Information Notice 1994-17, Strontium-90 Eye Applicators: Submission of Quality Management Plan (QMP), Calibration, and Use

Strontium-90 Eye Applicators: Submission of Quality Management Plan (QMP), Calibration, and Use

ML031060614
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	03/11/1994
Revision:	0
From:	Paperiello C J NRC/NMSS/IMNS
To:
References
IN-94-017, NUDOCS 9403080349
Download: ML031060614 (7)

UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555March 11, 1994-NRC INFORMATION NOTICE 94-17: STRONTIUM-90 EYE APPLICATORS:SUBMISSION OF QUALITY MANAGEMENTPLAN (QMP), CALIBRATION, AND USE

Addressees

All U.S. Nuclear Regulatory Commission Medical Use Licensees.

Purpose

The NRC is issuing this Information Notice to remind licensees authorized topossess Sr-90 for authorized uses described in 10 CFR 35.400(e) of the needto: (1) implement and submit a quality management plan (QMP) that includespolicies and procedures to meet the requirements described in 10 CFR 35.32;and (2) inform all licensees of recent information regarding the use andcalibration of Sr-90 eye applicators.

Description of Circumstances

There has been confusion as to the need for a QMP for Sr-90 eye applicatorsused for patient treatment procedures. The NRC's Office of the GeneralCounsel advised the technical staff that because the QM program requirementsin 10 CFR 35.32 apply to many brachytherapy dose," the use of Sr-90 eyeapplicators, as described in 10 CFR 35.400(e), requires submission of a QMP.This Information Notice reminds Sr-90 eye applicator licensees of therequirement to submit and implement a QMP that meets the requirements of 10CFR 35.32.Additionally, this letter alerts licensees to possible discrepanciesassociated with the calibration of Sr-90 eye applicators and reminds licenseesof the regulatory requirements associated with their calibration and use.Discussion-Submissi0n of a Oualitv Management PlanIf you are licensed forAand using a Sr-90 eye applicator, the NRC'sregulations require you to submit a QMP that meets the requirements of 10 CFR35.32. The QMP should provide high confidence that radiation from the Sr-90eye applicator will be administered as directed by the authorized user. Thesubmitted QMP should include written policies and procedures that meet thefive objectives, as described in 10 CFR 35.32(a):P 943 E 08034 9q031,,,9403080349 .11 : ' O,,.%l >XV1 I -M0

.-- A IN 94-17March 11, 1994 . That prior to administration, a written directive, signed and datedby an authorized user, is prepared for each applicableadministration.(A written directive for Sr-90 eye-applicators means an order, inwriting, for a specific patient, dated and signed by an authorizeduser prior to administration of radiation. It must include theradioisotope, the treatment site, source strength (corrected fordecay), and exposure time (or equivalently, the total dose).2. That prior to each administration, the patient is identified by morethan one method as the individual named in the written directive.3. That final plans of treatment and related calculations are inaccordance with the respective written directive.4. That each administration is in accordance with the writtendirective.5. That any unintended deviation from the written directive isidentified and evaluated, and appropriate action taken.Additionally, to meet the requirements of 10 CFR 35.32(b), you need policiesand procedures for conducting a review of the QMP to verify compliance of allaspects of the program at intervals no greater than 12 months. The review isto include a representative sample of patient administrations, all recordableevents and all misadministrations, and any corrective actions taken.Licensees may make modifications to their QMPs to increase the program'sefficiency provided the program's effectiveness is not decreased.10 CFR 35.32(e) requires licensees to submit modifications to their QMP to theappropriate NRC regional office within 30 days after the modification has beenmade.If you are licensed for a Sr-90 eye applicator, but are not, or do not intendto use it, you may submit a "negative declaration' in lieu of a QMP. Thiswritten declaration must commit to your submission of a QMP to NRC prior touse of the Sr-90 eye applicator for patient treatment procedure IN 94-17March 11, 1994 Calibration and Use of Strontium-90 Eve aDplicatorsThe NRC staff has had discussions with and received correspondence fromresearchers at the National Institute of Standards and Technology (NIST) aboutlarge discrepancies among calibrated outputs assigned to Sr-90 eyeapplicators. The manufacturer's original calibrations may have been in unitsthat are no longer used or have little relationship to System Internationaleunits in use today. Further, comparisons between units from differentmanufacturers may be meaningless and misleading. Finally, discrepancieslarger than 10 percent still exist when comparing output measurements betweencompetent measurement labs using state-of-the-art techniques.The above information was provided to NRC's Advisory Committee on Medical Usesof Isotopes (ACMUI) at its November 1 and 2, 1993, meeting. The ACMUI membersadvised the staff that calibration was not a critical factor in the use ofSr-90 eye applicators for treating pterygium because licensees treat forresponse rather than to tolerance. The ACHUI recommended that NRC informlicensees of the potential problems associated with calibration of Sr-90 eyeapplicators. The Committee also recommended cautioning licensees that if theyuse an applicator, other than the one currently in their possession or buy anew one, their current technique may not be applicable to another devicebecause of variances in stated and actual exposure rates for the differentiapplicators.NIST offers a service for the calibration of Sr-90 eye applicators thatprovides: (1) the calculation of the emission rate, and (2) a mapping of theSr-90 distribution across the face of the applicator in order to ascertainuniformity of dose. For further information on the NIST calibration service,contact either Dr. Christopher Soares at (301) 975-5589 or Dr. Bert Coursey at(301) 975-5584. Although NIST is, to the best of the staff's knowledge, theonly provider of such a service, there may be others. NRC is not requiringthat licensees participate in the NIST program, and accepts calculations ofexposure time based on the original vendor's calibration, corrected forradioactive decay.Since 10 CFR 35.400(e) identifies the Sr-90 eye applicator as a brachytherapydevice, licensees are reminded that 10 CFR 35.59, Requirements for possessionof sealed sources and brachytherapy sources," does apply to Sr-90 eyeapplicators. Specifically, licensees must perform applicable leak tests andsurveys 4escrlbed in 10 CFR 35.59. Additionally, 10 CFR 35.400(e) limits theuse of S"90-veye applicators to "treatment of superficial eye conditions."LicenseebAtL6'reminded that NRC authorization for use of a Sr-90 eyeapplicator'for'pattent procedures does not authorize its use on treatmentsites other than the ey V. IN 94-17March 11, 1994 This Information Notice requires no specific action or written response. Ifyou have questions about the information in this notice, please contact theappropriate-technical contact listed below.Carl J. Paperiello, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand SafeguardsTechnical contacts:Jim Dwyer, RI(215) 337-5309Jacqueline Burks, RIV(817) 860-8132John Pelchat, RII(404) 331-5083Cassandra Frazier, RIII(708) 790-5704James(510)Sally(301)Montgomery, RV975-0249L. Merchant, NMSS504-2637

