ML20059C106

Report to Congress on Abnormal OCCURRENCES.April-June 1993

ML20059C106
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Issue date:	09/30/1993
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
References
NUREG-0090, NUREG-0090-V16-N02, NUREG-90, NUREG-90-V16-N2, NUDOCS 9311010015
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NUREG-0090 Vol.16, No. 2 Report to Congress on Abnormal Occurrences April - June 1993 U.S. Nuclear Regulatory Commission

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NUREG-0090 Vol.16, No. 2 Report to Congress on Abnormal Occurrences April-June 1993 Date Published: September 1993 Omce for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555

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Abnoanal Occurrences,2nd Otr CY93 Previous Reports in Series NUREG 75/090 (January-June 1975), published October 1975.

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

NUREG-0090, Vols.1 through 15 (January-March 1978 through October-December 1992), published June 1978 through March 1993.

i NUREG-0090, Vol.16 No.1 (January-March 1993), published June 1993.

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l NUREG-0090, Vol.16, No. 2 ii u

Abnormal Occurrences,2nd Qtr CY93 ABSTRACT Section 208 of the Energy Reorganization Act of 1974 misadministrations and one involving a research reactor identifies an abnormal occurrence as an unscheduled inci-that operated without a safety system. One pool irradi-dent or event that the Nuclear Regulatory Commission ation facility contamination event, two medical misadmin.

determines to be significant from the standpoint of public istrations (one " sodium iodide" and one brachytherapy),

health or safety and requires a quarterly report of such and one industrial radiographer overexposure event that events to be made to Congress.This report covers the pc.

were reported by NRC Agreement States are also dis-ried from April 1 through June 30,1993.

cussed. He report also contains information updating This report discusses four abnormal occurrences at NRC.

one previously reported abnormal occurrence and infor-licensed facilities, three involving medical brachytherapy mation on three other events of interest.

iii NUREG-0090, Vol.16, No. 2

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Abnormal Occurrences,2nd Qtr CY93 CONTENTS Page Abstract............................................................................................

iii Preface.........................................................................................

Vil I n trod u ction.................................................................................. vii Th e Regula tory Syst em.......................................................................... vil Reportabl e Occurr ences......................................................................... vii Agre e m en t S ta t es............................................................................... viii Foreign Information.............................................................................. viii Reporting of Closed Abnormal Occurrences....................................................... viii Report to Congress on Abnormal Occurrences, April-June 1993...........................................

1 N ucl ear Power Plants..............................................................................

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

1 i

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

1 93-5 Medical Brachytherapy Misadministration at Parkview Memorial Hospital in Fort Wayne, Indiana...............................................

1 93-6 Inoperable Research Reactor Scrams at University of Virginia in Charlottesville, Virginia.....................................................

2 93-7 Medical Brachytherapy Misadministration at Merry Memorial Medical Center in St. Joseph, Michigan.................................................

3 93-8 Medical Brachytherapy Misadministration at Keesler Medical Center, Keesler Air Force Base, in Biloxi, Mississippi.....................................

4 Agreem e nt S tate Licensees...........................................................................

5 AS 931 Contamination of PoolIrradiator Facility Owned by Radiation Sterilizers, Inc., in Decatur, Georgia.................................................

6 AS 93-2 Medical " Sodium Iodide" Misadministration at Grenada Lake Medical Center in Grenada, Mississippi.........................................

7 AS 93 3 Medical Brachytherapy Misadministration at Maine Medical Center in Portland, Maine..................................................

7 AS 93-4 Industrial Radiographer Overexposure Event at Murphy Oil Refinery in M eraux, Louisiana......................................................

8 References..........................................................................................

9 Appendix A - Abnormal Occurrence Criteria............................................................ 11 Appendix B - Update of Previously Reported Abnormal Occurrences...................................... 15 Oth er NRC License e:............................................................................ 15 92-18 Loss of Iridium.192 Source and Medical Therapy Misadministration at Indiana Regional Cancer Center in Indiana, Pennsylvania............................... 15 v

NUREG-0090, Vol.16, No. 2

Abnormal Occurrences,2nd Qtr CY93 CONTENTS (cont.)

Appendix C - Other Events of Interest................................................................. 17 N ucl ear Power Plants............................................................................. 17 1.

High Pressure Coolant Injection Steam Release at Quad Cities Nuclear Powe r S tatio n........................................................................ 17

2. Electrical Power Transient at Oconee Nuclear Station....................................... 17 Oth er NRC Licensees............................................................................ 19

3. Radiographer Radiation Exposure Exceeding Regulatory Limits............................... 19 h

NURisG-0090, Vol.16, No. 2 y;

Abnormal Occurrences,2nd Otr CY93 PREFACE Introduction The Regulatory System The system of licensinE and regulation by which the NRC ne Nuclear Regulatory Commission reports to the Con-carries out its responsibilRies is implemented through gress each quarter, under provisions of Section 208 of the rules and regulations in Title 10 of the Code of Federal Energy Reorganization Act of 1974, any abnormal occur-Regulations. This includes public participation as an ele-rences involving facilities and activities regulated by the ment. 'Ib accomplish its objectives, the NRC regularly NRC. An abnormal occurrence (AO)is defined in Section conducts licensing proceedings, inspection and enforce-208 as an unscheduled incident or event that the Commis-ment activities, evaluation of operating experience, and sion determines is significant from the standpoint of pub-confirmatory research, while maintaining programs for lic health or safety.

establishing standards and issuing technical reviews and studies.

Events are currently identified as abnormal occurrences in licensing and regulating nuclear power plants and the for this report by the NRC using the crit eria and a:compa-uses of byproduct nuclear materials, the NRC follows the nying examples listed in Appendix A.nese criteria were philosophy that the health and safe'y of the public are best promulgated in an NRC polig statement that was pub-ensured through the establishme

>f multiple levels of lished in the Federal Register on February 24,1977 (Vol.

protection. Dese multiple levels can be achieved and 42, No. 37, pages 10950-10952),

maintained through regulations specifying requirements that will ensure the safe use of nuclear materials. De reg-ulations include design and quality assurance criteria ap-The NRC policy statement was published before licensees propriate for the various activities licensed by the NRC.

were required to report medical misadministrations to the An inspection and enforcement program helps ensure NRC. Few of the examples in the policy statement are compliance with the regulations.

applicable to medical misadministrations.Therefore, dur-ing 1984, the NRC developed guidelines for selecting such events for abnormal occurrence reporting. These guide-Reportable Occurrences lines, which have been used by the NRC since the latter part of 1984, augment the NRC pc! icy statement examples Actual operating experience is an essential input to the and are summarized in*Ihble A-lin Appendix A. On Janu-regulatory process for assuring that licensed activities are ary 27,1992, new medical misadministration definitions conducted safely. Licensees are required to report certain became effective. nerefore, revised guidelines for iden-incidents or events to the NRC. His reporting helps to tifying medical misadministrations as abnormal occur-identify deficiencies early and to ensure that corrective rences are currently being developed. The revised guide-actions are taken to prevent recurrence.

lines will be published for comment in the Federal Regis-ter.

For nuclear power plants, dedicated groups have been formed both by the NRC and by the nuclear power indus-try for the detailed review of operating experience to hcip In order to provide wide dissemination of information to identify safety concerns carly; to improve dissemination of the public, a Federal Register notice is issued on these ab-such information; and to feed back the experience into li-normal occurrences. Copies of the notice are distributed censing, regulations, and operations. In addition, the to the NRC Public Document Room and all Local Public NRC and the nuclear power industry have ongoing efforts Document Rooms. At a minimum, each notice must con-to improve the operational data systems, which include tain the date and place of the occurrence and describe its not only the type and quality of reports required to be sub-nature and probable consequences.

mitted, but also the methods used to analyze the data, in order to more effectively collect, collate, store, retrieve, and evaluate operational data, the information is main-He NRC has determined that only those events de-tained in computer-based data files, scribed in this report meet the criteria for abnormal occur-rence reporting.This report covers the period from April nree primary sources of operational data are Licensee 1 through June 30,1993. Information reported on each Event Reports (LERs) submitted pursuant to 10 CFR event includes date and place, nature and probable conse-50.73, immediate notifications made pursuant to 10 CFR quences, cause or causes, and actions taken to prevent re-50.72 and medical misadministration reports made pur-currence.

suant to 10 CFR 35.33.

1 vii NUREG-0090, Vol 16, No. 2 I

Abnormal Occurrences,2nd Q1: CY93 Except for records exempt from public disclosure by stat.

