ML20070N313

Report to Congress on Abnormal OCCURRENCES.July-September 1993

ML20070N313
Person / Time
Issue date:	03/31/1994
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
References
NUREG-0090, NUREG-0090-V16-N03, NUREG-90, NUREG-90-V16-N3, NUDOCS 9405050338
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Text

4 NUREG-0090 Vol.16, No. 3

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Report to Congress on Abnormal Occurrences July - September 1993 U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data p+* " coq, f/

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Available from Superintendent of Documents U.S. Government Printing Office Mail Stop SSOP Washington, DC 20402-9328 A year's subscription consists of 4 issues for this publication.

Single copies of this publication are available from National Technical Information Service Springfic!d, VA 22161

NUREG-0090 Vol.16, No. 3 l

Report to Congress on Abnormal Occurrences July - September 1993 Date Published: March 1994 Omce for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 i

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Abnormal Occurrences,3rd Qtr CY93 Previous Reports in Series i

NUREG 75/090 (January-June 1975), published October 1975.

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

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

NUREG-0090, Vol.16, Nos.1 through 2 (January-March 1993 through April-June 1993), published June 1993 through September 1993.

ii NUREG-0090, Vol.16, No. 3 u

Abnormal Occurrences,3rd Qtr CY93 AllSTRACT Section 208 of the Energy Reorgantzation Act of 1974 that were reported by the Agreement States are also dis-identifies an abnormal occurrence as an unscheduled inci-cussed, based on information provided by the Agreement dent or event that the Nuclear Regulatory Commission States as of November 1,1993. The report also contains determines to be significant from the standpc, int of public information pdating four previously reported abnormal health or safety and requires a quarterly report of such occurrences at NRC-licensed facilities and three reported events to be made to Congress.This report covers the pe-by the Agreement States, and includes information on riod from July 1 through September 30,1993.

two cther events of interest.

This report discusses two abnormal occurrences at NRC-Appendix D has been added to this report which includes licensed facilities. One involved a medical sodium iodide events submitted by Agreement States that are likely to be misadministration and one involved a 1981 fatal radiation categorized as abnormal occurrences. For these events, exposure of a radiographer. One industrial radiographer insufficient information was available as of November 1, overexposure event and four medical misadministrations 1991, to positively identify them as abnormal occurrences.

iii NUREG-0090, Vol.16, No. 3 u__

Abnormal Occurrences,3rd Qtr CY93 CONTENTS Page Abstract iii Preface.........................................................................................

vii I n t rod u ction................................................................................. vil

'Ih e Regu la tory Syst em......................................................................... vil Reportabl e Occu rre nces......................................................................... vii Agre e m e n t S ta t e s.............................................................................. viii Foreign Informat ion............................................................................ viii Reopening of Closed Abnormal Occurrences........................................................ viii Report to Congress on Abnormal Occurrences, July-September 1993......................................

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

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

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

1 93-9 Medie-Sod:um Iodide Misadministration at Osteopathic IIospital Founders Asso' aion DisA (doing business as)Thisa Re Thisa, Oklahoma..........................gional Medical Center in 1

93-10 1981 Fatal Radiation Exposure of a Radiographer in Northeast Oklahoma..................

2 Agre em e n t S tat e Lice nsees...........................................................................

3 AS 93-5 Medical Teletherapy Misadministration at Alta Bates Medical Center in B erk el ey, California............................................................

3 AS 93-6 Overexposure of a Radiographer at X.Cel Group in Corpus Christi, Rxas..............

4 AS 93-7 Medical Radiopharmaceutical Misadministration by " Unspecified Licensee" in Albany, N ew York..............................................................

5 AS 93-8 Medical Sodium Iodide Misadministration at Inland Imaging in Spokan e, Was h in g t on..........................................................

6 AS 93-9 Medical'%letherapy Misadministration by

• Unspecified Licensee"in New York, New York..........................................................

7 References....................................................................................

8 Appendix A - Abnormal Occurrence Criteria.........................................................

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

13 Nuclear Power Plants...................

13 86-15 Differential Pressure Switch Problem in Safety Systems at La Salle Facility..................

13 93-1 Steam Generator Tbbe Rupture at Palo Verde Unit 2...................................

13 v

NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Otr CY93 CONTENTS (cont.)

Other NRC Licensees.....................

...............................14 91-2 Medical Diagnostic Misadministration at Hutzel Hospital in Detroit, Michigan...............

14 93-2 Medical Sodium Iodide Misadministration at Ingham Medical Center in 14 Lansing. Michigan.............................................................

15 Agre em en t Stat e License es.....................................................................

AS 88-5 and 884 Medical'Ibletherapy Misadministrations at Sacred Heart Hospital in Cumberland. Maryland.........................................

15 AS 93-3 Medical B;achytherapy Misadministration at Maine Medical Center 15 in Portland, Main e...............................................................

16 Appendix C - Other Events Of Interest.............................................................

16 O th er NRC Licensees..............................

Medical Misadministration at Veterans Administration Medical Center in Dallas, 'Ibxas............. 16 17 Agre e m e nt S ta t e Licensees......................................................................

Medical Misadministration at Roger Wdliams Medical Center in Providence, Rhode Island..........

17 Appendix D - Agreement State Events Being Considered As Abnormal Occurrences........................

18 PAS 93-1 Medical Brachytherapy Misadministration at Richland Memorial Hospital in Columbia, South Carolina......................................................

