or lealting static elimination devices had been reported (we Section 2.1.1.3). "* Routine environmental effluent release reports. e.g.. reports reqmred by 10 CFR 40.65 and 10 CFR 70.59. were not included in the totals for sourec materials and special nuckar nuterials licensees. 3 NUREG-1272, Section 2

.1 -l AEOD Annual Report,1988 Table 2 Categorization of Reports of Nonreactor Events that Were Reported during 1988 No. of Category

Associated Reports Personnel radiation exposures.....................................

39 Imst, abandoned, and stolen material.............................. " 81 leaking sources................................................. " 15 Release of material............................................. 22 Con su m er prod u cts............................................. 2 Fuel cycle (e.g., mills, UFe facilities, special nuclear material)........... 14 I nd ustrial radiography............................................ 13 Manufacturing and distribution (including medical).................. 19 Commercial and industrial measuring systems (excluding well logging)... 31 Other"*....................................................... fil Total............ 303

An NRER database record may be associated with more than one category of event. For example. a report from a radiography licensee concerning a personnel radiation exposure would be counted in the total number of radiation exposure events as well as in the total number of events involving radi-ography.

"These numbers would be significantly higher if all lost or leaking static elimination devices had been reported (see Section 2.1.t.3). "*"Other" includes categories such as medical. transportation, and miscellaneous. 2.1.1.2 Radiation Overexposure Events Radiography The three radiography exposures (three individuals) involved whole body exposures of licensee personnel of The non:cactor database conta.ms information on 39 6.1,4.47, and 1.3 rem. respectively. The individual who events for which there was the potential for or an ac-received 6.1 rem also received an extremity exposure of tual rndiation overexposure in 1988. Of the 39 cvents, 118 rem. 16 inva!ved aviual overexposure, The types of licen. sees asmciated with the 16 actual overexposure events CommercialandIndustrial reported during 1988 follow: The three reports of exposures (three individuals) from commercial and industrial licensees involved licensee Medical and Academic 6 personnel. The exposures include a whole body expo- ] sure of 3.64 rem; a dose commitment of 5.29 rem from Radiography 3 Commercial and Industrial 3 tritium uptake; and an extremity exposure of 21.7 rem, Fuel Cycle 1 respectively. Other 3 Fuel Cycle In-vivo lung counting showed that one employee at a Medicaland Academic fuel cycle facility received an exposure that exceeded the quarterly limit of 520 hours exposure at the MPC. l The six reports of exposures (six individuals) from I medical and academic licensees involved licensee per-The reports of three events (four individuals)in this j sonnel. The exposures include a thyroid exposure from category involved licensee personnel. One person iodine-125 that exceeded the quarterly limit of 520 received an exposure of about twice the quarterly limit hours exposure at the maximum permissible concentra. from americium-241 uptake (1986 Ment); another tion (MPC); two whole body exposures of 1.63 and 1.26 person received a whole body dose of 9.09 rem; and rem per quarter; and three extremity exposures of each of two persons received an extremity dose of 58 18.75. 35.15, and 61.31 rem. respectively. rad. NURIL1272, Section 2 4

Nonreactors-Operational Experience 2.1.1.3 Other Types of Events On July 18,1988,3M requested the continuation ofits authority under license to manufacture static climina-The Nonreactor Assessment Staff reviewed other tion devices for research and development purposes, classes of event reports: lost or stolen sources, aban. but not for distribution. 'lhis licensee,3M, r.eported to doned sources, leaking or contaminated sources, con. NRC that, as of August 5,1988, a total of more than sumer products, fuel cycle facility events, industrial ra. 47,000 devices (about 86 percent of those distributed) diography, manufacturing and distribution, and gauges had been returned; of this total, about 1.8 percent had and measuring systems. The events in these categories removable contamination that exceeded 0.005 micro-did not have any reported effect on public health and curie. Of the devices used in the food, beverage, cos-safety. metic, and radiopharmaceutical industries, about 4.7 percent had removable contamination that exceeded 0.005 microcurie. About 97 pement of the devices used There were two significant events m 1988 m. which in these industrics had been returned. there was a release of materials-Ashland Chemical Company (ACC), a general licensee, reported that in October 1988, information from 3M indicated that there had been significant alpha contamination at its about 800 devices could not be located, i.e., these de-Easton, Pennsylvania, facility from a Minnesota Mining vices were considered to be lost. and Manufacturing Company's (3M) static climinator; and Radiation Sterilizers, a Georgia licensec, reported The data on both the fraction of sources that had re-that a cesium source used in its irradiator had leaked movable contammation m excess of 0.005 microcurie and contaminated the irradiator pool water. (i.e., sources that were considered to be leaking) and the number of lost sources indicate that there was sub-stantial underreporting of contaminated and lost static On January 22,1988, ACC reported that there was al-elimination devices. pha contamination at its Easton, Pennsylvania, plant and, on January 23 and 24, a similar alpha contamina-A report, failure Im'estigation of 3M Series 900 Static tion was determined to be present at its Dallas, Texas, Elimination Devic es, NUREG/CR-5145, was published plant. Six of twelve 3M static elimination air guns at in July 1988. l Dallas showed evidence of leakage.1he original con-tamination had been discovered when a customer of On June 7,1988 cesium-137 contamination was de-ACC inquired about possible contamination of one of tected in the water shielding of Radiation Sterilizer's its products. On January 22, NRC inspectors confirmed Georgia irradiator. The contamination was determined the presence of contamination at Easton. to be caused by leakage from Waste Encapsulation Storage Facility (WESF) capsules, leased from the De-partment of Energy (DOE), that were located in the On January 25,1988, NRC issued an Order requiring 3M to suspend distribution of compressed-air static water pool at the irradiator. As a result of the leakage, on July 29, NRC sent a Confirmatory Action Letter to chmmators and to delme the scope of the problem. an irradiator owned by Radiation Sterilizers in Wester-Inspection of 3M's static climinator program identified numerous failures of compressed-air and other types of ville, Ohio. The Order required the licensee to suspend use of the WESF capsules. The licensee is in the proc-static chmmation devices. Many of the failures appar-ess of returning all of the cesium capsules to DOE. The ently occurred in environments that are typical of the root cause of the leakage has not yet been determined. workplace in and the processes for which these devices are used. Several additional Orders were issued, culmi-2.1.2 Medical Misadministration nating in a February 18,1988, Order requiring suspen-sion of distribution and a recall of essentially all 3M 1he NRC regulates certain aspects of the uses of reac-polonium-210 climinator devices. tor-produced radioisotopes in nuclear medicine and therapeutic radiology. Certain diagnostic and therapy misadministration are reported to NRC pursuant to For several months following the initial discovenes of the requirements in 10 CFR 35 2 and 10 CFR 35.33. problems with static climmators, staff in all NRC re-Diagnostic misadministration, as used in NRC regula-gion;d offices, Agreement States, Non-Agreement tions, refers to the misadministration of radioisotopes l States, the Office of Nuclear Materials Safety and Safe-in nuclear medicine studies such as liver sezms and bone guards, and the U.S. Food and Drug Administration scans. Therapy misadministration, as used in NRC (FDA) conducted surveys of selected general licensee regulations, refers to the misadministration of radiation facilitics to evaluate the extent of the prob!cm with the from cobalt-60 teletherapy or radioisotopes used for static eliminators. The FDA found no evidence of prod-radiation therapy. uct contammation in any of the 320 sites associated with the food, beverage pharmaceutical. medical de-Over the last eight years (1981-1988), medical facilitics vice, and cosmetic applications that they visited, licensed by NRC to use radioisotopes in nuclear medi-5 NUREG-1272, Section 2

AEOD Annual Report,1988 cine and radiotherapy for humans have been required However, for therapy misadministration, causes of the to report misadministration. During that period, licen-misadministration have varied somewhat from year to sees have reported 64 misadministration involving year. Most of the events, however, might have been therapy procedures and 3,216 misadministration in-avoided through the implementation of revised or new volving diagnostic procedures. The NRC estimates, quality assurance procedures. based on statistics from the " Patterns of Care"' study of the American College of Radiology, that approxi-For diagnostic misadministration, the causes have es-mately 350,000 therapies requiring the use of sentially been the same over time. Overall the data do teletherapy machines would have been performed by not show a discernible trend. Relatively simple proce-NRC-licensed facilities during thc eight-year period. dures, such as checking the patient's identification There were 36 reported teletherapy misadministration against the procedure and asking the patient to state that involved 108 patients over the same period; these his or her name, might reduce the frequency of these represent an error rate of 0.0003 per patient. diagnostic misadministration. From data in a recent study by the Technologist Section In general, the low error rates calculated from reported data on misadmmistrations indicate that most hcensed of the Society of Nuclear Medicine, the NRC estimates that about 32 million diagnostic procedures would have programs are operated in a way that mmimtzes misad-mmistrations. been performed at NRC-licensed facilities during the same eight-year period, giving an error rate of 0.0001 2.1.2.1 Misadministration Reported during 1988 error per procedure.2 Table 3 gives estimates of error rates for the various types of therapy procedures and For 1988,344 of the approximately 2,400 NRC licen-for diagnostic procedures. sees authorized to perform nuclear medicine studies or radiation therapy reported one or more misadministra-Therapy misadministration are associated with proce-tions, a total of 405 reports involving 470 patients. Of dures in which large doses of radiation are administered the 405 reports of misadministration for 1988,393 to patients to achieve a therapeutic effect. Diagnostic concerned diagnostic misadministraties, and 12 con-misadministration are associated with procedures de-cerned therapy misadministration. signed to permit a diagnosis to be made with little ex-posure to the patient. An exception to the usual diag-2.1.2.1.1 Therapy Misadministration nostic administration procedure is the use of iodine-131 for diagnostic procedures that may deliver thyroid or Twelve therapy misadministration were reported in other organ doses of several hundred to several thou-1988. Five of the misadministration involved sand rad. teletherapy; five involved brachytherapy; and two in-volved radiopharmaceutical therapy. AEOD's annual review of data on misadministration has indicated that the number of events reported for Two of the teletherapy misadministration involved a therapy and diagnostic misadministration shows no transcription error of the prescribed dose; one involved significant change with time. an error in the formula incorporated into the hospital's Table 3 Error Rate for Misadministration (Based on aggregated eight year data) i NRC Estimate No. of No. of Patient Type of No.of Studies Events Patients Error Rate Thera Tele herapy 352.000 36 108 0.0003 Brachytherapy 176,000 17 17 0.0001 Radiopharmaceutical 105,000 11 11 0.0001 Diagnostic 32,000,000 3216 3577 0.0001 8"Iluman Resources Survey of Nuclear Medicine Technologists- 'Kramer. S., llanks. G. II., and Diamond, J. J.,

Summary Results 1984." prepared by the iluman Resource Task Force of the Tech-from Fourth Facihties Master list Survey Conducted by Patterns of nologist Section.*Ihe Society of Nuclear Medicine,lournalof Nu.

Care Study." Int. / Radiat. Oncol. tho!. Phys 9.12,1983. c/ car Medicine Technology, Vol.13, No. 3 September 1985. NUREG-1272, Section 2 6

Nonreactors-Operational Experience treatment planning computer; one involved an error in more detail in Section 2.1.2.1.3, " Diagnostic Misad-the prescribed anatomical treatment area; and the last ministrations of Iodine." resulted from an error in calculating the exposure time. It should be noted that the reporting requirements for diagnostic misadrninistrations were changed to incorpo-Two of the five 1988 brachytherapy misadministration rate a change m the threshold for reporting. In accor-resulted from an inadvertent selection of a source con-dance with the new requirements of 10 CFR 35.33, di-taining the wrong amount of radioactive material by agn stic misadmimstrations occurring after April 1, personnel involved in the brachytherapy treatment; two 1987, need be reported only if-other brachytl.crapy misadministration involved the the misadministration involved the use of ra-use of inadequate procedures for loading brachytherapy sources into the applicator; and the last resulted from dioactive material not intended for medical the use of the wrong chart to compute the treatment

use, se.

the administered dose was fivefold different from the prescribed dosage, or One of the two radiopharmaceutical therapy misad-the patient was likely to receive an organ dose ministrations involved an error in the calculation of the dosage to be administered and the other resulted from greater than 2 rem or a whole body dose inadequate assay of the dosage in the dose calibrator. greater than 500 mrem, Even with the change in reporting requirements for AEOD believes that these therapy misadministration diagnostic misadministration, the number of misad-might have been prevented if licensees had been fol-ministrations reported in 1988 was not significantly dif-lowing their aircady established quality assurance pro-ferent from the average number reported in previous cedures or had improved their existing quality assur-years. Since at least one organ dose for most commonly ance procedures. used radiopharmaceuticals is about 2 rem, and a misad-ministration that results in any organ dose of 2 rem is 2.1.2.1.2 Diagnostic Misadministration reportable, most of the misadministration continue to be reportable. As in previous years, essentially all of the diagnostic reiisadministrations for 1988 involved either the admini-As was noted earlier, relatively simple quality assurance stration of the wrong radiopharmaceutical or the ad-procedures, such as checking the patient's identification ministration of a radiopharmaceutical to the wrong pa- "E.mst the study and the patient's medical history or tient. The number, type, and cause of diagnostic misad-askmg the patient to state his or her name, might re-ministrations are about the same as for those reported duce the frequency of events involving adtmmstration in 1987. The causes reported by licensees are generally of the wrong radiopharmaceutical or admmistering a the same as those reported in the past, i.e., simpic er-procedure to the wrong patient. rors associated with (1) preparation of radiophar-iagnostic Misadm.. trations ofIod.ine 2.1.2.1.3 D. sms maceuticals, (2) pro:essing nuclear medicine requisi-tions, and (3) patient identification. Seven of the diagnostic misadministration reported to the NRC in 1988 involved the administration of Of the 393 reports of diagnostic misadministration iodine-131 in amounts that resulted in the delivery of received in 1988,292 involved the administration of the patient organ doses that ranged from 2 rad to 440 rad. wrong radiopharmaceutical to a patient and 85 involved Causes of these misadministration included (1) failure the administration of a radiopharmaccutical to the to verify patient identification;(2) mix-up of radiophar-wrong patient (these two types of misdaministrations maceutical labels; (3) misunderstanding a physician's accounted for % percent of the reported misad-order; and, (4) unfamiliarity of hospital personnel with ministrations). 'Ihc remaining diagnostic misadministra-infrequently performed iodine-131 procedures. tions included six that involved the wrong route of ad-ministration (i.e., a toute of administration other than 2.1.2.2 Misadministration Reported for 1981-1988 that intended by the prescribing physician) and ten that involved a diagnostic dose of a radiopharmaceutical Table 4 shows the number of misadministration reports that differed from the prescribed dose by gream than received in 1988 and those received in previous years. 30 percent. Of the 393 reports of diagnostic mirad-It also lists the number of reports, the number of pa-ministrations, seven involved the misadministration of tients, and the number of licensees reporting misad-iodine-131. 'Ihese misadministration are discussed in ministrations. 7 NUREG-1272. Section 2

