ML20100J161

Report to Congress on Abnormal OCCURRENCES.July-September 1995

ML20100J161
Person / Time
Issue date:	02/29/1996
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
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References
NUREG-0090, NUREG-0090-V18-N03, NUREG-90, NUREG-90-V18-N3, NUDOCS 9602280295
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NUREG-0090 Vol.18, No. 3 Report to Congress on Abnormal Occurrences July - September 1995 U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data

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AVAILABILITY NOTICE Availability of Reference Materials Cited in NRC Publications Most documents cited in NRC publications will be available from one of the following sources:

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 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.

The following documents in the NUREG series are available for purchase from the Government 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-tions, and Nuclear Regulatory Commission Issuances.

Documents available from the National Technical Information Service include NUREG-series reports and technical reports prepared by other Federal agencies and reports prepared by the Atomic Energy Commission, forerunner agency to the Nuclear Regulatory Commission.

Documents available from public and special technical libraries include all open literaturc items, such as books, journal articles, and transactions. Federal Register notices, Federal and State legislation, and congressional reports can usually be obtained from these libraries.

e Documents such as theses, dissertations, foreign reports and translations, and non-NRC con-ference proceedings are available for purchase from the organization sponsoring the publica-tion cited, j

Single copies of NRC draft reports are available free, to the extent of supply, upon written i

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 regulatory 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 i

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 QJartefly issues.

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NUREG-0090 Vol.18, No. 3 Report to Congress on Abnormal Occurrences July - September 1995 Date Published: February 1996 Omcc for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 f

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i Abnormal Occurrences,3rd 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.

NUREG-0090, Vols.1 through 17 (January-March 1978 through October-December 1994), published June 1978 through May 1995.

- NUREG-0090, Vol,18, No.1 (January-March 1995), published July 1995.

NUREG-0090, Vol.18, No. 2 (April-June 1995), published October 1995.

i NUREG-0090, Vol.18, No. 3 ii

i Abnormal Occurrences,3rd Otr CY95 ABSTRACT I

Section 208 of the Energy Reorganization Act of This report addresses three AOs at NRC licensed 1974 identifies an abnormal occurrence (AO) as facilities. Wo involved medical brachytherapy an unscheduled incident or event that the Nuclear misadministrations and one involved ingestion of Regulatory Com;nission determines to be radioactive material by research workers. One AO significant from the standpoint of public health or submitted by the Agreement States is included. It safety and requires a quarterly report of such involved importation into the United States of a occurrences to be made to Congress. His report package having excessive radiation. No updates of provides a description of those incidents and previously reported AOs are included in this events that have been determined to be AOs report. No "Other Events of Interest" items are during the period of July 1 through September 30, being reported.

1995, i

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iii NUREG-0090, Vol.18. No. 3

Abnormal Occurrences,3rd Otr CY95 CONTENTS Page Abstract...................................................................................

iii Preface...................................................................................vii In trod uction............................................................................ vii The Regulatory System................................................................... vii Reportable Occurrences................................................................... viii Agreement States....................................................................... viii Foreign Information..................................................................... viii Reopening of Closed Abnormal Occurrences.............................................. viii Report to Congress on Abnormal Occurrences, July-September 1995.............................

1 Nuclear Power Plants....................................................................

1 Fuel Cycle Facilities (Other than Nuclear Power Plants)....................................

1 Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)....

1 95-7 Medical Brachytherapy Misadministration at Marshfield Clinic in Marshfield, Wisconsin.......................................................

1 95-8 Medical Brachytherapy Misadministration at Providence Hospital in Sou thfield, Michigan........................................................

2 95-9 Ingestion of Radioactive Material by Research Workers at the National Institutes of Health in Bethesda, Maryland..............................

3 Agreement State Licensees...............................................................

3 AS 95-5 Importation of a Package Having Excessive External Radiation into the United States from the Republic of Korea............................