Presently, information on reportable occurrences in ute and/or regulation, information concerning reportable Agreement State licensed activities is publicly available at occurrences at facilities licensed or otherwise regulated the State level. For the purpose of developing a nation-by the NRC is routinely disseminated by the NRC to the wide database, Agreement States are encouraged to pro-nuclear industry, the public, and other interested groups vide information to the NRC on reportable events.

as these events occur.

In early 1977, the Commission determined that abnormal Dissemination includes special notifications to licensees occurrences happening at facilities of Agreement State li-and other affected or interested groups, and public an-censees should be included in the quarterly reports to nouncements. In addition, information on reportable Congress. The abnormal occurrence criteria included in events is routinely sent to the NRC's more than 100 Local Appendix A are applied unifonnly to events at NRC ar.d Public Document Rooms throughout the United States Agreement State licensee facilities. Procedures have and to the NRC Public Document Room in Washington, been developed and implemented, and abnormal occur-D.C. The Congress is routinely kept informed of report-rences reported by the Agreement States to the NRC are able events occurring in licensed facilities.

included in these quarterly reports to Congress.

Another primary source of operational data is reports of

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reliability data submitted by licensees under the Nuclear Plant Reliability Data System (NPRDS). The NPRDS is a Foreign Information voluntary, industry-supported system operated by the In-stitute of Nuclear Power Operations (INPO), a nuclear utility organization. Both engineering and failure data are The NRC participates in an exchange of information with submitted by nuclear power plant licensees for specified various foreign governments that have nuclear facilities.

plant components and systems.' Die Commission consid-This foreign mformation is reviewed and considered m ers the NPRDS to be a vital adjunct to the LER system for the NRC s assessment of operating experience and m its the collection, review, and feedback of operational expe-

[esearch and regulatory activities. Reference to foreign rience; therefore, the Commission periodically monitors ini rmation may occasionally be made m these quarterly the NPRDS reporting activities.

abnormal occurrence reports to Congress; however, only domestic abnormal occurrences are reported.

Agreement States Reopening of Closed Abnormal Section 274 of the Atomic Energy Act, as amended, au-Occurrences thorizes the Commission to enter into agreements with States whereby the Commission relinquishes and the States assume regulatory authority over byproduct.

The NRC reopens previously closed abnormal occur-source, and special nuclear materials (in quantities not ca-rences if significant new information becomes available.

pable of sustaining a chain reaction). Agreement State Similarly, previously reported Other Events of Interest programs must be comparable to and compatible with the items are updated if significant new information becomes Cornmission's program for such material.

available.

NUREG-0090, Vol.16, No. 2 y;;;

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Abnormal Occurrences,2nd Otr CY93 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES APRHe-JUNE 1993 Nuclear Power Plants NRC is reviewing events reported at the nucicar power mined that no events were abnormal occurrences.

plants licensed to operate. For t his report, N RC has deter-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.)

There are currently over 7,500 NRC nuclear material li-using a high-dose-rate brachytherapy treatment device, censes in effect in the United States, principally for the ne device uses a 296 000 megabequerel (MBq) (8 curie use of radioisotopes in the medical, industrial, and aca-

[Ci]) iridium-192 (Ir-192) source.

demic fields. Incidents were reported in this category from licensees such as radiographers, medical institu-The brachytherapy treatment was the final part of a cura-tions, academic in'stitutions, and byproduct material us-tive radiation treatment series.

ers. NRC is reviewing events reported by these licensees.

For this report, NRC has determined that the following The location of the treatment area was unusual for vagi-events were abnormal occurrences using the criteria and nal treatments and required a different starting position guidelines given in Appendix A. As noted in the Preface for the Ir-192 source than is normally used for such treat-to this report, the guidelines for identifying medical mis-ments. Both the dosimetrist and the medical physicist per-administrations as abnormal occurrences are currently formed the treatment calculations working together (the being revised.

second series of calculations was not an independent check) and both used the incorrect starting location for the source position. The error was not detected, and the 93-5 Medical Brachytherapy Misad-treatment was performed as scheduled. As a result, the.

ministration at Parkview in t ended 500 cGy (500 rad) radia tion dose was delivered to Memorial Hosp tal in Fort an area 5.25 centimeters (2.07 inches) away from the in-i tended treatment area. A small portion of the mtended Wayne, Indiana treatment area received a radiation dose ranging from 50 to 300 cGy (50 to 300 rad) according to the licensee.

The following information pertaining to this event is also being reported concurrently in the Federal Register Ap-On January 6,1993, the error was discovered during a re-pendix A (see Event 'Iype 3 in 'lhble A-1) of this report cord review by a dosimetrist. The referring physician and notes that a therapeutic exposure to a part of the body not the patient were informed of the error, The licensee re-scheduled to receive radiation should be considered an ported the misadministration to NRC on January 7,1993.

abnormal occurrence.

The incident constitutes a misadministration because the radiation dose was administered to the wrong treatment Date and Place-December 9,1992; Parkview Memorial site. On January 18,1993, the patient received an addi-Hospital; Fort Wayne, Indiana.

tional treatment using the high dose rate brachytherapy treatment device. The treatment plan was revised to meet Nature and Probable Consequences-On December 9, the intended objectives of the earlier treatment, taking 1992, a 62-year-old patient was scheduled to receive a 500 into account the lower dose already received by a portion i

centigray (cGy)(500 rad) radiation dose for vaginal cancer of the treatment area.

1 NUREG-0090, Vol.16, No. 2

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Abnormal Occurrences,2nd Qtr CY93

.s De licensee reported that no physical effect was ob-Nature and Probable Consequences-Since Novemberof served as a result of the misadministration.The NRC re-1992, the University of Virginia's research reactor had taincd a medical consultant to evaluate the circumstances been experiencing a series of spurious scrams.De scrams of the misadministration. The consultant concluded that were occurring without any annunciator indication. He-no noticeable biological effect is expected as a result of cause of the design of the scram annunciator system, the the misadministration.

licensee staff did not believe that the unannunciated scrams were being caused by electrical supply line noise. A Cause or Causes-Because of the unusual configuration member of the licensee's staff who was in charge of the of the treatment area, the standard treatment parameters electronic maintenance at the facility concluded that the used for vaginal brachytherapy treatment were not appli-most likely source of the problem was in the scram logic cable. A medical physicist and a dosimetrist prepared the system. Herefore, when he experienced unannunciated dose calculations working together and made the same scrams on April 28,1993, while performing the duties of error in assuming the initial position of the treatment the Senior Reactor Operator (SRO), he independently source.

began trouble-shooting the problem to try to isolate the source of the scrams. There was no specific procedure in The licensee's Quality Management Program requires place to provide guidance for the trouble-shooting activi-that an independent check of the dose calculations be per.

ties.

formed by a qualified individual before the treatment is initiated. Such an independent check was not performed.

With the reactor shutdown, the SRO first interchanged some of the electronic equipment in the reactor control console. nat action did not remedy the sit uation so he in-Act. ions Taken to Prevent Recurrence terchanged some other equipment, i.e., two mixer / driver License-The licensee has revised its procedures for pre-(MD) modules. The MD modules appeared to be identi-paring the treatment plans for the high-dose rate brachy-cal in their external appearance and both had the same therapy procedures. It has made improvements in the cal-identification number. After approximately 30 minutes, culation notebook and other related data used in no further scrams were received so the SRO briefly con-ferred with the Reactor Admmistrator about the situa-preparing the treatment plans and the dose calculations.

tion, and the reactor was restarted. Neither the SRO nor the Reactor Administrator realized that the NRC -NRC Region III conducted a special inspection on January 28 and 29,1993, to review the circumstances sur-trouble-shooting actions (exchangmg the MD modules) rounding the misadministration (Ref.1). An NRC medi-were mamtenance activities. Therefore, no postmamte-cal consultant was also retained to review the case.

nance testing was performed to ensure that the safety sys-tems were operating as required.

The NRC inspection determined that the licensee failed The reactor was operated at full power for the next 5.5 ~

to follow its Quality Management Program requirement hours with a change in SROs every 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />. No scram sig-for an mdependent check of brachytherapy dose calcula-nal was received during that period. During a normal i

tions. Other violations were identified which did not di-shutdown of the reactor at the end of the day on April 28, rectly relate to the misadmmistration. A notice of viola-another SRO, who was then in charge of reactor opera-I tion was issued to the bcensee.

tions, decided to complete the shutdown by introducing an electronic period scram. De scram logic, however, This item is considered closed for the purposes of this re" failed to produce the expected period scram and the SRO 1

port.

manually scrammed the reactor, which resulted in safe shutdown of the reactor, j

93-6 Inoperable Research Reactor Cause or Causes-ne principal causc of the incident was Scrams at University of Virginia the SRO exchanging the MI> modules in the reactor con-

I * "" I*' "S I"^d"'*"'IY. defeated five f the in Charlottesville' Virginia scrams required for reactor operation. Other eontributmg causes were not recognizing the exchanging of the mod-The following infonnation pertaining to this event is also ules as a maintenance activity, lack of adequate procc-beir.3 m,orted concurrently in the Federal Register. Ap-dures defining maintenance and troubleshootmg actm-pendix A (see Items No.10 and 11 for all licensecs) of this ties, and failure to perform post-maintenance testmg of j

report notes that a major deficiency in operating, manage-the safety system pnor to restarting reactor operatiens.

ment, or procedural controls that impact safety should be considered an abnormal occurrence.

