ML20126M143

Report to Congress on Abnormal OCCURRENCES.July-September 1992

ML20126M143
Person / Time
Issue date:	12/31/1992
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
References
NUREG-0090, NUREG-0090-V15-N03, NUREG-90, NUREG-90-V15-N3, NUDOCS 9301080213
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3 Availabic from Suominierulent of Documents U.S Gon rnrnent Printing Office Post Office llox 37002 Wastungton. O t. 20013 7007 A year's sulocription consists of 12 iswet for ttus potilitation.

Single copies of this publication are available f rom tJational Technical intormation Service, Springf wid, VA 2216)

NUREG-0090 Vol.15, No. 3 Reaort to Congress on Abnormal Occurrences July - September 1992 I) ate Published: 1)cccmber 1992 Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555 f.....g,

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l l'revious Iteliorts in Series NUlti:() ~13'090 (Jauuar)-lune 1975), pubbsheJ October 1975.

NUltl% 0090 -1 through -10(July-September 1975 through October-December 1977). published hiatth 1976 through Atatch 1978.

NUltl'.(1-0990 Vols. I through 14 (January 41arth 1978 through October-December 1991). published June 1978 through Wrch 1991 NUltlR0090, Voi.15. Nos. I and 2 (January 41atth 1992 and Apnl-June 1992), pubbshed July 1992 and September 1994 b

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Abnormal Occurrences,3rd Qtr CY92 AllSTRACT h

Section 208 of the linergy Reorganifation Act of 1974 plant. Two abnormal occurrences involving medical mis-9 identifies an abnormal occurrence as an unscheduled inci-administrations (both therapeutic) and one involving dent or event that the Nuclear Regulatory Commission overexposure of a radiographer at N RC licensed facihties determines to be significant from the standpoint of public were discussed in this report. In addition, another abnor-health or safety and requires a qu/.rterly report of such mal occurrence was reported by an NRC Agreement events to be made to Congress This report covers the State. The report also contains information updating a period from July I through September 30,1992.

previously reported abnormal occurrence.

There were no abnormal occurrences at a nuclear p.mer s

iii NURl!G-0090. Vol.15, No. 3

Abnormal Occurrences. 3rd Otr CY92 CONTENTS Page iii Abstnict ViI PrelaCe,

vii Introduction vii

'the itegulatory System vii iteportab!c Occurrences

... viii Agreement States viii I oreign Infor mation I

Iteport To Coupess On Abnormal Occurrences. July-September 1992.

1 Nuclear Power Plants 1

Fuel Cycle l'acihties (Other than Nuclear Power Plants)

Other NitC 1.icensees (industrial Itadiographers, Medical Institutions, Industrial Users, etc.).

1 97-9 Medical ~lherapy Nhsadministration at Cooper llospital/ University 1

]

Medical Center in Camden. New Jersey 92-10 lixtremity Overexposure of a Itadiocrapher at MQS Inspection. Inc., I?ictd Site 2

in Trenton, Michigan 92 -!1 Medical Therapy Misadministration at the Medical Center of Delaware, incorporated, 3

in Wilmington, Delaware.

3 Agreement State 1.icensees AS 92-1 Medical Diagnostic Misadministration at Southwest Texas Methodist ilospital 4

in San Antomo, Texas 5

Iteferences.

7 Appendir A-Abnormal Occurrence Criteria.

I1 Appendix 11-Update Of Previously iteported Abnormal Occurrences.......,

11 Other Ni(C 1.icensees 90-19 Medical Diagnostic Misadministration at Copley liospital in Morrisville, Vermont I1 13 Appendit C-Other livents Of Interest.

13 Nuclear Power Plants 1.

las.of-Coolant livent at the 1 ort Calhoun Station 13 15 References for Appendices l

1 NU RI!O-0090. Vol.15. No. 3 y

Abnormal Occurrences,3rd Otr CY92 PREFACE Ilitrodtletiori rules and regulations in Title 10 of :he Code oflederai Regulatiom. This includes public participation as an ele.

The Nuclear Regulatory Commission reportt to the Con-ment. To accomplish its objechves NRC regularly con-press each quarter under provisions of Section 20S of the ducts licensing proceedmgs, inspection and enforcement linergy 1(corgani/ation Act of 1974 on any abnormal oc-activities, evaluation of operating experience, and confir-currences mvolving facihties and activities regulated by snatory research, while maintaining programs for estab-ihe NRC. An abnormal occurrence is defmed in Sec.

hsning standards and issuing technical reviews and stud-tion 20S as an unscheduled incident or event that the ies.

Commission determines is significant f rom the standpoint in heensing and regulating nuclear power plants and the of public health or safety uses of bypnsduct nuclear materials, the NRC follows the inents are currently identif ed as abnormal occurrences phdosophy that the health and safety of the public are best ensured through the establishment of multiple levels for this report by the NRC using the criteria and accompa.

of protection.These multiple levels can be achieved and nying examples hsted in Appendix A.These criteria were maintained through regulations specifying requirements promulgated in an NRC policy statement that was pub.

that will ensure the safe use of nuclear materials.The lished in the Federal Register on Februaiy 24, 1977 regulations include design and quahty assurance criteria (Vol. 42, No. 37, pages llN50-10952).

appropnate for the various activities Ucensed by the NRC. An inspection and enforcement program helps en-The NRC pokey statement was published before been.

sure comphance with the regulations sees were required to report medical misadministrations to th< NRC. I ew of the examples in the polie, staterrent are apphcahic to medical misadmimstrations. Therefore, lleportable Ocetirreiices during 19S4, the NRC developed guidehnes for selectmg such events for abnorma' occurrence reporting. These Actual operatmg experience is an essential input to the guidehnes, which have bten used by the NRC smce the regulatory process for assunng that licensed activitics are latter part of 1984, augment the NRC policy statement conducted safely. l.ieensees are required to report certain examples and are summan/ed m Table A-1 m Appen-incidents or evems to the NRC, Tbis reporting helps to dix A. On January 27, 1992, new medical misadmm-identify deficiencies early and to ensure that corrective istration defmitions became effective.'lherefore, revised actions are taken to prevent recurrence.

guidelmes for identifying medical misadministrations as abnormal acurrences are currently being developed.

