ML20069B940

Report to Congress on Abnormal OCCURRENCES.October-December 1993

ML20069B940
Person / Time
Issue date:	04/30/1994
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
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References
NUREG-0090, NUREG-0090-V16-N04, NUREG-90, NUREG-90-V16-N4, NUDOCS 9405310231
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i NUREG-0090 Vol.16, No. 4 Report to Congress on Abnormal Occurrences October - De.cember 1993 U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data l

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NUREG-0090 Vol 16, No. 4 Report to Congress on Abnormal Occurrences October - December 1993 Date Published: April 1994 Omce for Analysis and Evaluation of Operational Data U.S. Nu ' ar Regulatory Commission We king.on, DC 20555

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~ Abnormal Occurrences,4th Qtr CY93 Previous Reports in Series NUP.EG 75/090 (January-June 1975), published October 1975.

l NUREG-0090-1 through 10 (July-September 1975 through October-December 1977), published March 1976 through March 1978.

NUREG-0090, Vols. I through 15 (January-March 1978 through October-December 1992), published J une 1978 through March 1993.

NUREG-0090, Vol.16, Nos. I through 3 (January-March 1993 through July-September 1993), published June 1993 through March 1994.

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ii NUREG-0090, Vol.16, No. 4

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Abnormal Occurrences,4th Qtr CY93 ABSTRACT l

Section 208 of the Energy Reorganization Act of 1974 misadministrations, and one involved an overexposure to identifies an abnormal occurrence as an unscheduled inci-a nursing infant. Seven abnormal occurrences that were 1

l dent or event that the Nuclear Regulatory Commission reported by the Agreement States are also discussed, determines tobe significant from the standpoint of public based on information provided by the Agreement States health or safety and requires a quarterly report of such as of February 28,1994. Of these events, three involved events to be made to Congress. This report covers the pe-brachytherapy misadministrations, one involved a tele-nod from October 1 through December 31,1993.

therapy misadministration, one involved a theft of radio-This report discusses six abnormal occurrences at NRC-active material during transport and improper disposal, l

licensed facilities. Five involved medical brachytherapy and two involved lost sources.

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iii NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Otr CY93 CONTENTS Page-Abstract............................................................................................

iii Preface............................................................................................. vii In t rod u ctio n................................................................................... Vii Th e Regula tory Syst em........................................................................... Vil Reportable Occu rrences....................................................................... ". Vii Agre em e n t S ta t es............................................................................... viii Foreign Informat ion.............................................................................. vili Reopening of Closed Abnormal Occurrences........................................................ viii Report to Congress on Abnormal Occurrences, October-December 1993...................................

1 Nucl ear Power Plants.............................................................................

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

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

1 93-11 Medical Brachytherapy Miradministration at Washington University Medical School in St. Louis, M issouri....................................................................

1 93-12 Medical Brachytherapy Misadministration at Mercy Hospital in Scranton, Pennsylvania.......

2 93-13 Medical Brachytherapy Misadministration at Mountainside Hospital in Mon tclair, New Jersey.................................................................

3 93-14 Exposure to a Nursing Infant at Queen's Hospital in

- Ho n ol ul u, Hawaii.....................................................................

4 93-15 Medical Brachytherapy Misadministration at Good Samaritan Medical Center in Za n e svill e, O hio......................................................................

5 93-16 Medical Brachytherapy Misadministration at Marquette General Hospital in Marqu et t e, Michigan................................................................

6 Agree m en t S tat e License es...........................................................................

6 AS 93-10 Theft of Radioactive Material During Ransport and Improper Disposal.................

6 AS 93-11 Found Source at Scrap Metal Facility in Magnolia, Arkansas...........................

8 AS 93-12 Medical ~bletherapy Misadministration at Rocky Mountain Gamma Knife Center in Denver, Colorado.................................................

9 AS 93-13 Lost or Stolen Radiation Source at BPB Instruments, Inc. in Midland, Texas............ 10 AS 93-14 Medical Brachytherapy Misadministration at Michael Reese Medical Center in Ch ica go, Illinois................................................................ 11 AS 93-15 Medical Brachytherapy Misadministration at Mt. Sinal Medical Center in Miami B each, Florida..........................................................

11 AS 93-16 Medical Brachytherapy Misadministration at Richland Memorial Hospital in Columbia, South Carolina.............................................. 12 y

NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Qtr CY93 CONTENTS (cont.)

References.......................................................................................

14 Appendix A - Abnormal Occurrence Criteria...........................................................

15 Appendix B - Update of P.eviously Reported Abnormal Occurrences..................................

19 O th e r N RC Lice n se e s....................................................................

19 92-18 Iess'of Iridium-192 Source and Medical Therapy Misadministration at Indiana Regional Cancer Center in Indiana. Pennsyhania................................

19 92-19 Medical Therapy Misadministration and Tbmporary Loss of Brachytherapy Source at Yale-New Haven Hospital in New Haven. Connecticut.................................

19 93-3 Medical Therapy Misadministration Involving the use of a High Dose-Rate Remote Afterloader Brachytherapy Device at Yale-New Haven Hospitalin New Haven, Connecticut....................

20 93-10 Medical Sodium Iodide Misadministration at Osteopathic Hospital Founders Association DBA (doing business as)Tblsa Regional Medical Center in 7bisa, Oklahoma 20 Agreement State Licensees.....

21 AS 87-5 Therapeutic Medical Misadministrations at Northern Westchester Hospital Center, Westchester County, New York.............................................. 21 AS 88-4 Multiple Medical Therapy Misadministrations at Rochester General F ospital, M on roe Cou n ty, New Yo rk..................................................... 22 AS 93-7_

Medical Radiopharmaceutical Misadministration by " Unspecified Liccasee" in Any, New York.

22 AS 93-8 Medical Sodium Iodide Misadministration at Inland Imaging in Spokane, Washington....................

23 Appendix C - Other Events Of Interest 25 Nuclear Power Pbnts.

25 1.

Cracks in the Core Shroud at Brunswick Unit 1 Nuclear Plant............................. 25 2.

Jet Pump Beam Failure at Grand Gulf Nuclear Plant.................................... 27 3.

Fire at Enrico Fermi Nuclear Plant, Unit 2.......................................... 28 4.

Steam Generator Boiled Dry at McGuire Nuclear Plant, Unit 2 as a Consequence of a Loss of Offsite Power............................................... 29 O t h e r N RC Licensees........................................................................ 30 5.

Medical Brachytherapy Misadministration at the University of Minnesota in Minneapolis, Minnesota 30 Appendix D - Agreement State Events Being Considered As Abnormal Occurrences........................ 31 vi NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Otr CY93 f

PREFACF, l

Introduction and safety.These events are not reportable as abnormal occurrences but are provided as other events of interest.

The Nuclear Regulatory Commission reports to the Con-Appendix D has been added to this report which includes gress each quarter, under provisions of Section 208 of the events submitted by Agreement States that are likely to be Energy Reorgamzation Act of 1974, any abnormal occur-categorized as abnormal occurrences.

rences involving facilities and activities regulated by N RC.

An abnormal occurrence (AO)is defined in Section 208 as For these events, insufficient information was available in an unscheduled meident or event that the, Commission time for publication to positively identify them as abnor '

determines is significant from the standpomt of pubh,c mal occurrences.

health or safety.

l Events are currently identified as abnormal occurrences The Regulatory Sy, stem for this report by NRC using the criteria and accompany-ing examples listed in Appendix A. Rese criteria were l

promulgated in an NRC policy statement that was pub-The system oflicensing and regulation by which NRC car-lished in the Federal Register on February 24,1977 (Vol. 42, rics out its responsibilities is implemented through rules and regulations in Title 10 of the Code offederalRegula-No. 37, pages 10950-10952).

tions. This includes public participation as an element.Tb The NRC policy statement was published before licensees accomplish its objectives. NRC regularly conducts licens-i were required to report medical misadministrations to ing proceedings, inspection and enforcement activities,-

NRC. Few of the examples in the policy statement are evaluation of operating experience, and confirmatory re-applicable to medical misadministrations.Therefore, dur.

search, while maintaining programs for establishing stan-ing 1984, NRC developed guidelines for selecting such dards and issuing technical reviews and studies.

events for abnormal occurrence reporting. These guide-lines, which have been used by NRC since the latter part In licensing and regulating nuclear power plants and the of 1984, augment the NRC policy statement examples and uses of byproduct nuclear materials, NRC follows the phi-l are summarized in'Ihble A-1 in Appendix A. On January I sophy that the health and safety of the public are best 27,1992, new medical misadministration definitions be-ensured by establishing multiple levels of protection.

came effective.Therefore, revised guidelines foridentify-These levels can be achieved and maintained through reg-ing medical misadministrations as abnormal occurrences ulations spectfying requirements that will ensure the safe are currently being developed.ne revised guidelines will use of nuclear materials. The regulations include design be published for comment in the Federal Register, and quality assurance criteria appropriate for the various activities licensed by NRC. An inspection and enforce-In order to provide wide dissemination of information to ment program helps ensure compliance with the regula-tions.

the public, a Federal Register notice is issued on NRC ii.

censee abnormal occurrences. Copies of the notice are distributed to the NRC Public Document Room and all I.Acal Public Document Rooms. At a minimum, each no.

Reportable Occurrences tice must contain the date and place of the occurrence and describe its nature and probable consequences.

Actual operating experience is an essential input to the regulatory process for assuring that licensed activities are NRC has determined that only those events described in conducted safely. Licensees are required to report certain this report meet the criteria for abnormal occurrence re-incidents or events to NRC. This reporting helps to identi-porting. This report covers the period from October 1 fy deficiencies early and to ensure that corrective actions through December 31, 1993. Information reported on are taken to prevent recurrence.

cach event includes date and place, nature and probable consequences, cause or causes, and actions taken to pre.

For nuclear power plants, dedicated groups have been vent recurrence.

formed both by the NRC and by the nucIcar power indus-try for the detailed review of operating experience to help Appendix 13 contains updated information on previously identify safety concerns early; to improve dissemination of reported abnormal occurrences, such information; and to feed back the experience into li-censing, regulations, and operations. In addition, NRC Appendix C provides descriptions of events that can be and the nuclear power industry have ongoing efforts to perceived as significant but do not involve a major reduc-improve the operational data systems, which include not i

tion in the level of protection provided for public health only the type and quality of reports required to be sub-vii NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Otr CY93 mitted,but also the methods used to analyze the data. In States whereby the Commission relinquishes and the crder to more effectively collect, collate, store, retrieve, States assume regulatory authority over byproduct, and evaluate operational data, the information is main-source, and special nuclear materials (in quantities not ca-l tained in computer-based data files.

pable of sustaining a chain reaction). Agreement State l

programs must be comparable to and compatible with the Three primaty sources of operational data are Licensee Commission's program for such material.

Event Reports (LERs) submitted pursuant to 10 CFR 50.73, immediate notifications made pursuant to 10 CFR Presently, information on reportable occurrences in i

l 50.72, and medical misadministration reports made pur-Agreement State licensed activities is publicly available at suant to 10 CFR 35.33.

the State level. For the purpose of developing a nation-wide database, Agreement States are encouraged to pro-l Except for records exempt from public disclosure by stat-vide information to.NRC on reportable events.

l ute and/or regulation,information concerning reportable occurrences at facilities licensed or otherwise regulated in early 1977, the Commission determined that abnormal by NRC is routinely disseminated by NRC to the nuclear occurrences happening at facilities of Agreement State 11-industry, the public, and other interested groups as these censees should be included in the quarterly reports to events occur.

Congress. The abnormal occurrence criteria included in Appendix A are applied uniformly to events at the NRC Dissemination includes special notifications to licensees and the Agreement State licensee facilities. Procedures and other affected or interested groups, and public an-have been developed and implemented, and abnormal oc-l nouncements. In addition, information on reportable currences reported by the Agreement States to NRC are events is routinely sent to the NRC's more than 100 Local included in these quarterly reports to Congress.

Public Document Rooms throughout the United States and to the NRC Public Document Room in Washington, D.C.The Congress is routinely kept informed of report-Foreign Information able events occurring in licensed facilities.

Another source of operational data is reliability data sub-NRC participates in an exchange ofinformation with vari-mitted by licensees under the Nuclear Plant Reliability

"( *E"E *"**n stQanannudear{aQ.hs mgn mformation is reviewed and considered m the Data system (NPRDS).The NPRDS is a voluntary,indus-try-supported system maintained by the Institute of Nu-s assessment of operayng experience and in its [e-clear Power Operations (INPO), a nuclear utility organi-search and regulatory activities. Reference to foreign m-zation. Iloth engineering and failure data are submitted by f rmation may occasionally be made in these quarterlyab-n rmal ecurrence reports to Congress; however, only nuclear power plant licensees for specified plant compo-nents and systems. The Commission considers the domestic abnormal occurrences are reported.

NPRDS to be a useful supplement to the LER system for 11 ti, review, and feedback of operational expe-Reopening of Closed Abnormal Occur-rien e.

rences Agreement States NRC reopens previously closed abnormal occurrences if significant new information beccmes available. Similarly, Section 274 of the Atomic Energy Act, as amended, au-previously reported Other Events of Interest items are thorizes the Commission to enter into agreements with updated if significant new information becomes available.

1 viii NUREG-0090, Vol.16, No. 4

l-Abnormal Occurrences,4th Qtr CY93 i

i REPORT TO CONGRESS ON ABNORMAL OCCURRENCES g

OCTOBER-DECEMBER 1993 a

Nuclear Power Plants NRC is reviewing events reported at the nuclear power determined that no events were abnormal occurrences.

plants licensed to operate. For this report, NRC has-Fuel Cycle Facilities (Other than Nuclear Power Plants)

NRC is reviewing events reported by these licensees. For abnormal occurrences.

this report, NRC has determined that no events were.

Other NRC Licensees (Industrial Radiographers, Medical Institutions, _

Industrial Users, etc.)

