ML20077B857

NMSS Licensee Newsletter.No. 91-1

ML20077B857
Person / Time
Issue date:	03/31/1991
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N91-1, NUREG-BR-117, NUREG-BR-117-N91-1, NUDOCS 9105150305
Download: ML20077B857 (11)

Text

6TgNMSS Licensee!NewsletterL

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9 U.S. Nuclear Office of Nuclear NUREGlBR-0117

• Q Regulatory Material Safety No.91-1

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Commission and Safeguards March 1991 1

I THE NUCLEAR REGULATORY COMMISSION activities do not result in any internal dose, such as irra-(NRC) ISSUES M AJOR REVISION OF 10 CFR diators, radiographers, and gauge users need not concern PART 20 themselves with the committed dose equivalent.

The dose limit is expressed as the total egc"in dose

'this article is the first in a series that will discuss the im-canivalent (Tl!DE). The TEDl! is expressed as a sum of portant changes in radiation protection standards made the external and internal dose components:

by the sweeping revisions in the new 10 CFR Part 20. Sub-sequent articles will focus on the application of the new TEDE = Deep Dose Equivalent (external dose)

Part 20 to particular categories of licensees.

+ Committed Effective Dose liquivalent (internal dose).

NRC is issuing, as a final rule, a revised Part 20, " Stand-lhe TEDl! has to be evaluated if both the internal and ards for Protection against Radiation, to Title 10. Lhap-ter 1, of the Code of Tcdcral Regulations' external dose com;unents have to be monitored. The in-ternal or external doses are required (10 CFR 20.502) to The rule (and the related Federal guidance on occupa-be monitored if the individualis li4cly to receive an inter-tional exposure) adopt the System of Dose 1.. imitation nal or external dose in excess of 10 percent of the applica-ble dose limits, i.e., an internal committed effective dose proposed by the International Commission on Radiolog,

cal Protection (ICRP), first issued in 1977 in ICRP Publi-equhaknt m mm of R5 rem N x 5 rem)or a deep-cation No. 26, which introduced several new concepts in dose equivalent (external dose)in excess of 0.5 rem.The radiation protection. One of the major changes is the Mehhood of an individual receiving an internal dose m mess of 0.5 rem is determmed from:

abandonment of the so-called " critical organ concept,"

based on limiting the dose to the organ with the highest dose. The " critical-organ approach' neglects doses to and ambient air-sampling data and expected occupancy

times, originating from other organs (doses to one organ caused by radionuclides present in another organ). The new ap-breathingaone air sampling data for workers, anu proach is based on an effective dose equivalent, which is the previous bioassay measurements on the individual or o

sum of the radiation doses to each major organ multiplied other workers.

by an organ weightingfactor, that represents the fraction of the total risk of fatal cancer and serious genetic effects

'Ihe 1 kelihood of exceeding an annual external dose of contributed by each irradiated organ.

0.5 rem can be determined from:

In the revised Part 20, the use of the effective dose o external surveys of dose rates and expected occu.

equivalent concept relates to internal doses. The dose p mey times, from external radiation specified by a deep dose equiva-o prior personnel momtoring device readings (e.g.,

lent, which is the dose evuated at a depth of 0.01 m (1 cm)in tissue.

thermoluminescent dosimeter ( ILD) badges) for t he individual or other workers m I ie same area, and The revised Part 20 employs the concept of a committed calculations of expected dose.given the source activ-dose equivalent for evaluating the internal dose from ity, shiciding, distance, and occupancy times.

radionuclides that have been ingested, inhaled, or have entered the body through the skin or through wounds and if both the deep-dose equivalent (external dose) and are retained in internal organs. The committed dose committed effective dose equivalent (internal dose) are equivalent assigns the internal dose that would be required to be monitored (i.e., both are likely to exceed predicted to be delivered over a subsequent 50 year 0.5 rem), then the TEDE must be calculated by summing period (accounting for both biological climination and these two values. If either the internal dose or external radioactive decay) to the year of intake, l icensees whose dose contribution is not required to be monitored (is 9105150305 910331 PDR NUREC BR-0117 R PDR

hi ARCil 1991 NhiSS 1.lCl!NSlill unlikely to exceed 0.5 rem), then the internal and exter.

N!!WSLIITFliR CONTI:.NTS nal doses do not have to be summed. If neither the inter-nal nor external dose contnbutions are likely to exceed j

Page 0.5 rem, then neither requires mdividual monitoring by Noassay, whole. body counting, or use of personnel-1.

NRC issues hiajor Revision of 10 CFR momtoring devices such as 'lLDs or lapel air samplers.

Part 20 (Contact: liarold Peterson, Sur eys of ambient radiation levels and airborne radioae-301-492-3640)..........

I tive material levels would still be required to ensure the continued safety of the workplace.

2.

Nuclear 1 uel Cycle Seminar for i.icensees (Contact: lidwin Flack 301-492-0405).

2 NUCLl!AR FUl!L CYCL.li SiihilN AR l'OR 3.

Recall of hiedical Devices (Contact:

LICliNSlillS Roy Caniano,70S-790-5500) 2

'the Nuclear Regulatory Commission (NRC)is sponsor-4.

Irradiator incident Summary (Contact:

ing a IX day Nuclear i uct Cycle Seminar on hiay 9 and John Grobe,708-790-5500).

3 10, 1991. at the Airport Ramada Renaissance liotelin Atlanta, G A. Representatives of the Department of lin-5.

