Press Release-I-01-006, NRC to Discuss Apparent Violation with Washington, D.C., Hospital: Difference between revisions

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{{#Wiki_filter:NRCNEWSU.S.NUCLEARREGULATORYCOMMISSIONOFFICEOFPUBLICAFFAIRS--REGIONI475AllendaleRoadKingofPrussia,PA19406No.I-01-006February14,2001CONTACT:DianeScrenci,(610)337-5330/e-mail:dps@nrc.govNeilA.Sheehan,(610)337-5331/e-mail:nas@nrc.govNRCTODISCUSSAPPARENTVIOLATIONWITHWASHINGTON,D.C.,HOSPITALNuclearRegulatoryCommissionstaffwillmeetwithrepresentativesofaWashington,D.C.,medicalfacilityonWednesday,February21,todiscussanapparentviolationofagencyrequirements involvingtheuseofNRC-licensedradioactivematerialforcancertreatments.SibleyMemorialHospitalofficialswilltakepartinthepredecisionalenforcementconferenceat10a.m.attheNRCRegionIoffice,475AllendaleRoad,KingofPrussia,Pa.Themeetingwillbe heldinthePublicMeetingRoomandbeopentothepublic.OnSeptember28and29,2000,theNRCconductedasafetyinspectionatSibleyMemorial,locatedat5255LoughboroRoad.Theinspectionwaslimitedtoareviewoftwomisadministrations involvingapairofpatientstreatedforeyetumorswithiodine-125implantslastSeptember.(The radioactivematerialisusedtokillcancercells.)TheNRChasdeterminedthat,duetoacalculationerror,twopatientsreceiveddosestotheirtumorshigherthantheplannedamountof7,000centiGray(cGy).Specifically,theerrorresultedin onepatientbeingadministeredadoseof11,470cGyandtheotherpatientadoseof10,866cGy.AmedicalconsultantcontractedbytheNRCtorevieweacheventhasconcludedthatwhiletheremaybeanincreasedriskofcomplicationsbecauseofthehigherdoselevels,theriskissmallcompared tovisionproblemssecondarytothetreatment.Theconsultantalsofoundthatbothpatientswere checkedbytheirreferringphysiciansfollowingthemisadministrationsandnospecificadverseeffects werenoted.Basedontheinspection,theNRChasidentifiedoneapparentviolation:Afailuretohavewrittenproceduresinplacepertainingtocalculationstoensurethatradioactivesourcesorderedfromvendors foruseduringtreatmentswerethecorrectstrength.ThedecisiontoholdapredecisionalenforcementconferencedoesnotmeanthattheNRChasdeterminedaviolationhasoccurredorthatenforcementactionwillbetaken.Rather,thepurposeisto discussapparentviolations,theircausesandsafetysignificance;toprovidethelicenseewithan 2opportunitytopointoutanyerrorsthatmayhavebeenmadeintheNRCinspectionreport;andtoenablethelicenseetooutlineitsproposedcorrectiveaction.Nodecisionontheapparentviolationswillbemadeatthisconference.ThatdecisionwillbemadebyNRCofficialsatalatertime.
{{#Wiki_filter:NRC NEWS U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF PUBLIC AFFAIRS -- REGION I 475 Allendale Road King of Prussia, PA 19406 No. I-01-006                                                                    February 14, 2001 CONTACT: Diane Screnci, (610) 337-5330/e-mail: dps@nrc.gov Neil A. Sheehan, (610) 337-5331/e-mail: nas@nrc.gov NRC TO DISCUSS APPARENT VIOLATION WITH WASHINGTON, D.C., HOSPITAL Nuclear Regulatory Commission staff will meet with representatives of a Washington, D.C.,
#}}
medical facility on Wednesday, February 21, to discuss an apparent violation of agency requirements involving the use of NRC-licensed radioactive material for cancer treatments.
Sibley Memorial Hospital officials will take part in the predecisional enforcement conference at 10 a.m. at the NRC Region I office, 475 Allendale Road, King of Prussia, Pa. The meeting will be held in the Public Meeting Room and be open to the public.
On September 28 and 29, 2000, the NRC conducted a safety inspection at Sibley Memorial, located at 5255 Loughboro Road. The inspection was limited to a review of two misadministrations involving a pair of patients treated for eye tumors with iodine-125 implants last September. (The radioactive material is used to kill cancer cells.)
The NRC has determined that, due to a calculation error, two patients received doses to their tumors higher than the planned amount of 7,000 centiGray (cGy). Specifically, the error resulted in one patient being administered a dose of 11,470 cGy and the other patient a dose of 10,866 cGy.
A medical consultant contracted by the NRC to review each event has concluded that while there may be an increased risk of complications because of the higher dose levels, the risk is small compared to vision problems secondary to the treatment. The consultant also found that both patients were checked by their referring physicians following the misadministrations and no specific adverse effects were noted.
Based on the inspection, the NRC has identified one apparent violation: A failure to have written procedures in place pertaining to calculations to ensure that radioactive sources ordered from vendors for use during treatments were the correct strength.
The decision to hold a predecisional enforcement conference does not mean that the NRC has determined a violation has occurred or that enforcement action will be taken. Rather, the purpose is to discuss apparent violations, their causes and safety significance; to provide the licensee with an
 