AEOD Annual RepoW,1988 3 Table 4 Misadministration Reports for 1981-1988 l 1981 1982 1983 1984 1985 1986 1987 1988 Therapy misadministration 10 4 4 14 4 7 9 12 Diagnostic misadministration 2 3 2 3 3 5 5 7 (involving Iodine-131) Diagnostic misadministration 428 414 332 395 377 433 409 386 (other) No. of patients 517 451 437 442 410 495 459 470 No. of licensees reporting 351 355 293 318 293 369 348 344 For 1981 through 1988, licensees reported 64 therapy 'Ihere has not been a substantial change in the number, misadministration to the NRC, or an average of 8 type, or cause of any of the types,of medical misadmin-therapy misadministration per year. Over the eight-is! rations reported to the NRC over the eight year pe-year period,36 of these therapy misadministration in-ricd that reporting requirements have been in eff ect. volved teletherapy,17 involved brachytherapy, and 11 Essentially all of the misadministration resulted from involved radiopharmaceutical therapy. The dominant human error. causes for the teletherapy misadministration were dose calculation errors and misreading or misunderstanding 2.2 Reporting of Abnormal Occur-therapy presenptions or orders. The dominant causes of the brachytherapy misadministration were errors in renceS dose calculation and use of the wrong activity sources. The 11 radiopharmaceutical therapy misadministration AEOD prepares the quarterly Abnormal Occurrence were predominantly caused by failure to assay doses (AO) Report to Congress and the associated Federal before administering them or the use of the wrong Register notices, and, after staff coordination, sends form of the radiopharmaceutical. In general, the causes them to the Executive Director for Operations and, of all of the therapy misadministration were human subsequently, to the Commission for review and ap-crrors involving dose calculations, patient set-up or proval. An AO may be an individual incident, a recur-treatment, and patient identification. ring event, a generic concern, or a series of incidents that the Commission determines is significant from the The NRC received an average of 400 diagnostic misad. standpoint of public health or safety, ministration reports annually from 1981 through 1988; q the number ranged from 334 to 438 reports per year, 'there were five nonreactor and eleven medical misad-j The number of reports received annually has not ministration events that werc determined to be AOs in i changed substantially over the eight years. Most (96 1988. Of these, three of the five nonreactor AOs oc- { percent) of the diagnostic misadministration involved curred in NRC-regulated states and two in Agreement j the wrong radiopharmaceutical(administration of a States. Seven of the eleven misadministration AOs pharmaceutical for the wrong study) or the wrong pa-occurred in NRC-regulated states and four in Agree-j tient, with the misadministration stemming from hu-ment States. man error. A summary of 1988 nonreactor and medical misad. In each of the eight years from 1981 through 1988, a ministrat;on AOs (reported by both NRC and Agree-small number of diagnostic misadministration have ment State licensees)is provided in Appendix C to this involved the misadministration of iodine-131. An aver-report (i.e., NUREG-1272, Vol. 3, No. 2, Contractors). age of four such events has been reported annually; the A summary of 1988 AOs at nuclear power plants and range is from two to seven reports per year. A few of research reactors is provided in Appendix B to the these misadministration have involved the administra-companion volume of the AEOD Annual Report (i.e., tion of large amounts of iodine 131. NUREG-1272, Vol. 3, No.1, Power Reactors). NUREG-1272, Section 2 8

Nomcactors-Operational Experience 2.3 Results of Selected AEOD 2.4 Selected Ongoing Technical Studies Studies . Review of Everns at Large Pool-Type Irradiators AEOD is continuing work on the iollowing technical (AEODIS807) studies: 1. Review of nonreactor events in Agreement States, Large pool-type gamma irradiators are used in applica. tions such as the " cold" sterilization of medical and 1981-1987. pharmaceutical supplies. Recent changes in Federal This review will collect data on all nonreactor regulations make it possible to use these irradiators extensively in the preservation of foodstuffs. Because of events reported to Agreement States from 1981 this possible large increase in the use of irradiators, the through 1987, analyze the data, and provide a Office of Nuclear Materials Safety and Safeguards was comparison with events reported in NRC-licensed interested in knowing what events had occurred that

states, I

involved irradiators. He data on these events would be used as background data for developing new regulations 2. Review of therapy misadministration that in-on irradiators. The scope of the study was to assess all volved computers, available operating information on large (greater than or equal to 250,000 euries) pool-type irradiators, ii. This technical review will provide an analysis of censed by both the NRC and the Agreement States, five teletherapy misadministration events in which and events at foreign facilities. In the study, the staff multiple patients received too much or too little found that about 0.12 event has been reported per irra. radiation and for which a computer program was diator-year. Most of the events were precursor events, used. The analysis is directed toward identifying in that there was no evidence of damage to the radioac. the errors that resulted in the misadministration tive sources or major degradation in the xvel of safety and suggesting methods for avoiding such errors. of the facility using the scmrces. Events with more sig-nificant impacts had a reported frequency of about 0.01

3. ' Review of licensee procedures that involved the ~

event per irradiator-year. However, iSe actual rate of use of radioactive iodine. occurrence of events of safety concern e the staff may be higher than these rates indicate because there are This technical review will analyze the use of radio-few specific reporting requirements for events at irra-active iodine for diagnostic and therapy proce-diators. As a result of this study, AEOD suggested that dures that were performed under an Investiga-NRC consider developing a regulation for large pool-tional New Drug Exemption to identify the cause type irradiators that would specify requirements for (1) of the events. (NRC licensees, pursuant to 10 reporting breakdowns in access control systems; (2) pc-CFR Part 35, may use any byproduct material in a riodic inspection of the source movement and suspen-diagnostic radiopharmaceutical or any generator or sion system; (3) systems to detect source leakage and reagent kit for the preparation and diagnostic use product contamination; (4) allowable pool leakage; and of a radiopharmaceutical that contains byproduct (5) feedback of information on operational events in-material for which the FDA has accepted a "No-volving safety-important systems (Le., requirements for tice of Investigational Exemption for a New Drug" reporting of specific events). or approved a "New Drug Application.") Patients involved in these events received unintended thy-A report, Review of Events at Large Pool-Type Irradiators, roid and other organ doses that ranged from a few NUREG-1345, was published in March 1989. hundred to several hundred rad. l l I j 9 NUREG-1272, Section 2

3 Summary The AEOD review of the data on nonreactor events the NRC in 1988 did not show any significant changes and medical misadministration that were reported to from the data reported to the NRC in previous years. 11 NUREG-1272, Section 3

Appendix A Report on 1988 Nonreactor Events ( l

Appendix A AEOD/N901 Report or,1988 Nonreactor Events by the Nonreactor Assessment Staff Office for Analysis and Evaluation of Operational Data Prepared by: Kathleen M. Black 2

Contents 1 Nonreactor Event Report Database......... A-1 2.1.5 Consumer Products................. A-10 2 Review of 1988 Nonreactor Events.......... A-3 2.1.6 Fuel Cycle Facilities................ A-10 l l 2.1 Events that Occurred during 1988......... A-3 2.1.7 Radiography...................... A-11 2.1.1 Radiation Exposures................... A-4 2.1.8 Manufacturing and Distribution........ A-11 2.1.2 Lost, Abandoned, and Sto!en Material... A-6 2.1.9 Gauges and Measuring Systems........ A-11 2.1.3 Leaking or Contaminated Sources...... A-9 2.2 Abnorral Occurrences................ A-14 2.1.4 Release of Materials.................. A-10 3 Fin din gs.............................. A-15 Tables 1 Types of Licensees that Submitted Nonreactor 5 Abandoned Well-Lorging Sources,1988..... A-9 Reports during 1988................... A-3 6 Leaking Sources,1988................... A-10 2 Categorization of Reports of Nonreactor Events that Were Reported during 1988........... A-4 7 Radiography Exposures,1988............. A-12 3 Personnel Radiation Exposures,1988....... A-5 8 Manufacturing and Distribution,1988..... A-12 4 lost or Stolen Sources,1988.............. A-7 9 Gauges and Measuring Systems,1988...... A-13 l i l l A-iii NUREG-1272

I Nonreactor Event Report Database The Nonreactor Event Report (NRER) database for AEOD generally does not incorporate information on the Office for Analysis and Evaluation of Operational transportation events into the NRER database since Data (AEOD) contains information on licensed nuclear the Department of Energy funds a transportation materials and fuel cycle operational events and on incident file, which is maintained by Sandia National personnel radiation exposure events.De NRER data-laboratories. ncir report on Radioactive Material base management systemi provides for input, storage, Transportation Accident / Incident Analysis retrieval, and computer-assisted analyses of operational (SAND-85-1016) 2 contains information about this event data; the system may be used to identify trends in transportation incident file and summarizes data from operational safety events that may signal a need for the file for 1971 through 1985. remedial actions by the NRC, licensees, or both, 'The NRER databue uses the System 1022 database management 8McClure,.I. D., and Tyron-Ilopko, A., Radioactive Material (RAM) system that operates on the Oak Ridge National laboratory DEC Transporarwn Acident/ Incident Analysis (SAND-85-1016), March System-10 computer. 1986. A-1 NUREG-1272, Appendix A

2 Review of 1988 Nonreactor Events 2.1 Events that Occurred during 1988 personnel radiation exposure would be counted in the total number of radiation exposure events as well as in The NlWR database includes 199 records of events the total number of events involving radiography. The that were entered into the database during 1988. Infor. 199 nonreactor licensee reports were cataloged as 303 mation on these events vos contained in reports sub. entries in ten different areas. Note that because some mitted by nonreactor licensees to the regional offices or reports are associated with more than one category of in other documents, primarily reports of inspections event, the total number of events exceeds the total conducted by NitC. The NREll database does not in. number of reports. clude information from certain fuel cycle licensee re-ports, such as those related to routine effluent releases, A report of a contamination event at Ashland Chemical nor does it include information from reports of medical Company (ACC), Easton, Pennsylvania, a general li-misadministration, which are included in Appendix 11 censee, resulted in an investigation of the event and a to this volume of the AEOD Annual Report. Table I recidl of essentially all devices similar to the one that provides information on the types of licensees for which had resulted in contamination at ACC. Data supplied information was entered into the database. by the Minnesota Mining and Manufacturing Company (3M). the manufacturer of the device, shows that a sub-Table 2 provides information on how the reports for stantial number of't!cvices are unaccounted for and nunreactor events were categorized and entered into should be considered " lost," and that a substantial the database. An NRER database record may be associ-number of devices were found to have excessive ated with more than one category of event. For exam-amounts of removable contamination. Hased on these plc, a report from a radiography licensee concerning a data from 3M. the data in Table 1 and Table 2, which Table 1 Types of1.icensees that Submitted Nonreactor Reports during 1988 No. of Reports Type of 1.icensee Received

Academic.

3 Medical 34 Commercial and industrial measuring system. 57 Well-logging 26 Other measuring system 31 Manufacturing and distribution (excluding medical) " 11 Industrial radiography 11 Fixed site Multiple locations (field). 1 10 Irradiator. 5 Research and development 23 Source materials"* 5 Mills. O UFs facilities. Other. 3 Special nuclear material (including plutonium) 20 Agreement State.. 4 Other "2fz Total 199

Medical misadmimstration re[ orts are not included.

"'lhese numbers represent regurts that were reccived by NitC: these numbers would be significantly higher if all hist or leakmg static chmination devices had been reported. "* Routine environmental ef tluent sclease rc[ orts, e.g., tc;wts reymred by 10 CI'R 40.65 and 10 CI'R 7u.59. were not included in the totab for source matenah and special nuclear materirds bcensecs. A-3 NUREG-1272, Appendix A

AEOD Annual Report,1988 Table 2 Categor zation of Reports of Nonreactor Events that Were Reported during 1988 No. of Category

Associated Reports Personnel radiation exposures............................................

39 Imst, abandoned, and stolen material..................... " 81

'15 Leaking sources R elease of material..................................................

