ML20045H961

Report to Congress on Abnormal OCCURRENCES.January-March 1993

ML20045H961
Person / Time
Issue date:	06/30/1993
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
References
NUREG-0090, NUREG-0090-V16-N01, NUREG-90, NUREG-90-V16-N1, NUDOCS 9307220177
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NUREG-0090 Vol.16, No.1

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Report to Congress on Abnorma_ C'ccurrences 1

January - March 1993 U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data

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- Available from Superintendent of Documents U.S. Government Printing Office Post Office Box 37082 Washington, D.C. 20013-7082 A year's subscription consists of 4 issues for this publication.

Single copies of this publication are available from National Technical Information Service, Springfield, VA 22161 IhM

NUREG-0090 Vol.16, No.1 Report to Congress on Abnormal Occurrences January-March 1993 j

I l> ate Publi.sted:. lune 1993 Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatery Commission Washington, DC 20555

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Abnormal Occurrences,1st Otr CY93 Previous Reports in Series NUREG 75/090 (January-June 1975), published October 1975.

N UREG-0090-I 1hrough -10 (July-September 1975 through October-December 1977), published March 1976 through March 1978.

NUREG-0090, Vols. I through 14 (January-March 1978 through October-December 1991), published June 1978 through March 1992.

NUREG-0090, Vol.15 Nos. I through 4 (January-March 1992 through October-December 1992), published J uly 1992 through March 1993.

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

Abnormal Occurrences,1st Qtr CY93 AHSTRACT Section 208 of the Energy Reorganization Act of 1974 There is one abnormal occurrence at a nuclear power identifies an abnormal occurrence as en unscheduled plant and three abnormal occurrences involving medical incident or event that the Nuclear Regulatory misadministrations (two therapeutic and one diagnostic)

Commission determines to be significant from the at NRC-licensed facilities discussed in this report. No standpoint of public health or safety and requires a abnormal occurrences were reported by the NRC's quarterly report of such events to be made to Congress.

Agreement States. The report also contains information

'lhis report covers the period from January 1 through updating three previously reported abnormal March 31,1993, occurrences, and information on two events of interest, iii NUREG-0090, Vol.16, No.1

Abnormal Occurrences.1st Qtr CY93 CONTENTS Page Abstract..

iii.

Preface...

vii I n trod uct ion...................................................

vii The Regulatory System.....

vii Reportable Occurrences......

vii.

Agreement States.

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Foreign Information......

viii Report To Congress On Abnormal Occurrences, January - March 1993...

1 Nuclear Power Plants.......

1 93-1 Steam Generator Tube Rupture at Palo Verde Unit 2 1

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

2 P

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

2 93-2 Medical" Sodium Iodide" Misadministration at Ingham Medical Center in Lansing, Michigan......................

2-93-3 Medical Therapy Misadministration Involving the Use of a High Dose-Rate Remote Afterloader Brachytherapy Device at Yale-New Haven Hospital in New Haven. Connecti:ut..........

3 93-4 MedicalTherapy Misadministratious Papastavros' Associates Medical Imaging in Wilmington, Delaware..................

4 Agreement State Licensees......

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. References.......

7 Appendix A-Abnormal Occurrence Criteria.....

9 Appendix B-Update of Previously Reported Abnormal Occurrences......

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Fuel Cycle Facilities...............

L 91--6 Potential Criticality Accident at the General Electric Nuclear Fuel and

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Component Manufacturing Facility in Wilmington, North Carolina 13 Other NRC Licensees.........................

14 92-14 Medical'Rerapy Misadministration e.t Memorial Hospital of Laramie County in Cheyenne, Wyoming............................

14 92-19 Medical Therapy Misadministration and Temporary I_oss of Brachytherapy Source at Yale-New Haven Hospital in New Haven, Connecticut 14 Appendix C-Other Events of Interest 15 '

N uclear Power Plants............................................................. ~15 1.

Unauthorized Forced Entry into the Protected Area at Three Mile Island Unit 1.......... 15 Fu el Cycle Facil.ities................................

17 2.

Re' ease of Nitrogen Dioxide Gas at Sequoyah Fuels Corporation....

17 References for Appendices........................... -................

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

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Abnormal Occurrences,1st Otr CY93 PREFACE Introduction rules and regulations in Title 10 of the Code of federal Regulations. This includes public participation as an The Nuclear Regulatory Commission reports to the element, To accomplish its objectives, the NRC regularly Congress each quarter, under provisions of Section 208 of conducts licensing proceedings, inspection and the Energy Reorganization Act of 1974, any abnormal enforcement activities, evaluation of operating occurrences involving facilities and activities regulated by experience, and ccmfirmatory research, while maintaining the NRC. An abnormal occurrence (AO) is defined in programs for establishing standards and issuing technical Section 208 as an unssheduled incident or event that the reviews and studies.

Commission determines is significant from the standpoint of public health or safety.

in licensing and regulating nuclear power plants'anr1 the uses of byproduct nuclear materials, the NRC follows the Events are currently identified as abnorrnal occurrences philosophy that the health and safety of the public are for this report by the NRC using the criteria and best ensured through thc establishment of multiplelevels accompanying examples listed in Appendix A. These f protection. These multiple levels can be achieved and criteria were promulgated in an NRC policy statement m intained through regulations specifymg requirements that will ensure the safe use of nuclear materials. The that was published in the Tcdcral Register on February 24, 1977 (Vol. 42, No. 37, pages 10950-10952).

regulations include design and quality assurance criteria appropriate for the various activities hcensed by the NRC. An inspection a.a enforcement program helps The NRC policy statea nt was published before

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licensecs were requirco to report medical misadministrations to the NRC, Few of the examples in the policy statement are applicaNe to medical Reportable Occurrences misadministrations. Therefore, during IWi. the NRC developed guidelines for selecting such events for Actual operating experience is an essential input to the abnormal occurrence reporting. These guidelines, which regulatory process for assuring that licensed activities are have been used by the NRC since the latter part of 1984, e nducted safely. Licensees are required to report certam augment the NRC policy statement examples and are incidents or events to the NRC.This reporting helps to summarized in Table A-1 in Appendix A. On January 27, dentify deficiencies early and to ensure that corrective 1992, new medical misadministration definitions became actions are taken to prevent recurrence.

effective. 'lherefore, revised guidelines for identifying For nuclear power plants, dedicated t',roups have been medical misadministrations as abnormal occurrences are formed both by the NRC and by th'e nuclear power currently being developed.The revised guidelines t. Se industry for the detailed review of operating experience published for comment in the federal Register, to help identify safety concerns early; to improve dissemination of such information; and to feed back the in order to provide wide dissemination of informatwn experience into licensing, regulations, and operations. In the pubhc, a Federal Register notice is issued on these addition, the NRC and the nuclear power industry have abnormal occurrences. Lopics of the notice are ongoing efforts to improve the operational data systems, distributed to the NRC Public Document Room and all which melude not only the type and quality of reports Local Public Document Rooms. At a minimum, each required to be submitted, but also the methods used to notice must contain the date and place of the occurrence analyze the data, in nrder to more effectively collect, at.d describe its nature and probable consequences.

collate, store, retrieve, and evaluate operational data, the information is maintained in computer-based data files.

A hc NRC has detcrmined that only those events described in this report meet the criteria for abnormal Three primazy sources of operational data are Licensee occurrence reporting.This report covers the period from Event Reports (LERs) submitted pursuant to 10 CFR January 1 through March 31,1993. Information reported 50.73,immediate notifications made pursuant to 10 CFR on each event includes date and place, nature and 50.72 and medical misadministration reports made probable consequences, cause or causes, and actions pursuant to 10 CFR 35.33.

taken to prevent recurrence.

