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- DL September 11, 1986 N
Note to: Sam Pettijohn Office for Analysis and Evaluation of Operational Data Barry Pineles Office of General Counsel Patricia Vacca Material Licensing Branch James A. Deye, Chairman, Professional Council American Association of Physicists in Medicine Robert J. Shalek, Director, Radiological Physics Center M. D. Anderson Hospital i
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From: Norman L. McElroy l Material Licensing Branch, USNRC ]
re: Radiation Therapy Misadministration Reports The Office for Analysis and Evaluation of Operational Data has recommended that this office distribute to HRC licensees the information in its report
" Therapy Misadministration Reported to the NRC Pursuant to 10 CFR 35.42."
Decause the information may be useful to all persons that provide radiation l therapy services, I have made arrangements to have the attached article, which summarizes the report and makes some general observations, printed in the American College of Radiology monthly newsletter.
Could you please take a few minutes to read the article and mark it up, and then return your comments to me by September 26.
Thank you Norman L. McElroy Material Licensing Branch, 396-55 USNRC Washington, DC 20555 8712020075 e71201
[52 36942 PDR, l
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- 5. All radiation termination rc iuirements to be realized by harduare. 9. Firmware (RONf) allowed in s fety termination.
- 6. Do not depend on softu are 1 it safety. 10. User shotJd never have access t control soft w are. Sernce mode shall allow servicing.
- 7. Redundancy essential for sa ety actions.
I1. Effect oflinac and other i Ml n iisc on low level digaal circuitry.
IL Restrict number of manual restarts by operator. Provide separate, independent operater oserr le bottom on the conwle that permits 12. Automanc checking ofirterlot a Software can be used to check fre-manual shutdown of the fac aty. quemly the integnty of hardua e.
I C. L Karimark Announcements SEARCll I OR EDITOR OR NEW AIP PUBLICATION Search Committee The Americe.n Institute of Physn wdi sotm launch a new publication de- lloward G Voss Chairrran Enrico Clementi s oted io sen mg those in the phy sn s commumty w ho use ccmputen m their Department of Physics IBM Engineermg Laboratory work. Our Committee has been ct arged with scarching for the first Editor, Arizona State Unhersit) Dept 4FU. hiail Stop 428 m ho vill take the lead in this imp irtant and challengmg new sentare. We Tempe, AZ 85287 Neighborhood Road sohcit your assistance in idennfyi 'g persons u ho are especially well quah- (602) 965-7147 or lease Kingston, NY 12401 fied for this position. messages at (602) 965-356 L (914) 385 0413 The precise form of the new pubh ation will greatly depend on the Editor. Don R llamann, Dept. licad Scott Kirkpatnck The Task Force that made the p iposal for this new journal emidoned a Surface Physics Research IBM Watson Research Center Journal /magazme format that wo ild provide for archhal articles as wcli as Hell 1. laboratories P O Hos 218 less formal, magazine-hke feature < of a very tunely nature, resiew articles P.O. Ilox 261, Room IC 217 Yorktow n lleights, NJ 1059R (on both software and hardware), new s items and other features ofimmedi- Murray ihil, NJ 07974 (914) 78 0 7864 ate mterest. The journal /magarh a may aho base a number of major see- (201) 582 4454 j tions on such broad areas as comp 4tational phydes, teaching physics at the j advanced undergraduate level an.1 above, and the use of computers m ex- Robert 11 Marks E. F. Rednh !