Revised Technical Position on Waste ergy,FederalI!mergency hianagement Agency,linviron-Form Provides Guidance on Cement mental Protection Agency, Institute for Nuclear Power Stabilization of low Level Wastes Operations, and State Radiological Health !! ranches (Contact; hiary Adams,301492-0505) 3 have been invited to attend. 'lhe seminar is open to all public and pnvate parties interested in the implementa-6.

louisiana linergy Services Submits tion of radiological safety and safeguards programs.

Application for Nation's First Commercial Uranium linrichment Plant (Contact:

At the seminar, NRC representatives will provide infor.

Peter I oysen,301-492-0685).

i mation on NRC policies and procedures applicable to Iuct cycle licensees, and update peading issues and policy 7.

Advisory Committee on the hiedical Uses matters.The topics to be discussed include: new 10 CFR of isotopes (Contact: Antoinette hiassey, Part 20 Implementation Pnicedures. Nuclear Criticality 301-492-0769)..,...

4 Safety issues, linforcement Policy, hiaterial Control and Physical Secunty issues, and international Atomic En-8.

Rulemakings Published December 1,1990-ergy Agency (I AI!A) Safety and Safeguards Programs, January 31,1991 (Contact: Paul Goldberg.

Representatives of fuel cycle licensees will be invited to 5,

discuss their programs and concerns in complying with 301-492-0631)

NRC regulations, and their views on pending NRC issues 9.

Information Notices Published December l' and policies. NRC believes this seminar will provide use-1990-January 31,1991 (Contact: Paul fut information to all levels of fuel facility personnel, and Goldberg. 301-492-0631)...........

5 should especially benefit personnel implementing and rnanaging radiological safety and safeguards programs at

10. Selected Significant I! vents Reported to the facihties. 'lhere will be no registration or tuition costs for U.S. Ndelcar Regulatory Commission this seminar.

(Contact: Kathleen illack, 301-492-4495)..

6 The NRC contacts for the seminar are hit. Charles J.

ii. Significant Enforcement Actions Against llaughney, Chief of the Fuel Cycle Safety liranch, at hiaterials Licensees (Contact: Joe NRC lleadquarters (301-492-3328); hit. William E.

Delmedico, 301-492-0739).

8 Cline, Chief, Nuclear hiaterials Safety and Safeguards, NRC Region 11 (404-331-0346); and hir. James

12. Update on Radiographer Safety Claik. Vice President, Nuclear Fuel Services, Inc.

Certification 10 (301-770-5510), if you hase any comments or sugges-Comments, and suggestions you may have for infor-mation that is not currently being included, that RiiCALL OF hiliDICAL DEVICES might be helpful to licensees, should be sent to:

In hiay 1990, hiinnesota hiining and Nianufacturing E. Kraus Company (3ht)sent a bulletin to owners of 3Ni Fletcher.

NhiSS Licensee Newsletter Editor Suit Delcos applicators informing them of possible ovoid Office of Nuclear hiaterial Safety and Safeguards detachments from the handles of the devices. At the time One White Flint North, hiail Stop 6-A-4 of the issuance of the bulletin,it was estimated that there U.S. Nuclear Regulatory Commission wereapproximately9151'letcher Suit Delcosapplicators Washington. D.C. 20555 in use in the United States.'the applicators are routinely 2

used in a clinical setting in conjunction with cesium-137 and shut the system down. 'the operator noted the sourc e brachytherapy sources in the intracavitary treatment of light indicators w cre green and the cell monitor indicated certain types of cervical and/or uterine cancer, no detectable radiation levels. 'the operator, accompa.

nied by two other employees, entered the cell maze with The issuance of the bulletin in May 1990 was prompted by suney instruments. As the operator turned the last cor-several instances where the ovoids became loose or de-ner into the cell, he noticed that his survey instrument tached from the applicators. Although, to date, no signifi-was reading a radiation les el in escess of 1.0 mRihr. Uptm cant problems have been reported to NRC regarding the seeing this increase in raJiation levels, the individuals im-loose ovoids, the consequences resulting from this type of mediately lefI the mate and called the Radiation Safety problem could lead to an ovoid rotating in the handle dur-Officcr (RSO)and other management personnel for as-ing patient treatment, resulting in un alteration of the sistance.

predicted dose distribution, reduced shielding to the pa-tient's rectum and bladder, or even the possibility that the The simultaneous failures of two safety systems allowed ovoid could remain in the patient when the applicator is the entry into the irradiator male. lhe first failure dis-removed, thus necessitating surgical removal.

abled the cell radiation monitor.'lhe wiring on the GM probe in the cell was found to be degraded, presumably 3M's analysis of the problem revealed that the loose or due to radiation damage. 'ihe nonfunctional monitor did detached ovoids were the result of accelerated wear not trip the system and allowed access to the cell. When caused by users cleaning the devices with non-the GM tube was rewired and a new probe installed, the recommended liquid disinfectants and sterilizing solu-system functioned properly. 'Ihe second failure involved tions. These non recommended solutions could, over the source rack hoist cable system. A limit switch on the time, attack the silver braring that secures the ovoid to cable winch failed (possibly due to dirty contacts) and al-the handle of the applicator. in December 1989,3M sent lowed the source rack to travel below the normal storage to all users of the applicator a poster reminder of proper position when the winch failed to stop.The cable contin-cleaning methods to be used for sterilization using either ued to run out and then rewound on the spoolin the op-autoclave or gas. The May 1990 bulletin sent to the users posite direction, raising the source rack to a position only of the applicators also advised against the use of non-4 to 5 feet below the surface of the water. The irrathator recommended cleaning solutions and reiterated proper system was" fooled"into thinking that the sources were in cleaning techniques.

the normal storage position.

