ML20086N683
| ML20086N683 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1995 |
| From: | NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | |
| References | |
| NUREG-0090, NUREG-0090-V18-N01, NUREG-90, NUREG-90-V18-N1, NUDOCS 9507250296 | |
| Download: ML20086N683 (25) | |
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NUREG-0090 Vol.18, No.1 Reaort ':0 tongress on m
A5ilormal Occurrences January - March 1995 U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data pn uc q o
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0090 R PDR
AVAILABILITY NOTICE Availabihty of Reference Materials Cited in NRC Publications Most documents cited in NRC pubhcations will be available from one of the following sources:
1 1
1.
The NRC Public Document Room, 2120 L Street, NW., Lower Level, Washington, DC 20555-0001 2,
The Superintendent of Documents, U.S. Government Printing Office, P. O. Box 37082, Washington, DC 20402-9328 3.
The National Technical Information Service Springfield, VA 22161-0002 l
Although the listing that follows represents the majority of documents cited in NRC publica-tions, it is not intended to be exhaustive.
Referenced documents available for inspection and copying for a fee from the NRC Public Document Room include NRC correspondence and internal NRC memoranda: NRC bulletins, circulars, information notices, inspection and investigation notices; licensee event reports; vendor reports and correspondence; Commission papers; and applicant and licensee docu-ments and correspondence.
i The following documents in the NUREG series are available for purchase from the Government i
Printing Office: formal NRC staff and contractor reports, NRC-sponsored conference pro-ceedings, international agreement reports, grantee reports, and NRC booklets and bro-chures. Also available are regulatory guides, NRC regulations in the Code of Federal Regula-l tions, and Nuclear Regulatory Commission Issuances.
1 Documents available from the National Technical Information Service include NUREG-series l
reports and technical reports prepared by other Federal agencies and reports prepared by the Atomic Energy Commission, forerunner agency to the Nuclear Reguistory Commission.
Documents available from public and special technical libraries include ell open literature f
items, such as books, journal articles, and transactions. Federal Register notices, Federal
)
and State legislation, and congressional reports can usually be obtained from these Ihreries.
Documents such as theses, dissertations, foreign reports and translations, and non-NRC con-ference proceedings are ava!!able for purchase from the organization sponsoring the publica-tion cited.
Single copies of NRC draft reports are available free, to the extent of supply, upon written request to the Office of Administration, Distribution and Mail Services Section, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Copies of industry codes and standards used in a substantive manner in the NRC regu'atory I
process are maintained at the NRC Library. Two White Flint North,11545 Rockville Pike Rock-ville, MD 20852-2738, for use by the public. Codes and standards are usually copyrighted and may be purchased from the originating organization or, if they are American National Standards, from the American National Standards Institute,1430 Broadway, New York, NY 10018-3308.
A year's subscription of this report consists of four overterly issues.
NUREG-0090 Vol.18, No.1 Report to Congress on Abnormal Occurrences January - March 1995 Date Published: July 1995 OITice for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Wasliington, DC 20555-0001
,><..as, l
Abnormal Occurrences,1st Otr CY95 Previous Reports in Series NUREG 75/090 (January-June 1975), published October 1975.
NUREG-0090-1 through 10(July-September 1975 through October-December 1977), published March 1976 through March 1978.
NUR EG-0090 Vols.1 through 16 (January-March 1978 through October-December 1993), published June 1978 through March 1994.
l NUREG-0090, Vol.17, No.1 (January-March 1994), published August 1994.
NUREG-0090, Vol.17, No. 2 (April-June 1994), published October 1994.
NUREG-0090 Vol.17, No. 3 (July-September 1994), published January 1995.
NUREG-0090, Vol.17, No. 4 (October-December 1994), published May 1995.
NUREG-0090, Vol.18. No.1 ii
l Abnormal Occurrences,1st Otr CY95 AUSTRACT Section 208 of the Energy Reorganization Act of during the period of January 1 through March 31, 1974 identifies an abnormal occurrence (AO) as 1995.
an unscheduled incident or event that the Nuclear Regulatory Commission determmes to be lhis report addresses one AO at an significant from the standpoint of public health or NRC-licensed facility which involved a medical safety and requires a quarterly report of such brachytherapy misadministration. The report also contains updates of one AO previously reported occurrences to be made to Congress. This report by an NRC licensee and three AOs previously provides a description of those incidents and reported by the Agreement States. No "Other events that have been determined to be AOs Events of Interest" items are being reported.
iii NUREG-0090, Vol.18, No.1 l
l 1
Abnormal Occurrences,1st Qtr CY95 CONTENTS Page Abst ract................
iii Preface......
vii Introduction......
vii Th e Reg ula t o ry Sys t e m.............................................................. vii Reportable Occ u rrences............................................................ viii A g r eeme n t S t at es.................................................................. viii Foreign Information
....................... viii Reopening of Closed Abnormal Occurrences ix Report to Congress on Abnormal Occurrences. January-March 1995...........................
