ML20056B549
| ML20056B549 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1990 |
| From: | NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | |
| References | |
| NUREG-1272, NUREG-1272-V04-N02, NUREG-1272-V4-N2, NUDOCS 9009040059 | |
| Download: ML20056B549 (68) | |
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r AVAILABILITY NOTICE Availability of Reference Materials Cited in NRQ Publications Most documents cited in NRC publications will be avallatte 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. Govemment Printing Office P.O. Box 37082, Washington, DC 20013 7082 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 NRC Public Document Room include NRC correspondence and Internal NRC memorandal NRC Office of Inspection and Enforcement bullotins, circulars, information notices, inspection and investi-gation noticest Licensee Event Reportst vendor reports and correspondencel Commission paperst and applicant and licensee documents and correspondence.
The following documents la the NUREG series are avellable for purchase from the GPO Ssles 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 Nucler.r 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, joumal and periodical articles, and transactions. Federal Register notices, federal and state legislat!on, and congressional reports can usually be obtained trom 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 Offics of Information Resources Management, Distribution Section, U.S.
Nuclear Regulatory Commission, Washington, DC 20555.
Copies of industry codes and standards used in a substantive manner 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, l
New York, NY 10018.
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F E ~) '~ C " N F
ANALYSIS AND EVALUATION OF OPERATIONAL DATA
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1989 ANNUAL REPORT ps NONREACTORS s
.i U.S. NUCLEAR REGULATORY COMMISSION 4
JULY 1990 The map on the cover highlights in white those States for which NRC continues to regulate the use of radioactive material in nonreactor applications. The other States have signed agreements with NRC allowing them to perform this role.
4 i
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 o
o Semiannual Report, July-December 1984, AEOD/S$02, April 1985 o
Annual Report 1985, AEOD/S601, April 1986 Report to the U.S. Nuclear Regulatory Commission on Analysis and Evaluation of Operational Data-1986,
.O NUREG-1272, AEOD/S701, May 1987 Report to the U.S. Nuclear Regulatory Commission on Analysis and Evaluotion of Operational Data-1987, Power o
Reactors, NUREG-1272, AEOD/S804, Vol. 2, No.1, October 1988 Report to the U.S. Nuclear Regsdatory Commission on Analysis and Evaluation of OperationalData-1987, Non-o reactors, NUREG-1272, AGOD/S804, Vol. 2 No. 2, October 1988 Of]icefor Analysis and Evaluation of Operational Data 1988 Annual Report, Power Reactors, NUREG-1272, Vol,3, o
No.1, June 1989 Officefor Analysis cnd Evaluation of Operational Data 1988 AnnualReport, Nonreactors. NUREG-1272, Vol. 3, o
r No. 2, June 1989 V
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De annual report of the U.S. Nuc1 car Regulatory information from such sources as licensee event re-
' Commission's Office for Analysis and Evaluation of ports, diagnostic evaluations, and reports to the NRC's
. Operational Data (AEOD)is devoted to the activities Operations Center. This report also compiles the status
- performed during 1989. The report is published in two of staff actions resulting from previous incident Investi-p L separate parts. NUREG-1272, Vol. 4, No.1, covers gation Team (irr) reports. NUREG-1272, Vol. 4, power reactors and presents an overview of the operat-No. 2, covers nonreactors and presents a review of the -
ing experience of the nuclear power industry from the events and concerns during 1989 associated with the NRC perspective, including comments about the trends use of licensed material in nonreactor applications, of some key performance measures. The report also such as personnel overexposures and medical misad-includes the principal findings and issues identified in ministrations. Each volume contains a list of the AEOD ~
AEOD studies over the past year and summarizes reports issued for 1980-1989.
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lii NUREG-1272
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- j Contents Abst ract..................................... iii 2.1.2 Medical Misadministrations.............. 5 Abbreviations '................................ vil 2.1.2.1 Misadministrations Reported During 1989 6
. Execut ve ummary........................... ix 2.1.2.1.1 Therapy Misadministrations........... 6 i S 1. Introduction............................... 1 2.1.2.1.2 Diagnostic Misadministrations......... 6 i- - 2 ' Feedback From Nonreactor Licensee 2.1.2.1.3 Diagnostic Misadministrations of lodine. 7 Operational Erperience....................
3 2.1.2.2 Misadministrations Reported for I
1981'1989 *************** ***** ** 7 2.1 Overview of Operating Experience.........
3 2.2 Reporting of Abnormal Occurrences........ 8
- 2.1.1 Nonreactor Events.....................
3 2.3 Results of Selected AEOD Studies.......... 8 2.1.1.1 Events Reported During 1989..........
3 2.4 Selected Ongoing Technical Studies......... 8 2.1.1.2 Radiation Overexposure Events......... 4 2.5 Other Projects........................... 9 2.1.1.3 Other Types of Events................
5 3 S u mmary................................. 11 Appendices 4
A Report on 1989 Nonreactor Events D
Reports issued From 1981 Through 1989 il Medical Misadministration Report E
Status of AEOD Recommendations C
Summary of 1989 Abnormal Occurrences 4
Tables
'l' Types of Licensees That Submitted 3
Types of Licensees Associated With Over-Nonreactor Reports During 1989............ 3 exposure Events.......................... 4 4
Error Rate for Misadministrations 6
3 Categorization of Repons of Nonreactor Events That Were Reported During 1989..... 4 5
Misadministration Reports for 1981-1989.... 8 NUREG-1272 v
t
Abbreviations AEOD NRC's Office for Analysis and Evaluation NMSS NRC's Office of Nuclear Material Safety of Operational Data and Safeguards AO abnormal occurrence NRC U.S. Nuclear Regulatory Commission EPA
. U.S. Emironmental Protection Agency NRER nonreamor event repott FDA U.S. Food and Drug Administration ppm parts per million IND investigational exemption for a new drug QA/QC quality assurance / quality control 3M Minnesota Mining and Manufacturing Co.
SNM special nucicar material MPC maximum permissible concentration
(-
vii NUREG-1272
Executive Summary One of the activities of the Office for Analysis and which involved 486 patients,407 reports concerned Evaluation of Operational Data (AEOD)is the review diagnostic misadministrations. In addition, there were and evaluation of operating experience of nonreactor three misadmini>trations of iodine-131 in 1989 in which programs involving the use of materials licensed by the patients received thyroid doses of more than 1,000 rad.
t U.S. Nuclear Regulatory Commission (NRC), such as source material, natural and enriched uranium, and.
About 7 million diagnostic procedures and 180,000 byproduct materials.The AEOD review and evaluation therapy procedures are performed nationwide caen identifies safety-ugnificant events and concerns, their year, with about 40 percent of thcGe procedures being causes, and the trends mdicated by the events. When performed by NRC licensecs and the remainder by
' AEOD identifies a safety concern, the AEOD staff Agreement State licensees. There has not been a recommends agency actions to resolve the problems substantial difference in the number, type, or cause of
~ underlying the safety concern.
any of the medical misadministrations reported to the NRC in any year from 1981 to p89. The error rate for Approximately 8,000 licensees are authc red by the therapy and diagnostic misadmmistrations reported for
- NRC to possess and use licensed materials outside of 1989 was about 0.0001 (or 10- ) per patient, the same reactors. 'the majority of licensees (about 5,500) are as in the previous 8 years.
i tuthorized to use byproduct materials for such applica-tions as radiography, gauges, and well logging. Approxi-mately 2,500 licensees are authorized to administer in 1989, AEOD initiated preparation of a videotape on byproduct materials or radiation from byproduct mate-good practices in preparing and administering radio-rials to individuals for medical diagnosis or therapy, pharmaceuticals. This videotape, which was completed c
in the summer of 1990, utilized data from reported The dominant health concern associated with the use of medical misadministrations to identify those practices licensed materials is the possible damage that can occur that result in the most frequent types of misadministra-from overexposure to radiation. In 1989,28 nonreactor tions. The vidcotape illustrates those good practices events were reported to the NRC in which 40 individu-that are designed to avoid errors in preparing and als received exposurcs that were greater than those administering radiopharmaceuticals. Oak Ridge Associ-permitted by NRC regulations. All of the individuals ated Universitics wrote the script, and Argonne Na-were employees oflicensees.
tional1;iboratories filmed the videotape. Copies of the videotaps will be distributed to all NRC medical licen-The NRC received repcrts of 10 therapy misadministra-sees and Avecment States to improve the feedback of tions in 1989. Of the 417 reports received during 1989, experience to nuclear medical technologists.
ix NURl!G-1272
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1 Introduction v,
- 'Ihc NRC licenses the use of reactor-produced iso-resolve problems with potential safety-related implica-topes, the milling of uranium, and the subsequent tions.
processing of either natural or enriched uranium and
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special nocicar material (SNht). Certain States, re-The role of AEOD in the regulatory process is to ferred to as Agreement States, have the authority to provide a capability for the timely collection and analy-regulate the possession and use of these materials, sis of operating experience, independent of the routine g
except for large amounts of enriched uranium or SNht.
regulatory activitics associated with licensing, inspec-l tion, or enforcement, and to feed back the lessons
'Ihc NRC has approximately 8.000 licensecs authorized learned to the appropriate offices of the NRC, the L
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' to possess and use natural uranium and SNht (pre-affected portions of the industry, and the public.
L dominantly in support of the reactor fuel cycle) and AEOD implements this role in the nonreactor area byproduct materials of SNht. Of these licensecs, about through the analysis and evaluation of operational
$,500 are authorized t a use byproduct materials for safety data associated with the use of radioactive mi te-such applications as radiography, gauges, and well rials in nonreactor applications. AEOD publishes
~ logging. About 2,500 medical licensees are authorized -
studies of specific operational events and, as appropri-to administer byproduct materials or radiation from ate, recommends agency actions to reduce the probabil-these materials to individuals for medical diagnosis or ity that these events will recur with the same frequency
- th:rapy. A relatively small number of licensees use or will lead to more serious events.
_ uranium or SNht in fuct cycle operations.
AEOD tracks the recommendations contained in its NRC nonreactor licensees are required to reporg studies until they are resolved. The recommendations cvents such as those involving personnel overex.
are for internal action by the appropriate NRC pro-posure (10 CFR 20.405(a)), a leaking or contaminated gram office or regional office. The office to which the source (10 CFR 34.25). release of material (10 CFR recommendation is addressed is responsible for review-
- 20.40$(a)), lost or stolen materials (10 CFR 20.402), or ing and implementing the recommendation as appro -
A andoned well+ logging sources (10 CFR 39.77). Events prmte.
b may also be reported as required by a license condition AEOi) keeps informed of studies undertaken by other or may be 1ncluded in an inspection report. Generally, organtzations within the NRC and normally will not these licensed programs have little impact on the duplicate a study unless a particular need or a special public health and safety.
circumstance e-ists.'Ihus, the nonreactor staff of -
AEOD does not review in depth all nonrcactor events -
R.le of AEOD or operating problems.
'AEOD was established in 1979, reporting directly to AEOD also coordinates the overall NRC operational the Erreutive Director for Opemtions, as one of the data program and serves as a central point for interac-Commission's earliest major efforts toward improving tion with domestic and foreign organizations perform-the use of licensee operating experience to identify and ing similar work; q
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NUREG-1272, Section 1 e
2 Feedback From Nonreactor Licensee Operational Experience During 1989, the NRC received reports of a large data; the system may be used to identify trer'ds in number of events that irwolved NRC and Agreement operational safety events that may signal a need for States. This section provides an overview and summary remedial actions by the NRC, licensees, er both, of events involving nontcactor facilitics and medical misadministrations that were reported in 1989. Gener-2.1.1.1 Events Reported During 1989 ally, only a small fraction of events reported by Agrec-ment State licensecs is included in this report, for About 200 to 300 reports of events are received annu.
example, events that have been published in a prelimi-ally, or about 4 cvents per 100 licensees. The NRER nary notice of occurrence by one of NRC's regional database includes 279 records of events that were
- offices, entered during 1989.* Information on these events was contained in reports submitted by NRC licensees to the regional offices or in other documents, primarily re-2.1 Overview of OperatinM ports of inspections conducted by the NRC.
Experience Table 1 provides information on the types of licensees 7
11.1 Nonreactor Events for which information was entered into the database.
Table 2 provides information on how the reports of The AEOD Nonreactor Event Report (NRER) data-nonreactor events were categorized.
base contains information on licensed nuclear materials and fuct cycte operational events and on personnel radiation exposure events. The NRER database man-
.ne NRl R database skies not include information from reports agement system pmvides for input, storage, retrieval, of medical miudministrations. See section 2.1.2. -Medical Mis-cnd computer-assisted analyses of operational event miminiurations." for a discussion of these data for 1989.
Table 1 Types of Licensees That Submitted Nonreactor Reports During 1989 No. of Reports Type of Licensee Received
- Acad e m ic............,......................
12 Medical...................................................
50 Commerciai and industrial measuring system...................
57 Well loggin g........................................
28 Other measuring syst em.............................
29 Manufacturing and distribution (excluding medical)..............
24 Industrial radiography.......................................
16 "ix e d si t e........................................
1 Multiple locations (field)...........................
15 I rra d ia t o r................................................
2 Research and development..
25 Sou rce m at e rial s "........................................
11 Mills............................................
3 U Fe facilities...................................
2 Other.................................
6 Special nuclear material (including plutonium)"..............
14 Ag re e m e nt S t at e.......................................
34 Other.......................
.24 To t al..........................
279
' Medical miudmimstration reports are not included.
" Routine environmental effluent iclease reports, for example, reports required by 10 Cl R 4045 and 10 CI'R 70.59, are not included in the toiah for source materials and gecial nuclear materials beenwes 3
NURiiG-1272, Section 2
AEOD Annual Report,1989 l
Table 2 Categorir.ation of Reports of Nonreactor Events That Were Reported During 1989 No. of Category
- Associated Reports Personnel radiation exposures.......................................
28
- lost, abandoned, and stolen material.................................
124 Lea kin g sou rces...................................................
13 Release of ma t erial..............................................
21 Fuel cycle (e.g., mills. UFe facilities, special nuclear materitd............
13 Industrial radiography................................. ).............
(
16 Manufacturing and distribution......................................
31 Commercial and industrial measuring systerns.........................
31 Other".......................................................
14 Total.........................................................
331
'An NRER data base record may be associated with more th.in one category of event. I'or example, a report from a radiography licen >ce 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 radiography.
"*0ther" includes categories such as transportation and iniweltaneous.
2.1.1.2 Radiation Overexposure Events one finger; and three individuals received quarterly The nonreactor database contains information on 28 cvents for which there was a radiation overexposure in Radiography 1989. Table 3 provides information on the types of licensees associated with the 28 overexposure events The 11 reports of radiography exposures came from l
reported during 1989.
10 licensecs; 14 individtmis were overexposed m these events.
Table 3 Types of Licensees Associated With Seven of the events concerned eight individt al occupa.
Overexposure Events tional exposures that exceeded the quarterly limit of 1.25 or 3 rem. Three events that resulted in the overex.
No.of No. of posure of four individuais involved a failure to retract Type of Licensee Reports.
Exposures the radiography sot'rce completely. The exposures were 4.6 and 2.7 rem,36.3 rem, and 93 rem whole body, re.
Medical and academ.ic 10 17 spectively. Two over:xposures resulted when an indivi.
dual tripped over equipment, exposing the radiography Radiography 11 14 source. Two individuals received whole-body doses of Agrecrr.cnt States
- 3 5
2.1 and 1.7 rem. respectively, in this event.
Other
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._4 Total 28 40 An event was reported in which radiographers had not completely retracted the source. No exposures resulted
. Note that only those events that weic reported to Agreement States because the radiographers were alerted to the existence and that were publahed in a preliminary notice of occurrence have of a high radiation field by alarming dosimeters.
been included in the report.
Mcdical und Academic
^R'"*'"' S'"I"
'" Agreement States. Ipved concerning overexposures
. me reports wem ac The 10 reports of exposures (17 individuals) from sve mdividuals received whole.
medical and academic licensees involved NRC licensee rersonnel. The reports included 3 reports of 10 indi-bo.dy doses of from 4 to 66 rem in these events, all of h msuhed from mWography operations.
viduals who received exposures from activities not w
licensed by the NRC, for example, fluoroscopy. In Other other events, a physician received an exposure of 50 rem to the fingert two individuals received skin The reports of three events (three individuals)in this doses of 27 rem and from 135 to 365 rem, respectively; category involved occupational exposures that exceeded an individual received a dose of 172 rem to the tip of the quarterly limits of 10 CIH Part 20. In a fourth NUREG-1272. Section 2 4
Nonreactors-Operational Experience I
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eve % reported by a research und development licen-from cobalt-60 teletherapy or radioisotopes used for se, 3 cmployee had an uptake of 115 nanocuries of radiation therapy.
ioua,. -125.
An estimated 7 million diagnostic nuclear medicine 2.1.1.3 Other Types of Events procedures,30,000 radiopharmaceutical therapy proce-dures (the ingestion or injection of radioactive com.
1he nontcactor assessment staff reviewed reports of pounds for patient therapy treatment), and 50,000 other classes of events: lost or sto cn sources, aban-brachytherapy procedures (the insertion or implanta-doned sources, leaking or contaminated sources, con-tion of scaled sources containing radioactive material sumer products, fuct cycle facility events, industrial fer patient therapy treatment) are performed annually radiography, manufacturing and distribution, and in the United States. In addition,100,000 patients gauges and measuring systems.The events in these receive cobalt-60 teletherapy treatments (external use categories did not have any reported effect on the of radiation for patient treatment) cach year '
public health and safety.
The NRC estimates that about 40 percent of all these Two of the manufacturing and distribution reports were procedures are performed annually by NRC licensees Part 21 seports.' Amersham reported to the NRC that and 60 percent by Agreement State licensees.