In addition to advising users of proper cleaning tech-

'lhe radiation levels near the pool were calculated to be niques, the May 1990 bulletin also provided instructions in the R/hr range, with the sources in this position. If the for the users to test their applicators for defects and pro-sources had been compicicly out of the water, levels vided instructions on making arrangements for any defec-would have been much higher, llad the operator not ap-tive applicators to be returned to 3M for repair.To date, propriately used his survey instrument when walking nine applicators (approximately one percent of those in down the mare, a significant radiation dose might have use) have been returned to 3M for repair. In December been received. This incident showed that the survey in.

1940,3M announced that effective January 1,1991, they strument is truly the operator's last line of defense are no longer going to be selling or manufacturing the against a potentially lethal environment.

Fletcher Suit Delcos applicators.

If you possess 3M Fletcher Suit Deleos applicators and Rl!VISliD TliCilNICAL POSITION ON WASTl!

did not receive 3M's bulletin, please notify Mr. Roy J.

FORM PROVIDES GUIDANCl! ON Cl!Ml!NT Caniano of the Region III office at 708-790-5500.

STAlllLIZN110N OF l.OW l.EVlil. WASTliS The Office of Nuclear Material Safety and Safeguards IRRADI ATOR INCIDENT SUMM ARY (NMSS) has issued a revision to the " Technical Position on Waste Form." The revision provides more compre-This brief description of a problem at an irradiator facility hensive guidance on cement stabilitation of low level is intended to stress the importance of proper cell entry waste.

procedures.

The regulatory basis for the technical position is 10 CFR in December 1989, a Region lit megacurie cobalt-60 irra.

Part 61, which defines a waste classification system based diator experienced simultaneous failures of safety sys-on th: radionuclide concentrations in the waste and sets tems, which allowed an operator access to the irradiation minimum characteristics for waste intended fer disposal.

cell while the sources were in an exposed position. Fortu-Structural stability is intended to ensure that the waste nately, the operator used proper cell entry procedures does not degrade and cause failure of the disposal unit and avoided any significant exposure. 'Ihe problem oc-cover or lead to an increase in leach rate. Stability is also curred on a back shift and was detected by the operator intended to provide protection from inadvertent iatru-when he noticed that some of the irradiated product was sion,in that the waste form will be more recognizable and underdosed. Ile decided to investigate the irradiation cell nondispersible during its hazardous lifetime. Structural 3

E

stability can be provided by the waste itself, by proccamp United States utihties, I'luor Daniel, Inc., and Ureneo, the waste to a stable form, or by placing the waste in a sta-1.td., filed an upphcation with NRC for a hcense for a ble structure such as a high inteprity contamer (lilC) or commercial gas centrtfuge uranium enrichment plant to engineered structure.The regulations of 10 CI:R 20.311 be known as the Claiborne itnrichment Center. When require pencrators to prepare wastes that meet the re-fully operational later in the 1940's, the Claitorne lin-richment Center will have a capacity of 1.$ million quirements of 10 CI'R Part 61.

separative work units (SWUs) per year, or atebt 15 per-

'Ihe " Technical Position on Waste l'orm" was mitiall> de-cent of the ennchment needs of the nation's nuclear veloped in 1983, to provide guidance to waste penerators pow er utilitieClhe plant design is based on the latest pas on waste form test methods and results acceptable to the centrifuge technology used by Urenco at its ennchment Nuclear Regulatory Commission (NRC) for implemen-plants m the United Kingdom, the Netherlands, and the ting the 10 Cl R Part 61 waste stabihty enteria. One way 1:cdcral Republic of Germany, to demonstrate waste form stability is to ref erence an ap-proved topical report, because these topical reports are Cunently, all uranium ennchment plants in the United reviewed and approved in accordance with the accept-States are owned by the Department of I nergy and are ance criteria contained in the technical position. Cur-therefore uempt from NRC regulation. The Claiborne rendy, there are seven approved topical reports; three re-Enrichment Center will be hcensed pursuant to 10 CI'R fer to waste solidtfication prwesses and four adJress Parts 40 and 70, based on amendments to the Atomic En-HlCs. 'lhirteen other topical reports are under review; crgy Act that were enacted late last year. the amend-three of these are for lilCs and ten are for waste sohdifi-ments also spell out requirements for an environmental cation processes. All new topical reports, as w ell as those impact statement nr.J a single, mandatory hearing, and currently under review, will be required to comply with arrangements for inspection and operation, insurance the standards and procedures in the revised technical and decommissionmp, and no indemnification.

position.

I or more information about the Claiborne Enrichment SMce the initial issuance of the " Technical Position on Center, contact Peter 1 oysen in the Division of InJustrial Waste l'orm," it has become necessary to more closely and hiedical Nuclear Safety, at 301-442-0685.

address the use of cement to stabilite low level wastes.

'Ihis revision to the technical position provides adJitional guidance on waste form specimen preparation, statistical m'ISORY COWil*lH ON Till! hiEDIC Al, sampling and analysis, waste characterization. process USI3 Ol' ISOTOPl3 control progtam (PCP) specimen preparation and ex-amination, surveillai.ce specimens, and reporting of NRC consened a meeting of the Advisory Committee on

mishaps, the hiedical Uses of hotopes (ACh1UI) on January 14 and 15,1991,in Alexar.dna, Virginia,to request ACh1UI The guidance provided in the revision is the culmination guidance on certain reputatory issue: and to provide the of an extended period of study and information pathenng ACh1UI with status reports on: (1) a petition for rule-and exchange between the NRC staff and representatives making about the practice of nuclear medicine and of government laboratories, the Advisory Committee on radiopharmacy; (2) a rulemaking on basic quality assur-Nuclear Waste (ACNW), cement processing vendors' ance (O A)in medical use-(3)cxpansion of the AChiUl; other waste form vendors, nuclear utilities, and State (4) development of a hiedical Visiting I'cllows Program regulatory agencies. Especially usefulin the development WVI P); and (5) a video training tape being des eloped on of this revision was the mformation r:ychanged in a Work-good practices in prepanng and administering radio-shop on Cement Stabilization of low l.evel Radioactive pharmaceuticals.