1 Nuclear Power Plants..................
1 Fuel Cycle Facilities (Other thar Nuclear Power Plants)..................................
1 Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)....
1 95-1 Medical Brachytherapy Misadministration at Welborn Memorial Hosptalin Evansville, I n d i an a..........................................................
1 Agreement State Licensees.......................
2 References...........
3 Appendix A - Abnormal Occurrence Criteria.................................................
5 Appendix B - Update of Previously Reported Abnormal Occurrences...........................
9 Other NRC Licensees..........
9 92-18 Loss of Iridium-192 Source and Medical Therapy Misadministration at Oncology Services Corporation in Indiana, Pennsylvania..............
9 l
Agreement State Licensees...........
10 l
AS 88-5 Medical Teletherapy Misadministration at Sacred Heart Hospital in Cumberland. Maryland..........
10 l
AS 88-6 Multiple Medical Therapy Misadministrations at Sacred Heart Hospital in Cumberland, Maryland 10 AS 93-9 Medical Teletherapy Misadministration by " Unspecified Licensee"in New York, New York 10 Appendix C - Other Events of Interest.
13 References for Appendices.....
14 y
NUREG-0090. Vol.18. No.1 L
Abnormal Occurrences,-1st Qtr CY95 -
PREFACE Introduction description of its nature and probable consequences.
The Nuclear Regulatory Commission (NRC)
NRC has determined that, of the incidents and reports to Congress each quarter, under events reviewed for this reporting period, only provisions of Section 208 of the Energy those that are described in this report meet the Reorganization Act of 1974, any abnormal criteria for reporting as AOs. This report covers occurrences (AOs) involving facilities and the period from January 1 through March 31.
'T'
~ Section 208 as an unscheduled incident or event activities regulated by NRC. An AO is defined in 1995. Information reported on each AO includes date and place, nature and probable that the Commission determines to be significant consequences, cause or causes, and actions taken from the standpoint of public health or safety.
to prevent recurrence.
NRC identifies an AO for the purpose of this Appendix B contains updated information on report using the criteria in Appendix A. The previously reported AOs.
criteria were initially promulgated in an NRC pohey statement that was published in the Federal Appendix C contains information on incidents Register on February 24,1977 (Vol. 42, No. 37, that can be perceived as significant but do not pages 10950-10952).
involve a major reduction in the level of protection provided for public health and safety.
These events are not reportable as AOs but are This policy statement was published before provided as "Other Events of Interest."
medical licensees were required to report misadministrations to NRC and few of the examples in the policy statement were applicable The Regulatory System to medical misadministrations. Therefore, in 1984, NRC adopted additional guidance for AO The system of licensing and regulation by which reporting of medical misadministrations. These NRC carries out its responsibilities is guidelines augment the NRC policy statement implemented through the rules and regulations in examples and are summarized in Table A-1 in Title 10 of the Code ofFederalRegulations. This Appendix A.
includes public participation as an element. To accomplish its objectives, NRC regularly conducts On January 27,1992, new medical licensing proceedings, inspection and enforcement misadministration requirements became effective.
activities, evaluation of operating experience, and As directed by the Commission, the staffis confirmatory research, while maintammg Programs for establish, g standards and issumg m
currently developing a new policy statement for reporting incidents and events to Congress. The techmcal reviews and studies.
policy statement will be published for public comment in the Federal Register prior to final In licensing and regulating nuclear power plants and the uses of byproduct nuclear materials, NRC Commission approval for use in developmg f uture AO reports.
follows the philosophy that the health and safety of the public are best ensured by establishing multiple levels of protection. These levels can be In order to provide wide dissemination of achieved and maintained through regulations information to the public, a Federal Register notice specifying requirements that will ensure the safe is issued on NRC licensee AOs. Copies of the use of nuclear materials. The regulations include notice are distributed to the NRC Public design and quality assurance criteria appropriate Document Room and all Imcal Public Document for the various activities licensed by NRC. An Rooms. At a minimum, each notice must contain inspection and enforcement program helps ensure the date and place of the occurrence and a compliance with the regulations.
vii NUREG-0090, Vol.18 No.1
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Abnormal Occurrences,1st Otr CY95 Reportable Occurrences Agreement States Section 274 of the Atomic Energy Act, as Operating experience is an essential input to the amended, authorizes the Commission to enter regulatory process for assuring that licensed into agreements with States whereby the activities are conducted safely. Licensees are Commission relm, qmshes and the States assume required to report certain incidents or events to regulatory authority over byproduct, source, and NRC. This reporting helps to identify deficiencies special nuclear materials (m quantities not and to ensure that corrective actions are taken to capable of sustaining a cham reaction). As part prevent recurrence.