3 Appendix A - Abnormal Occurrence Criteria.................................................

7 Appendix B - Update of Previously Reported Abnormal Occurrences............................ 11 Appendix C - Other Events of Interest........................................................ 13 v

NUREG-0090. Vol.18, No. 3

Abnormal Occurrences,3rd Otr CY95 PREFACE Introduction NRC has determined that, of the incidents and events reviewed for this reporting period, only The Nuclear Regulatory Commission (NRC) those that are described in this report meet the reports to Congress each quarter, under criteria for reporting as AOs. This report covers provisions of Section 208 of the Energy the period from July 1 through September 30, Reorganization Act of 1974, any abnormal 1995. Information reported on each AO includes occurrences (AOs) involving facilities and date and place, nature and probable activities regulated by NRC. An AO is defined in consequences, cause or causes, and actions taken Section 208 as an unscheduled incident or event to prevent recurrence.

that the Commission determines to be significant from the standpoint of public health or safety.

Appendix B contains updated information on previously reported AOs.

NRC identifies an AO for the purpose of this report using the criteria in Appendix A. The Appendix C contains information on incidents criteria were initially promulgated in an NRC.

that can be perceived as significant but do not policy statement that was published in the Fedeml involve a major reduction in the level of Register on February 24,1977 (Vol. 42, No. 37, protection provided for public health and safety.

pages 10950-10952).

Rese events are not reportable as AOs but are This policy statement was published before medical licensees were required to report misadministrations to NRC and few of the examples in the policy statement were applicable ne Regulatory System to medical misadministrations. Therefore, in 1984, NRC adopted additional guidance for AO He 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 Thble A-1 in Title 10 of die Code of Federal Regulations. This Appendix A.

includes public participation as an element. 'Ib 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 staff has confirmatory research, while maintaining developed a new policy statement for reporting Programs for establishing standards and issuing incidents and events to Congress. The policy techmcal reviews and studies, statement was published for public comment in the Federal Register on January 9,1996 (Vol. 61, In licensing and regulating nuclear power plants No. 6, pages 661-669).

and the uses of byproduct nuclear materials, NRC follows the philosophy that the health and safety In order to provide wide dissemination of of the public are best ensured by establishing information to the public, a Federal Register notice multiple levels of protection. These levels can be is issued on NRC licensee AOs. Copies of the achieved and maintained through regulations notice are distributed to the NRC Public specifying requirements that will ensure the safe Document Room and all local Public Document use of nuclear materials. The regulations include Rooms. At a minimum, each notice must contain design and quality assurance criteria appropriate the date and place of the occurrence and a for the various activities licensed by NRC. An description of its nature and probable inspection and enforcement program helps ensure consequences.

compliance with the regulations.

vii NUREG-0090, Vol.18, No. 3

Abnormal Occurrences,3rd 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 activities are conducted safely. Licensees are agyegments with States whereby the mt required to report certain incidents or events to Commission relinquishes and the States assume

8"tatory authority over byproduct, source, and NRC. This reporting helps to identify deficiencies special nuckar materials (in quandties not and to ensure that corrective actions are taken to capable of sustaimng a cham reaction).

prevent recurrence.

Agreement State programs must be comparable to and compatible with the Commission's For nuclear power plants, dedicated groups have program for such material.

been formed, both by NRC and the nuclear power industry, for the detailed review of operating

. Presently, information on reportable occurrences experience to help identify safety concerns early; for Agreement State licensed activities is publicly to improve dissemination of such information; available at the State level. For the purpose of and to feedback the experience into licensing, developing a nationwide database, Agreement regulations, and operations. In addition, NRC and States are encouraged to provide information to the nuclear power industry have ongoing efforts to NRC on reportable events.

improve the operational data systems, which include not only the type and quality of reports In early 1977, the Commission determined that required to be submitted, but also the methods AOs happening at Agreement State licensed used to analyze data. In order to more effectively facilities should be included in the quarterly collect, collate, store, retrieve, and evaluate reports to Congress. The AO criteria included in operational data, the information is maintained in Appendix A are applied uniformly to incidents computer-based data files.

and events that occur at NRC and Agreement State licensed facilities. Procedures have been developed and implemented, and AOs reported Three primary sources of operat.ional data are by the Agreement States to NRC are included in Licensee Event Reports (LERs) submitted the quarterly reports to Congress.

pursuant to 10 CFR 50.73, immediate notifications submitted pursuant to 10 CFR 50.72, and medical misadministration reports submitted Foreign Information pursuant to 10 CFR 35.33.