22 Consu m e r prod ucts..................................................... 2 Fuel cycle (e.g., mills, UF facilities, special nuclear material).................. 14 Ind ust rial radiography................................................. 13 Manufacturing and distribution (including medical).......................... 19 Commercial and industrial measuring systems (excluding well logging).......... 31 Other*".............................................................. 62 303 Total....................

An NRER database record may be associated with more than one category of event. For example, a report from a radiography licensee concerning a penonnel radiation exposure would be counted in the total num-ber of radiation esposure events as well as in the total number of events involving radiography.

"nese numbers would be significantly higher if all lost or leaking static elimination devices had been re. ported. ""Other" includes categories such as medical transportation, and miscellaneous. represent the number of events reported to the NRC, inhalation 40 MPC hours / week for 13 substantially understate the number of reports of lost weeks, MPC (maximum or leaking static elimination sources that should have permissible concentration) been, but were not, received by NRC. is given in 10 CFR Part 20, Appendix B, Table I, Col.1 2.1.1 Radiation Exposures minors 10% of above limits The criteria that define overexposure are defined in 10 CFR 20.101(a) end (b),20.103(a), and 20.105. The lim-Unrestricted areas: its are as follows: individuals 0.5 rem / year, subject to rate limitations Restricted areas: whole body 1.25 rem / calendar quar-There were 39 reports of events received during " 988 ter, or 3 rem / calendar in which there was the potential for or an actual radia-quarter, if the individual's tion overexposure. Of the 39 events,16 involved actual prior occupationalexposure overexposure. Information on the exposure reports is is obtained in writing,and included in the NRER database and is provided in Ta-the accumulated exposure ble 3. does not exceed 5 (N-18), where N is the individual's The types of licensees accociated with the 16 actual age overexposure reported during 1988 follow: Medicaland Academic 6 extremity 18.75 rem / calendar Radiography 3 quader Commercial and Industrial 3 Fuel Cycle 1 skin 7.5 rem / calendar quarter Other 3 NUREG-1272, Appendix A A-4

Nonreactors-Events Table 3 Personnel Radiation Exposures,1988 License Event No. Licensee Number location Date Exp. Type Exp. Abington Memorial Hosp. 370043202 Abington, PA 101587 0 Badge American Airlines 351396401 Tulsa, OK 041288 0 Baster Healthcare Corporation 522117501 Aibonito, PR 050188 1 Whole Body Bill Miller,Inc. 301528301 Wynnewood, OK 0 Brigham and Women's Hosp. 201713101 Boston, MA 111186 1 Thyroid C & R Laboratories 531917902 Honolulu, HI 071088 1 Whole Body Extremity Certainteed Corporation 221571201 Milan, OH 112688 0 Crank Companies 492117201 Oreybull, WY 020188 1 Badge Dept. of Air Force 422353901 Wright Pat., OH 100486 0 Inhalation Dept.of Army 120072206 Chambersburg, PA 040488 0 Dept.of Navy 452364601 Norfolk,VA 062888 0 Badge E I Dupont De Nemours & Co. 200032021 N Billeric, MA 050288 1 Internal Gearhart Industries 420645803 Gate Ci:y, VA 050188 0 Badge H&G Inspection 422683801 WY 072988 0 Badge High Mountain Inspection Serv. 492680801 Mills, WY 011587 0 Badge Joslin Diabetics Foundation 201526601 Boston, MA 111587 1 Extremity LIT Corporation 200138202 Clinton, MA 040188 0 Badge Massachusetts Inst, of Tech. 200153702 Cambridge, MA 110187 1 Extremity Measurex Corporation AS* New Milford, CT 091688 2 Extremity Mercy Hosp. 370132102 Pittsburgh, PA 041388 0 Mount Auburn Hosp. 201206302 Cambridge, MA 082988 0 MOS Inspection,Inc. 120062207 Midland, MI 110388 1 Whole Body Penn Inspection Co. 352114401 Arkla, OK 051288 0 Robt Wood Johnson Univ. Hosp. 291017303 New Brunswick, NJ 070588 0 Badge Rohm and Haas Co. 370166501 Philadelphia, PA 031888 0 Schlumberger Well Services 420009003 Fairmont, WV 100187 0 Badge Sinai Samaritan Med. Ctr. 480328001 Milwaukee, WI 020188 1 Whole Body St. Agnes Hosp. 480241902 Fond Du I2c, WI 091688 0 Badge St. James Hosp. 291299701 Newark, NJ 060186 0 Badge St. Joseph's Hosp. & Med. 291019102 Paterson, NJ 061588 1 Whole Body St. Mary's Hosp. 451136201 Richmond, VA 120788 0 Star Jet Services 351572701 Oklahoma City, OK 011588 0 Badge State of Montana 251149801 Billings, MT 110188 0 Badge Syncor 372109201 Allentown, PA 110187 1 Extremity Trutom (U.S.), Ltd. 062075501 Milford, CT 081288 1 Whole Body UNC Naval Products, Inc. 060688'01 Uncasville, CT 052286 1 Internal Veterans Administration M.C. 310078602 Buffalc, NY 011488 1 Extremity Welex 420106807 Oklahoma City, OK 020188 0 Badge W elex 420106807 Oklahoma City, OK 110187 1 Whole Body 'AS meam Agrerment State license. A-5 NUREG-1272, Appendix A

AEOD Annual Report,1988 Medicaland Academic None of the 81 events resulted in a radiation overexpo-sure. The six reports of exposures (six individuals) from medical and academic licensees involved licensee per. Lost or Stolen Source sonnel. '1he exposures include a thyroid exposure from iodine-125 that exceeded the quarterly limit of 520 Of the 67 reports of lost or stolen sources,17 sources hours exposure at the maximum permissible concentra-were found; 3 pacemakers were buried, and 1 was prob-tion (MPC); two whole body exposures of 1.63 and 1.26 ably buried: 7 sources were inadvertently sent to com-rem per quarter; and three extremity exposures of mercial waste disposal; and 1 event occurred in whieti 18.75,35.15, and 61.31 rem, respectively. material was lost at sea.'Ihe ultimate disposition of the sources reported lost or stolen in the remaining 38 Radiography events is unknown. Table 4 presents a list of these events. The three radiography exposures (three individuals) involved whole body exposures of licensee personnel of 1he investigation of an event at ACC, a generallicen-6.1,4.47, and 1.3 rem, respectively. The individual who see, in which a 3M static elimination device containing received 6.1 rem also received an extremity exposure of polonium-210 was found to be leaking, showed that, in 118 rem. October 1988, approximately 800 devices out of a total of about 40,000 devices could not be located, i.e., they Commercial and Industrial were considered lost. These devices, unlike many de-vices authorized by a general license, were leased by The three reports of exposures (three individuals) from 3M, the manufacturer, to the general licensees and commercial and industrial licensees involved licensee were to be returned to 3M when the one-year lease personnel. 'lhe exposures include a whole body expo-expired. These 800 devices were reported missing in sure of 3.64 rem; a dose commitment of 5.29 rem from both Agreement and Non-Agreement States Although tritium uptake; and an extremity exposure of 21.7 rem, these 800 devices were reported missing during the in-respectively. vestigation, NRC had received only seven reports of the loss of this type of polonium-210 source. Compar-Fuel Cycle ing the large number of missing devices with the seven reports of missing devices indicates substantial under-In. vivo lung counting showed that one employee at a reporting of these lost devices (see the seven lost fuel cycle facility received an exposure that exceeded polonium-210 sources listed in Table 4 of this appen-the quarterly limit of 520 hours exposure at the MPC. dix). Other Generally, the sources whose whereabouts are unknown contain relatively small amounts of The reports of three events (four individuals)in this radioactivity-fewer than 100 millicuries. The lost trit-category involved licensee personnel. One person re-ium (H3) sources, sources authorized by a general li-ceived an exposure of about twice the quarterly limit cense, were larger, containing from 0.5 curie to 12 cu-from americium-241 uptake (a 1986 event); another rics of tritium. The larger tritium sources were con-person received a whole body dose of 9.09 rem; and tained in exit signs that were stolen from a theatre in each of two persons received an extremity dose of 58 St. Imuis, Missouri, and a garage in State College, rad. Pennsylvania. The lost phosphorus-32 items contained 500 millicuries each; one of the lost americium sources 2.1.2 Lost, Abandoned, and Stolen Material contained I curie; and the lost gadolinium source also contained I curie. Licensees are required to report the loss or theft of licensed material that has occurred in such quantities Three moisture-density devices were reported lost and and under such circumstances that it appears to the five were reported stolen. Of these eight lost or stolen licensee that a substantial hazard may result to persons devices, five were recovered undamaged. in unrestricted areas (10 CFR 20.402(a)(1)). Abandoned Well-Logging Sources Eighty-one events were reported during 1988 that in-volved lost, abandoned, or stolen licensed material. NRC licensees are required to report the location of Tables 4 and 5 provide summaries of these events. Of abandoned well-logging sources to NRC. The 14 events these events,67 involved lost or stolen material and 14 reported during 1988 did not result in av kncwn re-involved abandoned, irretrievable well-logging sources, leases. NUREG-U.72, Appendix A A-6

Nonreactors-Events Table 4 Lost or Stolen Sources,1988 Ucense Event Final Isotopet Location Licensee Numbertt Date Disposition Am-241 Lombard, IL Professional Service Industries 121694101 111888 Found Am-241 Indianapolis, IN E & Il Paving, Inc. 132129001 122188 Found Am-241 largo, MD Froeling & Robertson,Inc. 450889002 092288 Found Am-241

Dearborn,

MI Ford Motor Co. GL 071588 Unknown Am-241 Saginaw, MI Professional Serv ces, Inc. 121694101 031788 Found i Am-241 White Ilear, MN Geotechnical Engineering 222027101 052488 Unknown Am-241 Cranford, NJ Dames & Moore,Inc. 291669502 121288 Unknown Am-241 OK llPil Wireline Services 352688501 112388 Unknown Am-241 Sweetwater, TN Dept.of Agriculture 190091506 032888 Unknown Am-241 Fort Worth, TX Gearhart Industries 420645803 121087 Found Au-198 Springfield, MA Ilay State Med. Ctr. 200141205 060188 Unknown C-14 Indianapolis, IN Eli Lilly and Co. 130113302 052588 Comm Waste C-14 Milwaukee, WI Veterans Administration M. C. 480213022 021888 Found C-057 Minneapolis, MN Minneapolis Children's M. C. 222049901 052588 Unknown C-060 Sewickley, PA llerthold Systems 372122601 092088 Found Cs-137 Hethesda, MD Dept. of licalth and 11uman Sys. 190029610 080188 Unknown Cs-137 Ilutte. MT Montana Resources, Inc. 252680901 071587 Unknown Cs-137 Gallia Cty, Oil Southern Ohio Coal Co. 341649501 033188 Unknown Cs-137 Philadelphia, PA St. Agnes Med. Hosp. 371365101 080688 Unknown Cs-137 Danville, WV Stanford Mining Co. 371822601 110188 Unknown Fe-55 Princeton, NJ SRI / David Sarnoff Research Ctr. 290800501 040188 Unknown Gd-153 Iloston, M A Ilrigham and Women's llosp. 201713103 112988 Unknown 11-3 Detroit, Mi Stroh lirewery Co. 211717402 080388 Unknown 11-3 St lauis, MO General Cinema GL 010588 Unknown 11-3 Duncan, OK Schlumberger Well Services 420009003 010180 Unknown 11-3 State College, PA llorough of State College GL 010788 Unknown 11-3 Itill AFII, UT Dept. of Air Force 422353901 010586 Unknc wn 1-125 Rootstown, OH Northeastern Ohio U. Coll. Med. 341819601 020188 Com' Waste 1-125 llorsham, PA ICN Micromedic 371670601 121587 Unknown 1-131 Princeton, NJ Squibb Technical Operations 290013901 081588 Found 1-131 St Albans, VT Northwestern Med. Ctr. 441666901 032688 Unknown Ir-192 Midland, MI Midland Hosp. Ctr. 210154902 101388 Found Ir-192 Morgantown, WV Virginia Univ.11osp. 472303501 091188 Unknown Ni-63 Antarctica Dept. of Commerce 051199701 110187 Comm Waste Ni-63 Boston, M A Boston Univ. Med. Ctr. 200221501 122787 Unknown Ni-63 Somerville, NJ Ethicon 290278606 042088 Unknown Ni-63 Wright Pat.,01I Dept.of Air Force 430123501 122288 Unknown Footnotes at end of table. (cont.) = A-7 NUREG-1272, Appendix A

AEOD Annual Report,1988 Table 4 Lost or Stolen Sources,1988 (cont.) license Event Final Isotopet. location Licensee Numbertt Date Disposition Ni-63 Pittsburgh, PA NUS Corporation GL 121288 Comm Waste P-32 New Haven, CT Yale Univ. 060018303 051888 Comm Waste P-32 Wilmington, DE E I Dupont De Nemours 070045500 080268 Unknown P-32 Cleveland, OH Univ. Hosps. of Cleveland 340546901 012088 Unknown Pm-147 Waltham, MA Hewlett Packard GL 040688 Unknown Po-210 Block Drug Co. GL 012788 Unknown Po-210 Hartford, CT Ili-g Nytronics, Inc. GL 071988 Unknown Po-210 Sterling H, MI Detroit Plastic Molding Co. GL 010188 Unknown Po-210 Plymouth, MN Honeywell GL Unknown Po-210 Madison, PA Westinghouse GL 020888 Found Po-210 Galesville, WI 12ke Center Industries GL 030188 Found j Po-210 Waukesha, WI Mold Rite Products GL 020988 Unknown Pu-238 Richmor.', VA St. Mary's Hosp 030388 Unknown Pu-238 Washington, DC Washington Hesp. Ctr. 062188 l Pu-238 Ann Arbor, MI Univ.of Michigan 101182 Pu-238 Newark, NJ Newark Beth Israel Med. Ctr. 072088 Pu-238 Bristol, PA Ixwcr Bucks Hosp. 082684 SNM San Diego, CA General Atomics 122288 Found Sr-90 Woodlynn, NJ No license NL 062988 Found Tc-99m Two Rivers, WI Computerized Medical Imaging 482453301 120688 Found Th Indianapolis, IN Allison Gas Turbine 061988 Comm Waste Th Tinker AFB, OK Dept. of Air Force 422353901 060188 Found U-235 Big Rock Point, MI 010184 Unknown U-238 Concord, MA Nuclear Metals, Inc. 091688 Unknown Unat None (Edlow Int. NL 050988 Sea & Allied Chem.) Y Columbia, MO Univ.of Missouri 240051335 041588 Unknown Z Norwalk, CP Norwalk Hosp. 060694101 042887 Comm Waste Z Washington, DC Catholic Univ.of America 080207503 042988 Unknown Z Newark, NJ LFE Corp. 200138216 040188 Found tY means other, and Z means unspecified, itGL means general license, and NL means no license.