penmental work. It is expected th, t there will be Asweiate Editors for each Arnerican Institute of Phpics Deparnnent of Physics of the sections, 335 E. 45th Stcect and Auronorny New Yorx, NY 10017 Unnerdty of Maryland Aswithmost AIPjournals thejot of the Editor is a part-time position, with ( 212 ) 661-94N College Park, MD 20742 the editorial office usually kicated at the company or institution where the (301) 454 353I indnidual is employed on a fulla me basis.1 he editor's office is presided with full-time stati asdstance to help manage the editorial operation- Larry Smarr, Director Donald C. Welh which includes reeching subnutte ! manuscripts, sending chem to quahtied Supercomputer Center National Radio Astronom) referees for rniew, and sendmg a cepted ntanusenpts to the AIP produc- Unkenity of Ilhnon Obsen atory non office for pubhcanon. The naganne part of the pubhcation w d! be I oomis 1.aboratory of Phpies Edgemont RoaJ i handled by a full-time pmfession. ' eduerial staff at AIP. 1110 West Green Street Charlotten ille, V A Urbana, IL 61801 2290L2475 It is planned to appomt the i ditor n January 1987, w ith the first issue of the (217) 244 0072 (bu4 > 24t 9277 pubhcanon to appear approuma: ly one year lakr. A pilot ise ue is sched-
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uled for September 1987. We urge .ou to contact the Chairman or any other 64 N /! A /
member of t he Search Committee egardmg possible car.d: dates or for adJi-nonalmformanon We would a:s, appreciate it if >ou w ould pass this infor. NRC REPORTS IN 1]IERAPY MIN ADMINISTR AllONS mation along to a colleague w ho aay be interested or w ho may be able to help us. The members of the Conu .ittee are listed along with their addrewes The Nuclear Regulatory Commis', ion has pubbshed a st udy of theraps mn-and phoac numb (rs, for your coo. emence. admimstranons reported under its misadmmistranon reportmg require-ment
- The study examines the twenty 4cten misadministration that were Thank you far your assntance, reimrted over the period November 1980 through July 1984 l
lloward G. Voss The specdic causes of the misadministration, detaded in Table 1, are of l Chairman, Search Comnmtee course related to the treatment modality. Nonetheless three biisie themes run through the reports nadequate training, inattention to detad, and lack of redundancy.
Inadequate traimng may result in individuah causmg misadmmistranons.
Although addinonal trammg may not reduce the chance of anth.netic miv takes,it should clearly impress on each individualinvoh ed in the radianon
! t herapy process that clear communication of concepts and quaniities as u ell as systemane checks for reveahng mistakn early m the process are both j i
I 11 l i e_______-___-_____.__ >
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, 1 essential for the dehvery of quahty radiation therapy. Each bit ofinforma. Lac k ofiedundancy means there is no mechanisn for chet king for mistakes.
tion that plays a role in the process, w hether specific to the panent or to the An indeper. dent check requires having a second individual nammc each treatment facdity, must be carefully exammed for clarity, applicabihty, and data entry, whether a phpical measurement or a number copied from a correctnns. Each indnidual involved in the process should be stror. gly table of values, and check each arithmetic operation for correctness. Redun-encouraged to ask foi clarification of the radiation therapy process as it is dancy requires that two separate sy stems produce the same result. For treat-apphed to the patient at hand if there is any unclear or unexpected step or if ment planning, the best method of early detection of mistakes may be a an expected step is missing. simple independent check. Redundancy or independent checks may aho be needed in cach facihty's procedures for ineasuring radiathn parameters, Inattention to detad is often the medium m w hich a misadministration event usmg those measuremems fer treatment planmng, and applying radiation germinates. T his is not a problem specific to the radiation therapy process. to patients. In radiauon therapy or any other andeavor, an independent Any procew or product that requiro individual attention to a multitude of outside auditor may be able to detect mistakes in both pnycess design and related quantities that are similar in magmtude and used repeatedly will process apphcation as well as citing areas where a change in the process q likely contain mistakes Computerized treatment planning may reduce the might reduce the d.ance for mistakes.
chance of mistakes in sealed source treatment planning, and " record and verify" systems rray reduce the chance of mistakes in teletherapy adminis- This leads to some general recommendation.3 for quality assurance designed tration. But even these s;mtems perform their functions on quanuties that to address problems stemmmg from inadequate attention to detad and lack are mitially measured. recorded, and entered into memory by individuals. of redundancy.
'For a copy of the report, write to Kathy Black, Omcc for Analysis and Ths radiation therapy process should be planned with aids for the individ-1: valuation of Operational Data, N uclear Regulatory Commission. Wash- ual in mmd. This requires recognition that individuals are likely to make ington, DC 20555. Ask for report AEOD/C595. mistakes. In addition to obWous aids, such as tables and graphs . hat are clearly titled and easy to read, improvements might be obtained by color Table L Therapy misadmwatrations reported to NPr fmm November co6ng data tables to specific teletherapy units, and establishing a uniform 1980 to July 194 written prescription format. Ilased on inspectirn reports, the NRC believes that about ten percent of teletherapy licensees perform incomplete telether-T eletherapy apy unit calibrations and spot-checks Checklists could M used to assure completeness.
