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U.S. Nuclear Office of Nuclear NUREGIBR-01 17/1 Regulatory Material Safety No. 00-2.~Commission and Safeguards June-July 2000

NRC REVIEW OF TOKAI-MURA NUCLEARCRITICALITY ACCIDENT

On September 30, 1999, a nuclear criticalityaccident occurred in a precipitation tank at theJCO Inc. facility located at Tokai-mura, Japan.The accident lasted about 20 hours and resulted intwo worker fatalities and elevated radiationexposures to several hundred other workers andmembers of the public. [The exposure of membersof the public is normally not expected for criti-cality accidents. However, the facility was locatedin a densely populated area, with the nearestresidence only 100 meters (110 yards) from thearea of the accident, and no actions were taken toevacuate people from the vicinity until about5 hours after the accident was initiated, becauseof emergency management problems and the lackof a facility emergency plan.] About 160local residents were evacuated from within 350meters (385 yards) of the site boundary, andabout 310,000 people were sheltered within a10-kilometer (6.2 mile) radius of the site. Opennews sources estimate the economic loss at over$93 million. The Japanese government revokedthe business license of JCO Inc. and initiated acriminal investigation. Subsequent reports fromthe Japanese regulatory authorities indicatedthat the accident was an irradiation event-caused by direct radiation, and not a con-tamination event. There were no measurableenvironmental consequences.

As a result of this accident, the Presidentrequested the U.S. Nuclear RegulatoryCommission (NRC) to conduct a review of U.S.commercial facilities, to ensure that a similaraccident would be unlikely to occur. NRC initiatedsteps to review the safety operations at U.S.-licensed and -certified fuel cycle facilities,determine the implications for NRC's oversightprogram, and issue a report addressing the lessonslearned and implications. The proposed report

was made publicly available on April 24, 2000, asSECY-00-0085, "Review of the Tokai-muraCriticality Accident and Lessons Learned," andthe staff briefed the Commission on the reportduring a public meeting on May 8, 2000.

The direct cause of the criticality accident was theconduct of operations at the JCO facility. Briefly,the event involved the dissolution of over 16kilograms (36 lbs) of uranium oxide enriched toabout 18.8% uranium-235 (U-235) in nitric acid,and their subsequent addition in 2.6-kilogram(5.7-1b) batches into an unfavorable geometryvessel (precipitation tank). This action resulted ina high concentration of U-235 that wassufficiently reflected and moderated for thegeometry of the vessel to generate a supercriticalpower burst and sustain a quasi steady-statenuclear chain reaction for about 20 hours after theinitial pulse. The actual processing operationviolated the operating procedures that wererequired and approved by the regulatory authorities.Because there are indications that the companydeveloped multiple sets of procedures to increaseproduction efficiency without obtaining the approvalof the regulatory authorities, the Government ofJapan has initiated a criminal investigation.

NRC review of the reports from the Japanesegovernment indicates that there were threeoverarching root causes: (1) inadequate regulatoryoversight; (2) lack of an appropriate safetyculture; and (3) inadequate worker training. Thelicensing review incorrectly concluded that therewas no possibility of a criticality accident.Consequently, no criticality accident alarm systemwas required nor installed and the facility was notincluded in the National Plan for the Preventionof Nuclear Disasters (e.g., the facility did not havean emergency plan). Furthermore, the regulatoryauthorities had not inspected the facility since 1992.

NMSS Licensee Newsletter(June-July 2000)

ContentsPage

1. NRC Review of Tokai-Mura NuclearCriticality Accident ............... 1

2. Responsibilities of the Division ofIndustrial and Medical Nuclear Safety ............... 2

3. NRC Issues Final Rule AmendingWell-Logging Regulations,1OCFR Part 39 ............... 3

4. NRC to Hold Workshop onDecommissioning Issues ............... 4

5. NRC Staff Forms Institutional ControlsWorking Group .5..............

6. Cavalier Challenge ............... 6

7. Significant Enforcement Actions ............... 6

8. Generic Communications Issued(March 1, 2000-June 30, 2000) ............... 7

9. Selected Federal Register Notices(April 1, 2000-June 30, 2000) ............... 8

10. Significant Events ............... 10

11. Correction ............... 14

The safety culture that developed at the facilitywas also inappropriate. Deviations from approvedoperating procedures began to occur several yearsbefore the company developed a second set ofprocedures to use to increase productivity. TheProduction and Quality Assurance departments,reviewed and approved the second set ofprocedures but the Safety Department did not.Within a year before the accident, about one-thirdof the facility staff was laid off. Of the threeworkers involved in the accident, two had neveroperated the 18.8 percent enriched uraniumprocess, and the third worker had only severalmonths of experience the last time it was run,about 3 years ago. There was no managementaction taken before the restart of the 18.8 percentenriched production run, to assure that the safetylimits were properly disseminated to the workersthrough proper procedures, postings, and training.

If the workers had been informed that certainactions could result in a criticality, this event, in

all likelihood, would not have occurred, becausethe workers would have understood the im-portance of adhering to the process safety limits.

After the accident, NRC increased NRC residentinspector focus on the implementation ofcriticality safety programs at the high-enricheduranium facilities and gaseous diffusion plants.NRC also issued Information Notice 99-31, toalert licensees to the circumstances surroundingthe accident, and evaluated the lessons learned asthey became available from various sources. Areview of the individual deficiencies identified ascontributing to the accident or emergencyresponse problems determined that each wasadequately addressed by the current NRCoversight program.

The staff concluded that the accident root causeswere similar to causes of previous criticalityaccidents that have occurred in the world. Thecurrent safety program carried out at commercialU.S. fuel facilities makes a similar accidentunlikely. Finally, emergency response plansprovide defense-in-depth at U.S. facilities.

(Contact: William S. Troskoski, 301-415-8076;e-mail: [email protected])

RESPONSIBILITIES OF THE DIVISION OFINDUSTRIAL AND MEDICAL NUCLEARSAFETY

This is the first in a series of articles explainingthe responsibilities of each of the Divisions withinthe Office of Nuclear Material Safety andSafeguards (NMSS). Other Divisions and groupswithin NMSS will be discussed in future NMSSLicensee Newsletters.

NMSS is responsible for licensing, inspection, andenvironmental reviews for all activities regulatedby the U.S. Nuclear Regulatory Commission(NRC), except operating power and all non-power

Comments, and suggestions you may havefor information that is not currently beingincluded, that might be helpful to licensees,should be sent to:E. KrausNMSS Licensee Newsletter EditorOffice of Nuclear Material Safety

and SafeguardsTwo White Flint North, Mail Stop W-A-23U.S. Nuclear Regulatory CommissionWashington, D.C. 20555-0001

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reactors. NMSS also performs safeguardstechnical review of non-reactor licensing activities,including export and import of special nuclearmaterial. NMSS develops and implements NRCpolicy for the regulation of activities involving theuse and handling of radioactive materials, such as:uranium recovery activities; fuel fabrication anddevelopment; medical, industrial, academic, andcommercial uses of radioactive materials;safeguards activities; transportation of nuclearmaterials, including certification of transportcontainers; reactor spent fuel storage; safemanagement and disposal of low-level andhigh-level radioactive waste; and management ofrelated decommissioning.