For nuclear power plants, dedicated groups have been The reused guidelines wdl be published for comment in formed both by the N RC and by the nuclear power indus-the Tcdcral Register.

try for the detailed review of operating experience to help -

identify safety concerns early; to improve dissemination In order to provide wide dissernination of information to of such information: and to feed back the experience into the public, a Federal Register nottce is issued on each licensin, regulations, and operations. In addition, the abnonnaloccurrence.Copiesof the notice are distributed N RC and the nuclear pow er industry have ongoing efforts to the NRC Public Document Roem and all I ocal Pubhc to improve the operational data systems, which include Document Rooms. At a minimum, each notice must con-not only the t;pe and quality of reports required to be tain the date and place of the occurrence and desenbe its submitied, but also the methal, used to analyze the data.

nature and probable consequences.

In order to more effectively collect, collate, store, re-trieve, and evaluate opeiational data, the information is The NRC has determined that. only those events de-mai..tained in computer-based data files.

scribed in this report meet the criteria for abnormal oe-currence reporting. This report covers the period from Three primary sources of operational data are I icensee July I through September 30,1992. Information reported tivent Reports (IliRs)and immediate notifications made on each event includes date and place, nature and prob.

pursua nt to 10 CFR 5032 and medical misadministration able consequeneet cause or causes, and actions taken to reports made pursuant to 10 CFR 35.33.

prevent tecurrence.

lixcept for records exempt from public disclosure by stat-ute and/or regulation, information concerning teportable The llegtiliitory System occurrences at facilities licensed or otherwise regulated

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by the NRC is routinely disseminated by the NRC to the The system of licensing and regulation by which NRC nuclear industry, the public, and other interested groups carries out its responsibihties is implemented tbrough as these esents occur.

vii NURI!G-0090 Vol.15, No. 3

Abnormal Occ urrences,3rd Qtr CY92 Dissemination includes special notifications to licensees programs must be comparable to and comoatible with the and other affected or.nterested groups, and public an-Commission's program for such material.

nouncements. In addition, information on reportable events is routmely sent to the NitC's more than 100 hical Presently, information on reportable occurrences in public document nmms throuphout the United States and Agreement St atc heensed activities is publicly available at to the NRC Public Document floom in Washington, D.C.

the State level. Certain informaaon is also provided to the The Congress is routmely kept informed of reportable NRC under exchange of information provisions in the events occurring m licensed facilities.

agreements.

Another primary source of operational data is reports of in early 1977, the Commission determined that abnormal reliability data submitted by beensees under the Nuclear Plant Reliabihty Data System (NPRDS).The NPRDS ts a ocet.crences happening at facilities of Agreement State voluntary, industry-supported system operated by the In-licensees should be mcluded in the quarterly reports to Congress. The abnormal occurr ence criteria included in stitute of Nuclear Power Opcrations (INPO), a nuclear Appendix A are applied uniformly to events at NRC and utihty or ganization. Hoth eng.meermg and failure data are Agreement State licensee facilities. Procedures have submitted by nuclear power plant licensees for specified plant components and systems. l'he Commission consid-been developed and implemented, and al normal occur-rences reported by the Agreement States to the NRC are ers the NPRDS to be a vital adjunct to the LliR system for the collection, review, and feedback of operational expe-neluded in these quarterly reports to Congress.

rience; therefore, the Commission periodically monitors the NPRDS reporting activities.

g Oreigil lilfor11181IOlt Agreerneiit States The NRC participates in an exchange of information with various foreign governments that have nuclear facilities.

Section 274 of the Atomic linergy Act, as amended,

'Diis foreign information is reviewed and considered in authorizes the Commission to enter into agreements with the NRC's assessment of operating experience and in its.

States whereby the Commission relinquishes and the research and regulatory activities. Ref'.rence 10 foreign States assume regulatory authority over byproduct, information may occasionally be made in these quarterly source, and special nuclear materials (in quantities not abnormal occurrence reports to Congress; however, only capable of sustaining a chain reaction). Agreement State domestic abnormal occurrences are reported.

NURl!G-0WL Vol.15 No. 3 viii N.

Abnormal Occurrences, 3rd Otr CY92 REPORT TO CONGRESS ON AllNORMAL OCCURRENCES JULY-SEPTEMilER 1992 Nuclear Power Plants

'lhe NRC is reviewing events reported at the nuclear NRC has not determined that any events were abnormal power plants licensed to operate. For this report, the oc urrences.

Fuel Cycle Facilities (Other Than Nuclear Power Plants)

The NRC is reviewing events reported by these licensees, events were abnormal occurrences.

l'or this tcport, the NRC has not determined that any Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)

'lhere are currently over 8000 NRC nuclear material November 11,1991 to January 7,1992. The licensee had licenses in effect in the United States, principally for use discovered the error on January 24,1992, after the review of radioisotopes in the medical, industrial, and academic of patient charts in preparation for the Quality Manage-fields,incidentswere reported in this category from licen-ment Program submittal. 'Ihe error caused a 12.2 percent sees such as radiographers, medical institutions, and underdosing of the patients.

byproduct material users. The NRC is revicwing events Four patients received extern:.1 beam therapy (Linear reported by these licensees. l'or this report, the N RC has Accelerator) in addition to the radiation received from determined that the following events were abnormal oc-the Ir-192 implants. Patient A was to receive 1043 rads currences using the enteria and guidelines given in Ap-from an Ir-192 intracavitary bronchiai implant for the penda A. As noted in the Preface to this report, the treatment of lung cancer and received 916 rads on No-guidelines for identifying medical misadministrations as vember 11,1991. Patient Alater received 5576 rads from