Presenp ion Redundancy must be integral to the design of the adiation therapy process.
Total daily dose was delivered from each port (2)* Both independent checks and redundancy are needed Each entry and cal-Oral and wrnten prescriptions were different (l) culation in a treatrnent plan should be checked by an individual who did not ihmst dose of 500 rad /3 da w as interpmed as i,00 rad x 3 da ( 1) make the treatment plan. If a treatment plan was generated by computer, Proper body side was not clear (I) there should be a manual check of the dose to a selected point within the patie.rt. Each patient's chart should be reviewed weekly to check for accu-Treatment p4mmag mulated dose and implementation of prescription changes. A quahty assur-ance program for the teletherapy unit should include a weekly chetk of the Tumor depth w as incorrectly measured (I) teletherapy unit ou'put and an occasional detailed examination of the com.
Tumor depth w as inem rectly recorded ( I) plete teletherapy process including physical measurements, by an outside Dosimetrist uwd a rong computer program (1) expert with an eye towards systematic erron and system improvements.
Dosimetry tables for wrong ; mt were used (1)
Anthmetic mistakes were made (3 ) Finally, a program that requires a physical measurement of the dose or amount of radioactivity actually adtmmstered to the individual patient Records would provide assurance that the given dow is the same as the presenbed dose. Such measurements are now done for radiopharmaceutical therapy Anthmetic mistakes were made ( 1) and occasionally for some teletherapy cases. but because of experne or tma-Poor handw nimg of numerals cauwd misunderstanding (I) sailabihty of equipment are not commonplace.
I%ywal meawnmenn The N RC is currently examining steps it m:ght take to improse the quality of radiation therapy and reduce the frequency of toisadministrations.
Wedge factors were measurcJ incorrectly ( l-53 patients affected) ,
Apphcation lege of Radiology (1) many of the i roposed standards for usage base bten widely adopted, for example, the i mgnation of the pulse sequence repeti-iield hkicks were not used (l) . ion time, echo time and ins ersion ti ne as TR, TE, and TI, respectiveb , and the use of standard orientations forthe dispig ofimages made in different Itrachytherapy planes. The second edition of this vork has now been pubbshed (2) and while it is not markedly changed frr n the previous edition, we would hke to Treatmtni planning point out and discuss iome of the ; hanges in the hope that they would be similarly widely adopted.
Dose rate was much higher than first estimated ( l)
First, the title hs been changed t. Glossary of MR 7'crm3, and the terms Appheation magnetic resonance ( M R) and ma, netic resonance imaging ( M RI) appear throughout, as wcll as NMR and E' R.That is, w hile nm rejecting the use of Wrong sources were loaded in apphcator ( 2) the more specific terms NMR and ESk, we are accepting the now wide-Source fell out of apphcator (l) spread use of the general terms mag ictic resonance and magnetic raonance Source was improperly seated in applicator i 1 ) Imagmg in medical apphcations Radiopharmaceuticai Therapy While the abbreviations TR, TE. md Tl have tven well accepted, their numencal values alone are f reque 'tly used as a convement shorthand to Wrong radiopharmaseutical was adminhiered i 2) desenbe a particular imagmg sequ<,ce. The lack of a standard sequence in Assay date on umt bsage vos not read ( 3 ) which to give these numbers is a otential source of miscommumcation Patient was improperly identifwd (1) Accordmg!), we propose that the umbers be gnen m the order TR/TE/
T!. with the value in rmthseconds rthe third number bemg used only far inversion <rcosery m. aging ), i or ewnple, the sequency 30fW20/1500 ?
" Numbers in parenthesis mdicate number of esents of the type described would denote a TR of 3000 msec. E of 20 msec ana TI of 1500 msec.
12
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}mduSJ}teAdQ Imple, interf g /JM NRC analyzes specific causes r -
ndard lFrom page of therapy misadministration A study of 27 therapy misadministra- The report identifies three basic areas the ACR-I :c will con- tions reported to the Nuclear Regula-tinue to a of weakness: inadequate training, inat-l y to review tory Commission between November tention to detail, and lack of redun.