Waste, held in June 1989. 'Ihe workshop proceedings have been published as NUREO/CP-0103, available The staff bnefed the ACh1Ul on a petition for rule-film the U.S. Government Printing Office and from the making submitted by the American College of Nuclear National Technical Information Senice.

Physicians and Society of Nuclear Niedicine (ACNP-SNhi) in June 1954 (54 l'R 38229h in res[xmse, on Questions on the revised technical position paper and re-August 23,1990, NRC pubhshed an interim final rule in quests for copics should be directed to hiary Adams the federal Register, permitting authorized user physi-(301 4 92-0505), Division of low Level Waste hianape-cians to request departures from the manufacturer's ment and Decommissioning.

nstructions for preparation of diagnostic radiopharma-ceuticals or for indications for use and route of admini.

LOUISI AN A ENERGY SERVICES SUllhilTS stration for therapeutic radiopharmaceuticals.The rule is APPLICATION I OR N ATION'S I 1RST in effect until August 23,1993. During the 3 > car penod COhihiERCI AL UR ANIUbi ENRICHNIENT Pl. ANT covered by the rule, NRC will collect data on the number and nature of depmures requested by authorited users.

On January 31,1991, louisiana Energy Senices, LP., a The ACN1UI discussed alternative means for obtaming hmited partnership compnsing subsidianes of three such information and made recommendations to 4

eliminate certam requirements in the mlcrim rule, as well 1,

Pubhshed 12/17/90 as to binaden the scope of devmtions allowed to author-ired users.

2.

Contact:

Don Joy, 301-492-0352 On January 16,1990, NRC pubhshed proposed amend.

ments to 10 Cl R Part 35 that would sequire medical use INI ORht ATION NOTICES PUlli.lSill D licensees to estabhsh and implement a basic Q A program DI.CI:hilli R 1,1990-J ANUARY 31,1991

($51 R 1439). NRC held several meetings and workshops on the proposed rule with NRC licensees, Agreement Note that these are only summaries of mformation no-State licensees, and professional organuations. *lhe tices. Informauon Notices ar e automahcally sent to licen.

AChiUI made additional comments on termmology, see categories to which they pertam. II a notice appears defmitions, the content of official repons, and patient-relevant to >our hcensed operation and it has not been notification requirements.

received, we recommend that you obtain the ne. ice or NRC is expandmg the ACh1UI committee in IT91 and replacing one resigning member. Norninations are being sought for a brachytherapy physician, a consumer repre.

A.

Denial of Access to Current I aw l.csel Radioactive sentathe, and a person with a State regulatory perspec-Waste Dnposal l'acihties-IN No. 40-75, dated tive. 'the in) and Drug Administration and U.S. Pubhe December 5,1990 ilcalth Serv ce have each been asked to nommate one in.

Technical

Contact:

Robert Ilogg. 301-492-0579

)

dividual to the committee.

'Ihis notice informs generators of low lesel radicactive

'the NRC staff briefed the AChiUI on the issue of ade.

waste m hiichigan (only) that, beginning Noseraber 10, quate supervision, as required by 10 CI'R Part 35, and 1490, access to the ew. ting low level radioactive waste particularly on the appropriate level of supervision both dispsal facihties has been denied. 'lhis restriction may for physicians in traming who are listed on NRC hcenses cause problems, includmg that of licensees exceedmp as authorized users and for all individuals performing authorved possession hmits due to an accumulation of tasks delegated by authori/ed users, w aste and inadequate waste storage facilities. N RC ir.for-matiot; Notices No. 40-09 and No. h9-13, and Generi:

The AChlUI reviewed a vidw traming tape, produced by 1 etters 65-14 and 81-38 offer guidance on managing the the NRC Office for Analysis and i valuation of Opera.

accumulation of waste. Questions on the hcensing conse-tional Data (AEOD), on good practices in preparmg and quences of disposal restrictions should be directed administering radiopharmaceuticals, and determined to: Nuclear hiaterials Safety tiranch, Region 111, that the video tape, as edited, is acceptable, deals with 700740-5625. Pohey questions shoulJ be addressed to:

topical material, and will be made available to 'icensees Paul 11. Inhaus, Operations liranch, Division of low-for possible use m initial training programs and m re.

I.evel Waste hianagement and Decommissioning, fresher training of technologists.

301-492-0553.

The next meeting of the AChiUI wdl be hel'J on hiay 9th and luth,1991 in the Washington D.C. metronditan

11. I itness for Duty-IN No. 40-81, dated Decem-area.

ber 24,1990 Technical Contacts: I.. I flush, Jr., 301-442 4 44 For additionalinformation on AChiUI activities, please R. UConnell, 301-492-0627 contact: 12rry W. Camper,Section I mder, hiedical and k f0"DCf'30I-492-lh43 Academic N ction, USNRC,301-4d.,417.