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abnormal occurrences are currently being revised, external beam therapy. Patient 11 was to receive 1266 rads to the head and neck from an Ir-192 interstitial implant 92-9 Medical Therapy Misadministra ion for the treatment of cancer and received 1112 rads on November 12,1992. Patient 11 later received 4600 rads at Cooper llospital/ University Medi, fr m extern I be m therapy. Patient C was to receive cal Center in Camden, New Jersey 2150 rads from an Ir-192 interstitial implant for the treat-mm st etmeer and received 1888 rads on Decem-The following information pertaining to this event is also ber 2,1991. I atient C later received 5940 rads from exter-being reported concurrently in the Federal Register. Ap-na beam therapy. Patient D was to receive 2000 rads to pendix A (see Event Type 5 in Table A-1) of this report ongue W me tnatment M canm fmm an k-W2 notes that a therapeutic misadministration affecting two interstitialimplant and received 1756 rads on January 7, or more patients at the same facility can be considered an D later received 5940 rads from external abnormal occurrence.

beam therapy.,The licensee has determined that the above patient's treatments were not compromised by the Date and Place-November 11,1991 to January 7,1992; small decrease in the total dose received when the exter-Cooper llospital/ University Medical Center; Camden, nal beam therapy treatment is factored into the assess-New Jersey.

ment.

Nature and Probable Consequences-On January 27, O,e patient did not receive external beam therapy. On 1992, the NRC Region I office was notified by telephone November 21,1991, Patient E was prescribed to receive that five therapeutic misadministrations involving 4628 rads to the pelvis for the treatment of cancer from an Iridium-192 (Ir-192) wire occurred at Cooper llospitall Ir-192 interstitial implant and received 4063 rads. Patient University Medical Center at Camden, New Jersey from E's attending physician had originally calculated a desired 1

NUREG-0090, Vol.15, No. 3 s

_ ~ m Abnormal Occurrences, 3rd Qtt CY92 dose between 4000 and 4500 rads and wanted to include Date and Place-July 6,1992; a temporary radiography hypertheimia treatment.11yperthermia treatment re-field site in Trenton, Michigan.

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quired insertion of interstitial microwave antennae so that heat treatment was terminated within one hour be-Nature and Probable Consequences-On July 6,1992, a fore the implants were inserted and was initiated within licensee radiographer was assigned to radiograph various one hour af ter the implants were removed.The attending pipes at a construction site. Radiography is a non-physician was informed ly the licensee's staff that the destructive testing technique which uses a scaled radia-implants would have to be removed at unreasonable tion source to make Lray-like images of heavy metal times in order to fall within the attending physician's

objects, desired dose range. The attending physician then agreed to give 4628 rads so that the second hyperthermia treat.

De configuration of this job required that the radiogra-ment could be given at a more reasonabic time. Since the

- phy exposure device (camera) be suspended 20 feet above -

actual delivered dose fell within the attending physician's the floor, %e radiation source is exposed using a remote initial range, the licensee does not foresce any adverse cable to make the film image and then is retracted into the -

effects for Patient I!.

shielded camera. After an exposure, the radiographer used an aerial platform to reach the camera. He per-Cause or Causes-It was determined that the cause of the f rmed a radiation survey as he approached to assure that misadministration was an input enorinto the treatment tk source was m the shield. He radiographer was wear-planning computer. Specifically, the source calibration ing his audible alarm radiation measuring device, but it was turned off, factor was in non-Systeme Internationale (SI) units (non-metric), however, the computer was set to receive the data m Si units and the setting was not changed.

%e radiographer then moved the camera to reach the camera port to lock the radiation source inside. When he removed the tube which guides the source, he discovered

- Actions Taken to Present Recurrence the radiation source was exposed about 4 inches outside the camera.The source had apparently shifted into the Lirensee-The licensec's corrective action was to include unshielded position when the radiographer moved the the calibration factor that is used during treatments in camera to lock it. nc source was locked into place in its their records for implant Source Inventory-SourceType exposed condition. The radiographer immediately re-

- Characteristics so that the licensee can verify that the turned to ground level, but later returned to the camera proper factors are used, to unlock it so that the radiation source would be re-t tracted into its shield.

NRC-An NRC Region I inspector conducted an inspec-tron of the meident on August 5, if)2, to determine the De incident was subsequently reenacted by the licen-circumstances associated with the misadministration.The see's Radiation Safety Officer and NRC inspectors to inspector's findings were in agreement with the licensee evaluate the radiation exposure received by the radiogra-concernmg the cause of the misadmmistration. The in-pher. The calculation by the Radiation Safety Officer,.

spector determined that the licensee's corrective actions based on a series of reenactments, indicated a minimum

- were adequate to prevent recurrence. Inspection findings 440 rem exposure to the individual's hand. NRC inspec-

_regardmg the misadmmistration are documented in In-tors estimated that the dose was about 880 rem. He--

spection Field Notes approved September 9,1992. (Ref.

radiation measuring device worn by the worker indicated 1).

a whole body radiation exposure of about 250 millirem.

The worker's hand was evaluated and monitorev by medi-This item is considered closed for the purposes of this cal radiatien specialists at an area medical center. No -

report.-

short-term physical changes to the skin of the hand were observed.

92-10 Extremity Overexposure of a Radiog.