! progress c roups and to 1980 and July 1984 has beca released dancy, McElroy said. Details of each are function to the new by the NRC.
NEMA dit further explained in the study.
image rm The specific causes of the misadmin. The report proposes some general aget.ienti mmittee win htrations are related to the treatment recommendations for quality assurance be respo (luating and modality, explained Norman L McElroy intended to address problems stem-enhancin} ice of ACR- in the NRC material licensing branch ming from inadequate attention to NEMA st; .,. undertaking who briefly described higHights of the detail and lack of redundancy, he further standards desig i. study. Examples of the misa.!ministra- explained. They are as follows:
tions reported are:
Tha future of digital Imaging
- The radiation therapy process Given the dynamic > rowth of digital should be planned with aids for the Teletherapy imaging in radiology, a 1d the probabil- individualin mind. This requires recog-ity that significant inromis will be made
- Prescription nition that individuals are likely to on film imaging throug i the growth of -Total daily dose was delivered make mistakes. In addition tc obvious image plate and other t< chnologies, the from each port aids, such as tables and graphs that are future of the digitallmaze management -Oral and written prescription 3 clearly titled ud easy to read, improve-system seems ever mor< real. The well- were different, ments might be obtained bv color cod-informed speculanon i- that when the -Iloost dose o. 500 rad /3 da was ing data tables to specific teletherapy number of digitally fo matted exami- interpreted as 500 rad x 3 da. units, and establishing a uniform writ.
nations exceeds 50 1 ,ercent of the -Proper body size was not clear. ten prescription format. Based on departmental vo'lume, the need for
- Treatment planning inspection reports, the NRC believes operational economics .ind better cost -Tumor depth was incorrectly that about 10 percent of teletherapy control may speed the ci inversion proc. measured cr ecorded. licensees perform incomplete tele-ess, llospitals will see ibe image man- -Dosimetrist used wrong com. therapy unit calibrations and spot agement system as par of a hospity purer program. checks. Checklists could be used to wide information sysu.m, which will -1)osimetry tables for wrong unit assure completeness.
provide better communications, more were used.
-Arithmen.e mistakes were made.
- Redundancy must be integral to etlicient delivery of radt > logic informa-tion, and rid us of th : inefficiencies
- Rec rds the design of the radiation therapy process. Both independent checks and of managing both di : ital and filrn -Arithmetic mistakes were made.
images. With a look 'it the current ~P or handwriting of numerals redundancy are needed. Each entry
. giawth rate of digital it iaging and the cauwd misunderstanding, and calculation in a treatment plan ysic 1 measummems should be checked by an individual growing access to digit il technologies
-Te@e factors wem nrasured who did not make the treatment plan.
which potentially repl. ce films, one can speculate that thi, . vill happen in mcorrectly (1-53 patients affected). !f a treatment plan was generated by
- Appucadon computer, there should be a manual the early 1990s.
-Field blocks were not used. check of the dose to a selected point within the patient. Each patient's chart A word of advice should be reviewed weekly to check An important messagt to radiologists Brachytherapy for accumulated dose and implementa.
instrumental in equipmc it purchases is * 'I.reatment planning I on of prescription changes. A quality that the equipment bou tht today may -Dose rate was much higher than assurance program for the teletherapy be the equipment thal will be net- tirst estimated. unit should include a weekly check of worked later, within the useful lifetime
- Appucation the teletherapy unit output and an occa-of the purchase A rad ologist should -Wrong sources wcY loaded in s onal detailed examination of the com-seriously consider speci ying the ACR- applicator. plete teletherapy process, including NEMA digital communications standard -Source fell out of. applicator. physical measurements, by an outside for new equipment slost imaging -Source was improperly seated in expert with an eye towards systematic equipment manufactur rs are now e pplicator. errors and system improvements.
implementing the ACR AEM A interface. .
Retrofitting may be costis and difficuh.