.this notice informs licensees not currently subject to NRC required fitness for duty programs of the impor-RULEhiAXINGS PUlli.lSilED DECEhillER 1, tance NRC places on the concept of a drug. free 1990-J ANUARY 31,1991 workplace in all aspects of nuclear material usage, man-agement, and handhng. It also describes the Federal PROPOSED RUI.ES Anti Drug Abuse Act of 1988, under which a conviction for possession or distribution of a controlled substance

• Licenses and Radiation Safety Requirements for may result in toss of eligibility for an NRC license. denial large Irradiators" or revocation of an NRC license, or removal from NRC-1.

Published 12/04/90 licensed activities. Independent of the Act, NRC may act on its own authority to deny, rewke, suspend, or modify a 2.

Contact:

Dr. Stephen hicGuire,301-492-3757 license or to remove an individual from licensed activi-ties, upon conviction. NRC plans to promulgate a rule o "hiaterial Control and Accounting Requirements for that would impme specific fitness-for duty requirements Uranium Enrichment I acilities Producing Special on Category I fuel facilities and shipments, subject to l

Nuclear hiatenal of I ow Strategic Significance" 10 Cl:R 73.20.

5

C, Requaements for Use of Nuclear Reputator)

Date Repirted: Septen,ber 14,1940 Commission 4NiiC-)Apprtwed 'Iransport Padares I kensee: hiuskogee Reponal Niedical Center I

for Shipment of Type A Quantities of RaJioactne hluskopee, OK hiatenal-IN No 4042, dated December 31,1991 Technnal

Contact:

Earl P. Easton,301-442-0642 On Septembei 19,1990, the hcensee notified NRC that a 1his notice informs registered users of NRC approseJ therapeutic misadmmistration had occurred The radia-packages of pertinent NRC and IX)T requacments for tion oncologist had identified the treatment error 6 months after it occurred, but had not irnmediately recog-the tise of NRC approved'lype 11 packapes for shipment nited it as a reportable misadmmistrationJihe treatment of lype A quantities of raduuctise materutsflhis notice error invoived admmistrahon of 2160 rads (from a apphes to les els of radauctive materub, that are not re-cobalt 40 teletherapy unit) to the right pisterior neck qtared to be shipped in an N RC-appros ed packape, under rather than to the left pnterior neck, as prescribed.

the exemption granted in 10 Cl R 71.10, D. firachytherapy Source hlanagement-IN No.41-02,

'the IKensee reported that the oncologist had initially lurticipated in the treatment simulation and had ap.

dated Januan 7,1991 Technical Co'ntact: Sally hierchant, 301-492-0637 proved simulation radiographs before treatment; how-ever, he had not noticed that the wrong side of the pa-This notice emphasi/cs to medical use hcensees the tient's neck had been the subject of the simulation.'lhis potential radiation hatards resultmg from improper han-error was attributed to the patient treatment being simu-dling of brachytherapy scaled sources. In sescral recent lated in the prone position, rather than in the routine cases, described in the notice, improper handhng of supmc position. Sescral of the beensee's staff memacrs, sources has resulted in unmtended radiation doses.1.i-meludmg the teletherapy physicat, therapy dosimetrist, censees are reminded of their responsibilities to take techmcal staff, and oncologist, had reviewed the patient'b measures required by regulations: provide radiation chart and participated in treatment and followup obser-safety mstruction to all personnel caring for a pauent un-vations, although none had recognized the error. 'the on-derpomp implant therapy; make the required suveys; cologist had palpated an enlarged cervical lymph node on mamtain adequate records and return all sources to the the patient'b lef t side duting the September 6,1990 physi-storage area promptly upon removal and count the num-cal examination, which prompted his subsequent review of the treatment chart and identification of the error. All her returned-treatment records mdicated that the right side of the patbnt's neck was treated, although the prescription

!! hianagement of Wastes Contaminated with RaJio-(karly indicated that treatment *as to be given to the left active hiaterials (" Red llag" Waste and Ordmary

'ide-Trash)-IN No. 41-03, dated January 7,1991 Technical

Contact:

Samuel Z. Jones,301-492-0554 1he h(ensee's raJution oncologist advised NRC that no n'Jverse ef fects were obsened durmg routine followup This notice reminds medical use licensees to carefully exarninations, and that no significant effects are antici-monitor all waste that may be contaminated with radioac'.

tive materials. Waste management facilities not author, pated as a result of the rnisadministration.

i/ed to receive licensable radioactis e materials are findmp wastes contaminated with detectable levels of radioactive livent 2: hiedical Diagnostic hiisadministration materials m waste shipments f rom hospitals. In a number of recent incidents described in this notice, monitoring Date Reported: June 1,1990 equipment with preset detection levels, installed at 1.icensee: Overlook ilospital landfills anJ medical waste incinerators, has detected ra-Summit, NJ dioactive materuls m waste shipments from hospitals. In some cases, the landfdis and incinerators have rejected An outpatient was scheduled for a nuclear medicme the shipments and returned them to the penerators. In study, by telephone, by the referring physician's office.

~

pencral, landfills and medical waste incin:rators are not

.lhe nuclear medieme department understood the doc-authorized to recene or manage radioactne waste. ( er-s office to request an appomtment for an iodine-131 tain radiologically-contaminated biomedical wastes are scan. 'the patient brought the written prescription to the exempt from Nuclear Regulatory Commission regulatory utpatient department and then went to the nuclear control or may be disposed of through specihe procedut es medicine department for the schedukd study, The nu-prescribed by regulation.

clear medicine department did not receive lhe written prescription until af ter the study was completed.The ver.