4 Actions Taken to Prevent Recurrence Date and Place-April 28,1993; the University of Virgin-Licensee-ne Reactor Director was notified of the prob-ia: Charlottesville, Virginia, lem when no scram was received the evening of April 28 i

I NUREG-0090, Vol.16, No. 2 2

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i Abnormai Occurrences,2nd Qtr CY93 and an investigation was begun into the cause of the prob-Date and Place-February 16, 1993; hiercy hiemorial lem. As a result of the investigation, the licensee initiated hiedical Center; St. Joseph, Michigan, various corrective actions including: (1) maintaining the reactor in safe shutdown until the problem was investi-Nature and Probable Consequences-On February 16, i

gated, understood, and reviewed with the Reactor Safety 1993, at 5:00 p.m., a patient was undergoing a brachshera-Committee (RSC) and with the NRC; (2) notifying the py procedure using cesium-137 (Cs-137) sources.The ra-j University the community, and the NRC of the problem; diation oncologist involved in this procedure failed to (3) requesting a peer review from the National Organiza.

properly rotate the insert of the brachytherapy device tion of Test, Research, and Training Reactors (TRTR);(4) containing the sources, and one source containing 862.1 determining the root cause(s) of the event and taking cor-megabecqu erel (M Bq)(23.3 millicuries [ mci]) Cs-137 fell rective actions; (5) determining if there were any prob-out of the insert onto the patient's bed.The source landed lems with the hardware, schematics, and Standard Oper-on an absorbent pad that was placed between the patient ating Procedures (SOPS) which may have contributed to and the surface of the bed 'Ihe loss of the source was not this event and taking actions to correct the problems observed by the oncologist or the medical physicist who noted; and (6) determining if any administrative correc-was assisting him.

tive actions were needed.

On February 17, at about 8:20 a.m., a nurse observed a small piece of metal between the patient and the absor-NRC-A reactive inspection was conducted on May 3, bent pad.He nurse thought it was a small screw and re-1993. Staff members from NRC Region Il and headquar-trieved it, placmg it in a paper cup on the bedside table.

ters participated in this inspection. A follow-up inspection The radiation oncologist and the medical physicist weic was conducted on June 3 and 4,1993, again with participa-tion from NRC Region II and headquarters. Apparent n t,ified, and they identified thc object as a cs-137 source.

i Usmg tongs, they placed it in a shielded storage container.

violations of regulatory requirements were identified and discussed with licensee management and the SRO in-volved in the incident during a June 29,1993, enforcement The dislodged source was subsequently placed in the conference held in the NRC Region 11 Office. Ihe licens-treatment device, and the treatment plan was revised to ee presented its perspective on the significance of the reflect that the source was implanted for a red uced period notice of violation and proposed m, position of civil penal-event, its causes, and the licensec s corrective actions. A of time.The revised treatment plan indicated that thisim-plant time reduction for the one source would result in an ty was issued by the NRC on J uly 28,1993. Violations were underdose of about 6 percent to the intended treatment proposed for operating the reactor without five safety sys-site.

tem channels required by thelbchnical Specifications and for failing to verify that the safety system channels were The licensee calculated that the dislodged source resulted operable following maintenance, as required by the Tech-in a radiation dose of about 45.8 centigray (cGy)(45.8 rad) i meal Specifications. These were categortzed in thc aggre-to the perineum, an area different from the intended -

gate as a Severity Level II problem (Severity Levels I treatment site. In addition, the licensee stated that there through V range from the most signiticant to the least sig-is no evidence of clinical effects on the patient as a result nificant) and a civil penalty of $2000 was proposed. The h-of the radiation exposure from the dislodged source.

censee paid the civil penalty on August 26,1993.

This incident is considered a misadministration because a This item is considered closed for the purposes of this re-part of the patient's body received unscheduled radiation port.

exposure.The licensee reported that both the patient and a

the referring physician had been notified of the incident.

The NRC staff calculated the dose to the nurse who dis-93-7 Medical Brachytherapy Misad-covered and handled the dislodged source. Based on in-mlntStration at Mercy Memorial formation supplied by the nurse on her handling of the Medical Center in St. Joseph, source, NRC calculated that she received a 4.25 cGy (4.25 l

rad) radiation exposure to the surface of the hand in con-t ggE tact with the source.

1 The following information pertaining to this event is also Cause or Causes-The cause of the misadministration being reported concurrently in the Federal Register Ap-was the radiation oncologist's failure to properly rotate pendix A (See Event Type 3 in Table A-1) of this report the Cs-137 source insert while loading the source into the notes that a therapeutic exposure to a part of the body not ireatment device. In addition, the nurse who discovered scheduled to receive radiation should be considered an the dislodged source had not received any training on the I

abnormal occurrence.

size and appearance of the brachytnerapy sources.

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NUREG 0090, Vol.16, No. 2 P

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Abnormal Occurrences,2nd Otr CY93 i

l Actions Taken to Prevent Recurrence incident, who in turn formally notified NRC. RIC's initial

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report noted that a patient who was to receive a total dose Licensee-The licensee conducted refresher training for of 1400 centigray (cGy)(1400 rad) to the right lower lung its nurses to explain brachytherapy proce< lures and pro-had also received an unintended dose of approximately vided them with instructions.

2.09 cGy (2.09 rad) to the facial area.

NRC-NRC Region III conducted a special inspection The incident involved a brachytherapy treatment using an from March 26 through April 7,1993, to review the cir-iridium-192 highdose-rate remote afterloading device.

cumstances surrounding the misadmmistration (Ref. 2).

De written directive prepared by the authorized user pre-l An NRC medical consultant was also retained to evaluate scribed two treatment doses of 700 cGy (700 rad) each to '

the circumstances of the event.

be delivered to the lower lobe of the patient's right lung.

The first treatment dose was administered on June 2, nem.spection identified several apparent violations of 1993, using a single endobronchial catheter, as prescribed NRC requirementsincluding:(1)substantialfailure toim-in the written directive.The second treatment dose was to plement a Quality Management Program for brachyther-be administered on June 10,1993, using two endobron-apy procedures; (2) failure of the RSO to adequately m' chial catheters, one positioned in the lower lobe of the vestigate the accident to identify a misadmm, istratton, and right lung and the second positioned in the middle lobe of to assess overexposure to the nurse's hands;(3) failure t the lung.De fractional dose prescribed for the lower lobe adequately instruct nurses caring for brachytherapy pa-was delivered as intended. The fract onal dose for the i

i tients; and (4) failure to make evaluations to assure com-middle lobe was not deli ned as prescribed in the written pliance with NRC exposure limits for occupational work-directive due to incorrect positioning of the source.

ers. On August 2,1993, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalties in r

the amount of $6,250.The licensee paid the civil penalties The mispositioning of the source resulted from an error m, on August 12,1993.

entering the length of the catheter into the treatment plannmg computer. De treatment plan established by he authorized user called for use of two catheters, each This item is considered closed for the purposes of this re-with a length of 150 centimeters (cm) (59.1 mches [in.]).

p rt.