The Division of Industrial and Medical NuclearSafety (IMNS) is one of four divisions in NMSS.IMNS directs NRC's principal rulemaking andguidance development, licensing, inspection, eventresponse, and regulatory activities for materials-as opposed to reactors-licensed under theAtomic Energy Act of 1954, as amended, toensure safety and quality associated with thepossession, processing, and handling of nuclearmaterial. NRC's four Regional Offices are 'responsible for licensing and inspection of about5200 licenses in 18 States. Thirty-two other States,known as Agreement States, have assumedresponsibility for nuclear materials and areresponsible for about 16,000 licenses. IMNSprovides central direction to NRC's regionalprograms and cooperates with the AgreementStates on a national program for material safety.The direction of NRC's program includesoversight of health physics and radiationprotection, nuclear safety review, and use oflicensed materials in medicine, research, industry,and other purposes, with a focus on assuringsafety and the effective and efficient deliveryof regulatory services. IMNS is headed byDr. Donald A. Cool, Director, andDr. Josephine M. Piccone, Deputy Director.

IMNS also plans, develops, monitors, and directstechnical rulemakings and regulatory guides, forall NMSS activities, including those related to fuelcycle and materials, safeguards, transportation,decommissioning, the management of nuclearwaste, and closure of uranium recovery facilities.The division manages the agency program for"exempt" use of radioactive material and forevaluation of sealed sources and devices. As partof the national program for materials safety,IMNS provides technical support for training ofregional and Agreement State licensing andinspection staffs and provides technical supportand guidance to the Regions on licensing,inspection, and enforcement activities and, on

request, to the Agreement States. The divisionidentifies and takes action to control safety issues;responds to allegations; and directs NRCcontingency and response operations dealing withaccidents, events, and incidents under itsresponsibility.

(Contact: Paul Goldberg, NMSS, 301-415-7842;e-mail: [email protected])

NRC ISSUES FINAL RULE AMENDINGWELL-LOGGING REGULATIONS, 10 CFRPART 39

On April 17, 2000, the U.S. Nuclear RegulatoryCommission (NRC) published a final rule, in theFederal Register (65 FR 20337), amending 10 CFRPart 39, "Licenses and Radiation SafetyRequirements for Well Logging," its regulationsgoverning licenses and radiation safetyrequirements for well logging. The final rulemodifies NRC regulations dealing with:low-activity energy compensation sources (ECS');tritium neutron generator target sources; specificabandonment procedures in case of an immediatethreat; changes to requirements for inadvertentintrusion on an abandoned source; and thecodification of an existing generic exemption. Italso authorizes the removal of obsolete date, andthe updating of regulations regarding consistencywith the Commission's metrication policy. TheEnvironmental Assessment conducted for thisrulemaking demonstrated that there would be nosignificant impact on public health and safety northe environment, resulting from this amendment.The final rule became effective on May 17, 2000.Several of the more significant changes are:

1. The regulations were amended to recognizethe use of a low-activity radioactive source,known as an ECS, contained within somewell-logging tools used in well-logging, and toprovide requirements governing its use. TheECS is used to calibrate the well-logging toolwhile the well is being drilled. This smallradioactive source is used in addition to thelarger radioactive source used to actually "log"a well. The ECS is typically less than 1.85MBq (50 microcuries), as compared with thenormal 110 GBq-to 740-GBq (3-to 20-curie)sources used in well-logging. 10 CFR Part 39,originally promulgated in 1987, did not provideany specific provisions for these low-activitysources, and many of the requirements inPart 39, when applied to an ECS, are notappropriate nor necessary to protect publichealth and safety and the environment.

Examples of requirements considered overlyburdensome for licensees using ECS', include:

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those addressing well abandonment (10 CFR39.15 and 39.77); leak-testing (10 CFR 39.35);design and performance criteria for sealedsources (10 CFR 39.41); and monitoring ofsources lodged in a well (10 CFR 39.69). Therule change provided that only those sectionsdealing with leak-testing (a revised Section39.35 specifically addresses ECS); physicalinventory (10 CFR 39.37); and records ofmaterial use (10 CFR 39.39), apply to the useof an ECS.

The most significant change excludes an ECSfrom the costly procedures for wellabandonment if only an ECS is lost within oiland gas wells, where a surface casing is used toprotect fresh-water aquifers. However, if asurface casing is not used, the well-abandonment requirements would continue toapply. The rule establishes 3.7 MBq (100microcuries) as the limit for an ECS. The3.7-MBq (100-microcurie) limit should allowlicensees flexibility in designing new sources ofthis kind while maintaining their radioactivitywithin an environmentally safe level. AlthoughECS sources will not be required to meet therequirements in 10 CFR 39.41, their sourceswill be required to be registered pursuant to10 CFR 32.210. Unless already otherwiseexempted, ECS leak tests will need to beperformed at a minimum of every 3 years.

2. Tritium neutron generator target sourceswould be subject to the requirements of Part39, except for the sealed source design andperformance criteria (10 CFR 39.41), and thewell-abandonment procedures (10 CFR 39.15and 39.77), when a surface casing is used toprotect fresh-water aquifers. The ruleestablished 1110 GBq (30 curies) of tritium asthe limit for a tritium neutron generator targetsource. The tritium neutron generator targetsources will continue to be required to beregistered pursuant to 10 CFR 32.210 and tomeet applicable industry standards.

3. Section 39.77 provides the requirements fornotification and procedures for abandoningirretrievable well-logging sources. This sectionspecifies that NRC must approve implemen-tation of abandonment procedures beforeabandonment. In some circumstances, such ashigh well pressures that could lead to fires orexplosions, the delay required to notify NRCcould cause an immediate threat to publichealth and safety. This section was revised toallow a licensee to use its judgment toabandon a well immediately, without priorNRC approval, if the licensee believed a delay

could cause such a non-radiological threat. Incase of an immediate abandonment, thelicensee is required to notify NRC and justifythe need for an immediate abandonment afterthe fact.

4. Section 39.15, which provides requirementsfor abandoning irretrievable sealed sources,has been revised to provide performance-based criteria for inadvertent intrusion on thesource. This modification will allow licenseesgreater procedural latitude while continuing toensure source integrity. For example, if asignificant amount of drilling equipment mustalso be abandoned above the logging tool, theequipment itself may be deemed effective inpreventing inadvertent intrusion on the source.

5. TWo revisions were made to 10 CFR 39.41,"Design and performance criteria for sealedsources." The first incorporated an existinggeneric exemption for sealed sources thatwere manufactured before 1989 and met olderstandards. The second added an optionalacceptable standard by referencing oil-welllogging requirements in the AmericanNational Standards Institute/Health PhysicsSociety document N43.6-1997.