SEEECTl:D SIGN!!'ICANT EVENTS REPOlril!D bal request for the nuclear medicine study had not been 10 Tile U.S. NUCl. EAR REGUI.A'l ORY verified by a written prescription before the study was COhthilSSION performed. When the department did receive the w ritten prescription, personnel noted that the written prescrip-I! vent h hiedical Therapy hiisadminstration tion requested a thyroiJ scan, not an iodine-131 scan.

6

'the patient had a benign tumor ten *med from a thyroid The primary cause of 3.he misadministration appeared to lobe in June 1989. Subsequent thyroid scans indicated be the difficulty in viewing the pmstate area using an that the patient had a normally functioning thyroid.1he ultrasonic probe, which had been used to view and licensee does not expect any significant consequences to position the implants. Ultrasonic imaging is often diffi-the patient.

cult and inexact, especially for soft tissue organs.

Event 3: hiedical Therapy hiisadministration 1he licensee has adopted revised procedures to prevent recurrence of the misplacement of the iodine-125 seeds Dde Reported: April 19,1940 in procedures of this nature.1hc revisionsinclude an im-Licensee: Yuma Regional Medical Center proved measuring techniqu6 " ensure proper seed.

Yuma,A7, depth placement and improveo ultrasonic image analysis.

On April 19, 1990, a patient's uterine tumor was im-planted with 224 iridium-192 seeds, using 32 surgical de-Event 5: Radiation Overexposure of r. Radiographer vices fitted with hollow tubes (trochars), each device con-taining 7 seeds on a ribbon. The prescribed dose was Date Reported: October 5,1990 about 2000 rads. Five seeds were stripped from one

1. censee: Western Stress, Inc.

trochar when an attempt was made to remove both the Bordentown New Jersey tmchar and the seeds.1hc trochar had inadvertently been placed in a necrotie cavity within the tumor, permit-On October 5,1990, the licensee notified NRC that an ting the seeds to go into the cavity, rather than being incident had occurred earber that evening while a radiog-stopped by tissue.

rapher and his assistant were working at a temporary job.

site.The radiographic operation mvolved the use of a ra-An unsuccessful attempt was made to remove the five diography device contaming n WL5 curie iridium-192 stripped seeds, When the tsochar that had contained the scaled source. The licensee reprted that the source be-snagged ribb(m was removed, it was discovered that its tip came disconnected from the drie cable and remained in was now bent, presumably by the stony hardness of the the guide tube.

tumor.

After cranking out the source for tue sixth exposure, the The five seeds were left in the tumor center. These seeds radiographer heard a crash and saw that the magnetically delivered a dose considerably in excess of that prescribed.

mounted stand that held the collimator and end. cap had flowever, a medical consultant stalco that the patient's fallen from the side of the tank and was lymg on the con.

poor prognosis outweighed any harm from additional crete pad.1he source guide tube end. cap with the colli-

mdiation, mator had been approximately 10 feet above the concrete pad for this exposure.

Event 4: Medicallherapy Misadministration The radiographer attempted to crank the source back Date Reported: August 29,1990 into the camera, but found that the guide tube was looped. The radiographer then dragged the camera back Licensee: University of Cincinnati by pulling on the drive cable to straighten out the guide Cincinnati, Oil tube. After straightening the guide tube, the radiogra-pher was able to fully retract the cable, and thought that On August 29, 1990, 86 iodine-125 seeds were perma-the source was in the camera. Subsequently, the radiogra.

nently implanted in a patient.1he seeds totaled 27.5 pher removed his two self-reading pocket dosimeters and millicuries of iodine-125. A dose of 16,000 rads was pre-his thermoluminescent dosimeter badge from his neck, scribed for the prostate gland tumor.

1he radiographer walked to the end of the source guide Subsequent licensee review determined that most of the tube with his survey meter, but did not refer to it for any seeds had been implanted too deeply and had passed indication of radiation. lle grasped the end of the source through the prostate into the surrounding tissue. As a re-guide tube with his left hand and removed the tape that sult, the radiation dose to the prostate was negligible.The held the collinator in place with his right hand. lie begat licensee estimated a dose of 15,000 rads to the tissue be-to unscrew the end cap from the source guide tube, to ex-yond the prostate gland, considerably greater than the change it for a lighter end cap assembly, As he removed dose that would have been received if the seeds had been the cap, the source chain ecmtaining the scaled source fell positioned as intended, out of the end cap assembly onto the concrete pad.The radiographer then dropped the source guide tube and 1he licensee does not anticipate any significant effects to end-cap, and rapidly left the immediate area.

the patient as a result of the misadministration. Further treatment, including a repeat of the implant procedure, A source. recovery team from the camera manufacturer was planned.

was sent to the site and safely recovered the source.

7

l NRC dose estimates indicated a whole toJy exposure to Radiation Safety Officer of the incident until the aksis-the radiographer of about 8.9 rem and an extremity expo-tant's hand showed clmical ugns of a radiation injury.

sure of about 1070 rem.'this would clearly have been pre-vented by following radiation safety procedures. NRC en-NRC estimated that the dose to the assistant radiog-forcement action is underway.

rapher's hand w as betw een 1500 to 3000 rem.1hc w hole-tudy dose to the assistant, as measured by h;s ther-moluminescent dosimeter, was 365 millirem. Illood Event 6: Radiation Overexposure of a Radiographer samples were taken from the assistant for cytogenetic tests: the results indicated an equivalent whole body ex-Date Reported: November 26,1990 posure of about 10 rem or less.

Licensee: Tumbleweed LRay Company On November 29,1990, the NRC inspector noted that llurns Flat, Oklahoma the assistant's thumb, index, and rniddle fingers were se-verely blistered and swollen. Ile was immediately admit.