NRC participates in an exchange of information Except for records exempt from public disclosure with various foreign governments that have by statute and/or regulation, information nuclear facilities. This foreign mformation is reviewed and considered in the NRC's assessment concerning reportable occurrences at facilities licensed or otherwise regulated by NRC is f perating experience and in its research and t

routinely disseminated by NRC to the nuclear yegulatory activities. Reference to foreign industry, the public, and other interested groups inf rmation may occasionally be made m, these as these events occur.

quarterly AO reports to Congress; however, only domestic AOs are reported.

Dissemination includes special notifications to licensees and other affected or interested groups, Reopening of Closed Abnormal and public announcements. In addition, Occurrences information on reportaSle events is routinely sent to the NRC's Local Public Document Rooms NRC reopens previously closed AOs if significant throughout the United States and to the NRC new information becomes available. Similarly, Public Document Room in Washington, D.C.

previously reported "Other Events of Interest" are Congress is routinely kept informed of reportable updated if significant new information becomes events occurring in licensed facilities.

available.

NUREG-0090, Vol.18, No. 3 viii

Abnormal Occurrences,3rd Qtr CY95 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES JULY-SEPTEMBER 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 was determined to be significant enough to be the third 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 was determined to be significant enough to be the third quarter of 1995. Using the criteria and reported as an AO.

OTHER NRC LICENSEES (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)

There are approximately 22,000 active material 10 percent and the actual dose is greater than 1.5 licenses for the use of byproduct materials in times the prescribed dose can be considered an industrial, medical, and academic applications in AO.

the U.S. Twenty-nine States, known as Agreement States, have entered into agreements with NRC to Date and Place-June 8,1995; Marshfield Clinic; assume regulatory authority for approximately Marshfield, Wisconsin.

15,000 of these licensees within their States. NRC is responsible for regulating approximately 7000 Nature and Probable Consequences-A patient licensees located in the remaining 21 States, the was prescribed a dose of 1640 centigray (cGy)

District of Columbia, and all U.S. territories.

(1640 rad) for a low dose rate brachytherapy NRC has reviewed all incident and event reports treatment of the cervix usmg cesium-137 sources.

received from NRC licensees through the third After the sources were implanted, but prior to quarter of 1995. Using the criteria and guidehnes completion of the treatment, the physician entered m Appendix A of this report, the following the wrong date for removal of the sources into the occurrences were determmed to be sigmficant final treatment plan. Because of this error the enough to be reported as AOs.

treatment was extended for an additional day. As a result, the calculated administered dose was 2440 cGy (2440 rad) which was approximately 50 95-7 Medical Brachytherapy Percent greater than the prescribed dose.

Misadministration at Marshfield Clinic in Marshfield, Wisconsin The physician informed the patient of the misadministration both verbally and in writing.

The following information pertaining to this event The licensee evaluated the consequences of the is also being reported concurrently in the Fedeml misadministration and determined that there Register. Appendix A (see Event Type 5[a] in would be no adverse health effects.

'Ihble A-1) of this report notes that administering a therapeutic dose from a sealed source such that An NRC medical consultant evaluated the the calculated total treatment dose differs from consequences of the misadministration and the prescribed total treatment dose by more than agreed with the licensee's conclusion.