Pacemaker mterred with body.

" Pacemaker probably interred with body. NUREG-1272, Appendix A A-8

Nonreactors-Events Table 5 Abandoned Well. Logging Sources,1988 Ijcense Event Isotope Ixcatica Licensee Number Date 113 Offshore, IA Atlas Wircline 420296401 031788 Am-241 Offshore, IA Ocarhart Industries 420645803 063088 Am-241 Mc Clain Cnty., OK Gear = rt Industries, Inc. 420645803 073188 Am-241 Offshore Schhanberger Tech Corporation 420009003 080888 Am-241 Offshore, IA Schlumberger Tech Corporation 420009003 042588 Am-241 Offshore, LA Schlumberger Tech Corporation 420009003 072288 Am-241 Offshore, LA Schlumberger Tech Corporation 420009003 082288 Am-241 Offshore, TX Schlumberger Tech Corporation 420009003 121887 Am-241 Offshore, TX SchlumbergerTech Corporation 420009003 070888 Am-241 Offshore, LA Welex Halliburton 420106807 082488 Am-241 Canadian Cnty., OK Welex 11alliburton 420106807 122687 Am-241 Campbell Cnty., WY Welex Halliburton 420106807 121787 Am-241 Unita Cnty., WY Western Atlas International 420296401 102488 Cs-137 TX Penwood Wireline, Inc. 422689101 061688 In nxwi cases, when an Am 241 source was hst. a Cs-137 source was also k>st. 2.1.3 Leaking or Contaminated Sources in food, beverage, cosmetic, and pharmaceutical appli-cations had more than 0.0005 microcurie of removable Certain licensees are required to leak test sources and contamination. Approximately 1.8 percent of all re-to report leaking sources under 10 CFR 34.25; others turned devices (ebout 47,000) had more than 0.005 are required to leak test sources and to report leaking rnicrocurie of removab!c contamination. These fractions sources as a condition of their license. In both cases, a indicate a generic problem with using these devices, removable contarnination 7cceding the most common and, when thee: fractions are coupled with the fact that test limit for removable contamination (0.005 micro-about 50,000 devices are distributed by 3M annually, curie)is considered cvidence of leakage. Removable there appears to have been a substantial underreport-contamination exceeding the amount specified in 10 ing of the leakage of the 3M devices. CFR 34.25 or a license condition must be reported to the NRC. On June 7,1988, cesiem-137 contamination was de-tected in the water stonge pool of Radiation Fifteen occurrences of leaking or contaminated sources Sterilizers, Inc., Decatur, Georgia, an Agreement State were reported during 1988. Table 6 includes informa-licensee. The contamination was caused by a leaking tion from reports of these events. None of the events cesium capsule leased from the DOE. resulted in a radiation overexposure. The isotopic sources found to be leaking or contaminated contained On June 10 and July 29,1988, NRC issued Confir-cadmium, cobalt, cesium, tritium, krypton, nickel, and matory Action Letters (CALs) to Radiation Sterilizers, polonium. Inc., of Westerville, Ohio. The later CAL ordered the licensee to suspend operations and place the Waste A review of the report of a leaking polonium-210 Encapsulation Storage Facility capsules in storage. The source manufactured by 3M at ACC lead to a recall of heensee is m the process of returning the cesium cap-substantially all static elimination devices manufactured sules to DOE. by 3M. Wipe tests of returned devices reported by 3M for the period ending August 12,1988, showed that The root cause of the leaking capsule in the Decatur, about 4.5 percent of the static elimination devices used Georgia, pool has not yet been dearmined. A-9 NUREG-1272, Appendix A

AEOD Annual Report,1988 Table 6 Leaking Sources,1988 License Event Isotope location Licensee Number Date Manufacturer Cd-109 Lynn, MA General Electric Co. 201990801 071988 Kevex Co-57 E I Dupont De Nemours NEN 200032021 010187 Cs-137 GA Radiation Sterilizers AS 060788 DOE Cs-137 Upton, WY Goodwell, Inc. 01299401 102188 11-3 W. Newton, MA Dept.12tbor Ind. GL 012588 Custom Mat'Is 11-3 Chambersburg, PA Dept. of Army 120072206 040488 Kr-85 Woods Hole, M A Woods lloie Oceanographic Inst. 202226402 010188 NER-584 Ni-63 lloulder, CO Dept. of Commerce 051199701 072180 Isotope PDT 1;ib Ni 63 Winchester, M A Dept. of Health and Human Sys. 200836101 092988 Hewlitt i Ni-63 Oklahoma City, OK Oklahoma Gas & Electric 352683701 020488 Perkin Elmer l Po-?i0 CA KTI Chemical GL 012888 3M Po-210 CA Xicor GL 012988 3M Po-210 Newark AFI),011 Dept. of Air Force 422353901 070388 3M Po-210 Easton, PA Ashland Chemical Co. GL 3M Po-210 Philadelphia, PA General Electric 370200605 122187 3M 2.1.4 Release of Materials When the leaking source at ACC's Easton, Pennsylva-nia, plant was found and reported, and other leaking sources were found at their Dallas, Texas, plant, staff There were 24 events reported during 1988 in which from all NRC regional offices, Agreement States, Non-radioactive mmerials were released. Generally, the agreement States, the Office of Nuclear Materials events had little effect on any area beyond the immedi-Safety and Safeguards, and the U.S. Food and Drug ate area of the release. However, one event, leakage of Administration (FDA) conducted smveys of selected a polonium-210 static elimination device at ACC did general licensee facilities to evaluate the extent of the have far-reaching effects since an investigation of the problem with the leaking static eliminators found at release at ACC resulted in the recall of essentially all ACr. The FDA found no evidence of product contami-of the static elimination devices manufactured by 3M, nanon at any of the 320 sites associated with food, bev-the manufacturer of the device that leaked at ACC. crage, pharmaceutical, medical device, and cosmetic applications that they visited. 2.1.5 Consumer Products The americium source that may have been sent to a scrap dealer was a generally licensed gauge that con-tained one curie of americium-241. An additional category of event.

consumer products,"

was defined u.J included in the database in 1985. Re-2.1.6 Fuel Cycle Facilities ports of this category of event describe events m, which radioactive material was found in, or had a reasonable NRC entered information about 14 fuel cycle events probability of being introduced into, nornicensed con-into the nonreactor event database in 1988. None of sumer produs a the events concerned mills or milling, but 2 concerned the manufacture of uranium hexafluoride, and 12 oc-curred at fuel fabrication facilities. A brief description NRC received two reports during 1988 in which radio-of each of these events follows. (Note that these events active material was found in, or had a reasonable prob-do not include reports of routine effluent releases.) ability of being introduced into, nenlicensed consumer products. First, the leaking source at ACC resulted in Afanufacturing Events the contamination of an industrial chemical, and, sec-ond, an americium-241 source may have been sent to a Allied Signal in Metropolis, Illinois, reported a release scrap dealer. of radioactive material that was cimsed by a small crack NUREG-1272, Appendix A A-10

Nottreactors-Events . in a hydrofluorinator shell that permitted the loss of taminated vessels was repeatedly emptied into the tank about one pound of uranium to the stack. Maximum over time. contamination occurred about 25 feet from the build-ing. A second release of material occurred at Allied UNC, Uncasville, Connecticut, reported that in-vivo Signal when a seal leak on a calciner permitted 300 testing showed that one employee had received an in-pounds of calcined oxide to spill on a concrete pad. ternal exposure in excess of the quarterly limit of 520 Neither of these events resulted in significant releases. hours exposure at the maximum permissible concentra-tion. Sequoyah Fuels Corporation in Gore, Oklahoma, re-ported the receipt of an overfilled uranium hexafluo. Westinghouse, Columbia, South Carolina, reported a ride cylinder from DOE. small Zircaloy fire, failure of a pump that resulted in five gallons of solution spilling on the floor and a trans-Uranium fuelfabrication Event, p rtation accident that involved a truck carrying eight fuel assemblics. Advanced Nuclear Fuels Corporation, Hanford, Wash-2.1.7 Radiography mgton, reported three events: G) deformation of the cooling water jacket on a sintering furnacc (2) a fire ball at the sintering furnace; and (3) a fire m oil-soaked There were 13 events reported during 1988 that in-msulation on a drier. Maintenance was mdicated as volved radiography. All except one of theae Occurred at contributing to all events. remote sites or involved transportation. Table 7 pro- . vides information on these reported events. Nine of the events concerned overexposure or potential overexpo. Habcock and Wilcox, Parks Township, Pennsylvania, sures (Table 3 of this appendix provides a list of these counted radioactive material on filters in an unventi-nine events). Three events involved transportation of lated rocn, an action NRC considered not appropriate radiography devices, anc! one involved contamination of for the risk involved. At another Babcock and Wilcox a piece of radiography equipment. plant in Lynchburg, Virginia, NRC found several exam-ples of less than adequate adherence to criticality con-2.1.8 Manufacturing and Distribution trol requirements. There vrre 19 reports of events that concerned manu-Combustion Engineering, Windsor, Connecticut, sent facturing and distribution during 1988. Table 8 provides filters that contained more than 56.5 grams of information about these events. These licensees have uranium-235 to a waste disposal with incorrect labell-no unique reporting requirements for events involving ing. These shipments did not meet the exemption crite. health and safety unless the requirements are incorpo-ria of 10 CFR Part 71 for fissile material. Further, in-rated into a license condition or an Order. Only one of spectors found several examples of failure to adhere to the events, the leaking source at ACC, lead to any sig-criticality control requirements at Combustion Engi-nificant findings (see Section 2.1.3 of this appendix). neenng. 2.1.9 Gauges and Measuring Systems General Atomics (GA), San Diego, California, reported the suspected loss of an amount of enriched uranium; IIolders of specific licenses to possess gauges are re-G A later found that the apparent loss was caused by an quired to report failures of, or damage to, shieldmg, error in accounting and that no material had actually 0n/off mechamsms, or mdicators of the gauge, or detec-been lost. tion of removable contammation on the gauge. In addi-tion, these licensees must report, pursuant :o 10 CFR Part 20, lost or stolen materials, releases of material, General Electric, Wilmington, North Carolina, re-etc. Reports of events concerning gauges or measuring ported a leakage from a 20,000-gallon tank containing systems occurring in 1988 were identified by the pro-nitrate; the leaking effluent went into the site's process gram codes of the licensee. None of the events was by i lagoon. itself significant. Nuclear Fuel Services, Erwin, Tennessee, reported Reports of 23 events concerning gauges or measuring finding uranium in a large, unsafe geometry tank used systems were received during 1988. Table 9 includes to store chemicals. This event occurred because a ura-information from these reports. Reports of 1988 gauge nium solution from a safe geometry ccmtainer was inad-events also include events discussed in Section 2.1.1 of vertcally returned to the tank or solution from con-this appendix. A-11 NUREG-172, Appendix A 4

AEOD Annual Report,1988 i Table 7 Radiography Exposures,1988 i License Event Type of Isotopet location Licensee Number Date Event

i Ir-192 Milford, CT Trutom (U.S.), Ltd.

062075501 081288 EXP Ir-192 Wilmington, DE Conam Inspection Services /Fol. 421655901 022388 TRS Ir-192 Honolulu, III C & R I;tboratories 531917902 071088 EXP Ir-192 Norfolk, VA Dept.of Navy 452364601 062888 EXP 1r-192 WY H&G Inspection 422683801 072988 EXP l Ir-192 Hasin, WY Atlas Wircline 420296401 032388 TRS ( Ir-192 Mills, WY High Mountain Inspection Serv. 492680801 111587 EXP l Y Williamsport, PA Pullman Power Products Corp. 370804201 051088 Z Aiea, HI Finlay Testing Laboratories $31780407 081787 TRS Z Arkla Cty, OK Penn Inspection Co. 352114401 051288 EXP 1 Z Tulsa, OK American Airlines 351396401 041288 EXP J Z Wynnewood, OK Hill Miller, Inc. 301528301 EXP ) tY means other, and Z means unspecified. 1

Abbreviation Type of event liXP lixpsure TRS Transportation l

i Table 8 Manufacturing and Distribution,1988 License Event Type of Isotopet location Licensee Numbertt Date Event

Cd-109 Lynn, M A General Electric Co.