2 opportunity to point out any errors that may have been made in the NRC inspection report; and to enable the licensee to outline its proposed corrective action.
No decision on the apparent violations will be made at this conference. That decision will be made by NRC officials at a later time.
                                                    #}}

Latest revision as of 05:59, 24 November 2019

Press Release-I-01-006: NRC to Discuss Apparent Violation with Washington, D.C., Hospital
ML010540086
Person / Time
Issue date: 02/14/2001
From:
Office of Public Affairs Region I
To:
Category:Press Release
References
Press Release-I-01-006
Download: ML010540086 (2)
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Text

NRC NEWS U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF PUBLIC AFFAIRS -- REGION I 475 Allendale Road King of Prussia, PA 19406 No. I-01-006 February 14, 2001 CONTACT: Diane Screnci, (610) 337-5330/e-mail: dps@nrc.gov Neil A. Sheehan, (610) 337-5331/e-mail: nas@nrc.gov NRC TO DISCUSS APPARENT VIOLATION WITH WASHINGTON, D.C., HOSPITAL Nuclear Regulatory Commission staff will meet with representatives of a Washington, D.C.,

medical facility on Wednesday, February 21, to discuss an apparent violation of agency requirements involving the use of NRC-licensed radioactive material for cancer treatments.

Sibley Memorial Hospital officials will take part in the predecisional enforcement conference at 10 a.m. at the NRC Region I office, 475 Allendale Road, King of Prussia, Pa. The meeting will be held in the Public Meeting Room and be open to the public.

On September 28 and 29, 2000, the NRC conducted a safety inspection at Sibley Memorial, located at 5255 Loughboro Road. The inspection was limited to a review of two misadministrations involving a pair of patients treated for eye tumors with iodine-125 implants last September. (The radioactive material is used to kill cancer cells.)

The NRC has determined that, due to a calculation error, two patients received doses to their tumors higher than the planned amount of 7,000 centiGray (cGy). Specifically, the error resulted in one patient being administered a dose of 11,470 cGy and the other patient a dose of 10,866 cGy.

A medical consultant contracted by the NRC to review each event has concluded that while there may be an increased risk of complications because of the higher dose levels, the risk is small compared to vision problems secondary to the treatment. The consultant also found that both patients were checked by their referring physicians following the misadministrations and no specific adverse effects were noted.

Based on the inspection, the NRC has identified one apparent violation: A failure to have written procedures in place pertaining to calculations to ensure that radioactive sources ordered from vendors for use during treatments were the correct strength.

The decision to hold a predecisional enforcement conference does not mean that the NRC has determined a violation has occurred or that enforcement action will be taken. Rather, the purpose is to discuss apparent violations, their causes and safety significance; to provide the licensee with an

2 opportunity to point out any errors that may have been made in the NRC inspection report; and to enable the licensee to outline its proposed corrective action.

No decision on the apparent violations will be made at this conference. That decision will be made by NRC officials at a later time.

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