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NUREG-0090, Vol.18, No. 3

Abnormal Occurrences,3rd Otr CY95 Cause or Causes-The licensee failed to notice Nature and Probable Consequences-A patient that the planned explant time documented in the was prescribed a dose of 1230 centigray (cGy) final treatment plan did not represent the (1230 rad) for a palliative manual brachytherapy prescribed treatment time documented in the treatment of the brain using an iridium-192 seed.

written directive. Also, the licensee's written directive / low dose rate brachytherapy log form, After implantation, confirmatory x-rays were used to record events occurring during low dose taken but could not confirm the location of the rate brachytherapy treatments, did not contain a seed and the treatment was terminated about 31 location to document the prescribed time for hours after implantation. The licensee determined source removal.

that the seed was implanted about 4 centimeters (1.57 inches) from the intended treatment site of the brain. Consequently, the wrong treatment site Actions Taken To Prevent Recurrence received an unintended radiation dose of about 739 cGy (739 rad) and the tumor received only Licensee-He licensee revised its written about 72 cGy (72 rad).

directive / low dose rate brachytherapy log form to include documentation of the actual implantation The licensee determined that no adverse health time, and the time for the prescribed and actual effects would result from the misadministration.

removal of sources. Additionally, the revised form An NRC medical consultant has reviewed the case will include verification of such times by a but has not yet submitted a report to NRC. The licensee staff member.

I censee notified the referring physician and the patient about the misadministration.

NRC-NRC conducted an inspection and Cause or Causes-The licensee said that the seed reviewed the circumstances surrounding the became detained at the elbow of the applicator misadministration. NRC also retained a medical during implantation and changed direction. The consultant to review the case. A Confirmatory physician consequently encountered resistance Action Letter was issued which confirms that the while inserting the source and assumed that it heensee will verify that its authorized users meet reached the intended treatment site. A traming and experience requirements. A Notice of confirmatory x-ray taken at the time of insertion Violation was issued with five Severity Level IV did not show the location of the source. (The violations.

licensee had used a fluoroscope [real time imaging) during simulation of the treatment, but a This event is considered closed for the purpose of fluoroscope was not used to observe the actual this report.

seed implantation.)

Actions Taken To Prevent Recurrence Licensee-The licensee reported that when using 95-8 Medical Brachytherapy this type of applicator in the future, fluoroscopy Misadministration at Providence will be used to assure proper implantation of radioactive material.

Hospital in Southfield, Michigan The following information pertaining to this event the circumstances surround (mg the ed an nvesdgahn m dew cn is also being reported concurrently in the Fedeml Register. Appendix A (see Event Type 3 in Table misadmtmstration. The NRC staff is currently A-1)of this report notes that a therapeutic reviewing the inspection results for possible exposure to any part of the body not scheduled to vi lations, and enforcement action is pending.

receive radiation can be considered an AO.

This event is considered closed for the purpose of Date and Place-July 25,1995; Providence Hospital; Southfield, Michigan.

NUREG-0090, Vol.18, No. 3 2

i Abnormal Occurrences,3rd Otr CY95 i

95-9 Ingestion of Radioactive Bureau of Investigation (FBI), the NRC's Office Material by Research Workers at of Investigations (OI), and the NIH Police l

the National Institutes of Health Department are currently investigating the event.

The AIT has concluded its inspection efforts. 01 l

In Bethesda, Maryland continues to work with the FBI.

The following information pertaining to this event is also being reported concurrently in the Fedeml Cause or Causes-Because of the ongoing Register. Appendix A (see General Criterion 1) of investigation, NRC has not reached a final this report notes that a moderate exposure to, or conclusion as to the cause of the event.

release of, radioactive material licensed by or otherwise regulated by the Commission can be an abnormal occurrence.

Actions Taken to Prevent Recurrence Date and Place-June 28,1995; National LIC'.nsee-The licensee continues to investigate Institutes of Health (NIH); Bethesda, Maryland.

the incident. He licensee performed bioassay sampling to identify the isotope, calculate Nature and Probable Consequences-A pregnant Preliminary estimates of intake, and determine the scope of the contam, ation. In addition, the m

research employee became internally contaminated with phosphorus-32 (P-32) and was h,censee will take actions to enhance security for sent to a local hospital for treatment.

handhng radioactive materials.