The length of the first catheter and source position was properly entered at the treatment planning computer 93-8 Medical Brach}'theraIiY Misad-

• "5 I" "* P '*i"**'s d sim trist believed that the length and source posit. ion for the second catheter were i

ministration at Kecsler Medical properly entered. However, it was later discovered that Center, Kecsler Air Force Base, due to an erroneous keystroke, a default value of 100 cm (39.4 in.)was entered as the length of the second catheter.

in BilOXI, Mississippi This resulted in an error in the source position since the actual distance of source travel is determined by subtract-The following information pertaining to this event is also ing an " offset" value from the length of the catheter.The being reported concurrently in the Federal Register. Ap-error in the source position was recognized by the autho-pendix A (see Event %pe 3 in 'Ihble A-1) of this report rized user as the treatment was underway and the treat-notes that a therapeutic exposure to a part of the body not ment was promptly stopped.

scheduled to receive radiation should be considered an Following consultation with the device manufacturer and f

abnormal occurrence.

review of the treatment planning computer data and the Date and Place-June 10,1993; Keester Medical Center; data available from the remote afterloading device con-Keesler Air Force Base;11iloxi, Mississippi, trol console, permittee representatives determined that the source had been positioned approximately 10 cm (3.9 Nature and Probable Consequences-On June 14, 1993, in.)in front of the patient's face for a period of approri-the United States Air Force Radioisotope Committee mately 46 seccmds. The estimated dose to the patient's Secretariat (RIC) notified NRC Region IV of an incident face was determined to be approximately 2.09 cGy (2.09 involving a brachytherapy treatment which occurred at rad). In the absence of the licensee's RSO, and based on Keesler Medical Center on June 10,1993. He permit-advice provided by the manufacturer's representative, the tee's Radiation Safety Officer (RSO) was not present at permittee's staff determined that Ihe incident did not con-the facility on June 10.The permittee staff involved with stitute a therapeutic misadministration.The remainder of the treatment did not initially recognize the incident as a the prescribed treatment dose was delivered to the middle misadministration.The incident and related facts were re-lobe of the patient's right lung later that day.Through dis-ported to the RSO when he returned to the medical cen-cussions with the RSO, the RIC, and the NRC staff, the ter on June 14.The RSO subsequently notified RIC of the permittee subsequently determined on June 14 that a mis-t NUREG-0090, Vol.16, No. 2 4

~. -

Abnormal Occurrences,2nd Qtr CY93 administration had occurred and reported the incident to tered the treatment on June 10 acknowledged that they NRC and the patient as required.

had only verified the source dwell times noted on the I

treatment planning and device control computer print.

sts. Megh k dweH posWon vane on M recods NRC inspectors were at the medical center on June 23 and 24,1993, to review the circumstances associated with was incorrect (because the error was propagated in both the misadministration and its probable cause(s).

computer systems), the dosimetrist and physicist stated that they probably would have identified the error ti they -

Cause or Causes-Based on interviews with permittee i

representatives and reenactment of the treatment plan-ning and setup, the apparent root cause of the misadmi-Actions Taken to Prevent Recurrence nistration was determined to be an erroneous keystroke at the treatment planning computer console. The permit.

Permittee-Following the misadministration, the permit-tee's dosimetrist demonstrated for the NRC inspectors tee modified a checklist that had been used by the staff to the sequence of steps taken during treatment planning, verify that certain actions were completed prior to treat-noting that the correct value of 150 cm (59.1 in.) had been ment. The modifications included requirements to (1) entered for both catheters on June 10. However, the dosi.

physically measure each catheter prior to use for patient metrist believed that after the length of the second cathe-treatments and document the measured length of the ter was entered, she depressed the "F2" function key to catheter on the checklist form,(2) document the planned enter another treatment parameter and accidentally distance from the end of the catheter to the first dwell po-touched the "F1" function key with her hand at the same sition on the checklist form,(3) have the authorized user time This caused the catheter length value to change to and medical physicist verify the documented catheter i

the default value of 100 cm (39.4 in.) with only the sound length and dwell positions and sign the checklist for ap-of a " beep" to warn the operator, Through repetitive test.

proval, and (4) include a review of the checklist in the per-ing of different keystroke sequences, the dosimetrist de.

mittee's Quality Management Program.

l termined that this was the only sequence that would re-produce a reset of the catheterlength to the default value NRC-An inspection was conducted on June 23 and 24, once the length was manually entered at the treatment 1993, to review the misadministration and its probable planning console.This sequence of steps was repeated for cause(c)(Ref. 3). Based on the results of the inspection, the inspectors several times during the inspection and in two apparent violations were identified relative to the

- each instance, the catheter length defaulted to 100 cm permittee's Quality Management Program. These in-(39.4 in.).

cluded (1) a failure to implement and maintain a Quality Management Program that met the objective of ensuring that radiation from byproduct material was administered A contributing factor to the misadministration was the in accordance with a written directive, and (2) failure to failure of permittee staff to verify the dwell positions for indicate the radioisotope to be used for brachytherapy each catheter prior to performing the treatment as re-treatments in 22 written directives. In addition, several quired by an " Operating Instruction" established by the weaknesses were identified in the permittee's written -

permittee. Although this operating instruction was not in-Ouality Management Program. The inspection findings corporated in the permittee's Quality Management Pro, indicated that the failure to verify the source dwell posi-gram, it did require that individuals administering patient tions prior to performing a patient treatment was an iso-treatments using the high-dose-rate remote afterloading lated event and that the permittee staff had complied with l

device verify both the source dwell time and source dwell the applicable operating instruction during previous pa-1 positions prior to administering a treatment.This require.

tient treatments. A Notice of Violation was issued on July ment was established to ensure that treatment parame.

20,1993. A Civil Penalty was not proposed.

ters entered in the device control unit matched the pa-rameters entered in the treatment planning computer.

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

Both the dosimetrist and medical playsicist who adminis-port.

[

Agreement State Licensees i

i j

Procedures have been developed for the Agreement events to the NRC for inclusion in these quarterly repoJs i

States to screen unscheduled incidents or events using the to Congress. During this period, the Agreement States re-l same criteria as the NRC (see Appendix A) and report the ported four events as abnormal occurrences.

i W

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

~

P a

Abnormal Occurrences,2nd Qtr CY93 i

AS 93-I Contamination of PoolIrra.

elevated ievels of Cs-137 dissolved in the pool water, con-firming the presence of one or more leaking sources.This diator Facility Owned by was the first recorded instance of a leaking WESF cap.

Radiation Sterilizers, Inc.,

sule. A joint Federal / State task force, consisting of the in Decatur, Georgia Georgia Department of Natural Resources (DNR), the Georgia Department of Human Resources (DHR), and NRC, was established to assist with the RSI incident.

Appendix A(see Example 5 of"For All Licensees")of th.is report notes that any loss of licensed material in such After review and recommendation by the joint task force quantities and under such circumstances that substantial and upon discussion with RSI, on June 11,1988, the State hazard may result to persons m unrestricted areas should of Georgia formally requested that DOE manage the ef-be considered an abnormal occurrence.

fort to identify the leaking capsule, develop a plan for the safe removal of the leaking capsule, manage the removal This event occurred in June 1988 in Georgia, an Agree-of the damaged capsule, and oversee the cleanup and re-ment State by a joint Georgia and NRC incident Evalua-covery activities at RSL DOE responded immediately to tion 'Ihsk Force. He investigated incident was docu-the State's request and dispatched resources from the mented in NUREG-1392, " Leakage of an Irradiator Westinghouse Hanford Corporation. The joint Federal /

Source - the J une 1988 Georgia RSI Incident," published State task force was also expanded to include representa-in February 1990. At that time, neither the State norNRC tives from the Food and Drug Administration (FDA)and identified the event as an AO.The state reevaluated the the U.S. Environmental Protection Agency (EPA).

incident against the reporting criteria in 1993 and con-cluded that the event should be classided as an AO.

This incident generally was confined to the RSI facility, with no evidence of major discharges to the environment.'

Date and Place-J une 6,1988; Radiation Sterilizers, Inc.,

There was no evidence of overexposure, although areas of Decatur, Georgia.

minor contamination were found in a warehouse, the of-i fice carpet, one automobile seat, one individual's pants Nature and Probable Consequences-On June 6,1988, and spots on a carpet at a residence, all of which were de-the Radiation Sterilizers, Inc. (RSI) facility in Decatur, contaminated. Some medical products sterilized at the Georgia, ceased sterilizer operations utilizing its pool ir.

RSI facility before the incident was discovered were con-radiator because of the detection of dissolved radioactive taminated; however, the only contaminated products re-cesium-137 (Cs-137)in a 25,000 gallon pool of water in leased from the RSI facility were in a shipment that was which 252 stainless steel encapsulated radioactive sources recalled before it reached its destination.

were stored. The Cs-137 sources, which were leased from the Department of Energy (DOE), had a total activity of Five suspected leaking (damaged) sources were initially approximately 444,000 terabecquerel [TBql (12 megacu-removed from the storage pool. One was confirmed to be ries)[ mci]).The sources were Waste Encapsulation Stor-leaking. Subsequently, the remaining 247 source capsules age Facility (WESF) capsules manufactured by DOE, un-were examined for leakage. None were found to be leak-der the By-product Utilization Program (BUP). This ing. On November 19,1990, the last of the capsules was DOE program was initiated with a mission to develop the shipped off site and final decontamination of the facility means for application of radioactive fission products for began. On September 11,1992, the DOE contractor com-the benefit of society. Under BUP, the sources were de-pleted decontamination of the facility and began the sur-signed for waste storage, not as gamma radiation sources.

vey. DOE estimated cost of the cleanup to be 45 million In 1985, however, NRC agreed that use of WESF sources dollars. On November 11,1992, the DOE contractor com-could be authorized in a limited number of commercial pleted the free release survey and the DNR contractor demonstration facilities, including irradiators such as completed the confirmatory survey. By December 16, RSI's that operate in the " wet load, wet storage, dry irradi-1992, DNR received the free release survey. On January i

ation" mode.