201990801 071988 LKS Co-57 Germany E I Dupont De Nemours NEN 200032021 010187 IXS Cs-137 Upton, WY Goodwell, Inc. 491299401 102188 LKS 11-3 W. Newton, M A Dept. Labor Ind. GL 012588 IXS 1-125 Newark, NJ No license NL 021688 TRS 1-125 Port Newark, NJ No license (Airborne Exp.) NL 021688 TRS Kr-85 Woods llote, MA Woods Hole Oceanographic Inst. 202226402 010188 IXS Mo-99 Hillerica, M A E I Dupont De Nemours NEN 200032021 101688 TRS Mo-99 Newark, NJ Newark Airport NL 102488 ' ITIS Ni-63 Houlder, CO Dept. of Commerce 051199701 072188 LKS Ni-63 Winchester, MA Dept. of Health and Human Sys. 200836101 092988 LKS Ni-63 Oklahoma City, OK Oklahoma Gas & Electric 352683701 020488 LKS Po-210 CA KTI Chemical GL 012888 LKS Po-210 CA Xicor GL 012988 LKS Po-210 Newark AFB,011 Dept. of Air Force 422353901 070388 LKS Po-210 Easton, PA Ashland Chemical Co. GL LKS, RLM Po-210 Philadelphia, PA General Electric Co. 370200605 122187 IXS Xc-133 Dillerica, MA E I Dupont De Nemours NEN 200032021 052688 RLM,TRS Z Tulsa, OK St. Francis Hosp. 35071ci301 080188 MSC tZ means unspecified. ttGL means generallicense, and NL means no beense. ' Abbreviation Type of event tXS leaking source MSC Miscellaneous RLM Release of material TRS Transportation NUREG-1272, Appendix A A-12

Nonreactors-Events Table 9 Gauges and Measuring Systems,1988 License Event Type of Isotopet

12) cation Licensee Number Date Event

Am-241 12)mbard, IL Professional Service Industrie.i 121694101 111888 LAS Am-241 Indianapolis IN E & B Paving,Inc.

132129001 122188 LAS Am-241 Largo, MD Frocling & Robertson,Inc. 450889002 092288 LAS Am-241 Saginaw, MI Professional Services, Inc. 121694101 031788 1AS Am-241 White Bear, MN Geotechnical Engineering 222027101 052488 LAS Am-241 Cranford, NJ Dames & Moore,Inc. 291669502 121288 LAS Am-241 Whippany, NJ Soils Engineering Services, Inc. 291841601 051088 LAS Am-2d 1 Caney, OK Oklahoma Dept. of Transportation 101788 MSC Am-241 Ellwood C, PA West Penn Asphalt Co., Inc. 372052901 032388 MSC Am-241 Havertown, PA Urban Engineers, Inc. 371915901 103188 MSC Am-241 Taylor, PA Empire Sanitary I;mdfill, Inc. 372807501 022888 MSC Am-241 Austin, TX Southwestern laboratories 422682801 032288 Am-241 Burlington, NJ Woodward-Clyde Consultants 291976502 080988 MSC Cd-109 Lynn, M A General Electric Co. 201990801 071988 LKS Cs-137 Butte, MT Montana Resources, Inc. 252680901 071587 LAS Cs-137 Wechawken, NJ New Jersey Dept. of Transportation 290594301 073088 MSC Cs-137 Marion, OH Marion Steel Co. 342112301 061088 RLM Cs-137 Milan, OH Certaintec Corporation 221571201 112688 EXP Cs-137 Danville, WV Stanford Mining Co. 371822601 010188 LAS Kr-85 Lee's Summit, MO AT&T Technology System 240601502 031888 RLM Ni-63 Kingsville, MO Amereco Environmental Service 242495201 093088 MSC Ni-63 Oklahoma City, OK Oklahoma Gas & Electric 352683701 020488 LKS Z Canton, OH Timken Co. 341520702 120788 MSC tZ means unspecified. ' Abbreviation Type of event EXP Exposure IAS lost or stolen source IXS 1 raking nource MCS Miscellaneous RLM Release of material A-13 NOREG-1272, Appendix A

AEOD Annual Report,1988 1 2.2 Abnormal Occurrences ne AOs for Agreement State licensees involved-radiation injury t< two radiographer and in the Report to Congress on Abnormal Occurrences (AO) for the first three quarters of 1988, three events release of radioactr.. material during a trans-for NRC licensees' and two events for Agreement State p rtation accident. licensees were determined to be AOs. The AOs for NRC licensees involved-In the first Agreement State AO, a radiography overex-posure occurred to one ankle of each of two individuals release of polonium.210 from static elimination with doses estimated to be in the range of 860 to 1,940 devices manufactured by 3M rem and resulted in radiation burns. In the second Agreement State AO, a model SPEC 2T radiographic significant widespread breakdown in radiation exposure device fell from the back of a truck onto a safety at Case Western Reserve University Re-roadway. The device was struck by a car and dragged search Laboratories, Cleveland, Ohio, and some distance. At some point during the event, the 48-curie iridium-192 source became separated from the significant breakdown in management and pro-cedural controls at a medical facility. 7:00 p.m., and the source was recovered from the road-way on the following morning. A greenish powder, be-A report to the NRC disclosed the first event, and a lieved to be depleted uranium, was also found at the news inquiry led to a disclosure of the second event. accident scene.The agency of the Agreement State The third event stemmed from findings of a routine calculated that any passing motorist could have re-inspection of the licensee's facility. Sc. tion 2.1.3 of this ceived an exposure of less than 1 millirem from the appendix provides a discussion of the details of the source lying in the roadway; this exposure would not be polonium-releare event. an overexposure, i l NUREG-1272, Appendix A A-14

3 Findings The number of events that was reported to the NRC in stantially all of the devices similar to the device that 1988 was about the same as in previous years and none leaked at ACC. In addition, the leakage of a had a significant impact on the public health and safety, cesium-137 capsule at a Georgia irradiator may have a The discovery of product contamination from a leaking substantialimpact on the future use of these DOE-source at ACC did have far-reaching effects since an manufactured sources. The root cause of this event is investigation of this event resulted in the recall of sub-still unknown. f A-15 NUREG-1272, Appendix A

Appendix B Medical Misadministration Report

Appendix B AEOD/N802 Medical Misadministration Report Medical Misadministration Reported to NRC from January 1988 through December 1988 by the Nonreactor Assessment Staff Office for Analysis and Evaluation of Operational Data Prepared by: Harriet Karagianms i i

Contents 1 Introduction............................. B-1 23 Diagnostic Misadministration.......... - B-5 2 Therapy and Dia ostic Misadministratious - 2.3.1 Diagnostic Misadministration ofIodine.. B-5 Reported to NR during 1988.............. B-3 2.3.2 Diagnostic Misadministration that involve 3.1. G eneral.............................. B-3 the Mislabeling of Radiopharmaceutical 2.2 'Iherapy Misadministration............ B-3 Doses by Radiopharmacies............ B-6~ 2.2.1 Teletherapy Misadministration............ B-3 2.4 Abnormal Occurrences..................- B-6 2.2.2 Brachytherapy Misadministration........ B-4 3 Licensce-Proposed Corrective Actions...... ' B-9.- 2.2.3 Radiopharmaceutical'lherapy Misadministration..................... B-5 -4 Findings and Conclusions !................ B-11 Tables 1 Medical Misadministration Reported to NRC 3 'lype and Probable Cause of'Iherapy d u ring 1988............................ B-3 Mtsadministrations Reported for 19 8....... B-4 2 Misadministration Reports for 1981-1988.... B-3 1 I B-iii NUREG-1272 -

I 1 Introduction ) The Office for Analysis and Evaluation of Operational the frequency of the event and the magnitude of the Data (AEOD) reviews reports of medical misadminis-potential effect of the event. trations of radiopharmaceuticals or radiation from iso-topes regulated by NRC.i AEOD's review of these re. Regarding the frequency of misadministration events ports submitted to NRC during 1988 is documented in from 1981 through 1988, licensees have submitted 36 this appendix. therapy misadministration reports that involved teletherapy machines. In these 36 events, a total of 108 Medical misadministration are reported to NRC pur. patients were overtreated or undertreated. The NRC suant to the requirements contained in 10 CFR Part 35. estimates, using patient statistics from the " Patterns of The revised 10 CFR Part 35, which became effective on Care"2 study of the American College of Radiology, April 1,1987, defines a misadministration to mean ad. that the error rate per patient is about 0.0003. ministering of-Licensees have reported about 3,200 diagnostic misad-1. a radiopharmaceutical or radiation from a scaled ministrations to NRC over this same eight-year period. A recent study by the Technologist Section of the Soci. source other than the one intended; ety of Nuclear Medicine estimated that about 10 mil-li n diagnostic procedures are performed annually in 2. a radiopharmaceutical or radiation to the wrong the United States.3 Smce NRC regulates only 21 of the E" 50 states, NRC estimates that about 4 million procc-dures are performed annually'by NRC licensees alone. 3. a radiopharmaceutical or radiation by a route of administration other than that intended by the The estimated diagnostic error rate per procedure is OR prescribing physician; Regarding the magnitude of the potential or actual ef-4. a diagnostic dosage of a radiopharmaceutical dif-feet of a therapy or diagnostic misadmmistration, ther-fering from the prescribed dosage by more than 50 apy misadministration are associated with procedures percent; in which large doses of radiation are administered to patients to achieve a therapeutic effect, and diagnostic 5. a therapy dosage of a radiopharmaceutical differ-misadministration are associated with procedures re-ing from the prescribed dosage by more than 10 quiring small doses of radiation. An exception is the percent; or diagnostic administration of iodine-131. 6. a therapy radiation dose from a scaled source such Diagnostic misadministration that result in the errone-that errors in the source calibration, time of expo-ous administration of iodine-131 may result in thyroid sure, and treatment geometry result in a calcu-doses that range from several hundred rad to several lated total treatment dose differing from the final thousand rad. These doses may approximate therapy-prescribed total treatment dose by more than 10 equivalent misadministration. Since both teletherapy percent. misadministration and diagnostic misadministration have about the same estimated error rate, therapy Diagnostic misadministration, as ue:d in NRC regula-misadministration and some iodine-131 misadministra-tions, refers to the misadministrson of radioisotopes tions, as a class, appear to be individually and collec-in nuclear medicine studies such as liver scans and bone tively more significant than diagnostic misadministra-scans. Therapy mimdministration, as used in NRC tions. AEOD, therefore, reviews in detail reports of regulations, refers to the misadministration of radiation therapy misadministration and misadministration that from cobalt-60 teletherapy, brachytherapy, or radio-involve administering iodine-131. Most reports of pharmaceutical therapy. diagnostic misadministration are reviewed from a col-lective or statistical viewpoint. The significance of any event stems from the potential effect of the event on public health and t.afety. Gencr-ally, the total risk ascribed to an event is a function of 2Kramer, S., Ilanks, G.E., and Diamond, J.J., " Summary Results from Fourth Facihties Master List Survey Conducted by Patterns of Care Study," int. J. Radiat. Oncol. Biol. Phys. 9.12,1983. 3"Iluman Resourecs Survey of Nuclear Medicine Technolo-1The Atomic Energy Act of 1954, as amended in 1974,liruits the gists-1984," prepared by the lluman Resource Task Force of the NRC's regulation of radiocctwe materials to reactortrcduced ism Technologist Section,The Society of Nuclear Medicine,Joumalof tops. Nuclear Medicine Technology, vol.13, No. 3, September 1985. B-1 NUREG-1272, Appendix H

AEOD Annual Report,1988 This appendix is a compilation of data on misadminis-tions: Therapy and Diagnostic Misadministration Re-trations reported to NRC from January 1988 through ported to NRC; Licensee Proposed Corrective Actions; December 1988 and is divided into the following sec-and Findings and Conclusions. I J l l NURI!G-1272, Appendix il 11 - 2 i

2 Therapy and Diagnostic Misadministration Reported to NRC during 1988 2.1 General of repcrts, the number of patients involved, and the number of licensees reporting misadministration. From January 1988 through December 1988 NRC li. About the same number of diagnostic misadministra-censees involved in mdiation therapy and nuclear medi. tions were reported for 1988 as were reported annually cine reported 12 therapy misadministration and 393 for the previous seven years. The number of therapy diagnostic misadministration. misadministration reported during 1988 was slightly higher than the average number reported each year Table 1 summarizes the statistics for the merlical misad. from 1981 through 1987, ministrations reported to the NRC for 1988. ti the approximaldy 2,400 NRC licensees authorized to pc-form neacar medicine studies or radiation therapy,344 2.2 Therapy Misadm.. trat. ions inis reruned one misadministration or more for a total of 405 reports involving 470 patients. Of the 405 reports Licensees reported 12 therapy misadministration dur-of misadministration for 1988,393 (97 percent) were ing 1988. Five of the misadministration involved diagnostic misadministration, and 12 (3 percent) were teletherapy, five involved brachytherapy, and two in-therapy misadministration. volved radiopharmaceutical therapy. Table 3 presents data on the type and probable cause of the misad. Table 2 liste the number of misadministration reports ministrations. received during 1988 and those received during the pre-vious seven years. This table also provides the number 2.2.1 Teletherapy Misadministration Table 1 Medical Misadministration Licensees reported five teletherapy misadministration Reported to NRC during 1988 during 1988. Two of these misadministration involved a transcription error of the prescribed dose; the other Misadministration three events had different causes. Diagnostic Therapy Total In the first case, the prescription was revised for the third time. He new transcription that was prepared to No. of reports 393 12 405 incorporate the revision, incorrectly indicated a total of 10 treatments rather than 8 as prescribed. The error No. of patients was not discovered during the course of the treatment involved 438 32 470 and as a result, the patient received a dose 25 percent No. of licensees higher than the prescribed dose. The error was discov-reporting 334 10 344 cred during a posttreatment review of the patient's chart. Table 2 Misadministration Reports for 1981-1988 Year Type of Misadministration 1981 19F2 1983 1984 1985 1986 1987 1988 i Therapy 10 4 4 14 4 7 9 12 l Diagnostic (involving iodinc-131) 2 3 2 3 3 5 5 7 I Diagnostic (other) 428 414 332 395 377 433 409 386 No. of patients $17 451 437 442 410 495 459 470 No. of licensees reporting 351 355 293 318 293 369 348 344 13 - 3 NUREG-1272, Appendix B