(Contact: Bruce Carrico, NMSS, 301-415-7826,e-mail: [email protected])

NRC TO HOLD WORKSHOP ONDECOMMISSIONING ISSUES

On July 21, 1997, the U.S. Nuclear RegulatoryCommission (NRC) published the final rule on"Radiological Criteria for License Termination"(the License Termination Rule or LTR) asSubpart E to 10 CFR Part 20. NRC regulationsrequire that a materials licensee submit aDecommissioning Plan (DP) to support thedecommissioning of its facility if it is required bylicense condition, or if the procedures andactivities necessary to carry out the decom-missioning have not been approved by NRC andthese procedures could increase the potentialhealth and safety impacts on the workers or thepublic. NRC regulations also require that reactorlicensees submit Post-shutdown DecommissioningActivities Reports and License Termination Plans(LTPs) to support the decommissioning of nuclearpower facilities.

As part of our continuing efforts to involve theregulated community, and other stakeholders, inour Decommissioning program, we will hold aworkshop November 8-9, 2000, at theCommission's Headquarters in Rockville,Maryland. The workshop will be to provide a

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forum for us to describe, and obtain feedbackfrom, nuclear industry and non-industrystakeholders, on our process, and guidance fordeveloping and evaluating DPs and LTPs. We willalso describe, and receive feedback on, currentissues associated with the decommissioning ofnuclear facilities, and identify areas and strategiesfor improving the decommissioning process.

Each day will feature presentations from NRCHeadquarters and regional staffs and roundtablediscussions on our process for reviewing DPs andLTPs, our expectations for the contents of DPsand LTPs, current policy and technical issuesrelated to decommissioning, and key issuesidentified since promulgation of the LTR. Whenfinalized, the agenda for the workshop will beposted on the NRC Website at: http:/Avww.nrc.gov/NMSSIDWM!DECOMIdecomm.html

The workshop will be open to the public andinvited licensees, industry and non-industrystakeholders, and State regulators. Registrationwill be held from 7:45 to 8:30 a.m. on the first dayof the workshop, November 8, 2000, at theentrance of the Two White Flint NorthAuditorium at 11545 Rockville Pike, Rockville,MD. There will not be any pre-registration, norregistration fee, and the workshop will run from8:30 a.m to 4:45 p.m. on both days. In addition,the workshop will be transcribed, and thetranscripts, and any material presented at theworkshop, will be posted on NRC's Website.

(Contact: Nick Orlando, 301-415-6749, e-mail:[email protected])

NRC STAFF FORMS INSTITUTIONALCONTROLS WORKING GROUP

On July 21,1997, the U.S. Nuclear RegulatoryCommission (NRC) published the final rule on"Radiological Criteria for License Termination"(the License Termination Rule) as Subpart E to10 CFR Part 20 (62 FR 39058). Subpart Eestablishes criteria at 10 CFR 20.1402 for therelease of sites for unrestricted use, if the residualradioactivity that is distinguishable frombackground results in a total effective doseequivalent to an average member of a criticalgroup that does not exceed 0.25 milliSievert peryear (mSv/yr) (25 mrem/yr) and the residualradioactivity has been reduced to levels that are aslow as is reasonably achievable (ALARA).Subpart E also establishes criteria at 10 CFR20.1403 for license termination with restrictionson future land use, as long as specific conditionsare met, and criteria for license termination in

unusual situations where the site may exceed the0.25-mSv/yr (25-mrem/yr) limit, but would not bepermitted to exceed 0.10 mSv/yr (10 mrem/yr) or0.50 mSv/yr (50 mrem/yr), under certainconditions. 10 CFR 20.1403(b) requires thatlicensees make provisions for legally enforceableinstitutional controls that provide reasonableassurance that the total effective dose equivalentfrom residual radioactivity distinguishable frombackground to the average member of the criticalgroup will not exceed 0.25 mSv/yr (25 mrem/yr).Institutional controls include measures to controlaccess to the site and minimize disturbances toengineered measures established by the licenseeto control the residual radioactivity. They includeadministrative mechanisms (e.g., land use restric-tions) and may include, but not be limited to,physical controls (e.g., signs, markers, and fences).

NRC staff has formed an Institutional ControlsWorking Group to explore the issues associatedwith these institutional controls and developsuggested policies and procedures for addressingthe issues. The Working Group will continue theefforts undertaken by the NRC staff in developingthe guidance in draft Regulatory GuideDG-4006, "Demonstrating Compliance with theRadiological Criteria for License Termination"(DG-4006). Note that the guidance summarizedin DG-4006 will be incorporated in the "StandardReview Plan (SRP) for Decommissioning" theNRC staff is currently developing.

The goals of the Working Group are to:

1. Identify policy issues associated withinstitutional controls for which resolutions arerequired and develop possible resolutions;

2. Develop model institutional controlinstruments, such as acceptable language fordeed restrictions and financial assuranceinstruments;

3. Develop various decommissioning scenariosand the institutional controls that would beapplicable to each scenario; and,

4. Develop/enhance current definitions in 10CFR 1400-1405 and develop guidance oninstitutional controls.

The Working Group includes staff from the Officeof Nuclear Material Safety and Safeguards andthe Office of the General Counsel. Currently, theWorking Group is reviewing the "RestrictedUse/Alternate Criteria" section of the SRP.

(Contact: Dominick Orlando, 301-415-6749,e-mail: [email protected])

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CAVALIER CHALLENGE

The U.S. Nuclear Regulatory Commission (NRC)conducted a tabletop exercise, called CavalierChallenge, in Lynchburg, Virginia, on May 24,2000. This was a joint Federal, State, and localexercise to examine and validate the concepts ofoperations for responding to an event involvingexternal threats or weapons of mass destruction ata nuclear facility, which would raise bothradiological safety and law enforcement issues.Cavalier Challenge was designed to provide astructured discussion forum, based on a scenarioor set of conditions, for decision-makers orresponders in a low-stress, no-fault environment.The exercise was intended to be both educationaland developmental in that disconnects,perceptions, and procedures could be identified,examined, and corrected.

The primary goals of Cavalier Challenge were to:(1) examine the relationships and understandingof participating organizations on how they wouldwork together in response to an event with nuclearsafety and law enforcement aspects; (2) foster apositive working relationship among responders tosuch an event; and (3) examine elements of theNRC/Federal Bureau of Investigation (FBI)concept of operations, incorporate lessons learnedfrom this exercise, revise the concept, anddistribute the concept for interim use to NRC, theFBI, and other responders. The exercise focusedon three major activities: (1) examining theassessment and notification requirements andcorresponding organizational interfaces ofresponders to an event with significant nuclearsafety and law enforcement aspects; (2) examiningthe activation and deployment requirements ofresponders to the event; and (3) examining theresponse actions, command and control, andpublic interface requirements in response tothe event.