18 PAS 93-2 Medical Misadministration at Mayo Clinic in Scottsdale, Arizona...................... 19 f

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l vi NUREG-0090, Vol.16', No. 3

Abnormal Occurrences,3rd Qtr CY93 PREFACE IntrOdUCliOn and safety. Dese events are not reportable as abnormal occurrences but are provided as other events of interest, ne Nuclear Regulatory Commission reports to the Con.

gress each quarter, under provisions of Section 208 of the Appendix D has been added to this report which includes Energy Reorganization Act of 1974, any abnormal occur-events submitted by Agreement States that are likely to be rences involving facilities and activities regulated by NRC.

categorized as abnormal occurrences. For these events, An abnormal occurrence (AO)is defined in Section 208 as insufficient information was available m. time for publica-an unscheduled incident or event that the Commission tion to positively identify them as abnormal occurrences.

determines is significant f om the standpoint of public health or safety.

The Regulatory System Events are currently identified as abnormal occurrences for this report by NRC using the criteria and accompany.

He system oflicensing and regulation by which NRC car.

ing examples listed in Appendix A. These criteria were ries out its responsibilities is implemented through rules promulgated in an NRC policy statement that was puo.

and regulations. in Title 10 of the Code of Federal Regula-lished in the Federal Register on February 24,1977 (Vol.

tions. This includes public participation as an element. 7b 42, No. 37, pages 10950-10952).

accomplish its objectives, NRC regularly conducts licens-ing proceedings, inspection and enforcement activities, ne NRC policy statement was published before licensees evaluation of operating experience, and confirmatory re-were required to report medical misadministrations to search, wbde maintaining programs for establishing stan-NRC. Few of the examples in the policy statement are dards and issuing technical reviews and studies.

applicable to medical misadministrations. Therefore, dur-ing 1984, NRC developed guidelines for selecting such In licensing and regulating nuclear power plants and the events for abnormal occurrence reporting. These guide, uses of byproduct nuclear materials, NRC follows the phi-lines, which have been used by NRC since the latter part losophy that the health and safety of the public are best of 1984, augment the NRC policy statement examples and ensured by establishing multiple levels of protection.

are summarized in Thble A-1 in Appendix A. On January These levels can be achieved and maintained through reg-27,1992, new medical misadministration definitions be.

ulations specifying requirements that will ensure the safe came effective.Therefore, revised guidelines for identify.

use of nuclear materials. The regulations include design ing medical misadministrations as abnorma! occurrences and quality assurance criteria appropriate for the various are currently being developed.The revised guidelines will activities licensed by NRC. An inspection and enforce-be published for comment in the Federal Register.

ment program helps ensure compliance with the regula-tions.

In order to provide wide dissemination of information to the public, a Federal Register notice is issued on NRC li-censee abnormal occurrences. Copies of the notice are Reportable Occurrences distributed to the NRC Public Document Room and al',

Local Public Document Rooms. At a minimum, each no-Actual operating experience is an essential input to the tice must contain the date and place of the occurrence and regulatory process for assuring that licensed activities are describe its nature and pmluhla mquences.

conducted safely. Licensees are required to report certain incidents or events to NRC.This reporting helps to identi-NRC has determined that only those events described in fy deficiencies early and to ensure that corrective actions this report meet the criteria for abnormal occurrence re.

are taken to prevent recurrence.

porting.His report covers the period from July 1 through September 30,1993. Information report'ed on each event For nuclear power plants, dadicated groups have been includes date and place, nature and probable conse-formed both by the NRC and t y the nuclear power indus-quences, cause or causes, and actions taken to prevent re-try for the detailed review of operating experience to help currence.

identify safety concerns early; to improve dissemination of such information; and to feed back the experience into li-appendix B contains updated information on previously censing, regulations, and operations. In addition, NRC reported abnormal occurrences.

and the nuclear power industry have ongoing efforts to improve the operational data systems, which include not Appendix C provides descriptions of events that can be only the type and quality of reports required to be sub-perceived as significant but do not involve a major reduc-mitted, but also the methods used to analyze the data. In tion in the level of protection provided for public health order to more effectively collect, collate, store, retrieve, vii NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 and evaluate operational data, the information is main-States assume regulatory authority over byproduct, tained in computer-based data files.

source, and special nuclear materials (in quantities not ca-pable of sustaining a chain reaction). Agreement State Three primary sources of operational data are Licensee programs must be comparable to and compatible with the Event Reports (LERs) submitted pursuant to 10 CFR Commission's program for such material.

50.73, immediate notifications made pursuant to 10 CFR 50.72, and medical misadministration reports made pur-Presently, information on reportable occurrences in suant to 10 CFR 35.33.

Agreement State licensed activities is publicly available at the State level. For the purpose of developing a nation-Except for records exempt from public disclosure by stat-wide database, Agreement States are encouraged to pro-ute and/or regulation, information concerning reportable vide information to NRC on reportable events.

occurrences at facilities licensed or otherwise regulated by NRC is routinely disseminated by NRC to the nuclear In early 1977, the Commission determined that abnormal industry, the public, and other interested groups as thcse occurrences happening at facilities of Agreement State li-events occur.

censees should be included in the quarterly reports to Congress. The abnormal occurrence criteria included in and other affected or interested groups, and public an-and the Agreement State licensee facilities. Procedures

.j Dissemination includes special notifications to licensees Appendix A are applied uniformly to events at the NRC nouncements. In addition, information on reportable have been developed and implemented, and abnormal oc-events is routinely sent to the NRC's more than 100 Local currences reported by the Agreement States to NRC are Public Document Rooms throughout the United States included in these quarterly reports to Congress.

and to the NRC Public Document Room in Washington, D.C.The Congress is routinely kept informed of report-p able events occurring in licensed facilities.