of the cooperative effort between the Agreement l
States and the Commission with respect to the For nuclear power plants, dedicated groups have control of radiation hazards associated with the been formed, both by NRC and the nuclear power use of such material, the Agreement States, industry, for the detailed review of operatmg through compatible regulations, require the experience to help identify safety concerns early; reporting of incidents and events, involving to improve dissemmation of such information; nuclear material, by the regulated community.
and to feedback the experience into licensing, regulations, and operations. In addition, NRC Information on such reportable occurrences for and the nuclear power industiy have ongoing Agreement State licensed activities is publicly efforts to improve the operational data systems, available at the State level. In support of NRC's which include not only the type and quality of effort to id'entify and report abnormal reports required to be submitted, but also the occurrences, the Agreement States voluntarily methods used to analyze data. In order to more provide information to NRC on events that effectively collect, collate, store, retrieve, and occurred in their State that meet the AO criteria evaluate operational data, the information is as defined in Appendix A. For the purpose of maintained in computer-based data files.
developing a nationwide database, Agreement States are encouraged to provide information to Three primary sources of operational data are NRC on reportable events.
Licensee Event Reports (LERs) submitted pursuant to 10 CFR 50.73, immediate In early 1977, the Commission determined that notifications submitted pursuant to 10 CFR 50.72, AOs happening at Agreement State licensed and medical misadministration reports submitted facilities should be included in the quarterly pursuant to 10 CFR 35.33.
reports to Congress. The AO criteria included in Appendix A are applied uniformly to incidents nd events that occur at NRC and Agreement Except for records exempt from public disclosure State bcensed facilities. Procedures have been by statute and/or regulation, information deseloped and implemented, and AOs reported concerning reportable occurrences at facilities Agreement States to nRC are meluded m licensed or otherwise regulated by NRC is the quarterly reports to Congress.
routinely disseminated by NRC to the nuclear industry, the public, and other interested groups as these events occur.
Foreign Information Dissemination includes special notifications to NRC participates in an exchange of information licensees and other affected or interested groups, with various foreign governments that have and public announcements. In addition, nuclear facilities. This foreign information is
(
information on reportable events is routinely sent reviewed and considered in the NRC's assessment i
to the NRC's Local Public Document Rooms of operating experience and in its research and throughout the United States and to the NRC regulatory activities. Reference to foreign Public Document Room in Washington, D.C.
information may occasionally be made in these l
Congress is routinely kept informed of reportable quarterly AO reports to Congress; however, only events occurring in licensed facilities.
domestic AOs are reported.
NUREG-0090, Vol.18, No.1 viii
Abnormal Occurrences,1st Otr CY95 Reopening of Closed Abnormal updated if significant new information becomes Occurrences available.
NRC reopens previously closed AOs if significant new information becomes available. Similarly, previously reported "Other Events of Interest" are f
I ix NUREG-0090, Vol.18, No.1
i i
Abnormal Occurrences,1st Otr CY95 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES JANUARY-h! ARCH,1995 NUCLEAR POWER PLANTS NRC has reviewed all incident and event reports guidelines in Appendix A of this report, none of received from licensees for operating nuclear the occurrences reviewed for this reporting period power plants in the United States (U.S.) through were determined to be significant enough to be the first quarter of 1995. Using the criteria and reported as an AO.
FUEL CYCLE FACILITIES (Other than Nuclear Power Plants)
NRC has reviewed all incident and event reports guidelines in Appendix A of this report, none of received from licensees for the milling, processing, the occurrences reviewed for this reporting period and fabrication of nuclear fuelin the U.S.through were determined to be significant enough to be the first quarter of 1995. Using the criteria and reported as an AO.
OTIIER NRC LICENSEES (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
Here are approximately 22,000 active material Date and Place-November 18,1994; Welborn licenses for the use of byproduct materials in Memorial Baptist Hospital, Inc.; Evansville, industrial, medical, and academic applications in Indiana. Nature and Probable Consequences - On the U.S. Twenty-nine States, known as November 18,1994, a 73-year-old female patient Agreement States, have entered into agreements was prescribed to receive a brachytherapy with NRC to assume regulatory authority for treatment dose of 600 centigray (cGy)(600 rad) at approximately 15,000 of these licensees within the vaginal cavity using a GammaMed Ili high their States. NRC is responsible for regulating dose rate afterloading unit. However, because of approximately 700() licensees k)cated in the a treatment error the patient received a 1250 cGy remaining 21 States, the District of Columbia, and (1250 rad) dose instead of the prescribed dose.
all U.S. territories. NRC has reviewed all incident and event reports received from NRC licensees The licensee identified the misadministration through the first quarter of 1995. Using the during a quality management review on November criteria and guidelines in Appendix A of this 21,1994. The licensee reported the event to the report, the following occurrence was determined NRC on November 22,1994, and followed up with to be significant enough to be reported as an AO.
a written report on December 6,1994. The referring physician was notified. The patient was notified on November 23,1994, by the licensee's Radiation Safety Officer and was provided with a 95-1 Medical Brachytherapy Written report of the incident.