1 There are currently over 7,500 NRC nuclear material without being programmed to do so and without a guide r

licenses in effect in the United States, principally for the tube and applicator attached to the channel. The use of radioisotopes in the medical, industrial, and unguided source lay at an approximate distance of 3 academic fields. Incidents were reported in this category centimeters (cm) (1.2 inches [in]) from the nearest skin by licensees such as radiographers, medical institutions, surface for approximately 5 minutes. The licensee academic institutions, and byproduct material users. NRC estimated that less than 0.1 centigray (cGy) (0.1 rad) of is reviewing events reported by these licensees. For this additional dose was delivered to the skin surface.

report,usingthecriteriaandguidelinesgivenin Appendix A, NRC has identified the following events as abnormal On February 26,1993, a very similar incident occurred at -

occurrences. As noted in the Preface to this report, the the same facility. The incident involved a different patient guidelines for identifying medical misadministrations as and the same remote afterloader unit.The device again abnormal occurrences are currently being revised.

ejected the same strength and type of radioactive source without being programmed to do so. However, in this case, the source - lay near the patient's leg for 93-11 Medical Brachytherapy approximately 60 to 75 minutes, at an approximate Misadininistration at distance f 5 cm (2 in) from the nearest skin surface.The licensee estimated the additional dose to the patient's leg Washington University to be approximately 3.5 coy (3.5 rad).

Medical School in In both cases, the treatment of each patient was l

St. Louis, Missourl completed on another LDR remote afterloader unit in I

another room of the medical center.

The following information pertaining to this event is also being reported concurrently in the Federal Register.

Cause or Causes-After the first incident on January 7

- Appendix A(see EventTjpe 3in'Ihble A-1)of this report 1993, a manufacturer service engineer, who studied the notes that a therapeutic dose that results in any part of the device malfunction, was unable to identify the cause of body receiving unscheduled radiation can be considered the failure during his repair visit. The licensee's staff an abnormal occurrence.

subsequently tested the device for 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> without discovering the cause of the failure, and concluded that Dite and Place-January 7,1993 and February 26,1993; the device was acceptable for use.This decision was based Washington University Medical School; St. Louis, on the fact that they could not reproduce the malfunction.

Missouri.

The remote afterloader was put back into service. On l

February 26,1993, the device failed again when a second l

Ntture and Probable Consequences-On January 7, unprogrammed source was ejected by the afterloader.

l 1993, a Nucletron Micro-Selectron low-dose-rate (LDR)

After this incident, which resulted in the second remote afterloader unit ejected a radioactive source misadministration, the manufacturer provided a different 1

NUREG-0090, Vol.16, No. 4 l

Abnormal Occurrences,4th Otr CY93 3

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field engineer who correctly diagnosed the problem as a Nature and Probable Consequences-On October 15, l

failure in an operational amplifier.

1993, Mercy llospital in Scranton, Pennsylvania, notified NRC Region I of a therapeutic misadministration A previous recommendation made by the manufacturer involving a Nucletron MicroSelectron high dose rate i

to store unused sources in the auxiliary storage safe, (11DR) remote afterloader which occurred at the facility I

instead of the remote afterloader's mobile storage on April 23, 1993. The licensee identified this i

container, may have contributed to the incident. The misadministration during a review of the past treatment j

second field engineer indicated that some of the safety records.

I features which prevent sources from being erroneously l

ejected were not in effect or were not monitored by the A patient was scheduled to receive brachytherapy device for the unprogrammed channels containing the treatment to the apex of her vagina in three fractions unused sources.

using a Nucletron Micro Selectron 11DR remote afterloader. The prescribed dose was 500 centigray (cGy)

Actions Taken To Prevent a Recurrence (500 rad) for each fraction and the use of a ring applicator was specified. On April 13, 1993, the patient was Licensee-The licensee informed the NRC that use of the administered the first fractional treatment. After an two Micro-Selectron-LDR remote afterloader units will examm pon of the patient following the first treatment, be discontinued and a new model LDR afterloader will be the physician revised the written directive and prescribed 4

l installed. NRC has also asked the licensee to address the a change from the ring applicator tg a standard vagmal manufacturer's recommendation for storing the sources cylindrical applicator for the remammg two treatments.

and the removal of some of the safety features, and any On April 23,1993,durmgtheadmmistrat,onof thesecond i

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resulting corrective actions, treatment, the therapist erroneously entered the catheter length of 920 millimeter (mm) (36.2 mch) into the treatment computer instead of the intended 992 mm (39.1

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NRC-The vendor has now revised the device's operating inch).The physician failed to identify this error during his j

software to monitor and generate error messages and review of the treatment parameters prior to the initiation l

1 audible alarms for unprogrammed (unused) channels.

of the treatment' The NRC has sent a letter (Ref.1) to the licensee i

identifying the two events as misadministrations and 1

requestmg that the licensee ensure the required As a result of this erroneous entry, a majority of the 4

notifications to the referring phys,cians and patients have treatment dose was administered to an unintended region i

near the opening of the vagina, and the intended site received an underdose differing from the prescribed dose by more than 20 percent. The physician stated that no 4

During an NRC safety inspection conducted from adverse clinical effects are expected as a result of the i

November 15 to 18,1993, the mspectors focused on these underdose to the target site because this treatment was two meidents m addition to other inspection areas. The intended to administer a booster radiation dose. The results of this mspection are still under review.

oncologist also stated that the patient is not expected to experience any adverse effects as a result of the 500 cGy This report will be further evaluated when additional (500 rad) overexposure to the wrong treatment site information becomes available.

misadministration. The NRC medical consultant, in his report to Region I, also stated a similar opinion (that it is unlikely the patient will suffer any adverse effects from 93-12 Medical Brachytherapy -

the misadministration).

1 Misadministration at Mercy The third fraction of the treatment was administered to i

Hospital in Scranton, the patient on April 29,1993, as prescribed.

Pennsylvania The referring physician and the patient have been The following information pertaining to this event is also notified. The licensee submitted a written report of the being reported concurrently in the Federal Register.

misadministration to NRC Region I on October 29,1993.

m Appendix A(see Event'Iype3in'Ihble A-1)of thisreport notes that a therapeutic dose that results in anypart of the Cause or Causes-The therapist did not enter the correct l

body receiving unscheduled radiation can be considered catheter length during initial setup for the second an abnormal occurrence.

treatment. The licensee followed established proc::Jures; however, the procedure did not require verification of all i

Date and Place-October 15, 1993; Mercy Hospital; parameters at the time of the second check prior to each Scranton, Pennsylvania.

treatment.

i NUREG-0090, Vol.16, No. 4 2

Abnormal Occurrences,4th Qtr CY93 i

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l Actions Taken to Prevent Occurrence Date and Place-July 1,1993; Mountainside llospital; Montclair, New Jersey.

i Licensee-He licensee has instituted a requirement that a medical physicist also review the final treatment plan Nature and Probable Consequences-On December 1, prior ' to initiating the treatment. De treatment 1993, during a routine inspection, NRC-identified a

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parameters for all brachytherapy (HDR) treatments will therapeutic misadministration involving a high-dose-rate I

be transferred electronically to the magnetic card directly (HDR) remote afterloader, which occurred at from the simulator. De output of this card will be Mountainside Hospital in Montclair, New Jersey, on July -

reviewed by the medical physicist and the oncologist 1,1993. 'NRC identified the misadministration while

- before the initiation of the treatment.

reviewing the licensee's Radiation Safety Committee (RSC) meeting minutes for 1993.

l' NRC-Region I conducted a special inspection at Mercy On July 1,1993, a patient was scheduled to receive the last Hospital on October 19, 1993. Inspection Report No.

030-02983/93-001, issued November 5,1993, identified.

of three brachytherapy treatments to the right mainstem.

' bronchus. Each fraction was to dehver 750 centigray (cGy) two apparent violations: (1) failure to require supervised (750 rad) to the target using a Nucletron Micro-Selectron individual to follow written quality management HDR remote afterloader and a mtrabronchial catheter, procedures (QMP) 10 CFR 35.25(a)(2); (2) failure to During the July 1,1993 treatment, the radiation include policies and procedures in the QMP to meet the oncol gist mistakenly connected the catheter to the HDR objective that each administration is in accordance with afterloader with a 750 mm (29.5 inch) transfer tube the written directive 10 CFR 35.32(a). After receipt and mstead of a short connector. This prevented the source review of the medical consultant's report, Region I issued a Notice of Violation to the licensee on February 9,1994, from entering the m, trabronchial catheter, and while classifying the two violations at Severity Level IV in delivering a negligib!c dose to the tumor, the face, the lenses of the eyes, the thyroid, and the whole body of the accordance with the NRC Enforcement Policy.

patient received unscheduled exposure.

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An NRC medical consultant has been retained to review Tne source strength at the time of the incident was l

this misadmmistration. De medical consultant's report 161,000 megabecquerel (4.35 curie) of iridium-192 and (Ref. 3) was received by Region 1 oh February 3,1994. Die the exposure time was 445.5 seconds. Following the l

medical consultant questioned the licensee concernmg its reconstruction of the incident by the licensee, the surface identification of a radiation oncologist as the referring dose to the lens of the left eye was determined by the physician. After discussion with the NRC s medical licensee to be 1.97 cGy (1.97 rad), the dose to the chin (the consultant, the hcensee identified the patient s physician closest surface of the body) was 4.56 cGy (4.56 rad), and as the primary referring physician and then agreed t the dose to the thyroid was 3.07 cGy (3.07 rad). The notify the physician. Followmg a review of the medical physician identified the error upon termination of the consultant's report, Region I confirmed m a telephone treatment and wrote a memorandum about the incident conversation that the licensee had contacted the patient,s to the hospital's physicist and radiation safety officer physician regarding the misadmm, istration. The licensee (RSOA' stated that both referring physicians have been notified of this misadministration. De radiation oncologist had The physician mistakenly determined that the incident discussed the misadm, istration with the patient on was not a misadministration, and so advised the RSO.The m

October 21,1993.

RSO, relying on the physician's judgment, did not notify NRC and filed the report in the RSC minutes folder.The This item is considered closed for the purpose of th.

radiation oncologist decided against making up the missed is report.

third fraction of therapy.

On ecember 3,1993, NRC notified the licensee by 93-13 Medical Brach) therapy t

telephone that ' he event constituted a misadnunistration Misadministration at and the licensee notified the NRC Operations Center on l

Mountainside Hospital in the same day. The licensee's written report of the misadmm,stration, dated December 13, 1993, was i

Montclair, New Jersey received in the NRC Region I office 'on December 17, 1993.

The following information pertaining to this event is also being reported concurrently in the Federal Register.

After review of the report, Region I called the licensee to Appendix A(see Event %pe 3 in'Ihble A-1)of this report determine if the referring physician and the patient were -

notes that a therapeutic dose that results in any part of the notified of the misadministration.The licensee forwarded body receiving unscheduled radiation can be considered a copy of a letter dated December 20, 1993, from the an abnormal occurrence, radiation oncologist to the referring physician confirming 3

NUREG-0090, Vol.16, No. 4

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Abnormal Occurrences,4th Qtr CY93 i

a December 6,1993, telephone conversation in which the setup and treatment as recommended NRC Bulletin referring physician was informed of the 93-01, it is likely that this misadministration would not misadministration. He letter indicated that the referring have occurred. In the consultant's opinion, a medical physician did not feel it would be in the patient's best physicist would have been more likely to have noticed the interest to be notified of the misadministration.

human error in the set up of the third HDR treatment.

NRC contracted a medical consultant to determine the An enforcement conference has been scheduled.

l significance of the misadministration to the patient.He I

medical consultant's report was received by Region I on This report will be further updated when additional February 3,1994.The consultant's calculations of doses to information becomes available.

the lens of the left eye, the chin, and the thyroid of the patient agreed with the licensee's estimates, based on the strength of the source, the time of exposure and the 93-14 Exposure to a Nursing Infant distances of the source from the patient. He consultant at Queen'S Hospital in l

concluded that the patient would not suffer any adverse Honolulu, Hawaii effects from the misadmtmstration. The medical consultant also determined that the oncologist failed t notify the patient of the misadministration because he did The following information pertaining to this event is also j

not fully understand the requirements of 10 CFR being reported concurrently in the Federal Register.

l 35.33(a)(3). After discussions with the consultant, the Appendix A(see General Criterion 1) of this report notes referring physician agreed to inform the patient of the that a moderate exposure to, or release of, radioactive misadministration.

material licensed by or otherwise regulated by the Commission can be considered an abnormal occurrence.

Cause or Causes-An error by the attending physician in Date and Place-December 2,- 1991; Queen's Medical connecting the catheter to the HDR remote afterloader, Center; Honolulu, Hawaii.

and the failure of the console operator to recognize the faulty connection were the direct causes of the event.

Nature and Probable Consequences-On October 25, Both individuals relied on the treatment computer t 1993, during a routine safety inspection, a Region V indicate any problems with the therapy setup. The inspector discovered an unreported unscheduled computer on a Nucletron HDR ts not designed to alert the exposure to the thyroid of a 9-month-old nursing infant.

user to an mcorrect connection of a longer transfer tube.

On December 2,1991, a patient was administered 0.56 megabecquerel (15 microcuries) of iodine-131 for a In addition, the medical consultant's report indicates that diagnostic scan. Although the patient noted on a hospital the second mdividual observing the transfer tube form that she was breastfeeding, the technologist failed to connection durmg each treatment setup was a different notice this notation until the patient returned for a scan console operator. Since the console operator in the following day. The patient was informed of the attendance during the third treatment had not been oversight by the licensee and was instructed to stop present during the prior treatments, he/she was unaware breastfeeding. De authorized user and the referring of the mtended setup.

physician were also notified on December 3,1991.

Actions Taken to Prevent Occurrence The licensee's Radiation Safety Officer calculated the infant's absorbed thyroid dose to be approximately 250 Licensee-The licensee arranged for additional training millisievert (mSv)(25 rem) based on information obtained by Nucletron on July 30,1993. The training was attended during an uptake scan of the mother 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> after the by both HDR remote afterloader units authorized users administration.

and by three technologist-console operators.

The NRC retained a medical consultant to evaluate the NRC-NRC is reviewing the licensee's December 17, circumstances of this misadministration. The consultant 1993 misadministration report (Ref. 4) and the findings of estimated the dose to the infant's thyroid to be between the December 1,1993 NRC inspection. An NRC medical 160 to 650 mSv (16 to 65 rem). The medical consultant consultant was retained to review'the misadministration.

concluded that the infant is not likely to experience any adverse effects as a result of this misadministration.

The medical consultant's report dated February 1,1994, was received by the NRC Region I office on February 3, Cause or Causes-Failure of a supervised technologist to 1994. In addition to the comment made in the above adequately review the hospital form used to inform the sections, the consultant indicated that if the licensee had hospital staff that a patient is pregnant or breastfeeding as required a medical physicist to be present during every he/she was instructed by the authorized user.