Except for records exempt from public disclosure by statute and/or regulation, information concerning The Regulatory System reportable occurrences at facilities licensed or other-wise regulated by the NRC is routinely disseminated by

'1he system of licensing and regulation by which the NRC the NRC to the or * - industry, e n% and other carries out its responsibilities is implemented through interested groups % : sse eventt tw vii NUREG-0090 0 16, No.1

Abnormal Occurrences,1st Qtr CY93 Dissemination includes special notifications to licensecs capabic of sustaining a chain reaction); Agreement State

- i and other affected or interested groups, and public programs must be comparable to and compatible with the announcements. In additio... information on reportab!c Commission's program for such material.

cvents is routinely sent to thc NRC's more than 100 Iecal Public Document Rooms throughout the United States Presently, information on reportable occurrences in and to the NRC Public Document Room in Washington, Agreement State licensed activities is publicly available at '

D.C. The Congress is routinely kept informed of the State level. For the purpose of developing a reportable events occurring in licensed facilitics.

nationwide database, Agreement States are encouraged to provide information to the NRC on reportable events.

Another primary source of operational data is reports of reliability data submitted by licensees under the Nuclear In early 1977, the Commission determined that abnormal Plant Reliability Data System (NPRDS). The NPR DS is a occurrences happening at faci'ities of Agreement State i

voluntary, industry-supported system operated by the licensees shoula be meluded in the quarterly reports to Institute of Nuc! car Power Operations (INPO), a nuclear Congress. Ihe abnormal occurrence criteria included m utihty organization. Both engineering and failure data at c Appendix A are applied uniformly to events at NRC and submitted by nuclear power plant beensecs for specified Agreement State licensec facilities. Procedures have been developed and implemented, and abnormal plant components and systems. The Commission considers the NPRDS to be a vital adjunct to the LliR occurrences reported by the Agreement States to the system for the collection, review, and feedback of NRC arc included in these quarterly reports to Congress.

i operational experience; therefore, the Commission periodically monitors the NPRDS reporting activitics.

Foreign Inforniation The NRC participates in an exchange of information with Agreenient States various foreign governments that have nuclear facilitics.

This foreign information is reviewed and considered in Section 274 of the Atomic linergy Act, as amended, the NRC's assessment of operating experience and in its at.thorizes the Commission to enter into agreements with research and regulatory activitics. Reference to foreign States whereby the Commission relinquishes and th information may occasionally be made in these quarterly States assume regulatory authority over bypraduc.,

abnormal occurrence reports to Congress; however, only

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source, and special nuclear materials (in quantitics not domestic abnormal occurrences are reported.

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Abnormal Occurrences,1st Qtr CY93 i

REPORT TO CONGRESS ON ABNORMAL OCCURRENCES J ANUARY-MARCH 1993 Nuclear Power Plants The NRC is reviewing events reported at the nuclear Immediately after the reactor trip, pressurizer level -

power plants licensed to opcrate. For this report, the decreased to less than the 0-percent reference mark and NRC has determined that the following events were remained less than 0 percent for about 1.5 minutes until abnormal occurrcnces.

high pressure safety injection restored the level to about 8 percent. The pressurizer did not empty and the minimum pressure reached was 11.6 MPa absolute (1,687 psia).The 93-1 Steam Generator Tube Rupture operators commenced cooldown and depressurization at 6:03 a.m.and isolated the faulted SG at 7:28 a.m.The unit at Palo Verde Unit 2 entered Mode 4 (hot shutdown) at 10:29 a.m. and the pcrators placed the unit on shutdown cooling at 10:35 The following information pertaining to this event is also p.m. on March 14,1993. lhc Alert was terminated at 1:15 being reported concurrently in the Federal Register, a.m. on March 15,1993, and the unit entered Mode 5 Appendix A (Exampic 2 of "For Commercial Nuclear (cold shutdown) at 5:56 a.m.

Power Plants') of this report notes that a major degradation of the primary coolant pressure boundary An Augmented Inspection Team (AIT) was sent by the' c2m be considered an abnormal occurrence.

NRC to investigate the Palo Verde Unit 2 cvent.The AIT concluded that the operating crew performed Date and Place-March 14,1993: Palo Verde Unit 2, a competently. However, wcaknesses werc identified in the Combustion Engineering-designed, System 80 model, licensec's implementation of emergency plan actions, pressurized-water reactor (PWR), operated by Arizona including event classification, activation of the emergency Public Service Company and located near Wintersburg, response facilities, and promptly determinhg Arizona, about 80 kilometers (50 miles) west of Phoenix, accountability for on-site personnel. Weaknesses were Anzona.

also found in the procedures, equipment, and training j

associated with responding to a SG tube rupture. The i

l Nature and Probable Consequences-At 4:34 a.m., while tube failure did not result in a radiological release to the at 98.8 percent power, Unit 2 experienced a tube rupture environment that exceeded regulatory limits.The event in steam generator (SG) no. 2. A substantial and did not result in exceeding aTechnical Specifications (TS)

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continuaus decrease in pressurizer level and pressure safety limit. All notifications to the NRC and off:;ite were observed by the operators in the control room. In agencies were made in a timely manner.'Ihe Arf repon response, the operators started the third charging pump documented in NRC Inspection Report

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and isolated letdown at 4:37 a.m. Pressurizer level and 50-529/93-14, was issued on April 16,1993 (Ref.1).

pressure continued to decrease and the operators mam. ally tripped the reactor at 4:47 a.m., at which time It should be noted that several SG tube rupture events i

pressurizer level was about 25 percent. At 4:48 a.m., the occurred at other nuclear power plants, and were safety injection and containment isolation signals previously reported as abnounal occurrences. North actuated when the piessure reached 12.7 megapascal Anna Unit I had a SG tube plug failure February 25,1989 (MPa) absolute (1,837 pounds per square inch absolute (AO 89-1 in NUREG--0090, Vol.12, No.1) and another

[ psia]). All engineered safety features equipment on July 15,1987 (AO 87-15 in NUREG-0090, Vol.10, I

actuated as required-No. 3). McGuire Unit I had a SG tube rupture on March 7,1989 (AO 89-2 in NUREG-0090, Vol.12. No.1), while The licensee declared an Unusual Event at 4:58 a.m., due Ginna had one on January 25,1982 (AO 82-4 in to the safety injection system actuation. The licensee NUREG-0090, Vol. 5, No.1).

upgraded the emergency classification to an Alert at 5:02 a.m., based upon the operators' observation that reactor Cause or Causes-The cause of the tube rupture is still j

coolant system leakege was in excess of 167 liters per

. under investigation by the licensee.

minute (Umin)(44 gallons per minute [gpm]). At a later date, the maximum tube leak rate was estimated to be Actions to Prevent Recurrence about 909 Umin (240 gpm), which exceced the makeup capacity (485 Umm [128 gpm]) of the three positive Licensee-The licensee conducted a root cause displacement charging pumps that were operating.

investigation.

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Abnormal Occurrences,1st Otr CY93 i

NRC-The event is still under staff review.The NRC will Future reports will be made as appropriatc.

review the Arl's findings and those of the licensee, and l

will take appropriate actions.

Fuel Cycle Facilities j

(Other than Nuclear Power Plants)

The NRC is reviewing events reported by these licensces.

For this report, the NRC has determined that no events were abnormal occurrences.