Foreign Information 4

Another source of operational data is reliability data sub-NRC participates in an exchange ofinformation with vari-mitted by bcensees under the Nuclear Plant Reliability ous foreign governments that have nuclear facilities. This DataSystem(NPRDS). IheNPRDSisavoluntary mdus-foreign information is reviewed and considered in the try-supported system maintamed by the Institute of Nu-NRC's assessment of operating experience and in its re-clear Power Operations (INPO), a nuclear utility orgam-search and regulatory activities. Reference to foreign in-zatton. Both engmeenng and failure data are submitted by formation may occasionally be made in these quarterly ab-nuclear power plant licensees for specified plant compo-normal occurrence reports to Congress; however, only nents and systems. The Commission considers the domestic abnormal occurrences are reported.

NI RDS to be a useful supplement to the LER system for the collection, review, and feedback of operational expe-

'i * ""'

Reopening of Closed Abnormal Occurrences Agreement States NRC reopens previously closed abnormal occurrences if

~

Section 274 of the Atomic Energy Act. as amended, au-significant new information becomes available. Similarly, thorizes the Commission to enter into agreements with previously reported Other Events of Interest items are States whereby the Commission relinquishes and the updated if significant new information becomes available, viii NUR EG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES JULY-SEPTEMBER 1993 Nuclear Power Plants NRC is reviewing events reported at the nuclear power determined that no events were abnormal occurrences, plants licensed to operate. For this report, NRC has Fuel Cycle Facilities (Other than Nuclear Power Plants)

NRC is reviewing events r ported by these licensees. For abnormal occurrences.

this report, NRC has determined that no events were Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)

There are currently over 7,500 NRC nuclear material than five times the intended dose to that body part, should licenses in effect in the United States, principally for the be considered an abnormal occurrence.1 use of radioisotopes in the medical, industrial, and academic fields. Incidents were reported in this category Date and Place-July 27, 1993; Osteopathic Hospital by licensees such as radiographers, medical institutions, Founders Association DBA (doing business as) Tbisa academic institutions, and byproduct material users. NRC Regional Medical Center;1bisa, Oklahoma.

is reviewing events reported by these licensees. For this

)

report, using the criteria and guidelines given in Appendix Nature and Probable Consequences-The licensee A, NRC has identified the following events as abnormal reported that on July 27, 1993, a wrong patient was i

occurrences. As noted in the Preface to this report, the admm, istered 0.21 gigabecquerel (GBq) (5.7 millicuries l

guidelines for identifying medical misadministrations as

[ mci]) of iodine-131 (I-131). On July 27,1993, diagnostic abnormal occurrences are currently being revised.

Procedures were prescribed for two outpatients, patients A and B, using technettum-99m (Ib-99m) for patient A and I-131 for patient B. Prior to the administration, the technologist involved in the procedure believed that patient A was the one prescribed to receive I-131 and addressed patient A by name and requested a second form 93-9 Medical Sodium Iodide of identification. Patient A responded positively and Misadministration at Presented a social security card as the second means of identification. The technologist copied the social security Osteopathic Hospital Founders number and attached it to patient A's chart. However, the Association DBA (doing business written directive was not checked for verification of the patient's name. As a result patient A was administered a as) %1sa Regional Medical o.21 GBq (5.7 mci) dosage of 1-131 intended for patient Center in Wisa, Oklahoma B.

I

'Ihe following information pertaining to this event is also ine definition of a misadministration was revised in 10 CFR 35.2 and being reported concurrently in the fedeml Register.

became effective on January 27,199?. ne revision defines a new Appendix A(see Eventlype 1inThble A-1)of this report tm f maadnuns, trati n in*ns sodium Me. ne exu' tins ab normai occurrence guidelines for misadnumstrations do not include notes that a diagnostic dose of a radiopharmaceutical to a specific examples for these types of misadministrations but are pres-part of the body receiving radiation improperly, if greater ently under revision.

1 NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 The technologist recognized the misadministration within possible violations, and enforcement action is pending minutes of its occurrence and immediately notified the (Ref.1).

nuclear medicine physician. The physician prescribed Ipecac to induce vomiting, which was administered within Future reports will be made as appropriate.

15 minutes of the administration of I-131, and Lugol's solution (potassium iodide) as a blocking agent which was 93-10 1981 Fatal Radiation Exposure admmistered after emesis, approximately 45 minutes after the I-131 administration. The referring physician of a Radiographer in Northeast and patient were notified of the misadministration.

Oklahoma ne licensee reported that the patient received a thyroid in response to a 1993 General Accounting Office report dose of about 1600 centigray (cGy)(1600 rad) as a result of entitled " Nuclear Regulation," NRC conducted a file the misadministration. The patient will be examined review of this previously reported event.

during subsequent follow-up visits to the medical center.

The following information pertaining to this event is also ne NRC staff retained a medical consultant to evaluate being reported concurrently in the Federal Register.

the potential medical effects on the patient as a result of Appendix A (see Example 1 of "For All Licensees")of this the misadministration.The medical consultant estimated report notes that an exposure of the whole body of an that, due to the administration of Lugol's solution, the individual to 250 millisievert (25 rem) or more of radiation dose to the patient's thyroid is in the range of 400-700 cGy can be considered an abnormal occurrence.