Misadministration at Welborn An NRC medical consultant was retained to Memorial Baptist Ilospital in evaluate the medical consequences of the Evansville, Indiana misadministration. The medical consultant expressed concern that long term effects such as fibrosis or loss of bk>od supply may occur as a The following information pertaining to the event result of the 1250 cGy (1250 rad) treatment. He is also being reported in the Federal Register.
medical consultant also suggested that this case Appendix A (see Event Type 5 in Table A-1) of be considered for the U.S. Department of Energy this report notes that a therapeutic dose that is (DOE), Office of Epidemiology and Health greater than 1.5 times the prescribed dose can be Surveillance long term medical study program.
considered an abnormal occurrence.
Information regarding the DOE program and a 1
NUREG-4)090, Vol.18, No.1
Abnormal Occurrences,1st Qtr CY95 copy of the NRC medical consultant's report were manufacturer. Prior to this misadministration, provided to the referring physician.
the device operators were required to verify only operator entered data. Also, the unit was Cause or Causes-NRC concluded that the cause evaluated by the licensee's medical physicist and a of the misadministration was twofold:(1) the GammaMed service representative. As a result of technologist failed to activate a button that the evaluation, the printed circuit board (card) automatically corrects for treatment time based with the read-only-memory integrated circuits on source decay, failed to notice a display containing the defective software program was indicating the treatment time correction that replaced with a card having the correct software would have been entered automatically, reentered program.
the treatment time instead, and failed to notice the error; and (2) the treatment software did not NRC-NRC conducted a safety inspection on stop the technologist from proceeding after the November 30 and December 1,1994 (Ref.1). An initial error was made as it was supposed to interoffice review of the event was conducted because an integrated circuit containing the through December 8,1994, to review the software code failed to operate.
circumstances of the misadministration. No violations of NRC requirements were identified.
Action Taken To Prevent Recurrence As a result of the incident, NRC contacted the manufacturer of the GammaMed Ili and sent a Licensee-In order to prevent recurrence of the letter to all GammaMed Ili users to inform them incident as of November 25,1994, the licensee of this potential problem and tell them how to test revised its internal " Policy and Procedure for all their software to prevent similar events.
IIDRs" to require both individuals operating the unit to verify the displayed time factor and His item is considered closed for the purpose of compare it to the factor supplied by the this report.
AGREEMENT STATE LICENSEES The 29 Agreement States have approximately guidelines as NRC, and to voluntarily report those 15,000 active material licenses for the use of occurrences that have been determined to be byproduct materials in industrial, medical, and significant enough to be considered as AOs.
academic applications. Procedures have been Using the criteria and guidelines in Appendix A developed for Agreement States to screen of this report, no occurrences were determined to incidents and events using the same criteria and be significant enough to be reported as an AO.
NUREG-0090, Vol.18, No.1 2
Abnormal Occurrences,1st Qtr CY95 REFERENCES 1.
Letter from BJ. IIolt, Chief, Nuclear License No. 13-01674-02, dated January 12, Materials Inspection Section 1, Division of 1995.*
Radiation Safety and Safeguards, to Marjorie Soyugenc, President, Welborn Cancer Center /Welborn Memorial Baptist Hospital, Inc., forwarding Inspection Reput No.
- ^f g *;*jlll,'e/gj y Q"g, $ 8j"*l,eed,',yey]f f
p
(
030-33236/94002, Docket No. 030- 33236, inston, oc.
l I
i 3
NUREG-0090, Vol.18, No.1
Abnormal Occurrences,1st Qtr CY95 APPENDIX A ABNORMAL OCCURRENCE CRITERIAI De following criteria used to determine an averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed abnormal occurrence (AO) were set forth in an 500 times the regulatory limit of Appendix B, NRC policy statement published in the Fedeml Table II,10 CFR Part 20 [CFR 20.403(b)(2)].
Register on February 24,1977, (Vol. 42, No. 37, pages 10950-10952).
4.
Radiation or contamination levels in excess of design values on packages, or loss of An event will be considered an AO ifit involves a confinement of radioactive material such as major reduction in the degree of protection of the (a) a radiation dose rate of 1000 mrem per public health or safety. Such an event would hour three feet from the surface of a package involve a moderate or more severe impact on the containing the radioactive material, or (b) public health or safety and could include but need release of radioactive material from a not be limited to:
package in amounts greater than the regulatory limit.
1.
Moderate exposure to, or release of, radioactive material licensed by or otheiwise 5.