It had received numerous complaints from customers that its Model 899-Scries source assemblics were Over the last 9 years (1981-1989), medical facilities hanging up in the S-tube of the exposure devices.
licensed by the NRC to use radioisotopes in nuclear Amersham discontinued distribution of this model medicine and radiotherapy for humans have been radiography source. At the time of the report,33 of the required to report misadministrations. During that 34 sources had been replaced; the last was to be re-period, NRC licensees treated an estimated 360,000 placed within a week of e report.
teletherapy patients and performed 180,000 brachy-therapy,110,000 radiopharmaceutical, and 35 millbn The second Part 21 report was received from Minne-diagnostic procedure Also over the 9 year period,40 sota Mining and Manufacturing Company's (3M's) teletherapy,22 brachytherapy,12 radiopharmaceutical Medical Devices Division. The company reported two therapy, and 3,623 diagnostic misadministrations were events in which the Heyman cesium-137 source had reported to the NRC. These misadministrations repre-separated from its wire handle. A review of these sent an error rate per patient of 0.0003 for teletherapy events by 3M showed that a statistical sampling plan for and 0.0001, that is, on the order of 10 4, for brachy-testing the adequacy of a brazed connection between therapy, radiopharmaceutical therapy, and diagnostic the source and the handle permitted sources with procedures (see Table 4).
inadequate sour:c to-wire joints to be distributed. All existing sources were to be retested, and manufacturing Therapy administrations are associated with procedures processing and testing specifications were to be modi-in which large doses of radiation are administered to ficd for sources m mufactured in the future.
patients to achieve a therapeutic effect. Diagnostic administrations are associated Wth procedures designed The defects reported in these Part 21 reporth had n to permit a diagnosis to be made with little exposure to known impact on the public health and safety.
the patient. An exception to the usual diagnostic administration procedure is the use of iodine-131 for 2,1,2 Medical Misadministrations diagnostic procedures that may deliver to the thyroid or other organ a dose of several hundred to several thou.
1hc NRC regulates certam aspects of the uses,o[
sand rad.
reactor produced radioisotopes m r.uclear medicme and therapeutic radiology. Certain diagnostic and therapy AEOD's annual review of data on misadministrations misadministrations are reported to the NRC pursuant has indicated that the number of reported therapy and to the requirements in 10 CFR 35.2 and 10 CFR 35.33.
diagnostic misadministrations shows no significant Diagnostic misadmmistration, as used in NRC regula-How ver, for therapy misadministra-tions, refers to,the misadmmistration of radioisotopes dh i
bc varied in uclear medicine studies such as renal scans and somewhat from year to year. Most of the misad-bone scans. therapy m,sadministration, as used in NRC owever, might have been avoided i
regulations, refers to the misadministration of radiation
- 10 Cl R Pa. 21.
- Reporting of Defects and Noncompliance,"
"U.S. Nuclear Regulatory Commission. *nasic Quality Assurrince requires any individual director or responsible ofricer of a firm Program. Records and Reports of Misadministrations or Events sup ' components for any activity licensed by the NRC to Relating to the Medical Use of Hyproduct Material (10 Cf'R nou NRC of any defects that could create a substantial Part 35L" tederal Rentrer. Vol. 55, No.10. January 16.1990, safe hazard.
pp.1439-1449 5
NUREG-1272, Section 2
l AllOD AnnualIteport,1989 Table 4 Error Rate for hilsadministrations (llased on aggregated 9-) ear data)
Estimated No.
No. of Type of of Procedures by h11sadmin.
No. of Error Procedure NitC Licensees istrations Petients Itate
' therapy Teletherapy 360,000*
40 112 0.0003 litachytherapy 180,000 22 22 0.0001 Itadiopharmaceutical 110,000 12 12 0.0001 Diagnostic 35,000,000 3623 4167 0.0001
- I'stimated nun her of panents who received Idetherapy trealtnents from 1981 through 1989.
through the implementation of revised or new quality
'lhree of the five 1989 brachytherapy misadministra-assurance procedures.
tions resulted from an inadvertent selection of a source containing the wrong amount of radioactive material by For diagnostic misadministrations, the causes have bcensec personnel, one resulted from the wrong iso-essentially been the same. Overall the data do not show tope being entered into the computer, and the last a discernible trend. Itclatively simple procedures, such resulted from a misinterpretation of a computer error as checking the patient's identifict, tion against the message before the brachytherapy treatment.
procedure and asking the patient to state his or her name, might reduce the frequency of these diagnostic T' e radiopharmaceutical therapy misadministration misadministrations.
involved the administration of iodine-131 to the wrong patient.
In general, the low error rates calculated fcom reported AllOD believes that these therapy misadministrations data on misadministrations suggest that most licensed might have been prevented if licensees had been fol-programs are operated in a way that mmimires misad-low ng their established quality assurance procedures ministrations.
or had improved their existing quality assurance procc-dures.
2.1.2.1 511sadministrations Iteported Durint,1989 2.1.2.1.2 Diagnostic h11sadministrations For 1989,326 of the approximately 2,500 NitC licen-sees authorized to perform nuclear medicine studies or As in previous years, essentially all of the diagnostic radiation therapy reported one or more misadministra, misadministrations for 1C89 involved either the t.dmin-tions, a total of 417 repor*., myolving 486 patients. Of istration of the wrong.adiopharmaceutical or the ad-the 417 reports of misNministrations for 1989,407 ministmtion of a rMiopharmaceutical to the wrong concerned diagnostic.nisadministrations and 10 con, patient. The noner, type, and cause of diagnostic cerned therapy mise Jministrations.
misadministrations are about the same as for those reported in 1988.'the causes reported by licensees are generally the same as those reported in the past, that 2.1.2.1.1 Ther.ipy h11sadministrations is, simple errors associated with the preparation and administration of radiopharmaceuticals, such as
'llen therapy r.isadministrations were reported in 1989.
(1) faulty processing of nuclear medicinc requests and 1 our of the inisadmmistrations involved teletherapy, (2) inadequate identification of patients.
five involved brachytherapy, and one involved radio-pharmaceutical therapy.
Of the 407 reports of diagnostic misadministrations received in 1989,265 (65 percent) involved the admin-Two of the teletherapy misadministrations involved an istration of the wrong radiopharmaceutical to a patient error in identifying the correct patient. One involved imd 98 (24 percent) involved the administration of a miscommunication among the licensee's staff regarding radiopharmaceutical to the wrong patient. (These two the treatment area of the patient's anatomy, and the types of misadministrations accounted for 89 percent of last mis a result of human error during the simulation the reported misadministrations.) included in the process.
remaining diagnostic misadministrations were 26 that NUltt!G-1272, Section 2 6
Nonreactors-Operational F.xperience involved a diagnostic dose of a radiopharmaceutical (3) picking up the wrong radiopharmaceutical, and that differed from the prescribed dose by more than 50 (4) lack of training.
percent and 9 that in olved the wrong route of admin-istration (that is, a route of administration other than 2.1.2.2 Misadministrations Reported for 1981-1989 that intended by the prescribing physician). Of the 407 reports of diagnostic misadministrations,10 involved Table 5 shows the number of m.isadm.. tration reports mis the misadministration of iodine-131.
received in 1989 and in previous years, it also lists the number of reports by type of misadministration, the 11 should be noted that the reporting requirements for number of patients, and the number of licensees diagnostic m6r,dminietion: were changed to incorpo-reporting misadministrations.
rate a revision in the threshold for reporting. In accor-dance with the new requirements of 10 CFR 35.33, For 1981 through 1989, licensecs reported 74 therapy diagnostic misadministrations occurring after April 1, misadmmistrations to the NRC, or an average of 8 per 1987, need be reported only if year. Over the 9-year period,40 of these therapy misadministrations involved teletherapy,22 involved brachytherapy, and 12 inmlved radiopharmaecutical the misadministration involved the use of radio, therapy (1hc dommant causes for the teletherapy e
active material not intended for medical use, misadmmistrations were errors m dose calculation, the administered dosage was f vcfold different errors in identifying the patient, and misreading or misunderstanding therapy prescriptions or orders 'lhe e
from the prescribed dosage, or dominant causes of the brachytherapy misadministra-the patient was likely to receive an organ dose tions were errors in dose calculation and use of the e
greater than 2 rem or a whole imdy dose greater wrong activity sources.'the 12 radiopharmaceutical than 500 mrem.
therapy misadndnistrations we predominantly caused by failure to assay doses before administering them or
!!ven with the change in reporting requirements for the use of the wrong form of the radiopharmaceutical.
diagnostic misadministrations, the number of misad-In general, the causes of all of the therapy misadmin-ministrations reported in 1989 was not significantly istrations were human crrors involving dose calcula-different from the average number reported in previous tions, patient setup or treatment, and patient identifica-years. Since the dose for at least one organ for most tion.
commonly used radiopharmaceuticals is about 2 rem, and a misadministration that results in any organ dose
.lhe NitC received an average of 400 diagnostic misad-of 2 rem is reportable, most of the misadmtmstrations ministration reports annually from 1981 through 1989; continue to be reportable.
the number ranged from 334 to 438 seports per year.
'lhe number of reports received annually has not As was noted earlier, relatively simple quality assurance changed substantially over the 9 years. Most (90 per-procedures, such as checking the patient's identification cent) of the diagnostic misadmini utions invoh'ed the against the study and the patient's medical history or wrong radiopharmaceutical(adtn...ncation of a phar-maceutical for the wrong study) or the wrong patient, asking the patient to state his or her name, might with the misadministrations stemming from human reduce the frequency of events involving administration
- error, of the wrong radiopharmaceutical or administeriag a radiopharmaceutical to the wrong patient, in each of the 9 years from 1981 through 1989, a small number of diagnostic misadministrations involved the 2.1.2.1.3 Diagnostic Misadmints'trations oilodine misadministration of iodine-131. An average of 4 such events has been reported annually; the range is from 2 to 10 reports per year. A few of these misadministra-Ten of the diagnostic misadministrations reported to tions involved the adtvinistration of large amounts of the NRC in 'j989 involved the administration of iodine-131.
iodine-131 in amounts that resulted ir. the delivery of patient thyroid or othei organ doses that ranged from 2 rad to 9,000 rad.'three of these misadministrations There has not been a substantial change in the number, resulted in thyroid doses of more than 1,000 rad.The type, or cause of any of the medical misadministrations remaining iodine-131 misadministrations delivered less reported to the NRC over the 9-year period that than 50 rad to the thyroid. Causes of the iodine-131 reporting requirements have been in effect, lissentially misadministrations included (1) failurc to verify patient all of the misadministrations were a result of human identification, (2) misunderstanding a physician's order, error.
7 NURl!G-1272, Section 2
l AEOD Annual Report,1989 Table 5 Misadministration Reports for 1981-1989 Type of Misadministration 1981 1982 1983 1984 1985 1986 1987 1988 1989 Averate
- !herapy 10 4
4 14 4
7 9
12 10 8
Diagnostic lodine-131 2
3 2
3 3
5 5
7 10 4
Other 428 414 332 395 377 433 409 386 397 397 No.of patients
$17 451 437 442 410 495 459 470 486 463 No. of licensees
"'".""'"8
... 2?3.
... 3"...32t 333 35' 355 293 328 3"
348 2,2 Reporting of Abnormal Occurrences Technical Review, Technical Review of 7herary blisadininistration That invohrd Afultiple Patients AEOD prepares the quarterly Abnortnal Occurrence and the Use of Computer T eatrnent Planning Pro.
Report to Congess and the associated TederalRegister U"'"'(AEUUII908) notices and, after staff coordination, sends them to the in this study, the AEOD staff reviewed five events Executive Director for Operations and, subsequently, in which more than 100 patients received an incor.
to the Commission for review and approval. An abnor-rect therapy dose. One of the events was attribut-mal occurrence (AO) may be an Individual incident, a able to an administrative decision that was compli-recurring event, a generic concern, or a series of inci-cated by a change in the consulting physicist, in dents that the Commission determines is significant addition, the duration of the event was increased from the standpoint of the public health or safety.
because a prompt review of the computer treat-ment plan was not made for a patient with Four nonreactor and eight medical misadministration crytherna.
events were determined to be AOs in 1989. Of these, The other events all involved errors in manual two of the four nonreactor AOs occurred in NRC-calculations used to convert computer output to regulated States and two in Agreement States. All of the desired item, for example, machine on time.
the medical misadministration AOs occurred in NRC-These errors were ascribed to lack of training and regulated States. A summary of 1989 nonreactor and lack of procedures as no other causes were evi-tuedical misadministration AOs (reported by both NRC dent.
and Agreement State licensees)is provided in Appen-dix C to this report. A summary of 1989 AOs at 2.4 Selected Ongojug Technical Studies power plants and research reactors is provided m, nuclear Appendix 11 to the companion volume of this report AEOD is continuing work on the following technical (NUREG-1272, Vol. 4, No.1, Power Reactors).
studies:
Review of nonreactor events in Agreement States, 2.3 Results of Selected AEOD Studies I98I~I987 This review will collect data on all nonreactot Engineering Evaluation, Use of Rcdioactiie lodine events reported to Agreement States from 1981 o
for In' qucnt biedical Studies and Those Performed through 1987, analyre the data, and provide a Und
.m FDA linestigational Etcinprion for a New comparison with events reported in NRC-licensed Dr>
lND)(AEOD/N901)
States.
.i cswo mehytherapy incidents involving re-In this engineering evdluation, the AEOD staff reviewed four misadministrations involving an iso-Inote afterloadm, g and manually loaded devices tope of iodine in whict tbc patient received an This study will analy7e the use of iridium-192 for organ dose of several *.andred rad. This evaluation brachytherapy procedures where patients being found that there mt f e a generic problem associ-treated received unintended radiation therapy b
ated with the ust tadioactive iodine for infre-doses. Events involving both remote afterloading quently performed medical studies and those per-devices and manually loaded devices and sources formed under an IND.
are being reviewed.
l NUREG-1272, Section 2 8
]
r Nonreactors-Operational Experience 2.5 Other Projects identify those practices that result in the most fre-
[
quent types of misadministrations. 'Ihe videotape o
Production of a videotape on good practices in illustrates those good practices that are designed to avoid errors in preparing and administering nuclear medicine radiopharmaceuticals. It was scripted by Oak In 1989, AEOD initiated preparation of a video-Ridge Associated Universities and filmed by Ar-tape on good practices in preparing and adminis-genne National 12boratories. Copics of the video-tering radiopharmaceuticals. This videotape, which tape will be distributed to all NRC medical licen-was completed in the summer of 1990, utilizes sees and Agreement States to improve feedback of data from reported medical misadministrations to experience to nuclear medical technologists.
t i
i s
}
9 NUREG-1272, Section 2
3 Summary
.The A110D review of the data on nontcactor events the NRC in 1989 did not show any significant changes and medictd misadministrations that were reported to from the data reported to the NRC m previous years.
1I NURiiG-1272, Section 3 i
i
i'_.
I q-m -
Appendix A i
Report on 1989 Nonreactor Events j
1
')
i l
i j
i h
'k
Appendix A AEOD/N90-01 Report on 1989 Nonreactor Events i
by the i'
Nonreactor Assessment Staff Office for Analysis and Evaluation of Operational Data i
Prepared by Kathleen M. Black h
e 4
w l
Contents
.1 Nontcactor Event Report Database........
1 2.1.5 Consumer Products..................
12 l
2 Review of 1989 Nontcactor Events.........
3 2.1.6 Fuct Cycle Facilities.................
12 2.1 Events That Occurred During 1989.......
3 2.1.7 Radiography........................
13 i
2.1.1 Radiation Exposures..................
4 2.1.8 Manufacturing and Distribution........
14' 2.1.2 lost, Abandoned, and Stolen Sources...
6 2.1.9 Gauges and Measuring Systems........
14 2.1.3
- t. caking or Contaminated Sources......
11 2.2 Abnormal Occurrences.................
14 2.1.4 Release of Materials..................
12 3 Findin gs...............................
17 i
Tables 1 'Iypes of IJcensees That Submitted Nonreactor 5 Abandoned Well-logging Sources,1989....
10 Reports During 1989.....................
3 6 Leakm, g Sources,1989...................
11
- 2. Categorbation of Reports of Nonreactor E !cnts 'ihat Were Reported During 1989...
4 7 Radiography Events,1989................
13 3. Personnel Radiation Exposures,1989.......
5 8 Manufacturing and Distribution,1989......
15 4 lost or Stolen Sources,1989..............
7 9 ' Gauges and Measuring Systems,1989......
16 iii NUREG-1272. Appendix A
1 Nonreactor Event Report Database 3
The Nonreactor Event Report (NRER) database for transportation events into the NRER database as the the Office for Analysis and Evaluation of Operational Department of Energy funds a transportation incident Data (AEOD) contains information on licensed nuclear file, which is maintained by Sandia National Laborato-materials and fuel cycle operational events and on per-rics. Sandia's report on Radioactive Material Transpor-sonnel radiation exposure events. The NRER database tation Accident / Incident Analysis (SAND-85-1016)'
management system provides for input, storage, re-contains information about this transportation incident trieval, and computer-assisted analyses of operational file and summarizes data from the file for 1971 through event data; the system may be used to identify trends in 1985.
operational safety events that may signal a need for temedial actions by the NRC, licensees, or both.
- y,'3"gl,];3"jfM,Dj;,II,%4.["'[$'gy.gj"'{$,Qch AEOD generally does not incorporate information on 1986.
l l
l l
l 1
NUREG-1272, Appendix A
2 Review of 1989 Nonreactor Events 2.1 Events That Occurred During censees for which information was entered into the da.
tabase.
j 1989 Table 2 provider information on how the reports for The NRER database includes 279 records of events nonreactor events were categorized and entered into that were entered into the database during 1989. Infor-the database. An NRER database record may be associ.
mation on these events was contained in repotts sub-ated with more than one category of event. For er.=-
mitted by nonreactor licensees to the regional offices or plc, a report from a radiography licensN concerning a in other documents, primarily reports of inspections personnel radiation exposure would 'se counted in the conducted by the NRC.The NRER database does not total number of radiation exposure events as well as in include information from certain fuel cycle licensee the total number of events involving radiography. The rcports, such as those related to routine effluent 279 nonreactor licensee reports were cataloged as 331 releases, nor does it include information from reports entries in 11 different areas. Note that because some of medical misadministrations, which are included in reports are associated with more than onc category of Appendix il to this volume of the AEOD Annual Re-event, the total number of events exceeds the total port. Table 1 provides information on the types of li-number of reports.
Table 1 Types of 1.icensees That Submitted Nonreactor Reports During 1989 No. of Reports Type of 1.icensee Received
- Aca d e m ic.............................................