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

There are currently over 7,500 NRC nuc! car material thyroid scan to detect or rule out thyroid cancer. There licenses in effect in the United States, principally for the was a miscommunication between members of the use of radioisotopes in the medical, industrial, and support staff. The technologist who received the call academic fields. Incidents were reported in this category understood that the referring physician wanted a whole from licensees such as radiographers, medical body scan to rule out thyroid metastasis and to look at a

- institutions, and byproduct material users. The NRC is thyroid nodule.The medical technologist entered a whole reviewing events reported by these licensees. For this body scan into the scheduling record.

report, the NRC has determined that the following events were abnormal occurrences using the criteria and On May 11,1992, a 47-year old patient received 366.3 guidelines given in Appendix A. As noted in the Preface megabecquerel (MBq) '(9.9 millicurie.(mci]) of to this report, the guidelines for identifying medical iodine-131 in capsule form as preparation for a whole misadministrations as abnormal occurrences are body scan. This procedure is normally used after a patient -

currently being revised.

with thyroid cancer has had the thyroid removed or ablated to determine if the cancer originating in the thyroid has spread elsewhere in the patient's body. The -

93-2 Medical " Sod.ium Iodide" patient still had an active thyroid and.the patient's Misadministration at Ingliam physician intended that the patient receive a thyroid scan to help determine if a thyroid nodule was cancerous. The Med.ical Center in Lans.mg, thyroid scan is a different procedure from a whole body Mielligan scan and as performed at the licensee's facility uses 370.

MBq (10 mci) technetium-99m, a different radio-t

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The following information pertaining to this event is also pharmaceutical than iodine-131, being reported concurrently in the Federal Registcr.

Appendix A(see EventTypc4 inTable A-1)of this report On May 12,1992, the patient returned to the licensee's notes that a diagnostic dose of a mdiopharmaceutical that nuclear medicine department for the scan.The image of is greater than five times the prescribed dose can be the initial scan showed that the patient's thyroid was considered an abnormal occurrence.1 intact and that an error had been made. The technologist performing the scan immediately reported the situation -

Date and Place-May 11,1992;Ingham Medical Center; to the supervising physicians. The licensee's procedures -

Dmsing, Michigan.

for an iodine-131 whole body scan specified that this diagnostic procedure be used only on individuals whose Nature and Probable Consequences-The referring thyroid had been removed.

physician's staff. telephoned the licensee *s nuclear medicine department on May 5,1992, to schedule a The referring physician and the patient were notified of the misadministration.The licensee has been monitoring 2ne definition of misadministration was revised. ne revision 10 CFR E2 became effective on January 27,1992. ne revision de-Initially, the licensee determined that the incident was' fines a new type of misadminstration " Sodium Iodide."he current not a misadministration and did not te ort it to the NRCi abnormal occurrence guidelines for tidsadmimstrations do not in-clude specific examples for wxiium iodide misadministrations. For This was because the correct dosage and procedure were these types of misadministrations the staffis currently using the at>.

used for the study, as understood by the technologist to normal occurrence guidelines leurrenny under revisonL have been requested. The licensee contacted NRC t

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4 Abnormal Occurrences,1st Qtr CY93 Region III about the incident after reading about a similar On March 2,1993, NRC Region H1 issued a Confirmatory case in an NRC Office of Nuclear Material Safety and Action Letter to the licensee documenting its agreement Safeguards newsletter. A licensee consultant reviewed to provide training to the nuclear medicine staff on ti>e the case with NRC Region lH on February 19, 1993.

requirements of the QM Program, NRC regulations, and Following that discussion, the consultant reported the NRC licensee requirements (Ref. 3). No procedures incident as a misadministration because the procedure using more than 1.11 MBq (30 Ci)of iodine-131 were to requested by the patientis physician, a thyroid scan, would be performed before the training was completed. The normally use a

different radiopharmaceutical, licensee also agreed to make certain that its procedures technetium-99m.

for iodine-131 studies are consistent with the QM Program.

Cause or Causes-ne basic causes of this misadmin-istration were a miscommunication between the referring Future reports will be made as appropriate.

physician's office and the licensee, and a failure of the licensec to follow its Quality Management (QM) Program 93-3 Medical Therapy for procedures using radioactive pharmaceuticals.

Misadministration IHVolVing The licensee's QM Program, which was implemented in the Use of a High Dose-Rate January 1992, requires that a written directive be Remote Afterloader prepared for procedures using more than 1.11 MBq (30 Brachytherapy Device at microcurie [ Ci]) of iodine-131. However, no written directive was prepared for this procedure.

Yale-New Haven Hospital in a

n, nnece ne licensee's procedure for a whole body iodirie-131 scan required that the patient's thyroid had been removed The following information pertaining to this event is also previously. The licensee's procedures were not effective being reported concurrently in the Federal Register.

in determining if the patient had an intact thyroid-Appendix A(seeEventType3inTable A-1)of thisreport notes that for a therapeutic exposure,if parts of the body The nuclear medicme department staff had not received receiving radiation improperly would have normally training on the requirements of the licensee's QM received radiation anyway, had the proper administration Program which included the provision that a written been used, and the actual dose ir greater than 1.5 times directive had to be issued for a whole body scan (using that intended to the above described body part, the event more than 1.11 MBq [30 pCi] of iodine-131).

can be considered an abnormal occurrence.

Date and Place-January 21, 1993; Yale-New Haven Actions Taken to Prevent a Recurrence Hospital; New Haven, Connecticut.

Licensee-The licensee has revised the procedures for Nature and Probable Consequences-A patient was thyroid cancer studies and provided training for nuclear prescribed to receive three treatments of 700 centigray medicine personnel in the QM Program requirements.

(cGy) (700 rad) per treatment to the vagina using a Gamma Med high dose-rate remote afterloader NRC-A special inspection was conducted from brachytherapy device (HDR). During the first treatment February 25 to 26,1993, to review the circumstances on January 21,1993, the physician mistakenly inserted the surroundm, g the iodine-131 misadmmistration (Ref. 2).

HDR applicator into the patient's rectum instead of the The NRC has also retamed a medical consultant to review vagina, as prescribed, ne licensee discovered the error the case.

immediately after the treatment was completed and the j

patient was immediately notified.The licensee estimated The NRC consultant concluded that the most probable that the patient received approximately 350 cGy (350 rad) effect of the misadministration would be permanent to the vagina and 700 cGy (700 rad) to the rectum. At the hypothyroidism, and he noted that evidence suggested time of the NRC inspection on January 22,1993, the that this condition had already occurred.No other health licensee had planned to make up the dose to the vagina effects would be expected as a result of the during the remaining two treatments and to add shielding misadministration.

to the applicator to prevent significant additional dose to Several violations of NRC requirements were identified in the inspection. n ese violations and the The patient's physician, the physician who delivered the implementation of the licensee's OM Program are still therapy, and an NRC Medical Consultant are presently under review by the NRC for possible enforcement evaluating the probable consequences of this action.

misadministration.

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Abnormal Occurrences,1st Qtr CY93 Cause or Causes-The licensee did not confirm the gigabecquerel (GBq) (30 minicurie [ mci]) of iodine-131 h

treatment site before the treatment was given as required be administered. On January 13,1993, the technologist by its Quality Management (QM) Program.

ordered a 1.11 GBq (30 mci) dose from the radiopharmacy. The dose was received on January 14, Action Taken to Prevent Recurrence 1993. The technologist noted that the label on the lead i

container indicated 1.07 GBq (29 mci) of iodme-131, but -

i Licensee-The licensee added a procedure requiring did not note that the labei indicated that two capsules physicians to visually insert applicators. In addition, the were present in the vial. A second technologist who licensee committed to a complete prograra assessment by removed the vial from the lead container and placed it in an outside expert. This commitment was formalized by the dose calibrator for assay also failed to note that labels the NRC in a Confirmatory Order Modifying License on both the lead container and the vial indicated the issued on April 26,1993 (Ref. 5).

presence of two capsules. The assayed dose was consistent with the activity noted on the label. The NRC-NRC Region I conducted a special inspection at technologist transferred the dose from the supplier's vial the facility on January 22,1993 (Ref. 3). An NRC medical to a glass vial for administration to the patient. Only one consultant was contacted to provide a clinical assessment of the capsules came out of the vial.The presumed empty of the effects of this rnisadministration.The licensee was lead container that still contained the plastic vial and offered the opportunity to participate in an Enforcement remaining capsule was placed in the nuclear medicine hot Conference but declined, believing that it would not be laboratory for storage. The licensee discovered the i

able to provide the NRC with any additionalinformation.

remaining capsule on February 1,1993, when the NRC recomrrended an enforcement action. A Notice of technologist was preparing lead containers for disposal.