Any loss oflicensed material in such regulated by the Commission; quantities and under such circumstances that substantial hazard may result to persons in 2.
Major degradation of essential safety-related unrestricted areas.
equipment; or 6.
A substantiated case of actual or attempted 3.
Major deficiencies in design, construction, theft or diversion of licensed material or use of, or management controls for licensed sabotage of a facility.
facilities or material.
7.
Any substantiated loss of special nuclear Examples of the types of events that are evaluated material or any substantiated inventory in detail using these criteria are:
discrepancy that is judged to be significant relative to normally expected performance For AH Licensees and that is judged to be caused by theft or diversion or by substantial breakdown of the 1.
Exposure of the whole body of any individual accountability system.
to 25 rem or more of radiation; exposure of the skin of the whole body of any individual 8.
Any substantial breakdown of physical to 150 rem or more of radiation; or exposure security or material control (i.e., access of the feet, ankles, hands or forearms of any control, containment, or accountability individual to 375 rem or more of radiation systems) that significantly weakened the
[10 CFR 20.403(a)(1)), or equivalent protection against theft, diversion, or exposures from internal sources.
sabotage.
2.
An exposure to an individualin an 9.
An accidental criticality [10 CFR 70.52(a)].
unrestrict dose rece,ed area such that the,whole body 10. A major deficiency in design, construction, or ived exceeds 0.5 rem m one calendar year [10 CFR 20.105(a)].
operation having safety implications requiring immediate remedial action.
3.
The release of radioactive material to an unrestricted area m, concentrations which,if
- 11. Serious deficiency in management or procedural controls in major areas.
- 12. Series of events (where individual events are M"[E# N2Yse*N'$*'n'ugatcId.
not of major importance), TeCurring incidents, ra tthe mi d ec-tive, the staff is currently devekiping a policy statement revising and MCidents With implications for s,m,lar ii criteria for various types of Aos. lhe changes pertinent to the 10 facilities (generic incidents) that create major CFR 20 revison will also be included in that draft pohey state-ment. Upon Commission's approval, the appropriate changes to safety Concern.
this Appendix will be published.
5 NUREG-0090, Vol.18, No.1
Abnormal Occurrences,1st Qtr CY95 For Commercial Nuclear Power Plants For Fuel Cycle Licensees 1.
Exceeding a safety limit of license Technical 1.
A safety limit oflicense Technical Specifications [10 CFR 50.36(c)].
Specifications is exceeded and a plant' shutdown is required [10 CFR 50.36(c)].
- 2.. Major degradation of fuelintegrity, primary coolant pressure boundary, or primary 2.
A major condition not specifically considered containment boundary.
in the safety analysis report or Technical Specifications that requires immediate 3.
Ioss of plant capability to perform essential remedial action.
safety functions such that a potential release of radioactivity in excess of 10 CFR Part 100 3.
An event that seriously compromised the guidelines could result from a postulated ability of a confinement system to perform its transient or accident (e.g., loss of emergency designated function.
core cooling system, loss of control rod system).
Medical Misadministrations 4.
Discovery of a major condition not As discussed in the Preface to this report, the specifically considered in the Safety Analysis NRC policy statement on AOs was published Report (SAR) or Technical Specifications that before licensees were required to report medical requires immediate remedial action.
misadministrations to the NRC. Therefore, during 1984, NRC developed guidelines for 5.
Personnel error or procedural deficiencies selecting such events for AO reporting. These that result in loss of plant capability to guidelines, which are summarized in Table A-1, perform essential safety functions such that a augment 4he NRC policy statement.
potential release of radioactivity in excess of 10 CFR Part 100 guidelines could result from As noted in the Preface, revised guidelines are a postulated transient or accident (e.g., loss currently being developed because new medical of emergency core cooling system, loss of misadministration definitions became effective on control rod system).
January 27,1992.
NUREG-0090, Vol.18, No.1 6
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Abnormal Occurrences,1st Qtr CY95 Table A-1 NRC Guidelines for Selecting Medical Misadministration Events for Abnonnal Occurrence (AO) Reporting AO Repor' ting Threshold Event 'I)pe Diagnostic Exposure Therapeutic Exposure (1) Administering a radiopharma-If the improper administration If the improper administration ceutical or radiation from a results in any part of the results in any part of the body scaled source other than the body receiving unscheduled receiving unscheduled radiation, an one intended.
radiation, an AO report should AO report should be proposed for be proposed if:
any such event.