(400-700 rad). He medical consultant believes the medical consequences of the misadministration would be Note-This event occurred in January 1981 in Oklahoma, negligible.

and was previously reported to Congress in NUREG-0090, Vol. 4, No. I as an "Other Event of Cause or Causes-10 CFR Part 35 states that individuals Interest." At that time, NRC did not identify the event as under the supervision of authorized users must follow the an AO because it had not been conclusively determined instructions of supervising authorized users and follow that the radiation exposure resulted from material the written radiation safety and quality management subjected to licensing by NRC or by the Agreement procedures established by the licensee. The licensee's States. NRC reevaluated the incident against the AO Quality Management (QM) Program states that " prior to reporting criteria in 1993 and concluded that the event each administration the patient's identity as the individual should be classified as an AO.

named in the written directive will be verified by more than one method." De licensee's program also states Date and Place-January 1981; location determined to be that "The person administering the radiopharmaceutical northeastern Oklahoma based on best available must verify that the type of radiopharmaceutical, the information.

dosage, and route of administration are in accordance with the written directive and check the dosage in a dose Nature and Probable Consequences-On January 22, calibrator." However, the licensee staff failed to check the 1981, the State of Oklahoma notified NRC Region IV that written directive.

an individual had been admitted to the Okmulgee Memorial Hospital, Okmulgee, Oklahoma, with serious Actions Taken to Prevent Recurrence radiation injuries to his chest and left forearm. The individual was later determined to be an unemployed Licensee-The licensee revised the QM procedures to radiographer living in Henryetta, Oklahoma.

prevent recurrence of similar misadministrations. He revisions include the following requirements: (1) the On January 5,1981, an NRC licensee (Bill Miller, Inc.)in prescribing physician must be present at each Henryetta, Oklahoma, reported that a radiographic administration of I-131 dosage for whole body scans; (2) exposure device containing a 1221 gigabecquerel (33 the technologists must double check the curie) iridium-192 source was discovered missing radiopharmaceutical and patient identification against following a quarterly inventory on January 2,1981. He the written directive; and (3) the technologists must cross licensee stated that the device had been stored in a locked check the department's requisition with the name, the enclosure in a company truck while the truck was parked dose, and the patient's identifying documents.

in the back yard of a licensee employee's residence in Henryetta. NRC investigators later noted signs of forced NRC-NRC Region IV conducted an inspection at 'Ibisa entry on the truck's camper shell door and determined Regional Medical Center on August 10-11,1993, to that the theft occurred about December 30,1980. A review the circumstances associated with the search for the missing source by representatives of the misadminMration and its probable cause(s). The NRC licensee and the State of Oklahoma Department of Public staff is currectly reviewing the inspection results for Health was unsuccessful. The licensee subsequently NUREG-0090, Vol.16, No. 3 2

Almormal Occurrences,3rd Qtr CY93 reported on January 5,1981, that the missing source had Region IV was notified that the individual had died of his been anonymously returned intact to a licensee injuries. NRC conducted a second investigation, but no representative's residence.

substantial additional facts were identified.

NRC investigators interviewed the exposed individual.

Cause or Causes-Based on circumstantial evidence, it and he stated that he could not recall how or when he appears that the death was caused by a self-inflicted received the exposure. Medical authorities estimated his exposure to the stolen source. The licensee's security exposure occurred between December 15,1980 and measures were found to meet NRC requirements in 10 January 5,1981. Cytogenetic studies of a sample of the CFR 20.207 and 34.23.

patient's blood indicated that he receied an equivalent whole body dose of 365 centigray (cGy) (365 rad) from Actions Taken to Prevent Recurrence iridium-192 or 405 cGy (405 rad) from cobalt-60. The individual maintained that he had last worked witti a Licensee-NRC documents indicate that no licensee radioactive source during the first week of October 1980 action was warranted or taken.

and that he first noticed an irritation on his chest and arm in November 1980.

NRC-The investigation identified no violations of NRC requirements (Ref. 2,3, and 4).

The exposed individual refused to be interviewed by NHC a second time. He directed that any further contact with This item is considered closed for the purpose of this him be made through his lawyer. On July 27,1981, NRC report.

Agreement State Licensees Procedures have been developed for the Agreement therapeutic procedures, became reportable in California, States to screen unscheduled incidents or events using the as a result of amendments to the regulations effective same criteria as NRC (see Appendix A)and to report the October 5,1989. Misadministrations of machine produced events to NRC for inclusion in these quarterly reports to ionizing radiation are not included in this reporting Congress. During this period, the Agreement States requirement.)

Since no requirement to report reported five events as abnormal occurrences.

misadministrations existed at the time of the event and Information on these events that was provided by the the regulation to report misadministrations, when it Agreement States as of November 1,1993, is included in became effective, did not contain any retroactive this report to Congress.

reporting requirement, ABMC did not violate any regulatory requirements in not reporting the event. It appears that no institutional conspiracy or willful attempt AS 93-5 Medical Teletherapy to mislead the State Regulatory agency existed. Any f C nSP racy or willful failure to provide i

Misadministration at Alta PPear nce complete and truthful information appears to have Bates Medical Center in resulted from miscommunications and misunder-Berkeley, California standings."