The NRC limit for extremity exposures is 18.75 rem in a rapher at MQS Inspection, Inc., Field -

c lend r quarter. Therefore, the reenactment showed that the exposure received was substantially over the Site m. Trente n, Mich.igun limit.The whole body radiation exposure was within the The following information pertaining to this event is also being reported in the Fedcral Register. Appendix A (see Cause or Causes--.The overexposure occurred as a result i -

lixample i of "For All Licensees") of this report notes of the failure of the tadiographer to use an audible alarm

- that an exposure of the fect. ankles, hands, or forearms of exposure measuring device as required by NRC regula-any individual to 375 rem or more of radiation can be tions. The locking mechanism allowed the source to bc considered an abnormal occurrence?

locked in place while it was still exposed.

NURiiG-0MO, Vol.15, No. 3 2

Abnormal Occurrences 3rd Otr CY92 -

He radiographer was wearing an audible alarm device Date and Place-August 11,1992;ne Medical Centerni

. required by the NRC for radiography work, but the device

= Delaware, incorporated; Wilmington, Delaware, was turned off. The device had been turntd off to con-serve battery power while the radiographer was doing Nature and Probable Consequence-On August 12.

paperwork, but had not been turned back on for the 1992, the NRC Region I office was notified by tele phone remainder of the day. Use of an operable alarm device by the licensee's radiation safety office that a therapeutic could have avoided or minimiicd the overexposure.

misadministration involving a cobalt-60 teletherapy unit occurred on August 11,1992.

t Actions Taken to Prevent Recurrence The physician's written directive called for 3015 rads in 15 Licensee-The licensee alerted its staff to the potential fractions to be delivered to the central area of the pelvic problem with the locking mechanism of this type of radt-region with the teletherapy machine set up in a fixed ography camera. It also provided additional training on modality, During the 14th fraction, the radiation therapy the use of the required audible alarm radiation devices technologist (RTT) did not ensure that the teletherapy and included venfying that the devices are turned on machine was set in the fixed modality and started the during routme internal audits of radiography activities.

treatment.The previous patient had received treatment The radiographer was restricted indefinitely from further n the rotational modality and the setting of the machine.

work with radioactive matenals.

was not changed.The patient received a total of 160 rads to the pelvic treatment area instead of the prescribed 200 NRC-The NRC Region III conducted a special inspec-rads. In addition, the licensee estimates that the patient tion r % licensee's activities on July 8-10,1992 (Ref. 2).

received an estimated dose of 80 to 110 rads to the left Thy inspection identified three vtalations of NRC re-side of the pelvis outside of the treatment area and be.

- quirements_ associated with the overexposure incident:

tween 60 to 70 rads to the right side of the pelvis outside of (1) the extremity exposure m excess of the 18.75 rem limit the treatment area.The licensee has determined that the for a calenc'ar quarter; (2) failure of the radiographer to patient will not suffer any adverse effects in the areas that wear an operable audible radiation monitonng device; received an uwter.ded radiation dose. De licensee will -

and (3) failure to perform an adequate radiation survey of nerease the presenbed dose for the 15th fraction to make the radiography camera m that the radiographer did not up for the underdosing during the 14th fraction, survey the full circumference of the camera.De first two violations were classified as a Severity Level I problem, eorCauses-Itwasdeterminedthatthecauseof the and the third as a Level IV violation (on a scale m which misadministration was the failute of the licensee to follow beverity Levels I through V are the most and least signifi.

the department's Quality Management (QM) Program, cant, respectively). On October 9,1992, a $5,000 fme was The licensee's QM Program calls for two R1Ts to be proposed for the first two violations. No fine was pro ~

present when a patient is being set up to ensure that the posed for the third vmlation (Ref. 3). On November 2' setup is donc properly.The first R'IT did not ensure that 1992, the licensee paid the em! penalty.

the setup was donc correctly and the second RTT was out -

of the department getting another patient.

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

Actions Taken to Prevent Recurrence 92 Medical Therapy Misadministration Lice nsee-The licensee's corrective action was to provide at the Medical Center of Delaware, a training session to all RTTs on the requirements of the Incorporated, in Wiln.ington, Dela.

Quality Management Program.

- ware NRC-An NRC Region I inspector conducted an inspec-tion on November 19, 1992, to determine the circum-De following information pertaining to this event is also stances associated with the misadministration. The in-being reported concurrently in the Federal Register. Ap.

l pendix A (see I! vent Type 3 in Table A-1) of this report spection findings are still under review by the NRC, and.

enforcement action is under consideration.

notes that r therapeutic exposure to a part of thelxxty not l;

scheduled to receive radiation can be considered an ab- -

normal occurrence.

Future reports will be made as appropriate.

Agreement State Licensees

-_ Procedures have been developed for the Agreement same criteria as the NRC(sec Appendix A)and report the States to screen unscheduled incidents or events using the events to the NRC for inclusion in these quarterly reports l

3 NUREG-0090, Vol.'15, No. 3

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1.

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' Abnormal Occurrences, 3rd Qtr CY92 to Congress. l'or this period, the Agreement States re-review the examination. lie discovered the dose error, ported the following event as an abnormal occurrence.

The doctor reported that based on a normal thyroid up-I take of 15% for mdine-131, a dose of five millicuries l

AS 92-1 Medical Diagnostic Misadministra-would dehva apures of 4000 rads to the thyroid and -

t,on at Southwest Texas Methodist

. 35 rads to the whole lxx!y, i

i l

llospital in San Antonio, Texas The misadministration was reported to the patient's re.

Appendix A (see I! vent Type 4 in Table A-1) of tbts ferrmg physician, and he was advised that a radiation dose report notes that administering a diagnostic dose of a of this magnitude to the thyroid could result in develop-radiopharmaceutical that is greater than five times the ment of hypothyroidism.The referring physician plans to prescribed dose can be considered an abnormal occur-follow the patient accordingly.

" C-i Cause or Causes-The misadministration occurred be-This write-up is based on information provided to the caum a nu car m n

n og cn e re-NitC in October 1992 by the Ac,reement State of Texas 9

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body scim because of the location of the mass to be im-l._

for inclusion in this report.

pred.