Violation and Proposed imposition of Civil Penalties, and The patient was administered 0.56 GBq (15.1 mci) of Confirmatory Order Modifying License were issued on iodine-131, instead of the intended dose of 1.11 GBq (30 April 26,1993 (Ref. 5). (License modification required mci).The misadministration was reported as required on that the licensee's radiation safety program be improved February 1,1993. The patient and the patient's physician as recommended by an outside expert.)The enforcement were notified of the error and the patient was scheduled action was based on this event and AO 92-19, which is for follow-up therapy on February 10, 1993c The discussed in Appendix B. The cumulative amount of licensee's physician expected no adverse effects as a

$10.000 for the violations was based on the combined result of the misadministration. While the therapeutic events.

dose administered was actually about 0.5 times the prescribed dose, the staff believes that this Future reports will be made as appropriate.

misadministration should still be considered an abnormal l

t occurrence.

93-4 Medical Therapy I

Misadininistration at Cause or Causes-ne misadministration was caused by failure of the licensee to establish and implement a Papastavros' Associates Quality Management (QM) Program as required by 10 y

Medical Imaging in CFR 35.32(a). In particular, failure of the licensee to i

establish procedures to ensure that each therapy Willnington, Delaware administration is in accordance with the written directive The following information pertaining to this event is also t

being reported concurrently in the Federal Register.

Appendix A(see Event Type S inTable A-1)of this report Actions Taken to Prevent Recurrence not es that a therapeutic dose that is less than 0.S times the prescribed dose can be considered an abnormal Licensee-The licensee's plan for preventing recurrence

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occurrence, of the misadministration includes three steps: (1)to prepare and implement a written QM Program and Date and Place-January 14, 1993; Papastavros' provide training; (2) to have the radiopharmaceutical Associates Medical Imaging: Wilmmgton, Delaware.

supplier indicate the number of capsules in each vial on the packing slip provided with iodin >131 therapy doses; Nature and Probable Consequences-On February 1, and (3) to require the nuclear medicine technologists to 1993, NRC Region I was notified by telephone that a read the label on the vials and lead containers to therapeutic misadministration of iodine-131 occurred at determine the number of capsules present in the vial, and

' the licensee's facility.' In early January, the nuclear then verify that the required number of capsules are -

medicine technologist received a telephone call from the administered to the patient. in adftion, the vial into referring physician requesting that a patient be scheduled which the capsules are transferred after initial assay will for a third treatment for hyperthyroidism and that 1.11 be reassayed to ensure that all capsules are transferred.

NUREG-0090 Vcl.16, No.1 4

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i The written QM Program was received by the NRC on was held on March 1,1993, to discuss.the inspection February 11,1993.

findings and actions taken by the licensee in response to the CAL On March 18,1993 NRC Region 1 issued a i

NRC-NRC Region.I conducted an inspection on Notice of Violation with a Severity Level III (Severity February 3,1993 (Ref. 6). Because the misadministration Levels I through V range from the most significant to the resulted in an underdose to the patient and the therapy least significant) violation and $250 Civil Penalty (Ref. 8).

could be completed, the NRC did not contact a medical The licensee paid the Civil Penalty. The licensee's consultant to review this misadministration. A corrective and preventive actions will be reviewed during Confirmatory Action Letter (CAL)(Ref. 7)was issued to the next NRC inspection of the licensed program.

the licensee on February 5,1993, which described the commitments made by the licensee to establish and This item is considered closed for the purposes of this

- implement a QM Program. An Enforcement Conference report.

Agreement State Licensees Procedures have been developed for the Agreement quarterly reports to Congress. For this period, the

States to screen unscheduled incidents or events using Agreement States reported no events as abnormal the same criteria as the NRC (see Appendix A) and occurrences.

report the events to the NRC for inclusion in these c

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NUREG-0090, Vol.16 No.1

Abnormal Occurrences,1st Otr CY93 REFERENCES 1.

Letter from John B.

Martin, Regional 5.

Letter from Hugh L Thompson, Deputy Executive Administrator, NRC Region V, to W. F. Conway, Director for Nuclear Materials Safety, Safeguards, Executive Vice President, Nuclear, Arizona Public and Operations, NRC, to Norman G. Roth, Service Company, April 16, 1993, forwarding Assistant Vice President, Yale-New Haven Inspection Report No. 50-529/93-14, Docket No.

Hospital, forwarding Notice of Violation and 50-529, April 16,1993.*

Proposed Imposition of Civil Penalties, and Confirmatory Order Modifying License, Docket No.

2.

Letter from Charles E. Norelius, Director, Division 030-01244, April 26,1993.*

of Radiation Safety and Safeguards, NRC Region III, to David Kreiger, Vice President, Ingham 6.

Letter from Richard W. Cooper, II, Director,-

Medical Center Corporation, forwarding Inspection Division of Radiation Safety and Safeguards, NRC Report No. 030-02132/93-001, Docket No.

Region I,

to Garth A.

Koniver, Director.

030-02132, April 1,1993.*

Papastavros' Associates Medical Imaging, forward-ing Inspection Report No. 030-11379/93-001 and 3.

Corfirmatory Action Letter No. CAleRill-93-001 Closure of Confirmatory Action Letter (CAL) No.

from A.13ert Davis, Regional Administrator,NRC 1-93-001, Docket No. 030-11379, February 18, Region III, to David A. Kreiger, Vice President 1993.*

Operations, Ingham Medical Center Corporation, Docket No. 030-02132, March 2,1993.*

7.

Confirmatory Action Letter (CAL) No. 1-93-001 from Richard W. Cooper, II, Director, Division of 4.

Letter from Richard W. Cooper, II, Director, Radiation Safety and Safeguards, NRC Region I, to Division of Radiation Safety and Safeguards, NRC Garth A. Koniver, Director, Papastavros' Associates Region I, to Vincent Conti, Senior Vice President, Medical Imaging, Docket No. 030-11379, February Administration, Yale-New Haven Hospital, for-5,1993.*

warding - Special Inspection Report No.

030-01244/93-002, Docket No.

030-01244, 8.

Letter from Thomas T.

Martin, Regional February 18, 1993.*

Administrator,NRCRegionI,to Garth A.Koniver, Director, Papastavros' Associates MedicalImaging, forwarding Notice of Violation and Proposed Iub$ftb' N. I

' "$ N s5 N N kid lr#$ $.[ $,

Imposition of Civil Penalty, Docket No. 030-11379, n

ington. DC 20555.

March 18,1993.*

9 7

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

Abnormal Occurrences,1st Otr CY93 i

I APPENDIX A ABNORMAL OCCURRENCE CRITERIA The following criteria for this report's abnormal (b) release of radioactive material from a package in occurrence (AO) determinations were set forth in an amounts greater than the regulatory limit NRC policy statement published in the FederalRegister on February 24,1977 (Vol. 42, No. 37, pages 10950-10952).

5.

Any loss of licensed material in such quantitics and under such circumstmces that substantial hazard An event will be considered an AO if it involves a major may result to person: in unrestricted arcas.

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 modcrate or diversion of hcensed matenal or sabotage of a more severe impact on the public health or safety and facWty.

could include but need not be limited to:

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 otherwisc regulated by the judged to be significant relative to normally Commission; expected performance and that is judged to be caused by theft or diversion or by substantial breakdown of the accountability system.

2.

Major degradation of essential safety-related equipment; or 8.

Any substantial breakdown of physical security or material control (i.e., access control, containment, 3.

Maj.or deficiencies m design, construction, use of, or or accountability systems) that significantly management controls. for licensed facilities or weakened the protection against theft, diversion, or material.

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.