In response to an in9uiry in April 1992, from The Plain After review.ng the State's reports of this event, NRC deiermined that this event was an abnormal occurrence.

Dealer, a Cleveland, Ohio, newspaper, the Radiologic Health Branch (RHB) of the State of Caliform,a Appendix A (see event 'lype 5 in 'Ihble A-1) of this report investigated a fatal radiation exposure that occurred in notes that a therapeutic exposure that differs from the 1987 at Alta Bates Medical Center (ABMC)in Berkeley, f nal prescribed treatment by more than 10 percent and Califorma. At the request of the State, NRC assisted in that results in adverse effects worse than would be the investigation. The West Coast Gancer Foundation expected for the normal range of exposures presen' bed, should be considered an abnormal occurrence.

(WCCF), the medical physics consulting firm that planned the radiation therapy treatment that resulted in Date and Place-December 4,1987; Alta Bates Medical the fatal exposure, was not included in this investigation.

Center; Berkeley, California.

The investigation was completed in 1993.

Nature and Probable Consequences-A 9-year-old As a result of this investigation, the State determined that autistic boy was admitted to Childrens Hospital in the event was a misadministration and sent its Oakland, California, for a tonsillectomy. Post surgical investigation reports to NRC. However, the State in its pathological examination identified a cancer of the final report stated "(Note: Medical misadministrations patient's nasopharynx. The patient was given involving radioactive materials used in diagnostic and chemotherapy and was scheduled to receive radiation 3

NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 l

4 therapy at ABMC using a cobalt-60 (Co-60) source of whether the radiation is produced by machine or 186,850 gigabecquerel (5050 Curie).ne treatment was to radioactive matcrials.

be performed at ABMC because Childrens Hospital did Provide investigational techniques for inspectors not have the capability to provide radiation therapy.

who will or might be assigned to investigational l

ABMC used West Coast Cancer Foundation (WCCF), a duties.

medical physics consultant organization, to do treatment Establish mechanisms for NRC support in RHB e

planning. Based on information provided by WCCF, investigations of events of special or joint interest.

radiation therapy treatments began on December 4,1987.

He treatments were temporarily stopped on December Require all individuals and organizations subject to j

e 24,1987, and were to resume in January 1988. However, State regulatory control involving the use of when the patient returned to restart treatment, there had radioactive materials, and/or ionizing radiation been anatomical changes which required treatment producing machines, to report to the State replanning. He replanning was done by the same Regulatory body all lawsuits or malpractice suits dosimetrist that had done the original plan. He alleging injury or improper use of such materials or dosimetrist discovered that an error had been made in machir.es.

planning the first treatment series. He error had resulted in doubling the prescribed dose that the patient was His event will be further evaluated when the information supposed to have received during the initial treatment to prevent recurrence is available.

phase. He fact that an error had occurred was promptly communicated to the r atient's physicians and by them t AS 93-6 Overexposure of a the patient s moth r.".he subsequent prognosis provided by a consultant was grave, the patient was expected to die Radiographer at X-Cel within 2 years. The patient died at Childrens Hospital on Group in Corpus Christi, August 21,1988.

'Ibxas C use or Causes-He cause of the misadministration Appendix A(see Example 1 of"For All Licensees")of this was an error made by a WCCF dosimetrist in plannmg the report notes that an exposure of the feet, ankles, hands, or first radiation therapy treatment series. He error forearms of any individual of 375 rem or more should be resulted in the patient recemng double the prescribed considered an abnormal occurrence.

dose durmg the mitial treatment phase and resulted m adverse health effects.

Date and Place-May 22, 1993; X-Cel Group; Corpus Christi, Thxas.

Actions Taken to Prevent Recurrence Nature and Probable Consequences-On May 22,1993, Licensee-ne State investigation reports that were sent an Agreement State licensee, X-Cel Group, reported a to NRC did not discuss the actions taken by the licensee to radiography event involving a camera locking mechanism prevent recurrence. At the time of this event, the licensee that came apart from the camera.nis allowed the source was not required to report this event as a assembly (pigtail) and 3626 gigabecquerel (98 curic) misadministration, therefore, this information is not iridium-192 source to be pulled from the camera. A available.

radiographer is believed to have picked up the source with the thumb and index finger of his right hand resulting in St:te Agency As a result of the 1993 investigation, RHB an overexposure. An immediate call was made to the newmmended that the State take the following actions to regional State inspector in Corpus Christi requesting an minimize recurrences, and to identify similar occur-investigation of the mcident.

rences. (nese recommendations have not yet been implemented.)

ne incident occurred after midnight on May 22,1993.

ho radiographers working in low light conditions were performing radiography using a Gamma Century Model o

Require certification of specialists m the fields of SA camera. Approximately 30 radiographs had been radiological physics and dosimetry as those fields performed.nc radiographs were taken for development apply to the practice of radiation therapy, or provide and the radiographer took off his film badge and pbced it for State recognit,on of such certification by on his clipboard, thinking the radiography was completed, i

appropriate national or international bodies.