This exercise was noticed as a closed meeting.Approximately 100 people were invited toparticipate as players or observers. Participantsincluded personnel from NRC, the FBI, U.S.Department of Energy, Federal EmergencyManagement Agency, licensees, and State andlocal decision-makers and responders.Representing NRC at the exercise wereCommissioner Jeffrey Merrifield; Region IIAdministrator Luis A. Reyes; Incident ResponseOrganization (IRO) Director Frank Congel;Nuclear Material Safety and Safeguards (NMSS)Division of Fuel Cycle Safety and SafeguardsDirector Michael Weber; and supporting technicalstaff from NMSS, IRO, and Region II. Thisexercise used a fictitious facility located in

Lynchburg, VA. BWX Technology agreed to playthe licensee at the exercise, which made theexercise more realistic. Most attendees thoughtthe exercise was a success. It provided attendeeswith the opportunity to meet each other face-to-face. Many thought that future exercises shouldfocus more on State/local responses and Federalassistance to State/local authorities, with a reducedemphasis on higher-level coordination, such aslead Federal agency determination. It was alsonoted that the NRC/FBI interface in public affairsshould be further developed in future exercises.

(Contacts: Yen-Ju Chen, NMSS, 301-415-5615,e-mail: [email protected]; Roberta Warren, NMSS,301-415-8044, e-mail: [email protected])

SIGNIFICANT ENFORCEMENT ACTIONS

Detailed information about these enforcementactions can be accessed via the U.S. NuclearRegulatory Commission's (NRC's) homepage[http:I/www.nrc.gov/OE/j. Click on "EnforcementActions." Cases are listed alphabetically. To accessthe complete enforcement action, click on thehighlighted text after the name of the case.

Medical

Jersey City Medical Center, Jersey City, NewJersey EA 2000-014. A Notice of Violation for aSeverity Level Ill violation was issuedFebruary 22, 2000. The action was based on thefailure (on at least eight occasions) to secure theNuclear Medicine Department hot laboratorywhere radioactive material was located. A civilpenalty was not proposed because the licensee hadnot been the subject of an escalated enforcementaction within the last 2 years, and credit waswarranted for corrective actions that wereconsidered prompt and comprehensive after NRChad identified the violations.

Pocatello Regional Medical Center, Pocatello,Idaho EA 99-332. A Notice of Violation for aSeverity Level Ill problem was issued on March 3,2000. The action was based on the failures: (1) tosecure a generator from unauthorized removal asit was stored in an unrestricted area; (2) to limitthe external dose from a generator temporarilystored in an unrestricted area to .02 Sv (2millirem) in any 1 hour; (3) to provide NRC with awritten report within 30 days of an incidentinvolving radiation levels in an unrestricted areathat exceeded 10 times the limit contained in10 CFR 20.1301; and (4) to conduct adequatesurveys to evaluate any associated radiologicalhazards caused by the incident. A civil penalty wasnot proposed because the facility had not been thesubject of escalated enforcement action within the

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last two inspections and credit was warranted forcorrective action that was prompt andcomprehensive.

Radiography

Maxim Technologies of New York, Inc.,Mechanicsville, New York EA 2000-002. ANotice of Violation was issued January 10, 2000,for a Severity Level Ill violation. The actioninvolved the performance of radiography inVermont and Connecticut (States under NRCjurisdiction), from August through October 1999,by individuals who were not certified through aradiographer certification program by a certifyingentity. A civil penalty was not proposed becausethe facility has not been the subject of anescalated enforcement action and credit was alsogiven for corrective actions that were consideredprompt and comprehensive.

Well-Logging

Allegheny Wireline Services, Weston, WestVirginia EA 99-034 and 00-005. A Notice ofViolation and Proposed Civil Penalty in theamount of $5500 was issued on February 8, 2000.The action was based on a Severity Level Illproblem comprised of two violations concerningdeliberate falsification of well site radiationsurveys, and a Severity Level Ill violationregarding the deliberate failure of the RadiationSafety Officer to provide adequate oversightconcerning the completion of the well site surveys.No credit was warranted for the identification ofthe problem or the violation since NRC identifiedit. Credit was given for corrective actions thatincluded additional training, revising proceduresfor conducting radiation surveys, increasing fieldaudit frequencies, and disciplinary action againstthe individuals involved.

Other

Mallinckrodt, Inc., Maryland Heights, MissouriEA 99-322. A Notice of Violation was issued onJanuary 11, 2000, for a Severity Level Ill violation.The violation involved the failure to notify NRCand the State agency after declaring an Alert. Acivil penalty was not issued because the licenseehad not been the subject of escalated enforcementaction. Credit was also warranted for correctiveaction because the corrective actions were promptand comprehensive.

West Virginia University, Morgantown, WestVirginia EA 99-300. A Notice of Violation andProposed Imposition of Civil Penalty in theamount of $2750 was issued on February 4, 2000.

The action was based on a Severity Level Illviolation involving failures to secure fromunauthorized removal, or limit access to, licensedmaterial. The violations involve unsecuredportable gauges and laboratories that wereunlocked and unattended. The licensee had notbeen the subject of escalated action in the past 2years, but credit was not warranted for correctiveactions, because the security violation had notbeen corrected after the licensee had identified iton three separate occasions before the November1999 inspection.

Individual Actions

Leonard Frye-IA 99-050. A Notice of Violationwas issued on February 8, 2000, based on aninvestigation involving the deliberate failure of theRadiation Safety Officer at Allegheny WirelineServices to provide oversight sufficient to ensurethe completion of radiation surveys and radiationsurvey records, as required. An Order was notissued because of the individual's forthrightnessin the case, and the corrective actions taken bythe licensee.

(Contact: Sally Merchant, OE, 301-415-2747;e-mail: [email protected])

GENERIC COMMUNICATIONS ISSUED

(March 1, 2000-June 30, 2000)

Note that these are only summaries of U.S.Nuclear Regulatory Commission genericcommunications. If one of these documentsappears relevant to your needs and you have notreceived it, please call one of the technicalcontacts listed below. The Internet address for theU.S. Nuclear Regulatory Commission (NRC)library of generic communications is-www.nrc.gov/NRC/GENACT/GC/index.htmI.Please note that this address is case-sensitive andmust be entered exactly as shown.

Information Notices (INs)

IN 2000-02, "Failure of Criticality Safety Controlto Prevent Uranium Dioxide Powder Accumu-lation," was issued on February 22, 2000. Thisnotice was issued to all fuel cycle conversion,enrichment, and fabrication facilities, to alertthem to a problem recently noted withsafety-significant level probes that are notself-checking. A level probe in a uranium dioxidepowder hopper failed without indicating a failedcondition. This allowed powder to accumulateand approach the criticality safety mass limitbefore discovery.Contact: Sheryl A. Burrows, NMSS,301-415-6667, e-mail: [email protected].

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IN 2000-03, "High-Efficiency Particulate AirFilter Exceeds Mass Limit Before ReachingExpected Differential Pressure," was issued onFebruary 22, 2000. This notice was issued to allfuel cycle conversion, enrichment, and fabricationfacilities to alert them to a potentially significantnuclear criticality risk for high-efficiencyparticulate air filters that could accumulate specialnuclear material beyond a safe mass.Contact: Dennis C. Morey, NMSS,301-415-6107, e-mail: [email protected].

IN 2000-04, "1999 Enforcement Sanctions forDeliberate Violations of NRC EmployeeProtection Requirements," was issued onFebruary 25, 2000. This notice was issued to alllicensees to remind them of the sanctions thatcould result from deliberately violating NRCEmployee Protection requirements.Contact: Michael Stein, OE, 301-415-1688,e-mail: [email protected].