L Exposure of the whole body of any individual to 25

11. Serious deficiency in management or procedural rem or more of radiation; exposure of the skin of the whole body of any individual to 150 rem or more of controls m major areas.

radiation; or exposun of the icet, ankles, hands or

12. Series of events (where m. dividual events are not of -

t forearms of any individual to 375 rert or more of m j r importance), recurring incidents, and ince radiation [10 CFR 20.403(a)(1)], or equivalent dents with implications for similar facilities (generic exposures from internal sources, 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 Technical 3.

The 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 1imit of Appendix B,TableII 10 CFR boundary.

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

3.

loss of plant capability to perform essential safety 4.

Radiation or contamination 1evels in excess of design functions such that a potential release of radio-values on packages, or loss of confinement of activity 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).

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

Abnormal Occurrences,1st Otr CY93 4.

Discovery of a major condition not specifically 2.

A major condition not specifically considered in the ccmsidered in the Safety Analysis Report (SAR) or safety analysis report or Technical Specifications Technical Specifications that requires immediate that requires immediate remedial action.

remedial action.

3.

An event that seriously compromised the ability of a confinement system to perform its designated I

5.

Personnel error or procedural deficiencies that function.

result in loss of plant capability to perform essential safety functions such that a potential release of Medical Misadministrations radioactivityin excess of 10 CFR Part 100 guidelines could result from a postulated transient oraccident As discussed in the Preface to this report, the NRC policy (e.g., loss of emergency core cooling system, loss of statement on AOs was published before bcensees were control rod system).

required to report medical misadmmtstrations to the NRC. Therefore, during 1984, the NRC developed guidelines for selecting such events for AO reporting.

For Fuel Cycle Licensees These guidelines, which are summarized in Table A-1, augment the NRC policy statement.

1.

A safety limit of license Technical Specifications is As noted in the Preface, revised guidelines are currently exceeded and a plant shutdown is required [10 CFR being developed because new medical misadministration 50.36(c)).

definitions became effective on January 27,1992, I

NUREG-0090, Vol.16, No. I 10

Abnormal Occurrences,1st Otr CY93.

1 Table A.1 NRC Guidelines for Selecting Medical Misadministration Events for Abnormal Occurrence (AO) Reporting AO Peporting Threshold Event Type Diagnostic Exposure Therapeutic Exposure i

(1) Administering a radiopl:arma-If the improper administration if the improper administration ceutical or radiation from a _

resultsin any part of the results in any part of the body -

sealed 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 -

greatcr 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

. 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.

(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 Type 1.

Event Type 1.

' ll NUREG-0090, Vol.16, No.1

-m+r num w

6

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

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

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

dose of a radiopharma-proposed if:

ceutical differing from the prescribed dose by more (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 -

exposure, and treatment dose,or geometry result in a calculated total treatment dose difering (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 concern.

NUREG-0090, Vol.16, No.1 12

~.

Abnormal Occurrences,1st Qtr CY93 APPENDIX B UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES During the January through March 1993 period, NRC provide the initial and any subsequent updating licensees, Agreement States, Agreement State licensees, information on the abnormal occurrences discussed. (The and other involved parties, such as reactor vendors and updating provided generally covers events that took place architect-engineering firms, continued with the during the report period; some updating, however, may implementation of actions necessary to prevent be more current as indicated by the associated event recurrence of previously reported abnormaloccurrences.

dates.) Open items will be discussed in subsequent The referenced Abnormal Occurrence Reports below reports in the series.

Fuel Cycle Facilities P ant facilities where improvements had been 91-6 Potential Criticality Accident at l

imp emented. After many of theimmediate actions were l

the General Electric Nuclear completed, the status report frequency was changed to I,*tlei and Component monthly and then to quarterly, with a corresponding Manufacturing Facility in decrease in the number of NRC management meetings.

t On March 1,1993, the licensee submitted a status report Wilm,ington, North Carol,na indicating the closure of the last open items. A meeting i

was held with the licensee on April 20,1993 to review the -

His abnormal occurrence was originally reported in completion of the PIP.

NUREG-0090, Vol.14. No. 2, " Report to Congress on Abnormal Occurrences: April-June 1991."

It was In addition to those actions included in the PIP, the updated in Vol.14, No. 3; Vol.14, No. 4: and Vol.15, No.

licensee identified other actions which will be taken to

1. The May 29,1991 event, involvmg degraded nuclear provide additional long term improvements to facility criticality safety controls, was investigated by an NRL operations. These actions were not part of the PIP, but Incident Investigation Icam (IFI). The NRC Irl report the NRC will continue to monitor their status during was published in August 1991 as NUREG-1450 (Ref.

future routine inspections.

B-1). The abnormal occurrence is further updated as follows:

In August 1991, the Director, Office of Nuclear Material NRC inspections of the facility continued at an increased Safety and Safeguards, appointed a task force to review frequency during 1992. The inspectors reviewed the existing licensing and inspection programs for fuel operations in progress including the preoperational cycle and major materials facilities. The task force testing and start-up of a new fuel conversion system and conducted an in-depth reexamination of the regulatory major modifications to waste processing systems. Dese system for these types of facilities and prescated findings inspections emphasized review of the irnplementation and recommendations for improving the licensing, and maintenance of nuclear criticality safety controls.

inspection, training, guidance, and regulatory base The inspections also reviewed the actions being taken by associated with fuel cycle facilities and major materials licensees. The task force report, NUREG-1324, the licensee to improve performance in the area of nuclear criticality safety.

" Proposed Method for Regulating Major Materials Licensees," was published in February 1992 (Ref. B-2). In As reported earlier, the licensee conducted a review of October 1992, the staff informed the Commission of its actions needed to improve its nuclear criticality safety action plan that responds to NUREG-1324. The staff piogram following the May 29, 1991 incident. These presently is in the process of implementing this action included long term actions to be completed to upgrade plan, following guidance provided by the Commission in equip-nent, systems and programs. These actions were January 1993.He generic actions resulting from the IIT incorporated into a Performance Improvement Program report will be completed within the framework of the staff (PIP). Initially, the licensee submitted status reports on action plan. The plant-specific items resulting from the the PIP biweekly which were supplemented by periodic IIT report are being handled individually.

meetings with NRC management. Dese meetings were conducted to provide NRC management the opportunity This item is considered closed for the purpose of this to discuss and review improvement activities and tour report.

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

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Abnormal Occurrences, lot Qtr C' Y93 Other NRC Licensees i

92-14 Medical Therapy AbnorTnal occurrences: October-December 1992." De D" ""I

'" "* "'" I' " Pd ' d ^S I " *S Misadministration at Memorial Hospital of Laramie County in Cheyenne, Wyoming As previously mentioned, on December 2,1992, the This abnormal occurrence was originally reported in licensee, Yale-New' Haven Hospital in New Haven, NUREG-0090, Vol.15, No. 4, " Report to Ccngress on Connecticut, notified the NRC that a L3 gigabecquerel Abnormal Occurrences: October-December 1992." The (GBq) (35 millicuric [ mci]) brachytherapy source, was abnormal occurrence is updated as follows:

discovered to be missing earlier that day. It was subsequently learned that the source was probably lost As previously mentioned, on October 22,1992, the before or during a brachytherapy treatment. which licensee notified NRC Region IV that a therapeutic resulted in a therapeutic misadministration.

misadmm, istration had eccurred on August 19, 1992, involving a brachytherapy implant procedure utilizing iridium-192 as seeds encased in nylon ribbon (small scaled radiation sources utilized for interstitial treatment On the same day the patient, a 39-year old female, was to of cancer). Because of a discrepancy in the units of receive 18.48 gray (Gy) (1,848 rad), to the cervix for measurement of w hat was ordered and what was received, cancer treatment. Because one of the prescribed sources the radiation dose to the patient's prostate gland was was lost, the actual dose to the patient was only 12.35 Gy 56.69 gra) (Gy) (5,669 rad), rather than the 32.35 Gy (1,235 rad). In addit. ion, another source was misplaced (3,235 rad) that was prescribed.