Several shots needed to be retaken, and the radiograp her o

Amend the California Radiation Control Regulations to be consistent with respect to use of 7b move the camera from the first retake location to the radioactive materials and/or ionizing radiation, second retake location, the radiographer took the NUREG-0090, Vol.16 4

N _ __ - __ - __ _ -___-_-__

, No. 3

Abnormal Occurrences,3rd Qtr CY93 crank-out cable in his left hand and lifted the camera with ordinary 3.2 millimeter (1/8 inch) in diameter by 1.0 his right hand. He took a few steps and the cable fell from centimeter (3/8 inch)in long-length roll pins. The specific the camera to the ground. He placed the camera on a reason for inquiring about the dimensions of the roll pins truck tailgate, thinking he had a disconnect. He picked up and the insight (s) obtained from this information were not the crank-out approximately 122 centimeters (cm)(4 ft) provided in the information provided by the State.

from the end, and moved his hand quickly toward the connector end. He grabbed what he thought was the cable This item is considered closed for the purpose of this connector and brought it to within 15 cm (6 in) of his face.

report.

When he realized it was the source, he dropped it, alerted his partner, and ran from the area.

AS 93-7 Medical Radio-A follow-up investigation was performed on May 27,1993.

pharmaceutical A reenactment and radiation exposure calculation Misadministration by mdicated the radiographer received an estimated whole body exposure of 6 millisievert (mSv)(0.600 rem). A worst

" Unspecified Licensee" case extremity exposure to the fingers was estimated to be in Albany, New York 19.25 sievert (1925 rem). At the time, no syrnptoms of radiation injury were noted on the fingers.

Appendix A(see EventType SinThble A-1)of this report notes that administering a therapeutic dose that is greater No dose to the lens of the eyes was estimated because the than 1.5 times the prescribed dose should be considered source was held in proximity of the face for only 1 to 2 an abnormal occurrence.

seconds. However, the State of Tbxas was contacted by NRC to deterrnine the related exposure. NRC was Date and Place-October 5,1992;" Unspecified Facility;"

informed that due to the short duration of exposure, the Albany, New York, dose to the lens of the eyes was estimated to be equal t the whole body dose (6mSv [0.600 rem]).

The name of the licensee was not provided by the State of New York. NRC has asked the State of New York to provide this information, but it has been reported that Cause or Causes,Ihe lock insert of the radiography State law limits its ability to report this information.

camera is held m place by two roll pins. One roll pin was missing, and may have been missing for some time. The NRC legal staff has reviewed the relevant New York State second roll pm, was m the camera housing, but not inside laws regarding disclosure of the identity of facilities in the lock insert. This allowed the lock msert, the spring, which incidents occurred warranting reporting as and the movable insert to be pulled from the lock box.The abnormal occurrences. The New York State Public drive cable was connected to the pigtail, and when the k)ck Health Law provides that "any incident reporting insert pulled from the kick box, the dnve cable pulled the requirement imposed upon diagnostic and treatment pigtail from the camera, thereby exposing the source.

centers...shall be kept confidential and shall not be Routine maintenance had been performed on the camera, released..." (NY CIS Pub Health, Article 28, Section but a missing roll pin is not readily noticeable during 2805-M.)1hc only exceptions provided in the law are routine maintenance. 'I,wo radiographers operated the release to the NYS Health Department or to other camera immediately prior to the meident without any hospitals. Discussions with the staff and attorneys for the difficulty.

NYS Health Department indicate that the department will provide a description of the incident but will delete Actions Taken to Prevent Recurrer,ce the identity of the facility and patient. The NRC Office of General Counsel advises that NRC is not itself bound by Licensee-The radiographer who was exposed was this State law so NRC could release the information if the restricted from conducting radiation work. All personnel State provided it to NRC. However,if the State refuses to were informed that future failure to wear a film badge provide it to the NRC, there is na c(mflict with Federallaw would result in termination of employment. A letter was because the abnonnal occurrence reporting requirement, sent to sub-offices and other radiography licensees in the Section 208 of the Energy Reorganization Act of 1974, area describing the incident.

does not apply to Agreement State licensees nor Agreement State agencies. However,if investigation of State Agency-A Notice of Violation was sent to the the incident results in enforcement action, then the licensee and radiographer for an extremity exposure in information provided to NRC regarding the abnormal excess of 187.5 mSv (18.75 rem) and failure of the occurrence will be updated to include the enforcement radiogra; her to wear personnel monitoring. The action and since that is public information, the identity of manufacturer was questioned about the pins, which are the facility would be provided at that time.

5 NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Otr CY93 Nature and Probable Consequences-A patient was than 5 times the prescribed dose should be considered an administered 303.4 megabecquerel (MBq) (8.2 millicuric abnormal occurrence?

[ mci])of phosphorus-32(P-32),instead of the presenhed Date and Place-December 14, 1992; Inland Imaging; 185 MBq (5 mci) of P-32, as an outpatient recching Spokane, Washington.

radiation therapy treatment. He patient was discharged in stable condition. De attending physician and the Nature and Probable Consequences-A patient that was patient were notified of the misadministration.

prescribed a diagnostic thyroid procedure using 0.26 to 0.37 megabecquerel (MBq) (0.007 to 0.010 millicurie

[ mci]) of iodine-131 (I-131) erroneously received 1%.1 Cause or Causes-Insufficient information is available on MBq (5.3 mci) of I-131. As a result, the licensee stated the cause(s) of this event. NRC has asked the State of New that the patient's thyroid received a dose of approximately York to provide additional information regarding the 7950 centigray (7950 rad). NRC has asked the State of cause(s)of this event.

Washington to identify if the patient had borderline hypothyroidism prior to the misadministration.