12 M e d ical...............................................
50 Commercial and industrial measuring system................
57 Well loggin g...................................
28 Other measuring system.........................
29 Manufacturing and distribution (excluding medical)..........
24 Industrial radiography...................................
16 Fixed si t e.......................................
1 M ultiple locations (field)..........................
15 I rrad ia t o r..............................................
2 Research and development...............
25 Source mat e rials"......................................
11 Mills...........................................
3 U Fe fa cilit i es...................................
2 IDther.......................................
6 1
Special nuclear material (including plutonium)"...........
14 l
Agreeme n t S ta t e...................................
34 Other...................................
JJ l
Total.............................................
279
- Medical misadministration reports are not included.
- *Routme environmental effluent release reports, for example, reports required by 10 CI R 40.65 and 10 CI'R 70.59 are not included in the totals for source materials and special nuclear materials beensees.
3 NUREG-1272, Appendix A
m, 3m l5 7
AEOD Annual Report.1989 a
Table 2 Categorization of Reports of Nonreactor Events That Were Reported During 1989 No.of Category
- Associated Reports Personnel radiation exposures............................................
28 l ost. abandoned, and stolen material......................................
124 l eaki ng sou rces........................................................
13 R elease of mat e rial.....................................................
21 i
il Fuel cycle (e.g., mills. UFe facilities, special nuclear material)..................
13 I
Ind ust rial radiography...................................................
16 Manufacturing and distribution...........................................
31 Commercial and industrial measuring systems 31 Other"...............................................................
14 Total.............................................................
331
'An Nittilt database record may be awcinted with more than one category of event. I:or exampIc a report from a cadnigraphy hansee concerning a personnel radiatum ex of radiation exposure events as well as m the total number of eve;xcure would be courted in the total number nts involving radiography.
- *"Other* includes editegories sin:h as transportati<m and misce!!ancous.
2.1.1 Radiation Exposures During 1989,28 reports were reported in which one or more persons received an exposure in excess of the The criteria that dcfine overexposures are contained in above limits. Information on these events is given in 10 CFit 20.101(a) and (b). 20.103(a), and 20.105. The Table 3.
limits are as follows:
The types of licensees associated with the 28 exposures Restru,csed areas:
follow:
whole body 1.25 rem / calendar quarter, or 3 rem / calendar quarter, No. of Ind iIl als if the individual's prior occu.
Tjpe of g eensee Reports Overexposed pational exposure is ob.
tained in writing and the ac.
cumulated exposure does Medical and academic 10 17 not exceed 5 (N 18). where Itadiography 11 14 N is the individual's age Agreement State 3
5 cifremary 18.75 rem / calendar quarter otal 3
skin 7.5 rem / calendar quarter y
inhalation 40 MPC (maximum permis' hiedicaland Academic sible concentration) hours /
week for 13 weeks; MPC is
'Ihe 10 reports (representing overexposures of 17 peo-given in 10 CFil Part 20.
ple) include 3 reports of 10 individuals who received Appendix it. Table 1. Col. I exposures from activitics not licensed by the NRC, for example, fluoroscopy. These three reports came from minors 10% of above limits two licensees.
Unrestricted arras:
In other events, a physician received an exposure of 50 rem to the finger; two m, dividuals received skm individuals 0.5 rem / year, subject to rate doses of 27 rem and from 125 to 365 rem. respectively; limitations an individual received a dose of 172 rem to the tip of NURI!O-1272. Appendix A 4
r W
Nonreactors-Events Table 3 PersonnelItadiation Exposures,1989 License Event No Licensee Number Location Dete Exp Type Exposure Adycx t'orp.
199105301 llampton, VA 04/12/89 1
Whole llody AS Sun Ray Testing AS*
Downey, CA 01/03/89 1
Whole llody AS Mobile lab, Inc.
AS Norco, LA 08/26/89 1
Whole llody AS Technical Welding Lab.
AS llouston, TX 02/31/89 3
Whole llody Dr. Machara, M.D.
532329001 lionolulu,111 05/10/89 1
Extremity Edwards Pipeline Testing, Inc.
352319301 Tulsa, OK 09/18/89 1
Whole llody L
Fairviw General llospital 34021 Q 1 Cleveland, Oli 11/01/89 1
Whole llody Genc4'rak Systems 2o2371301 Farmington, M A 06/06/89 1
Ingestion i
Glitsch 10cid Services 341407101 Erie, PA 08/15/89 1
Whole llody 1lospitalof Univ,of PA 370011807 Philadciphia, PA 02/15/89 1
Whole flody LFH Corp > ration 200138202 Clinton, M A 01/15/89
'I Whole Ik>dy LFE Corporation 200138202 Clinton, M A 02/01/89 1
Whole Body MOS Inspection 120062207 Elk Grove, IL 11/15/88 2
Whole Ikx!y Non-Destnictive Testing 291974201 Manville, NJ l1/01/88 1
Whole ikxly Non Destructive Testing 291974201 Manville, NJ 01/31/89 i
Whole llody North American Inspection, Inc.
372337001 laurys Sta., PA 08/06/89 2
Whole llody Ohio State University 340029302 Columbus, Oil 03/10/89 1
Whole llody Quality Eng. Serv. & Testing 352681501 Tulsa, OK 12/23/88 1
Whole ikxty Itiverview Medical Center 290970202 Red llank, N1 04/19/89 1
Skin Rorer Central Research 370880201 llorsham, PA 08/15/89 1
Whole ikx!y Sinal Samaritan Medical Center 480328001 Milwaukee, WI 02/01/89 - 6 Whole llody Sinal Samaritan Medical Center 480328001 Milwaukee, WI 05/01/89 3
Whole llody St. l.ouis Testing laboratories 240018802 St. louis, MO 02/01/89 1
Whole ikxly TEI Analytical Services,Inc.
372800401 Gould, MI 12/14/89 1
Extremity Tri-State Associates,Inc.
452496701 Wo(xibridge, VA 08/31/89 2
Whole llody University of Puerto Rico
$20194608 San Juan, PR 11/02/89 i
Whole ikdj Yale University 060018303 New llaven, CI' 05/17/89 i
Skin Yale University 060018303 New llaven, CI' 08/15/89 1
Extremity
' AS meatu Agreenwnt State licenw.
one finger; and three individuals received quarterly ex-the radiography sour:c completely. The overexposures nosures in excess of 1.25 rem in a calendar quarter.
for these events ranged from 2.6 to 93.3 rein whole body. Two overexposures resulted when an it,dividual Radiography tripped over equipment, exposing the source. Two indi-viduals received exposures of 2.1 and 1.7 rem, respec-The 11 reports of overexposures while performing radi-tively, in this event.
ography came from 10 licensces. Fourteen individuals were overexposed in the events.
One radiogmphy event was reported in which radiogra-
- Seven of the events concerned occupational exposures phers had not completely retracted the source into the of eight individuals that exceeded the quarterly limit of exposure device.They were alerted to the existence of 1.25 or 3 rem.Three events that resulted it' the overex-high radiation fields because they were wearirig alarm-posure of four individuals involved a failure to retract ing dosimeters.
5 NURl!G-1272, Appendix A r
W I AEOD Annual Report,1989 Agreement States -
sources were found; in one event the source was sent to i
a commercial waste disposal facility; and in one event j
'Ihree reports of exwsttres from Agreement State 11-the material was in a vehicle that was stolen. In the ccnsecs concernM overexposures received by radiogra-fifth event, a large number of tools was imported from phy personnel.?ive individuals received from 4.3 to 66 France by Schlumberger Technology Corp. There was 1
re m whole-body doses in these cycnts.
no notice on the tools that they contained 2.7 -
microcuries of Am-241; the location of many of the Other sources remains unknown but the sources are believed to have been thrown out with trash (commercial waste).
Four licensees reported overexposures. Three of the events, reported by three holders of licenses for manu*
Cesium 1.;7 (Cs-137)-Fourteen reports involved facture and distribution, concerned occupational expo-events in which cesium sources were reported to have -
i sures that exceeded the quarterly limits of 10 CFR been lost. M three events, the source was found; in two Part 20.The fourth event, reported by a research and events, the source was believed to have been sent to a development licensee, concerned an internal exposure scrap dealer; and in one event, the source was lost at to lodme.125. An emphiyce had an uptake nf 115 -
sea. The disposition of the materialin the remaining l
nanocunes.
events is not known.
r
- 2J.2 Lost, Abandoned, and Stolen Sources Tritium (Ib3)-Of eight reports of lost tritium, four were re ons of stolen exit signs; none of these snurces f
Licensecs are required to report the loss m theft of could oc four d. One event was reported in which -
i licensed sources that has occurred in such quantitics Mium-conta,ning exit signs were found at a collere and under such circumstances that it appears to the dormitory. Tacre was no information about the site licensee that a substantial hazard may result to persons from which these signs were removed. In addition to in unrestricted areas (10 CFR 20.402(a)(1)). During these five reports that concerned exit signs, there were 1989,124 events were reported that involved lost.
two reports of lost devices that contained tritium and abandoned, or stolen licensed material. Tabics 4 and 5
- one report of tritium whose disposition is unknown, provide summaries of these events. Ninety nine events involved lost or stolen material and 25 involved aban' doned, irretnevable well legging sources. None of the lodine 125 and 131 (1-125 and 1 131)-Six cvents were.
events resulted in a known radiation overexposure-reported concerning lost I 125 sources: three concerneo I 125 seeds that could not be found; one involved I ' ' # * *'"
- I""' *0 ""'h ' h* ' ** ' " ' ' * * **
I*'
Lost or Stolen Sources waste disposal f acility; one involved 1 125 trash that was y w,an m ln am g pacb n nem Of the 99 lost or stolen sources,22 sources were found; age c ntaining t
mnts reponed con-4
-3 pacemakers were buried, and I was probably buried; p was found in two can tW l
ccr g 9 sources were inadvertently sent to commercial waste disposal facilitics; and 2 cvents occurred in which mate-material was sent to a commercial waste disposal facil-rial was lost in a lake or at sea, in two events, the up n m cam an n
pc was st in tranpa-E "" "'
source had been sent to a scrap dealer; and in one event, radioactive material was incinerated. The ulti-mate disposition of the sources reported lost or stolen Iridium 192 (Ir-192)-Of the five reported losses of in the remaining 59 cvents is unknown. Table 4 pre.
'r-192, the material was found in two events, in two.
sents a list of these events.
cases, seeds used in therapy treatments were lost, and in one event, one large Ir 192 source was reported lost Generally, the lost sources consisted of scaled sources, I" If" "'P II'
~ isotopes used in research or medical treatment, or trit-lum exit signs, Molybdenum.99/ technetium-99m (Mo-99/rc-99m)- -
Of the three reported losses of these isotopes, the ul'i-Amencium 241 (Am.241)-Of the 15 reports of lost mate disposition is unknown for two of the events. In americium sources,10 involved moisture density all cases, the losses resulted from theft-of a vehicle,m gauges. One gauge was lost during shipping and AliOD two events and of n Mo-99/Fc-99m generator in the
. has no record of its being found. The other nine gauges third event.
+
were stolen.Three of these stolen gauges have been recovered; there is no information about the remaining Nickel 63 (Ni-63)-Foe: events were reported in which six gauges. Five other events were reported in which Ni 63 sources, three of which were gas chromatograph americium sources were lost. In two of the events. the sources, were lost.
NURIIG-1272 Appendix A 6
Nonreactors-Eycnts Table 4 Lost or Stolen Sources,1989 Probable License Event Ultimate isotopc' l.ocation Licensee Number" Date Disposal Am 241#
Phoenix, AZ AS Speedie & Associates AS 09/19/89 Unknown Am 241#
San Diego, CA AS American Engineering AS 01/01/89 Unknown Am 241#
Ft. Lauderdale, FL NL Keith Senars, Atty, NL 07/18/89 Unknown Am 241#
Miami, FL NL Professional Services Inc.
NL 03/15/89 Unknown
- Am-241#
North Miami, FL Langan Engineering Associates 291578602 03/24/89 Unknown Am-241#
Des Moines, IA AS lowa Department of Health AS 08/19/89 Found Am 241#
Lafayette, IN Professional Service Industry 120194101 11/18/88 Found
- Am-241 Michigan City, IN NDC Systems, Inc, 042326401 08/31/89 Found Am 241#
Ilardstown, KY AS Hidden Hollow Const. Co.
AS 07/16/89 Unknown Am 241#
Imuisville, KY AS Presnell & Associates AS 05/19/89 Unknown am-241 South Hadley, MA GL James River Graphics Group GL 10/04/88 Commercial Waste Am 241 OR AS Siemens AS 11/11/89 Unknown Am-241 Hobden, NJ U.S. Testing 290248807 05/32/89 Found Am 241 TX Schlumberger Technology Corp.
420009003 02/22/89 Unknown Am 241#
Richmond, VA Froching & Robertson,Inc.
450889002 05/12/89 Found Ba 133 Reston, VA Reston Hospital Center 451789801 10/09/89 Untnown C-14 Midland, Mt.
Dow Chemical 210026506 04/20/89 Uranown C-14 Flathead lake, MT University of Montana 250170603 11/29/89 Lake Cd 109 Madison Heights, M1 GTE Valenite Corp.
211743601 01/16/89 Unknown C136 Farmington, MA Gene-Trak Systems 202371301 03/28/89 Unknown Co-57 New Orleans, LA Veterans Admin. Med. Ctr.
170132207 08/21/89 Unknown Cr-51 Glenolden, PA E.1. Dupont de Nemours 070045537 12/22/88.
Unknown Cs-137 Offshore Halliburton Company 350050204 12/16/88 Sea Cs-137 Opelika. AL AS Uniroyal Goodrich Tire Co.
AS 07/06/89 Scrap Cs-137 New Haven, CT Yale New Haven Hospital.
060081903 03/05/89 Found Cs-137 Lexington, KY Stanford Mining Co.
371822601 01/10/89 Unknown
' Cs 137 Ilethesda, MD National Institutes of..calth 190029610 08/31/88 Unknown Cs-137 Kalamazoo, M1 GL Upjohn Inc.
GL 10/19/89 Scrap Cs 137 St. Louis, MO St John's Mercy Medical Ctr.
240079403 12/29/89 Unknown 3
Cs-137 Laurel, MS AS Masonite Corporation AS 12/19/89 Unknown Cs-137 Triangle Park, NC Environmental Protection Agency 321404804 09/01/89 Unknown Cs-137 Dayton, OH Cargill, Incorporated 341730601 08/02/89 Found Cs 137 Oklahoma City, OK Bridgestone/Firestone 351361701 11/29/89 Unknown Cs-137 Philadelphia, PA Thomas Jefferson University 370019806 12/15/89 Unknown Cs 137 Austin, TX 3M 220005706 01/24/89 Unknown Cs 137 Houston, TX GL Maxwell House GL 10/18/88 Found H3 Colorado Springs, CO Dept. of Air Force 422353901 08/22/89 Unknown H3 Orlando, FL Dept. of Navy 091977001 08/18/89 Unknown H-3 Mountain Home,ID Grade School, Mountain Home GL 10/02/89 Unknown Footnotes at end of table.
7 NUREG-t272, Appendix A
AEOD AnnualReport,1989 Tabh 4 Sant.)
Probable License Event Ultimate isotopc' location Licensee Fumber" Date Disposal l' 3 -
M1 GL Marriott Courtyard OL 08/17/89 Unknown h3 Battle Creek, MI GL Kellogg Arena GL 03/30/89 Unknown H3.
Columbus, OH NL Ohio State University NI.
02/12/89 Found 1:-3 Ilouston, TX Schlumberger Technology Corp.
420009003 01/10/89 Unknown H3 Madison, WI Promega Biotec 482011101 05/03/89 Unknown I125-Cambridge, MA Metpath, Inc.
202804201 03/23/89 Unknown I125' South Port, ME Binax, Inc.
182816701 05/18/89 Unknown 112C Royal Oak, MI William Beaumont Hospital 210133301 06/29/89 Unknown 1125 Royal Oak, MI -
William Beaumont Hospital 210133301 11/05/89 Unknown
~I125 Camden, NJ Our Lady of Imurdes Med. Ctr.
290643101 04/13/89 Commercial Waste 1125 Philadelphia, PA
'Ihc Lankenau Hospital 370780504 12/15/88 Incinerator I131-Plainfield, NJ NL New Jersey State Police NL 10/17/89 Unknown I131 Princeton, NJ E. R. Squibb & Sons, Inc.
290013902 12/16/88 Found I131 South Plainfield, NJ NL Del. Med. Inc.
NL 10/17/89 Unknown b131 Pittsburgh, PA The Western Pennsylvania 370213601 04/29/89 Found Hospital 1 131 Charlottesville, VA Univ. of Virginia 450003426 05/03/89 Commercial.
Waste Ir 192 Leanoro, CA NL NL 09/05/89 Unknown Ir192-South Bend,IN Memorial Hospital 131888101 09/08/89 Found Ir 192 Minneapohs, MN University of Minnesota 220018708 04/07/89 Unknown Ir-192 San Antonio,TX Dept. of Air Force 422353901 09/18/89 -
Unknown Ir 192 Springfield, VA Coast Tumor Insititute 451975701 09/20/89 Found Kr 85 Battle Creek, MI Dept. of Air Force 422353901' 08/25/89 Unknown -
Kr 85 Niagara, WI GL Niagara o Wisconsin Paper GL 10/27/88' Found r
Mo-99/
Miami, FL AS Medical Delivery Services AS 07/16/89 Unknown Tc-99m Mo-99/
Billerica, MA E. L Dupont de Nemours 200032201
' 08/26/88 Found Tc 99m Mo-99/ '
Charlotte, NC NL Associated Carriers NL 01/06/89 Unknown Tc.99m Ni.63 Washington, DC Environmental Protection Agency 191544003 02/15/89 Unknown Ni 63 Wilmington, DE F. I. Dupont de Nemours 070045502 10/18/89 Unknown
' Ni-63
' exington, KY Dept of Army 160503301 04/17/89 Unknown
. Ni-63 1 oston, MA Boston University 200221501 03/09/89 Unknown L
Np 237 Columbus, OH Ohio State Universi y I40029302 03/10/89 Unknown t
' P 32 At tens, GA Dept. of Agriculture 190091503 03"n/89 Commercial Waste
' P 32.