NUREG-0090, Vol.16, No. 4 4

Abnormal Occurrences,4th Qtr CY93 Actions Taken to Prevent Recurrence location. Another mdiograph was done to verify the source location. He treatment time was recalculated to Licensee-The screening procedure used to inform the deliver the total original intended dose and the treatment j

hospital staff that a patient is pregnant or breastfeeding was completed without further difficulty.

was incorporated into the clinical procedure manual. It was reviewed by each of the technologists, and it will be He sources were in the improper location for about three reviewed by all new technologists upon being hired. It will hours, delivering an estimated dose to the larynx area of also be reviewed annually during a radiation safety about 282 centigray (282 rad). An NRC medicalconsultant training course, evaluated the medical aspects of the brachytherapy misadministration and concluded that the dose to the NRC-NRC conducted inspections on September 28 and larynx and surrounding area is not clinically significant.

October 25-27, 1993. The December 2,

1991 misadministration was noted and reviewed during these He physician verbally notified the patient of the inspections. A number of violations were identified as a misadministration following the successful reinsertion of result of these inspections and escalated enforcement the source ribbon. A written report was provided to the actionsarebeingconsidered. AnNRCmedicalconsultant patient on November 15,1993.

was also retained to review the case.

Cause or Causes-The immediate cause of the This report will be further updated when additional misadministration was an apparent crimp in the catheter information becomes available.

which resulted in the seeds not being placed correctly.

He seeds were blocked by the crimp at the level of the 93-15 Medical Brachytherapy Misadministration at Good An inexperienced radiation therapy technician implanted the source. During interviews, the physician stated that it Samaritan Medical Center would be difficult for an inexperienced person to know the in Zanesville, Ohio difference between a properly seated ribbon and when ribbon insertion was impeded by a crimp in the catheter.

The following information pertaining to this event is also being reported concurrently in the Federal Register.

Actions Taken To Prevent Recurrence Appendix A(see Eventlype 3inihble A-1)of this report notes that a therapeutic dose that results in any part of the Licensee-The licensee's plan for preventing recurrence body receiving unscheduled radiation can be considered of the misadministration included: (1) formalizing the an abnormal occurrence.

dosimetrist's " rule of practice" regarding comparison of the ribbon and catheter lengths prior to source Date and Place-November 10, 1993; Good Samaritan implantation in order to ensure that the ribbon is properly Hospital; Zanesville, Ohio.

seated; (2) providing training to all radiation therapy technologists and each medical physicist in the new Nature and Probable Consequences-A patient was Procedure; (3) requiring that the authorized user P ysically implant source ribbons; (4) requiring that each h

being treated for lung cancer. The treatment included performing an iridium 192 therapeutic implant. The radiation therapy technologist receive hands-on training prescribed treatment dose was 6000 rad to the patient's and instruction in source implantation; and (5) requiring lung. On November 10, 1993, a catheter was surgically that the " stat" post-insertion radiograph be hand carried implanted in the patient. Iridium-192 seeds, contained in to the prescribing physician for evaluation as soon as a ribbon, were inserted into the catheter.

Possible to determine proper source placement.

Following normal licensee procedure, the physicist NRC-A special safety inspection was conducted by NRC requested that the attending nurse order a " stat" chest Region III on January 19, 1994 to review the x-ray in order to verify source position. The " stat" circumstances surrounding this misadministration. An NRC medical consultant was also retained to review this radiograph was completed and two hours later upon review of the film, the seed positions could not be case. Based on the results of the special inspection (Ref.

visualized.1\\vo additional radiographs using different 2), NRC identified an apparent violation that is being considered for escalated enforcement action.

techniques were done. In the second radiograph, completed one hour later, the seeds were located in the patient's throat. The ribbon was removed and the This report will be further evaluated when additional physician successfully reinserted the ribbon to the proper information becomes available.

5 NUREG-0090, Vol.16, No. 4 l

1

Abnormal Occurrences,4th Qtr CY93 93-16 Medical Brachytherapy nis placement error did not result in additional exposure t

ther agant Misadministration at Marquette General Hospital The intended treatment area received about 50 percent of in Mar 9uctte* Michi an the intended dose. Subsequently, the patient received an E

additional dose to the uterus to complete the prescribed The following information pertaining to this event is also treatment. The licensee infonned the patient of the treatment mm.

being reported concurrently.in the Federal Register.

Appendix A(see Event'Iype3inThble A-1)of thisreport Cause or Causes-ne hospital routinely uses two notes that a therapeutic dose that results m any part of the lengths of catheters for brachytherapy treatments, a body recetymg unscheduled radiation can be considered shorter catheter for vaginal procedures and a longer one an abnormal occurrence.

for uterine procedures. The medical physicist inadvertently placed the cesium-137 sources in the Date and Place-November 17-19, 1993; Marquette shorter (vaginal) catheter instead of the required long General Hospital; Marquette, Michigan, catheter for the uterine procedure prescribed.

Nature and Probable Consequences-On November 17, Actions Taken to Prevent a Recurrence 1993, a patient was undergoing a brachytherapy procedure using cesium-137 sealed sources placed in a treatment Licensee-ne hospital has revised its procedures to device (catheter) inserted into the patient's uterus. When include added precautions for assuring the correct length the catheter was removed on November 19, it was catheter is used in each brachytherapy procedure, observed that it was too short to have been fully inserted into the uterine cavity.ne three sources in the catheter NRC-The NRC conducted a special inspection had actually been in the patient's vagina instead of the beginning November 29, 1993, to review the uterus.

circumstances surrounding the misadministration. No violations of NRC regulations were identified, but the The case was evaluated by an NRC medical consultant licensee was directed to review its Quality Management who concluded that the lower vagina received a radiation Program to determine what modifications were needed to dose of 2,700 centigray (2,700 rad) when it would not have prevent similar misadministrations in the future. The received a significant dose if the treatment had been NRC also retained a medical consultant to evaluate this performed as planned. The medical consultant concluded case.

that the radiation doses to the vagina would not be expected to cause any acute or long tenn effects because This report will be further updated when additional the vaginal tissue is extraordinarily tolerant of radiation.

information becomes available.

Agreement State Licensees Procedures have been Jeveloped for the Agreement Date and Place-Over several years prior to February States to screen unscheduled incidents or events using the 1993; Maryland Heights, Missouri and rural Madison and same criteria as NRC (see Appendix A) and to report the Macoupin Counties, Illinois.

events to NRC for inclusion in these quarterly reports to Congress. During this period, the Agreement States have Nature and Probable Consequences-This event identified the following events as abnormal occurrences.

involved the diversion of nuclear medicine generators Information for these events provided by the Agreement from the transportation stream by an employee of a States as of February 28,1994, is included in this report to courier service who delivers them to hospitals and picks

Congress, them up for return to the manufacturer. They were apparently stolen in order to reclaim the lead shielding as -

scrap metal. The generator internals were burned in an AS 93-10 Theft of Radioactive open barrel in a residential area and the ashes were often Material During 'Ransport discarded in rural wooded areas.The practice had gone on for several years before authorities became aware that it and Improper Disposal was occurring. ne details are as follows:

Appendix A (see Exampic 6 of"For All Licensecs") of this On February 7,1993, local police in Bunker Hill, Illinois, report notes that a substantiated case of actual or reported the discovery in a public park of medical vials attempted theft or diversion of licensed material should that appeared to have contained radioactive material.

be considered as an abnormal occurrence.

Investigation by the Illinois Department of Nuclear NUREG-0090, Vol.16, No. 4 6

Abnormal Occurrences,4th Qtr CY93 Safety (Department) revealed that the material was The daughter and son-in-law also stated that the scrap partially burnt glassware and saline vials from several yard had originally accepted the uranium shields until nuclear medicine generators. Surveys revealed that some they discovered the " Radioactive" markings. The recycler of the items were contaminated with radioactive material.

then made the individual retrieve the shields from the facility. After taking back the shields, the deceased Further investigation revealed that a resident of Bunker individual, along with his daughter and son in law, Hill worked for a courier service in St. Louis, Missouri, discarded the shields in wooded and low-lying areas along and delivered and picked up packages containing rural roads between the scrap yard and their residence in 1

radioactive material at area hospitals. The same resident, Bunker Hill. The daughter and son-in-law identified and his landlord, had been approached by local law locations where they recalled discarding the shields.

enforcement officials on several occasions to cease burning in a steel drum next to his residence. An On May 6 and 7,1993, Department staff along with State examination of the grounds around his apartment Poh,ce personnel performed radiation detectors and metal building revealed other glassware similar to that found in detector surveys m the areas where the shields were the city park. Several attempts by Department personnel known to have been discarded. That search, along with and local police to interview this individual were previous discoveries by citizens, allowed the recovery of unsuccessful and on February 22, the Department was approximately half of the 29 missing uranium shields.The informed that the individual had passed away the day shields were retneved by the courier company for before from natural causes.The individual's daughter was transport back to New York. The search was suspended contacted by mail and was asked to allow the Department until the water level in the creeks had dropped to a level that allowed the creek beds to be scarchd.

to perform surveys for radioactive contamination in the residence she and her husband shared with her fatherand Although the n. k to the gental public from this s

her small children. She did not respond to the request.

prolonged diversion of rm'oactive matertal is not significant, the radiain exposure to the deceased Several months before these events, a res. dent of the i

individual could have been significant due to his direct j

rural Alton, Illinois, area, reported to the Department the contact with the generators. The individual apparently discovery of a stainless steel cylinder that bore the believed that, since the hospitals could no longer use the j

markmg " radioactive" along with "Umon Carbide, generators, there was not radioactive material left in

'lhxedo, NY." At the time, the purpose of the cylinder was them. However, no estimate of his exposure could be not knon, but other markings indicated that it contained made without more information. The daughter and depleted uranium for shielding. During March and April son-in-law stated that the material was never stored or of 1993, several more cylinders were reported by citizens processed in their apartment, so no contamination or m the rural Alton area. Some of these cylinders bore the related exposure to minor children would have occurred.

marking "Cintichem" instead of "Um,on Carbide," but were otherwise identical. When contacted, Cintichem The findings of the investigation did reveal accountability personnel stated they had reported to their courier that 29 problems in the current method for returning used

?

uramum-shielded generators, enroute to New York from generators. In the case of lead-shielded generators used pharmacies and hospitals throughout the country, had not in community hospitals, once a return authorization is arnved. All of these generators were apparently part of a issued by the manufacturers, no mechanism exists to weekly shipment of such generators by the same courier confirm that they have arrived. In the case of the semce m St. Louis for whom the deceased Bunker Hill uranium-shielded generators, the inherent value of $1800 resident had worked.

for the uranium shield caused each one to have a serial number etched on it along with the other required At this point, the Department requested the Illinois State markings. These generators were known to be missing l

i Police to assist in the investigation. The State Police during the fall of 1992. The individual was able to cover up investigator interviewed the daughter and son-in-law of the thefts by removing the bills of lading from the shipping the deceased individual and discovered that the individual documents and destroying them so the courier service had had been stealing nuclear medicine generators for several no record that the packages existed.

years in order to reclaim the lead and to sell it to a local metal recycler. The daughter and son-in-law said that the Since the courier service operated in Missouri, the generators' accessories were burned in a steel drum on Department could not compel it to implement any the grounds of the apartment building in which they lived corrective action. Additionally, the U.S.

Nuclear and that the ashes were usually dumped in rural wooded Regulatory Commission apparently has no jurisdiction areas. The individual in question had assumed that the over these transportation activities. Jurisdiction resides uranium-shielded generators also contained lead with the U.S. Department of Transportation, but no shielding and had stolen an entire palette of them while violation of Title 49 of the Code offederalRegulations (49 they were awaiting transport back to New York.

CFR) appears to have been committed by the courier 7

NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Qtr CY93

)

service. Legal nction could not be pursued against the ne source was described as a lbxas Nuclear Model 5176 individual since he is deceased.

source holder, Serial Number 82656, containing 148 gigabcoquerel (4 curies) of Cs-137. He source was Cause or Causes-The cause of the incident was criminal distributed under TN 'Ibchnologies general license.

theft of radioactive material from the transportation stream.The failure to detect the thefts in a timely manner A TN lbchnologies Project Engineer traced the serial was due to m, adequate accountability of packages m the number to Elk Roofing Plant in Stevens, Arkansas.This return process.

facility has been sold to Lapry Paper Company, Upon completion of the phone call, the State Health Actions Taken to Prevent Recurrence Physicist called Tillman Scrap Yard to ensure that the source was located in an area away from the general public Licensee-No licensee was directly involved in this and personnel working in the scrap yard. An employee incident. The individual responsible for the occurrence with 1111 man Scrap Yard informed the State that the died from natural causes before legal action could be source had been placed in a metal bin and moved to the

taken, back of the scrap yard. The scrap yard employee was instructed to keep everyone away from the source and was State Agency-No violation of the Illinois Administrative given assurance that the State would be responding as Code or the Code offederalRegulations had occurred.The soon as possible.

Illinois Department of Nuclear Safety could have issued an order agamst the mdividual to cease the diversion or A team was dispatched to the lillman Scrap Yard where pursued criminal action with the cooperation of the State they immediately went to the area where the source was Police, but he died before such action could be taken.The located. The source had been placed in a metal scrap bin Department could not compel a courier operatmg in for relocation to the back of the yard. The source and the Missoun to take corrective action when no violation of detector was mounted to a piece of pipe. A swipe was taken on the surface of the source holder to determine if regulations could be identified on the courier s part.

the scaled source had been damaged in any way. No NRC-No federal regulations were violated. The radiation levels involved were low and represented a very The source was then removed from the bin.The shutter small risk to the public's health and safety. Extended and was found to be padlocked in the open position. The repeated exposure to low level radiation and the possible padlock was cut away and the shutter was secured in the inhalation from burning the vials could have had adverse closed position. The mounting bolts were also removed effects to those directly involved in the theft and isolating the source from the associated equipment.

destruction of the generator remains but there was no indication of such effects. No NRC actions were taken.