AEOD Annual Report,1988 Table 3 Type and Probable Cause of Therapy Misadministration Reported for 1988 Dose different from prescribed by > 10 % (Teletherapy) Transcription error of the prescribed dose....................................... 2 Error in the formula for computer treatment planning............................. 1 Error in the anatomical area to be treated....................................... 1 Calculational error of the time exposure......................................... 1 Dose different from prescribed by > 10 % (Brachytherapy) The wrong activity brachytherapy sources were used............................... 2 Inadequate procedures for placement of the brachytherapy sources in the applicator... 2 Error in calculating the treatment dose.......................................... 1 Dose different from prescribed by > 10 % (Radiopharmaceutical Therapy) Error in calculation of dosage.................................................. I Inadequate assay of dosage in dose calibrator.................................... 1 In the second case, the technologist transcribed,in the errors and properly suspended the treatment at 5,015 - patient's chart, the wrong dose for a patient treatment rad instead of the intended 6,600 rad. area.The error resulted in the patient receiving a dose approximately 16 percent higher than the prescribed 2.2.2 Brachytherapy Misadministration l dose. The error was detected while reviewing the treat-ment records after the radiation sequelac had already Licensees reported a total of five brachytherapy misad-occurred. 'Ihe licensee reported that the misadministra. ministrations during 1988 that were caused by (1) tion, in this case, contributed to the misadministration sources with the wrong activity being loaded into the sequelac, including subcutaneous fibrosis, lymphedema, source applicator, (2) an error in calculating the and neuropathy. brachytherapy treatment dose, and, (3) inadequate pro-cedure for placement of the brachytherapy sources in In the third case, the misadministration involved an the applicator. error in the formula that was incorporated into the hos-In the first case, two 15 milligram (mg) radium-pital's treatment planning computer used for the calcu-equivalent cesium sources were intended to be loaded lation of the beam on-time., As a result, over a period n an applicator for a patient receiving brachytherapy of 13 months,21 patients received less than 90 percent treatment. However, because of similar color coding of of the presenbed teletherapy dose. the 15 mg and 20 mg sources, a 15 mg and 20 mg source were inadvertently loaded in the applicator in-In the fourth case, a patient received 2,000 rad to an stead of the two intended 15 mg sources. The error was unmtended treatment area (right pelvis)instead of that discovered after the sources were removed and re-prescribed (left pelvis). The hcensee reported that it is turned to the storage area. not certam whether the therapist made a conscious de-cision or an error in interpreting the bane scan before In the second case, a 30 mg radium-equivalent cesium treatmg the right pelvis. source, instead of the intended 20 mg source, was inad-vertently selected for a brachytherapy treatment. Al-In the remaining case, a calculational error in the time though an initial survey of the sources had been com-exposure resulted in significantly greater fractional pleted, the error was not identified until the source was doses being administered during the second and third removed from the patient and returned to the storage weeks of treatment than that which was intended by the area. As a result of using a source with the wrong activ-original prescription. The original therapy prescription ity, the patient received 5,198 rad instead of the in-was for treatment with cobalt-60 to a total dose of tended 3,993 rad. 6,600 rad at 200 rad per fraction for 33 fractions over six and one-half weeks. After the third week of patient In the third and fourth cases, the misadministration j treatment, the physician became aware of calculational resulted from using inadequate procedures for loading NUREG-1272, Appendix 11 B-4

Nonreactors-Medical Misadministration brachytherapy sources into an applicator. In the third greater than 50 percent. The number of diagnostic re-case, the patient received 1,490 rad from the bra-ports for 1988 was about equal to the average rate for chytherapy treatment instead of the intended 2,500 rad, each of the seven previous years,1981 through 1987. and, in the fourth case, the patient received 6,180 rad 'Ihe annual number of diagnostic reports ranged from instead of the intended 5,000 rad. 334 in 1983 to 438 in 1986, with an average of 400 per year. The types and causes of the diagnostic misad-In the fifth case, a patient undergoing iridium-192 ministrations were about the same as those reported in brachytherapy treatment received a dose of 1,800 rad previous years. Effectively, all of the diagnostic misad-instead of the intended 750 rad. 'Ihe licensee reported ministrations involving the wrong radiopharmaceutical that the error resulted from using the wrong chart to or the wrong patient stem from human error, compute the treatment dose. The error was discovered shortly after completing the treatment. .Ihe primary errors associated with the administration of a radiopharmaceutical to a patient were-Also in 1988, a brachytherapy event occurred that in-errors in the preparation or delivery of radiophar-volved a patient who was suffering from mild senile maceutical doses, dementia.'Ihe patient removed four of the implanted mislabeling of radiopharmaceutical doses, and cesium-137 sources before the treatment was complete. misinterpretation of the physician's order. As a result, the patient received a dose of 2,200 rad instead of the intended 4,000 rad. It has not yet been The primary errors associated with the administration determined by the NRC staff whether this event meets of a radiopharmaceutical to the wrong patient follow: the criteria for the definition of misadministration un- 'Ihe wrong patient's name was entered on the der 10 CFR 35.2. requisition. The wrong patient was delivered to the nuclear l 2.2.3 Radiopharmaceutical Therapy medicine department. Misadministration The patient's identity was not correlated with the correct study. Two of the therapy misadministration reported for The patient answered to the wrong name. 1988 involved radiopharmaceutical therapy. One of the two misadministration involved the administration of Relatively simple quality assurance procedures (check-7.5 millicuries of phosphorus-32 sodium phosphate, ing the patient's identification against the study and the instead of the prescribed dosage of 4 millicuries of the patient's medical history; asking the patient to state his same radiopharmaceutical. The error resuhed from the or her name) might reduce the frequency of these incorrect calculation of the dosage to be administered. events. 2.3.1 Diagnostic Misadministration of Iodine In the other case, the patient received a dose of iodine-131 that was 14 percent higher than the in-Imicensees reported seven diagnostic iodine-131 misad-tended dose. The radiopharmacy that dispensed the ministrations during 1988. Two iodine misadminstra-dosage used inadequate procedures to assay the tions involved the administration of the wrong dosage iodine-131 dosage in the dose calibrator. The hospital of iodine-131 meta-iodobenzylguanidme for adrenal personnel involved in the administration of the dosage procedures. These procedures were performed under assumed that the radiopharmacy had sent the requested an investigational exemption for a new drug (IND).* dosage and proceeded with the administration. The error in both cases was due to the personnel being unfamiliar with performing these new procedures and 2.3 Diagnostic Misadministration their rnisunderstanding the dosage order. As a result of admmistering the wrong dosage, the patient s adrenal Of the 393 reports of diagnostic misadministration re, medullae received about 300 md instead of the esti-ceived during 1988,292 involved the administration of rnated intended dose of 50 rad. the wrong radiopharmaceutical 'o a patient and 85 in-Another two of the seven misadministration involved volved the adminstration of a rauapharmaceutical to an error in verifying the patient's identification, the the wrong patient (these two types of misadministra-tions accounted for 96 percent of the reported misad- .NRC materials heenseesdiagnostic radiopharmaceutical or anyiu ministrations). Of the remammg diagnostic misad-byproduct material in a ministrations, six involved a route of administration generator or reagent kit for preparation and diagnostic use of a h" other than that intended by the prescribing physician, $73nd $5'" ib'r i eda ain cd c and ten involved a diagnostic dose of a radiophar-Investigational Exemption for a New Drug" dND) or approved a maceutical that differed from the prescribed dose by "New Drug Apphcation tNDA)." H-5 NUREG-1272, Appendix B

AEOD Annual Report,1988 radiopharmaceutical labels, and the procedures pre-supply many hospitals, a single mislabeling event could scribed. As a result, the patient's thyroid received 8 rad result in multiple patients being administered the in one case and 300 rad in the other case rather than wrong radiopharmaccatical. the intended dose. Such an event occurred on April 28,1988, and involved In the fifth misadministration, a misunderstanding of the dispensing by a radiopharmacy of 17 patient dos-the physician's order was made. As a result, the patient ages of technetium-99m (Tc-99m) sodium pertech-was administered 218 microcuries of iodine-131 hip-netate improperly labeled as Tc-99m methylene dis-puran for a renogram instead of an ultrasound study. phosphonate, a bone imaging agent.His event resulted The licensee estimated a patient dose of 10 rad to the in 14 diagnostic misadministration at seven hospitals, thyroid,6 millirad to the total body, and 2 rad to the NRC attributed the mislabeling error to the radiophar-kidneys. macy's lack of control of licensed activities. In the sixth aise, the nuclear medicine personnel did As previously indicated in this appendix, the calculated 1 not read the vial label, and, as a result, the patient re-crror rate for diagnostic misadministration from re-l ceived 262 microcuries of iodine-131 instead of the in-ported data is very lo-;,0.01 percent; however, radio- ) tended 262 microcuries of iodine-123. nc estimated pharmacy practice appears to be an area where efforts i thyroid dose from iodine-131 was 440 rad instead of the expended to reduce human errors could be productive. l intended dose of 2 rad. ) 2.4 Abnormal Occurrences The seventh case involved a misreading of the dosage. As a result, a lactating patient was administered 108 In the Report to Congress on Abnormal Occurrences microcuries of iodine-131 instead of the intended 108 (AO) for the first three quarters of 1988, seven medical microcuries of iodine-123.nc patient received an esti. misadministration events reported by NRC licensees mated thyroid dose of 100 rad instead of the intended and four events reported by an Agreement State licen-1 estimated dose of 700 millirad. see were determined to be AOs. The iodine-131 misadministration that were reported The AOs for NRC licensees included-during 1988 delivered organ doses that ranged from 2 a rnedical therapy misadministration that involved rad to 440 rad.The underlying causes of these misad-ministmtions appear to have been (1) personnel who a patient receiving a radiopharmaceutical were unfamiliar with procedures because the proce. (phosphorus-32) dosage in excess of that pre-dures were new or infrequently performed, (2) error in scribed; verifying the patient's identification, (3) misunderstand-iag of the physician's order, and (4) misreading of vial a medical therapy misadministration that involved and dosage labels. treatment of the wrong side of a patient's pelvis; %c diagnostic iodme misadministration that were re-twenty-one medical therapy misadministration + ported to the NRC during 1988 did not include any that had occurred dunng 1985 and 1986, but were events in which the thyroid received nearly a therapy-reported to the NRC in April and May of 1988; equivalent dose. Therefore, these 1988 events were less a medical diagnostic misadministration in which senous than some reported in previous years. the patient received the wrong radiopharmacy: ti-cal; 2.3.2 Diagnostic Misadministration that involve the Mislabeling of Radiapharmaceutical Doses by a medical diagnostic misadministration that in-Radiophannacies volved a p:.tient receiving a radiopharmaceutical The mislabeling of radiopharmaceutical doses accounts for approximately 10 percent of the reported misad-a rnedical diagnostic misadministration involving ministrations. About 60 percent of these diagnostic an 1ND containing iodine-131; and misadministration result from mislabeled doses being dispensed by radiopharmacies. The causal factors asso-a medical therapy misadministration involving i ciated with the mislabeling of radiopharmaceutical brachytherapy. l doses by radiopharmacies (simple human error result-ing from inattention to details) are generally the same Details of the first two events and the last event are as for hospitals. Ilowever, because radiopharmacies can given in Section 2.2 of this appendix. ne 21 therapy NUREG-1272, Appendix B H-.6

Nonreactors-Medical Misadministration misadministration resulted from an error in the calcu-tic misadministration in which a patient received 1,000 lation of the teletherapy " beam on-time," using infor-times more iodine than the scheduled procedure re-mation generated by a treatment planning computer. quired. The technician ordered the wrong amount of The diagnostic misadministration in which the patient received the wrong drug occurred when a student tech-nologist picked up the wrong syringe; and the diagnostic Two of the four events from Agreensent State licensees misadministration involving the administration of more involved the use of computer treatment programs. In than the prescribed arnount of a radiopharmaceutical the first of these events, there was an error in the re-dosage occurred because a technologist handed the dundant use of wedge factors that had already been crong syringe to a physician who injected the material incorporated in the computer program that was used without properly checking the material or determining f]r dose treatment planning. In the second, a computer the procedure for which it was administered. program file that had not been updated when a source change was made was used in dose treatment planning. The diagnostic misadministration involving the IND resulted from the technologist failing to find the proper dosage that was listed in the hospital's procedures. The fourth Agreement State event involved a telether-apy misadministration in which the wrong part of a pa-There were four AOs in Agreement States. In one tient's brain was exposed to radiation when a port on event, an Agreement State reported a medical diagnos-the teletherapy device was misaligned. l l l l l l l 1 11-7 NUREG-1272, Appendix B