(a) the actual dose to the If the parts of the Imdy wrong body part is receiving radiation greater than five times improperly would have the upper limit of the received radiation anyway, normal range of had the proper administration exposures prescribed been used, an AO report for diagnostic procedures should be proposed if:
involving that body part, or (b) there are clinical (a) the actual dose is greater indications of any than 1.5 times that intended adverse health effects to the above described body to the wrong body part.
parts, or, If the parts of the body (b) the actual dose is less than receivmg radiation 0.5 times that intended to the improperly would have above described body parts, or, received radiation anyway, had the proper administration (c) the above described bodyparts been used, an AO report should show signs of adverse health he proposed if:
effects greater than expected had the properadministration been used, or (a) the actual dose is greater (d) the event (regardless of any than five times that intended health effects) affects two or to the above described body more patients at the same parts, or, facility.
(b) the above described body parts show signs of adverse health effects greater than expected had the proper administration been used.
(2) Administering a radio-An AO report should be An AO report should be pharmaceutical or radiation proposed if:
proposed for any such event.
to the wrong patient. or (a) the actual dose to the wrong patient exceeds five times the prescribed dose for the intended patient, or (b) the event results in any adverse health effects.
(3) Administering a radiophar-Same guidelines as for Same guidelines as for maceutical or radiation by a Event l}pe 1.
Event l}pe 1.
Abnormal Occurrences,1st Otr CY95 Table A 1 (Continued)
AO Reporting Threshold Event Type Diagnostic Exposure Therapeutic Exposure route of administration other than that intended by the pre-scribing physician.
(4) Administering a diagnostic An AO report should be Not applicable.
dose of a radiopharma-proposed if:
ceutical differing from the prescribed dose by more than 50 percent.
(a) the actual dose is greater than five times the prescribed dose, or, (b) the event results in adverse health effects worse than expected for the normal range of exposures prescribed for the diagnostic procedure.
i (5) Administering a Not applicable.
An AO report should be therapeutic dose of proposed if:
a radiopharmaceutical differing from the prescribed (a) the actual dose is greater dose by more than 10 percent; than 1.5 times the prescribed or administering a therapeutic dose,or, radiation dose from a scaled source such that crrors in the (b) the actual dose is less than source calibration, time of 0.5 times the prescribed exposure, and treatment dose,or geometry result in a calculated total treatment dose (c) the event results in adverse from the final prescribed health effects worse than total treatment dose by more would be expected for the than 10 percent.
normal range of exnosures prescribed for the therapeutic procedure, or, (d) the event (regardless of any health effects) affects two or more patients at the same facility.
(6) llecurring or series of For cither diagnostic or therapeutic exposures, an AO report should be events (regardless of the proposed for recurring events or a series of events (in which each individual number of patients or misadministration is not of major importance) that ercate a significant facilities involved).
public health or safety concern.
(7) Generic events.
For cither diagnostic or therapeutic exposures, an AO report should be proposed for misadministrations with generic implications that create a signific:mt public health or safety concern.
NUREG-0090, Vol.18, No. I g
1
Abnormal Occurrences,1st Qtr CY95 APPENDIX B P
UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES During January through March 1995, NRC discussed below contain a summary of licensees, Agreement States, Agreement State information presented in previous reports and any licensees, and other involved parties, such as subsequent updated information provided during reactor vendors and architect-engineering firms, the reporting period. Those updated events which continued with the implementation of actions still require additional information will be necessary to prevent recurrence of previously discussed in future reports.
reported abnormal occurrences (AO). The AOs OTHER NRC LICENSEES 92-18 Loss of Iridium-192 Source caused 94 other people to receive radiation and Medical Therapy ranging from 400 microsievert to 220 millisievert Misadministration at Oncology (40 millirem to 22 rem). The source was Services Corporation in eventually mixed by accident with medical biohazard waste and was subsequently found and Indiana, Pennsylvania recovered at the site of a company that had been contracted to dispose of biological waste material.
This abnormal occurrence (AO) was on..gmally reported in NUREG4)090, Vol.15 No. 4, " Report to Congress on Abnormal Occurrences, The AO report is updated as follows:
October-December 1992," under the title " loss of Iridium-192 Source and Medical Herapy The licensee submitted information in letters Misadm,m,stration at Indiana Reg onal Cancer dated August 31,1994, and October 4,1994, in i
Center m Indiana, Pennsylvam,a.
response to the NRC's Notice of Violation and Proposed Imposition of Civil Penalties dated May The AO critena used were:
31,1994. After consideration of the licensee's responses, NRC concluded that an adequate basis was not provided for withdrawal of any of the (1) Event Type 5,in Table A-1-A therapeutic violations or for mitigation of the civil penalties.
dose that is greater than 1.5 times the An " Order Imposing Civil Penalties-$280,000" prescribed dose; and (Order) was issued on April 24,1995 (Ref 1). The licensee has 30 days to pay the civil penalties.
(2) For All Licensees, No. 2-An exposure to an The licensee may also within 30 days of the date individual in an unrestricted area such that of the Order request a hearing on the Order.
the whole body dose received exceeds 0.5 rem in one calendar year.