IN 2000-05, "Recent Medical MisadministrationsResulting from Inattention to Detail," was issuedon March 6, 2000. This notice was issued to allmedical licensees to remind addressees of theimportance of following written directives andprocedures, and the need to pay attention todetail, especially when verifying patient identity,programming treatment devices, and preparingtreatment doses.Contacts: Susan L. Greene, NMSS,301-415-7843, e-mail: [email protected] D. Jones, RIII/DNMS, 630-829-9832,e-mail: [email protected].

IN 2000-07, "National Institute for OccupationalSafety and Health Respirator User Notice:Special Precautions for Using CertainSelf-Contained Breathing Apparatus AirCylinders" was issued on April 10, 2000. Thisnotice was issued to all holders of operatinglicenses for nuclear power reactors, andnon-power reactors, and all fuel cycle andmaterial licensees required to have anNRC-approved emergency plan, to alertaddressees to a recent Respirator User Notice,issued by the National Institute for OccupationalSafety and Health, that recommends specialattention and increased oversight and inspectionsfor certain high-pressure aluminum seamless andaluminum composite hoop-wrapped cylindersmade of aluminum alloy 6351 -T6.Contacts: William M. Troskoski, NMSS,301-415-8076, e-mail: wmt @ nrc.gov.James E. Wiggington, NRR, 301-415-1059,e-mail: [email protected].

Regulatory Issue Summaries (RIS)

RIS 2000-09, "Standard Review Plan forLicensee Requests to Extend the Time PeriodsEstablished for Initiation of DecommissioningActivities," was issued on June 26, 2000. Thissummary was issued to all material licensees toinform them that NRC will now implement thestandard review plan entitled, "Licensee Requeststo Extend the Time Period Established forInitiation of Decommissioning Activities."Contact: John T. Buckley, NMSS, 301-415-6607,e-mail: [email protected].

RIS 2000-10, "Technical Information to FacilitatePublic Access to the U.S. Nuclear RegulatoryCommission's Agency-Wide Documents Accessand Management System (ADAMS)," was issuedon June 30, 2000. This summary was issued to allNRC licensees to provide individuals andorganizations outside of NRC with informationthat will assist them in accessing, via the Internet,the publicly available portion of NRC's ADAMS.This RIS provides detailed technical (computing)information for use by network or systemadministrators in resolving certain types ofproblems; directions for locating updatedmaterials on the Internet, as they becomeavailable; and directions for contacting NRC staffwho will provide support on this endeavor.Contact: NRC Public Document Room,202-634-3273 or 800-397-4209, e-mail:[email protected].

(General Contact: Mark A. Sitek, NMSS,301-415-5799, e-mail: [email protected])

SELECTED FEDERAL REGISTER NOTICES

(April 1 - June 30, 2000)

NOTE: U.S. Nuclear Regulatory Commission(NRC) contacts may be reached by mail at theU.S. Nuclear Regulatory Commission,Washington, DC 20555-0001.

FINAL RULES

"Energy Compensation Sources for Well Loggingand Other Regulatory Clarifications," 65 FR20337, April 17, 2000.Contact: Mark Haisfield, 301-415-6196, e-mail:[email protected].

"List of Approved Spent Fuel Storage Casks: PSNAVSC-24 Revision," 65 FR 24623, April 27,2000.Contact: Richard Milstein, (301) 415-8149,e-mail: [email protected].

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"List of Approved Spent Fuel Storage Casks:TN-68 Addition," 65 FR 24855, April 28, 2000.Contact: Gordon Gundersen, 301-415-6195,e-mail, [email protected].

"List of Approved Spent Fuel Storage Casks:Holtec HI-STORM 100 Addition," 65 FR 25241,May 1, 2000.Contact: Merri Horn, 301-415-8126, [email protected].

"Revision of Fee Schedules; 100% Fee Recovery,FY 2000," 65 FR 36946, June 12, 2000.Contact: Glenda Jackson, 301-415-6057; e-mail:[email protected].

List of Approved Spent Fuel Storage Casks:Standardized NUHOMS-24P andNUHOMS-52B Revision, 65 FR 38715, June 22,2000.Contact: Stephanie P. Bush-Goddard, Ph.D.,301-415-6257, e-mail: spbinrc.gov.

List of Approved Spent Fuel Storage Casks:VSC-24 Revision, 65 FR 38718, June 22, 2000.Contact: Gordon Gundersen, 301-415-6195,e-mail: [email protected].

PROPOSED RULES

"Interim Storage for Greater Than Class CWaste," 65 FR 37712, June 16, 2000.Contacts: Mark Haisfield, 301-415-6196, [email protected]; Philip Brochman, 301-415-8592,e-mail: [email protected].

List of Approved Spent Fuel Storage Casks:Standardized NUHOMS<Register> -24 andNUHOMS <Register> -52B Revision, June 22,2000.Contact: Stephanie P. Bush-Goddard, Ph.D.,301-415-6257, e-mail: [email protected].

List of Approved Spent Fuel Storage Casks:VSC-24 Revision, 65 FR 38795, June 22, 2000.Contact: Gordon Gundersen, 301-415-6195,e-mail: [email protected].

OTHER NOTICES

"Notice of Issuance and Availability ofNUREG-1617, Standard Review Plan forTransportation Packages for Spent Nuclear Fuel,"65 FR 20939, April 18, 2000.

"Notice of Issuance and Availability ofNUREG-1567, Standard Review Plan for SpentFuel Dry Storage Facilities," 65 FR 20839,April 18, 2000.

"Metabolic Solutions: Denial of Petition forRulemaking," 65 FR 21673, April 24, 2000.Contact: James Smith, 301-415-6459, e-mail:[email protected].

"Notice of availability and request for comments:Consolidated Guidance about Materials Licenses:Program-Specific Guidance about Licenses forSpecial Nuclear Material of Less Than CriticalMass (NUREG-1556, Vol.17)," 65 FR 24514,April 26, 2000.Contact: Carrie Brown, 301-415-8092, e-mail:[email protected].

"Standard Review Plan for the Review of aLicense Application for the Tank WasteRemediation System Privatization Project: Noticeof Availability," 65 FR 25004, April 28, 2000.Contact: Michael Tokar, 301-415-7251, e-mail:[email protected].

"Revision of the NRC Enforcement Policy," 65FR 25368, May 1, 2000.Contacts: Bill Borchardt, OE, 301-415-2741,e-mail: [email protected] Pedersen, OE, 301-415-2741, e-mail:[email protected].

"Notice of Termination of Section 274i Agreementwith Louisiana," 65 FR 25508, May 2, 2000.Contact: Kevin Hsueh, 301-415-2598, e-mail:[email protected].

"United Plant Guard Workers of America;Receipt of Petition for Rulemaking(PRM-76-1)," 65FR 30018, May 10, 2000.Contact: David L. Meyer, ADM, 301-415-7162or toll-free: 1-800-368-5642: or e-mail:[email protected].