and was in contact with one of the patient's legs for a On March 22,1993, the NRC transmitted to the licensee period of time, which resulted in an estimated dose to the

' a Notice of Violation and Proposed Imposition of Civil leg of 2.6 Gy (260 rad). The referring physician and Penalty in the amount of $1,250 (Ref. B-3). Three patient were notified of the misadministration. He violationswercidentified.Twoof theviolationsidentified misplaced source had been inadvertently put with were collectively classified at Severity Level IH (Severity hospital linen, and was Lubsequently recovered at an Levels I through V range from the most significant to the offsite laundry facility.

least significant, respectively). These violations involved the failure to perforrn an appropriate verification of source strengths of brachytherapy sources prior to implantation, and the failure to conduct training of the An Enforcement Conference was held on January 6, licensec's radiation physicists on the elements of the 1993. On January 13,1993, NRC Region I recommended Quality Management Program.

to the Office of Enforcement (OE) that a Severity Level Ill vi 1 tion (Severity Levels I through V range from the The licensce admitted the violation and paid the civil m st significant to the least significant, respectively) with penalty in full.

a Civil Penalty be issued with the Notice of Violation. A This item is considered closed for the purpose of this Notice of Violation and Proposed Imposition of Civil report.

Penalties, and Confirmatory Order Modifying License were issued on April 26,1993 (Ref. B-4). (License modification required that the licensee's radiation safety 92-19 Medical Therapy program be improved as recommended by an outside isadm.. trat. ton and expert.)The enforcement action was based on this event M.

tms Temporary Loss of and AO 93-3, which is discussed in this report. The cumulative amount of $10,000 for the violations was Brachytherapy Source at b sed n the combined events.

Yale-New Haven Hospital in New Haven, Connecticut This abnormal occurrence was originally reported in This item will be updated from time to time as new NUREG-0090, Vol.15, No. 4. " Report to Congress on significant information becomes available.

[

NUREG-0090, Vol.16 No.1 14

Abnormal Occurrences,1st Qtr CY93 APPENDIX C OTIIER EVENTS OF INTEREST The following items are described because they may reduction in the level of protection provided for public possibly be perceived by the public to be of public health health or safety; therefore, they are not reportable as an or safety significance.These items did not involve a major abnormal occurrence.

Nuclear Power Plants 1.

Unauthorized Forced Entry into the protection of public health and safety during a nuclear Protected Area at Three Mile Island event.) The vehicle proceeded approximately 57.6 m (189 Unit I ft), crashed through the Unit I turbine building roll-up 3

door constructed of corrugated aluminum, and came to a stop 19.2 m (63 it)inside the turbine building. The turbine Three Mile Island Nuclear Generating Station Unit 1 building roll-up door collapsed on top of the vehicle, the (TMI 1) is a

liabcock and Wilcox-designed vehicle and door came to rest upon striking a secondary pressurized-water reactor (PWR), operated by General system condensate resin liner and pushed it Public Utilities Corporation, and located on an island in approximately 1.9 m (6 ft). The upper fittings and the lid i

the Susquehanna River, about 16 kilometers (km) (10 of the resin liner container were damaged as it passed miles [mi]) southeast of Harrisburg, Pennsyh'ania.

under the auxiliary steam line, where insalation was also dented. He roll-up door also struck the auxiliary boiler support equipment and caused minor damage.

At 6:53 a.m. Eastern Standard Time (EST) on February 7, 1993, with Unit 1 operating at full power and with no ne plant operators in the control room were notified of I

unusual plant operations in progress or significant the event by a call from the off-going (getting ready to equipment being out of service, an intruder drove a leave) operations shift foreman, who witnessed the station wagon into the Three Mile Island site entrance vehicle travel through the parking lot and heard the jmd continued past the North Gate guardhouse traveling vehicle breach the PA gate and turbine building roll-up m the outbound traffic lane at an estimated speed of door. They were also alerted by the SPO who was 56-64 kilometers per hour (km/hr)(35-40 miles per hour informed of the event by the North Gate SPOs. The

[ mph]).De North Gate was staffed by site protection control oom personnel responded by locking control officers (SPOs). Normal site procedure calls for the dnver room fire doors, and implementating emergency to stop the vehicle and for each occupant to present an response procedures which included classifying the event owner-controlled area (OCA) badge before entermg the as a Site Area Emergency (as of 7:05 a.m.), performing site. The mtruder continued into the OCA on the required notifications, and maintaining and monitoring outbound traffic lanc, across the bridge spanning the the continued operation of the plant at full power in Susquehanna River, and was observed to travel through a accordance with TMI procedures.

posted stop sign. The SPOs at the North Gate notified other onsite SPGs, thus prompting other security The security staff responded by posting security personnel to respond. De vehicle passed through a personnel to intervene at selected predesignated vital second stop sign, and contmued south towards the TMI-1 areas, confirming vital area integrity, and with the aid of protected area (PA) Processing Center (PC) building.

offsite responders, conducting a search for the intruder. -

The vehicle turned cast past the front of the PC, and He U.S. Army explosives ordnance disposal (EOD) unit turned south travelm, g an additional 27,4 meters (m)(90 was called in. EOD surveyed the vehicle and conducted a feet [ft]) where it hit PA Gate 1 and proceeded through preliminary search for explosive devices. During a second the gate. As the vehicle passed through PA Gate 1, the search-and-clear operation, security personnel found and bottom of the gate pivoted upward for the vehicle to pass apprehended the unarmed intruder. The intruder was through.

located at the bottom of the turbine building in a small space under piping in the condenser area, and offered no ne PA alarm system generated alarms upon detecting resistance.he intruder was initially qu estioned on site by t

that the vehicle breached the gate, prompting the security Pennsylvania State Police, then escorted off site in personnel to assess the situation by closed circuit custody, he vehicle was removed from the turbine television. (These are industrial security measures in an

_ building, and the EOD unit completed a detailed search '

owner controlled area and are not directed toward confirming that no explosives were present. The intruder 15 NUREG-0090, Vol.16, No.1 -

Abnormal Occurrences,1st Otr CY93 -

1 i

was placed under court-mandated observation and not contain qualifying guidanec to the operators and treatment in a Commonwealth of Pennsylvania facility.

may not be appropriate in all security event conditions covered by the procedure.

When the licensee began implementing the emergency The security force responded appropriately to the response program following the operations shift supesvisor's classification of the event and declaration of specific challenge presented by the intruder, a Site Area Emergency effective at 7:05 a.m., site There were conflicts between operations, personnel were assigned to emergency responsibilities.

ne licensee also notified the Commonwealth of emergency response, and security actions that Pennsylvania response organizations and the NRC.

resulted from limited key card access, the locking of These' organizations responded by activating their the control room fire doors and personal safety respective response facilities. The licensee activated its concerns.

emergency response organization in a limited manner because the event myolved security issues which The licensee focused on reestablishing the security e

restricted site access, precluded the use of predesignated f the facility and climinating the mtruder threat.

plant areas (such as the Technical Support Center and The HH management departed from its emergency.

shift supervisor's office), and prevented actuation of the plan and procedures to address the immediately emergency response organization in the typical manner.

known conditions, and did not fully consider the The NRC also focused its emergency response primarily p ssibility of radiological sabotage which could on the security aspects of the event.

w n nt M scope emergencyicsponse capabilities.

Upon visually m.specting plant equipment, verifying plant The NRC focused its response on security concerns and did not fully staff response facilitics in parameters to be withm. the Technical Specifications limits, and confirmmg that the safety systems were preparation to address the broader implications of any radiological sabotage.

available, at 4:25 p.m., the licensee ended the Site Area Emergency.