Thesourcewaspackedm, a133-liter (35-gallon)drumand labeled as a Yellow-II package.ne radiation readings on This item is considered closed for purposes of this report.

contact were 0.23 microcoulomb per kilogram per hour (C/kg/hr) (0.9 milliroentgen per hour [mR/hr]) and at 1 meter (3.3 feet) 0.015 C/kg/hr (0.06 mR/hr). The source AS 93-11 Found Source at Scrap was removed from the affected area. A contamination survey of the enttre work area was carried out. No Metal Facility in Magnolia, contamination was found. The area was released for Arkansas unrestricted use.

Aftet several discussions with the lawyers of Elk Roofing Appendix A (see Example 5 of"For All Licensees",)of this Company and Lapry Paper Company, it was decided that report notes that any loss of heensed material m such Elk Roofing Company would pay for the final disposal of quantities and under such circumstances that substantial the gauge. A representative from TN 1bchnologies came hazard may result to persons in unrestricted areas should to the department on April 26, 1993, and took final be considered an abnormal occurrence.

possession of the device.

Date and Place-March 24,1993; Thllman Scrap Yard; Cause or Causes-Insufficient information is available to Magnolia, Arkansas.

determine the cause(s) of this event. NRC has asked the State of Arkansas to provide any additional information Naturs and Probable Consequences-On March 24, regarding the cause(s) of this event.

1993, approximately 4:15 p.m., an employee with TN Actions Taken to Prevent Recurrence ibchnologies notified the State by phone that a

cesium-137 (Cs-137) source had been located at 1111 man Licensee-Insufficient information is available on the Scrap Yard in Magnolia, Arkansas, action (s) taken by the licensee to prevent recurrence.

NUREG-0090, Vol.16, No. 4 8

Abnorm:I Occurr:nces,4th Otr CY93 NRC has asked the State of Arkansas to identify any The team then generated two separate treatment plans licensee action (s).

for the two separate targets. The radiation oncologist was consulted and concurred with the dose prescription. It was State Agency-Insufficient information is available on the noted that the "X" coordinates for the targets indicated a l

action (s) taken by the State Agency to prevent right-of-midline stereotactic position, but the patient's I

recurrence. NRC has asked the State of Arkansas to head was tilted inside the frame, placing the midline of provide additional information regarding the State the brain to the left of the midline of the stereotactic Agency's action (s).

system. Therefore, the coordinates were accepted as plausible. After initiating the treatment sequence for the next exposure, the physician reviewed the target points This report will be further evaluated when additional and noticed that the X coordinates mdicated a definite information becomes available.

l nght-side target. The physicist immediately termmated l

the exposure and notified the physician of a possible tre tment err r. It w s determined that the Y and Z AS 93-12 Medical TbletheraPY coordinates were accurate, but the X offset resulted m a Misadministration at Rocky target miss by 16 millimeters (0.63 inches).

Mountain Gamma Knife The brainstem was stated to be the only critical structure Center, Denver, Colorado within the 10 percent isodose contour. Reconstruction of the dose profile indicated that less than 10 cubic Appendix A(see EventType 3inThble A-1)of this report millimeters received no more than 2.5 gray (Gy)(250 rad).

notes that a therapeutic dose that results in any part of the The tolerance dose for the brainstem was stated to be 10 body receiving unscheduled radiation can be considered Gy (1000 rad). The remainder of the dose within the 10 an abnormal occurrence.

Percent isodose line was stated to be of in the cerebrum and cerebellum. It was the opinion of the neurosurgeon that the dose delivered was well below the dose-volume Date and Place-July 8,1993; Rocky Mountain Gamma threshold for mducmg any neurological damage.

Knife Limited Liability Company; Denver, Colorado, Cause or Causes-The angiographic study was done in an Nature and Probable Consequences-A patient was x-ray room with the patient supine and with the x-ray tube admitted on July 8,1993, for treatment of a longstanding on the patient's left. This room was different than that arteriovenous malformation (AVM) in the left posterior previously used for gamma knife studies. The physicist dura of the brain. The patient was taken to the special had been aware of only one angiography room at the procedures room in the radiology department of the hospital in which the x-ray tube was always on the patient's hospital where a series of lateral and posterior / anterior right.

(P/A) angiograms were performed. These were used to identify the AVM targets. The films were given to the Although the images were " intuitively correct" to the physicist who optically scanned them into the computer neurosurgeon and physicist, they were perceived as planning system. Concurrently, the patient was taken to incorrect by the computer software. The physicist was Magnetic Resonance Imaging (MRI) where a series of apparently able to override the computer rejection of the scans was performed.

data to continue with the procedure.

The floating point error is described as an error resident in The physicist and neurosurgeon worked to complete the the calculation code of the software platform, and is not a dose planning function, however, several anomalous part of the LGP program.The licensee was assured by the events were noted during the process: (1) during the software developers that this error message would result

" definition process," the screen showed a sudden in two outcomes if it ever happened again. The program "floatmg pomt error" message.,Ihis was described as would crash on the next command, or it would self-correct senous but the cause of the message was not known;(2) prior to the next command. None of the participants has i

the definition program m the Leksell Gamma Plan (LGP) been able to recreate this floating point error.

refused to accept on at least two occasions the " correct" orientation of the image, as viewed by the physicist and Actions Taken to Prevent Recurrence neurosurgeon. Eventually, the neurosurgeon and physicist had to instruct the LGP to accept the image they Licensee-The licensee has implemented a policy that knew to be intuitively correct, but which the computer had any computer error message, regardless of origin or failed to recognize. At this point, the screen images seriousness, will require termination of the preparation appeared correct as to orientation for diagnosis, however, for treatment.The software will not be overridden under the planning team did not realize that the P/A image was any circumstances. A Quality Assurance (QA) Program reversed in regard to the LGP dose-planning system.

has been instituted for angiographic images, including the 9

NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Qtr CY93 use of proximal and distal markers. The physicist will been lost or stolen. BPB again notified the State ag'ency personally observe the acquisition of the angiographic on September 8,1993, that after a thorough search, the images. A policy has been implemented that no treatment source was not found.

will be based on angiographic images alone. Confirmation will be obtained by superimposing the dose profiles over A State agency investigation determined that the source the MRI and other images obtained with the same was documented to be present and in the control of BPB stereotactic frame placement as the angiographic images, on March 31,1992. An inventory conducted on July 7, All treatment plans are sent to and verified by the 1992, did not indicate that the source was present. De Director of the Hospital of the Good Samaritan in Los most likely scenario is that the source was lost or stolen Angeles, California.The Director, a physician, was stated between the dates of March 31,1992, and July 7,1992.

to have performed several hundred gamma knife NRC has asked the State of Tbxas to determine why this procedures and is a member of the gamma knife QA event was not reported sooner, team.

BPB believes that a disgruntled employee may have taken State Agency-Two on-site inspections have been the source to cause problems for the company. Employees 1

conducted by the State staff, to verify the adequacy of and exemployees were interviewed concerning the lost corrective actions. The information submitted to the source and all interviewees claimed to have no knowledge State department has been reviewed and accepted by the of its disappearance. The possible loss or theft was Division's Medical Advisory committee as being accurate reported to the Midland County Sheriff's Department.

and corrective actions appropriate. The Division has required and accepted an application to name the Surveys were performed in areas around Midland. BPB teletherapy physicist on the license. Because no alternate placed an ad in the Midland newspaper offering a $10,000 teletherapy physicist has been submitted on the license, reward for information leading to the recovery of the the license will allow no treatments to be performed in the source. The State agency issued a press release describing absence of the primary teletherapy physicist.

the source, warning that it should not be handled, and requesting that BPB or the State agency be contacted if No enforcement actions or penalties have been imposed the source is found. All attempts to locate the source have i

on the licensee. The new procedures and policies been unsuccessful.

submitted by the licensee have been reviewed by the Division and appear appropriate to prevent a recurrence.

According to the manufacturer, Amersham, the radiation profile for the 555 GBq (15 Ci) americium / beryllium The application to amend the license to include the source indicates 5.16 millicoulomb per kilogram (mC/kg) i teletherapy physicist, and two additional radiation (20 roentgen) per hour gamma dose rate and 4.64 mC/kg oncologists is currently under review by the State.

(18 roentgen) per hour neutron dose rate at 5 centimeters (2 inches).

This item is considered closed for the purposes of this report.

Cause or Causes-The State agency investigation determined that the major contributing factor was lack of an adequate tracking system for receiving and shipping of AS 93-13 Lost or Stolen Radiation radioactive sources. Also, a high turnover rate at the local Source at BPB Instruments, m nager / radiation safety officer position contributed to the lack of proper tracking controls of the source.

Inc., in Midland, Texas Actions Taken to Prevent Recurrence Appendix A(see Example 5 of"For All Licensees")of this report notes that a loss of licensed material in such Licensee-BPB is rewriting the job duties for the local quantities and under such circumstances that a and corporate radiation safety officers and is atoo substantial hazard may result can be considered as an reviewing and rewriting the procedures manual to a'd in abnormal occurrence.

tracking each source of radiation.

D te and Place-September 2,1993; BPB Instruments, Agency-He State agency is reviewing the incidet.t to Inc.t Midland, Tbxas, determine the nature and extent of enforcement action.

NRC has asked the State of Tbxas to provide additional Nature and Probable Consequences-BPB Instruments, information on the State's action (s) upon completing Inc., notified the State of Tbxas agency that during a their review of the incident.

physical inventory a 555 gigabecquerel (GBq) (15 curic

[Ci]) americium / beryllium source made by Amersham

%:s report will be further evaluated when additional (Serial Number 7004NE) was not located and may have information becomes available.

NUREG-0090, Vol.16, No. 4 to

Abr'ormal Occurrences,4th Qtr CY93 AS 93-14 Medical Brachytherapy patient's care to conduct a quality assumnce review.ne

• **"*** *"""d d that the incident occurred due to Misadministration at lack of communication of the pnor thempy during the Michael Reese Medical planning of the brachytherapy treatment. They Center in Chicago, Illinois rge mmend d that no brachytherapy be given without a signed, wntten prescription by the attending physician.

'The written prescription must contain information about Appendix A(see Event'lype Sin'Ihble A-1)of this report all radiation therapy given to the patient. The medical notes that administering a therapeutic dose that is greater center has adopted the committee's recommendations than 1.5 times the prescribed dose should be considered and has mitiated traming to the affected staff. nis action an abnormal occurrence.

should prevent a recurrence of a sumlar event.

Date and Place-October 6 through 10, 1993; Michael State Agency-De results of the on-site investigation by Reese Hospital and Medical Center; Chicago, Illinois.

IDNS agrees with the findings of the licensee's quality assurance review. The licensee's proposal appears to be Nature and Probable Consequences-A 68-year-old adequate to prevent recurrence.

woman with Stage H vaginal cancer was referred to the l

hospital's radiation therapy department for treatment. A This item is considered closed for the purpose of this l

plan was developed to deliver a total dose of 6000 report.

centigray (cGy) (6000 rad) by a combination of 4000 cGy (4000 rad) from an external beam (linear accelerator) and 2000 cGy (2000 rad) from vaginal implant therapy. The AS 93-15 Medical Brach}' therapy l

external beam therapy was completed on September 9, Misadministration at Mt.

1993. The patient was then evaluated and plans were Sinai Medical Center in l

made to complete the implantation portion of the treatment. The treatment plan for the implant therapy Miann Beach, Florida included calculations for the time required to deliver 6000 cGy (6000 rad). He dose already delivered by the external Appendix A (see Event Type 3 in'Ihble A--1) of this report beam was not considered in the plan, notes that a therapeutic dose that results m any part of the body receiving unscheduled radiation can be considered an abnormal occurrence.

The attending physician reviewed the dose calculations on October 9, the fourth day of the implant, and determined Date and Place-Between September 28 and November that the duration of the implant treatment was likely t 24, 1993; Mt. Sinal Medical Center; Miami Beach, have been too long. He tmmediately removed the Florida' implants. Calculations revealed that the patient received 4000 to 4500 cGy (4000 to 4500 rad) from the Nature and Probable Consequences-On December 3, brachytherapy treatment. 'Evo days later, on Monday 1993, the State of Florida, Office of Radiation Control October 11, the attending physician verified with the (ORC) was notified by phone that eight patients with a physics staff that his dose calculations were correct. A total of 22 treatments, had received therapeutic exposure telephone report was made to the Illinois Department of to parts of the body not scheduled to receive radiation.

Nuclear Safety (IDNS) on 'Ibesday October 12,1993, and n ese exposures were delivered by a Nucletron an on-site investigation by IDNS staff was conducted on Micro-Selectron high-dose-rate (HDR) remote October 14. A written report from the licensee was afterloader brachytherapy treatment unit. The device submitted to IDNS on October 26. The patient had been used an iridium-192 (Ir-192) scaled source of notified of the event by the attending physician on approximately 300 gigabecquerel (8.1 curie) as of October 20.

December 1,1993. All the patients were receiving gynecological booster treatments after external beam Cause or Causes-ne reportable event was caused by a radiotherapy.

failure to account for the previously administered external beam therapy.The incident occurred due to lack The licensee reported that the cause of the of communication of the prior therapy during the misadministrations was due to the use of a 1.5 meter (4.9 planning of the brachytherapy treatment.

foot) Obstetrical / Gynecological (OB/Gyn) transfer tubc/ applicator combination length instead of a 1.0 meter Actions Taken to Prevent Recurrence (3.3 foot) length as intended. Seven of the eight patients were treated with a single transfer tube with an average Licensee-As soon as the licensee's management exposure per treatment of 3.6 centigray (cGy)(3.6 rad).

determined that a reportable event had occurred, they The exposures were given at approximately 51 centimeter formed a committee of professionals not involved in the (cm) (20 inch) from the intended site and outside of the 11 NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Qtr CY93 patients' bodies, with the source being approximately 30 authorized to place the llDR unit back in service. nc to 34 cm (12 to 13 inch) from the patients' knee area.The remainder of the investigation is expected to be licensee reported that no physical effects were observed completed in the next several weeks. NRC has asked the j

or expected in these patients. One patient was treated State of Florida to provide additional information with four catheters and one transfer tube per treatment.

regarding their follow-up of this incident.

He transfer tube was used to treat the vaginal vault and the four shorter catheters were used to treat the his report will be further evaluated when additional interstitial tissues. Since the transfer tube was longer than inforrr.ation becomes available.

the four interstitial catheters, it was looped over the patient's knee for comfort. His patient developed skin AS 93-16 Medical Brachytherapy erythema in this arca and a conservative estimated dose of Misadministration at 4000 to 6000 cGg (4000 to 6000 rad) to the knee area was calculated.