"Memorandum of Understanding Between theFederal Bureau of Investigation and the NuclearRegulatory Commission," 65 FR 31197, May 16,2000.Contact: John Davidson, 301-415-8130, e-mail:[email protected].

"Notice of availability of NUREG/CR-6642,'Risk Analysis and Evaluation of RegulatoryOptions for Nuclear Byproduct MaterialSystems,"' 65 FR 31620, May 18, 2000.Contact: Torre Taylor, 301-415-7900, e-mail:[email protected].

"Notice of Availability of NUREG-1700,'Standard Review Plan for Evaluating NuclearPower Reactor License Termination Plans,' " 65FR 35675, June 5, 2000.

"State of Oklahoma: NRC Staff Assessment of aProposed Agreement Between the Nuclear

9

Regulatory Commission and the State ofOklahoma (Ist printing)," 65 FR 36169, June 7,2000.Contact: Patricia M. Larkins, 301-415-2309,e-mail: [email protected].

"Notice of availability of NUREG-1712, 'NuclearByproduct Material Risk Review: Results ofSurvey of NRC and Agreement State MaterialsLicensing and Inspection Personnel,' "June 8,2000.Contact: Ms. Torre Taylor, 301-415-7900,e-mail: [email protected].

"Nuclear Energy Institute; Receipt of Petition forRulemaking (PRM-72-5)," 65 FR 36647, June 9,2000.Contact: David L. Meyer, 301-415-7162 ortoll-free: 1-800-368-5642, e-mail:[email protected].

"Notice of Availability and Request for Commentson draft NUREG-1556, Volume 18, 'Con-solidated Guidance about Materials Licenses:Program-Specific Guidance about ServiceProvider Licenses,' " 65 FR 36846, June 12, 2000.Contact: Carrie Brown, 301-415-8092, e-mail:[email protected].

"Use of Screening Values to DemonstrateCompliance with the Final Rule on RadiologicalCriteria for License Termination," 65 FR 37186,June 13, 2000.Contact: Dr. Rateb (Boby) Abu-Eid,301-415-5811; fax: 301-415-5398; or e-mail:[email protected].

"Notice of Issuance and Availability ofNUREG/CR-6672, 'Reexamination of Spent FuelShipment Risk Estimates,' " 65 FR 37186, June13, 2000.

"NRC Staff Assessment of a Proposed AgreementBetween the Nuclear Regulatory Commission andthe State of Oklahoma (2nd printing)," 65 FR37437, June 14, 2000.Contact: Patricia M. Larkins, 301-415-2309,e-mail: pml(nrc.gov.

"NRC Staff Assessment of a Proposed AgreementBetween the Nuclear Regulatory Commission andthe State of Oklahoma (3rd printing)," 65 FR38607, June 21, 2000.Contact: Patricia M. Larkins, 301-415-2309,e-mail: pmltnrc.gov.

"NRC Staff Assessment of a Proposed AgreementBetween the Nuclear Regulatory Commission andthe State of Oklahoma (4th printing)," 65 FR

39966, June 28, 2000.Contact: Patricia M. Larkins, 301-415-2309,e-mail: [email protected].

Natural Resources Defense Council; Receipt ofPetition for Rulemaking, 65 FR 40548, June 30,2000.Contact: David L. Meyer, 301-415-7162 ortoll-free: 1-800-368-5642 or e-mail:[email protected].

"Governors' Designees Receiving AdvanceNotification of Transportation of Nuclear Waste,65 FR 40704, June 30, 2000.Contact: SpirosDroggitis,301-415-2367,e-mail: [email protected].

(General Contact: Paul Goldberg,301-415-7842, e-mail: [email protected])

SIGNIFICANT EVENTS

Event 1: Sodium Iodide RadiopharmaceuticalMisadministration at Hermann Hospital inHouston, Texas

Date and Place-August 4, 1999; HermannHospital; Houston, Texas.

Nature and Probable Consequences-On August 5,1999, the licensee Radiation Safety Officerprovided written notification to the TexasDepartment of Health, Bureau of RadiationControl (BRC) of a medical misadministrationinvolving the administration of iodine-131 (I-131)to the wrong patient. The licensee reported thattwo female out-patients (who both spoke Englishas a second language) were involved in the error,which occurred on the morning of August 4, 1999.Patient A (for whom the therapeutic dose ofI-131 was intended) was approximately 55 yearsold; Patient B (who inadvertently received theI-131 dose) was approximately 64 years old.Patient B had completed a scheduled bone densityscan and was still in the nuclear medicinedepartment. At that time, the technologistmisidentified her as the patient who was to receivea therapeutic dose of I-131. Patient B was thenadministered 1.01 gigabecquerels (27.3 milicuries)of 1-131 at approximately 10:40 a.m. (CDT) andwas sent home. Patient A was later observed tostill be in the waiting room needing to beadministered the I-131. At this time, the licenseerealized that the misadministration had occurred.Patient A was then administered the prescribeddose of I-131 and returned home.

At approximately 4:00 p.m (CDT) on August 4,1999, the Radiation Safety Officer, the Chief ofthe Nuclear Medicine Department and the

Nuclear Pharmacy Manager were dispatched toPatient B's home to discuss the misadministrationwith her and her husband. With the patient'sconsent, the Nuclear Medicine Physician initiatedthe administration of supersaturated potassiumiodide (1 milliliter three times per day) andfurosemide (lasix) at an initial dose of40 milligrams per day, to reduce the patient'sradiation exposure caused by the error. Theadministrations were completed at approxi-mately 5:20 p.m. (CDT). The misadministeredpatient received a radiation dose to thethyroid of approximately 22,000 centiGray (rad).This radiation dose left the patient with an 85percent chance of functional loss of her thyroid,and replacement thryroid hormone will berequired indefinitely.

Actions Take to Prevent Recurrence

Licensee-The licensee changed its proceduresfor all outpatient therapeutic treatments thatinvolve radioactive material. The patientinformation sheet form was changed to askquestions like: "What is your name?" "Whatis your date of birth?" ....instead of havingquestions requiring "yes" or "no" answers. Thelicensee will also ask outpatients to show a pictureform of identification as a mean of properlyidentifying a person. For pediatric patients, theparent or guardian must confirm the identificationof the patient.

State Agency-BRC staff conducted aninvestigation and agreed with the licensee'sfindings and believes that the licensee's correctiveactions are adequate to prevent recurrence.

Event 2: High Dose-Rate Remote AfterloaderMisadministration at Queen's Medical Center inHonolulu, Hawaii.

Date and Place-October 27, 1999; Queen'sMedical Center; Honolulu, Hawaii.

Nature and Probable Consequences-OnOctober 28, 1999, a medical physicist representingthe licensee reported a medicalmisadministration, which occurred on the daybefore, involving a single fractional treatment.The treatment was performed using a Nucletronhigh-dose-rate (HDR) remote afterloading deviceloaded with an iridium-192 source ofapproximately 252 gigabecquerel (6.8 curies). Thelicensee categorized the treatment as amisadministration because the patient received anunintended dose of 380 centiGray (rad) to theright nasal cavity. This treatment was the first offour scheduled fractions intended to deliver a total

dose of 1520 centiGray (rad) to a specifiedlocation in the nasopharynx.