Iowa City, IA Veterans Admin. Med. Ctr.
'140082201 04/08/89 Commercial Waste 1
P 32 Billerica MA E. I. Dupcmt de Nemours 200032021 07/14/89 Unknown l
P Boston, MA E. L Dupont de Nemours 200032021 07/07/89 Unknown i
NUllEG-1272, Appendix A 8
Nonrcsctors-Events -
i t
Table 4 (cont.).
Probable License Event Ultimate Isotope' location Licensee Number" Date Disposal
= P 32 Cambridge, MA Harvard University 200029753 01/19/89 Unknown P 32 Pittsburgh, PA Microbac labs 3720N402 02/23/89 Commercial l
Waste P-32 Seattle, Vr A '
Veterans Admin. Med. Ctr.
/60099001 04/26/89 Unknown Po 210 Rocky Mount, VA GLThe lane Company T
01/17/89 Unknown Pu 238 Washington, DC Washington Hospital Center 05/30/89 t
Pu 238 -
IA AS Mercy Hospital AS 11/02/89 ft Pu 238 Stratford,14J Kennedy Memorial Hosps.
02/20/89 t
Pu 238 Newark, NJ Newark Beth Israel Hosp.
08/25/89 t-S 35-Groton t.
Pfizer, Inc.
060586901 02/03/89 Commercial Waste Sr-90 Woodburn, f AS Uniroyal Goodrich Tire Co.
AS 09/07/89 Unknown Tc-99m South Amboy, NJ South Amboy Memorial Hospital 291706401 02/22/89 Commercial Waste
=Tc-99m Folcroft, PA.
Syncor Corporation 371846101 06/28/89 Unknown Tc-99m 1 Two Rivers, WI Computerized Med. Imaging 482453301 01/24/89 Found-Th-232 Warrington, PA Nuclear Research Corporation 05/28/89 Unknown '
- 11 201 South Plainfield, NJ Medi-Physics, Inc.
291536003-05/16/89 Found Tle201 Cleveland, OH Metrohealth Medical Center 340374910
' 06/21/89
. Unknown -
Xc-133 Winchester, M A Winchester Hospital 201197301 06/06/89 Unknown Xc-133 Ilaraga, MI Iron County General Hospital 211858601 09/24/89 Found Y
McClellan, CA Dept.of Army 422353901 06/14/89 Unknown J
Washington, DC Dept. of Health & Human Sys.
081548401 10/06/89 Unknown
.Y Durham,' NC Veterans Admin. Med. Ctr.
320ll3R01 12/05/89 Found Y
Salt 12ke, UT AS Health Physics Northwest Or.
AS 03/07/89 Found Z
Cleveland, OH Boldell Health Center 340546901 08/07/89 Found Z
McKeesport, PA NL Stecimet Co.
NL 08/02/89 Found Z
RI AS St. Joseph Hospital AS 10/16/89 Commercial' Waste
'# means moisture density gauge. Y means other (more than one isotope), and Z means unspecified.
" AS means Agreement State beense, Gt, means general license, and NL means no license.
- tPacemaker interred with body, ttilody was cremated; location is unknown.
9 NUREG-1272, Appendix A
l AROD' Annual Report,1989 TaNe 5 Abandoned Well. Logging Sources,1989 '
isotope License Event location Licensee Number" Date Am-241t -
No. Slope, AK Schlumberger Technology Corp.
420009003 06/22/84 Am 241 Tuscaloosa, AL AS State of Alabama AS 10/02/89 Arn 241 Offshore, LA Schlumberger Technology Corp.
420009003 12/22/88 Am 241 Offshore, IA Schlumberger Technology Corp.
420009003 01/20/89 Am-241
' Offshore, LA Schlumberger Technology Corp.
420009003 09/15/89-Am.241 Offshore, IA Schlumberger Technology Corp.
420009003 09/29/89 Am 241 Offshore, LA Sperry-Sun Drilling Senices 422684401 01/19/89 Am 241 Offshore, IA Sperry-Sun Drilling Services 422684401 08/15/89 Am 241 Snow Shoc, PA Allegheny Nuclear Surveys 291197601 09/26/89 Am 24I Offshore, TX Sperry-Sun Drilling Senices 422684401 12/22/89 Am 241 Lincoln Cty., WY Halliburton Co.
420106807 10/05/89 Cs-137 -
North Slope, AK Halliburton Co.
420106807 05/03/89
~ Cs-137 Offshore, LA Halliburton Co.-
420645803 02/17/89 Cs-137 Offshore, IA flalliburton Co.
420106807 10/31/88 Cs-137 Offshore, LA Western Atlas Int'l., Inc.
420296401' 12/13/89 Cs 137 Sebutica, OK Davis Company 352120701 03/17/89 Cs-137 Natrona Cty., WP Western Atlas Int'l., Inc.
420296401 05/30/89 -
11 3 Offshore, LA Halliburton Co.
420106807 02/17/89 11 3 Offshore, IA Ilalliburton Co.
420106807 10/30/89 Il.3 Offshore, LA Schlumberger Technology Corp.
420009003 12/27/89
. 11 3 Offshore, IA Schlumberger Technology Corp.
420009003 01/01/89 Il 3 -
Offshore, IA Schlumberger Technology Corp.
420009003 01/15/89 Z
Western Atlas Int'l., Ines 420'96401 03/03/89 i
Z Natrona Cty., WY NL Coastal Oil and Gas Corp.
NN 11/15/82 Z
Natrona Cty., WY Western Atlas Int'l., Inc.
420296401 03/12/89
'7. means unspecified.
- AS mesm Agreement State license, and NL means no license.
tin most cases, when an Am-241 source is abandoned, a Cs-137 source is alw) abandoned.
1 Phosphorus-32 (P-32)-Seven reports involved events Plutonium-238 (Pu-238)-Four events were reported in which P 32 was reported to have been lost. In three that involved plutonium-powered pacemakers. In three events, the material is believed to have been sent to a cases, the device was interred with the body. In the commercial waste disposal facility. One of the four fourth event, the pacemaker was Icft in the body, which events in which the ultimate disposition of the phos-was cremated. The location of this pacemaker is un-phorus is unknown involved the theft of lead radiation known, but no contamination was found at the crema-shields that formerly held P-32; there was little or no tory.
P-32 contamination of the lead. In each of the other three events,500 microcuries of P-32 was lost. In two Other-As noted in Table 4, several other isotopes of the cases, the loss occurred on site. In the remaining were reported to be lost, including Da-133, C-14, event, a package containing P-32 was lost during ship-Cd 109, Cl-36, Kr-85, S-35. Sr-90, Tc-99m, TI-201, and ping.
NUREO-1272, Appendix A 10
Nonreactors.-Events None of the lost murces caused any known impact on sources and to report those that leak as a condition of the public health aiA safety.
their license. In both cases, a removable contamination exceeding the most common test limit for removable Abandoned Well-Logging Source 3 contamination (0.005 microcurie) is considered evi-dence of leakage. Removable contamination exceeding NRC licensees are required to report to the NRC the the amount specified in 10 CFR 34.25 or in a license location of abandoned well logging sources. The 25 condition must be reported to the NRC.
events reported during 1989 did not result in any known releases of radioactive materials (Table 5).
During 1989,13 occurrences of leaking or contami-2.1.3 Leaking or Contaminated Sources nated sources were reported. Table 6 includes informa-tion from reports of these events, none of which re-Pursuant to 10 CFR 34.25, certain licensees are re-sulted in a radiation overexposure. The sources found quired to leak test sources and to report any sources to be leaking or contaminated contained cesium, trit-that leak other heensees are required to leak-test ium, nickel, promethium, strontium, and other isotopes.
Table 6 Leaking Sources,1989 License Event Isoinpc Location Licensee N u:,.be r" Date Manufacturer Cs 137 Dostmeter Corp. of America 341347702 10/05/89 The Nucleus Cs-137 Ilaton Rouge,1 A AS Mary llird Perkins Can. Ctr.
AS 02/16/89 Cs-137 Venal, UT llalliburton Co.
420106807 07/04/89 H-3 Kelly AFil, TX Dept. of Air Force 422353901 07/21/89 US Radium Corp.
Ni-63 Ilurlington, M A lon Track Instruments, Inc.
201552503 12/05/89 Ni.63 East lansing. MI Michigan State University 210002129 12/02/89 Nuclear Source Service Ni 63 Columbia, MD University of Missouri 240051335 09/28/89 Ni 63 Missoula, MT Umversity of Montana 250170603 01/20/89 Ni 63 Seattle, W A Dept. of Commerce 462346301 07/20/89 Shimadzu Pm 147 White Sands, i M Dept. of Army 301235001 05/17/89 Amersham I
Sr-90 Pomona, CA NL General Nucleonics NL 07/20/89 GN1 12200 Y
Tonapah, NV Dept. of Air Force 422353901 07/25/89 Z
Research Park, NC Dept. of Health & Human Sys.
321235801 09/07/89
'Y means other (more than one imtope). and Z meam unspecified
" AS meam Agreement State beense. and N1 means no hcense.
Cestum 137 (Cs-137) sources-The leaking cesium Nickel-63 (Ni 63) sources 'Ihe leakmg sources were sources were reported by different licensees. Dosimeter all small sources used in gas chromatographs.
Corporation reported that 7 of 21 check sources ob-tained from The Nucleus had some removable contami-p 7g nation but the contammation on only one source ex.
g cceded the regulatory limit of 0.005 microcune.
source was separated from it.
Dosimeter Corporation notified the vendor and its own customers (12) that these check sources might be leak-Strontium-90 (Sr-90) source ~ A gauge contaming the ing.
source had been sold to a loicign company, and the Tntium (H-3) sources 21he leaking totium sources,1.2 original source had been replaced by some unknown curies, are used m momtors that are in the final stages party. The source was leaking when the gauge was re-of bemg remmed from use.
turned for repair.
I1 NI Pl:0 -1272. Appendix A
l ABOD AnnualIteport,1989 The number of leaking sources is about the same as Manufacturing Eirnts that reported in prior years; again as in prior years' e of the leaking sources resulted m, any known ex-Allied Signal, Metropolis, Illinois, reported the rupture of a 125,000-gallon hydrofluoric (liF) acid storage tank that was caused by freezing. The tank contained 33,000 2.1.4 Release of Materials gallons of 0.36 percent liF solution; about 80 percent flowed into a diked area. About half of the release During 1989,21 events were reported in v'hich radioac-overflowed to the ground.The fluoride content of lig-tive materials were released. Generally, the events had und waste from the plant was 5 ppm of fluonde m, n; the little effect on any area beyond the immedia.e crea of Environmental Protection Agency limit is 15 ppm.
the release, in two events, however, natural uranium in solution was released off site, Sequoyah Fuels Corporation, Gore, Oklahoma, re-ported a release of a small amount of hydrogen fluoride 2.1.5 auiner Products from a vaporizer, Maintenance work was being per-formed on a second vaporizer and a bleed valve on the An additional category of events, consumer products, system was left open, llesidual heat resulted in the re-was defined and included in the database in 1985. This lease of hydrogen fluoride through the biced valve, category includes events in which radioactive material Uranium Fuel Cyrle Events was found in, or had a reasonable probability of being introduced into, nonlicensed consumer products. Dur-Babcock & Wilcox reported a flash fire that ignited ing 1989, the Nlte received no reports of events in z rconium fines. The fire self extinguished in 30 sec which radioactive material was found m, or had a rea.
onds. One oPcrator was contaminated; there were no sonable probability of being introduced into, non-
. releases off site, licensed consumer products.
In a second event, at a Babcock & Wilcox facility in 2.1.6 Fuel Cycle Facilitics Lynchburg, Virginia, steam was generated when hot, cut pieces of a reactor coolant pump were placed in a The NltC entered information regarding 13 fuel cycle pool. Although th< re was some spread of contamina-events into the nonreactor event database in 1989, tion contained in t ic steam, there were no overexpo-Three of the events concerned mills or milling, two sures. A third evet t resulting in airborne contamination concerned the manufacture of uranium hexafluoride, in a cask-handling area was reported. No releases or and eight occurred at fuel fabrication facilities. A brief overexposures res alted from this event.
description of each of these events follows. (Note that In a fourth even'., llabcock & Wilcox reported that lig-these events do not include reports of routine effluent uid was observed in the new exhaust ventilation duct in releases.)
the uranium r,covery area when dissolution was in pro-gress. The lic,uid was removed and placed in safe ge-In addition to these 13 events at fuel cycle plants, an-ometry containers; the uranium content of the liquid other 6 events were reported at other facilities that was well below the safe limit. A fifth event concerned a handle uranium, thorium, or spent fuel, false emergency evacuation alarm.'Ihe false alarm re-sulted from a fault in the system.
Uranium Milling Events General Electric Company, Wilmington, North Caro-Atlas Corporation. Grand Junction, Colorado, released lina, reported that an individual injured the fingers of radon 222 to unrestricted areas in excess of 220 percent the left hand when the hand became caught in the of the maximum permissible concentration permitted mechanism of the radioactive material cover door that by 10 CFil 20.106 when averaged over 1 year, releases ash from the incinerator. Both fingers were severed just behind the fingernails. The individual was liighland in Situ reported that in situ leach fluids sent to the hospital for treatment, leaked from a production pipeline. Most of the liquid was c(mtained in the pipeline conduit; the remainder Westmghouse, Columbia, South Carolina, reported a flowed to a natural depression on the licensee's prop-false criticality alarm that occurred when a switch in the
- erty, computer room was accidentally opened.
Sparkling City Nue: car Corporation, Glen llock, Wyo-The Westinghouse facility at Waltz Mill, Pennsylvania, ming, reported the spill of about 7,000 gallons of yet-reported a fire in a 55-gallon drum in the decontamina-Iowcake slurry in the processing building. The belt tion building. No contamination resulted from the fire.
sheared on a yellowcake filter pump that transfers yet.
Six other events occurred at facilities that handle tho-lowcake to a dryer, allowing the sluny to escape.
rium, uranium, or spent fuel. Nebraska Power and NUllEG-1272, Appendix A 12
m t
Nonreactors-Events liight reported that non-fixed contamination of two An inspection of Cintichem, Inc., Tuxedo, New York, empty spent fuel shipping casks from the General Elec-showed that several bottles of raw fission waste did
- tric, Morris, Illinois, facility exceeded 22,000 disintegra-not contain (poisoned) raschig rings and that acid tions per minute per 100 cm2 when the casks arrived at washes were not routinely analyzed to determine the the Cooper Nuclear Station.
uranium 235 content. Upon anaiysis, the solution was found tn contain 4 g/l uranium 2J5; the license limit is in another event, thorium contamination in excess of 0.250 g/1.
NRC limits was found at the General Electric plant in Ravenna, Ohio. The contamination occurred when a Contaminated water was discharged through Cin-power failure permitted reverse air flow through the tichem's storm drain in its parking lot in both April and ventilation system, allowing contamination to enter a November of 1989. A broken, contaminated hot cell line was stated as the cause of the accident.
room.
' A shipment of waste from Nuclear Metals, Concord, 2.1.7 Radiography Massachusetts, was smoking when the trailer carrying the waste was opened at Harnwell, South Carolina. The During 1989,16 events were reported that involved probable cause of this event was moisture in poorly radiography. Table 7 provides information on these compacted scrap billets, reported events. Nine of th( events concerned overex-posures (l'able 3 of this appendix provides a list of A leak M n retention pond at Fansteel, Inc., Muskogee,-
these nine events). Two of the remaining events in-Oklahoma, resulted in the release of approximately volved transportation; fo.ir involved equipment prob-90,000 gallons of aqueous waste containing acid resi-lems that dia not result in overexposures; and the last -
ducs and waste metals, including uranium and thorium event involved three disconnects reported by a radiog-source materials, into the Arkansas River.
raphy device manufacturer.
Table 7 Radiography Events,1989 1.lcense Event Type of Isotope I ocation Licensee Number **
Date Eventt Co 60 Columbiana, OfI llran.Shon, Inc.
342585001 04/06/89 MSC Co-60 Erie, PA Allegheny 12boratories 372073401 06/11/89 MSC Ir-192 Elk Grove,IL MQS Inspection 120062207 11/15/88 EXP Ir-192 Portage, IN Testmaster Inst. Corp.
342427201 12/06/89 MSC
~ Ir-192 Norco, LA AS Mobile-Lab,Inc.
AS 08/26/89 EXP Ir 192 Burlington, M A Amersham Corp.
201283601 05/16/89 MSC Ir-192 Gould, MI TE! Analytical Services, Inc.
372800401 12/14/89 EXP 1r-192 '
Tulsa, OK Globe X Ray Services 351519401 12/21/89 TRS Ir192 Erie, PA Glitsch Field Services 341407101 08/15/89 EXP 1r-192 Ilouston, TX AS Technical Welding Lab.
AS 02/11/89 EXP Z
liraun Engineering Testing Co.
221653702 07/31/89 MSC
'Z Downey, CA AS Sun Ray Testing AS 01/03/89 EXP Z
St. leuis, MO St. leuis Testing 12boratories 240018802 02/01/89 EXP Z
Tulsa, OK Quality Eng. Serv. & Testing 352681501 12/23/88 EXP Z
VA Western Stress, Inc.
422690001 10/15/89 TRS Z
llampton, VA Advex Corp.
199105301 04/12/89 EXP
'7. means unspecified.
"AS means Agreement State beenw.
tEXi' expuure MSC-mellaneous TRS-transpn dr 1
13 NUREG-1272, Appendix A 8
i
$AEOD Annual Rcport,1989 c
~
i
-4..
U 12.1.8 L Manufacturing and Distribution.
of removable contamination on the gauge. In addition,-
- pursuant to 10 CFR Part 20, these licensees must re-f During 1989,31' events were reported that concerned port lost or stolen materials, releases of material, and
' anufacturing and distribution. Tabh 8 provides infor-so forth. Reports of events concerning gauges or meas-m mation about these events. IJcensees in this category uring systems occurring in 1989 were identified by the -
c
- have no unique reporting requirements for events in-program codes of the licensee. None of the events were ;
- volving health attd safety unless the requirements are by themselves significant During 1989,31 events were incorporated in a license condition or an order, reported concerning gauges or measuring systems. Ta-ble 9 includes information from these reports.