NRC formed an Augmented Inspection Team NRC-In addition to forming an AIT NRC (AIT), which included a medical consultant, to subsequently conducted a special inspection to review the incident. The medical consultant determine the effectiveness of NIH security over stated, based on the licensce's initial report, that radioactive materials.

there would not be any adverse health consequences to the researcher or the fetus. Also, NRC also issued two Confirmatory Action an NRC scientific consultant at the Oak Ridge Letters. The first confirmed the actions that the Institute for Science and Education's Radiation licensee would take to reduce the possibility of Internal Dose Information Center was consulted.

further ingestion and to determine the extent of An independent assessment was also performed the contamination. The second confirmed the by Lawrence Livermore National Laboratories.

actions that the licensee would take in response to the special inspection that reviewed the NIH The licensee subsequently found that 26 security policy for handling radioactive materials.

individuals (in addition to the pregnant researcher) were also contaminated. The Federal His event is closed for the purpose of this report.

AGREEMENT STATE LICENSEES The 29 Agreement States have approximately determined to be significant enough to be 15,000 active material licenses for the use of reported as an AO.

byproduct materials in industrial, medical, and academic applications. Procedures have been AS 95-5 Importation of a Package developed for Agreement States to screen Having Excessive External incidents and events using the same criteria and Radiation into the United guidelines as NRC, and to report those States from the Republic of occurrences that have been determmed to be orea l

significant enough to be considered as AOs.

Using the criteria and guidelines in Appendix A Appendix A (see For All Licensees, Example 11) of this report, the following occurrence was of this report notes that serious deficiency in 3

NUREG-0090, Vol.18. No. 3

Abnormal Occurrences,3rd Otr CY95 management or procedural controls in major forwarders] handled the packages in the United areas can be considered an AO.

States before they left Houston.)

Date and Place-December 20,1994; Omnitron The investigation also determined that at least 32 PeoP e in the United States were probably l

International, Inc.; Edgerly, Louisiana.

exposed to the excessive radiation from the Nature and Probable Consequences-Omnitron Package. The estimated doses for the people who received maximum exposure are as follows:

International received a package of radioactive (1) Los Angeles International Airport to Houston, material with external radiation levels Texas, 5.82 mSv (582 mrem); (2) Houston, Texas, approximately 18 times higher than allowed by the (freight companies, brokers and a repackager)

U.S. Department of Transportation (DOT). The 46.13 mSv (4613 mrem); and (3) Houston, Texas, package was one of two packages received from a to Edgerly, Lou,siana,0.84 mSv (84 mrem). The i

shipper in the Republic of Korea. Each package maximum estimated dose was received by an contained an iridium-192 source in the form of a emP oyee of a Texas repackaging firm because the l

wire that had an activity of approximately 16,650 rnegabecquerel(450 millicurie).

' Packages were stored near the employee,s workbench for a day or more while the "overpaks" were constructed.

The high radiat. ion levels were discovered during a routine survey of the packages upon receipt by Cause or Causes-The State of Louisiana's Omnitron personnel. The package had radiation Radiation Protection Division concluded that the readings of 37 millisievert (mSv)(3700 millirem reason the one package had an excessive radiation

[ mrem]) per hour at its surface and 1.4 mSv (140 profile was that the source wire was not secured mrem) per hour at 1 meter (39.37 inches). The in the safe or completely shielded position. This maximum levels allowed by DOT, which regulates suggests an improper preparation for shipment the transport of radioactive materials m the and a failure to perform a proper radiation survey United States, are 2 mSv (200 mrem) per hour at by the shipper in the Republic of Korea. There the surface and 0.1 mSv (10 mrem) per hour at 1 was no indication of damage to the package, or meter (39.37 inches).

any evidence to suggest that the source changed position during transport. The source wire was Omnitron notified the State of Louisiana's properly secured in the shielded position for the Radiation Protection Division of the event.

second package.