Richland Memorial Hospital in Columbia, South Carolina On the same day as the telephone report of the misadministration, an ORC inspector went to the ne followinginformation was provided by the licensee to licensee's facility to investigate the cause and assure the State of South Carolina and presented in the 1993 immediate corrective actions were taken, ne ORC third quarter " Report to Congress on Abnormal inspector confirmed the two different size OB/Gyn Occurrences," Appendix D, " Agreement States Events transfer tubes and assured that immediate action was Being Considered as Abnormal Occurrences".This event taken to segregate the tubes and assured that all transfer -

has been determined to be an abnormal occurrence based tubes were prei,erly measured and marked. Since on new information received since the initial report to adequate actions were taken and the authorized user Congress.nis abnormal occurrence report is updated as l

physician stated that it would be difficult and not advisable follows:

to switch from the HDR to other treatments for patients already undergoing HDR treatments, the licensee was Appendix A(see EventType 3 fn'Ihble A-1)of this report allowed to complete the therapy for patients that were notes that a therapeutic dose that results in any part of the currently undergoing HDR treatments.nese treatments body receiving unscheduled radiation can be considered have now been completed and the license has been an abnormal occurrence.

temporarily amended to a " storage only" status.

Date and Place-September 24,1992; Richland Memorial The investigation will continue with emphasis on Hospital; Columbia, South Carolina.

determining the causes of the use of incorrect length Nature and Probable Consequences-A radiation transfer tubes, and assuring the necessary corrective oncology nurse notified the Radiation Safety Officer that actions are m place prior to imtiating any new HDR she retrieved a 1.1 gigabecquerel (GBq) (30 millicurie treatments.

[ mci]) cesium-137 (Cs-137) source from a female Action Taken to Prevent Recurrence patient's bed, ne patient eventually developed an ulceration beneath her nght thigh as a result of bem, g Licensee-The licensee's immediate corrective actions exposed to this source.

consisted of the following: (1) removed long transfer The oncology nurse stated that the attending nurse was tubes from treatment room and made inaccessible; (2) putting the patient on a bed pan (approximately 10:00 requested Nucletron to place some type of identification a.m.) when she discovered the source and contacted the on t ransfer tubes; (3) marked all existing transfer tubes in oncology nurse. The licensee stated that the patient was HDR room; (4) revised the procedure and checklist used undergoing a 42-hour Cs-137 brachytherapy treatment to verify equipment set-up; (5) obtained an outside using an applicator. The applicator contained three consultant to assist in reviewing and modifying the sources of 1.39,0.93, and 0.93 OBq (37.5,25, and 25 mci)

Quality Assurance Program as needed; (6) scheduled of Cs-137. Each of the two ovoids were to have one 1.39 retraining by Nucletron of all individuals involved in the GBq (37.5 mci) source. However, one ovoid applicator use of the HDR; and (7) disallowed any new patient was found empty. NRC has asked the State of South treatments on the unit.

Carolina to provide clarification and additional details on the treatment plan including the sources used, the State Agency-The State agency has placed the licpnse on planned exposure time, the planned dose schedule, the a " storage only" status and is contmumg with the intended dose, and the dose received up to the time of the investigation as stated above. An independent consultant incident.

cill be obtained by the State to review the incident and advise on the appropriateness of all findings, conclusions ne entire applicator system was then unloaded and and necessary actions prior to the licensee being returned to the brachytherapy vault where all of the l

NUREG-0090, Vol.16, No. 4 12

i l

Abnormal Occurrences,4th Qtr CY93 sources were accounted for. A mdiation survey of the This was to be the patient's first of two treatments, and the patient's room after the unloading showed no additional dose deficit could be made up with the subsequent sources in the patient's room.

treatment. However, a second treatment was not attempted because the patient was unable to cooperate In an effort to determine the length of time that the enough to undergo a second treatment.

source was out of place, several people were interviewed.

The patient was asked and did not know how the source

.Ilie licensee stated that this event does not meet the could have gotten out of the applicator. The nurse, wh State's criteria for a misadministration because if the two days earlier loaded the Cs-137 sources into the source was removed sometime after 8:00 a.m. the dose patient,s applicators, said that there was nothmg unusual could be corrected with the subsequent treatment.

about that loading and that she was confident that she had However, NRC does not have sufficient information to loaded the applicator properly.

verify this and to complete an analysis.

NRC has received additional information since the 1993 l

The patient's radiation oncologist said that he had third quarter report. Although this information has l

checked the applicator after the insertion and each allowed NRC to conclude that this misadministration is an morning and evening of the treatment and had noticed abnormal occurrence, some concerns with the content of i

nothing unusual or any loose sources. His most recent the information provided by the licensee have been visit was at 8:00 a.m., on the morning of September 24, identified. NRC has asked the State of South Carolina to 1992. De attending nurse said that she had checked the investigate this event and to provide a follow-up event patient and noticed nothing until the morning of description.

September 24,1992, when she went to help the patient with the bed pan. Upon discovery of the sources, she then Cause or Causes-The licensee stated that either the i

contacted radiation oncology. She said that the patient source fell out of the applicator as it was being inserted had been on the bed pan several times during her and it was not noticed, or a person on the staff opened the treatment, and that she had checked under the patient applicator out of curiosity and improperly reinserted the and did not see any sources. The chief resident of source in a loose manner.

gynecological services checked the patient during treatment but did not manipulate the applicator.

Actions Taken to Prevent Recurrence The licensee's radiation safety officer report stated that 1,1censee4b prevent recurrence of this event, the there were no staff overexposures as a result of this nursing staff was given refresher radiation safety incident. The patient and family were notified. NRC has instruction regarding the use of radioactive sources for cancer tmatment, asked the State of South Carolina to identify the dose to j

the wrong treatment site, and to verify that the referring physician was notified of the misadmmistmtion.

State Agency-Insufficient information is available on the action (s) taken by the State Agency to prevent recurrence. NRC has asked the State of South Carolina to Since the nurse who inserted the Cs-137 sources insisted provide additional information regarding the State that she inserted them properly, and that the physician agency's action (s).

l had just checked the patient that morning and saw nothing, the time of source removal was estimated to be This event will be further evaluated when additional about 8:00 a.m.

information becomes available.

l 13 NUREG-0090, Vol.16, No. 4

. _ = _.

Abnormal Occurrences,4th Otr CY93 i

REFERENCES 1.

Letter from Roy J.' Caniano, Chief, Nuclear No.030-30954, License No. 34-16725-02, dated i

Materials Safety Branch, NRC Region Ill, to Robert February 11,1994, i

J. Hickok, Assistant Vice President for Medical Affairs, Washington University Medical School, 3.

The medical consultant's report is filed in Docket forwarding inspection reports No. 030-02271/93001, No. 030-02983 in the Region I Materials License 030-31205/93001, 030-15101/93001, Docket No.

Docket Room.

Inspection Report No.

030/02271,030-31205 and 030/15101, License No.

030-02983/934)01 issued November 5,1993, and the 24-00167-11, dated January 12,1994.

February 9,1994, Notice of Violation are in the PDR.

t l

2.

Letter from W. L Axelson, Director, Division of 4.

The medical consultant's report will be placed in the Radiation Safety and Safeguards, NRC Region III, to file for Docket No. 030-02470 located in the Region I Dan Sylvester, Vice President for Professional Materials License Docket Room. An inspection Services, Good Samaritan Hospital, forwarded report will be issued to the licensee by February 18, inspection report No.030-30954/94001, Docket 1994, and will be available in the PDR.

i l

1 a

-)

l NUREG-0090, Vol.16, No. 4 14 j

Abnormal Occurrences,4th Otr CY93 APPENDIX A ABNORMAL OCCURRENCE CRITERIA The following criteria used to determine abnormal (b) release of radioactive material from a package in c currence (AO) were set forth in an NRC policy amounts greater than the regulatory limit.

statement published in the FederalRegister on February 24,1977 (Vol. 42, No. 37, pages 10950-10952).

5.

Any loss of licensed material in such quantities and under such circumstances that substantial hazard An event will be considered an AO if it involves a major may result to persons in unrestricted areas.

reduction in the degree of protection of the public health 6.

A substantiated case of actual or attempted theft er or afety. Such an event would myolve a moderate or diversion of licensed material or sabotage of a more severe impact on the public health or safety and could include but need not be limited to:

ggY' 7.

Any substantiated loss of special nuclear material or 1.

Moderate exposure to, or release of, radioactive any substantiated inventory discrepancy that is material licensed by or otherwise regulated by the judged to be significant relative to normally expected Commission; performance and that is judged to be caused by theft or diversion or by substantial breakdown of the 2.

Major degradation of essential safety-related accountability system.

c equipment; or 8.

Any substantial breakdown of physical security or 3.

Major deficiencies in design, construction, use of, or material control (i.e., access control, containment, management controls for licensed facilities or or accountability systems) that significantly

material, weakened the protection against theft, diversion, or sabotage.

Examples of the types of events that are evaluated in 9.

An accidental criticality [10 CFR 70.52(a)].

detail using these criteria are:

10. A major deficiency in design, construction, or For All Licensees operation having safety implications requiring immediate remedial action.

1.

Exposure of the whole body of any individual to 25 rem or more of radiation; exposure of the skin of the

11. Serious deficiency in management or procedural whole body of any individual to 150 rem or more of controls in major areas.

radiation; or exposure of the feet, ankles, hands or forearms of any individual to 375 rem or more of

12. Series of events (where individual events are not of radiation [10 CFR 20.403(a)(1)], or equivalent major importance), recurring incidents, and exposures from internal sources, incidents with implications for similar facilities (generic incidents) that create major safety concern.

2.

An exposure to an individual in an unrestricted area For Commercial Nuclear Power Plants such that the whole body dose received exceeds 0.5 rem in one calendar year [10 CFR 20.105(a)].

1.

Exceeding a safety limit of license 'Itchnical Specifications [10 CFR 50.36(c)].

3.

He release of radioactive material to an unrestricted area in concentrations which, if 2.

Major degradation of fuel integrity, primary coolant 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 500 times pressure boundary, or primary containment the regulatory limit of Appendix B,'Ihble 11,10 CFR boundary.

Part 20 [CFR 20.403(b)(2)].

3.

Loss of plant capability to perform essential safety 4.

Radiation or contamination levels in excess of design functions such that a potential release of values on packages, or loss of confinement of radioactivity in excess of 10 CFR Part 100 guidelines radioactive material such as (a) a radiation dose rate could result from a postulated transient or accident of 1,000 mrem per hour three feet from the surface (e.g., loss of emergency core cooling system, loss of of a package containing the radioactive material, or control rod system).

15 NUREG-0090, Vol.16, No. 4

Abnormal Occurrrnces,4th Otr CY93 4.

Discovery of a major condition not specifically For Fuel Cycle Licensees considered in the Safety Analysis Report (SAR) or

'Ibchnical Specifications that requires immediate 1.

A safety limit of license 'Ibchnical Specifications is remedial action.

exceeded and a plant shutdown is required [10 CFR 50.36(c)].

5.

Personnel error or procedural deficiencies that 2.

A major condition not specifically considered in the result in loss of plant capability to perform essential safety analysis report or'Ibchnical Specifications that safety functions such that a potential release of requires immediate remedial action, radioactivity in excess of 10 CFR Part 100 guidelines could result from a postulated transient or accident 3.

An event that seriously compromised the ability of a (e.g., loss of emergency core cooling system, loss of confinement system to perform. its designated contrcl rod system).

function.

Medical Misadministrations As discussed in the Preface to this report, the NRC policy guidelines, which are summarized in Table A-1, augment i

statement on AOs was published before licensees were the NRC policy statement.

required to report medical misadministrations to the As noted in the Preface, revised guidelines are currently NRC. Th erefore, d uring 1984, NRC developed guidelines being developed because new medical misadministration for selecting such events for AO reporting. These definitions became effective on January 27,1992.

NUREG-0090, Vol.16, No. 4 16

Abnormal Occurrences,4th Otr CY93 Table A.1 NRC Guidelines for Selecting Medical Misadministration Events for Abnormal Occurrence (AO) Reporting AO Reporting Threshold j

Eveit Type Diagnostic Exposure Therapeutic Exposure (1) Administering a radiopharma-If theimproperadministration 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 body wrong body part is receiving radiation i

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 desented body to the wrong body part.

parts, or, l

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 body parts been used, an AO report should show signs of adverse health be proposed if:

effects greater than expected had the proper administration 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.

i (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.

(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 'lype 1.

Event 'lype 1.

17 NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Qtr CY93 l

Table A 1 (Continued)

AO Reporting Threshold Event %pe Diagnostic Exposure Therapeutic Exposure route of administration other than that intended by the pre-I scribing physician.

(4) Administering a diagnostic An AO report should be Not applicable.

dose of a radiopharma-proposed if:

ceutical differing from the presenbed dose by more (a) the actual dose is than 50 percent.

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.

(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 sealed source such that errors in the (b) the actual dose is less than source calibration, time of 0.5 times the prescribed c':posure, and treatment dose,or geometry result in a calculated total treatment dose differing (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 For either diagnostic or therapeutic exposures, an AO report of events (regardless should be proposed for recurring everts or a series of events of the number of (in which each individual misadmin stration is not of major patients or facilities importance) that create a significar:t public health or safety involved).

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.16, No. 4 18

Abnormal Occurrences,4th Otr CY93 1

l l

APPENDIX B l

l UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES i

l During the October through December 1993 period, NRC the initial and any subsequent updated information on the licensees, Agreement States, Agreement Statelicensees, abnormal occurrences discussed. (The update provided and other involved parties, such as reactor vendors and generally covers events that took place during the report architect-engineering firms, continued with the imple-period; some updating, however, may be more current as mentation of actions necessary to prevent recurrence of mdicated by the associated event dates.) Open items will previously reported abnormal occurrences. The be discussed in subsequent reports in the series.

referenced Abnormal Occurrence Reports below provide Other NRC Licensees 92-18 Loss of Iridium-192 Source licensee responded to the deficiency letter on December 7,1993, and " requested full and permanent relaxation of and Medical Therapy its entire license." This response is currently under NRC Misadministration at Indiana review.

Regional Cancer Center in nis report will be further evaluated when additional Indiana, Pennsylvania information becomes available.