[
Two of the manufacturing and distribution reports were
' 10 CFR Part 21 reportsA Amersham Corp. reported to.
2.2 Abnormal Occurrences -
the NRC that it had received numerous complaints from customers that its Model 899-Series source assem.
In the Report A us on AbnormalOccurrences for 4
, blies were hanging up in the S tube of the exposure 1989, two nonrea..or events for NRC licensees and two i
devices. Amersham discontinued distribution of this nonreactor events for Agreement State licensees were.
-model radiography source. At the time of the report,33 determined to be abnormal occurrences (AOs)." The
' of the 34 sources had been replaced; the last was to be AOs for NRC licensees involved replaced within a week of the report.
q An overexposure of a radiographer at a field site.
4
.The second Part 21 report was received from Minne-The exposure to the individual was 93.3 rem whole sota Mining and Manufacturing Company's (3M's) li dy,I calized to the right hip.
4 Medical Devices Division.The company reported two events in which the Heyman ecsmmil37 source sepa-Significimt breakdown of the radiation program at e
s
- rated from its wtre handle. A review of events by 3M three facilities operated by a licensee. Ilicassay showed that a statistical samphng plan for testmg the data showed that no licensee personnel exposures
. dequacy of a brazed connection between the source exceeded the NRC limits.
.a
='
. and the handle permitted distribution of sources with inadequate source to-wire joints.' All existina sources The Agreement State AOs involved exposure of radiog-were to be retested, and manufacturing processing and raphy personnel at ficid sites. In the first event, two testing specifications were to be modified for sources radiographers and a radiographer trainee received g;
. manufactured in the future.
who!c-body doses of 66 rem (calculated from reenact.
ment),7 rem, and 4.3 rem, respectively. In the second 1
' 2.1.9 ' Gauges and Measuring Systems
. event, a radiographer received a calculated dose to his.
left hand as high as 1,400 rem.
' i lloiders of specific licenses to possess gauges are re-
- quired to report failures of or damage to shielding, on/
Appendix C, " Summary of 1989 Abnormal Occurrences off mechanisms, or indicators of the gauge, or detection (Nonreactors)," provides a discussion of the details of these events as well as the medical misadministration -
- 10 CFR Part 21," Reporting of Defects and Noncompliance,"
= AOs.
minires any individual director or res nsible officer of a firm
$$ y Icie$ts t c u I cr ate s bs an I safety "S'{ Appendix 11 for a discussion of medical misadministration n
the hazard.
A d
ii;
[
LNURIIG-1272, Appendix A 14 r
- Y Nonreactors-Events Table 8 Manufacturing and Distribution,1989 i
License Event Type of
. Isotope
- Location Licensee Number Date Event *
- L Am 241-Kansas City, KS Alpha-Omega Geotech, Inc.
152318101 06/20/89-MSC
~
Am 241 Battle Creek, MI Soil & Materials Engineers 211715802 12/02/89 MSC Am 241 Pontiac, MI Testing Engrs. & Consultants -
211866801 07/07/89 MSC Am-241 Cedar Grove, NJ Shimel & Sor Testing Labs.
291945401 08/03/89 MSC Am 241 Summerdale, PA florings, Soil & Testing Co.
371958001 08/14/89 MSC Am 241 Weirton, VA D'Appolonia Engr. Div. Tech.
371711001 07/29/89 MSC Am-241 St. Croix, VI University of Virgin Islands
$52113101 10/05/89 MSC Co-60 Sewickley, PA llerthold Systems, Inc.
372122601 08/31/89 GAU Cs-137 Dosimeter Corn. of America 341347702 10/05/89 L.KS Cs-137 Danbury, Cr Testwell Craig 061972001 10/27/89 MSC'
' Cs 137 Mehoopany, PA Procter & Gamble 371246401 03/29/89 MSC 11 3 Illoomsburg, PA Safety Light Corporation 370003002 04/25/89 RLM 1r 192 Ilurlington, MA Amersham Corp.
201283601 04/07/89 Fr21 f r-192 Ilurlington, M A Amersham Corp.
201283601 07/06/89 RAD Ni 63 Norwalk, Cr Perkin Elmer Corporation 060213508 08/28/89 RLM Z
Ilattford, Cr Metro. District Commission 061519302 09/27/89 MSC Z
New Castle, Dil Dover Equipment & Mach.
072810701 01/22/89 MSC-Z llickam Air, til Construction 12bs., Inc.
532329301 11/18/89 MSC Z
lionolulu,111 C.W. Associates, Inc. DBA 532323101 03/17/89 MSC Z
llillerica, M A
- E. I. Dupont de Nemours 200032021 08/22/89 MSC Z
llurlington, M A lon Track Instruments, Inc.
201552503 12/05/89 LKS
-Z-Clinton, MA 1.FE Corporation 200138202 01/15/89 EXP L
Z Clinton, MA LFE Corporation 200138202 02/01/89 EXP Z
Grand Rapids, MI Entcla, Inc.
212470401 10/19/89 TRS
.Z St. Paul, MN Minnesota Mining & Mfg. Co.
220005706 03/17/89
-MSC Z
St. Paul, MN Minnesota Mining & Mfg. Co.
220005706 12/19/89:
Irr21 Z
Kansas City, MO Armco,Inc.
241080902 11/28/89 -
-MSC Z
Glendive, MT State of Montana 251149801 04/01/87 MSC Z
llorsham, PA Rorer Central Research 370880201 08/15/89 EXP-Z
. llorsham, PA Rorer Central Research 370880201 05/15/89 EXP Z
Pennsburg, PA Woodward.Clyde 371965401 01/19/89 MSC t
i
'Z means umpecified.
"I!XP-expowe G AU-gauge
' LKS-leaking source htSC-miscellaneous l'r21-Part 21 report r
terial
' IRS-tramportation 15 NUREG-1272, Appendix A
AEOD Annual Report,1989 Table 9 Gauges and Measuring Systems,1989 License Event Type of Isotope
- Location 1.icensee Number Date Event" g
Am-241 North Miami, FL I;ingan Engineering Associates 291578602 0344/89 LAS Am 241 Michigan City, IN NDR Systems, Inc.
042326401 08/31/89 1.AS Am-241 Kansas City, KS Alpha-Omega Geotech, Inc.
152318101 06/20/89 Am-241 llattle Creek, MI Soil & Materials Engineers 211715802 12/02/89 Am-241 Pontiac, MI Testing Engts. & Consultants 211866801 07/07/89 Am 241 Cedar Grove, NJ Shimel & Sor Testing Labs.
291945401 08/03/89 Am 241 Hoboken, NJ U.S. Testing 290248807 05/02/89 LAS Am-241 Summerdale, PA Horings, Soil & Testing Co.
371958901 08/14/89 MSC Am-241 Weirton, VA D' Appolonia Engr. Div. Tech.
371711001 07/29/89 Am-241 St. Croix, V1 University of Virgin Islands 552113101 10/05/89 Cd-109 Madison Hts., MI GTl! Valenite Corp.
211743601 01/16/89 IAS Co-60 Sewickley, PA Ilerthold Systems, Inc.
372122601 08/31/89 GAU Cr-51 Glenolden, PA E.1. Dupont de Nemours 070045537 12/22/88 LAS Cs-137 Danbury, CT Testwell Craig 06 972001 10/27/89 Cs-137 Lexington, KY Stanford Mining Co.
371822601 01/10/89 LAS Cs-137 Dayton, OH Cargill, Inc.
341730601 08/02/89 1.AS Cs-137 Oklahoma City, OK liridgestone/Firestone 351361701 11/29/89 LAS Cs-137 Mehoopany, PA Procter & Gamble 371246401 03/29/89 MSC H-3 Hattle Creek, MI Kellogg Arena 210599005 03/30/89 LAS Ni 63 Washington, DC Environmental Protection Agency 191544003 02/15/89 LAS P-32 Ilillerica, M A E. I. Dupont de Nemours 200032021 07/14/89 LAS P-32 Pittsburgh, PA Microbac labs.
372084402 02/23/89 LAS Z
Hartford, CT Metro. District Commission 06 519302 09/27/89 Z
New Castle, DE Dover Equipment & Mach.
072810701 01/22/89 MSC Z
Hickam AFil, HI Construction 1 abs, Inc.
532329301 11/18/89 Z
Honolulu, HI C.W. Associates. Inc. Dil A 532323101 03/17/89 Z
Grand Rapids, MI Entela, Inc.
212470401 10/19/89 TRS Z
Kansas City, MO Armco, Inc.
241080902 11/28/89 MSC Z
Glendive, MT State of Montana 251149801 04/01/87 Z
McKeesport, PA Stecimet Co.
371946901 08/02/89 1.AS Z
Pennsburg, PA Woodward-Clyde 371965401 01/19/89
- Z means unspecified 1
" G AU - gauge L AS -loat, abandoned. stolen source MSC-mtseellaneous TRS - transportation f
NUREG-1272. Appendix A 16
t' 3 Findings t
The number of events reported to the NRC in 1989 a significant impact on the public health and safety.-
was about the same as in previous years, and none had 17 NUREG-1272, Appendix A
F tt I'
l Appendix Bj u
Medical. Misadministration Report t
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LAppendix B AEOD/N90 ;
Medical Misadministration Report-1 by the Nonreactor Assessment Staff Office for Analysis and Evaluation of Operational Data J
Prepared by.
i l
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i.'
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(.
li +
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f Contents
! ! Introd uction.............................
1 2.3 Diagnostic Misadrdstrations.............
-6 2 Therapy and Diagnostic Misadministrations Reported to NRC During 1989.............
3 2.3.1 Diagnostic Misadministrations of Iodine...
7 2.1 ' G en e ral...............................
3 Diaknostic Misadministrations That Inv 2.3.2 the tislabeling of Radiopharmaceutical 2.2 Therapy Misadministrations..............
3 Dosages by Radiopharmacies............
7 2.2.1 Teletherapy Misadministrations.........
3 2.4 Abnormal Occurrences...................
-8 2.2.2 11rachytherapy Misadministrations.......
5 3 Licensee-Proposed Corrective Actions.......
-9
. 2.2.3 ' Radiopharmaceutical Therapy Misadministrations....................
6 4 Findings and Conclusions.................. - I 1 Tables
,1 i
' 1 Medical Misadministrations Reported to NRC 3 Error Rate for Misadministrations...........
4-D u ring 1989...............................
3
'I be and Probable Cause of The 4
h i dministrations Reported in 19 4
2 Misadministration Reports for 1981-1989....
3 L
t l
i iii NUREG-1272. Appendix 11 i
pr 1
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i s
1 Introduction; y
'g kN flhe Office for Analysis and Evaluation of Operational bone scans. Therapy misadministration, as toed in NRC (
a
(
- ; Data (AEOD) reviews reports of medical misadmini-regulations, refers to the misadministration of radia-V' strations of radiopharmaceuticals or radiation from -
5 tion in the treatment of patients from cobalt-60 htopes regulated by the NRC.' AEOD's review of-teletherapy (external use of radiation for patient ther- ?
r N.ese reparts submitted tc the NRC during 1989 is apy treatment), brachytherapy (insertion or implanta-
- documented in this appendix.
tion of scaled sources contalning radioactive material Im pad nt thyapy tmatmenO, m mWophannaccudcar b
t Medical misadministrations are reported to the NRC therapy. The significance of any event stems from the.
pursuant to the requirements in10 CFR Part 35.The p tential effect of the event on the public health ano -
revised 10 CFR part 35, which became effective on
~ safety. Oenerally, the total risk ascribed to an event is a,
- April 1,1987, defines a " misadministration" to mean function of the frequency of the event and the magnit
- the administration of-tude of the potential effect of the event.
1.
. A radiopharmaceutical or radiation '
Licensees have reported about 3,623 dirrnostic misad-from a scaled source other than the ministrations to the NRC over the 9-yeai period from -
g ne intended; 1981 to 1989. An estimated 7 million diagnostic nuclear -
medicine procedures are performed in this country b
12.-
A'radiopharmaceutical or radiation to annually. As the NRC regulates only 21 of the 50 :
- the wrong patient;;
States, the NRC estimates that about 3 million proce-
- w
- 3. 7A radiopharmaceutical or radiation by a
- dures are performed annually by NRC licensees alone/
'the estimated diagnostic error rate per procedure is '-
d
- route of administration other than that 0.0001.
- intended by the prescribing physician; Regarding the magnitude of the potential or actual.
M 4.
! A diagnostic dosage of a radiopharma-effect of a therapy or diagnostic misadministration, ceutical differing from the prescribed -
therapy misadministrations are associated with procc..
dosage by more than 50 percent; dures in which large doses of radiation are administeredL q
to patients to achieve a therapeutic effect, while diag-t j I
. 5.
' A therapy dosage of a radiopharma' nostic misadministrations are associated with procc.
1 ceutical diffenng from the prescribed dures requiring small doses of radiation. An exception -
dosage by more than 10 percent; or is the diagnostic administration of iodine-131, a
? 6; A therapy radiation dose from a scaled '
Diagnostic misadministrations that result in the errone.l source such that errors in the source ous administration of iodine-131 may result in thyroid calibration, time of exposure, and treat-or other organ doses that range from several hundred -
- ment geometry result in a calculated rad to several thoustmd rad. These doses may approxi--
. total treatment dose differing from the mate thempy-equivalent misadministrations.
a c final prescribed total treatment dose by q
Since bott; trations have about the same estimate q
is
- 2 more than 10 percent.
misadmtms
<0i
. Approximately 7 million diagnostic procedures and error rate, therapy rnisadministrations and some -
R inline-131 misadministrations, as a class, appear to 180,000 therapy procedures are performed nation.
L wide each year." The NRC estimates that rbout be individually and collectively more signifie mt than 3
L i40 percent of all these procedures are performed by diagnostic misadministrations. AHOD, therefore,
- i
!NRC licensees and those remaining by Agreement reviews in detail reports of therapy misadministratio, ns and misadministrations that involve administering e
- State' licensees.
iodine-13L Most reports of diagnostic misadministra.
M L Diagnostic misadministration, as used in NRC regula-tions are reviewed from a collective or statistical l
tions, refers to the misadministration of radioisotopes.
viewpoint, j
i Jv dn nuclear rnedicine studies such as renal scans and
~
This appendix is a compilation of data on misadmini.
9
- WAtomic Energy Act or 1954, as amee led in 1974, limits the strations reported to the NRC from January 1989
- NRrs regulation of radioactive materials to reactortroduced through December 1989 and is divided into the follow-
.i "Y$7Nu'elear Rebulator(v Commission,"Hasie Quality Assurance ing sections " Therapy and Diagnostic Misadministra-l and <cgris of htmaministrations or Events tions Reported to NRC During 1989,"" Licensee-
_I Pn ram, kccon
' ha* ihNNfifr. 00I55 tNoIa'n#h.No.
Proposed Corrective Actions," and " Findings and Conclusions, pp 109 1449.
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1 NUREG-1272, Appendix il l
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1
2 Therapy and Diagiostic Misadministrations Reported to NRC During 1989 2.1' General 1989 was about the same as the average number re-E'# """"
From Jammry 1989 through December 1989, NRC licenseca involved in radiation therapy and nuclear Table 3 provides estimates of error rates for the various medicine reported 10 therapy misadministrations and types of therrpy procedures and diagnostic procedures.
407 diagnostic misadministrations. Table 1 summarizes The error rate per patient is 0.0003 for teletherapy and the statistics for the medical misadministrations re.
0.0001 per procedure for brachytherapy, radiopharma-ported to the NRC for 1989. Of the approximately ceutical therapy, and diagnostic procedures. From 2,500 NRC licensees authorized to perform nuclear 1981-1989, there were 40 teletherapy,22 brachyther-medicine studies or radiation therapy,326 reported one apy,12 radiopharmaceutical therapy, and 3,623 diag-misadministration or more for a total of 417 reports nostic misadministrations.
involving 486 patients. Of the 417 reports on misad-ministrations for 1989,407 (98 percent) involved diag-isatlm.. trat. ions 2.2 Therapy M.
inis nostic misadministrations and 10 (2 percent) involved therapy misadministrations.
Licensees reported 10 therapy misadministrations during 1989. Four of the misadrninistrations involved teletherapy, five involved brachytherapy, and one Table 1 Medical Misadministrations involved radiopharmaceutical therapy.
lleported to NitC During 1989 Table 4 presents data on the type and probable cause Misadministration of the misadministrations.
Diagnostic Therapy Total 2.2.1 Teletherapy hiisadministrations No.of reports 407 10 417 Licensees reported four teletherapy misadministrations during 1989.Two of the' teletherapy misadministrations No. of patients my lved an error m identifying the correct patient, one involved 476 10 486 mvolved miscommunication among the hcensee's staff
- No. of licensees regarding the treatment area of the patient's anatomy, reporting 317 9
326 and one resulted from human error during the simula-tion process.
Table 2 lists the number of misadmini:;tration reports In the first case, a patient received an unintended received during 1989 and those received during the cobalt-60 teletherapy dose of 100 rad to the brain
- previous 8 years. This table also provides the number of instead of the floor of the mouth (lower palate).Two reports according to type of misadministration, the elderly patients were prescribed fractionated cobalt 60 number of patients involved, and the number of licen-teletherapy treatments. Iloth patients were brought to sees reporting misadministrations. About as many the hospital at the same time. One patient was to be diagnostic misadministrations were reported for 1989 as treated for a lesion near the lower palate. Ilecause of were reported annually for the previous 8 years.The an identification error (names, physical appearances, number of therapy misadministrations reported during and treatment planning pictures were similar), the Table 2 Misadministration Reports for 1981-1989 Type of
. Misadministration 1981 1982 1983 1984 1985 1986 1987 1988 1989 Average Therapy 10 4
4 14 4
7 9
12 10 8
Diagnostic lodine-131 2
3 2
3 3
5 5
7 10 4
Other 428 414 332 395 377 433 409 386 397 397 No.of patients 517 451 437 442 410 495 459 470 486 463 No. of licensees reporting 351 355 293 318 293 369 348 344 326 333 I
3 NUllliG-1272, Appendix 11 i
EOD Annual Report,1989.