Initial simulation radiographs taken to determinethe appropriate dwell positions indicated astandard distal dwell position of 995 millimeters(mm) was appropriate. After patient setup andinsertion of the treatment catheter, a positionsimulator tool was used to verify the distal dwellposition of the catheter. The position simulator, asused by a staff dosimetrist, indicated a distal dwellposition of 950 mm and a repeat measurementgave the same value. During both measurements,the dosimetrist felt resistance when moving theslide pointer on the tool. Although the measureddistal dwell position was different from thatexpected, the measured 950-mm value wasbelieved to be correct because the dosimetrist wasable to reproduce the measurement. In addition,because catheters were sometimes customized atthe facility, by cutting them to shorter lengthswhen needed, the staff did not initially questionthe measured distance. None of the dwell positionmeasurements was independently checked byother members of the radiation oncology staff.Treatment was subsequently initiated.

The following day, a different dosimetristreviewed the case before delivering the secondtreatment fraction. Noting the recorded 950-mmdistal dwell position as somewhat unusual, in thatit was shorter than expected, he performed furtherchecks. Using the position simulator toll, thedosimetrist noticed the measuring cable wasdifficult to move past the 950-mm position.However, the dosimetrist was able to extend theposition simulator cable to the expected 955-mmposition. As a further check, the dosimetrist setthe position simulator to the 950-mm position andtook new radiographic films of the patient'snasopharynx, which showed the distal dwelldummy source displaced 45 mm from the positionintended. The dosimetrist performed a finalverification of the actual distal dwell positionusing the Nucletron "Special Mode" and dummysource wire. (With this selection, a dummy sourcewire is run through the catheter, using theNucletron unit, and the source travel is measuredautomatically.) When this mode of operation wasused, the measured distal dwell position was againdetermined to be 995 mm.

Actions Taken To Prevent Recurrence

Licensee-To prevent similar problems thelicensee initiated the following corrective actions:(1) the storage cabinet for HDR catheters waslabeled to specify the distal dwell positionassociated with each transfer tube, to remind theoperator to enter the correct value; (2) a new,

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replacement position simulator, previouslyordered by the licensee, was received and placedinto operation; and (3) there was a requirementfor a second member of the physics staff todouble-check the measurement process and datainvolving any use of a position simulator. Aworksheet used during the physics checks hasbeen modified to document the presence ofboth individuals.

NRC-U.S. Nuclear Regulatory Commission(NRC) staff from the Region IV office conductedan inspection to review the circumstancesassociated with the misadministration. This case isstill under review by an NRC medical consultant.

Event 3: Gamma Stereotactic Radiosurgery(Gamma Knife) Misadministration at HealthsouthDoctor's Hospital, Inc., Coral Gables, Florida.

Nature and Probable Consequences-The FloridaBureau of Radiation control (BRC) reported tothe U.S. Nuclear Regulatory Commission (NRC)Headquarters Operations Center that a medicalmisadministration had occurred at the licensee'sfacility on January 25, 2000. A patient diagnosedwith metastatic lung disease with up to 80 brainlesions identified was being treated with astereotactic radiosurgery procedure using theLeksell Gamma System, Model 23016 (gammaknife). The patient was receiving her fourth of fivetreatments when the misadministration occurred.Each treatment consisted of 16 lesions forirradiation. A treatment plan was developed todeliver to each lesion a minimum peripheral doseof 12 Gray (1200 rad). The misadministrationoccurred when the patient received a 12-Gray(1200-rad) peripheral dose to lesion site 16 (MRIz coordinates 70.7 mm) instead of lesion site 47(MRI z coordinates 85.0 mm). Site 16 waspreviously treated on December 28, 1999, with thesame dose. Lesion site 16 was located 6-mmsuperior, from site 47 in the z plane. The MRIslices are 3-mm slices in the z direction. The MRIslice at z coordinate 67.9 did not resolve the lesionat site 47. The radiation safety officer (RSO)indicated that the incorrect MRI was displayed onthe computer screen (z-70.7 mm instead of 65.0mm) and the treatment plan was calculated at thisincorrect coordinate. The RSO discovered thiserror on January 28, 2000, during the licensee'sroutine quality assurance review of the treatment,and reported it to the BRC that same date. TheBRC conducted an on-site investigation onFebruary 2, 2000, which included a review of thetreatment plans, the written directive, physician-approval procedures, and a reenactment of atreatment plan for the remaining untreated sites.The event was determined to be caused by human

error when the wrong treatment site was selectedin the computer. There was no malfunction of thegamma knife or computer equipment.

Actions Taken to Prevent RecurrenceI I .

Licensee-The licensee did not identify anycorrective actions nor changes in qualitymanagement procedures, that would haveprevented this type of human error. The licenseewill pay closer attention to detail.

StateAgency-State investigation found noviolations of the license nor regulations. Thelicensee's quality assurance program found theerror. The licensee had the wrong site set in thecomputer when the procedure was performed.The State did not identify any corrective actions orchanges that would have prevented this event.

NRC-The Office of Nuclear Material Safety andSafeguards is in the process of developing anInformation Notice to address gamma knifemisadministrations caused by human error.

Event 4: Significant extremity overexposure ofradiation workers at Mallinckrodt Medical, Inc.,in Maryland Heights, Missouri.

Date and Place-March 31, 2000; MallinckrodtMedical, Inc.; Maryland Heights, Missouri.

Nature and Probable Consequences-Thelicensee-a radiopharmaceutical manufacturingfacility-notified the U.S. Nuclear RegulatoryCommission (NRC) of an event involving anemployee directly handling an unshieldedmolybdenum-99 (Mo-99) technetium-99generator column. The column contained 700gigabecquerels (19 curies) (Mo-99) and 300gigabecquerels (8 curies) of technetium-99m(Tc-99m). Event reenactments determined thatthe individual may have held the column using histhumb and index finger of his left hand for as longas 50 seconds while attempting to correctalignment problems with the inlet and outletneedles. The individual wore a ring badge on theright hand to measure extremity dose, and thismonitor read 0.057 sieverts (5.7 rems).Calculations indicated that the dose to theindividual's thumb and index finger of the lefthand may be as much as 25-gray (2500-rad)shallow dose equivalent.

The licensee's investigation into the eventidentified two additional exposure situationsinvolving 13 other individuals in other areas ofthe facility.

One situation involved the hand-labeling ofproduct vials that contained approximately 740

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megabecquerels (20 millicuries) or iridium-111, anaccelerator-produced radioactive material. Tenindividuals, over the period between 1995 and1999, inclusive, held the product vials in their lefthands, with the index fingers on the tops of thevials and their thumbs on the bottoms, in closeproximity to the radioactive material, and appliedthe labels with their right hands. The individualsall wore their extremity monitors on their righthands. Licensee calculations determined that theindividuals involved in this practice receivedbetween 0.5- and 6-sievert (50- and 600-rem)shallow dose equivalents during calendar years1995 through 1999. Several individuals receivedexposures in excess of 0.5 sievert (50 rems) inmultiple years.