Date and Place-January 20, 1992; Southwest Texas Methodist llospital; San Antonio, Texas, Actions Taken to Present 8tecurrence Nature and Probable Consequences-On January 30, 1.lcensee-The licensee established a policy that the ad-l 1992, an iodine-131 thyroid scan was requested for a pa, ministration of any dosage of iodine-131 prcater than 100 tient to further evaluate a suspected right paratracheat microcuries must be reviewed by a staff radiologist li-mass to determine if the mass was a substernal goiter.The censed to administer radioactive materials with full technologist confused the thyroid scan requested with a knowledge of the clinical problem.The significance of the w hole body scan because the mass to be imaged was in the error was discussed with the technologist.

chest. As a result, the patient was administered 5 mil-lieuries ofiodine-131 for a whole body scan instead of 100 Agency-The licensee was cited by the Texas Bureau of microcuries of h>dme-131 for the prescribed procedure Itadiation Control for the misadministration in violation for a thyroid scan with substernal mass, of license procedures.

l llecause of the high activity in the thyroid at the time of This item is considered closed for the purposes of this the imapmg on January 31,1992, a doctor was asked to report.

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l NUREG-0090. Vol.15. No. 3 4

m:

Abnormal Occurrences, 3rd Otr CY92 ItEFEllENCES 1.

NI(C llegion I, Inspection l'ield Notes, Docket 04041,1icense No. 12-00622-07, Docket No. 030-No. 030-02512, September 9,1992; available for 0404), July 30.1992.'

inspection or copying for a fee in the NitC Itegion i 3.

Letter from A. Bert Davis,llegional Administrator, Public Document floom,475 Allendale Itoad, King NRC Region Ill, to 1lugh Doran, President, MOS of Prussia, PA 19,06-1415.

Inspection, Inc., forwarding a Notice of Violation and Proposed imposition of Civil Penalty, License No. 12-00622-07, Docket No. 030-04041, Octo-2.

Letter from Charles 11. Norelius, Director, Division ber 9,1992.*

of Radiation Safety and Safeguards, NitC Region III, to liugh Doran, President, MOS Inspection.

• ^J3pnygll*yf2$'i'Is!$" ISM"#Ir*1NN"Il5Uh2NE g

inc., forwarding NRC Inspection Report No. 030-2055s.

I 5

NUREG4K)90, Vol.1S, No. 3

Abnormal Occurrencen 3rd Q:r CY92 APPENDIX A AllNORM AL OCCURRENCE CRITERI A The following cnteria for this report's abnormal occur-5.

Any loss of licensed material in such quantities and rence (AO) determmations were set forth m an NRC under su:h circumstances that substantial hazard policy statement published in the fcdcra!Registu on Feb.

may result to perums in untestricted areas.

ruary 24,1977 (Vol. 42. No. 37, pages '10950-10952).

6.

A substantiated case of actual or attempted theft or diversion of licensed matenal or sabotage of a facil-An event will be considered an AO if it involves a major reduction in the degree of protection of the public health ity.

or safety. Such an event would involve a moderate or 1

bst mtiated ioss of sIiecial nuclear material or more severe impact on the public healta or safety and any mbs.antiated inventory discrepancy that is could include but need not be limited to; judged to be signific:mt relat:ve to normally ex-peded perfognap and mat Mu@ Me caused 1.

Maierate exposure to or iclease of, radioactive ma-by theft or diversion or by substantial breakdown of teriallicensed by or ot erwise regulated by the Corn-the accountability system.

h mission; 8.

Anv substantial breakdown of physical security or 2

Major degradation of essential safety-relate 1 equip-ma'terial control (i.e., access control, centainment.

or accountability systems) that significantly weak-ment; or ened the protection against (l'ef t diversion, or sabo-3.

Major deficiencies in d sign, construction, use of, or tage.

management controls for licensed facihties or mate-An accidental criticality [10 CFR 70.52(a)].

9.

rial.

10. A major deficiency in design, construction. or ope ra-Ihamples of the types of esents that are evaluated m tion having safety imphcations requiring immediate detail using these enteria are:

remedial action.

For AllIitensees

11. Serious deficiency in nvmagement or procedural controls in major arcas.

I.

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

12. Senes of events (where individual events are not of the whole body of any individual to 150 rcm or more najor importance), recurring incidents, and inci-of radiation; or exposure ci t he fect, ankles, hands or dents with implications for similar facilities (generic forearms of any individual to 375 rem or more ei incidents) that create major safety concern.

a radtation ] 10 CFR 20.403(a)(1)], or equivalcut expo-sures from intern l0 sources.

For Commercial Nuclear power plants 1.

Thceedmg a safety limit of license technical specifi-2.

An exoosure to an individual in an unrestncted area cations [10 CFR 50.36(c)].

such Utat the whole body dose received exceeds 0.5 rem in one calendar year {10 CFR 20.105(a)].

2.

Major degradation of fud integrity, primary coolant pressure boundary, or primary containment bound-3-

.Ihe release of radioactive materal to an unre-

"4, stricted mea in concentratims which, if 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 the 3.

Loss of plant capability to perform essemial tafety regulatorv hmit of Appendix H, Table II,10 CFR functions such that a potential relcase of radioactiv-

}

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

ity in excess of 10 CFR Part 100 guidelines could j

result from a postulated transient or accidem (e.g.,

4.

RadUtion or conisminalion tevels in excess of design loss of emergency core neling system, loss of con.

values on packages, or kss of confinement of radio-trol rod system).

active material such as (a) a radution dose rate of 3

1000 mreta per hout three feet from the surface of a 4

Diswvery of a major condition not specific.dly con-package containing the radioactive rnaterial. or sidered in the safety analysis repart (S AR) or techni-(b) release of radioactiw material from a package in cat specifications that requires immediate remed al amoums greater than the regulatory limit, action.