5,1993, after review and evaluation of the reports, DNR i

returned control of the facility to the owner, Sterigenics Operators of the RSI poolirradiator notified the State of International (formerly RSI), and terminated its radioac-Georgia Radiation Control Program that the safety sys.

tive materials license.

tem had prevented them from raising sources from the storage pool. Subsequently, radiation levels of 600 micro-Cause or Causes-The facility contamination resulted sievert (Sv) (60 millirem) per hour at the surface of the from one stainless steel cesium-137 source capsule, out of pool water were found, which indicated that one or more a total of 252 capsules, leaking in the source storage pool.

of the 252 Cs-137 source capsules used in the irradiator were leaking. Discrete samples of pool water were DOE has not identified the exact cause of failure of the collected and analyzed and the analytical results showed Cs-137 source capsule.

NUREG-0090, Vol.16, No. 2 6

Abnormal Occurrences,2nd Qtr CY93 Actions Taken to Prevent Recurrence gist immediately discovered the error and notified the physician (authorized user). Vomiting was induced within Licensee-The licensee requested that DOE (the source 5 minutes of administering the I-131 capsule.The patient manufacturer and the source lessor) manage the effort to was also acainistered a thyroid blocking agent,1.2 millili-identify the leaking capsule, develop a plan for its safe re-ters (ml) (0.04 fluid ounces [fl. oz.]) of potassium iodide.

moval, manage its removal, and oversee the cleanup and ne patient was also instructed to take additional thyroid recovery activities at RSL blocking agent 0.3 ml (0.01 fl. oz.) of potassium iodide, once a day for 14 days. A thyroid uptake and scan were NRC-Following the incident, NRC reevaluated the performed 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the incident.The thyroid uptake WESF sources and determined in early 1991 that WESF was 0.3 percent. The referring physician and the patient sources were not appropnate for long-term use in com-were informed of the misadministration.

mercial inadiator facilities and ensured that the remain-ing commercial users were so notified and advised to Cause or Causes-The misadministration occurred be-cooperate with DOE in scheduling removal of WESF cause the nucicar medicine technologist failed to identify sources from their facilities. As of the date of this report, the patient prior to the administration of the radiophar-l WESF capsules remain in place in two licensed irradia-maceutical.

tors, one in Virginia and one in Colorado (licensed by the State of Colorado). According to DOE staff, if certain Actm.ns Taken to Prevent Recurrence technical matters are resolved DOE plans to begin re-moving the remaining WESF sources from these facilities Licensee-The Radiation Safety Officer has implem-by the end of 1993.

ented new procedures for verification of patient identifi-cation and has committed to improve the supervision of State Agency-The State of Georgia secured the services personnel.The licensee also stated that patients who are of an independent consultant to verify the results of de-prescribed radiation therapeutic procedures will no long-contamination efforts by the DOE contractor. Once it was er be included in the same schedule with patients who are verified that the facility met Federal and State regulatory prescribed diagnostic procedures.

standards for decontamination, the State terminated RSI's materiallicense and returned control of the facility State Agency-The state agency staff has reviewed the cif to its owner. Georgia will no longer license highly soluble cumstances of the misadministration and will evaluate the cesium for this application.

I censee's corrective actions during the next inspection to be conducted in the near future.

Future reports will be made as appropriate.

His item is considered closed for the purposes of this re-AS 93-2 Medical " Sodium Iodide" port.

Misadministration at Grenada Lake Medical AS 93-3 Medical Bractlytherapy Misadministration at Maine Center in Grenada, Mississippi Medical Center in Portland, Maine Appendix A (see Event'Iype 4 in'Ihble A1)of this report notes that administering a diagnostic dose of a radiophar-Appendix A(see Event'Iype 3 in'Ihble A-1)of this report maceutical that is greater than five times the prescribed notes that a therapeutic exposure to a part of the body not dose should be considered an abnormal occurrence.

scheduled to receive radiation should be considered an abnormal occurrence.

This report is based on information provided to the State of Mississippi on April 3,1992.

Date and Place-November 11, 1992; Maine Medical I

Center; Portland, Maine.

I Date and Place-April 1,1992: Grenada Lake Medical Center; Grenada, Mississippi.

Nature and Probable Consequences-A patient was pre-scribed a brachytherapy treatment using 13 seeds of iridi-Nature and Probable Consequences-On April 1,1992, a um-192 in a nylon ribbon. The catheter used for the treat-patient scheduled to receive 3.7 megabecquerel (MBq) ment developed a kink and stopped 26 centimeters (cm)

(100 microcuries [Ci]) of iodine-131 (I-131) for a thyroid (10.24 inches [in.]) from the prescribed treatment area.

uptake study was administered 218.3 MBq (5.9 millicuries This resulted in a dose to the patient's hypopharynx area

[ mci]) of I-131. The 218.3 MBq (5.9 mci) dosage of I-131 of 3500 centigrays (cGy) (3500 rad), which was the pre-was to be administered to another patient. The technolo-scribed dose to the lung. The intended treatment area of 7

NUREG-0090, Vol.16. No. 2 O

Abnormal Occurrences,2nd Qtr CY93 the lung was estimated to have received less than 10 cGy hazard may result to persons in unrestricted areas should (10 rad).

be considered an abnormal occurrence.

Prior to implantation of the radioactive seeds, nonradio-Date and Place-May 7,1993; Murphy Oil refinery; Mer-active sources were implanted for visualization and dosi.

aux, Louisiana.

metry / treatment planning. The licensee performed x-rays which showed that the dummy seeds had reached their de.

Nature and Probable Consequences-While working at a sired location.The active seeds were to be inserted imme.

temporary job site at the Murphy Oil refinery, a 21 diately after withdrawal of the dummy seeds. However, year-old industrial radiographer employed by Inspection because of scheduling difficulties with the patient's room.

Specialists, Inc., using 3700 gigabecquerel (G Bq) (100 cu-and not wan ting a patient with radioactive seeds to remain ries) of iridium-192 in a SPEC 2-T exposure device, re-in the therapy department for an undetermined period of ceived a 276.6 millisievert (mSv)(27.66 rem) wholebody time, the dummy seeds were withdrawn but the catheter exposure as indicated by a thermoluminescent dosimeter remained in the patient. The radioactive seeds were im-badge. Reenactment of the events appears to indicate that planted sometime later. In retrospect the licensee esti.

the radiographer received the wholebody dose, and that mated that the kink in the catheter developed during the there was probably no extremity dose that would cause interval of removing the dummy seeds and inserting the acute (short-term) injury. A preliminary physical exami-active seeds, nation with blood tests indicated no indication of exces-sive exposure.

After the treatment was corapleted and while removing the catheterand the nylon ribbon together, the doctorand The radiographer's assistant is estimated to have received the Radiation Safety Officer both noticed the kink. The a dose of 9.6 mSv (0.96 rems).

licensee stated that no long-term effects are expected.

The patient was notified of the misadministration.

Cause or Causes-Radiography operations were being conducted on a large, open-top steel tank. De radio-graphers and camera had to be moved from place to place Act.mns Taken to Prevent Recurrence along the side of the tankin personnelbaskets.The radio-e a to lock the exposure device, so that when gra e rad [ grapWs assistant moved toward the device with Licensee-The licensee implemented the following ac-m tions: (1) measuring the nonradioactive seed strand when properly inserted (verified by x-ray) and marking the dis-k"ndle, the source moved slightly out of the shicided position. De radiographer apparently failed to tance on the active strand; (2) the dummy strand or similar read the survey meter while the source was exposed.The wire will be Icft in the catheter until immediately prior to radiographer and assistant realized after severaladdition-insertion of the radioactive strand; and (3) a fiim will be al exp sur s that their dosimeters were off scale.

taken of the area to be treated after the active seeds are inserted to ensure that they are in the correct location.

Actions Taken to Prevent Recurrence State Agency-The state agency is reviewing this event to Licensee-The licensee provided retraining to the entire determine necessary actions, staff with special counseling for the Operations Manager, who apparently did not follow written operating procc-Future reports will be made as appropn. ate.

dures.

State Agency-The Louisiana Radiation Protection Divi-AS 93-4 Industrial Rad.iographer sion (RFD) recommended to the licensee that routine Overexposure Event at physical examinations and blood work be performed. En-I rcement acti ns included citations foniotations asso-

?