This abnormal occurrence was originally reported in NUREG-0090, Vol.15, No. 4, " Report to Congress on 92-19 Medical Therapy l

Abnormal Occurrences," October-December 1992. The Misadministration and abnormal occurrence report is updated as follows:

'Ibmporary Loss of On December 1,1992, the ticensee notified NRC Region i Brachytherapy Source at of the loss of a scaled iridium-192 source from the high dose rate remote afterloader um,t at their Indiana Yale-New Haven Hose tal in i

Regional Cancer Center in Indiana, Pennsylvania. The New Haven, Connecticut source was left in the patient on November 16,1992, and l

as a result the patient received an estimated dose at 1 This abnormal occurrence was originally reported in centimeter (0.39 inch) of 1,600,000 centigray (cGy)

NUREG-0090, Vol.15, No. 4, " Report to Congress on (1,600,000 rad) instead of the intended dose of 1800 cGy Abnormal Occurrences," October-December 1992. The (1800 rad). In addition, several members of the general abnormal occurrence report is updated as follows:

public received radiation exposures of between 400 microsievert (40 millirem) and 220 millisievert (22 rem).

On December 3,1992, NRC was notified by the licensee that a 39 year old female patient received a 33 percent In addition to the actions described in the abnormal undertreatment during a brachytherapy treatment to the occurrence report for the second quarter of 1993 cenix and an unplanned 260 centigray (260 rad) exposure (NUREG-0090, Vol.16, No. 2), NRC prepared a to her leg. One of the prescribed sources was either never deficiency letter dated September 27,1993, requesting inserted or was removed from the applicator during l

that the licensee subniit a comprehensive description of treatment and left in her bedding.

l its Radiation Safety Program and Procedures, including program audits, facilities certification, personnel training NRC Region I conducted a special inspection on and qualifications, and any other information that it may December 3 and 4,1992. An Enforcement Conference consider accessary to support safe resumption of was held on January 6,1993. An NRC medical consultant brachytherapy operations. The licensec responded to this was retained to review the misadministration. For the request in letters dated September 29,1993, and October violations identified during the special inspection NRC 21, 1993. NRC reviewed the licensee's response using Region I proposed a Civil Penalty of $2,500. On January Policy and Guidance Directive, FC 86-4, Revision 1, 21,

1993, the licensee reported a

second "Information Required for Licensing Remote misadministration (AO 93-3). NRC elected to withhold Afterloading Devices". A deficiency letter was prepared issuance of the enforcement action for the first incident and sent to the licensee on November 4,1993. The and issued one enforcement action for both incidents.

19 NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Otr CY93 Following the staff's review of the second occurrence on to her rectum when the physician mistakenly inserted the April 26,1993, NRC issued a Civil Penalty in the amount ilDR applicator into the rectum instead of the vagina.

of $10,000 and Confirmatory Order Modifying License (Effective Immediately), which confirmed the licensee's NRC Region I conducted a special inspection on January proposal to have a program assessment performed by 26 and 27,1993.1he licensee was given the option of independent experts. The program assessment was participating in an enforcement conference but declined, completed on May 10 and 11,1993. On August 24,1993, A medical consultant was retained to review the the licensee submitted their Program Assessment Report misadministration. On April 26,1993, NRC proposed a and Program Improvement Plan which was formulated in Civil Penalty in the amount of $10,000 and Confirmatory response to the program assessment. On November 16, Order Modifying License (Effective immediately) which 1993, the licensee submitted the first of the required confirmed the licensee's proposal to have a Program quarterly reports on the implementation of the Program Assessment performed by independent experts. 'Ihe Improvement Plan and stated that all actions were Program Assessment was completed on May 10 and 11, completed. NRC Region I has reviewed the Program 1993. On August 24, 1993, the licensee submitted the Assessment Report and Program Improvement Plan and report of the Program Assessment and their Program is currently preparing a response.

Improvement Plan which was formulated in response to the Program Assessment. On November 16,1993, the On June 10,1993, the licensee responded to the Notice of licensee submitted the first of the required quarterly Violation and Proposed Imposition of $10,000 Civil reports on the implementation of the Improvement Plan Penalty. In this response, the licensee denied one and stated that all actions were completed. NRC Region I violation, took issue with the manner in which the civil has reviewed the Program Assessment Report and penalty was determined, and requested mitigation of the Program Improvement Plan and is currently preparing a civil penalty based on minimal safety significance and lack

response, of programmatic implications. On December 27, 1993, NRC responded to the licensee's request with an Order On June 10,1993, the licensee responded to the Notice of imposing Civil Penalties in the amount of $10,000. The Violation and Proposed Imposition of $10,000 Civil licensee responded to the Order by letter dated January Penalty. In this response, the licensee denied one 26,1994, and paid the Civil Penalty of $10,000.

violation, took issue with the manner in which the civil penalty was determined, and requested mitigation of the A routine inspection was conducted of the licensee's civil penalty based on minimal safety significance and lack program from September 28 through 30,1993. One minor of programmatic implications. On December 27, 1993, violation of regulatory requirements was identified by the NRC responded to the licensee's request with an Order inspector. This violation has since been corrected by the Imposing Civil Penalties in the amount of $10,000.1hc licensee.

licensee responded to the Order by letter dated January This report will be updated when additional information becomes available.

A routine inspection was conducted of the licensee's program from September 28 through 30,1993. One minor 93-3 Med.ical Therapy violation of regulatory requirements was identified by the inspector.1his violation has since been corrected by the Misadministration Involving

licensee, the Use of a High Dose-Rate

. Ibis report will be updated when additional information Remote Afterloader becomes available.

Brachytherapy Device at Yale-New Haven Hospital in 93-10 Medical Sodium Iodide New Haven, Connecticut Misadministration at Osteopathic Hospital

.Ih.ts abnormal occurrence was originally reported m.

l NUREG-0090, Vol.16, No.1, " Report to Congress on Founders Association DBA l

Abnormal Occurrences," January-March 1993. The (doing business SS) hlsa l

abnormal occurrence report is updated as follows:

Regional Medical Center in On January 21,1993, NRC was notified by the licensee Wisa, Oklahoma that a female patient received a 50 percent undertreatment during a brachytherapy procedure to the This abnormal occurrence was originally reported in vagina and an unplanned 700 centigray (700 rad) exposure NUREG-0090, Vol.16, No. 3, " Report to Congress on NUREO-0090, Vol.16, No. 4 20

Abnormal Occurrences,4th Otr CY93 l

Abnormal Occurrences: July-September 1993." The On January 11, 1994, the NRC issued a Notice of abnormal occurrence report is updated as follows:

Violation to the licensee.De licensee wascited for failing to require individuals working under the supervision of In July 1993 the wrong patient was administered 0.21 authorized users to follow the instructions of the gigabecqu erel (G Bq) (5.7 millicuries [ mci]) of iodine-131 supervising authorized user and the written radiation (1-131). He misadministration occurred because the safety and quality management procedures established by licensee failed to verify patient identity.

the licensee. Because the misadministration was the result of an isolated failure to follow the quality He NRC staff retained a medical consultant to evaluate management procedures and was of limited consequence the potential medical effects to the patient as a result of to the patient, no escalated enforcement action was taken the misadministration. He consultant provided a report by the NRC.

in October 1993, which stated that the impact of the incident on the status of the patient's health should be negligible, with no expected long term disability as a This item is considered closed for the purpose of this result of this misadministration.

report.

Agreement State Licensees AS 87-5 Therapeutic Medical teletherapy unit recalibrated. Wenty-two patients were identined as hasg recched inmect treatments ranging Misadministrations At from 50 percent underdose to approximately 100 percent Northern Westchester overdose (total dose). All of the associated plans were prep red by the same dosimetrist.

Hospital Center, Westchester County, New York An outside radiological physicist reviewed about 250 treatment plans including those of affected patients.He This abnormal occurrence was originally reported in conclusion was that the dosimetrist made somewhat NUREG-0090, Vol.10, No. 3., " Report to Congress on random mistakes, that is, plans were done with the correct Abnormal Occurrences," July-September 1987, and methods in some cases and incorrectly at other times, closed out at that time. It was reported that 22 patients Overall, the cases indicated a lack of understanding of the received cobalt teletherapy misadministrations at computer program used for treatment planning and the Northern Westchester Hospital in Westchester County, methods of calculation of timer settings from the New York, between 1982 and 1987.

computer output. Furthermore, there were no second checks performed which may have caught these mistakes.

His abnormal occurrence was reopened i>ecause the Northern Westchester Hospital Center was directed by original report contained several incorrect statements.

the State Health Department to follow up on the affected The following report was prepared by the State of New patients for at least 1 year and to provide status reports to York to correct the errors, the department. At the time of the last report (May 1988),

11 of the 22 patients had died. Some of the deaths may Date and Place-On August 5,1987, the New York State have been from complications related to the Department of Health Bureau of Enytronmental misadministration in question. Other patients returned Radiation Protection was notified that mistakes m for further treatment. All treatment records for the l

treatment planning had been discovered and that some affected patients were requested for reviewby the State's cobalt teletherapy patients had received excess radiation Radiological Health Advisory Committee. He at Northern Westchester Hospital Center.

committee did not have any comments that would counter the assertions by the hospital. The New York State Nature and Probable Consequences-The hospital had Department of Health notified the NRC that the contracted with a physics consulting group (Radiological dosimetrist involved is no longer working at the hospital Physics Associates, Elmsford, New York) to provide or any other facility in New York State, ne physicist in physics services. A dosimetrist from the group, who charge of the consulting group stopped providing therapy normally prepared treatment plans, was not available and services in New York State after the incident and only upon review of one plan by another physicist from the performed diagnostic x-ray and nuclear medicine group, it was discovered that the dosimetrist had made consulting services.

errors in his calculations. The State Health Department was notified of the mictakes and the hospital was directed The State requested the names of other facilities where to discontinue therapy until treatment plans had been physics services were performed by the same dosimetrist.

l reviewed and verified as correct and the cobalt ho other hospitals and a private office were identified 21 NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Qtr CY93 where the dosimetrist performed treatment planning. All This abnormal occurrence was reopened because the 1

three facilities were notified and had independent physics following new significant information concerning reviews of treatment plans. At one of the hospitals, enforcement action and the status ofIhe affected patients mistakes were found in two treatments involving a wedge; became available.

however, the total dose delivered was within 10 percent of that prescribed. At that same hospital, a mistake in the Enforcement action was initiated by the New York State calibration of an orthovoltage unit was discovered which Department of Health which included provisions that the resulted in 22 patients receiving doses in excess of 10 hospital take the following actions: commit to percent of those prescribed. That calibration was comprehensive quality assurance reviews for radiation performed by the senior member of the physics consulting therapy, submit quarterly progress reports for each group. Those patients were followed up and no adverse component of the stipulation, order of the enforcement outcomes were reported.

action, implement quality assurance reviews, mandatory periodic in-service training, testing of physics staff, and Cause or Causes-The dosimetrist involved lacked perform a periodic follow-up of the affected patients for understanding of the computer treatment planning 1-year,'

software and other basic methods in determining treatmen t times. Quality assurance of treatment planning Reports of the patient follow-up were submitted to the was inadequate and no second checks of treatment plans State of New York, Department of Health. As of were performed.

December 1990, the reported status of the patient's condition involved in the misadministration is as follows:

Actions Taken to Prevent Recurrence two patients had laryngectomies; one patient had necrosis of the larynx; three patients had discomfort m the Licensee-Insufficient information is available on the treatment area; one patient had a rib fracture; four action (s) taken by the licensee to prevent recurrence.

patients had skm, changes; three patients had atrophy m NRC has asked the State of New York to provide the breast; one patient had a radiation ulcer, one patient additional information regarding the licensee action (s).

had radiation proctitis, and m,ne patients died from complications not related to the misadmmistration.

State Agency-License conditions concerning the qualifications of physicists, treatment prescriptions, The State radiation control regulations have been revised second checks, and misadministrations were added to all to include requirements of Quality Assurance programs, teletherapy licenses in 1988. Since that time, the State audits of therapy programs, misadministration reporting Sanitary Code has been revised to include specific and training and experience requirements for therapy physicists.

requirements for quality assurance in radiation therapy for all therapy modalities.The State of New York believes The item is considered closed for the purposes of this that the dosimetrist involved no longer performs report.

treatment planning in New York State. The senior physicist in the consulting group did not perform any therapy functions in New York State after the incident.

AS 93-7 MedI'caI Radiopharmaceutical This report will be further evaluated when additional mformation becomes available.

Misadministration by

" Unspecified Licensee" in AS 88-4 Multiple Medical Therapy Albany, New York Misadministrations by This abnormal occurrence was originally reported in Rochester General NUREG-0090, Vol.16, No. 3, " Report to Congress on Abnormal Occurrences," July-September 1993. The Hospital in Monroe County, abnormal occurrence report is updated as follows:

New York Date and Place-October 5,1992.

This abnormal occurrence was originally reported in ne name of the licensee has been withheld by the State NUREG-0090, Vol.11, No. 4, " Report to Congress on of New York due to provisions in New York State Public Abnormal Occurrences," October-December 1988 and Health law.

closed out at that time. It was reported that 19 patients received cobalt teletherapy misadministrations at Nature and Probable Consequences-A patient was Rochester General Hospital in Monroe County, New administered 303.4 megabecquerel (MBq) (8.2 milli:urie York, between January 1988 and August 1988.

[ mci]) of phosphorus (P-32), instead of the prescribed 185 NUREG-0090, Vol.16, No. 4 22

Abnormal Occurrences,4th Qtr CY93 l

t MBq (5 mci)of P-32, as an outpatient receiving radiation AS 93-8 Medical Sodium lodide therapy treatment. The patient was discharged in stable Misadmm.. trat. ion at Inland is condition. The mistake was caught when the Chief

'Ibchnologist was reviewing the records of doses Imaging in Spokane, prescribed and comparing these to the doses Washington adamtstered. Immediate action was taken to follow-up on the discrepancy. The attending physician and patient his abnormal occurrence was originally reported in were notified of the misadmmtstration. He patient's NUREG-0090, Vol.16, No. 3, " Report to Congress on blood count monitoring frequency was changed from Abnormal Occurrences," July-September 1993. The monthly to bi-weekly and the patient was monitored for abnormal occurrence is updated as follows:

potential infections. Six weeks after the administ ration of P-32, the patient's blood count was normal er, > for a Date and Place-December 14, 1992; Inland Imaging:

decrease in the platelet count, which remained wilhin the Spokane, Washington.

l range of safety and represented the expected therapeutic l

response.