- Finally, a program that requires a 1 Radiopharmaceutical Therapy physical measurement of the dose or i Anyone with specJic questions about ACR-N8MA act vities should amount of radioactivity actuauy admin- i
-Wrong radiopharmaceutical was istered to the individual patient would write either to Gwilym i Lodwick at administered. provide assurance that t: e given dose is the ACR Reston Offce or Laura -Assay date on unit dosage was Murphy at NEMA, 210 L St., N.W., not read. the same as the prescribed one. Such Suite 300, Washington,1J.C. 20037. O -Ibtient was improperly identified. (Omtimmd on page p) act bulletin 1/87 7
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Centraliz$d membership ACR members Under the provisions of the centralized Hendershut. Thomas E. Schultheis. Rkhard P. New members of the American Col-Stephens,Jr., Fort Wayne; sponsors, Richard F, j membership program, each month the lege of Radiology are listed below: ;
CoUege publishes a list of physicians I",*fN#" ^,, .f'"g"*h>ughlan, Iowa Cu y; N' who ale seeking to join an ACR
- JulQnQNe;,j' I sponsors, Edmund A. rranken, Jr., Kenncih D. , y,,,,,m c. ,,,,p,,,, p,,aco,on, y,,.
Chapter. Dolan. Shigeru Ehara, Iowa Chy; sponsors,
- Anunidha Bhasin, Daltimore, Md.
The radiologists listed below have Ceorges Y. El-Khoury, Mary 11. Kathol.
- Chuck C. Cho, Columbus, Ohio.
aI) plied for membership in specific ALR LOUIS!ANA-Druce P. Ilordlee, Lake Char-les; sponsors, Ray 'l . liebert, A. Gene Lampson'
- George C. Curry, Dadas, Texas.
chapters. Any member who $vould like Marg t ilacrison, Monroe; sponsors, Lionci G
- Fdward F. Danielski, Jr., Onconta, N.Y.
to Comment on a Candidate S CrCden- Darra a Thomas V. McGumn 11, Robert C.
- David M. tider, inaitimore, Md.
tials has 30 days to submit a setter to the Mcueys. olds, Jr., Baron Rouge; spom"'%
- Danilo A. Ispinola. Bahimore, Md.
n+rd L Biuth, Ted Z. Coluns. ' . I avid D. Evans, Greenwich, Conn.
chapter secretary either in support of or , Myron Forman, Warminster, Pa.
in opposition to the candidate. A copy po" ^[ ^s Y
,[iMy "z['["tellins, R r ' "8'""
- ((,'$"$"
of the letter and all enclosures must he Hauman Edward Steiner, lloston; sponsors, 'h 3a 1 sent to: ACR MembershipDepartment,
- R chard S. Gordon, Lima, Ohio.
l Joseph T Ferrucci,Jr.,pck Wiuenberg Thomas G. Walker, Boston; sponsors, Christm A.
- Wuham L Illngtgen, Green Bay, Wis.
l gg
- Athanasouhs, Arthur C. Waltman.
- Lcc D. Katz, New llaven, Conn.
,I.he names of the candidates are fol- MIClllG AN-John J. Klin, Detroit; sponsors, Gee;ge A. Kling, Daniel R. Guyot.
- Dennis Kay, New Orleans, l.a.
lowed by the names of their sponsors.
- Irwin A. Keller, Manhasset, N.Y.
Missouri-James M. sauer, springfieht
- Kenneth P. Korte, Minneapohs, Minn.
sponsons, Calvin D. Itawkins, Jr., Thomas P.
- lo,e juho Mata, Mumi lleach, Fla.
ALAllAMA-Robert 11. Akenhead,iluntsville; 5
- CC"CY-
- Hoger M. Nocera, Glendale, Ariz, sponsors, Lowry it Young,Jr.,11. Cotton Ray. NEHRASKA-Jud W. Gurney, Omaha, spon-hors M.nhis P. Frick, James E McGUL
- Elin 11. Norsoph, llaltimore, Md. *!
