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NMSS Licensee Newsletter NMSS Licensee Newsletter U.S. Nuclear Office of Nuclear NUREG/BR-0117 Regulatory Material Safety No. 04-01 Commission and Safeguards March 2004 Contents Page possession (i.e., deuterium, tritium, curium, americium, neptunium, californium, berkelium, 1. Licensee Reporting for Nuclear Materials and enriched lithium). Management and Safeguards System, NRC Bulletin 2003-04....................................... 1 In October 2001, the DOE Office of the Inspector General (OIG) issued a report entitled, “Accounting 2. Medical Events Caused by Failure to for Government-Owned Nuclear Materials Provided Properly Measure the Radioactivity of to Non-Department Domestic Facilities.” Based on Samarium-153 Dosages ..................................... 2 information available from NMMSS, one of the findings in the report was that DOE “. could not 3. What’s New on the Medical Uses fully account for nuclear materials loaned or leased Licensee Toolkit Web Page ............................... 2 to domestic licensees.” As a result of the OIG findings, NRC believes that NMMSS balances 4. Significant Events ............................................. 2 should be confirmed and corrected as necessary, on the basis of a one-time reporting of licensee material 5. Significant Enforcement Actions ....................... 4 balances to NMMSS. 6. Generic Communications Issued To accomplish that goal, NRC is requesting, (September 29, 2003 - January 21, 2004) ........... 5 through a Bulletin, that licensees submit, to NMMSS, current material balance information for 7. Selected Federal Register Notices SNM and foreign obligated source material. (December 1, 2003 - February 29, 2004) ........... 6 Additionally, licensees will be requested to report material balance information for other Government- LICENSEE REPORTING FOR owned material types in their possession. The NUCLEAR MATERIALS MANAGEMENT Bulletin is available through the NRC public web AND SAFEGUARDS SYSTEM, page at: www.nrc.gov/reading-rm/doc-collections/ NRC BULLETIN 2003-04 gen-comm/bulletins/2003/bl03004.pdf. Once those values are submitted to NMMSS, the NMMSS staff Presently, the U.S. Nuclear Regulatory Commission will compare the reported information to the (NRC) requires certain NRC and Agreement State NMMSS book values and assist licensees in the licensees and certificate holders (hereafter referred resolution of any NMMSS book discrepancies. to as licensees) to submit data to the Nuclear Discrepancies that cannot be readily resolved may Materials Management and Safeguards System be referred to NRC for further action. However, it (NMMSS) about their receipts, shipments, is not the intent of this effort to cite licensees for inventories, and changes in inventory of special past reporting errors unless those errors demonstrate nuclear material (SNM). Additionally, reporting is a deliberate act of non-compliance with regulations required for source material pursuant to meeting and/or negatively impacted the licensees’ safety or international treaty commitments (hereafter referred safeguards controls. to as foreign obligated source material). The U.S. Department of Energy (DOE) has additional All licensees, including those licensed pursuant to reporting requirements associated with other 10 CFR Part 30, should review the Bulletin to material types owned by the Government in licensee determine if it is applicable to their operations. Licensees may communicate directly with the Calibrators for Beta- and Low-Energy Photon- NMMSS contractor or forward their questions to Emitting Radionuclides.” The IN described the NRC via e-mail to [email protected]. circumstances of medical misadministrations that occurred as a result of inaccurate radioactivity (Contact: Larry Harris, NSIR, 301-415-5072, measurement of samarium-153 dosages and some of e-mail: [email protected]) the potential sources of errors in measurement of beta- and low-energy gamma emitters. Based on the MEDICAL EVENTS CAUSED BY recent medical events described above, licensees are FAILURE TO PROPERLY MEASURE encouraged to review the IN and to verify that the THE RADIOACTIVITY OF SAMARIUM- radioactivities of beta- and low-energy gamma- 153 DOSAGES emitting dosages are properly measured. This IN can be found on NRC’s website at http:// Seven medical events were reported to the U.S. www.nrc.gov/reading-rm/doc-collections/gen- Nuclear Regulatory Commission (NRC), between comm/info-notices/2002/in02019.pdf. November 2003 and January 2004, each involving licensee failure to properly measure the radioactivity (Contact: Robert G. Gattone, RIII/DNMS, of samarium-153 dosages with dose calibrators. 