Nature and Probable Consequences-On December 14, 1992, a patient diagnosed as hyperthyroid was referred to the licensee by the Fairchild Air Force Base Hospital fora Cause or Causes-The licensee's account of the cause is thyroid uptake scan of.26 megabecquerel (MBq) to 3.7 as follows: The stated package dose was 185 MBq (5 mci),

MBq (7-10 microcuries) of iodine-131 (I-131). The calibrated to a date 10 days after the date on which the patient was mistakenly administered a 1% MBq (5.3 technolog,st drew the dose. The technologist failed to millicurie) dose of I-131, sodium iodide for a whole body t

take notice of the calibration date and assumed that the scan. As a result, the patient's thyroid received a dose of stated package dose of 185 MBq (5 mci) was drawn for approximately 7950 centigray (7950 rad).

admmistration.

Although the dose calibrator measurement of the prepared (drawn) dose indicated a The nuclear medicine technologist misinterpreted the significant discrepancy between the prescribed dose and orally requested procedure and failed to verify the the measured dose, the technologist failed to mvestigate requested procedure through review of the referring the cause 0f th,s discrepancy and did not notify the physician's written requisition. The patient's physician, an i

physician m regard to the discrepancy. A dose of 303.4 endocrinologist, was notified and did inform the patient.

MBq (8.2 mci) was admmistered to the patient by the physician, a Board Certified Radiologist.

The licensee reported that both a whole body scan and the requested thyroid uptake study were performed three d ys after the misadministration ",with no patient Actions Taken to Prevent Recurrence complaints or immediate side effects., The hcensee has noted that the patient will most probably be hypothyroid Licensee-The corrective actions reported by the for the rest of his life and that future litigation remains a licensee included the implementation of a modified Possibility No NRC or State medical consultant has been contracted to review this event.

radiopharmaceutical therapy protocol for P-32 and iodine-131 administrations, and training for the Cause or Causes-This event was attributed to human technologists. In addition, a work sheet and check list, error as a result of the technologist's inattentiveness and designed with several checks for technologists and relatively short enerience at this facility. Although the physicians prior to administration of the dose were referrmg physician s written request was available at the developed for P-32 therapy.The physician involved in the time the dosage was prepared and administered, the procedure was counselled and the technologist was technologist failed to reconcile the dose and study suspended from administration of therapy doses for a minimum period of six months. The Chief'Itchnologist prescribed with the dose and study given.

and Nuclear Medicine Physician will evaluate the Act,ons Taken to Prevent Recurrence i

technologist prior to allowing him or her to begin administering therapeutic doses again.

Licensee-The technologist and the lead technologist (who was not present) were counseled and reinstructed by State Agency-The State required the licensee to submit the authorized physician user / radiation safety officer. A a plan of corrective action designed to prevent review by the licensee of all such administrations for the recurrence.The corrective actions reported by the facility Prior 6 months revealed that the technologists were inconsistent in verifying written referrals with the study appear to be satisfactory.

given, prior to administration.The licensee stated that all iodine studies are required to be verified against the This item is considered closed for purpose of this report, written request slips prior to any iodine administration.

23 NUREG-0090, Vol.16, No. 4 l

Abnormal Occurrences,4th Qtr CY93 l

State Agency-The State has accepted the licensee's result of this incident, the next inspection has been determination for the cause of this event and subsequent scheduled for the seconi quarter of 1994.

l actions taken to prevent recurrence.This will be reviewed This item is considered closed for the purposes of this at the time of the next routine compliance inspection. As a report.

1 NUREO-0090, Vol.16, No. 4 24

Abnormal Occurrences,4th Otr CY93 l

t APPENDIX C OTHER EVENTS OF INTEREST l

The followingiftems are described because thley. may in the level of protection provided,for public health or

. possibly be perceived by the public to be of health or safety ~

= safety; therefore, they are not reportable as abnormal.

i' significance.'lhe items did not involve a major reduction -

. occurrences.

L

- Nuclear Power Plantsi 1.

Cracks In' the Core Shroud at Brunswick Unit 1 above the fuel (lower neutron fluency), but'because

. the H-3 weld was not a seam weld. The GE RICSIL Nuclear Plant had focused utility inspections on seam welds since In July -1993, while performing in-vessel visual

. previously observed cracking was reported adjacent to a circumferential seam weld in a core shroud of a inspections of the Brunswick Unit I reactor vessel core shroud in accordance..with the foreign owned GE boiling water reactor (BWR).

recommendations contained in General Electric Analysis of boat samples (a small size. material-Company (GE) Rapid Information Communication

' specimen) taken from the crack indicated that the Service Information ' Letter (RICSIL) No. 054, cracking is primarily intergranular stress corrosion j.

Carolina Power and Light Company discovered an cracking (IGSCC). - Crack; extension;is possibly l

approximate-360-degree cittumferential crack on assisted by neutron fluency and oxide wedging at:

l the inside diameter (ID) of the core support shroud certain locations. Susceptible material conditions, -

at the circumferential corner weld designated H-3.

weld.The core shroud is a cylindrical assembly inside high residual stress from fabrication, and exposure the reactor vessel which provides a partition to to a strong oxidizing environment are sufficient to properly distribute the flow of coolant delivered to Produce.the cracking observed. Because. these the vesseliThe core shroud is not an American factors are not consistently:present across the shroud, the location and degree of cracking varies i

Society of Mechanical Engineers (ASME) Code across the shroud.

component; however, its safety design basis is to:

In cddition to the crack in the H-3 weld, a,short axial (a) provide a floodable volume in which the core crack was also discovered during the n, utfal visual can be adequately cooled in the event of a inspection on the outside diameter (OD) of the breach in the Reactor Coolant System external shroud.mid section adjacent.to a horizonal seam to the reactor vessel, and

- weld designated H-4.

l (b) limit deflection and deformations. of the The occurrence of the crack found at weld H-3 was l

reactor vessel internals to assure that the -

analyzed and determined to be potentially' safety l'

control. rods and the core standby coolin8 significant because if weld H-3 failed completely and L

systems can perform their saf;ty functions a large main steam line break was to occur, the l

during abnormal operational transients.

L hydrodynamic loads across the shroud are sufficient to result in the top guide core structure being lifted The H-3 weld is a 5.72 centimeter (en) (2.25 inch above the fuel assemblies. Should this happen, the :

1

[in]) thick corner weld which joins the top guide lateral support to the assemblics would no longer be '

support ring to the shroud's 3.8 cm (1.5 in) thick provided and the control rods may fail to fully insert.

mid section which surrounds the fuel.The top guide l

support ring is a 7.6 cm (3 in) high x 19 cm (7.5 in)

The : licensee performed additional-visual deep section of type 304 stainless steel plate, with a

' examinations of all of the core shroud welds.These -

carbon content of about 0.06 percent,which serves as examinations revealed that the techniques required the transition between the larger diameter upper

. by the ASME Code were insufficient to detect the core shroud and the core shroud mid-section. The numerous. tight axial and circumferential IGSCC crack was located in the weld, heat-affected zone on cracks that were subsequently found at welds H-1, the short transverse edge of the top guide support H-2, H-4, H-5, and H-6a. In order to detect and to ring plate, and measured 2.4 cm (0.95 in) to 4.34 cm determine the extent of cracking in these welds, the (1.71 in) in depth. The crack was unique not only licensee had to enhance the examination techniques because of its significant length, depth, and location by brush cleaning the areas to be examined, using a

,/

25 NUREG-0090, Vol.' 16, No. 4

.~

.. - ~ -

L.

l Abnormal Occurrences,4th Qtr CY93 J

standard 1 mil (0.00254 cm [0.001 in]) wire as a re-examination revealed three 2.5 cm (1 in) calibration reference standard inlieu of the"0.08cm indications in the heat-affected zone of the weld (0.03 in) black line on a 18 percent neu tral grey card" H-2. A subsequent inspection in September required by the ASME Code, and preciselyfocus the revealed another 2.5 cm (1 in) long indication. The j

light source and camera to maximize the reflectivity indications were assumed to be cracks (although not j

of the crack. He result of these enhanced confirmed) and were conservatively evaluated by t he i

inspections revealed that the cracks associated with licensee in an Engineering Evaluation Report corner welds H-1 and H-2 were also of significant (EER). The quality of the 1991 tapes however was length. ne largest crack discovered at a scam weld insufficient to identify all of the types of cracks that location in the shroud mid-section shell plates was a had been confirmed on Unit 1.

106.7 cm (42 in) long circumferential crack at weld H-5.

The primary purpose of the above EER was to evaluate the significance of the indications observed He licensee evaluated the cracks in the core shroud in the Unit I shroud with respect to the operation of in accordance with the screening criteria contained the unit for another cycle, and to evaluate the in GE Report No. GENE-523-123-0993, Rev.1, significance of postulated conditions in the Unit 2

" Evaluation and Screening Criteria for the shroud with respect to operation of the unit until the Brunswick Shroud Indications." The report used a next refueling outage in March 1994.

762 cm (300 in) allowable through-wall flaw length which was derived from the limit load analysis as the The EER concludes that the structuralintegrity of basis for setting a screening criteria of 190.5 cm (75 the Unit I core shroud (without the repair that was in) for each 90-degree quadrant of the shroud. The performed) would be maintained, with full Final screening critoria was considered on a " rolling" Safety Analysis Report (FSAR) safety margins, for a quadrant basis with the worst cracking defining the minimum of one additional fuel cycle. Based on a 3

radial orienta; ion of a quadrant. The axial and comparison of the fabrication histories of the circumfercroal cracks at seam welds H-4, H-5, and shrouds, water chemistry history, operating time of H-6a were satisfactorily bounded by the screening the units, and similar IGSCC patterns, die licensee criteria.

concluded that the conditions seen on Unit 1 also bounded Unit 2. Therefore, Unit 2 will remain The cracks in the H-2 and H-3 welds exceeded the within its design basis and will be operated until the limits asscciated with the above criteria. Based on spring refueling outage in 1994.

I additional fracture mechanics analyses, the licensee concluded that the H-3 weld would be acceptable for Actions taken by the licensee to prevent recurrence continued operation without repair. Nonetheless, consisted of: (1) performing a detailed enhanced the licensee elected to implement a repair examination of the entire Unit I core shroud; (2) encompassing the H-2 and H-3 welds to justify performing an evaluation of the structural integrity continued operation of the shroud. De repair of the core shroud and determining that the crack at consisted of a series of twelve " brackets" with one

' ' 1 is the bounding case; and (3) implementing a installed at each 30-degree increment around the p nuanent repair utilizing mechanical clamps which diameter of the shroud.The brackets wereinstalled encompassed the H-2 and H-3 welds. De licensee on the outside surface of the shroud with two bolts has also held discussions with NRC and has indicated attaching the bracket to the upper shroud above that their Inservice Inspection (ISI) Program will be weld U-2, and two bolts attaching the bracket to the augmented to include inspection of the installed mid-section below weld H-3. The cracking (from less repair brackets. NRC issued Information Notice

)

than 0.75 cm to 1.8 cm [from less than 0.3 in to 0.7 in]

93-79 to alert other BWR Owners of the findings in depth) in the H-1 comer weld also exceeded the from the Brunswick Unit I core shroud inspections.

GE screening criteria for length. The licensee GE also issued Service Information Letter (SIL) No.

however concluded that this cracking did not require 572 which recommends that visual examinations be repair based on the fracture mechanics evaluation of performed of accessible areas on lx)th the ID and i

the H-3 weld cracking.

OD surfaces of the core shroud at the next scheduled I

refueling outage for all BWR plants with type 304 Based on the recommendation contained in RICSIL stainless steel shrouds with 6 or more years of power No. 054, the licensee had also visually examined Unit operation and for all plants with 1.cGrade (low 2 during a refueling outage in July 1991. No cracks carbon content) stainless steel shrouds with 8 or were identified at that time.The video tapes of the more years of power operation.

Unit 2 shroud in vessel visual inspection were re-examined based on the July 1993 Unit 1 findings.

His SIL recommends that inspections be performed Utilizing a digitized enhancement process, the with enhanced visual testing (a VT-1 system that can NUREG-0090, Vol.16, No. 4 26 i

I

Abnormal Occurrences,4th Qtr CY93 resolve a standard one mil [0.00254 cm (0.001 in))

jet pump disassembly and displacement of the mixer wire on the inspection surface).

section. The failure originated in an area in which a radius machining cut had been made in the forging.

This event is included in Appendix C because the This is an area of the bea n with a cross section public may perceive the damage to the core shroud smaller than the previously affected areas. The to be of public health and safety significance. A currently required UT beam examinations would not damaged core shroud can prevent a floodable detect cracking in the new location, because these volume from being maintained in the core during a examinations are typically performed in the areas breach in the Reactor Coolant System and inhibit t he with a history of cracking.

control rod and core standby cooling systems from performing the safety function. This condition was Visual examination of the failed beam, conducted discovered during routine inservice inspection with prior to the beam being sent offsite to a hot cell for the reactor shutdown and the reactor vessel examination, showed a crack of greater than 270 disassembly. De licensee has taken appropriate degrees of the cross section of the intact lug. He actions to correct the existing condition and to other lug had cracked in the same area and was prevent future damage to the core shroud. Generic missing.

communications have been issued by GE and NRC to alert other licensees of this potential safety Initial examination of the jet pump beam by General concern.

Electric Company, indicates that the probable cause of failure was an IGSCC-initiated crack that 2.