7 NUlEG-0090, Vol.15 No. 3 ~

..~. - - -.,,,. -. = ~. -.

~. _,. -.

Abnormal Occurrences, 3rd Otr CY92 -

' 5.'

Personnel error or prowdural deficiencies that re, exceeded and a plant shutdown is required {l0 CfR-salt in loss of plant capability to perform essential 50.36(c)).

safety functions such that a potential release of n.

dioactivity in etcess of 10 CFR Part 100 guideliner 2.

A major condition not specifically considered in the could result frota a postulated transient or accident (e.g, loss of einergency core coolmg system, loss of nfety analysis report or technical specifications that control rod systern).

requh es immediate remed.ial action, I'or fuel Cycle Licensees 3.

An evert that seriously compromised the ability of a confinement system to perform its designated func-1, A safety limit of license technical specifications is lion.

Medical Misadininistrations As discussed in the Preface to this report, the NR C policy the NRC policy statement, statement on Aos was published before licensees were required to report medical misadministrr ions to the

!.~

~ NRC.nerefore,during 1984, the NRC develoj ed guide.

As noted in the Preface, revised guidelines are currently L

lines for selecting such events for AO reporting. nese being developed because new rnedical misadministration

. guidelines.which tresummarizedinTable A-1, augment -

definitions became effective on January 27,1992, l1 l

l l

l_

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A I

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NUREG-0090, Voi.15 No 3 8

i r

E Abnormal Occurrences, 3rd Qtr CY92 r

Table A.1 NitC Guidelines for Selecting Medical Misadministration Events for Abnorinal Occurrence (AO) Reporting h.

AO Reporting lhreshold 1.'s e nt Ty pe Diagnostic l'.sposure Therapeutic Esposure (1) Admuustermp a ra.hopharma-If the improper admimstration if the imptoper administration ceutical or radation from a results in any part of the body results in any part of the taxly scaled sousee other than the receiving unscheduled radiation, receiving unscheduled radiation, one miended.

an M report should be pro-an AO report should be posed if:

proposed for any such event.

(a) the actual dose to the wrong If the par's of the body lxwly part is greater th n five receiving radiation improperly times the upper Imut of the would have received radiation normal range of exposures anyway, had the proper presenbed foi diagnostic pro-administration been used, an cedmes insolving that body AO report should be proposed par,.or if:

.I '

(b) there are clinical mdications (a) the actual dose is greater of any adverse health effects than 1.5 times that to the wrong body part.

intended to the above desenbed body parts, or, If the parts of the lxAly receiving radiation impioperly would have (b) the actual dose is less than received radiation anyway, had the 0.5 times that intended to proper administration been used, an the above described body AO report should be proposed if:

parts, or, t

i (a) the actual dose is greater than (c) the above described body five times that intended to the parts show signs of adverse aboic described body parts, or, health effects greater than expected had the proper (b) the above described body parts administration been used, or show signs of adverse health effects greater than expected (d) the event (regardless of any had the proper administration health effects) affects two or i-been used.

more patients at the same faci! 'v.

(2) Administering a radiopharma-An AO report should be proposed An AO report should be proposed ceutical or radiation to the if:

for any such event.

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.

l 1

9 NUREG-0090, Vol.15, No. 3

? Abnormal Occurrences,13rd Qtr CY92 Table A.1 (Continued).

AO Reporting Threshold i

' thent Type Diagnostic thposure

. Tlierapeutic Ihposure (3)f Adniinistering a radiopharma-Same guidelines as for I! vent Same guidelines as for Event ceutical or radiation by a -

Type 1.

Type 1.

route of admid..ation other than that intended by the prescribing physician.

-(4) Administerin'g a diagnostic An AO report should be proposed Not applicable.

dose of a radiopharmaceuti-if:

cal differing from the pre-scribed dose by more than (a) the actual dose is greater than 50 percent.

five times the prescribed dose, er, (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 therapeutic Not applicable.

An AO report should be dose of a radiopharmaceutical proposed if:

differing from the prescribed dose by more than 10 percent; (a) the actual dose is greater or administering a therapeutic

. than 1.5 times the radiation dose from a scaled prescribed dose, or, source such that errors in the

- source calibration, time of (b) the actual dose is less exposure, and treatment than 0.5 times the geometry result in a calculated prescribed dose, or total treatment dose differing

from the final prescribed total (e). the event results in adverse

(

treatment dose by more than health effects worse than 10 percent.

would he expected for the normai a ange of exposures prescribed for the thera-peutic procedure, or,.

(d) the event (tegardless of any health effects)affects two or mote patients at the same facility.

(6) Recutting or series of For either diagnostic or therapeutic exposures, an AO report should be events (regardless of the proposed for recurring esents or a series of events (in which each

- number of patients or individual misadministration is not of major import

) that create a facilities involved).

significant public health or safety concern.

(7) Generic events.

For either diagnostic or therapeutic exposures, an AO report should be proposed for misadministrations with generic implications that create a -.

significant public health or safety concern.

1 I NUREG-0090, Vol.15, No. 3 10

Abnormal Occurrences, 3rd Qtr CY92 APPENDIX 11 UPDATE OF PitEVIOUSIX llEPOllTED AllNOltM AL OCCUltitENCES During the July thwugh September 1992 period. NRC provide the initial and any subsequent updatmg informa-licensees, Agreement States Agteement State hcensees, tion on the abnormal occurrences discussed. (lhe updat-and other involved parties, such as reactor vendors and ing provided generally covers events that took place dur-architect-engineering firms, continued with the imple-ing the report period; some updating, however, may be mentation of actions necessary to prevent recurrence of more current as indicated by the associated event dates.)

previously reported abnormal occurrences. The refer-Open items will be discussed in subsequent reports in the enced Congressional abnormal occurrence reports below series.