Attachments:

1. List of Recently2. List of RecentlyIssued NMSS Information NoticesIssued NRC Information Notices* See previous concurrenceOI l IMAB l IAB 'IMAB TechEd* IMOB* IMOB lNAME SMerchantt2j AMCiamper JEGlenn EKraus KRamsey FCombsDATE l 02/24/94C 1 2 Z -24/94 12/29L93 0113/94 02/20/9OiFC- ZE iMN MINAME STreby WBrach CP aiejiello _DATE 02/04/94 02/07/94 03/0/940DOC NAME: 94-17.INOFFICIAL RECORD COPY

-S\fs._J Attachment 1IN 94-17March 11, 1994 LIST OF RECENTLY ISSUEDNMSS INFORMATION NOTICESUnformation Date ofNotice No. Subject Issuance Issued to94-1694-1594-0994-0793-10093-8093-77Recent Incidents Resultingin Offsite ContaminationRadiation Exposures duringan Event Involving a FixedNuclear GaugeRelease of Patients withResidual Radioactivityfrom Medical Treatment andControl of Areas due toPresence of Patients Con-taining RadioactivityFollowing Implementationof Revised 10 CFR Part 20Solubility Criteria forLiquid Effluent Releasesto Sanitary Sewerage underthe Revised 10 CFR Part 20Reporting Requirementsfor BankruptcyImplimentation of thedRevised-10 COR Part 2027i a'h rsrt-that Resultin InadVertent Transfersof Special Nuclear Materialat Fuel Cycle Facilities03/03/9403/02/9402/03/9401/28/9412/22/9310/08/9310/04/93All U.S. Nuclear RegulatoryCommission material and fuelcycle licensees.All U.S. Nuclear RegulatoryCommission licensees author-ized to possess, use, manu-facture, or distributeindustrial nuclear gauges.All U.S. Nuclear RegulatoryCommission medicallicensees.All byproduct material andfuel cycle licensees withthe exception of licenseesauthorized solely forsealed sources.All U.S. Nuclear RegulatoryCommission licensees.All byproduct, source, andspecial nuclear materiallicensees.All nuclear fuel cyclelicensee K- I..JAttachment 2IN 94-17March 11, 1994 _'LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to94-1694-1594-14Recent Incidents Resultingin Offsite ContaminationRadiation Exposures duringan Event Involving a FixedNuclear GaugeFailure to ImplementRequirements for BiennialMedical Examinations andNotification to the NRCof Changes in LicensedOperator Medical ConditionsIntersystem LOCAOutside Containment03/03/9403/02/9402/24/9402/22/94All U.S. Nuclear RegulatoryCommission material and fuelcycle licensees.All U.S. Nuclear RegulatoryCommission licensees author-ized to possess, use, manu-facture, or distributeindustrial nuclear gauges.All holders of OLs qr CPsfor nuclear power and non-power reactors and lllicensed reactor operatorsand senior reactoroperators.All holders of OLs or CPsfor nuclear power reactors.92-36,Supp. 194-1394-1294-11Unanticipated and Un-intended Movement ofFuel Assemblies andOther Components due toImproper Operation ofRefueling EquipmentInsights Gained fromResolving Generic4Ijsue.57; Effects ofi~jNmrotecton System--~n. 6n Safety-t 4 tqp entTurbine Overspeed andReactor Cooldown duringShutdown Evolution* 02/22/9402/09/9402/08/94All holders of OLs or CPsfor nuclear power reactors.All holders of OLs or CPsfor nuclear power reactors.All holders of OLs or CPsfor nuclear power reactors.OL -Operating LicenseCP -Construction Permit K../VIN 94-17March 11, 1994 This Information Notice requires no specific action or written response. Ifyou have questions about the information in this notice, please contact theappropriate'technical contact listed below.Carl J. Paperiello, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand SafeguardsTechnical contacts:Jim Dwyer, RI(215) 337-5309John Pelchat, RII(404) 331-5083Cassandra Frazier, RIII(708) 790-5704Jacqueline Burks, RIV(817) 860-8132James Montgomery, RV(510) 975-0249Sally(301)L. Merchant, NMSS504-2637

Attachments:

1. List of Recently Issued NMSS Information Notices2. List of Recently Issued NRC Information Notices63j1 b