On November 26,1940, the licensee nottfied NRC that ted to a hospital for 2 weeks.

on November 12, 1940, a radiographer's assistant may have sustained a possible radiation overexposure to his in late January, the physician contacted NRC, reported right hand 'the licensee stated that it was not informed of on the patient's progress, and said that he would supply the incident by the radiographer until the morning of NRC with periodic reports. NRC enforcement action is November 25, 1990, because the radiographer did not

underway, think an overexposure had occurred until the assistant radiographer's right hand became red and his fingers be-SIGNil1 CANT EN!'ORClibilNF ACrlONS gan to swell.

AG AINST N1ATERIA13 LICENSEES On the day of the incident, the radiographer and his assis-One way to avoid regulatory problems is to be aware of tant were performing radiographic operations at a tempo-enforcement problems others have faced.Thus, we have rary jobsite with a radiography device that contamed a ncluded here a discussion of some representative en-49 curie indium-192 scaled source.

forcement actions against materials licensees.1hese en-E ""

Af ter the sixth exposure, the radiographer lef t the imme-

• #E" ' "" "

diate area to load film. The assistant set up the seventh exposure and cranked out the source.1he assistant had A. Civil Penalties and Orders turned the crank about two or three turns when he saw that the magnetically mounted stand that held the guide 1.

Albert Einstein hiedical Center, Philadelphia, tube near the exterior of the tank had fallen.

Pennsylvania The assistant radiographer's alarming personne dosime-ter (chirper) had alarmed loudly when the guide tube had A Notice of Violation and Proposed imposition of fallen. The assistant stated that he cranked the source Civil Penalty was issued to emphasize the impottance back to the shielded position. The assistant's chirper of proper security of licensed material. Licensed ma-stopped alarming, so he thought the source was in the terial was stored in an unrestric;cd area unsecured shielded position in the radiography device. The assistant against unauthorized removal and not under imme.

radiographer then stated that he faded to pick up and use diate licensee control. A package oflicensed material was left outside in the hall.

his survey instrurr=nt to survey the radiography device and the source guide tube, because his chirper was not 2 Alt & Witzig Engineering,Inc., Indianapolis, alarming. (The licensee later reported that the chirper Indiana was found to be malfunctioning.) lie walked over to the Supplement V, EA 90-141 tank and repositioned the magnetic s:and and source guide tube with his right hand lie then returned to the A Noh of Violation and Proposed Imposition of crank handle to proceed with the exposure.

C y 1 Penalty was issued to emphasire the importance of complying with license and regulatory require-When he performed this exposure, he noted that his menu an enung e ec management men @

chirper did not alarm when the source was cranked out.

of licensed programs. hicisture/ density gauges in the After the exposure was completed, he noted his pocket beensce's vehicles were lef t unattended. There were dosimeter was off scale (greater than 200 millirem). At violationsof Nuclear RegulatolyCommission(NRC) about the same time, the radiographer returned and the requirements for safe transportation of licensed assistant told him what had happened and that his pocket material.

dosimeter had gone off scale.The assistant told the radi-ographer that he thought his pocket dosimeter was off 3.

Cabell lluntington llospital, iluntington, scale because he had bumped it earlier.1he radiographer West Virginia and his assistant continued to work and did not inform the Supplement VI EA 90-163 8

A Notice of Violation and Proposed imposition of compliance with NRC regulatory requirements and Civil Penalty was issued to emphasize the importance the licensee's radiological safety procedures.

of effective management oversight of the radiation safety program and compliance with radiation safety

10. North Detroit General llospital, Detroit, Michigan requirements.

Supplements IV and VI. EA 90-160

/

4.

Cambridge Medical Technology Corporation, A Notice of Violation and Proposed imposition of i

Hillerica, Massachusetts Civil Penalty was issued to emphasize the need for Supplement IV, EA 89-233 management oversight of the radiation safety pro-gram.

A Notice of Violation and Proposed impnsition of Civil Penalty was issued to emphasue the need for

11. Porter Memorial llospital, Valparaiso, Indiana effective controls over the release of radioactive ma.

EA 90-072 terial to unrestricted areas, lodine-125, as effluent, was released to the environment in amounts of about A Confirmatory Order Suspending lirachytherapy 9 times the regulatory limit.

Activities and Modifying License was issued because of lack of management control of the brachytherapy 5.

Deaconess llospital, Oklahoma City, Oklahoma program.

Supplements VI and Vil, EA 89-105

12. Roche Professional Ser ice Centers, Inc., Nutley, A Notice of Violation and Proposed Imposition of New Jersey Civil Penalty was issued to emphasize the significance Supplemen,s VI and Vil, EA 90-161 tbt NRC places on deceptive alteration of required docaments and the responsibility of a licensee to en.

A Notice of Violation and Proposed Imposition of sure hat ;ts employees are meeting all requirements, Civil Penalty us issued to em phasize the importance including compliance audits.

of the licensee's responsibilities for ensuring that li-censed activities are conducted in accordance with Nnet?. Motors Corporation, Saginaw, Michigan regulatory requirements, and that all information a.

%, ements IV and VI, EA 90-137 communicated to NRC is both complete and accu.

rate.

A N tice of Violation and Proposed Imposition of Ova %nalty was issued to emphasize the need for

13. St.1. uke's llospital, Cleveland, Ohio mm. nd effective management of the licensee's ra-Supplement VI, EA 90-128 di e safety program. A level gauge that contained a u millicurie cesium-137 scaled source was lost-A Notice of Violation and Propmed 'mposition of Civil Penalty was issued to emphasize the importance

?.

liigh Mountain Inspection Service, Inc., Mills, of making a detailed review of all patient treatment Wyoming planning charts before initiating teletherapy treat-Sup,lement IV, EA 90-104 ment.