Concurrent with the enforcement process, the licensee requested the termination of its license At that time,it was reported on November 16, on December 13,1993, with the license to be 1992 Oncology Services Corporation had lost a replaced by individual licenses issued to the 159.000 gigabecquerel (4.3 curie) sealed facilities named as locations of use on the iridium-192 source from a high dose rate (HDR)
Oncology Senices Corporation (OSC) license, remote afterloader brachytherapy unit at its ne OSC license was terminated on August 24, Indiana Regional Cancer Center in Indiana, 1994, concurrent with new licenses being issued to Pennsylvania, ne source had:(1) broken off of the facilities which were previously listed as the HDR unit while in senice:(2) subsequently locations of use on the OSC license.
killed a patient with a 1,600,000 centigray (1,600,000 rad) absorbed dose, after remaining on This event will be updated when additional the patient's body for almost 4 days; and (3) information becomes available.
9 NUREG-0090, Vol.18, No.1
Abnormal Occurrences,1st Qtr CY95 AGREEMENT STATE LICENSEES AS 88-5 Afedical Teletherapy an AO because it involved a moderate or more Misadministration at Sacred severe impact on public health or safety.
IIcart Ilospital in ne AO report is updated as folluws:
Cumberland, Maryland NRC is continuing to work with the State of This AO was originally reported in Maryland to obtain more information regarding NUREG-0090, Vol.11, No. 4, " Report to these incidents.
Congress on Abnormal Occurrences, October-December 1988."
His event will be updated when additional information becomes available.
The AO criterion used was a moderate or more severe impact on public health or safety, as stated AS 93-9 Medical hietherapy m the second paragraph of the General Criteria.
Misadministration by At the time it was reported that on September 2,
" Unspecified Licensee" in 1988, an 81-year-old patient received a New York, New York therapeutic dose of 1400 centigray (1400 rad) to a Tiu.s abnormal occurrence (AO) was on..gmally part of the body not scheduled to receive reported in NUREG-0090, Vol.16, No. 3, " Report radiation. The event was reported as an AO because it involved a moderate or more severe to Congress on Abnormal Occurrences, impact on public health or safety.
July-September 1993," under the title " Medical Teletherapy Misadmmistration by ' Unspecified Licensee'in New York, New York."
The AO report is updated as follows:
The AO criterion used was administering a NRC is continuing to work with the State of Maryland to obtain more information regarding therapeutic dose to a part of the body not scheduled to receive radiation.
this incident.
At that time, it was reported that on July 11,1992, This event will be updated when additional c balt-60 teletherapy treatmen'.s of 200 centigray information becomes available.
(cGy)(200 rad) each were to be admirastered to the right axilla (arn pit) of a patient.
AS 88-6 Multiple Medical The AO report is updated and closed out as Rietherapy Misadministrations at Sacred IIcart Ilospital in A 65-year-old patient undergoing a cobalt-60 Cumberland, Maryland teletherapy treatment was prescribed to receive a dose of 3600 cGy (3600 rad) to the right axilla in This AO was originally reported in 18 fractions of 200 cGy (200 rad) per fraction and NUREG-0090, Vol.11, No. 4. " Report to two fields (anterior and posterior) per fraction at Congress on Abnormal Occurrences, a rate of 5 fractions per week. His course was to I
October-December 1988."
be followed by a booster dose of 400 cGy (400 rad) 2 days following the end of the The AO criterion used was a moderate or more fractionated-<fose course of treatment.
severe impact on public health or safety, as stated in the second paragraph of the General Criteria.
During the course of simulation, the attending radiation oncologist was called from the room for At the time it was reported that over a 13-month an emergency case. During simulation the period 33 patients undergoing brain cancer technologist accidently photographed the wrong treatments had received therapeutic radiation side of the patient, namely the left axilla instead exposures from a cobalt-60 teletherapy machine of the right axilla as prescribed. The attending that exceeded the prescribed dose by at least 10 radiation oncologist subsequently reviewed the percent in each case. The event was reported as simulation films, which were incorrectly marked I
NUREG-0090, Vol.18, No.1 10
Abnormal Occurrences.1st Qtr CY95 as "right side," and approved them without incorrectly marked films without recognizing the recognizing the error. The port films taken at the error;(3) the patient was incorrectly set up for the initial patient set-up prior to therapy were initial treatment based on erroneous simulator correctly marked "left side," but were not films:(4) the portal films taken at the time of set recognized as the wrong treatment site by the up were marked correctly, but the simulation attending oncologist.
error remained undetected by the personnel involved; and (5) an independent verification of De patient was treated for five fractions of 200 the correct treatment site was not performed by L
cGy (200 rad) each for one week by three different the three different technologists who treated the technologists, and received a total dose of 1000 patient although they entered the treatment site as cGy (1000 rad) before the error was discovered.