3 Licensee-Proposed Corrective Actions The dominant corrective actions proposed by licensees Since the corrective actions and their effectiveness are were (1) retraining of personnel; (2) implementing new licensee specific, a meaningful determination of radiopharmaceutical labeling and handling procedures; whether corrective actions were effective would have to (3) implementing c.:w procedures for patient focus on the trend in misadministration rates for each identification; (4) implementing new procedures that licensee tnat reported several misadministmtions. require the technologist to check the patient's chart for llecause the highet.t misadministration rate estimated the physician's orders; and (5) reprimanding the for a sample of licensees was 0.1 percent, neither a technologist or other personnel. detailed evaluation of these rates nor the associated corrective actions have been inade. 1 l l 1 1 11-9 NUREG-1272, Appendix B

4 Findings and Conclusions Licensees reported 12 therapy misadministration dur-about the same as those reported for 1987. De causes ing 1988, a number somewhat higher than the number reported by licensees for 1988 are, generally, simple for previous years. Both the teletherapy and brachy-errors associated with (1) preparation of radiophar-therapy misadministration that occurred during 1988 maceuticals, (2) processing nuclear medicine requisi-might have been prevented by quality assurance proce-tions, and (3) patient identification. In addition, for dures that demanded verifying dose calculations, the misadministration involving the administration of type of treatment, and patient identificaten. iodine-131, the primary causes given were (1) personnel Essentially all of the diagnostic misadministration for who were unfamiliar with performing procedures be-1988 involved either the administration of the wrong cause the procedures were r.cw or infrequently per-radiopharmaceutical or the administration of a radio. formed, (2) error in verifying the patient's idertifica-pharmaceutical to the wrong paticnt. The number, tion, (3) misunderstanding of the physician's order, and type, and cause of diagnostic misadministration are (4) misreading of vial and dosage labels. l l l l l l ll-lI NUREG-1272, Appendix B

Appendix C Summary of 1988 Abnormal Occurrences-(Nonreactors) i i l

Abnormal Occurrences (AO) for CY 1988 (Nonreactors) Report No. AO No. Title of AO NUREG-0090 Description of Event NRC Licensees 88-4 Medical Diagnostic Vol.11, No.1 On November 23,1987, at Veterans Administration Medical Misadministration Center Albuquerque, New Mexico, a patient was admin-istered 50 : millicuries of technetium-99m instead of 3 mil-licuries of thallium-201 prescribed by the physician.The licensee reported that there were no deleterious effects on the patient. The misadministration was caused by a student technologist selecting the wrong syringe from the dosage cart. Corrective actions by the licensee included reprimand of the student technologist, new procedures for radiopharmaceutical labeling and handling, retraining of personnel, and improved supervision. l 88-6 Release of Vol.11, No.1 On January 21,1988, at Ashland Chemical Company, Easton. Polonium-210 from Pennsylvania, and subsequently at various other locations, it Static Elimination was found that static elimination devices manufactured by Devices Manufac-3M Company, St. Paul, Minnesota, had failed and caused tured by 3M radioactive contamination. The polonium-210 in these devices Company is contained in microspheres of zirconium pyrophosphate that have been plated wdi nickel and held in place with an epoxy adhesive. A por tulated cause of the failures is mois-ture or solvents in the environment that affect the epoxy adhesive that holds the radioactive material in the device. 'lhe licensee is investigating the cause of the failures. Plants where contamination has been found have been cleaned up. All 3M Company devices are being returned to the manufac-turer, with a few exceptions perraitted by NRC. No adverse health effects are expected because of the defective devices, and none have been found. 88-7 Medical Thcmpy Vol.11, No.1 Or. February 4,1988, a technician at the Medical X-Ray Misadministration Center, Sioux Falls, South Dakota, miscalculated the prescribed desage; a patient was administered 7.5 millicuries phosphorus-32 instead of the 4.0 millicuries prescribed by the physicir.n. 'Ihere were no apparent effects on the patient, and blood counts several weeks later showed normal blood elements. The technician adminhtering the dose was (cont.) C-1 NUREG-1272, Appendix C

AEOD Ar.nual Report,1988 Report No. AO No. Title of AO NUREG-0090 Description of Event NRC Licensees (cont.) 88-7 (cont.) reinstructed in the proper technique for calculating therapy doses and for reviewing the written physician orders prior to administering the doses. 88-8 MedicalTherapy Vol.11, No.1 On February 23,1988, the NRC was notified by St. Joseph's Misadministration Hospital, Milwaukee, Wisconsin, that a patient with a 10-year history of bladder cancer received a cobalt-60 radiation dose of 2,000 rad to the wrong side of the pelvis.The radiation therapist had prescribed treatment to the dorsal spine and left pelvis. However, a therapy tecimologist set the patient up and marked the right pelvis. The physicist, the chief technologist, and the dosimetrist did not notice the error. The patient exhibited no adverse aftereffects as a result of the misadministration. Because there was probably disease tht aughout the pelvic region, the dose given to the right pelvis could be cons,idered prophylactic treatment. The licensee agreed to develop and implement procedures that i require its staff to thoroughly review and implement proce-dures that require its staff to thoroGghly review all aspects of therapy prescriptions and treatment parameters when the following events occur: (1) during the initi-1 dose calculations, (2) just prior to initial treatment, and (3) during weekly chart checks. 88-9 Significant Wide-Vol.11, No.1 The violations occurred in Case Western Reserve University's spread Breakdown (Cleveland, Ohio) research program activities, not in in Radiation Safety medical care and treatment of patients. NRC inspections Program at Case during November and December 1987 identified about 20 Western Reserve violations of F9C requirements, involving the '. raining of University Research laboratory personnel, radiation safety practices, and control Laboratories and oversight of the laboratories using radioactive materials. Rese violatior:s and tbc failure to adequately correct past violations demonstrated a serious, widespread breakdown in the management of the hcensee's radiation safety program. Following suspension of all NRC-licensed work, tne licensee retained an interim Radiation Safety Officer, provided training to labomtory workers, and expanded the work of its consultant to review all laboratories for comnliance with University and NRC requirements. Extensive programmatic changes were made to the licensce's radiation safety program. There was no evidence that any workers or members oi the public received a significant radiation (cont.) NUREG-1272, Appendix C C-2

Nonreactors-Abnormal Occurrences Report No. AO No. Title of AO NUREG-0090 Description of Event . E'RC Licensees (cont.) 88-9 (cont.) exposure as a result of the violations found in the licensee's radiation safety program. On February 26,1988, the NRC issued to the licensee a proposed $10,000 civil penalty. The licensee paid the civil penalty. 88-10 Significant Breakdown Vol.11, No. 2 On March 24,1988, the NRC conducted a special, in Management and unannounced inspection at Riverton Memorial Hospital-Procedural Controls Health Trust, Inc., in Riverton, Wyoming. The inspec-at a Medical Facility tion was to assess the licensee's corrective actions taken as a result of nine violations identified in a previous inspection performed on September 30 and October 1, 1986; the violations resulted in a $2,500 civil pensity. The March 24,1988, inspection identified eight violations, four of them were the same as violations from the previous inspec-tion and two were related to previous findings.The causes were attributed to significant deficiencies in management oversight and control of the licensed program. On June 3, 1988, the NRC issued a proposed civil penalty of $5,000. The licensee took corrective actions, including hiring a consultant company to audit the hospital's radiation protection program for one year, at quarterly intervals. 88-11 Medical Diagnostic Vol.11, No. 2 On June 9,1988, a patient at the Veterans Administration Misadministration hMcal Center (Wadsworth), Ims Angeles, California, was administered a dose of 15 millicuries of technetium-99m diethylenetriaminepentaacetic acid (DTPA) for a bone metabolism, which exceeded the prescribed dose by a factor of 1,000. The licensee stated that no untoward effects on the patient were anticipated. The cause was due to the failgte of both a technician and a resident physician to follow protocol for radiopharmaceutical injections. As corrective action, the Chief of Service immediately conducted a review and discussion of injection procedures for all nuclear medicine staff members. ] 88-12 Multiple Medical Vol.11, No. 3 On April 6,1988, Marquette General Hospital, Marquette, I Therapy Misadmin-Michigan, reported to the NRC that a medical physicist, istrations conducting a quality assurance review of patient treatment records, discovered that the doses given to two patients a (cont.) ( C-3 NUREG-1272. Appendix C

AEOD Ancual Report,1988 Report No. AO No. Title of AO NUREG-0090 Description oY Event NRC Licensees (cont.) 88-12 (cont.) undergoing breast irradiation in November 1985 and March 1986 were about 85 percent of the prescribed doses. On May 5,1988, the licensee reported that 19 similar mis-administrations had been discovered during 1985 and until October during 1986 (when the procedure was discontinued). No medical damage to the patients was expected. The cause was due to an error in the manual calculations that were performed on the output of treatment planning computer. o De licensee submitted a quality assurance program to prev ~nt this type of event; the program was incorporated into the licensce's license. 88-13 Medical Diagnostic Vol.11, No. 3 On June 27,1988, a patient at the Fairfax liospital, Falls Misadministration Church, Virginia, was administered 2.7 millicuries of iodine-131 meta-iodobenzylguanidine (MIBG) rather than the intended dose of 500 microcuries of iodine-131 MIBG. This resulted in an estimated adrenal medullae dose of 268 rad. The thyroid burden should be negligible because the thyroid had been blocked with Lugols, as prescribed in the protocol. The patient exhibited no adverse health effects. He cause was due to a technologist's error in overlooking the proper dosage as listed in the department's procedure manual. The technologist was admonished and retrained. 88-14 Medical Therapy Vol.11, No. 4 On November 17,1988, a patient at Wilkes-Barre General Misadministration Hospital,Wilkes-Barre, Pennsylvania, being treated for an endo-bronchial tumor, received a dose of 1,800 rad rather than the prescribed dose of 750 rad to the right bronchus at a distance of 0.5 centimeters from an iridium-192 source. The licensee stated that no adverse healtn effects were anticipated and that the dose received by the tumor is within standard treatment protocols for that type of tumor.He cause was due to human error; the staff radiotherapy physicist used the wrong table of the manual that is used to develop s a treatment plan. As corrective actions, the license established a double independent verincation of treatment calculations, provided additional training, and provided an additional chart for determining maximum treatment times for each treatment plan. (cont.) NUREG-1272 Appendix C C-4

Nonreactors-Abnormal Occurrences i I Report No. AO No. Title of AO NUREG-0090 Description of Event Agreetnent State Licensees AS88-1 Radiation Injury Vol.11, No.1 On November 16,1987, two radiographer at North Shore to Two Radiographer X-Ray and Testing Company, Houston, Texas, received radiation burns caused by overexposure in the range of 860-1940 rem on the skin of one ankle. Apparent causes were a source that was in an exposed position and radiation surveys that were not properly conducted. Corrective actions by the licensee included stressing the importance of using the survey meter for employees performing radiography. I AS88-2 Radioactive Matcrial Vol.11, No. 2 On January 27,1988, a Model SPEC 2T radiographic Released during a exposure device, containing a 48 curie iridium-192 Transportation radioactive source, fell from the back of a Texas Accident licensee's (Houston Inspection Laboratories, Inc., Houston, Texas) truck onto a roadway. A vehicle following the truck struck the device and dragged it for a con-siderable distance. At some point during these c 'nts, the source became separated froin the device. '1he licensee found the source along the roadway the following day. The causes were due to the device not being properly secured for transportation and the employees not following procedures. Corrective actions included upgdrading procedures for handling and securing the exposure device. The State Agency issued a proposed administration penalty of $10,000 to the licensee. AS88-3 Medical Diagnostic Vol.11, No. 3 On May 17,1988, a patient at West Houston Medical Misadministration Center, Houston, Texas, scheduled for a diagnostic scan of the thyroid, was mistakenly administered 30 millicuries of iodine-131 in capsule form, rather than the prescribed dose of 30 microcuries of iodine-131 in capsule form. This resulted in an estimated dose to the thyroid of over 30,000 rad, which would be expected to destroy the thyroid's function. The cause was attributed to human error; the technologist placing the order for the radiopharmaceutical mistr.kenly said milli-curies, rather than microcuries. For corrective actions, the licensee is rewriting its protocols for each procedure to main-tain stricter controls on ordering and administering radiopharmaceuticals. (cont.) C-5 NUREG-1272, Appendix C i-

AEOD Annual Report,1988 Report No. AO No. Title of AO NUREG-0090 Description of Event Agreement State Licensees (cont.) AS88-4 Multiple Medical Vol.11, No. 4 Between January and August 1988, several patients at Therapy Misadminis-Rochester Hospital, Monroe County, New York, received trations cobalt teletherapy misadministration. Fourteen received doses exceeding the prescribed total doses by greater than 10 percent; the largest total overdose was 81 percent. In addition, five patients received fractional doses that exceeded the prescribed dose per fraction by greater than 50 percent, although their treatments were terminated before the total error exceeded 10 percent; the largest fractional overdose was 119 percent. An outside radiation oncologist was brought in, who is evaluating any possible effect on the patients. 'lhe cause is attributed to data factors for treatment calculations being mistakenly changed when a software upgrade was loaded into the computer. The inadvertent cham;e of data factors was due to lack of supervision, inadequate quality assurance, and an inadequate program to identify and climinate errors. These deficiencies are being addressed by the licensee. ASSS-5 Medical Therapy Vol.11, No. 4 Between August 8 and August 26,1988, an 81-year-old Misadministration patient at Sacred Hesrt Hospital, Cumberland, Maryland, received a total therapeutic dose of 1,400 rad to the wrong part of the body. The patient was scheduled to receive a total dose cf 3,000 rad to the right maxillary sinus from two ports of a.obalt-60 teletherapy unit. However, the hospital oncologist misaligned, me ri tt:e ports, which resulted in the base of the brair erroneously receiving 1,400 rad.The oncologist stated that the dose to the base of the brain did not result in any medical side effects. later, treatment to the right maxi!!ary sinus was resumed to deliver the originally prescribed total dose of 3,000 rad. As corrective actions, the oncologist stated she would exercise increased vigilance and alertness. Later, the State Agency discussed with the oncologist various + procedural changes to help preven, recurrence. AS88-6 Multiple Medical Vol.11, No. 4 Between September 1987 and Octoacr 1988,33 " terminal" Therapy Misadmin-patients, receiving palliative brain tu.nor treatments at istrations Sacred Heart Hospital, Cumberland, Maryland, received doses 75 percent in excess of the presciber! doses.The cause was attributed to the hospital onw;cgi t using a computer (, (cont.) NUREG-1272, Appendix C C-6