Inspectors from the State agency found that the package had a narrow beam of radiation from its The safe handling and transportation of top surface of approximately 180 mSv (18 rem) radioactive materials imported into the United per hour, and 22 to 37 mSv (2.2 to 3.7 rem) per States are highly dependent on the actions taken hour at other surface locations. The radiation by foreign shippers and their agents to properly levels were approximately 4 times the levels prepare the packages for shipment. There are no measured at the surface of the container DOT or NRC requirements for carriers or

("overpak")in which the package arrived.

shipping agents to monitor or survey shipments during transit in the United States.

During the ensuing investigation by State and Federal agencies, it was learned that the packages Actions Taken to Prevent Recurrence arrived in the United States at Los Angeles International Airport and were subsequently sent Licensee-Omnitron International provides by truck to a Continental Freight facility in training on source exchange procedures to both Houston, Texas, where they cleared Customs.

its foreign and domestic customers. In this case, it After being placed in "overpaks" by a repackager, supplied training to a Korean service company, the packages were sent by Federal Express truck which included training for a service manager and from Houston to Omnitron International in two service engineers. Its training procedures are Edgerly, Louisiana. (It should be noted that at being reviewed to emphasize the regulatory least eight companies [two brokers, two trucking requirements for transportation in the United companies, one repackager, and three freight States.

NUREG-0090, Vol.18, No. 3 4

Abnormal Occurrences,3rd Qtr CY95 DOT-DOT wrote two letters to the Competent NRC licensee, NRC dispatched an Incident Authority for Radioactive Materials Investigation Team (IIT). The IIT's finding are Transportation in the Republic of Korea asking documented in NUREG-1405, " Inadvertent for information about the shipper and the Shipment of a Radioactive Source from Korea to procedures or requirements for shipping such Amersham Corporation, Burlington, packages. NRC does not know of any other Massachusetts."

actions that are being taken to prevent recurrence.

It should be noted that in response to a similar This eveni is considered closed for the purpose of event which occurred in 1990 that involved an this report.

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NUREG-0090. Vol.18. No. 3

1 Abnormal Occurrences,3rd Otr CY95 3

APPENDIX A j

)

ABNORMAL OCCURRENCE CRITERIAI i

'Ihe following criteria used to determine an 3.

The release of radioactive materia' 'o an i

abnormal occurrence (AO) were set forth in an unrestricted area in concentrations which, if NRC policy statement published in the Fedeml 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 Register on February 24,1977, (Vol. 42, No. 37, 500 times the regulatory limit of Appendix B, pages 10950-10952).

Table U,10 CFR Part 20 [CFR 20.403(b)(2)].

An event will be considered an AO if it involves a 4.

Radiation or contamination levels in excess of major reduction in the degree of protection of the design values on packages, or loss of public health or safety. Such an event would confinement of radioactive material such as mvolve a moderate or more severe impact on the (a) a radiation dose rate of 1000 mrem per public health or safety and could include but need hour three feet from the surface of a package not be limited to:

containing the radioactive material, or (b) release of radioactive material from a

1.. Moderate exposure to, or release of, package in amounts greater than the I

radioactive material licensed by or otherwise regulatory limit.

i regulated by the Commission;

)

5.

Any loss oflicensed materialin such 2.

Major degradation of essential safety-related quantities and under such circumstances that equipment; or substantial hazard may result to persons in unrestricted areas.

i 3.

Major deficiencies in design, construction, use of, or management controls for licensed 6.

A substantiated case of actual or attempted facilities or material theft or diversion of licensed material or i

> sabotage of a facility.

Examples of the types of events that are evaluated in detail using these criteria are:

7.

Any substantiated loss of special nuclear material or any substantiated inventory For All Licensees discrepancy that is judged to be significant t

relative to normally expected performance 1.

Exposure of the whole body of any m. dividual and that is judged to be caused by theft or to 25 rem or more of radiation; exposure of diversion or by substantial breakdown of the the skm of the whole body of any mdividual accountability system.

to 150 rem or more of radiation; or exposure of the feet, ankles, hands or forearms of any 8.