"right axilla" in the treatment chart.
Upon discovery, the treatment was discontinued, the patient was correctly resimulated, and the To prevent recurrence, the licensee took the treatment was administered as prescribed. Both following corrective actions: (1) the internal the patient and the patient's referring physician procedures were amended to require the presence were informed of the event and the patient was of the attendmg radiation oncologist ti1roughout told that there would be no adverse effects. The the sunulation procedure, and to requ,re i
patient verbally indicated that he understood. The un mbiguous marking of the simulator films;(2) patient was followed clinically by the licensee and
!he semor technolpgist was required to there have been no adverse effects to date. A independently verify the correct patient, set-up, medical consultant was not involved.
dose, and treatment parameters before m, itiating treatment; and (3) the personnel myolved were "E
The underlying causes of the event are as follows:
(1) while the attending radiation oncologist was The City of New York concurred with the absent, the simulation technologist did not follow licensee's evaluation of the event and corrective the initial prescription which was correct, and actions.
incorrectly set up the patient for treatment:(2) the attending radiation oncologist approved the This event is closed for the purpose of this seport.
l l
)
11 NUREG-0090, Vol.18, No.1
Abnormal Occurrences 1st Qtr CY95 APPENDIX C OTIIER EVENTS OF INTEREST "Other Events of Interest" are reported because reportable as abnormal occurrences.
they can be perceived as being significant but have been determined not to involve a major During the period from January 1 through March reduction in the level of protection provided for 31,1995, no "Other Events of Interest" items were public health or safety; therefore they are not reported.
f 13 NUREG-0090, Vol.18, No.1
t Abnormal Occurrences,1st Qtr CY95-REFERENCES FOR APPENDICES 1.'
Letter from liugh L Thompson, Jr., Deputy Docket No. 030-31765, Ucense No.
Executive Director for Nuclear Materials 37-28540-01 dated April 24,1995.*
Safety, Safeguards and Operations Support, to Douglas R. Colkitt, M.D., President.
Oncology Services Corporation forwarding
- Efd*!"j,7g'M"'f/$YC,$'i,,, $l)%'
p, Order Imposing Civil Penalties - $280,000, inaion, oc.
NUREG-0090, Vol.18, No. I 14
NRC FORM 335 U S. NUCLEAR REGULATORY COMMISSION
- 1. REPORT NUMBER (240)
(Assigned by NRC, Add Vol.,
N9CM 1102, Supp., Rev., and Addendum Num-3200 32o2 BIBLIOGRAPHIC DATA SHEET b*r*-
" *"vl tSee instrucuans on the reverse)
NUREG-0090 Vol.18, No.1 2 mLe AND suuWLE
- ' ^ "'" "'""""*"'"
Report to Congress on Abnormal Occurrences:
January-March 1995 MONTH YEAR July 1995
- b. Au l tohlb)
- 6. TYPE OF REPORT Quarterly
- 7. PF.RIOD COVERED (inclusive Dates)
January-March 1995 8 PLRFORMING OHGANIZAllON - NAME AND ADDHESS (!f NRC, provide Division Office or Hegion, U.S. Nuclear Regulatory Commission, and malling address; if contractor, provide name and maihng address.)
Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
- 9. SPONSOHING OHGANIZAllON - NAME AND ADDRESS (if NRC, type *Same as above"; 6f contractor, provide NRC Division, Office or Region, U,S. Nuclear Regulatory Commission, and mailing address.)
Same as 8., above
- 10. SUPPLEMt.NT ARY NOTE S
- 11. ADSIRACT (200 words or less)
Section 208 of the Energy Reorganization Act of 1974 iden tifies an abnormal occurrence (AO) as an unscheduled incident or event that the Nuclear Regulatory Commission determines to be significant from the standpoint of public health or safety and requires a quarterly report of such occurrences to be made to Congress. This report provides a description of those incidents and events that have been determined to be AOs during the period of January 1 through March 31,1995.
This report addresses one AO at an NRC-licensed facility which involved a medical brachytherapy misadministration.The report also contains updates of one AO previously reported by an NRC licensee and three AOs previously reported by the Agreement States. No "Other Events of Interest" items are being reported.
- 12. KEY WORDS/DESCRIPTORS (List words or phrases that will assist researctuars in locating the report.)
- 13. AVAILABILITY STATEMENT Unlimited Medical: Misadministration: Brachytherapy
- 14. SECURfrY CLASSIFICATION (This Page)
Unclassified (This Report)
Unclassified
- 15. NUMUER OF PAGES 16, PRICE NRC FORM 335 (2-89) l l
i l
Printed
- on recycled paper l
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NUREG-0090, Vol.18, No.1 REPORT TO CONGRESS ON ABNORATAL OCCURRENCES JUlX 1995 ~
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