As of February 3,1994, it was known that the State of New He licensee reported tinat both a whole body scan and the York informed NRC that it will provide the requested requested thyroid uptake study were performed 3 days information on the causes of this abnormal occurrence after the misadmmistration "with no patient complaints or immediate side effects. No NRC or State medical j

within 30 days.

consultant was retamed to evaluate this event.

The referring physician and the patient were notified of Actions Taken to Prevent Recurrence the misadministration.

Cause or Causes-Based on information relating to the Licensee-The corrective actions reported by the actions taken, it was determined that the nuclear licensee included modifying the radiopharmaceutical medicine technologist misinterpreted the orally therapy protocol for P-32 and iodine-131 administrations, requested procedure and failed to review the referring and providing training for the technologists. In addition, a physician's written directive.The licensee stated that this work sheet was developed for P-32 therapy and the event was attributed to human error as a result of the physician involved in the procedure was counselled.

technologist's inattentiveness and relatively short work experience, and that the patient will most likely develop a hypothyroidism.

State Agency-Insufficient information is available on the Actions Taken to Prevent Recurrence action (s) taken by the State Agency to prevent recurrence. NRC has asked the State of New York t provide additional information regarding the State L.icensee-The technologist involved in the procedure and the chief technologist were counseled and Agency,s action (s).

reinstructed by the physician designated as the authorized user and by the Radiation Safety Officer. In addition, the As of February 3,1994, it was known that the State of New licensee stated that in the future, all sodium iodide York informed NRC that it will provide the requested pr cedures will be required to be verified against the information on the likelihood of harmful effects to the wntten directive pnor to admmistration.

patients within 30 days.

State Agency-De State Agency informed NRC that it will review the cause of this event ed hit r.r.y This event will be further evaluated when additional necessary actions. NRC has asked the State of information becomes available.

Washington to provide additional information regarding the State. Agency s action (s).

This event will be further evaluated when additional AS 93-8 Medical Sodium Iodide information becomes available.

Misadministration at Inland Imaging in Spokane,

• fte definition of a misadministration was revised in 10 CFR 35.2 and Washington became effective on nouary n, m2. ne revision defines a new type of misadministration involving sodium idodide. De existing ab.

normal occurrence guidelines for misadministrations do not include Appendix A(see Event'I)pe 4 in'Pable A-1)of this report specific examples for these types of misadministrations but are pres.

notes that administering a diagnostic dose that is greater ently under revision.

NUREG-0090, Vol.16, No. 3 6

Abnormal Occurrences,3rd Qtr CY93 AS 93-9 Medical %1etherapy occurrence will be updated to include the enforcement action and since that is public information, the identity of M.isadministration by the facility would be provided at that time.

" Unspecified Licensee" Nature and Probable Consequences-Cobalt-60 in New York, New York teletherapy treatments of 200 centigray (200 rad) each were to be administered to the right axilla of a patient.

Appendix A(see Event Type 3 inThble A-1)of this report However, the first five treatments were given to the left notes that administering a therapeutic dose to a part of axilla in emr. NRC has asked the State of New York to the body not scheduled to receive radiation should be Provide additronal information regarding the treatment considered an abnormal occurrence.

plan and the admuustered doses.

DIte and Place-July 11,1992; " Unspecified Facility";

Cause or Causes-Insufficient information is available to New York, New York.

identify the cause(s) of this event. NRC has asked the State of New York to provide additional information The name of the licensee was not provided by the State of regarding the cause(s) of this event.

New York. NRC has asked the State of New York to provide this information, but it has been reported that As of February 3,1994, it was known that the State of New State law limits its ability to report this information.

York informed NRC that it will provide the requested information on the causes of this abnormal occurrence NRC legal staff has reviewed the relevant New York State within 30 days.

laws regarding disclosure of the identity of facilities in which incidents occurred warranting reporting as Actions Taken to Prevent Recurrence abnormal occurrences. The New York State Public Health Law provides that "any incident reporting Licensee-Insufficient information is available on the requirement imposed upon diagnostic and treatment action (s) taken by the licensee to prevent recurrence, centers...shall be kept confidential and shall not be NRC has asked the State of New York to provide released..."(NY CLS Pub Health, Article 28, Section additional information regarding the licensee's action (s).

2805-M.)'Ihe only exceptions provided in 'he law are release to the NYS Health Department or to other State Agency-insufficient information is available on the hospitals. Discussions with the staff and attorneys for the action (s) taken by the State Agency to prevent NYS Health Department indicate that the' department recurrence. NRC has asked the State of New York to will provide a description of the incident but will delete provide additional information regarding the action (s) the identity of the facility and patient. The NRC Office of taken to prevent recurrence. The State was also asked to General Counsel advises that NRC is not itself bound by verify that the referring physician and patient were this State law so NRC could release the information if the notified.

Stateprovidedit toNRC. Howevar,if theState refusesto provide it to the NRC, there is no t onflict with Federal law As of February 3,1994,it was known that the State of New because the abnormal occurrence reporting requirement, York informed NRC that it will provide the requested Section 208 of the Energy Reorganization Act of 1974, information on the likelihood of harmful effects to the does not apply to Agreement State licensees nor patients within 30 days.

Agreement State agencies. However, if investigation of the incident results in enforcement action, then the This event will be further evaluated when additional information provided to NRC regarding the abnormal information becomes available.

7 NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 REFERENCES 1.

Reports from Osteopathic Hospital Founders Safety Branch, Region IV, dated February 18, Association DB A (doing business as) Thisa Regional 1981."