Murphy Oil Refinery in ciated with wholebody and extremity overexposures and a Meraux, Louisiana lack of adequate training. A civil penalty is being consio-Appendix A(See example 1 of"For All Licensees")of this report notes that any loss of licensed material in such This item is considered closed for the purposes of this re-quantities and under such circumstances that substantial port.

NUREG-0090. Vol.16, No. 2 8

O

Abnormal Occurrences,2nd Qtr CY93 j

REFERENCES 1

1.

Letter from Charles E. Norelius, Director, Division spection Report No. 030-0249/93001, Docket No.

.l of Radiation Safety and Safeguards,NRC Region III, 030-02049, May 10,1993.*

to David Ridderheim, President, Parkview Memorial Hospital, dated March 3,1993, forwarding Inspec.

3.

Letter from L J. Callan, Director, Division of Radi-tion Report No. 030-1593/93-001, License No.

ation Safety and Safeguards, NRC Region IV, to Ma-13-01284-02, Docket No. 030-01593.*

j r David Adams, USAF Radioisotope Committee, July 20,1993, forwarding Inspection Report No.

030-28641/93- 06, License No. 42-23539-01 AF, Dock-et No. 030-28641.*

2.

Letter from Chctles E. Norelius, Director, Division of Radiation Safety and Safeguards, NRC Region III,

. A copy is available for inspection or copying for a fee in the NRC Pub-to Robert P. Harrison, Chief Operating Officer, lic Document Room,2120 LStreet NW. (lower level),hhington, Mercy Memorial Medical Center, forwarding In.

DC 20555.

I r

t 9

NUREG-0090, Vol.16, No. 2

Abnormal Occurrences,2nd Otr CY93 APPENDIX A ABNORMAL OCCURRENCE CRITERIA The following criteria for this report's abnormal occur-release of radioactive material from a package in rence (AO) determinations were set forth in an NRC amounts greater than the regulatory limit.

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

5.

Any loss oflicensed materialin 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 or or safety. Such an event would involve a moderate or more severe impact on the public health or safety and chversion oflicensed material or sabotage of a facil-could include but need not be limited to:

ity.

7.

Any substantiated loss of special nuclear material or 1.

Moderate exposure to, or release of, radioactive ma' any substantiated inventory discrepancy that is teriallicensed by or otherwise regulated by the Com-judged to be significant relative to normally expected misston; performance and that is judged to be caused by theft or diversion or by substantial breakdown of the ac-2.

Major degradation of essential safety-related equip-countability system.

ment; 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 mate-or accountability systems) that significantly weak-

rial, ened the protection against theft, diversion, or sabo-tage.

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

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

l tail using these criteria are.

r

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

1.

Exposure of the whole body of any individual to 25 remormoreofradiation;exposureof theskinof 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 ra-

12. Series of events (where individual events are not of diation [10 CFR 20.403(a)(1)], or equivalent expo-major importance), recurring incidents, and inci-sures from internal sources.

dents with implications for similar facilities (generic incidents) that create major safety concern.

2.

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

1.

Exceeding a safety limit of license 'Ibchnical Specifi-

"*I

(')b 3.

The release of radioactive material to an unre-stricted area in concentrations which, if averaged 2.

Major degradation of fuel integrity, primary coolant 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 the regu-pressure boundary, or primary containment bound-latory limit of Appendix B, Thble II,10 CFR Part 20 ary.

[CFR 20.403(b)(2)].

Loss of plant capability to perform essential safety 4.

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

11 NUREG-0090, Vol.16, No. 2

)

1 Abaormal Occurrences,2nd Otr CY93 e

e 4.

Discovery of a major condition not specifically con-For Fuel Cycle Licensees..

sidered in the Safety Analysis Report (SAR) or'Ibch-1.

A safety limit of license Technical Specifications is nical Specifications that requires immediate reme.

dial action.

exceeded and a plant shutdown is required [10 CFR '

50.36(c)]..

S.

Personnel error or procedural deficiencies that re-2.

A major condition not specifically considered in the r

sult in loss of plant capability to perform essential safety analysis report or'Ibchnical Specifications that -

safety functions such that a potential release of ra-requires immediate remedial action.

t dioactivity 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 func-control rod system).

tion.

Medical Misadministrations As discussed in the Preface to this report, the NRC policy inglThese guidelines, which are summarized in 'Ihble A-1, statement on AOs was published before licensees were augment the NRC policy statement.

required to report medical misadministrations to'the As noted in the Preface, revised guidelines are currently -

NRC. Therefore, during 1984, the NRC developed being developed because new medical misadministration 1

guidelines for selecting such events for AO report-definitions became effective on January 27,1992.

l i

d i

I 1

i NUREG-0090, Vol.16, No. 2 12

-l

i Abnormal Occurrences,2nd Qtr CY93 i

t l

Table A 1 NRC Guidelines for Selecting Medical Misadministration Event:

for Abnormal Occurrence (AO) Reporting AO Reporting Threshold l

Event Type Diagnostic Exposure Therapeutie Exposure (1) Administering a radiopharma-If the improper administration If the improper administration ceutical or radiation from a results in any part of the

. results in any part of the body scaled source other than the body receiving unscheduled receiving unscheduled radiation, an one intended.

radiation, an AO report should AO report should be proposed for be proposed if:

any such event.

(a) the actual dose to the If the parts of the body wrong body part is receiving radiation greater than five times improperly would have the upperlimit of the received radiation anyway, normal range of had the proper administration exposures prescribed been used, an AO report for diagnostic procedures should be proposed if:

involving that body part, or (b) there are clinical (a) the actual dose is greater indications of any than 1.5 times that intended adverse health effects to the above described body to the wrong body part.

parts, or, If the parts of the body (b) the actual dose is less than l

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 s

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.

(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 ppe 1.

Event Wpe 1.

13 NUREO-0090, Vol.16, No. 2 l

Abnormal Occurrences,2nd Qtr CY93 Table A.1 (Continued)

AO Reporting Threshold Event 'Iype Diagnostic Exposure Therapeutic Exposure route of administration other than that intended by the pre-l scribing physician.

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

dose of a radiopharma-proposed if:

ceutical differing from the l

prescribed dose by more (a) the actual dose is i

than 50 percent.

greater than five times the presenbed dose, or, (b) the event results in adverse health effects worse than expected for the normal range of exposures prescribed for the diagnostic proccdure.

(5) Administering a Not applicable.

An AO report should be therapeutic dose of proposed if:

a radiopharrnaceutical 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 : anes the prescribed exposure, 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 events or a series of events of the number of (in which each individual misadministration is not of major patients or facilities importance) that create a significant 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 concem.

NUREGJJ090, Vol.16, No. 2 14

Abnormal Occurrences,2nd Qtr CY93 APPENDIX B UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES During the April through June 1993 period, NRC licens-and any subsequent updated information on the abnormal ees, Agreement States, Agreement State licensees, and occutrences discussed. (Ite update provided generally other involved parties, such as reactor vendors and archi-covers events that took place during the report period; tect-engineering firms, continued with the implementa-some updating, however, may be more current as indi-tion of actions necessary to prevent recurrence of pre-cated by the associated event dates.) Open items will be viously reported abnormal occurre.'ces. The referenced discussed in subsequent reports in the series.

Abnormal Occurrence Reports below provide the initial Other NRC Licensees 92-18 Loss ofIridium-192 Source and licensee's facilities in Exton and Lehighton, Pennsylvania, were wthned.

Medical Therapy Misadminis-tration at Indiana Regional There were four main causes of the event as discussed in the IR repon: 1) OSC had weaknessa jn its radiation Cancer Center in Indiana' safety program that contributed to the seriousness of the Pennsylvania event and radiation exposure consequences; 2) a number of weaknesses were found in the design and testing of This abnormal occurrence was originally reported in NU-Omnitron 2000; 3) the safety culture at IRCC contributed REG-0090, Vol.15, No. 4," Report to Congress on Abnor-significantly to the event; and 4) the overall regulatory mal Occurrences: October-December 1992." The abnor-versight of HDR afterloaders was weak.

mal occurrence is updated as follows:

ne manufacturer's (Omnitron) actions to prevent recur-rence are still undergoing FDA review.