Table 3' Error Rate for Misadministrations (Itased on aggregated 9 year data)
Estimated No.-
No. of Type of.
of Procedures Misadmini.
No. of Error Procedure
. by NRC Licensees strations Patients Rate Therapy Teletherapy 360,000*
40 112 0.0003 Ilrachytherapy 180,000 22 22 0.0001 Radiopharmaceutical 110,000 12 12 0.0001 Diagnostic 35,000,000 3623 4167 0.0001
-**Ihis figure represents the estimated number of patients that recci d t letherbpy treatmbnts.
Table 4 Type and Probable Cause of Therapy Misadministrations Reported in 1989 Dose different from that prescribed by > 10 percent (Teletherapy)
Error in identifying t he correct patient........................................... 2 Error in the anatomical area to be treated....................................... 1 Iluman error during the simulation process...................................... 1 Dose different from that prescribed by > 10 percent (llrachytherapy)
Wrong activity brachytherapy sources used....................................... 3 Wrong isotope entered into the treatment. planning computer....................... 1 Misinterpretation of a computer error message................................... 1 A radiopharmaceutical or radiation dose to the wrong patient (Radiopharmaceutical Therapy)
Error in identifying the correct patient.......................................... 1
' patient to be treated for the lesion near the lower of treatment. positioning tattoos, which would have palate received a brain dose. To prevent a recurrence indicated that the wrong patient was being treated. To o' @is misadministration. the licensee reported that in prevent a recurrence of this misadministration, the tL ruture cach patient's identification will be verified licensee reported that in the future the patient's identi.
by a photograph and oral communication or positive fication will be verificd by a photograph. In question.
identification by a second person. In support of this able cases, the physician will verify a patient's identifi-effort, the licensee also stated that only authorized eation'and treatment before the treatment is initiated.
personnel will transport teletherapy patients into the treatment room.
In the third case, a patient was prc'tcribed a cobalt-60 teletherapy treatment to the left '.tip and groin area, consisting of nine individual trer tments during which in the second case, a patient was prescribed a cobalt-60 300 rad were to be delivered er.ch time. llecause of teletherapy treatment for his right lung.The patient, miscommunication among the licensce's technole-however, received 250 rad to the lumbar / sacral spine.
gists, the patient's right hip w is treated instead of the This misadministration occurred because the technolo-left hip and groin. Ar. a resul, the patient received gist did not confirm the patient's identity with the 2.700 rad to the wrong hip. 'l o prevent a recurrence available photograph nor did he recognize the absence of this misadministration, the licensee developed a
.NUREG-1272, Appendix B 4
l
Nonreactors-Medical Misadministrations -
comprehensive quality assurance / quality control pro-To prevent a recurrence of this misadministration, the
- gram that was subsequently incorporated into its licensee stated that the departmental procedures were.
-license. In the future, the licensee also will provide revised to require an independent check of the source r
training and retrainirig for radiation therapy techt olo-loading.
gists and resident physicians in the oncology depart-In the second case, the misadmtmstration involved a -
ment.-
temporary brachytherapy iodine-125 brain implant i
in which a tube containing 189.14 millicuries of In the fourth case, a patient was prescribed 12 i dine-125 was to be placed mside surgically implanted cobalt-60 teletherapy treatments to the right thigh, catheters for the treatment. However, an error oc-with a dose of 250 rad for each treatment. The patient,.
curred in loading an individual iodine-125 tube m however, received a radiation dose of 250 rad to the which one of the seeds loaded had an activity of left thigh instead of the right thigh as prescribed. 'lhis 6.73 millicuries rather than 16.46 milkcunes presen, bed
- misadministration occurred because the technologist
'became disoriented when turning the table during the by the therapy plan. As a result, the total activity of
. simulation process and marked the wrong leg for nydme-125 placed in the catheters was 179.40 mil-heuries mstead of the presenbed 189.14 millicuries. As ucatment a result, the patient received a dose of 3,952 rad in-stead of the prescribed dose of 4,534 rad.
The licensee reported that in the future it will provide additional guidance to the simulator technologist,
'To prevent a recurrence of this misadministration, the review the completed simulation before the treatment, licensee stated that in the future, before implantation, 1
and establish a quality assurance program that will each tube containing iodine-125 seeds will be placed cover dosimetry, treatment planning, and the imple-into a dose calibrator to determine if the total activity mentation of radiation safety practices.The quality in the tube is the sum of the indivMual sources. In.
assurance program was subsequently incorporated into addition, the remaining sources in the storage contain-
+
the licensee's NRC license, ers will be counted for accuracy.
i in the third case, a patient was prescribed a brachy.
12,.
11rachytherapy M,isadm,imstrations therapy treatment of the cervix for which two -
cescam-137 sources were to be useme prescribed Licensees reported a total of five brachytherapy misad-source strengths were 25 milligrams (mg) radium-ministrations during 1989 that were caused by (1) an equivaler t and 20 mg radium equivalent.The pre-
' inadvertent selection of a source containing the wrong scribed totalimplant time was 26 hours3.009259e-4 days <br />0.00722 hours <br />4.298942e-5 weeks <br />9.893e-6 months <br />. After the amount of radioactive material, (2) the wrong isotope treatment was completed and the sources were re-
. being entered into the treatment-planning computer, turned to the storage facility, it was discovered that a l
- and (3) misinterpretation of a computer error message, 5-mg radium equivalent sourct. was used rrther than the prescribed 25 mg radium equivalent source. As a in the first case, a patient was prescribed a brachy.
tesult, the patient was underdosed by about 56 percent.
therapy treatment usinc a Illoedorn vaginal applicator
.lhe licensee reported that although the cesium-137
. with a smgle medium ovoid and a cylinder without a sources were appropriately color coded and the safe-
- sleeve. The ovoid should have contamed two sources source storage drawers were clearly labeled with the with a nominal activity of 10 milligrams radium-strength as well as the color of the sources contained eqmvalent per source, and the cylinder should have therein, there was one drawer that contained sources of contamed three sources with a minimal activity of two different strengths. The licensee believes that the 15 milligrams radium equivalent per source so that the mix-up was due to a human error that led to the selec-
- patient would receive the prescribed dose of 3,091 rad.
tion of the wrong color source. To prevent this type of Ilowever, after the treatment was completed and the misadministration from occurring again, the sources Illoedorn applicator was removed and returned to the have now been arranged so that each drawer contains a
- storage room, it was noted that the ovoid contamed source of only one strength.
only one 10 milligram source. As a result, the patient received 1,731 rad instead of the prescribed 3,091 rad.
In the fourth case, a patient was treated with inter oJ i
hyperthemia, lloth iodine-125 and iridium-192 sect.
i Fhe licensee stated that to make up for the difference were discussed as potential candidates because of between the prescribed dose and the actual dose to the considerations of cost and availability. A final decision patient, n Manchester medium ovoid was loaded with was made to use high activity iodine-125 seeds. Ilow-two sources with a nominal activity of 10 milligrams ever, in the final dose calculations, the dosimetrist t
radium-equivalent per source and the patient was erroneously entered iridium-192 instead of iodine-125 treated for an additional 18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br />. This procedure into the treatment plan. As a result, the patient re-brought the total treatment dose to 3,091 rad.
ceived 500 rad instead of the prescribed 2,500 rad.The 5
NUREG-1272. Appendix I
.x c
/ AEOD Armu!! Riport,1989 '
crror was discovered after a regular monthly brachy.
Special training will-be. provided for ' all
. therapy conference review of the patient % chart, technologists.
To prevent a recurrence of this misadministration,'the.
licensee stated that in the future another dosimetrist, in Only one technologist will handle all asp ~;ts of addition to the one implementing the ongmal plan, will the iodine-131 therapy and recognize the correct review brachytherapy dosages to confirm the proper patient before the treatment.
isotope, activity, distribution, and other important he technologist, the physician, and the patient -
e
' parameters. Iloth dosimetrists will initial the distribu-will be required to sign the therapy worksheet tions. Also, the dosimetry staff will include all brachy-concurrently, before administration of the therapy..
th:rapy charts in its regular independent chart checking routine.
23 Diagnostic Misadministrations in the fifth case, the misadministration involved a Of the 407 reports of diagnostic misadministrations
' Gamma Med Ili, a high. dose-rate, remote after-received in 1989,265 (65 percent) involved the admini-
- loading brachytherapy device con'aining 10 curies of stration of the wrong radiopharmaceutical to a patient an iridium-192 source. The prescribed Gamma Med and 98 (24 percent) involved the administration of a treatment ca!!cd for a total dose of 1,500 rad delivered radiopharmaceutical to the wrong patient (these two in three equal doses. I uring the last treatment, the types of misadministrations accounted for 89 percent of therapy technologist entered the treatment protocol the reported misadministrations). Of the remaining into the Gamma Med computer but misinterpreted a diagnostic misadministrations,26 involved a diagnostic computer error message. As a result, a decay factor of dose of a radiopharmaceutical that differed from the
- 267 instead of the correct factor of 128 was used. The prescribed dose by more than 50 percent and 9 involved patient received 1,000 rad instead of the p escribed 500 the wrong route of administration (that is, a route of rad for the third treatment.The Gamma Med treat.
administration other than the one intended by the ment, as delivered, resulted in a total dose of 2,000 rad.
prescribing physician).The number of diagnostic re-He licensee established new procedures to prevent a ports for 1989 was about equal to the average rate for recurrence of this misadministration.
cach of the 8 previous years,1981 through 1988. The annual number of diagnostic reports ranged from 334 '
In the AEOD 1933 Anmm/ Report, Nonreactors, a in 1983 to 438 in 1986, with an average of 400 per year.
. brachytherapy event was listed that involved a patient
,I'he types and causes of the diagnostic misadministra-who was suffering from mild senile dementia 'lhe tions were about the same as those reported in previ.
patient removed four implanted cesium-137 sources ous years. Effectively, all of the diagnostic misadmini-before the treatment was complete. At the time the strations myolving the wrong radiopharmaceutical or
. AEOD report was publishedi the NRC staff had not the wrong patient stem from human error.
determined whether or not this event met the criteria for a misadministration under 10 CFR Part 35.2. The The primary errors associated with the admm..istrat. ion event has since been determined not to be a misad-Of R radiopharmaceutical to a patient were errors r
ministration.
durm.g the preparation or admmistration of radiophar-
~
maceutical dosages, such as Mislabeling of radiopharmaceutical dosuges 2:23 Radiopharmaceutical Therapy e
Reconstitution of the wrong reagent kit Misadministrations Misinterpretation of the physician's order e
Selection of the wrong vial when drawing a dosage
..the one radiopharmaceutical misadm.. trat. ion re-mis ported for'1989 myolved the administration of 9 mil-Selection of the wrong syringe from the dosage cart
.E licuries of iodine-131 to the wrong patient. As soon The primary errors associated with the administration '
as the error was discovered, the patient was given of a radiopharmaceutical to the wrong patient were:
, potassium perchlorate and I ugol's solution to release iodine-131 already trapned in the thyroid and to bh>ck Wrong patient's name was entered on the further uptake. This m.sadministration resulted in an requisition.
Lestimated dose to the thyroid of approximately 820 Wrong patient was delivered to the nuc! car medi-rem.
cine department.
The licensee stated that the following steps will be Patient's identity was not correlated with the e
taken to prevent a recurrence of this type of misad-mmt smdy.
ministration:
Patient answered to the wrong name.
1
.NURl!G-1272, Appendix 11 6
Nonreactors-Medical Misadministrations i
2 The patient to be dosed should be seen by the 1.icensees stated that contributing factors for these e
primary errors were responsible nuclear medicine physician at the time of iodine administ:ation and a history should be Patient's chart was not checked.
taken and a physical should be performed to be e
e Procedure was new, certain of the indications for the dose.
Workload was heavy.
The physician should see the dosage in the dose e
- Patient's requisition was not checked.
calibrator and document it in a log book, verifying e
Student technologist was involved.
both the isotope and activity that had previously e
e Patient's identification bracelet was not checked.
been ordered in writing.
Relatively simple quality assurance procedures (check-The technologist may then administer the e
ing the patient's identification against the study and the iodine-131 without the physician necessarily being patient's medical history, asking the patient to state his
- present, or her name) might reduce the frequency of these if the patient is female and between the ages of e
wents.
11 and 55, a scrum quantitative pregnancy test thould be performed before administration of the 2.3.1 Diagnostic Misadministrations test.
of Iodine In the second case, a patient was prescribed 300 micro-curies of iodine-123 for a diagnostic thyroid procedure.
ic misadm.. trations reported t The patient, however, was administered a 3-millicurie mis Of the 407 diagnost.
the NRC in 1989,10 m, volved the admmistration of dosage of iodine-131. The licensee stated thW this mis-iodine-131 m, amounts that resulted in the delivery of administration occurred because the technoh> gist thyroid or other organ doses that ranged from 2 rad to misunderstood the study requested by the referring 9,000 rad.' Three of these misadmmistrations resulted physician, as well as the radiopharmaceutical and m thyroid doses of more than 1,000 rad. These cases, dosage that was to be administered.The licensee are listed below. Causes of the iodine-131 misadmmi-calculated the dose to the patient's thyroid to be about strations included (1) misunderstanding a physician s 4,700 rad.To prevent a recurrcnce of this misadmini-order, (2) picking }ip the wrong radiopharmaceutical, stration, the licensee stated that in the future no and (3) lack of trammg.
iodine-131 radiopharmaceuticals will be administered to a patient without prior approval by the nuclear In the first case, a patient was administered a 1-medicine physician. The licensee also developed a millicurie dosage of iodine-131 instead of the intend-quality assurance / quality control program that was ed dosage of 100 microcuries. The referring physician subsequently incorporated into its NRC license.
wanted an iodine-131 neck scan for ectopic thyroid tissue, which required the administration of in the third case, a patient was to receive 1 millicurie of 100 microcuries of iodine-131. Ilowever, the box on the iodine-123 for thyroid uptake and scan.This procedure nuclear medicine referral sheet for iodine-131 neck would result in an exposure to the thyroid of about 7 scan, post-thyroidectomy for carcinoma, which requires rad, llowever, because the technologist misunderstood a 1 millicurie dosage of iodine-131, was checked.
the wordmg in the notes made by the referring physi-cian on the patient's chart, the technologist adminis.
The nuclear medicine physician approved the neck scan tered 5 millicuries of iodine-131, a dosage intended for but did not specify that 100 microcuries of iodine-131 a whole-body iodine scan. As a result, the patient should be used. He assumed that the iodine was for a received an unintended dosage of between 1,200 and thyroid cancer procedure. The usual licensee's dose for 9,000 rad to the thyroid. The licensee stated that the diagnosis of thyroid cancer is 1 millieurie of iodine-131.
misadministration was caused by human error and lack The dose was, therefore, ordered and administered.
of training of involved personnel and that in the future The licensee calculated the dose to the patient's thy-the requested study for each patient will be verified, roid to be about 1,300 rad.
2.3.2 Diagnostic Misadministrations The licensee stated that the following steps will be That Involve the Mislabeling of taken in order to prevent a recurrence of this lladiopharmaceutical Dosages by misadministration:
Itadiopharmacies The mislabeling of radiopharmaceutical dosages ac-
lh.e graglualincrease in the number of diagnmtic iodine-131 counts for approximately 9 percent of the reported masadmmntratiom from 1981 to 1989 may be ascribed to the misadmm.. trations in 1989. About z percent of the is increase of du of kxhne-t31.gnmiic procedures requiring adminisitation total 407 diagnostic misadministrations resulted from i
7 NURI!G-1272. Appendix 11
1...
1 AEOD AnnualReport;1989.e w
h 1,i the dispens!ng of mislabeled doses by radiopharmacies._
e A medical therapy misadministration that involved ffhe causal factors associated with the mislebeling of cobalt-60 therapy treatment of the wrong patient's
- radiopharrnaceutical doses by radiopharmacies (simple thigh -
h 1 uman error resulting from inattention to details) are
, gcnera:iy the same as those for hospitals. However,
_ pv medical therapy misadm.. trations that -
mis
- because radiopharmacies can supply many hospitals, a involved a cobalt-60 teletherapy treatment of the-
~ ingle mislabeling event could result in the admin, wr ng patient-s
' istration of the wrong radiopharmaceutical to many -
A medical therapy misadministration that involved -
e
- patients.
a human error during the simulation process of the cobalt-60 teletherapy treatment -
As previously m. dicated in this appendix, the calculated
. error rate for diagnostic misadministrations from -
A medical therapy misadministration that involved '
e
. reported data is very low,0.01 percent; however, the administration of iodine-131 to the wrong radiopharmacy practice appears to be an area in which _
patient efforts expended to reduce human errors could be A medical diagnostic misadmm.. tration that productive.
is involved the administration of the wrong isotope of iodine 2.4 - Abnormal Occurrences A medical therapy misadministration that involved e
in the Report to Congress on Abnonnal Occurrences for the administration of the wrong amount of 1989, eight medical misadministration events were odine-131
- reported by NRC licensees. No events reported by Agreement State licensees were determined to be A medical diagnostic misadministration that e
- licensees inclinded -
radiopharmaceutical -
i l
4NURl!G-1272, Appendix 11 8
c, 1 '
3 Licensee-Proposed Corrective Actions
'The corrective actions most taken by licensees were
. As the corrective actions and their effectiveness are (1) retraining of personnel, (2) implementing new licensee specific, a meaningful determination of whether corrective actions were effective would have to radiopharmaceutical labeling and handling procedures, focus on the trend in misadmmistration rates for each
- (3) implementing new procedures for patient identifica-licensee that reported several misadmmistrations.
tion,(4)implerrentin8 new Procedures that re9uire the Because the reported misadministration rate estimated technologist to check the patient's chart for the physi-for a sample of licensees was 0.1 percent, neither a cian's orders, and (5) reprimanding the technologist or detailed evaluation of these rates nor the associated i
other personnel, wrective actions have been made.