Any substantial breakdown of physical individual to 375 rem or more of radiation security or material control (i.e., access

[10 CFR 20.403(a)(1)], or equivalent control, containment, or accountability exposures from internal sources.

systems) that significantly weakened the protection against theft, diversion, or 2.

An exposure to an m. dividual.

in an sabotage.

unrestricted area such that the whole body dose received exceeds 0.5 rem in one calendar 9.

An accident ntiedity [10 CFR 70.52(a)].

l year [10 CFR 20.105(a)].

10. A major d

.cy in design, construction, or i

operation h.,

g safety implications l

l ion January 1,1994, changes to ntle 10 of the Code (Fedemt requiring in sediate remedial action.

Residsens Part 20 were promulgated. At the Commisuon's direc-tive, the staff has developed a policy statement revising critena for l

various types of AOs De changes pertinent to the 10 CFR 20

11. Serious deficiency in management or l

Eof "fie co m# '"' Yin ficDIY* gee"r'" fanu*a"ry7 Procedural controls in major areas.

n 19% (WI.. No. 6, pages 661-669). Upon Commission's ap-prcval of the final policy statement, the appropnate changes to this

12. Series of events (where individual events are 3

APPendia will be pubh'ined.

not of major importance), rcCurring incidents, l

7 NUREG-0090, Vol.18. No. 3

_ _ _. _.. ~. _.

Abnormal Occurrences,3rd Qtr CY95 j

t and incidents with implications for similar of emergency core cooling system, loss of s

facilities (generic incidents) that create major control rod system).

safety concern.

For Fuel Cycle Licensees For Commercial Nuclear Power Plants 1.

A safety limit oflicense Technical 1.

Exceeding a safety limit of license Technical Specifications is exceeded and a plant Specifications [10 CFR 50.36(c)].

shutdown is required [10 CFR 50.36(c)].

2.

A major condition not specifically considered 2.

Major degradation of fuel integrity, primary in the safety analys,s report or Technical coolant pressure boundary, or primary i

S ecifications that requires immediate P

containment boundary.

remedial act,on.

i

. 3.

Loss of plant capability to perform essential 3.

An event that seriously compromised the i

safety functions such that a potential release of, radioactivity in excess of 10 CFR Part 100 ability of a confinement system to perform its guidelmes could result from a postulated designated function.

y transient or accident (e.g., loss of emergency Medical Misadministrations core cooling system, loss of control rod system).

As discussed in the Preface to this report, the NRC policy statement on AOs was published 4.

Discovery of a major condition not before licensees were required to report medical specifically considered in the Safety Analysis misadministrations to the NRC. Therefore, i

Report (SAR) or Technical Specifications that during 1984, NRC developed guidelines for requires immediate remedial action.

selecting such events for AO reporting. These guidelines, which are summarized in Thble A-1, 5.

Personnel error or procedural deficiencies augment the NRC policy statement.

that result in loss of plant capability to perform essential safety functions such that a As noted in the Preface, revised guidelines are potential release of radioactivity in excess of currently being devdoped because new medical 10 CFR Part 100 guidelines could result from misadministration definitions became effective on a postulated transient or accident (e.g., loss January 27,1992.

NUREG-0090, Vol.18, No. 3 8

Abnormal Occurrences,3rd Otr CY95 Table A-1 NRC Guidelines for Selecting Medical Misadministration Events for Abnormal Occurrence (AO) Reporting AO Reporting Threshold Event Type Diagnostic Exposure Therapeutic Exposure l

(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 evcnt.

(a) the actual dose to the if the parts of the body l

wrong body part is receiving radiation l

greater than five times improperly would have the upperlimit 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:

1 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 receiving 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 be proposed if:

effects greater than expected had the proper administration l

been used, or l

(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 I

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 Eventlype 1.

Event lype 1.