630-829-9823, e-mail: [email protected]) One medical event occurred when both a nuclear WHAT’S NEW ON THE MEDICAL USES pharmacy and a medical licensee failed to properly LICENSEE TOOLKIT WEB PAGE measure the radioactivity of a samarium-153 unit dosage. During initial measurement of the dosage Nuclear Material Safety and Safeguards staff radioactivity, the nuclear pharmacy erroneously recently revised the “Medical Uses Licensee multiplied the dose-calibrator displayed Toolkit: Regulations” section to add a link to the radioactivity by a “10 factor.” However, the dose proposed rule “Recognition of Specialty Boards.” calibrator was set to display the actual radioactivity. Although the public comment period has closed, this Therefore, the nuclear pharmacy labeled the dosage link can be used to review the draft proposed rule vial to indicate 10 times the actual radioactivity and the public comments. The “Medical Uses before transfer to a medical licensee. When the Licensee Toolkit: Other Guidance” section was medical licensee measured the dosage, it noted that revised to add licensing guidance for the Nucletron the radioactivity displayed on its dose calibrator was seedSelectron® System, Isotron brachytherapy approximately one-tenth of that on the vial label and sources, and Nucletron FIRST™ System, the newest the prescribed radioactivity on the written directive. 10 CFR 35.1000 medical use. The licensing The medical licensee contacted the nuclear guidance for the TheraSphere and SIRSphere pharmacy to discuss the discrepancy between the Yttrium-90 Microspheres was revised to clarify use radioactivity measured with its dose calibrator and of the medical end-point of stasis in the written that indicated on the label. The nuclear pharmacy directive as a means of specifying when to terminate informed the technologist that a “10 factor” had to implantation of the microspheres. Also the “Notes be applied to the radioactivity measured by the dose to Licensee” section in the licensing guidance for calibrator to obtain the actual radioactivity. The each 10 CFR 35.1000 medical use was revised medical licensee applied the factor provided by the to inform licensees that they can apply for nuclear pharmacy and erroneously determined that amendments that would permit them to make the dosage contained the prescribed radioactivity, changes to their radiation safety programs, to before administering it to a patient. As a result, the conform with future revisions in the licensing patient received approximately one-tenth of the guidance. These changes were made to inform prescribed samarium-153 radioactivity. licensees of current rulemaking activities or provide them with greater flexibility. Six other medical events occurred because a medical licensee used an incorrect dose calibrator (Contact: Donna-Beth Howe, 301-415-7848, potentiometer setting during measurement of the e-mail: [email protected]) radioactivity in samarium-153 dosages. As a result, the administered radioactivities were approximately SIGNIFICANT EVENTS 30 percent less than prescribed. Event 1: Dose to Fetus On June 12, 2002, NRC issued Information Notice (IN) 2002-19, “Medical Misadministrations caused Date and Place: November 20, 2003; by Failure to Properly Perform Tests on Dose Hillcrest Hospital, Mayfield Heights, Ohio 2 Nature and Probable Causes: The Ohio Bureau of NRC appointed an Augmented Inspection Team to Radiation Protection reported that a 19-year-old inspect the circumstances surrounding the UF6 leak. female patient was administered 5.18 gigabecquerel The cause of this event was the assistant fluorine (140.1 millicurie) of Iodine-131 for thyroid operator’s failure to configure valves correctly, carcinoma as prescribed. The patient did not which caused a section of the piping to pressurize believe that she was pregnant and completed the and leak. Contributing factors included the operator required forms indicating that she was not pregnant not having a procedure or checklist to designate the before the dose was administered. On December 5, proper valve positions, no oversight nor review to December 8, and December 11, 2003, quantitative ensure correct valve position, and the infrequent tests confirmed that the patient was pregnant. The nature of this task. results were provided to her endocrinologist, who recommended that a fetal dose calculation be Actions Taken to Prevent Recurrence performed. The licensee’s consultant informed the endocrinologist that the fetus would have received a Licensee: Corrective actions were discussed at a whole body dose of 19.6 centigray (rad). The public meeting held in NRC Headquarters on endocrinologist sent the results to the Center for February 11, 2004. Human Genetics at the University Hospital in Cleveland, Ohio, where an assessment determined (Contact: Angela Williamson, NMSS, that the pregnancy could safely continue. 301-415-5030; e-mail: [email protected]) Actions Taken to Prevent
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