+
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[
6:
,y 9
NUIEG-1272. Appendix 11 k
A 4 Findings and Conclusions
._ Licensees reported 10 therapy misadministrations dur-
. ceutical to the wrong patient. The number, type, and ing 1989, a number that is about the average number cause of diagnostic misadministrations are about the.-
reported for previous years. These teletherapy, brachy-same as those reported in previous years. The causes l
thertpy, and radiopharmaceutical therapy misadminis-reported by licensees for 1989 are, generally, simple -
- trations might have been prevented by quality assur-crrors associated with the preparation r ad administra-ance procedures that demanded verification of patient -
tion of radiopharmaceuticals, such as (1) processing dose calculations, the type of treatment, and patient nuclear medical requisitions and (2) identifying pa.
. Identification.
tients. In addition, for misadministrations involving.
iodine-131, the primary causes given were (1) misun-Essentially all diagnostic misadministrations for 1989 derstanding a physician's order, (2) picking up the
' involved either the admatistration of the wrong radis wrong radiopharmaceutical,(3) lack of training, and pharmaceutical or the administration of a radiopharma-(4) failure to verify the patient's identification.
t t
- l'
.t i
11 NURl!G-1272, Appendix 11
1 3
Appr idix;C T
Summary of 1989 Abnormal Occurre~nces
.(Nonreactors). '
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Abnormal Occurrences (AOs) for CY 1989 (Nonreactors) i Report No.
AO No.. Title of 40 NUREG-0090 Description of Event b
NRC Lkensees 89-3.
Medica!'lherapy Vol.12, No.1 On January 23,1989, a patient at Abbott Northwestern Misadministration Hospital, Minneapolis, Minnesota, suffering from a malignant -
tumor on his right femur (thigh), received a 250-rad radiation dose to his left femur by mistake. The patient was scheduled for 12 treatments of 250 rad each to the right thigh using a cobalt-60 teletherapy device. The misadministration was dis-
~!
covered after the first treatment to the wrong thigh. Treat-ment was subsequently performed on the right femur and the treatment schedule was continued. The licensee determined that the misadministration could possibly cause the patient increased fatigue and possible bone marrow ;appression in the left femur.
This misadministration was attributed to several personnel errors. In turning the table on which the patient was lying, the simulator technologist apparently became disoriented and marked the wrong thigh. The therapy physician checked and approved the incorrect thigh marking and treatment.The therapy technologist should have waited until the patient's, simulator checklist was available in the teletherapy unit be-fore commencing treatment. As corrective actions, the licen-see provided additional guidance to the involved personnel and upgraded its quality assurance / quality control program, U
.89-4
'M dicalTherapy Vol.12, No.1 On March 9,1989, a patient at Kennebec Valley Medical.
. Misadministration Center, Augusta, Maine, received a therapeutic treatment that was intended for another patient. A radiotherapy physi-clan had prescribed therapeutic treatments in fractionated i :,.
doses to two elderly patients from a Veterans' Administration j
facility. One patient was to be treated for a brain tumor; the
~
second patient was to be treated for a lesion near the lower palate. Iloth patients were brought to the hospital at the same -
time. Because of an identification error, the second (lower palate) patient was brought into the treatment room and the procedure for the brain tumor treatment was begun.'When o
R the error was discovered, the procedure was stopped. A total of 100 rad had been delivered to the brain of the patient. The patient had correctly received 2,400 rad to the lower palate from previous treatments.The licensee stated that no adverse effects are anticipated as a result of the misadministration.
4 NURiiG-1272, Appendix C
m-k J
. AEOD Annual Report,1989 I
Report No.
i AO No.
- Title of AO -
. NUREG-0090 Description of Event NRC Licensees (cont.)
. 89-4 (cont.)
The mistake was due to human error on the part of the staff of the radiotherapy department at the medical center. The' names, physical appearances, and treatment-planning pictures of both patients were similar. The licensee's planned correc-tive actions included a strengthening of its patient identifica-tion policies, along with confirmation by a second person of -
the patient's identity and treatment parameters.1 89-5 Medical Diagnostic Vol.12, No.1 On March 14,1989, a patient at New England Medical
- Misadministration Center Hospital, lloston, Massachusetts, was to receive an administration of 1 millicurie of iodine-123 for a diagnostic ;
scan. This procedure would result in an exposure to the thy roid of about 7 rad. However, a staff endocrinologist mistak-enly requested an iodine-131 uptake and scan. A floor admin-istrator, transcribing the request to a computer, selected an :
iodine-131 whole-body scan as the intended request.The dos-age for this incorrect procedure was prepared and adminis-tered to the patient by nuclear medicine department person :
nel, resulting in a dose to the patient of 5 millicuries of iodine-131. The misadministration resulted in a therapeutic dose to the thyroid of approximately 4,000 to 5,000 rad, with a '
possible range between 1,200 and 9,000 rad. This dosage could affect the function of the thyroid.The licensee stated that the patient, a cardiac patient under the care of an endo =
crinologist, might later have been administered a similar dos-age of toGne-131 for thyroid ablation as treatment for his cardiac condition. However, this is no basis for the misad-ministration; the incident would not have occurred if proper controls had been in place and followed.
The licensee stated that the misadministration was caused by human error on the part of the staff endocrinologist and lack of training of involved personnel. The root cause was inade.
quate supervision of department activities. The licensee's cor-rective actions included a change in the radiopharmaceutical.
requisition forms to include the patient's name, type of study,'
and isotope; approval of all iodine-131 use by the chief nu-clear medicine technologist before administration of doses to the patient; and additional training for all radiology residents, endocrinologists, and technologists during regularly scheduled quality assurance meetings. This incident was also reviewed by an NRC medical consultant. One of the consultant's recom-mended courses of action was to follow the patient yearly with thyroid function and imaging studies and palpation to reduce the risk of thyroid cancer and hypothyroidism.The hospital NUR120-1272, Appendix C 2
i
Nonreactors-Abnormal Occurrences.
Report No.
AO No.
Title of AO NUREG-0090 Description of Event
'i NRC Licensees (cont.)
> 89-5 (cont.)
committed to follow this course of action; however, before the :
June 10,1989, enforcement confer nce, the patient died be-cause of a longstanding cardiac condition.
i 89-7 Medical Therapy Vol.12. No. 2 Iletween March 13 and March 27,1989, at the Indiana Misadministration University School of Medicine, Indianapolis, Indiana, a 68-year-old male patient suffering from metastatic lung dis-j ease involving the spine and both hips received 2,700 rad to the wrong hip.
The misadministration resulted when the patient's left hip.
I was incorrectly marked for treatment with the patient in the prone position (face down); the bone scan, which was the ba-sis for the treatment, had been taken while the patient was in the supine position (face up).This mispositioning went unno-ticed and the right hip was erroneously marked and received I
the treatment. Treatment began March 13 and ended March 27, when the resident oncologist discovered the error while 3
reviewing the patient's chart. The patient and the patient's referring physicians were notified of the misadministration.
Treatment on the patient's left hip was subsequently begun on April 10.
j An NRC medical consultant concluded that in view of the
[
patient's widespread metastatic disease, the inadvertent.
l 2,700 rad dose to the right hip would not result in a signifi.
cant, untoward consequence to the patient.
The lack of a written prescription for the simulator technolo-gist contributed to the mispcsitioning of the patient on the simulator table and treatment of the wrong hip. In addition, the absence of Icft or right-side markers on the simulator radiograph and failure to audit positioning early in the treat-ment allowed the misadministration to go unnoticed during the treatment period. Corrective actions taken by the licensee included changes to its radiation oncology department's qual-ity assurance / quality control procedure for external beam ra-diation therapy. The procedure specifies precautionary steps to be taken before initiating treatments, a separate review by a physicist, and a weekly review of treatment charts for all patients undergoing treatment. Training will be provided for new personnel.
3 NURIiG-1272, Appendix C r
A--.'
4 ABOD Annual Report,1989
- Report No.
NUREG-0090 Description of Event
'I NRC Licensees (cont.)
L 89-9:
1 Medical Diagnostic Vol.12, No. 3 On May 23,1989, at Abbott Northwestern Hospital,.
Misadministration Minneapolis, Minnesota, a female patient who was o b c.i diagnostic test (thyroid scan) was administered the m radiopharmaceutical, which resulted in a radiatiot J m s
_ thyroid in the therapeutic range. Before the date d ; e 1
4 tration, the patient's physician telephoned the lien a i a-clear medicine department requesting that his pat given a thyroid scan. The patient, who had been diagnog s. -
having a thyroid nodule, v as to be treated on an outpatiem basis. A thyroid scan typically utilizes 300 microcuries of
=I iodine-123 (which would result in a dose to the thyroid of 1
about 5 rad) and is @ signed to locate a thyroid disorder.
(Iodine-123 is accelerator produced and is not under NRC.
regulatory jurisdiction.) When the referring physician tele-
't phoned the order, a scheduling secretary incorrectly wrote
" thyroid iodine-131 caps," rather than " thyroid scan." A.
= i technologist, seeing the order for thyroid iodine-131 caps, assumed the patient was to receive a whole-body scan and administered 3 millicuries of iodine-131 to the patic.nt. The q
purpose of the whole-body scan is to look for thyroid cancer i+
tissue that has traveled to other parts of the body. Patients L
who receive such a scan have had their thyroids removed or l;
made " nonfunctional" by therapy. Three millicuries of t
)
iodine-131 can damage a normal thyroid gland!The licensce's -
L chief nuclear medicine technologist discovered the error L
about 30 minutes after he patient received the iodine-131; L
the patient was given Lupl's solution to reduce the effects of the iodine on the thyroid, and the patknt's physician was noti-fled. The licensee estimated the ptient's thyroid radiation dose to be in the range of 3,000 rad. However, the NRC's I
medical consultant estimated the dose to be 4,700 rad ne.
s NRC's medical consultant observed that the patient would _,
J have a 10-percent chance 01 developing hypothyroidism within 2 years, and a 25-percent chance in 12 years. He recom-mended that the patient receive routine testing for thyroid i
function every 4 to 6 months.
J The licensee did not have adequate procedures to ensure that written prescriptions were required and that dosages were verified befnre they were administered. There was an error in
- communication between the patient's physician and the secre-tary scheduling the nuclear medicine examination (she listed.
the wrong isotope on the nuclear medicine schedule). The technologist assumed that a whole-body thyroid scan had been 3
ordered because " iodine-131 caps" was listed on the schedule.
The technologist stated that if he had checked the admitting diagnosis, " thyroid nodule," he would ht vc known that iodine-131 was the wrong isotope to use. The hospital had no procedure or requirement that technolog sts check the admit-ting diagnosis before giving radiopharmaceuticals to patients.
i NUREG-1272, Appendix C 4
Nonreactors-Abnormal Occurrences i
Report No.
A0 No.
Title of AO NUREG-0090 Description of Event NRC Ucensees koil.)
89-9 (cont.)
Corrective actions taken by the licensee included establish.
ment of procedures requiring that iodine-131 be given to pa-tients only with the prior approval of those individuals listed on the hospital's NRC license as " authorized" physicians. In addition, the licensee established proc @cs requiring a phy-sician to subm' 3 written prescription for the use of iodine-131 and rec;uiring nuclear medicine technologists to review a i
physicia. 4 reason for giving a patierit iodine-131 to ensure that the right isotope is used with the prescribed procedure and that the proper amount of iodine-131 is administered.
t 89-10 Medical Therapy Vol.12, No. 3 On Ju!y 24,1989, at Worcester City Hospital, Worcester, Misadministration Massachusetts, the wrong patient was administered 250 rad (from a cobalt-60 teletherapy unit) to the lumbar / sacral spine. The radiation therapy technician called the right pa-tient's name but did not confirm the patient's identity with the available photograph. The wrong patient responded.
When he was being positioned for therapy, fr;ckles on his back were mistaken for treatment positioning tattoos and used for the setup.The patient indicated that his se%,, was not correct, and the technician called the oncology physician to verify that the treatment was correct. The physician veri-fled that the treatment tvan correct on the chart but did not speak to or examine the patient.
The licensee has edvised the NRC thaw.o adtgrse effects are anticipated as a result of the misadministrar:lon.
This misadmini.<tration is attributed to human error by the staff of the licensec's radiotherag'y department.The radiation therapy technician had not previ6wly seen the patient. She, did not confirm the patient's identity with the available 1.hoto-graph and did not recognize the absence of treatment-positioning tattoos in the patiev'a lumburlsacra! spine area.
The oncology physician reviewe.J the patient's chart but did not verify the patient's identity. Corrective actions taken by the licensee included strengthen lng the patient identification policies and training technicians to obtain physician verifica, tion of patient setup before initiating treatment in question-able cases.
5 NURI!G-1272. Appendr.: C
s AEOD Annual Report,1989 Report No.
AO No.
Title of AO NUREG-0090 Description of Event NRC I.icensers (cont.)
89-11 Radiation Over-Vol.12, No. 3 On August 2,1989, a radiation overexposure occurred at a exposure of a field site near the Eric, Pennsylvania, facility of Glitsch Radiographer Field Services /NDE, Inc., North Canton, Ohio. A licensee-trained and licensee qualified radiographer with 6 years of experience received a whole body radiation exposure of 93.4 rem. After completing a radiograph, the radiographer re-tracted the source into its shicided position inside the device and surveyed the device and guide tube to verify that the source was fully retracted, lie failed, however, to lock the source into its shielded position. While setting up the next radiograph and repositioning the radiography device, the iridium 192 source apparently moved from its shicided posi-tion when the source's crank mechanism rotated. After com-pleting the radiograph, the radiographer checked his pocket dosimeter and noticed that it was offscale (more than 200 mil-liroentgen). lie reset his dosimeter to zero and continued ra-diographic operations even though he was aware that NRC regulations and licensec procedures require that all work be stopped and immediate notification be made when a dosime.
ter is discovered offscale. A dosimeter worn by the individual during radiographic operations from July 10 to August 2, 1989, revealed a cumulative exposure 'I about 93.4 rem. On the basis of licensee statements, intervaws with the radiogra-pher involved, and NRC reenactme its of the indi*"ual's ac-tions during the event, NRC inspectors concluded that the 93.4 rem exposure was localized to the individual's right hip, which was as close as 2 inches to the unshicided source during radiograph preparation. As of December 1989, no significant medical effects have been observed. An NRC medical con-sultant continues to monitor the individual.
This event was caused by the radiographer's failure to lock or otherwise secure the raclioactive source in its shielded posi-tion. Movement of the radiography device and the rotation of the source crank handl; allowed the source to move from its fully shicided position and to expose the radiographer to di-rect radiation. The mdiographer also failed to perform an adequate raAition survey to ensure the source was inside the shleiding before he approached the device. Corrective actions by the licensee included revoking the radiographer's radio-graphic certification pending retraining and testing and con-ducting a 2.hout radiation safety training class for radiography personnel in the Eric, Pennsyhania, facility. Refresher safety M
training was also conducted for all radiography personnel.
\\
l NORUG-d/2, Appendix C 6
4.
e
NontcDetors-Abnormal Occurrences Report No,
(-
AO No.
Title of AO NUREG-0090 Description of Event NRC Ucensees (cont.)
89-12 Significant Hrcak.
Vol.12, No. 3 During 1988 and 1989, major deficiencies existed in the radia-down and Careless tion safety program at three facilitics in Ohio operated by Disregard of the General Electric Co;r+any's (GE's) Lighting Business Group.
Radiation Safety Two of the facilitics, the Tungsten Products Plant, and the Program at nree Chemical Products Plant, are in Cleveland, and the third, the General Electric Ravenna Ir.p Plant, is in Ravenna. The deficiencies per-Manufacturing tained to the control of dispersibic powdered thorium (a natu-Facilitics rally occurring, radioactive, alpha.cmitting material). The deficiencies posed a poss.ble threat to plant workers because of potentialinternal der,osition of the thorium.The licensee was not performing so ne of 'he required contamination sur-veys and radiation exposure evaluations. Because cf these deficiencies, the licensee was not identifying all contaminated areas and determinations regarding employees' exposure to airborne thorium contained uncertaintics. Although major deficiencies existed in the licensce's survey and monitoring programs, subsequent bioassay tests of employees have indi-cated that NRC limits for exposure to thorium were not ex-cceded for any GE employec.
The causes of the event inclu6ed inadequate attention by management to radiation safety provisions and failure of man-agement to implement effective corrective actions to resolve problems, resulting in long term and recurring problems. This daation demonstrated a serious breakdown in the licenste's management of the radiation control pogram, as well as a carcicss disregard by the licensee of NRC requirements. Cor-rective actions taken by the licensee included revamping its radiation safcty program and making major modifications of the thorium handling system at the Ravenna plant, 89-13 Medical Diagnostic Vol.12, No. 4 On October 18,1989, at the Mayo Foundation, Rochester, Misadministration Minnesota, a patient received a diagnostic dose of a radio-active iodine compound that was 10 times the intended dose.
The referring physician intended that a patient receive a neck scan using 100 microcuries of iodine-131 but checked the box on the referral form indicating a scan using 1 millicuric of iodine-131.The hospital reported that the patient received an additional radiation exposure to the thyroid of about 1,200 rem beyond that intended by the referring physician. Had tht intended dose of 100 microcur%s been administered, the thy-roid would be expected to ree,ive an exposure of no more than about 140 rem. A medical consultant retained by the NRC indicated that the added dose would result in a very 7
NUREG-1272, Appendix C
AEOD Annual Report,1989 r
Report No.
AO No.
Title of AO NOREG-0090 Description of Event
. LC Licensees (cont.)
89-13 (cont.)
slight increase in the rish that the patient would develop hy.
pothyroidism or thyroid cancer. The consultant recommended that the hospital monitor the patient with annual thyroid function tests.
"Ihis misadministration occurred becau'c the referring physi-cian checked the wrong box on the nuclear medicine reierral sheet. 'Ihe nuclear medicine physician approved the nec k scan procedure but did not specify that it should be the neck sc an with the lower dose of 100 microcuries (i.e., the nucleat medi-cine physician did not write the prescription on the ord:r form). Corrective actions taken by the licensee included revi-sion of its procedures to require additional precaution i for procedures invoMng more than 20 microcuries of radi sactive iodine. Under the revised procedures, a nuclear medicine physician will review the request for the diagnostic test and the patient's chart and both the referring physician and the nuc! car medicine physician will approve the test and write the -
preset: bed dosage on the referral request form. The hospital's radiopharmacy will not dispense any quantities of iodine greater than 20 microcuries without a properly pr: pared re-ferral request form, including a prescription by a ntbar medicine physician.