Stephen 11. Munderloh, Mobile; sponsors,
- Ann P. salmon, liarlingen, Texas. )
David U. Inge, Pavel Liechtenstein. Buckhard NEW MEXICO-Sanders B. Saidman, Espanola, sponsors, Charles L Pfaff,Jr., David A. , Mi&d L Sdlovsky, Sunhury, Pa. l Weppelmann,13irmingham; sponsors, Meric
- John P. Mella, Ehzabeth City, N C. i M. saker, Donn J. Brascho. " #*'
- Onena F. Taylor, Tulsa, Okt t. )
ARIZONA-Cordell A. 13plin, Phoenix; NORTil CAHO!INA-llruno E. Itasara, Jr, Chnton; pon' ors, Donald L. Croutcher, John A. , lloths A Thomas,Jr.. l.ouisville, Ky. J sponsors, llertram E. Sosnow, T heodore
- Govindarajulo Vijayamohan, Putshurgh, Ditchek, Gorce. Donald C, Donahue, Asheville; spon- p3 sors, Nonnan A. Thorne, Timothy J. GaHagher' CONNECTICUT-Donald s. Weinstein, Alan L Hosen, Raleigh; sponsors, Wade !!.
- Andrew C. Warbeit, Albany, NX, New I.ondon; sponsors, Faruk II. Soydan, Peter
- Morgan t.. Washburn, Baltimore, Md.
Moser,Jr , L. Fuller lioneycuit.
M. Molloy.
- Frank P. Wilson, Jr., Victoria, Texas.
NORTil DAKOTA-Mark F. Fisher, His-marck; sponsors, Lee N. Podou, Norbert J.
- Jdfrey H. Zapolsky, Palmer, Mass. O DISTRICT OF COLL'MHIA-Elizabeth liayes, ,
Dethesda, MD; sponsors, David R. Buck, Danici (f Keele.
D. Maxwell OlllO-Katherine F. Gerke, Oregon; spon- l FLORIDA-Douglas R. Smith, Rockledge; sors, Paul J. Raglow, George D.Jacobs.
sponsors, Thomas 11. Clarke, Richard L snuth. PENNSvlNANIA-John P. Leicht, York; sponsors, Richard E. Kraus, Michael A. Gangloff.
gvif.deotapes a.d i 1
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nuNots-Caryn M. siacx, liinsdaie; sPon. ,
sors, Victor C. Mategrano, Jerry P. Petasnick-stephan F. strasser, Decatur; sponsors, Myron VERMONT-Ricnard R. iiennum. so >"""'
bury; sponsors, Harticy Neel, James R. Chandler reSdent WO%@Op ;
1 111. Brock T. Ketcham, Dennington, sponsors, Gooley, G. Richard Locke James J. Vesely, Terrill L. C liield, John P. Tampas.
Morris; sponsori, David W. Lando, Charles F. Two new videotapes on practice man.
WASHINGTON-John S. lio wen, scattici agement for radiology residents are Whimey, Jr. sponsors, Albert A Moss, John W. Loop' j INDIANA-Moises it Domingo, Evansville; WEST vlRGtNI A-Judith Taylor, Clarks- now available from the American Col-sponsors, Edgardo M, Sayoc, Alvin Korba Keuh hurg, sponsors, Francis J. O{Connor, liarry e8e A. of Radiolo8y Committec on Resi-A. Phillips, Ev9nsville; spann.rs, Eugene L Dishop. O dent Practice inf.ormation.
" Imaging Centers," narrated by Los Angeles attorney Steven R iiirschlick, discusses venture arrangements, types of partnerships, power structures as well as ethical concerns. The tape is 43 minutes long.
In " Entry Level Contracting,"
liirschstick covers key contract provi-NRC releases report sion,. seemau x aca and dc*ued compensation, fringe benefits, term On rnisadm.inis . trations and iermimoon coveraye, dispuie resolution among other subjects. This (from page 7) steps to improve the quality of radia- is a 23 minute tape.
tion therapy and reduce the frequency The videotapes are available on 1/2 measurements are now done for radio- of misadministration. inch VilS and 3/4 inch Umatic and will pharmaceutical therapy and occasion- For a copyof the report (AEOD/C5D5) be primarily used at resident work-ally for some Teletherapy cases, but write to Kathy Black, Of0cc for Analysis shops on practice economics. They are because of expense or unavailability of and Evaluation of Operational Data, also on loan, at no charge, from the equipment are not the norm. Nuclear Regulatory Commission, Wash- Comminee on Resident Practice The NRC is currently examining ington, D.C 20555, O Information. O 12 act bulleti .1/87