Otlier NitC Licensees 90-19 Medical Diagnostic Misadministra.

licensee described its corrective and preventive actions tion at Copley llospital in Morrisville, that would he taken as a result of the items of noncompli-ance i nuM Mase to the misadmii.stration.

Vermont

'lhis abnormal occurrence was originally reported in On July 15.1992, the NitC issued a Notice.of Violation NUltl!G -0090. Vol.13, No. 3, " Report to Congress on and the Proposed imposition of a Civil Penalty of $2500 Abnormal Occurrences: July-September '990." The ah-(RCI II-I)-

normal occurrence is updated as follow The licensee paid the ovil penalty and provided their As previously mentioned, on August 14,1990. NRC Re.

corrective and preventive actions in a !ctter dated gion I was ne'ified by the licensee in writing that a diag-August 10,1992.The licensee admitted that the Diagnos, nostic misadmimstration imolvmg iodine 131 (I-131) had tic Misadministration Report contained inaccurate infor-occurred at Copley llospital, Morrisviht, Vermont, on mation, but stated there had been no effort on their part August 7,1990. As a result, a patiem received an esti.

to deceive the NRC.

mated dose to the thyroid of 29 rads.

On October 7,1992, the licensee's proposal for ensurmg The NRC conducted an inspection of the licensed pro-the safe administration of radiopharmaceuticals was ap-gram on l'ebruary 20 and 21,1991. A Confirmatory Ac-proved. 'Ihe procedure requires that technologists obtain tion I.ctter (C Al No. 1-91-005) was issued on March 1, the written or verbal approval of the RSO or an author-1991, relative to the issues identificJ during the inspec.

i/ed user prior to the admimstration of radiopharmaceu-tion.The licensee com mitted in the C Al.to take specified ticals, except for those procedures covered by the Quality actions to present recurrence.

Management Program, which require that a written direc-tive from an authorized user physician be obtained prior On April 29,1992, an linforcement Conference was held to administration of the radiopharmaceutical.

to review the findmgs of Inspection No. 030-17125/

91-4K)1, the subsequent Office of Investigation fmdings This item is considered closed for the purposes of this and the licensce's response to cal No. 1-91-005. The report.

1I NURI!G-0090, Vol.15, No. 3

Abnormal Occurrences, 3rd Ott CY92 APPENDIX C OTilER EVENTS OF INTEREST Ihe following item is described because it may possibly be the level of protection provided for pubhe health or perceived ty the public to be of public health or safety safety; therefore, it is not reportable as an abnormal oc-significance.The item did not involve a major reduction in currence.

Nuclear Power Plants 1.

Loss-of Coolant Event at the Fort Cal.

assessed by the NRC resident inspectors that resp (mded to the event.

lloitti Station The licensee determined that the PCSV failere was

'the Fort Calhoun Static experienced a loss of coolant caused by a nut, which held the adjustment stem in place, event as a result of a stuck open pressuriier code safety that had backed out from its installed position due to valve that resulted in approximately 20.000 gallons of inadequatt torquing. llecause the nut had backed out,the water spilling into the contaiament sump. The licensee setpoint for the PCSV was altered and the valve chattered declared an All!RT as a result of the reactor coolant (i.e., opened and closed rapidly), v.hich caused internal system leakage that exceeded 40 gallons per minute. No valve damage.The damage to the valve was the reason the radioactivity was released outside the containment build-valve did not fully rescat.Th( licensee modified the pro-ing during the event.

cedure used for adjustment of he valve to specify that the nut be torqued to 400 foot-pounds. In addition, as a con-On July 3, the beensee experienced electncal proubs pervative measure, a locking device was designed and trutalled in the PCSV to ensure that the nut would not with an instrument inverter that supplies power to the nw from its mstalled position.

electrohydraulic control system (ElIC). This system is designed to automatically control the position of the tur-On August 22, the licensee experiu,ced an event similar bine control valves, and thus, regulate steam flow to the to the one that occurred on J uly 4.This event was initiated main turbine.,the problems with the instrument inverter because of a failure of a power supply in the 111IC control resulted in power being lost to the lillC system. As a cabinet, in contrast to the failure of an external supply result, the main turbine control valves went shut and that occurred during the July 3-4 event. The loss of power stopped all steam flow.

again caused the turbine control valves to shut and re-sulted in a high RCS pressure reactor trip. In this event, When steam flow to the main turbine stopped, an in-the PCSV opened at a pressure lower than its adjusted crease in the reactot coolant system (RCS) pressure re-setpoint. After the PCSV relieved the excess pressure, sui ed. As a result of the pressure increase, a teactor trip the valve fully shut and the plant remairad stable in a hat t

occurred and a pressunzer code safety valve (PCSV) shutdown condition. All other systems and components opened to minimize the pressure increase. After the valve operated as expected during this event.

fully opened, it failed to completely shut. This resulted in a lo'ss-of coolant event that exceeded 40 gallons per min.

For this latter event, the licensee's investigation revealed ute. The reactor coolant passed through the PCSV and that the PCSV lifted prematt. rely becaece of the method entered the quench tank. Once the quench tank was full, used in the testing laboratory to adjust the valve. The the disk on the tank ruptured and the coolant spilled on heensee determined that the temperature of the valve the floor of the comainment and then flowed into the body was a critical parameter to be considered when ad-containment sums The coolant collected in the sump and justments to the valve were made. The licensee revised p

was not released outside of the containment.

the procedure used to adjust the valve to include this 3

critical oarameter. The valve was reinstalled in the 1 ant A

and power operation resumed.