Previous TM1 events, drill critiques, and other reports identified security related weaknesses that On February 7,1993,in conformance with the Incident also werc evident during the February 7,1993 cvent.

Investigation Program, the NRC Executive Director for Operations requested that an Incident Investigation e

The NRC requirements for establishing and Team (IIT) be established to investigate the event. The maintaining a physical protection system, as used team included members with a broad knowledge of during the security program licensing process, do physical plant security, safeguards, emergency planning.

not consider use of a vehicle to bret.ch a PA barrier.

plant systems and operations, and criminalinvestigation.

In this event, the use of a vehicle reduced the The team included an industry consultant, two observers amount of time the security force had to assess and from the Commonwealth of Pennsylvania, and one respond to the threat.

observer from the NRC Office of the Inspector General.

The team was chartered to find facts and report He NRC's security inspection program was not e

appropriate findings and conclusions. The team's findings effective in revealing and evaluating the types of and conclusions are documented in NUREG-1485 (Ref, challenges demonstrated by this event.

C-1). The team concluded that:

The need to deviate from the security and emergencyplanimplementing documents mayhave e

The event resulted m. no actual adverse reactor been appropriate during the February 7,1993 cvent.

safety consequences and was of minimal safety 110 wever, compensatory alternatives were not sig fwance.

considered and reasonable action that departs from In consideration of the legal charges pending and the plant Technical Specifications in an emergency e

whether the mtruder acted at random or to obtain as permitted by paragraphs 50.54(x) and 50.54(y) of attention, the Irr was not able to obtam sufficient Title 10 of the Code of Federal Regulations, was not mformation to establish a motive for his actions on properly implemented.

February 7,1993.

The event exhibited numerous issues which delayed e

Maintaining power operations was an appropriate communications or inhibited the necessaiy flow of.

information.

decismn for this event.

This event was below the threshold used by the NRC for The decision to maiu%able, steady-state reactor determining an abnormal occurrence event because at no e

operations was in accordance with an established time was there any substantial reduction in the level of emergency procedure; however, this procedure does protection provided for public health and safety. The NUREG-0090, Vol.16, No.1 16

Abnormal Occurrences,1st Otr CY93 event did identify some potential programmatic security the staff to re-evaluate the adequacy of the Design Basis program weaknesses and the Commission has directed Threat.

Fuel Cycle Facilities 2.

Release of Nitrogen Dioxide Gas at made at 9:10 a.m. and later rescinded 9:51 a.m. at the Sequoyah Fuels Corporation direction of the on-site emergency director.

The release of several nitrogen oxide gases, the bulk of Sequoyah Fuels Corporation (SFC)is an NRC licensed which was nitrogen dioxide gas, resulted from_ an fuct cycle facility located in Gore, Oklahoma. In its uncontrolled chemical reaction that occurred when nitric process, the licensee uses digesters to dissolve " uranium acid was placed in what was supposed to be an empty concentrate" (uranium compounds, such as oxides and digester. De digester actually contained about 3,992 diuranates) to produce feed material for the solvent kilograms (8,800 pounds) of uranium concentrate.

extmetion system. %c batch dissolution process in the Uranium concentrate had been inadvertently added to digesters (SFC has a total of three digesters) reacts the digester due to operator error in operating the screw uranium concentrate with nitric acid to form uranyl conveyor and a faulty isolation valve which was stuck in nitrate.The operation typically charges 5,443 kilograms the open position.The fact that the uranium concentrate (12,000 pounds) of uranium concentrate to a mixture of was already present in the digester as the nitric acid was 5,678 liters (1,500 gallons) of 40-percent nitric acid and added climinated the operator's ability to control the 1,893 liters (500 gallons) of 60-percent nitric acid.

production of nitrogen oxide gases. The resultant Isolation valves on each digester are used to prevent the uncontrolled reaction overwhelmed the off-gas handling inadvertent addition of uranium concentrate into system and forced the nitrogen oxide gases out of the digesters which are not in use.

digester into the main process building.

The exothermic reaction of the uranium concentrate with ne nitrogen oxide gas escaped the main process building nitric acid results in production of nitrogen oxide gases, and was carried by a southeasterly wind toward Gore, which are treated by an off. gas handling system. To Oklahoma, which is located about 4.83 kilometers (3 ensure that the off-gas system is not overwhelmed, the miles) northeast of the plant. Residents of Gore did not licensee limits the feed rate of uranium concentrate as it report a visible cloud nor did they report eye or is added to nitric acid through the use of screw-type feed respiratory irritations of the type commonly associated conveyors. Control room operators moniter the off-gas with exposure to nitrogen dioxide. Licensee personnel handling system and if nitrogen oxide gases produced by performed air sampling at selected locations in the town the reaction begin to exceed the capability of the off-gas of Gore shortly after the release, and all air sampling handling system, an operator slows or stops the screw showed negative results.

conveyor, thereby limiting the feed of uranium concentrate and slowing the prodaction of nitrogen oxide However, several individuals, including licensee gases.

personnel and members of the public who were near the facility at the time.of the release, reported signs and symptoms characteristic of exposure to nitrogen dioxide At 8:52 a.m. on November 17,1992, about 1,225 gas. nose affected included 8 SFC employees who were kilograms (2,700 pounds) of nitrogen dioxide gas was present in the control room and other areas of the main released in the digester area of the main processbuildmg.

process building at the time of the release,3_ fishermen Fhe duration of the release was about 20 minutes.

who were fishing in the river adjacent to the plant Control room operators immediately announced to plant property,24 individuals who were working outdoors at a -

personnel that a release of nitric acid gases m the main tree farm k)cated across the river from the facility,2 process building had occurred. The operators mstructed individuals who were working at a sand and gravel SFC personnel to evacuate the western portion of the company located on the bank of the river near the plant building and gather m the eastern portion. (This property, and an individual who reported seeing the cloud announcement applied only to personnel m the main while enroute to Webber Oklahoma.

process building.)

The primary complaints of the affected indiv aals were

- At approximately 9:10 a.m., the safety engineerinformed coughing and irritation of the eyes, throat,.md mucous the emergency director that the plume was moving off site membranes. Several people also complained of nausea.

and that the event should be upgraded to a Site Area The three individuals with the most significant symptoms Emergency. A' Site Area Emergency declaration was included an individual who had a burning sensation with 17 NUREG-0090, Vol.16, No.1 y

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1

'l Abnormal Occurrences,1st Otr CY93 shortness of breath, another who had nausea and had known for some time that the valve was stuck or vomiting, and a third who was treated for corneal abrasion at least that it had been sticking, but apparently had (Ref. C-2).

elected to work around it rather than repair it.This was in violation of a caution statement in the The licensee's monitoring showed that no uranium was operating procedure, released from the site. The licensee estimated that the Uranium concentrate feed material was transported e

concentration of the nitrogen dioxide cloud at its property line was approximately 5 parts per million (ppm). The enoneously to the stuck open sliding gate valve by an improperl) operated feed conveyor, thus odor detection level is reported to be between 0.12 ppm and 1 to 2 ppm (Ref. C-2). For short term exposure via all wing the concentrate to enter the number-two

+

inhalation,10 to 20 ppm can cause mild irritation of the digester without operator knowledge. No inherent mechamsm existed that could have prevented this nose and throat. Ifigher concentrations (e.g.,25 to 50 enor or wamed the operator that it had occurred.

ppm) can cause an inflammation of the lungs. Other symptoms consistent with nitrogen dioxide exposure are Bioassay results indicated that there was no o

coughing, choking, headache, nausea and stomach or significant intake of uranium by SFC personnel, chest pam. These symptoms may occur during exposure or from 5 to 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> after exposure for lesser e

No measurable uranium was released off-site.