9 NUREG-0090, Vol.18 No. 3 l

Abnormal Occurrcnces,3rd 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 doc.c 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 cf fccts worse than expected for the normal range of exposures prescribed for the diagnostic procedure.

(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 errors 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 exposures prescribed for the therapeutic procedure, or, (d) the event (regardless of any health effects)affects two or more patients at the same facility.

(6) Recurring or series of For either 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 create a significant facilities involved).

public health or safety concern.

(7) Generic events.

For either diagnostic or therapeutic exposures, an AO report should be proposed for misadministrations with generic implications that create a significant public health or safety concern.

NUREG-0090, Vol.18, No. 3 10

I Abnormal Occurrences,3rd Qtr CY95 l

l APPENDIX B UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES During July through September 1995, NRC reported abnormal occurrences (AOs). During the licensees, Agreement States, Agreement State period from July 1 through September 30,1995, licensees, and other involved parties, such as no updates of previously reported AOs were reactor vendors and architect-engineering firms, received. Those updated events which still require continued with the implementation of actions additional information will be discussed in future necessary to prevent recurrence of previously reports.

11 NUREG-WX), Vol.18, No. 3

Abnormal Occurrences,3rd Otr CY95 l

APPENDIX C OTHER EVENTS OF INTEREST "Other Events of Interest" are reported because reportable as abnormal occurrences. During the they can be perceived as being significant but period from July 1 through September 30,1995, have been determined not to involve a major no "Other Events of Interest" items were l

reduction in the level of protection provided for reported.

public health or safety; therefore they are not I

i l

13 NUREG-0090, Vol.18 No. 3

NRC FORM 335 U.S. NUCLEAR REGULQTORY COMMISS;ON

1. REPORT WUMBER (2 89)

(Assigned by NRC. Add Vol..

NRCM 1102.

Supp., Rev., and Addendurn Nurn-i s201,3202 BIBLIOGRAPHIC DATA SHEET b" * - " *"Y 3 l

i (S.e instructwm on the reverse)

NUREG-0090 l

i Vol.18, No. 3

2. mLE AND SUDTITLE

^'" "'" "' ""*"*"'

Report to Congress on Abnormal Occurrences:

July-September 1995 MONTH YEAR February 1996 I

l

4. FIN OR GRANT NUMBER

6. AUTHOR (5)

6. TYPE OF REPORT Quarterly

7. PERIOD COVERED (inclusive Dates)

July-September 1995 l

8. PERFORMING ORGANIZAllON - NAME AND ADDRESS (if NRC prov6de DMelon. Office or Region. U.S. Nuclear Regulatory Comrnission, and malling address; 11 contractor, provide narne and malling address.)

Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 l

G. SPONSORING ORGANIZATION - NAME AND ADDRESS (if NRC, type *Same as above"i If contractor, provide NRC Divis6on, Off6ce or Reglon, U.S. Nuclear Regulatory Commission, and malling address.)

Same as 8., above

10. SUPPLEMENTARY NOTES

11. ABSTRACT (200 words or less)

Section 208 of the Energy Reorganization Act of 1974 identifies 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 i

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 July 1 through September 30,1995.

l This report addresses three AOs at NRC-licensed facilities. 'Iko involved medicalbrachytherapy misadministrations and I

one involved ingestion of radioactive material by research workers. One AO submitted by the Agreement States is in-cluded. It involved importation into the United States of a package having excessive radiation. No updates of previously l

reported AOs are included in this report. No "Other Events of Interest" items are being reported.

l l

l

12. KEY WORDS/DESCRIPTORS (List words or phrases that will assist researchers in locating the report.)

13. AVAILADIUTY STATEMENT Unlimited Medical Brachytherapy Misadministration; Ingestion of Radioactive Material; Package Having Excessive External Radiation

14. SECURITY CLASSIFICATION (This Page)

Unclassified (This Report)

Unclassified

15. NUMBER OF PAGES

16. PRICE NRC FORM 335 (2-89)

i J

Printed on recycled paper Federal Recycling Program

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