The licensee's operating staff cooled down the plant, using the natural circulation mode, in a timely manner, to The NRC is in the process of issuing an information minimize the loss of coolant. The licensee staffed its notice to all license holders to alert other licensees of the emergency. response facilities in a timelv manner and problems related to PCSVs. As a result of the July 3-4 provided information concerning plant status to the event. a Confirmatory Action I.etter (CAL) was issued to NRC, which had staffed the emergency response centers the licensee and an Augmented Inspection Team (Arr) in Region IV and Ileadquarters. The infonnation pro-was dispatched to the site on July 4,1992.'Ihe AIT noted vided by the licensee was independently confirmed and that the response by the operating staff to the event was 13 NURiiG-0090, Vol.15, No. 3

Abnormal Occurrences, 3r'd Qtt CY92 very good and that the health and safety of the public was are documented in an NRC Inspection Report (Ref.

protected throughout the event, because no radioactive C-1).

release occurredflhe cal. that was issued to the licensee specified that specific actions would be taken prior to For the August 22 event, a specialinspection team was allowing restart of the plant. The actions included deter-sent to the ite to review and eva!uate the acticas taken by mining why the inverter malfunctioned, the cause of the the licensee to address tht, >ccond occurrence of the fail-turbine control valves poing shut, and the root cause far ure of a PSCV to properly function.'the team noted that the failure of one of the two PCSVs to function properly.

the licensee performed an in.Jepth review of the cause of The licensee completed all the items listed in the CA1 the failure and idc.ntified, through in-place testing, en-4 and NRC inspectors independently verified that all items hancements to se method used to adjust the setpoint of had been completed prior to allowing the plant to be the PCSVs. The details of the results of the review are restartedflhe details of the review performed by the AIT provided in an NRC Inspection Report (Ref. C-2).

t N U Rl!G-0090, Vol.15. No.- 3 14 i

I

Abnormal Occurrences, 3rd Qtr CY92 REFERENCES FOR APPENDICES 11 - 1 Letter from Thomas T. Martin, Regional Adminis.

trator, NRC Region IV, to W. G. Gates, Division trator, N RC Region I, to Carolyn C. Roberts, Presi.

ManaEer, Nuclear Operations, Omaha Public dent, Copley llospital, forwarding a Notice of Vio-Power District, forwarding NRC Inspection Report lation and Preposed Imposition of Civil Penalty, No. 50-285/92-18, Docket No. 50-285, August 6, ljcense No. 44 -19196-01, Docket No. 030-17125, 1992.'

July 15,1997 '

C-2 Letter from A.11ill llcach, Director, DiYiSion Of C-1 letter from James 1 Milhoan, Regional Adminis-Reactor Projects, NRC Region IV, to W. G. Gates, Division Manager, Nuclear Operations, Omaha

%yy is avaitaue for ins /,nuon or co lmg for a fee in the NRC Pubhc Public Power District, forwarding NRC Inspection Ixcumeni lumm. 2120 Street NW.( smerincl),Washmgton.Dc Report No. 50-285/92-21, Docket No.050-00285, N 55-September 22,1992.'

b

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15 NUREG-0090, Vol.1.. No. 3

toc e onu a n u s ovett Ae ner,ut Atony couussou o nuesTuvu n men m.sps t.y unc. Am vu.

P FK,M 1 t Z hupp i Itev, and Adoordam Num-M.W UlBLIOGRAPHIC DATA SHEET

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< see muztum on t... m.o NUIWG-0090 Vol.15, No. 3 t ont no u,onnt

• " ^ " " " * " ' * " "

lleport to Congtess on Abnormal (kcurrences:

I vr. a July - Septernher 1992 vom n i

1)ccember 1992 4 e vi on camr tuusu4

b. Ao i t tu t t u j b TYPL Of HI PQHI Quarterly r resion covinto orous~a oei.o J uly - September 1992

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Office for Analysis and livaluation of Operational 1)ata U.S. Nuclear lleguLlory Comnussion Washington.1)C 20555 o s no, n uunaw c-m% ano ruo,no an. U.f NRC,16e "Sanw as above"; H cmuscta, provnoe NHC pmsinn, OMKe & beyon, tWONSOHir M OHGMMA DON - tv ME AND ADDRf SS k

)

Same as 8., above a sureu ut u r uw no u s 11 AHS T R ACT (200 wordt or less)

Section 208 of the linergy lleorganization Act of 1974 identifics an abnormal occurrence as an unscheduled incident ot event that the Nuclear llegulatory Commission determines to be significant from the standpoint of public health and safety and tequires a quarterly report of such events to be made to Congress. This report covers the period July thiough Septemt.cr 1992. Two abnormal occurrences involving medical therapy misadministrations at NitC-licensed facilities and one (.xtremity overexposure of a radtographer are discussed in this report. There were no abnormal occurrences at a nuclear power plant. There was one abnormal occurrence reported by NRC's Agreement States.

The report also contains information updating a previously reported abnormal occurrence.

11 AVAILA0!LITY STi.TEMENT

12. KEY WORDSIDESCR:PTo4S (Ust woos or phrat#w th.st wdl assist roseechers 6n locat.rq the report.)

Unlimited

14. ScCuRITY CLASSFICATION Medical Therapy Misadministrations (rnu raio Medical t hagnostic Misadministration Unclassified lixtremity Overexposure of a lladiographer (rhu seporo Unclassified

15. NUMtiEft Or PAGt 5 16 PHICE NHO FOHM 1h Q-69)

t i.

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Printed on: recycled:

paper l'

Feceral Recycling Program u

t

.m-,

DECEMBER 1992 -

- NUREG-4090, Vol.15, No. 3 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES UNITED STATES -

RRST CLASS MAP.

PCSTAGE AND FEES PAfD NUCLEAR REGULATORY COMMISSION--

ussac WASHINGTON, D.C. 20555-0001 PER*.tT NO. G 67 OFFICIAL BustNESS

' PENALTY FOR PRIVATE. USE, $300 g

.........