89-14 Medical Therapy Vol.12, No. 4 On November 30,1989, at the Kuakini Medical Center, Misadministration lionolulu, llawaii, a therapy dose of 9 millicuries of iodine.
131 was inadvertently given to the wrong patient (Patient A rather than Patient II). Patient A was to receive a 20-millicurie dose of a technetium-99m compound for a diagnos-tic procedure (bone scan). 'Ihis dose was administered and the patient was seated in the waiting room. Patient II, who was scheduled to receive an iodine-131 hyperthyroidism treat-ment, arrived, complcted an interview, signed a consent form, and was seated in the waiting room pending the iodine treat.
ment.The technologist prepared a dose of 9 millicuries of iodine-131 for administration and reportedly called Patient it flowever, Patient A responded.The technologist explained the iodine-131 treatment, scheduled a followup appointment, and adrainistered the dose to Patient A. 'Ihe patient then questioned the technologist, and it became evident that the wrong patient had been treated. Patient A was immediately informed of the error, and his stomach was pumped, retriev-ing 3.2 millicuries of the material.The patient was then given potassium perchlorate and Lugol's solution to release any iodine-131 already trapped in the thyroid and to block further
. NURiiG-1272, Appendix C 8
Nonreactors-Abnormal Occurrences Report No.
AO No.
Titw of AO NUREG-0090 Description of Event d
NRC Licensees (cont.)
89-14 (cont.)
uptake.The use of Lugol's solution continued for 14 days.
This misadministration resulted in an estimated dose to the thyroid of approximately 820 rem. Tr % dosage is not expected to affect the function of the patient's thyroid significantly, nor is it expected to cause any other adverse effects.
i The licensee stated that the misadministration was caused by human error on the part of the technologist and by inade-quate procedural controls. The root cause was inadequate supervision of department activities. Corrective actions taken by the licensee included (1) scheduling a training class for all technologists,(2) using a single technologist who is able to recognize the correc patient before treatment to hand!c all aspects of the iodine 131 therapy, and (3) requiring the tech-nologist, the physician, and the patient to sign the therapy worksheet concurrently before the dose administration.
- Agreement State Licensees
' AS89-1 Industrial Vol.12, No. 2 On February 11,1989, three employees (two radiographers Radiography and a radiographer traince) of Technical Welding Laboratory, Overexposures incorporated, Pasadena, Texas, were overexposed while per-forming radiography at Gulf Railcar, a manufacturing plant in llouston, Texas. During radiography operations, a source be-came disconnected resulting in an exposure of about 66 rem -
a to the first radiographer, based on a reenactment of the inci-dent. The second radiographer and the trainee received about 7 rem and 4.3 rem, respectively, as measured by their person.
nel monitoring devices.
The State of Texas concluded that there was no equipment failure.The disconnection occurred when the second radiog.
rapher initially failed to connect the source assembly prope.ly to the drive cable.The required survey of the radiogr phic device and the guide tube was not performed.
l
- AS89-2 Industrial Vol.12, No. 4 On August 26,1989, an employee of Mobil-imb, Inc., Harvey, Radiographer louisiana, received an overexposure of his left hand while Overexposure performing industrial radiography at Shell Oil Refinery in Norco, leuisiana. The radiographer's hand may have con-tacted the radioactive source while it was unshielded. The calculated exposure was about 1,400 rem, based on an investi-gation by the State of Imuisiana. The whole-body exposure 9
NUR[iG-1272. Appendix C
.m AEOD Annual Report,1989 Report No.
AO No.
Title of AO NUREG-0090 Description of Event Agreement State Licensees (cont.)
ASS 9-2 (cont.)
was about 12.9 rem, based on the reading of the radiogra-pher's thermoluminescent dosimeter. The State of louisiana advised the licensee to prcevide immediate medical attention, including a doctor's examination of the hand and blood tests.
After performing an exposure, the radiographer cranked in the source: however, the source was not fully retracted into the exposure device.*Ihc radiographer then performed an inadequate radiation survey that failed to detect the exposed sourec. Ilc locked the exposure device, took it to a pipe rack, and set the device into the rack. While preparing for the next exposure, he was located approximately 2 feet from the front of the exposure device in a squatting position, with his back to the device. After an estimated 8 minutes, he reached back, without turning around, and disconnected the source tube with his left hand. lic pulled the tube away and may have grazed the source capsule with his left palm. Within a couple of seconds, he noticed that the source was protruding about 4 inches from the nipple, lie immediately left the area and notified the lead radiographer. The lead radiographer cranked the exposed sourec fully into the exposure 4levice and sur-veyc4 and locked the device. After directing the radiographcr to return to Mobil-1.ab to turn in his thermoluminescent do-simeter badge, he took the exposure device to SPEC Inc., in Kenner, louisiana, for inspection. *lhe exposure device ap-peared to be working properly.Though the calculated expo-sure of the radiographer's hand may have been as high as 1400 rem, as estimated from a reenactment of the incident, the hand showed no indications of injury. Illood tests taken shortly after the incident, and again 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> later, were normal.
He State of leuisiana concluded that the primary cause of this event was the radiographer's failure to perform a proper radiation survey to determine if the sourec was in the safe position following a radiographic exposure. Corrective actions taken by the licensee included circulating a notice to employ-ces with their paychecks; the notice described the incident and stated that the cause of the event was failure to perform a proper radiation survey. In addition, the licensee increased the number of field audits of radiography being performed at job sites.
NUREG-1272, Appendix C 10
h' Appendix D Reports Issued From 1981 Through 1989 (Nonreactors) i
Nonreactor Reports issued From 1981 Through 1989 Nonreactor Reports issued in 1989 Engineering Evaluat8ons D:le Title No.
Author 06/89 Use of Radioactive lodine for Infrequent Medical N901
- 11. Karagiannis Studies and Those Performed Under an FDA Investigational Exemption of a New Drug (IND) 06/89 Report on 1988 Nonreactor Events K. Black 06/89 Medical Misadministration Report-Medical
- 11. Karagiannis Misadministrations Reported to NRC Frorr.lanuary 1988 Through December 1988 Technical Review Reports D:le Title No.
Author 05/89 Review of Therapy Misadministrations That involved 1 908 K. Black Multiple Patients and the Use of Computer Programs Nonreactor Reports issued in 1988 Special Study Reports D:te Title No.
Author 09/88 Review of Events at large Pool Type Irradiators SS07 E. Trager (NUREO-1345, March 1989)
Engineering Evaluations D:le Title No.
Author 10/88 Report on 1987 Nonreactor Events N801 K. Black 10/88 Medical Misadministrations Reported to NRC for N802 S. Pettijohn the Period January Through December 1987 Nonreactor Reports issued in 1987 Special Study Reports D:le Title No.
Author 10/S7 Radiography Overexposure Events involving S703 S. Pettijohn Industrial Field Radiography
- Published as Appenda A of NURiiG-1272. Vol. 3. Na 2, AFOD 193S AnwalReport.
- Publahed as Appenda 11 of NURiiG-1272. Vol. 3, Na 2. AEOD 1933 Annual Report 1
NUREG-1272, Appendix D
AIIOD Annual Report,1989 l
l Nonreactor Reports issued in 1987 (cont.)
Engineering Evaluations Date Title No.
Author 01/87 Diagnostic hiisadministrations Involving the N701 S. Pettijohn Administration of hiillicuric Amounts oflodine-131 03/87 Diagnostic hiisadministrations Reported to NRC for the N702 S. Pettijohn Penod January 1986 Through Decemb;r 1986 03/87 Report on 1986 Nonreactor Events N703 K. Illack Technical Review Reports Date Title No.
Author 11/87 Review of Data on Teletherapy hiisadministrations "I711 S. Pettijohn i
Reported to the State of New York That V'cre the Title of PNO-I-87-74A 12/87 Distribution of Information Notices anc. Other "1 - tss
'I714 S. Pettijohn hiailing"Information to Licensees That Have Us 5 at locations Remote From the lleadquartein IAcations Nonreactor Reports issued in 1986 Case Studies Date Title No.
Author 08/86 Rupture of an Iodine-125 lirachytherapy Source at the C601 S. Pettijohn Uruversity of Cincinnati hiedical Center Engineering Evaluations Date Title No.
Author 06/86 Report on 1985 Nontector l' ents and Five Year N601 K. Illack Assessment for 1981-1965 06/86 hiedical hiisadministrations Reported for 1985 and N602 S. Pettijohn Five-Year Assess nent of 1981-1985 Reports Nonreactor Reports issued in 1985 Case Studies Date Title No.
Author 12/85 Therapy hiisadministrations Reported to NRC Pursuant C505 S. Pettijohn to 10 CFR 35.42 1
NUREG-1272, Appendix D 2
Noarcactors-Reports,1981-1989 Nonreactor Reports issued in 1985 (cont.)
Engineering Evaluations D:te 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 Ilase N502 K. Black for the Period July-December 1984 07/85 Report on hiedical hiisadministrations for January-N503 S. Pettijohn December 1984 Nonreactor Reports issued in 1984 Case Studies Date Title No.
Author 09/84 lireaching of the Encapsulation of Scaled Well Irgging C405 S. Pettijohn Sources i
Engineering Evaluations D te Title No. -
Author 05/84 Report on hiedical h1isadministrations for January N204D S. Pettijohn Through June 1983 06/84 Nonreactor Event Report Database for the Period N401 K. Black i
July-December 1983 06/84 Events involving Undetected Unavailability of the N402 E. Trager Turbine-Driven Auxiliaiy FeedwaterTrain 07/84 Heport on hiedical hiisadministrations for July-N403 S. Pettijohn l
December 1983 1
l Nonreactor Reports bsued in 1983 l
[
Engineering Evaluations and Technical Reviews Date Title No.
Author l
l l
01/11 Nonreactor Event Report Database for the Period N209A E. Trager j
l.
Januaiy-Jtme 1982 l
03/18 l-125/1-131 Effluent Releases by hiaterial Licensees N301 S. Pettijohn 06/10 hiound I;iboratory Fabricated Pulle Sources N302 K.lilack 06/10 Americium Contamination Resulti g From Rupture N303 K. tilack n
of Well-1ogging Sources 06!!4 Nonreactor Event Report Database From Julv N209B K. Black l
through December 1982
~
07/14 Americium-241 Sources N304 I
3 NUREG-1272, Appendix D
AEOD Annual Report,1989 l
l Nonreactor P.cports Issued in 1983 (cont.)
l w..
Engineering Evalsations and Technical Reviews (coat.)
Date Title No.
Author 07/14 Report on Medical Misadministrations for January N204C S. Pettijohn 1981-December 1982 12/01 Potentially Leaking Americium-241 Sources N306 S. Pettijohn Manufactured by Amersham Corporation 12/28 Nonreactor Event Report Database for the Period N307 K, Black January-June 1983
]
03/10 Internal Exposure to Am-241 NT301 K. Black I
04/05 KayRay, Inc., Reports of Suspected 12 akin.g Scaled Nf302 S. Pettijohn Sources Manufactured by General Radioisotope Products 08/24 Possession of Unauthorized Scaled Source / Exposure NP303 S. Pettijohn Device Combinations by Mid Con Inspection Services, Inc.
Nonreactor Reports Issued in 1982 Engineering Evalcations Date Title No.
Author 02/82 Report on Medical Misadministrations for the Period N201 S. Pettijohn November 10,1980-September 30,1981 01/82 Buildup of Uranium Bearing Sludge in Waste Retention N202 K. Black Tanks 02/82 Lost Plutoniurn-238 Source N29)
K. Black 03/82 Report on Medical Misadministrations for CY 1981 N204 S. Pettijohn 04/82 Preliminary AEOD Review of Iodine-125 Scaled Source -
N205 E. Trager Leakage Incidents I-05/82 Eberline Instrument Corporation-Part 21 Report N206 K. Black 05/82 AEOD Review of lodme-125 Scaled Source N207 E. Trager j-Leakage Incidents 08/82 Potentially Leaking Plutonium-Beryllium Neutron N208 S. Pettijohn Sources 08/82 A Summary of the Nonreactor Event Report Database N209 K. Black for 1981 i~
11/82 Leaking Hoses on Self-Contained Breathing Apparatus N210 K. Black l
(SCHA) Manufactured by MSA l
NUREG-1272, Appendix D 4
Nonreactors-Reports, 1981-1989 Engineering Evaluations D:te Title No.
Author 03/81 Interim Report on 11rown Boveril'etatron Calibration N101 E. Trager Check Source 03/81 Imotator Incident at an Agreement State Licensce's N102 K. Black Facility (Becton Dickinson, Droken Bow, Nebraska) 04/81 Interim Report on the Octobet 1980 Fire at the N103 E. Trager Sweetwater Uranium Mill 04/81 Interim Report on the January 3,1981, Fire at the N104 E. Trager Atlas Uranium Mill 05/81 Interim Report on Tailings impount1 ment Liner Failure N105 E. Trager at the Sweetwater Uranium Mill 08/81 Review of Reports of I caking t'.adioactive Sources N106 B. Trager 12/81 Engineering Evaluation of Fire Protection at N107 E. Trager Nonreactor Facilitics 12/81 Notes on AEOD Review of Emissions From Tritium N108 E. Trager Manufacturing and Distribution Licensees 5
NUREG-1272, Appendix D
I Appendix E Status of AEOD Recommendations (Nonreactors)
I I
NI dI Appendix E Status of AEOD Recommendations ne Office for Analysis and Evaluation of Operational Formal recommendations are tracked and listed in this Data (AEOD) tracking system ensures that all formal section. Additionall, actions based on AEOD sugges.
AEOD recommendations are tracked until resolution is tions contained in et lincering evaluations and special achieved. At this time, no issues involving AEOD reports are routinely imp!cmented by NRC program recommendations are unresolved and warrant the offices.Rese AEOD suggestions are not formally Gttention of the Executive Director for Operations.
tracked or closed out by AEOD.
AEOD Recomunendation Tracking System Outstanding Recommendations
- Recommendation Source:
Case Study AEOD/C601 Responsible AEOD Engineer:
- 11. Karagiannis (Author: S. Pettijohn)
Title or
Subject:
" Rupture of an lodine 125 Brachytherapy Source at the University of Cincinnati Medi-cal Center" Recommendation 3:
NMSS should consider evaluating during the license issue, renewal, or amendment process licensee procedures for reusing high activity iodine-125 seeds in treating multiple patients.
Responsible Office /Div/Ilr Contact Priority NMSS/IMNS/IMAD J. blenn N/4 Status:
The manufacturer's safety guidance that accompanies the seeds now recommends that catheter seed loading and seed-unloading be performed in a fume hood and that moni-toring procedures be used to detect leaking seeds.This change to the package insert satisfies the intent of the recommendation and closes it out.
Recommendation Source:
Case Study AEOD/C505 Responsible
' ABOD Engineer:
K. tilack (Author: S. Pettijohn)
Title or
Subject:
" Therapy Misadministrations 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 mnie an item of compatibility for Agreement States.
Responsible Office /Div/Br Contact Priority GPA/SLITP V. Miller N/A Status:
Action will be taken on Recommendt tion 4 after action is taken on Recommendation 3, which is part of the rulemaking on Qu tiity Assurance in Radiation Therapy.
'In each caw. the number of the recommendation is the same as the number of the original case study.
I NUREO-1272, Appendix E
onu a u.a. wcLEAR REQULATORY COMMCStON
- 1. REPOR E. Rev. ano Anas'aum Num-uReu,ior, 8"* - " *"Fl 2801. m BELIOGRAPHIC DATA SHEET NUREG-1272 (see instructions on in, rever.ei Vol. 4, No. 2
- a. TirtE A m sve m tE 3 DATE REPORT PUBUSHED Office for Analysis and Evaluation of Operational Data uourg l
ygxn 3
1989 Annual Report - Nonteactors July 1990
- 4. FN OR GRANT NUMBER
- 6. AUTHO4(b)
- 6. TYPE OF REPORT Annual summary of regulatory activities for Non-reactors
- 7. PERIOD COVERED Onclusive Dates)
- 4. Flt.RFORM!NG ORGAN 12AllON - NAME AND AOrAESS (tf NRC, provios Division. Office or Region, U S. Nuclear Flopulatory Commiss6cn, and moiting modress, it contractor, provios name and matieng sodress ?
Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, D.C. 20555
- 9. SPONSORNO ORGANIZATON - NAME AND ADDRESS (if NRC, type
- Same as above*.11 contractor, provide NRC Division. Office or Regic i.
U.S. Nuclear Regulatory Commission, and mailing address )
Same as in item 8 10 SUPPLEMtNT ARY NOTE 6 11, ABSTRACT (200 words or less)
The annual report of the U.S. Nuclear Regulatory Commission's Office for Analysis and Evaluation of Operational Data ( AEOD)is devoted to the activities performed during 1989. The report is published in two separate parts.
NUREG-1272, Vol. 4, No.1, covers power reactors and presents an overview of the operating experience of the nuclear power industry from the NRC perspective, including comments about the trends of some key performance measures. The report alsc includes the principal findings and issues identified in AEOD studies over the past year and summarizes information from such sources as licensee event reports, diagnostic evaluations, and reports to the NRC's Operations Center. This report also compiles the status of staff actions resulting from previous Incident In-vestigation Team (IIT) reports. NUREG-1272, Vol. 4, No. 2, covers nonreactors and presents a review of the events and concerns during 1989 associated with the use of licensed material in nonreactor applications, such as per-sonnel overexposures and medical misadministrations. Each volume contains a list of the AEOD reports issued for 1980-1989.
13 AVAILABILITY ST ATEMENT
- 12. KEY WORDS/DEBeRIPTORS (List words or pnrases that wbtl assist researchers in locating the report )
Unlimited
- 14. SECURITY CLASSFtC ATON nonreactors g,,,,g medical misadmmistrations Unclassified abnormal occurrences (T h" P*)
AEOD recommendations Unclassified AHOD report listing 15 NUMBER OF PAGES 16 PRICE f
NRC FORM 335 (2-89)
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