A Notice of Violation and Proposed imposition of

14. St. Mary Medical Center, Hobart, Indiana Civil Penalty was issued to emphasize the importance EA 90-071 of strict adherence to NRC's radiation safety require-ments. An NRC inspector noted failures to perform a An Order suspending lirachytherapy Activities and required survey and an individual conductmg ra-Modifying Licenses was issued because of lack of diography without the perscnal supervision of a management control of the brachytherapy program, radiographer,

15. Syncor International Corporation, Chatsworth, 8.

Milwaukee County Medical Complex, Milwaukee, California Wisconsin Supplement VI, EA 90-144 Supplements IV and VI, EA 90-181 A Notice of Violation and Proposed Imposition of A Notice of Violation and Proposed Imposition of Civil Penalty was issued to emphasize the importa nce Civil Penalty was issued to emphasize the need for of licensee management aggressively monitoring and additional management oversight of licensed evaluating licensed activities and holding employees activities.

strictly accountable for conducting these activities safely and in accordance with the terms of the 9.

MQS Inspection, loc., lilk Grove Village, Illinois license.

Supplements IV and VI, EA 90-046

16. Tumbleweed X. Ray Company, Greenwood, A Notice of Violation and Proposed imposition of Arkansas Civil Peralty was issued to emphasize the need for li A 83-183 9

An Order Modifying 1.icense was issued because it A Notice of Violation was issued because of viola-was determined that the Radiation Safety Manager tions involving the improper transfer of licensed had made false statements to NRC and had falsified radioactive material.

records.

I UPDATE ON RADIOGRAPilER SAFETY CERTIFICATION I

17. University of Puerto Rico, San Juan, Puerto Rico Supplements IV and VI, EA 90-076 On March 19,1991, the Nuclear Regulatory Commission A Notice of Violation and Proposed Imposition of (NRC) issued a final rule that amended Part 34, "Li-Civil Penalties was issued to emphasize the need for censes for Radiography and Radiation Safety Require-stronger management oversight, more effective con.

ments for Radiographic Operations." The amendmcht, trols of the licensee's radiation program, and to en-intended to recognize and encourage participation in the sure that a qualified and NRC authorized individual American Society for Nondest ructive Testing's ( ASKI"s) performs the duties of the Therapy Physicist.

Industrial Radiography Radiation Safety Personnel" (IRRSP) cer ification program, provides radiography li-

18. West Shore llospital, Manistee, Michigan cense applie.e the option to affirm that all their active Supplement VI, EA 90-172 radiographers will bs ecrtified in radiation safety through ASNT's IRRSP program, bef are beginning duties as radi.

A Notice of Violation and Proposed imposition of ographers. This affirmation would be in lieu of each ap-Civil Penalty was issued to emphasize the need for plicant's describing an initial radiation safety training management ovctsight of the radiation safety pro-program for radiographers in the subjects outlined in Ap.

gram. A techrWian had injected a patient with oendix A of 10 Cl R Part 31, and the means used to test a approximately 20 t;mes the quantity of diagnostic

' radiographer's knowledge and understanding of these radiopharmaceutical needed to perform a nuclear subjects. ASNT is the only organization that has, to date, medicine image, submitted a certification program for NRC's review and recognition.

H. Severity Level til Violation, No Civil Penalty

.The amendment also allows NRC's existing licensees to substitute ASKI certification for certain verification pro-1.

Government of the District of Columbia, District of Cedures described in their license applications. Ijxisting Columbia General llospital, Washington, D.C.

licensees willbe able to substitute the ASN'I examination Supplement VII, EA 90-081 for the licenseci radiation safety examination, and to substitute ASNT certification for verifying the training A Notice of Violation was issued because of willful falsifications by a former D.C. General llospital and testing of experienced radiographers, as described in License applications.The licensees will not be required to Medical Physicist.

have their licenses amended to make these substitutions until the next license renewal date.

2.

Industrial NDT Services Division, Indianapolis, Indiana The amendment does not waive any of the ', raining re-Supplements IV and VI, EA 90-202 quirements of 10 CFR Part 34. By issuing this amend-A Notice of Violation was issued because of an over-ment, NRC encourages voluntat) participation in exposure to a radiographer's hand, subsequent ASNT's program.The ASNT certification program has errors, and a source becoming disconnected due to been underway since January 1991, and the results to various procedural errors.

date are promising.

3.

Mediq Imaging Services, Inc., Overland Park, Kansas The NRC staff has also initiated the deselopment of an-Supplement V, EA 90-173 other amendment to its regulations that will mandate ra-diation safety certification of radiographers by organiza-A Notice of Violati as issued because of transpor-tions other than licensees. The rulemaking would also tation violations.

put into the regulation the elements of third partycertifi-cation that would be necessary for NRC approval. NRC is 4.

Newrnan Memorial Hospital, Shattuck, Oklahoma establishing a goal of about 1 year for completing this Supplements V and VI, EA 90-191 rule.

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WIS DOCUMENT WAS PRINTED.USING RECYCLED PAPER.

UNITED STATES nast etnis uan NUCLEAR REGULATORY COMMISSION

'estaa ejeis enio WASHINGTON, D.C. 20555 PihMIT ho 0 47 0FFICIAL DUSINESS PENALTY FOR PRIVATE USE,4300

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