concentrations. Concentrations in higher dosages, and for longer exposure times than assumed to have existed off site in t his event, can be toxicologically more extensive At least one health and safety technician displayed and serious (Ref. C-2). An airborne concentration of 50 p r judgement by entering a visibly hary ppm is defined as immediately dangerous to life and unmeasured atmosphere m,, the main process health, the maximum concentration from which one buildmg without wearmg respiratory protection. In addition, another health and safety techmcian partly could escape within 30 minutes without any entered a visibly hazy area without wearmg escape-impairing symptoms or any irreversible health respiratory protection. Later measurements showed effects.

that the nitrogen dioxide airborne concentrations were 60 ppm, in excess of the levels that are Ir3 addition to gases released m. the process areas-mmediately dangerous to life and health.

mtrogen dioxide gas also entered the control room, requiring evacuation of nonessential personnel. The The control room ventilation system was not o

remaining personnel, control room operators and a shift effective in protecting control room operators from supervisor, were required to wear respiratory protective toxic gas. This condition apparently resulted from egmpment while they remam, ed in the control room t inadequate design and modification of the control momtor shutdown of the plant and to direct the facility's room ventilation system and other systems with response to the event. Subsequent investigation which it interfaced. A fluorine release in the cell demonstrated that pipe penetrations through a wall rooms that occurred in June 1992 appears to have -

located between the main process area and adjacent been an inadequately studied precursor to the office space were not scaled. As a result, airborne control room ventilation aspects of the November contamination was allowed to enter an air plenum which 17,1992 event.

rceirculated air into the control room and office areas.

On November 18, 1992, NRC issued a Confirmatory The NRC dispatched an Augmented Inspection Team Action Letter documenting SFC's commitment to keep (AIT) to SFC to evaluate the circumstances surrounding its uranium processes shut down until a fullinvestigation the incident. The team was on site from November 17 to of the event was completed and NRC was briefed on the 21 and from November 24 to 25,1992. The AIT investigation findings and concurred with the licensee's determined the plant conditions and the sequence of decision to resume production operations. Shortly after events; assessed the radiological and chemical the event, SFC notified NRC of its intent to permanently consequences of the event; and assessed the effect of suspend uranium hexafluoride conversion operations and procedures and training upon the event and upon the to ultimately decommission the facility. SFC also notified licensee's response to the event.

NRC of its intent to resume uranium reduction operations in order to fulfill contractual obligations after The AIT documented its findings and conclusions in an which the depleted uranium tetrafluoride facility would inspection report (Ref. C-3). In summary the AIT also be shut down. On December 23,1992, NRC concluded that:

concurred with SFC's decision to resume uratium reduction operations.

A sliding gate valve on the number-two digester was By letter dated March 25,1993, the NRC transmitted to stuck in the open position. Operations personnel SFC a Notice of Violation and Proposed Imposition of-NUREG-0090, Vol.16, No.1 18

Abnormal Occurrences,1st Qtr CY93 Civil Penalty of $18,000. In its transmittal cover letter, most significant to the least significant, respectively)

NRC stated that the violations associated with the event problem. (Ref. C-4) and SFC's response to the event were a very significant regulatory concern and classified the violations as a SFC responded by letter dated April 26,1993, and paid Severity Level II (Severity Levels I and V range frorn the the civil penalty.

?

l l

l l-i l

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

i

Abnormal Occurrences,1st Otr CY93 j

REFERENCES FOR APPENDICES B-1 U.S.

Nuclear Regulatory Commission, Confirmatory Order Modifying License, Docket No.

NUREG-1450, " Potential Criticality Accident at 030-01244, April 26,1993.*

the General Electric Nuclear Fuel and Component Manufacturing Facility, May 29, 1991," August C-1 U.S.

Nuclear Regulatory Commission, 1991.*

NUREG-1485, " Unauthorized Forced Entry into the Protected Area at Three Mile Island Unit 1 on B.2 U.S.

Nuclear Regulatory Commission, February 7,1993," April 1993.*

NUREG-1324," Proposed Mcthod for Regulating Major Materials Licensees," February 1992.*

C-2 Letter from Lynn V, Mitchell, M.D., M.P.H. and Ronald B. Coleman, Ph.D.,

The University of B.3 Letter from James L.

Milhoan, Regional Oklahoma, College of Medicine, to Ixonard J.

Administrator, NRC Region IV, to Jon M. Gates, Callan, Director, Division of Radiation Safety and Administrator, Memorial llospital of Laramie Safeguards, NRC Region IV, forwarding " Report:

County, forwarding Notice of Violation and Release of Nitrogen Dioxide, Sequoyah Fuels, Proposed Imposition of Civil Penalty, Docket No.

Gore, Oklahoma, 11/17/92," December 11,1992.*

0304)3496, March 22,1993.*

i B-4 letter from Ilugh L Thompson, Deputy Executive Administrator, NRC Region IV, to James J.

Director for Nuclear Materials Safety, Safeguards, Sheppard, President, Sequoyah Fuels Corporation, and Operations, NRC, to Norman G. Roth, forwarding Inspection Repon No. 40-8027/92-30, Assistant Vice President, Yale-New flaven Docket No. 040-8027, December 18,1992.*

llospital, forwardir.j; Nntice of Violation and j

Proposed Imposition of Civil Penalties, and C-4 Letter from James L Milhoan, Regional j

Administrator, NRC Region IV, to James J.

Sheppard, President, Sequoyah Fuels Corporation, 1

forwarding Notice of Violation and Proposed

• A copy is availabic for inspection or copying for a fee in t he NRC Public Imposition of Civil Penalty, Docket No. 040-8027, Document Room. 2 t 20 LStr eet NW. (tower Irvc!). Washington. DC March 25,1993.*

20sss.

21 NUREG-0090,' Vol.16, No.1

e IJRC FORM 335 U.S. NUCLEAR REGULATORY COf@AISSION

1. REPORT NUMBER (2-89)

(Assigned by NRC, Add Vol.,

NRCM 1102, 6upp., Rev., arms Addendum Num-6 seoi,3202 BIBUOGRAPHIC DATA SHEET b" $ - H any-)

cS instrueuans on the rev.rse)

NUREG-0090 Vol.16, No.1

2. TULE AND SUBMU:

• ' ^"' * *' ""*"*"'

Report to Congress on Abnormal Occurrences:

January-March 1993 MONN l

YEAR June 1993

4. FIN OR GRANT NUMBER

6. AUINOH(6)

6. TYPE OF REPORT Quarterly

7. PERIOD COVERED (inclusive Dates)

January - March 1993

8. PERFORMING ORGAN!ZATION - NAME AND ADDRESS (if NRC, provide Division, Office or Region, U.S. Nuclear Regulatory Commission, and malling address; if contractor, provide name and malling address.)

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

9. SPONSORING ORGAN 1ZATION - NAME AND ADDRESS (tf NRC, type "Same as above"; if contractor, provide NRC Division, Office or Region, U.G. Nuclear Regulatory Commission, and malling address.)

Same as 8., above l

1

10. SUPPLEMENTARY NOTES

11. ABSTRACT (200 words or less) t

?

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 January through March 1993. There is one abnormal occurrence at a nuclear power plant discussed in this report that involved a steam generator tube rupture at Palo Verde Unit 2, and none for fuel cycle facilities. Three abnor-mal occurrences invoh-ing medical misadminstrations (two therapeutic and one diagnostic) at NRC-licensed facilities are also discussed in this report. No abnormal occurrences were reported by NRC's Agreement States. The report also contains information updating previously reported abnormal occurrences.

17. KEY WORDS/DESCR$' TORS (List words or phrases that will assist researchers in locatin0 the report.)

13. AVAILABluTY STATEMENT Unlimited

14. SECURITY CLAS$6FICATION Medical Therapy Misadministrations (This rase)

Steam Generator Tube Rupture et "alo Verde Unit 2 Unclassified (This Report)

Unclassified

15. NUMBER OF PAGES

16. PRICE NRC FORM 335 (2-49)

. NUREU-0090, Vol 16, No. I !

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