Jet Pump Beam Failure at Grand Gulf Nuclear Plant propagated through to failure. Fatigue may have contributed to crack growth prior to failure. General The Grand Gulf Nuclear Plant consists of a single Electric Company recommended that the licensee of General Electric boiling water reactor design six all BWRs with beams that do not have the new heat (UWR 6) located near Port Gibson, Mississippi, and treatment should evaluate their plants with respect operated by Entergy Operations, Inc.

to mid-cycle failures of the jet pump beams. An accumulated service life of 8 years (Grand Gulf's On September 13,1993, Grand Gulf had a reactor time minus 1 year) was recommended as the scram on high-water-level due to an unplanned benchmark for evaluation until other guidelines can high-pressure core-spray (HPCS) initiation. The be established based upon additional testing of the immediate cause of the HPCS initiation was found to failed beam. Grand Gulf has replaced all of theirjet be a reactor low-water-level signal to the HPCS pump beams with spares available onsite.

circuitry.The reasons for the water level anomalies in the C and G channels could not be determined The licensee performed a review of the data immediately. During restart from the scram, jet available from Grand Gulf's inadvertent HPCS pump differential pressure anomalies were initiation and the water level anomalics during the discovered. Upon reaching higher flows in an effort recent restart. The proximity of the jet pump to the to investigate the problem, the plant experienced instrument nozzle of the affected instruments was oscillating water level indications on some considered and the most likely cause of the HPCS instrumentation, and instrument readings injection and the water level anomalics was characteristic of a displaced jet pump mixer section.

determined to be the impact of the water jet force A decision was made to enter the plant's planned from the displaced jet pump mixer on the instrument refueling outage about 3 weeks early, nozzle.

After reactor shutdown and disassembly, jet pump NRC issued Information Notice 93-101, " Jet Pump number ten (JP10) was found to have been displaced Hold-down Beam Failure," to alert licensees to the to between JP8 and JP9. The larger piece of the jet new type of failure not discussed in IE Bulletin j

pump beam for JP10 was found near JP6. The beam 80-07, "BWR Jet Pump Assembly Failure."

was found to have cracked and failed in an area not identified in previous BWR beam failures.

This event is included in Appendix C because it may possibly be perceived by the public to be of public Ultrasonic testing (LTF) examination of the health or safety significance. The displacement of in-service jet pump beams identified unacceptable the jet pump mixer willincrease the time required to indications on JP8 and JP21 in locations typical of re-flood the core to 2/3 core height; however, for the previous intergranular stress corrosion cracking jet pump failure to become a core cooling problem, it (IGSCC) failures. JP10 failed in the transition area has been shown that as many as 10-12 jet pumps between the main body of tbr beam and the hold must disassemble. The reactor was automatically down lugs. One lug failed con.pletely, leading to the shutdown when the failure occurred and was 27 NUREG-0090, Vol.16, No. 4 l

i

Abnormal Occurrences,4th Otr CY93 operated at low power only long enough to Airborne radioactive releases were in the range of determine that a jet pump failure had occurred.

those during normal operations.

3.

Fire at Enrico Fermi Nuclear Plant, Unit 2 An AugmentedInspection'Ibam(AIT).composedof NRC Region 111 (Chicago) and headquarters based The Fermi 2 Nucicar Power Plant consist of a single Persennel was sent to the Fermi 2 plant to General Electric boiling water reactor design 4 investigate this event.

(HWR 4) located near Monroe, Michigan. It is The licensee has not determined the cause of the operated by Detroit Edison Company, turbine damage. Five blades of the eighth stage of the No. 3 low pressure turbine failed and were On December 25,1993, the plant experienced a fire ej:cted. Other blades in the stage were damaged by m the mam generator and generator exciter, and a the debris. The licensee has not determined the catastrophic failure of the turbine. The fire m the scope of repairs or the expected length of the outage.

generator and exciter appeared to be the result of hydrogen leakage, explosion and burn.The cause of The AIT concluded that with few exceptions, plant the turbine failure is still under investigation.

personnel and equipment responded effectively to the turbine accident and brought the reactor to a safe At the time the Fermi plan t was at 93 percent power.

shut down condition.

At 1:15 p.m. a turbine trip and reactor scram occurred as a result of the turbine failure. All reactor Because of the volume of water generated by this safety systems functioned as intended, and the plant incident, the licensee announced in February 1994 shut down as designed. The licensee declared an that it planned to release up to l.5 millions gallons of Alert under its Emergency Plan.

slightly radioactive water. According to the licensee's announcement, any such releases would At About 1:30 p.m. an emergency response team not exceed the limits ofTitle 10 of the Code offederal entered the turbine building and observed heavy Regu'<rtions (10 CFR) for effluent release of smoke and flowing water from a number of sources radioactive materials.

including the fire suppression system. A small fire in the exciter area was extinguished. The fire The announcement of the plans to release the water suppression system in areas of the turbine building attracted considerable attention from the news was secured only after plant personnel determined media, general public, and State and local the fire was extinguished, governments.

The turbine failure resulted in damaged water lines The initial plan of the licensee was to release 532,000 g 11 ns of water contamed m the Condensate in the general service water system and the turbine building closed cooling water system. About 500,000 Storage Tank. The licensee had been processing the w ter with filters and demineralizers to mmtmize the gallons of water from the fire suppression system im f radioactwe contammation. Ens release and the damaged water lines accumulated in the basements of the turbine building and the adjacent

. provide addit,ional storage capacity for the radioactive waste processing building. Also mixed in water in the turbme building basement as it was the water was approximately 17,000 gallons of oil processed to remove radioactivity and other contaminants.

from the turbine seal and lubricating oil systems, Samples of the water in the tank were analyzed by A portion of a blade from the No. 3 low pressure the licensee, by NRC Region III in its mobile turbine penetrated the turbine housing and flew laboratory which was sent to the site, and by the State about 75 feet. Other debris from the turbine was of Michigan Department of Public Health. The ejected into the condenser hotwell beneath the analysis from all samples taken, showed the levels of turbine, damaging condenser tubes. The tube radioactivity to be a small fraction of the 10 CFR damage resulted in circulating cooling water from allowable effluent release limits.The radioactivity in the lake being pumped to the condensate storage the tank would represent a radiation dose of 0.02 tank and then into the reactor cooling system. Lake millirem to the maximally exposed individual. The water is high in mineral content and contain other allowable annual radiation dose limit from Fermi 2 contaminants that are not acceptable in the reactor effluent releases is 3 millirem per year.

cooling system water.

The contents of the Condensate Storage Thnk were l

There was no release of water containing released February 24-25, 1994. Measurements by radioactivity directly associated with the accident.

the NRC during the release showed no measurable NUREG-0090, Vol.16, No. 4 28

Abnormal Occurrences, 4th Qtr CY93 radioactivity above natural background levels at the the eventual actuation of the primary relief tank point it was released into Lake Eric. Measurements rupture disc and contributed to opening of some ice at the Monroe, Michigan, water supply facility condenser doors. One source of offsite power was showed no measurable radioactivity.

restored 1-hour and 15-minutes after the event initiation. The plant reached cold shutdown on December 29,1993.

Additional water releases may be made, depending on available storage capacity and water needs at the Fermi 2 site. Any such releases must meet NRC An NRC Augmented Inspection Team (AIT) was limits.

dispatched to the McGuire Nuclear Station on December 28,1993. Based on the findings from the This event is included in Appendix C because it had AIT inspection report, issued February 3,1994, the been perceived by the public to be of public health or team concluded that ineffective design controls, safety significance. The turbine damage, reactor associated with equipment overcurrent protection coolant system contamination, and release of schemes, led to the McGuire Unit 2 loss of offsite radioactive material do have financial implications power event. Original design and subsequent but did not result in a measurable increase in modifications relied on the main turbine generator radiation exposure or an increase risk to public to runback to the half power in the event of a single health and safety. The reactor was brought to a safe fault on one offsite source.This dependence was not shutdown condition and no personnel injuries clearly understood by the licensee. The runback occurred as a results of this event.

failed to function following a fault on one line, due to a misconfigured circuit card. Inadequately coordinated protective relays tripped the redundant 4.

Steam Generator Boiled Dry at McGuire Nuclear ffsite source m, stead of the mam generator output Plant, Unit 2 as a Consequence of a Loss of Offsite circuit breaker resulting in a loss of offsite power.

Power The McGuire Nuclear Station consists of two The AIT concluded that ineffective maintenance Westinghouse designed Pressurized Water Reactors and testing controls contributed to the failure of the (PWR) located in Huntersville, North Carolina, and B steam generator main steam isolation valve to fully close on demand. Clearance tolerances between operated by the Duke Power Company.

valve components were not established and checked a

n nn1 paa ng tempuatwe as On December 27, 1993, McGuire Unit 2 was recommended by the valve vendor. The valve was operating at 100 percent power when an electrical also not subjected to tests which would demonstrate insulator m the 525 KV switchyard failed. This its ability to function at operating temperature.

caused one of the two paths feeding the switchyard from the main generator to isolate. The main generator failed to runback as designed, and the The AIT also determined that corrective actions second offsite path isolated on overcurrent, regarding excessive cooldown and depressurization, resulting in a loss of offsite power to the plant.The from a previous loss of offsite power event, were not electrical transient caused a reactor trip and tuttine effective in preventing recurrence. As a result, this trip. Both emergency diesel generators started and event required engineered safety features to loaded as designed. An excessive cooldown and actuate. Without further actions to address this, a depressurization resulted in a low pressurizer safety injection is highly probable following loss of pressure safety injection followed by a steam line low offsite power event.

pressure safety injection and main steam isolation valve closure signal.The main steam isolation valve NRC is currently drafting an Information Notice to for the B steam generator failed to fully close, which discuss the importance of maintenance and testing caused continued depressurization of that steam of a steam generator main steam isolation valves at generator. Hecause the plant conditions were normal reactor operating temperature.

symptomatic of a steam leak outside containment, operators properly isolated all feedwater to the B steam generator, and over the next 1-hour and 15-This event is included in Appendix C because it may minutes, the steam generator boiled to a dryout possibly be perceived by the public to be of public condition. Primary system pressure was reduced in health or safety significance. This event did not order to maintain a maximum of 1600 psid across the involve a major reduction in the protection provided steam generator tubes by discharging through the for public health and safety; therefore, it is not pressurizer power operated relief valves. This led to reportable as an abnormal occurrence.

29 NUREG-0090, Vol.16, No. 4

Abnormal Occurrences,4th Otr CY93 Other NRC Licensees 5.

Medical Israchytherapy Misadministration at the The medical physicist who prepared the sour 'es took University of Minnesota in Minneapolis, Minnesota three 22.1 milligram radium equivalent sources from storage instead of the three 13 milligram sources.

De four sources prepared by the medical physicist This item was previously considered as an abnormal were then placed in the implant device. ne implant occurrence (AO) but was rejected because it did not was removed from the patient on J une 10 as planned.

meet the AO cnteria of 50 percent overdose.

The error in the source strengths was discovered on However, it is bemg considered for reportmg in June 14 when the medical physicist returned the "Other Events of Interest" of the AO report, as sources to the storage safe.

recommended by NRC Management Directive 8.1.

A brachytherapy misadministration occurred on The use of the incorrect source strength resulted in June 8,1993, at the University of Minnesota in the patient receiving a radiation dose of 3792 cGy Minneapolis, Minnesota. He misadministration (3792 rad) to the treatment area instead of the involved a patient receiving an absorbed dose of 3792 intended 2592 cGy (2592 rad). This represents a centigray (cGy)(3792 rad) mstead of the prescribed misadministration since the actual dose was 46 2592 cGy (2592 rad) for an overdose of 46 percent.

percent greater than that prescribed. The patient and the treating physician were notified of the On June 8,1993, a patient was to receive the first of misadministration.

two brachytherapy procedures for treatment of Since th.is was the first of two brachytherapy cervical cancer at the University of Minnesota, Minneapolis, Minnesota. He treatment involves treatments, the second treatment was modified to placement of sealed radiation sources in a holding account' for the excessive exposure in the first treatment.

device which is surgically implanted in the patient's

" 8 "'

NRC Region III (Chicago) retained an NRC medical consultant to evaluate the case. He concluded that The patient's physician prescribed the use of one the outcome of the two procedures together should cesium-137 source (9.1 milligram radium be equivalent to the course of treatment originally equivalent) and three cesium-137 sources (each 13 planned. No adverse effects would be anticipated as milligrams radium equivalent).

a result of the misadministration.

NUREG-0090, Vol.16, No. 4 30

Abnormal Occurrences,4th Otr CY93 APPENDIX D AGREEMENT STATE EVENTS BEING CONSIDERED 4

AS ABNORMAL OCCURRENCES J

For this report, there are no potentially significant events for reporting as abnormal occurrences.

with insufficient information to deterrnine applicability i

1 a

31 NUREG-0090, Vol.16, No. 4

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NRC FORM 335 U.S. NUCLE /R REGULATORY COMMIISION

1. HEPORY NUMBER (2-89)

(/ssilgned by NRC, Add Vol.,

f4RCM 1102, Supp., Rev., tnd Addendum Nurrw 320s,3202 BIBLIOGRAPHIC DATA SHEET b"*.

l' anY-)

(see instructions on ene reverse)

NUREG-0090 Vol.16, No. 4

a. TITLE AND SUBTITLE Report to Congress on Abnormal Occurrences:

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

l October-December 1993 MONm YEAR April 1994

4. FIN OR GRANT NUMSER

6. AUlHOR(6)

6. TYPE OF REPORT Quarterly

r. PERIOD COVERED (inclusive Dates)

October-December 1993 A PERFORM!NG ORGANIZATION - NAME AND ADDRESS (if NRC, provide Div;sion. Office or Region U.S. Nuclear Regulatory Commission, and melling address; 11 contractor, provide name and malling address.)

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

9. SPONSORING ORGANIZATION - NAME AND ADDRESS (If NRC, type "Same as above*i if contractor, provide NRC Division, Office or Region, 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 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 events to be made to Congress. This report covers the period from October 1 through December 31,1993 This report discusses six abnormal occurrences at NRC-licensed facilities. Five involved medical brachytherapy misadministrations, and one involved an overexposure to a nursing infant. Seven abnormal occur-rences that were reported by the Agreement States are also discussed, based on information provided by the Agreement States as of February 28,1994. Of these events, three involved brachytherapy misadministrations, one involved a telether-apy misadministration, one involved a theft of radioactive material during transport and improper disposal, and two in-volved lost sources.

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

13. AVAWW STATEMENT Unlimited Medical; Misadministrations; Brachytherapy; 'Ibletherapy; Radioactive; Overdose; g gg

14. SECURITY CLASSIFICATION (This Page)

Unclassified (This Report)

Unclassified

15. NUMBER OF PAGES

16. PRICE NRC FORM 335 (2-89)

1

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UNITED STATES

- FIRST CLASS Mall NUCLEAR REGULATORY COMMISSION POSTAGE AND FEES PAID WASHINGTON, D.C. 20555-0001 USNRC PERMIT NO. G-67 I,2055513953i OFFICIAL BUSINESS I

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