On December 1,1992, the licensee, Oncology Services Corporation (OSC), notified NRC Region I of the loss of The licensee hired a consultant to assess its radiation safe-an approximately 159.1 gigabecquerel (GBq) (4.3 curie ty prcgram immediately after the event occurred. He

[Ci]) sealed iridium-192 source from their high-dose-rate consultant provided the licensee with audit findings and (HDR) remote afterloader unit at their Indiana Regional suggested program upgrades. The licensee addressed the Cancer Center (IRCC), Indiana, Pennsylvania. The audit findings, created new operating and em ergency pro-source was left within a patient on November 16,1992, cedures, trained personnel on procedures and the NRC and as a result, the patient received an estimated dose at I requirements, and requested a Management Meeting centimeter (cm) (0.39 inches) of 16,000 gray (Gy) with NRC to discuss the implemented program upgrades.

(1,600,000 rad)instead of the intended dose of 18 Gy (1800 The licensee met with the NRC on January 27,1993. NRC rad). In addition, several members of the general public issued a meeting report on February 19,1993, discussing were also exposed and their radiation exposures ranged all commitments the licensee made during the meeting.

between 0.40 millisievert (mSv) to 0.22 sievert (Sv) (40 The licensee requested on February 9,1993, permanent millirem [ mrem] to 22 rem).

relaxation of the order suspending license to treat pa-Fents at the Greater Harrisburg Cancer Center and the Greater Pittsburgh Cancer Center. The licensee sub-The NRC Region I conducted an inspection of the IRCC mitted its action plan to NRC m a letter dated February i

on December 1 and 2,1992. On December 3,1992, NRC e ew th actim pan andissued a upgraded its response to an Incident Investigation Tbam deficiency letter to the licensee on March 5,1993. The h-(IIT). An order suspending the OSC license was issued on cense agabequesM a management meeting m hss January 20,1993. On February 8,1993, the IIT resented P

the issues described in the NRC's March 5,1993, deficien-its findings to NRC.

cy letter. The licensee met with NRC on March 23,1993.

j On March 29,1993, NRC issued a report discussing all l

NRC Region I conducted inspections of the licensee's fa-commitments the licensee made during the meeting. On cilities in Exton and Lehighton, Pennsylvania, on Decem-April 8,1993, the licensee submitted its upgraded action i

ber 8,1992. The inspectors identified several potential plan and invited NRC to inspect its Harrisburg and Pitts-violations. In the Order suspending license, the issues dis-burgh facilities to verify that alllicensee procedures and cussed in the Irr report and the inspection report for the NRC requirements were being followed as required. On l

15 NUREG-0090, Vol.16, No. 2 l

Abnormal Occurrences,2nd Qtr CY93 April 22,1993, NRC acknowledged receipt of the licens-May 11,1993, letters, NRC issued a license amendment ee's April 8,199.4 letter and agreed to inspect the Harris-on May 26,1993, and an inspection report on May 28, burg and the Pittsburgh facilities.

1993. On June 3,1993, the NRC Region I Regional Ad-ministrator approved a full Order relaxation request to The licensee submitted its program upgrades in letters treat patients, limited to OSC's facilities in liarrisburg dated February 15,1993, March 26,1993, and April 8, and Pittsburgh.

1993, that had been implemented to address all items out-lined in the Order suspending license. N RC Region I con-Since learning of the loss of the HDR afterloader source ducted an inspection at the licensee,s facility m Harris-and the death of the patient, the NRC conducted the inci-burg, Pennsylvania on April 26,77, and on May 3,1993, dent investigation, issued the team's report, and com-and an inspection at the licensee's facility m Pittsburgh, pleted the following actions: issued a Bulletin to Users of Pennsylvama, on April 28 and 29,1993. ' Die mspectors Omnitron 2000 HDR afterloaders (Bulletin 92-03), a B til-concluded that the licensee had addressed all procedure letin to Users of any HDR machine (Bulletin 93-01), an requirements, order suspending hcense issues, Bulletm Information Notice to all NRC licensees (Information requirements. and other regulatory rcquirements. The m-Notice 92-84) to assure the other users of HDRs were spectors also concluded that all personnel were trained on aware of the event. In addition, NRC issued Confirmatory all licensee and NRC requirements as they pertain 1 Action Letters to both OSC and Omnitron documenting iheir job.

safety precautions, and an Order on January 20,1993, sus-The licensee requested that its NRC license be amended pending the OSC license.

to include its current program as described in its February 15,1993, March 26,1993, April 8,1993, May 7,1993, and Future reports will be made as appropriate.

i i

NUliEG-0090, %L 16 No. 2 16

Abnormal Occurrences,2nd Otr CY93 APPENDIX C OTHER EVENTS OF INTEREST Th following items are described because they may possi-duction in the level of protection provided for public bly be perceived by the public to be of public health or health or safety; therefore, they are not reportable as an safety significance. De items did not involve a major re-abnormal occurrence.

Nuclear Power Plants 1.

Iligh Pressure Coolant Injection Steam mechanisms.Rere was no mcasurable rclease of ra-Release at Quad Cities Nuclear Power dioactivity from the plant.

Station The rupture discs which burst are 40.64 centimeters (16 inches) in diameter and are designed to prevent Quad Cities Nuclear Power Station consists of two overpressurization of the steam exhaust pipinglead-General Electric designed boiling water reactors ing from the HPCI turbine. He installation at Quad 1

(BWRs) located near Cordova, Illinois, and operated Cities has two rupture discs in sequence about 6 cen-by Commonwealth Edison Company.

timeters (2.5 inches) apart. Both discs must rupture before steam is released from the piping.

On June 9,1993, licensee personnel were perform-ing a routine quarterly surveillance test of the Unit 1 A special NRC inspection team was dispatched to the Quad Cities site.The four members of the team high pressure coolant injection (HPCI) system at Quad Cities Nuclear Power Station.The HPCI sys-c nducted an inspection from June 9 through 24, 1993.

tem is one of the plant's emergency reactor cooling systems. The HPCI pump is driven by a turbine De NRC team was not able to conclusively deter-which uses steam produced in the reactor. During minethecauseof theburstingof therupturediscs. A the test, both rupture discs on the steam exhaust I kely explanation is that water in the steam line pipe from the HPCI turbine ruptured, releasing caused a brief, localized pressure increase, and rup-steam into the room containing the equipment. Five tured the discs. It is also possible, however, that the people m the room were injured.The steam was ra' age or service degradation of the disc material could dioactive and the workers also received minor skin have caused the discs to rupture at a lower pressure contammation.

than their design pressure of 1,034 kilopascals (150 i

Valves on the steam supply line to the HPCI turbine automatically closed iully after about 50 seconds, ne utility has replaced all rupture discs in the HPCI terminating the stcam release into the room. A reac-system and in the reactor core isolation cooling sys-tor operator manually tripped the turbine when he tem. Steam drain level switches which control the observed that the steam line valves were closing.

draining of water from the turbine and the steam lines were also repaired. The inspection team con-(

Both Quad Cities units were in operation at the time cluded that these repairs and replacements were suf-l of the accident, and reactor operations were not af.

ficient corrective actions to prevent a recurrence of fected.

the accident, regardless of the actual rupture mecha-Dism.

The injured workers were taken by ambtuance to 10-cal medical facilities. They were decontamiaated 2.

Electrical Power Transient at Oconec and treated for burns. Four of the workers wer: re-Nuclear Station leased after treatment.The fifth worker had first and second degr ee burns over 20 percent of her body and Oconee Nuclear Station consists of three Babcock was hospitalized.

and Wilcox designed pressurized water reactors (PWRs) located near Seneca, South Carelina, and De pressure surge in the HPCI room, associated operated by Duk.e Power Company.

with the bursting of the rupture disc,blewa set of fire doors in the room off their hinges and blew open two On October 19,1992, Oconee Units 1,2 and 3 were additional sets of doors, damaging their latching operating at 100 percent power.Two units at Keowee 17 NUREG-0090, Vol.16, No. 2

Abnormal Occurrences,2nd Qtr CY93 Hydrostation are the redundant emergency power though not discussed in the licensce's vendor manu-sources in the event of a loss of offsite power, and are al, discussions with the vendor verified that voltage routinely used for a few hours several times a week swings were expected. The voltage surge in excess of to generate elcctrical power to the transmission grid.

200VDC was propagated through the switchyard On the day of the event,Keowee Unit I was generat.