Nonreactors-Abnormal Occurrences Report No. AO No. Title of AO NUREG-0090 Description of Event Agreement State Licensees (cont.) AS88-6 (cont.) program file that had not been upgraded when a sor ce change was made in March 1987. During the 13-month period, the therapy staff L ad noted severe skin erythemas on several of the patients and had expressed their concerns to the hospital oncologist; the ancologist, however, determined the crvthemas to be normal Curing treatment. Finally, the staff notified the hospital's co tsulting physicist who found the computer error and verified tt e misadministration. During the investigation, the hospital ruspended the oncologist, removed her as Radiation Safe ty Officer, and removed her as Chairman of the Medical Isot spes Committee.The hospital hired two interim oncologists and is actively pursuing hiring a full-time oncologist. Both the licensee and the State Agenc/ have hired consultants to evaluate the occurrences and tW, effects on the patients. State Agency enforcement action is pending receipt of the written reports from the independent consultants. C-7 NUREG-1272, Appendix C

i, Ap. endix D p Reports Issued from 1981 through 1988 (Nonreactors) -_--__.m._.___________ ,m,___,',_____

Nonreactor Reports Issued fmm 1981 through 1988 Nonreactor Reports Issued in 1988 l Special Study Reports Date Title No. Aut!.ar 09/88 Review of Events at Large Pool-Type Irradia; ors S807 E. Trager (NUREG-1345, March 1989) Engineering Evaluations Date Title No. Author 10/88 Report on 1987 Nonreactor Events N801 K. Black 10/88 Medical Misadministration Reported to NRC N802 S. Pettijohn for the Period January 1987 through December 1987 Nonreactor Reports Issued in 1987 Special Study Reports Date Title No. Author l 10/87 Radiography Overexposure Events Involving S703 S. Pettijohn Industrial Field Radiography Engineering Evaluations Date Title No. Author l 01/87 Diagnostk Misadministration Involving the N701 S. Pettijohn Administranon of Mi!!icuric Amounts of lodine-131 03/87 Diagnostic Misadministration Reported 'o NRC N702 S. Pettijohn i I for the Period January 1986 through Dec:mber 1986 03/87 Report on 1986 Nonreactor Events N703 K. Black Technical Review Reports Date Title No. Author 11/87 Review of Data on Teletherapy Misadministration.s 'I711 S. Pettijohn Reported to the State of New York that were the Title of PNO-I-87-74A 12/87 Distribution of Information Notices and Other "Ma 1 'I714 S. Pettijohn Mailing" Information Licensees that have Users at locations Remote froi. the Headquarters locations D-1 NUREG-1272, Appendix D

AEOD AnnualReport,1988 Nonreactor Reports Issued in 1986 Case Studies Date Title No. Author 08/86 Rupture of an lodine-125 Brachytherapy Source C601 S. Pettijohn at the University of Cincinnati Medical Center Engineering Evaluations Date Title No. Author l 06/86 Report on 1985 Nonreactor Events and Five-Year N601 K. Black Assessment for 1981-1985 06/86 Medical Misadministration.s Reported for 1985 and Five-N602 S. Pettijohn Year Assessment of 1981-1985 Reports 1 I Nonreactor Reports issued in 1985 Case Studies Date Title No. Author 12/85 Therapy Misadministration Reported to NRC C505 S. Pettijohn Pursuant to 10 CFR 35.42 Engineering Evaluations Date Title No. Author 05/85 Summary of the Nonreactor Event Report Data Base N501 K. Black for the I criod January-June 1984 06/85 Summary of the Nonreactor Event Report Data Base N502 K. Black for the Period July-December 1984 07/85 Report on Medical Misadministration for N503 S. Pettijohn January 1984-December 1984 Nonreactor Reports Issued in 1984 Case Studies Date Title No. Author 09/84 Breaching of the Encapsulation of Scaled C405 S. Pettijohn Well-Logging Sources (cont.) NUREG-1272, Appendix D D-2

Nonreactors-Reports; 1981-1988 Engineering Evaluations Date Title No. Author 05/84. Report on Medical Misadministration for January 1983 N204D S. Pettijohn through June 1983 06/84 Nonreactor Event Report Database for the period N401 K. Black July-December 1983 06/84 Events Involving Undetected Unavailability,y of the N402 E. Trager Turbine-Driven Auxiliary Feedwater Train 07/84 Report on Medical Misadministration for July 1983-N403 S. Pettijohn December 1983 Noarcactor Reports Issued in 1983 Engineering Evaluations and Technical Reviews Date Title No. Author 01/11 Nonreactor Event Report Database fer the N209A E. Trager Period January-June 1982 03/18 I-125/I-131 Effluer. Releases by Material Licensees N301 S. Pettijohn 06/10 Mound Laboratory Fabricated Pulle Sources N302 K. Black 06/10 Americium Contamination Res. ting from Rupture of N303 K. Black Well-Iogging Sources 06/14 Nonreactor Event Report Database from July through N209B K. Black December 1982 07/14 Americium-241 Sources N304 07/14 Report on Medical Misadministration for January 1981 N204C S. Pettijohn -December 1982 12/01 Potentially Leaking Americium-241 Sources Manufactured N306 S. Pettijohn by Amersham Corporation 12/28 Nonreactor Event Report Database for the period January N307 K. Black -June 1983 03/10 Internal Exposure to Am 241 NT301 K. Black 04/05 Kay-Ray, Inc. Reports of Suspected Leaking Scaled NT302 S. Pettijohn Sources Manufactured by General Radioisotope Products 08/24 Possession of Unauthorized Scaled Source / Exposure NT303 S. Pettijohn Device Combinations by Mid-Con Inspection Services, Inc. 1)-3 NUREG-1272, Appendix D

AEOD Annual Report,1988 Nonreactor Reports issued in 1982 Engineering Evaluations Date Title No. Author 02/82 Report on Medical Misadministration for the Period N201 S. Pettijohn November 10,1980-September 30,1981 01/82 Buildup of Uranium-Bearing Studge in Waste N202 K. Black Retention Tanks 02/82 lost Plutonium-238 Source N203 K. Black 03/82 Report on Medical Misadministration for CY 1981 N204 S. Pettijohn 04/82 Preliminary AEOD Review of Iodine-125 Scaled N205 E. Trager Source leakage incidents 05/82 Eberlien Instrument Corporation-Part 21 Report N206 K. Black 05/82 AEOD Review of Iodine-125 Scaled Source N207 E. Trager leakage Incidents 08/82 Potentially lxaking Plutonium-Beryllium Neutron N208 S. Pettijohn Sources 08/82 A Summary of the Nonreactor Event Report Database N209 K. Black for 1981 11/82 Iraking Iloses on Self Contained Breathing Apparatus N210 K. Black (SCH A) Manufactured by MSA Nonreactor Reports Issued in 1981 Engineering Evaluations Date Title No. Author 03/81 Interim Report on Brown Boveri Betatron N101 E. Trager Calibration Check Source 03/81 Irradiator incident at an Agreement State Licensee's N102 K. Black Facility (Becton-Dickinson, Broken Bow, Nebraska) 04/81 Interim Report on the October 1980 Fire at the N103 E. Trager Sweetwater Uranium Mill 04/81 Interim Report on the January 2,1981 Fire at the N104 E. Trager Atlas Uramum Mill 05/81 Interim Report on Tailings Impoundment Liner N105 E. Trager Failure at the Sweetwater Uranium Mill 08/81 Review of Reports of leaking Radioactive Sources N106 E. Trager 12/81 Engineering Evaluation of Fire Protection N107 E. Trager at Nonreactor Facilities (cont.) NUREG-1272, Appendix D D-4

Nonreactors-Reports; 1981-1988 Nonreactor Reports Issued in 1981 (cont.) Engineering Evaluations (cont.) Date Title No. Author 12/81 Notes on AEOD Review of Emissions from N108 E. Trager Tritium Manufacturing and Distribution Licensees l D-5 NUREG-1272, Appendix D

Appendix E i Status of AEOD Recommendations r.

Appendix E Status of AEOD Recommendations The Office for Analysis and Evaluation of Operational Formal recommendations are tracked and listed in this Data (AEOD) tracking system ensures that all formal section. Additionally, actions based on AEOD sugges-AEOD recommendations are tracked until resolution is tions contaired in engineering evaluations and special achieved. At this time, no issues involving AEOD rec-reports are routinely implemented by NRC program commendations are unresolved that would warrant the offices. These AEOD suggestions are not formally attention of the Executive Director for Operations. tracked or closed out by AEOD. AEOD Recommendation Tracking System Outstanding Recommendations

Recommendation Source:

Case Study AEOD/C601 Responsible AEOD Engineer: H. Karagiannis (Author: S. Pettijohn) Title or

Subject:

" Rupture of an Iodine-125 Brachytherapy Source at the University of Cincinnati Medi-cal Center" Recommendation 3: NMSS shodld consider evaluating during the license issue, renewal, or amendment l process licensee procedures for reusing high activity iodine-125 seeds in treating l multiple patients. Responsible Office /Div/Br Contact Priority NMSS/IMNS/IMAB J.GIenn N/A Status: NMSS/IMNS/IMAB will reach a decision on this recommendation by September 1989. Recommendation Source: Case Study AEOD/C505 Responsible AEOD Engineer: K. Black (Author: S. Pettijohn) Title or

Subject:

' Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42" Recommendation 4: In addition, to the extent that the NRC implements Recommendation 3, the action should be made an item of compatibility for Agreement States. Responsible Office /Div/Br Contact Priority GPA/SLITP V. Miller N/A Status: Action will be taken subsequent to action on Recommendation 3, which was incorpo-rated into a rulemaking on Quality Assurance in Radiation Therapy.

In each case, the number of the recommendation is the same as the number on the original case study.

E-1 NUREG-1272, Appendix E

NRC Fomu 335 U.S. NUCLE AR REGULATORY COMMissl0N

1. RE PORT NUMBE R NAC es e say7 11C2 car mNm 32m. 3m '

BIBLIOGRAPHIC DATA SHEET .UREG-1272 J (500 anstruCttons On the reversel Vol. 3, d.o. 2

2. TITLE AND SUBTITLE AEOD Office for Analysis and Evaluation of Operational Data 1988 Annual Report - Honreactors 3

DATE REPORT PUBLISHED A10 NTH

iAR June 1989

4. FIN OR GR ANT NUMBE R

5. AUTHORisi

6. TYPE OF REPORT dulua.L summry of regalatory activities for Hon-w w+rme'

1. PE R IOD COVE R E D concius n Dares, CY 1988

e. PE.R FO,,,Ruu,NG,.ORGA,Naz ATsON - N Auf AND ADDR eSS uor unC. ore.

o,s,on. orr,c.or e. eon. v. A neuan., n,esarer, comm,ss on.,ns m. o nu ascess or contr cror. oro,,e n. o,m Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Coranission Washington, D.C. 20555

9. SPONSORING OR G ANIZATION - N AM E AND ADDR ESS car nonC, ryou "samo u scon ~. ir onernerer.oroveer nrnC Divis,on. Oronce ar nes,on. V A nrocker nerektory Commswon, c

000 M96,long gcIsrpsso Same as in item 8

10. SUPPLEMENTARY NOTES

11. ABSTRACT 1200 estes or was Tne annual report of the U.S. iiuclear Regulatory Comission's Office for Analysis and Evaluation of Operational Data (AEOD) is devoted to the activities performed during 1938. Tae report is published in two separate parts. NUREG-1272, Vol.3, No. 1, covers Power Reactors and presents an overview of the operating experience of the nuclear power industry, including comments about the trends of some key performance measures. The report also includes the principal findings and issues identified in AEOD studies over the past year and summrizes information from Licensee Event Reports, Diagnostic Evaluations, and mports to NRC's Operations Center. NUREG-1272, Vol.3, No.2, covers Nonreactors and presents a review of nonreactor events and misadminis-trations that were reported in 1988 and a brief synopsis of AEOD studies published in 1988. Each volume contains a list of the AEOD reports issued for 1980-1988.

12. K E Y WORDS/DESCR:P10HS (tas woros or onreses ener wais msese reses,eners na emime ene seoon s i3 Ava LAsiuT v siattutNT Unlimited nonmaCtors i.. secun T y comme. cation medical misadministmtions

& mal courm nces Unclassified AEOD recommendatrns ,..,,o,,, AEOD mport listing Unclassified

15. NUMBER QF PAGE S

16. PR ECE NaC FOAu 336 (749-

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