The other situation involved three additionalindividuals who worked in one of the licensee'sproduct testing-laboratory. While performing theirduties in this laboratory, the individuals removedaliquots of radioactive material for testing fromproduct vials, using unshielded syringes, and insome instances, while holding the unshielded vialsin their hands. These individuals received between0.7- and 1.0-sievert (70- and 100-rem) shallowdose equivalents to their hands and fingers duringcalendar years 1997 and 1999. Again, some of theindividuals received exposures in excess of 0.5sievert (50 rems) in more than 1 year.

The licensee believed that the exposures recordedby the extremity monitors were the "doses ofrecord," and did not recognize the significantdifference between the recorded dose and theactual dose to the finger tips when handlingunshielded vials and syringes of radioactivematerial. This contributed to the licensee notbeing fully aware of the extent of inadequateradiation-handling practices. The extremitymonitor results for the individuals involved inthese last two situations did not provide anyindications that they were receiving doses inexcess of NRC regulatory limits.

Actions Taken to Prevent Recurrence

Licensee-Corrective actions include proceduremodification and conducting training sessions withemployees to review all applicable procedures.The licensee hired a contractor to perform aHazard/Barrier-Risk Assessment to ensure thatthe true root causes of this event are identified.

NRC-On July 18, 2000, NRC issued informationNotice 00-10, "Recent Events Resulting inExtremity Exposures Exceeding RegulatoryLimits." (This Information Notice alertedlicensees to recent events that resulted in

personnel receiving occupational extremity dosesin excess of the 0.5-sievert (50-rem) shallow doseequivalent limits specified in 10 CFR20.1201(a)(2)(ii).

Event 5: Gamma Stereotactic Radiosurgery(Gamma Knife) Misadministration at Universityof Maryland at Baltimore Hospital,Baltimore, Maryland.

Date and Place-April 20, 2000; University ofMaryland at Baltimore Hospital,Baltimore, Maryland.

Nature and Probable Consequences-The licenseereported a medical misadministration involving a52-year-old female patient who was scheduled toreceive gamma knife therapy to the 50 percentisodese line, for treatment of Pituitary Adenoma.The patient received 1260 centiGray (rad) to anunintended site, with a volume of approximately0.18 cubic centimeter (cm) at the base of thefrontal lobe. The unintended site wasapproximately 4.2 centimeters (cm) from theintended site. The Leksell Gamma System gammaknife (model 23016) uses 201 sealed Co-60sources of 1.1 Tbq (30 Ci) each for the radiationtreatment of human patients. The medicaldirective for this treatment was defined as 1800cGy (rad) administered over six administrations.The misadministration occurred during the firstadministration. The unintended site would havereceived approximately 160 cGy (rad) during thefirst fraction, had the first fraction been completedas prescribed. The treatment planning for thepatient was uneventful and was prepared andreviewed by a hospital gamma knife team of aradiation oncologist, a neurosurgeon, and amedical physicist. It appears from preliminaryinterviews that when two of the team memberswere adjusting the coordinates on the device'sstereotactic frame, the Y and Z coordinates werereversed. The frame adjustment is supposed to bechecked for accuracy by a nurse and the medicalphysicist. Normally, the coordinates are read outin a specific order. The licensee indicated that theorder might have been reversed because of a.specific frame orientation problem that occursapproximately once in every 20 treatments. Whenthe licenses started to set up for the secondadministration, the error was noted. Thetreatment plan was reevaluated to include somepartial dose to the tumor from the firstadministration, and the treatment was completedin seven administrations instead of six. Thepatient and the referring physician were notifiedof this misadministration on the same day theevent occurred. The licensee is reviewing previousmedical files to ensure that the s vitching ofcoordinates has not occurred before without a

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misadministration being identified. The rootcause of this event appears to be human errorsduring the setting and verification ofpatient-positioning parameters.

Actions Taken to Prevent Recurrence

Licensee-The licensee has developed andimplemented an additional procedure thatrequires more attention and better confirmationof coordinate placement on the frame.

State Agency-The additional proceduredeveloped by the licensee is under review by theMaryland Radiological Health Program (RHP).This event is still under investigation by RHP.

NRC-The Office of Nuclear Material Safety andSafeguards is in the process of developing anInformation Notice to address gamma knifemisadministrations caused by human error.

Event 6: Gamma Stereotactic Radiosurgery(Gamma Knife) Misadministration at HealthsouthMedical Center, Birmingham, Alabama

Date and Place-April 12, 2000; HealthsouthMedical Center; Birmingham, Alabama.

Nature and Probable Consequences-The licenseereported a misadministration where the gammaknife was set up incorrectly and delivered the doseto the wrong location of a patient's brain. Aradiosurgery treatment was to be delivered to theLeft Trigeminal Nerve of a 51-year-old woman,using the Leksell Gamma System (model 23016)gamma stereotactic radiosurgical unit (gammaknife) containing 243.9 Tbq (6592.8 Ci) (activity of8/1/95) of Co-60. On the same date, a 75-year-oldman was admitted for the identical treatment.During the signature phase of plan approval, thedose-delivery sheet of the 75-year-old man'streatment protocol was inadvertently transposedwith that of the 51-year-old woman's treatmentprotocol. As a result, the 51-year-old woman wastreated with the radiosurgery parameters intendedfor the 75-year- old man. This resulted in an8000-cGy (rad) dose to the wrong treatment siteof the patient's Left Trigeminal Nerve. The

intended prescription dose to the treatment sitewas 8000 cGy (rad) at the 50 percent isodese line.The actual dose delivered to the intendedtreatment site was 20 cGy (rad) (maximum) ascalculated by the licensee. A dose of 8000 cGy(rad) was delivered to a volume 88.6-cubicmillimeter volume inside the skull of the woman,but outside of the intended treatment site. Themisadministration was noted immediately afterthe delivery of the dose. The patient was notifiedverbally, within 24 hours. On April 20, 2000, thepatient returned to the medical center andreceived treatment to the intended treatment site.

Actions Taken to Prevent Recurrence

Licensee-As a result of the misadministration,the licensee took immediate action to prevent themixing of patient treatment protocoldocumentation. Each page of the treatmentprotocol was modified to contain a unique nameand time stamp, which will be reviewed by theRadiation Oncologist or Medical physicist asevidenced by initialing each page of the protocolnear this stamp), before the delivery of theradiosurgery treatment.

State Agency-the State staff conducted aninvestigation and agreed with the licensee'sfindings and believes that the licensee's proposalis adequate to prevent recurrence.

NRC-NMSS is in the process of developing aninformation Notice to address gamma knifemisadministrations caused by human error.

(Contact: Roberto Torres, 301-415-8112; e-mail:[email protected].

CORRECTION

In the March-April issue of the NMSS LicenseeNewsletter (No. 00-01), the article entitled"New Source Calibration and Dosimetry forPalladium-103 and Interstitial Sources," containederrors in the conversion of gray units (Gy) to radunits. The correct figures are: 115 Gy (11,5000rad); 124 Gy (12,4000 rad); and 135 Gy(13,500 rad).

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