125VDC control power system. This single failure ing power to the transmission grid for power peaking actuated several breaker failure circuits in the and Keowee Unit 2 was in standby, aligned to its switchyard Power Circuit Breakers and caused isola-emergency power path. Maintenance was in prog-tion. The licensee had not implemented a vendor.

ress to replace an Oconee switchyard control power recommended modification, which would have re-battery.'Ib support the replacement, the battery was duced the susceptibility of the relays to voltage disconnected and its battery charger was placed in surges. The NRC issued Information Notice 91-81 service, supplying the de bus. With the battery dis-that alerted licensees to the potential for this type of connected, the charger output voltage was expected problem. The Keowee Hydrostation operator re-to vary and voltage instabilities were not suppressed.

sponse was not adequate in that actions taken could A battery charger failure resulted in a voltage surge have interfered with the safety function of Keowee that caused spurious relay actuations, which initiated Unit 1. Additionally, the operator did not restore the event and isolated offsite power to Oconee Unit auxiliary power to the Keowee units in a timely man-

2. A lockout of the Oconee Unit 2 main generator ner.These were a result of a lack of adequate train-transformer caused a Unit 2 turbine generator trip ing and pryedaral guidance attributed to the orga-with a subsequent reactor trip. The reactor was suffi-nizational structure. Although it was relied upon as ciently cooled via natural circulation of reactor cool-the source of onsite emergency power, the Keowee ant and feedwater addition from the turbinedriven Hydrostation was not under the direct supervision of emergency feedwater pump. The other two Oconee Oconee Nuclear operations but rather part of the units were not directly affected and continued to op-Duke Power Hydrostation Department.This organi-crate; however, they wocid not have had automatic zational structure allowed for lack of effective man-off site power available in the event of a turbine gen-agement oversight regarding Keowee operations.

erator trip.

Procedures to recover from a switchyard isolation were not adequate. Use of the inadequate recovery Keowee Unit I responded to the loss of offsite power plan led to a Keowee Unit 2 trip during the recovery by separating its generator from the grid and at-and the loss of automatic offsite power availability to tempting to align to the overhead emergency power Oconee Units l and 3 in the event of a turbine gener-path; however, a circuit breaker lockout prevented ator trip.The bus transfer scheme of Keowee auxil-this function. Keowee Unit 2 started and, within 31 iary power unnecessarily challenged circuit breakers seconds, successfully energized the Oconee Unit 2 and resulted in a loss of auxiliary power for 51 min-emergency busses through the underground emer-utes on Keowee Unit I and 37 minutes on Keowce gency power path.The Keowee Hydrostation opera-Unit 2. He recovery was made only after an tor failed to identify that an emergency start signal "on-call" Keowee technician arrived at the site, diag-for the hydro units was present. The operator ob-nosed the problem, and restored power. The length served no load on Keowee Unit 1 and since the unit of time that a unit can operate is limited by the ability had previously been operating connected to the grid, to maintain hydraulic control oil pressure to the gov-he opened its output breaker based upon a perceived ernor.His controls the wicket gates of the turbine.

Without AC. awer, preloaded air pressure is used to grid problem without realizing that Keowee Unit 1 1

was supplying auxiliary power to Keowee Units 1 and pressurize the oil. The licensee has stated in docu-2.ne auxiliary power transfer scheme was such that mentation that one hour is the expected maximum both units then attemted to transfer to their respec-time.

tive alternate powei sources; however, two more cir-The event was caused by failure of the switchyard cuit breaker failures resulted m a loss of the ac power battery charger to properly regulate de voltage to its supplies to both Keowee units auxiliancs. Correc-bus when placed in a configuration without its bat-tive actions by operators and a techmcian to reset the tery connected. Voltage surges from the battery spunous lockout signals allowed Keowee Unit I to charger actuated breaker failure circuits on several align to its emergency path 52 minutes later and off-switchyard power circuit breakers reculting in an iso-site power to be restored 57 minutes after the mitta-lation of the switchyard from offsite power and isola-tion of the event.

tion of Keowee Unit I from the overhead path.

In reviewing this event, several problems were iden.

He licensee has taken numerous steps to prevent tified.The switchyard battery charger lineup was not recurrence and to improve reliability.The battery re-sufficiently reviewed regarding the potential for placement procedure was revised to ensure that a voltage surges if the battery was disconnected. Al-battery charger is not loaded without its associated NUREG-0090. Vol.16, No. 2 18

1 Abnormal Cccurrences,2nd Qtr CY93 battery. He breaker failure relays were modified structure was revised placing Keowce under the su-per vendor instructions to increase reliability during pervision of Oconee. The auxiliary power transfer high voltage conditions. Indication lights were in.

scheme was modified to inct case reliability. In addi-stalled at the Keowee control panel to provide direct tion, planned corrective actions include c' uit indication of an emergency sta.n Procedures were is-breaker modifications, the development of a preven-sued to provide guidance for operators following an tive maintenance program for relays, replacement of emergency start.The ability of a Keowee unit to sep-certain relays, t!.e development of job and task anal-arate from the transmission grid and energize the ysis for Keowet operators.

emergency path was tested. The organizational Other NRC Licensees 3.

Radiographer Radiation Exposure Exceed-device before contacting the licensee's Radiation ing Regulatory Limits safety Officer.

Sm took the following corrective actions: verbally On April 16, 1993, a radiography event occurred informed every radiographer of the event; followed which resulted m a radiographer employed by Scien-up the verbal disecssion with a written notice of the tific Inspection Tbchnology, Inc. (Sm), Hixson,'Ibn-event; increased emphasi: on the use of emergency nessee, receiving a radiation dose m excess of NRC limits. [While Sm is located m an Agreement State procedures during audits of the radiographer's per-(TN), Sm holds an NRC license (4125027-01) and formance; conducted classroom training on emer-gency procedur-s and use of alarming-ratemeters; was workmg under this license in the State of New reiterated management's expectations relative to Jersey when the overexposure occurred.] He event emergency procedures; reviewed and assessed past occurred as preparations were bemg made to begm a incidents to strers the need for safety; and increased radiography procedure at a work site m Salem emphasis on safety requirements involved in exami-County, New Jersey. While having difficulties in nation of equipment prior to placing it ira service.

lommg a radiography exposure device contammg 3,626 gigabecquerel (GBg) (98 curies [Ci]) of iridi-The radiographer involved in the event was removed um-192, a radiographer received 2.75 sievert (Sv) from licensed activities until the end of the calendar (275 rem) to his right hand and a 12 mSv (1.2 rem) quarter in which the event occurred to prevent fur-whole body dose. The radiographer did not respond ther exposure.

properly to indications provided by his radiation sur-vey meter or his alarming-rate-meter. The dose esti-He licensee sent the exposure device along with the mates are based on a reenactment of the event using sourre guide tube and drive cable mechanism to the the same equipment. NRC agreed with these dose equipment manufacturer for examination and test-estimates.

ing.The manufacturer found minor damage involv-ing a bent connector, but was unable to identify any He radiographer was examined by a physician fa]ure mechanism that could have prevented the trained at the Radiological Emergency Assistance source from returning to the shielded position and Center and Training Site (REAC/TS)in Oak Ridge, repositioning the selector ring to the locked position.

'Ihnnessee.The physician continued to follow the ra-diographer for several weeks after the event and no An NRC inspection was conducted at the licensee's observable effects of the exposure had been evident.

facilities on April 19, 1993, to review the circum-stances surrounding the event. An NRC medical The radiographer received the radiation overexpo-consultant was tetained to assess the medical aspects sure as a result of his failure to correctly respond to of the event.%e medical consultant concluded that warnings provided by his alarming-ratemeter and the licensee's dose estimates were reasonable. An the radiation survey meter off. scale reading. Instead enforcement conference was held with the licensee of leaving the immediate area of the exposure de-and escalated enforcement action resulted in Notice vice, he attempted to correct the problem. He also of Violation, Severity Leve111 (Severity Levels I failed to follow Sm's emergency procedures by at-through V range from the most significant to the tempting to correct the problem with the exposure least significant) and a $4000 Civil Penalty.

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19 NUREG-0090, Vol.16, No. 2

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NUREG-0090 Vol.16, No. 2

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• Report to Congress on' Abnormal Occurrences:

April-June 1993 Sepumber l MONTH year 1993':

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4. FIN OR GRANT NUMBER

6. AulHOH(6)

6. TYPE OF REPORT Quarterly l

7. PERIOD COVERED (inclusive Dates)

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8. PERFORMING ORGANIZATION - NAME AND ADDRESS (if NRC, provide Division Off6ce or Region, U.S. Nuclear Regulatory CommlFslon, and mallin0 address; if contractor, provide name and mailing address.)

I Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 2055541001

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11. ABSTRACT (200 words or less)

I 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 and safety and requires a quarterly report of such events to be made to Congress. This report covers the period

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12. KEY WORDS/DESCRIPTORS (L6st woros or phrases that will assist researchers in locating the report.)

13. AVAILABluTY STATEMENT Unlimited

14. SECURITY CLASSIFICATION Medical'Iherapy Misadministrations (m. rsse)

Research Reactor Unclassified Safety Systems (Twis asperi)

Industrial Radiographer Overexposure Reactor Scrams Unclassified '

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