Medical Center in Thisa, Oklahoma (Docket No.

030-02893), submitted to NRC on July 30,1993, and August 10,1993, in accordance with 10 CFR 35.33.*

4.

Memorandum from Karl V. Seyfrit, Director, Office of Inspection and Enforcement, NRC Region IV, to 2.

NRC Investigation Report No. 030-15283/81-01 Victor Stello, Jr., Director, Office of Inspection and dated April 21,1981."

Enforcement, NRC Headquarters, dated August 14, 1981."

3.

Memorandum from C. L Cain, Radiation Specialist, to Glen D. Brown, Chief, Fuel Facility and Material

" A copy is available for inspection, or copying for a fee,in the NRC

• A copy is available for inspection, or copying for a fee,in the NRC Public Document Room,611 Ryan Plaza Drive, Suite 400, Arling-Public Document Room. 21201.Strect NW. (Imer level), Washing-ton,'Ihas 76011.

ton, DC 20555.

l NUREG-0090, Vol.16, No. 3 g

Abnormal Occurrences,3rd Qtr CY93 APPENDIX A ABNORMAL OCCURRENCE CRITERIA

'Ihe following criteria used to determine abnormal (b) release of radioactive material from a package in occurrence (AO) were set forth in an NRC policy amounts greater than the regulatory limit.

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

5.

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

reduction in the degree of protection of the public health g

g or safety. Such an event would involve a moderate or i

M bd mM w h8e of a more severe impact on the public health or safety and could include but need not ba limited to:

facility.

7.

Any substantiated loss of special nuclear material or 1.

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

Major degradation of essential safety-related accountability system.

equipment; or 8.

Any substantial breakdown of physical security or 3.

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

weakened the protection against theft, diversion, or sabotage.

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

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

detail using these criteria are:

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

1.

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

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

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

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

2.

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

1.

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

3.

The release of radioactive material to an unrestricted area in concentrrtions which, if 2.

Major degradation of fuel integrity, primary coolant averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 500 times pressure boundary, or primary containment the regulatory limit of Appendix B, Table II,10 CFR boundary.

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

3.

Loss of plant capability to perform essential safety 4.

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

9 NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 4.

Discovery of a major condition not specifically For Fuel Cycle Licensees considered in the Safety Analysis Report (SAR) or Tbchnical Specifications that requires immediate 1.

A safety limit of license Tbchnical Specifications is remedial action, exceeded and a plant shutdown is required [10 CFR 50.36(c)).

5.

Personnel error or procedural deficiencies that 2.

A major condition not specifically considered in the result in loss of plant capability to perform essential safety analysis report or'lbchnical Specifications that safety functions such that a potential release of requires immediate remedial action.

radioactivity in excess of 10 CFR Part 100 guidelines could result from a postulated transient or accident 3.

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

function.

Medical Misadministrations As discussed in the Preface to this report, the NRC policy the NRC policy statement.

statement on AOs was published before licensees were required to report medical misadministrations to the NRC. nerefore, during 1984, NRC developed guidelines As noted in the Preface, revised guidelines are currently for selecting such events for AO reporting. These being developed because new medical misadministration guidelines, which are summarized in'Thble A-1, augment definitions became effective on January 27,1992.

NUREG-0090, Vol.16, No. 3 10

d Abnormal Occurrences,3rd Qtr CY93 4

Table A.1 NRC Guidelines for Selecting Medical Misadministration Events for Abnonnal Occurrence (AO) Reporting AO Reporting Threshold Event Type Diagnostic Exposure Therapeutic Exposure (1) Administering a radiopharma-If the improper administration if theimproperadministration ceutical or radiation from a results in 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 d

greater than five times improperly would have the upper limit of the received radiation anyway, normal range of had the proper administration exposures prescribed been used, an AO report for diagnostic procedures should be proposed if:

involving that body part, or (b) there are clinical (a) the actual dose is greater indications of any than 1.5 times that intended adverse health effects to the above 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, receivcd radiation anyway, had t.he proper adminis tration (c) the above described body ptrts 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 'Ippe 1.

Event 'lype 1.

11 NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 Table A 1(Continued)

AO Reporting Threshold Event Type Diagnostic Exposure Therapeutic Exposure route of administration other than that intended by the prc-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 i

of exposures prescribed for l

the diagnostic procedure.

(5) Admmistering a Not applicable.

An AO report should be therapeutic dose of proposed if:

a radiopharmaceutical differing from the prescribed (a) the actual dose is grcater dose by more than 10 percent; than 1.5 times the prescribed or administering a therapeutic dose,or, radiation dose from a scaled source such that errors in the (b) the actual dose is less than source calibration, time of 0.5 times the prescribed exposure, and treatment dose, or geometry result in a calculated total treatment dose differing (c) the event results in adverse from the final prescribed health effects worse than total treatment dose by more would be expected for the than 10 percent.

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

(6) Recurring or series For either diagnostic or therapeutic exposures, an AO report of events (regardless should be proposed for recurring events or a series of events of the number of (in which each individual misadministration is not of major patients or facilities importance) that create a significant public health or safety involved).

concern.

(7) Generic events.

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

NUREG-0090, Vol.16, No. 3 12

i Abnormal Occurrences,3rd Qtr CY93 1

1 1

APPENDIX B 1

UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES m

During the July through September 1993 period, NRC provide the initial and any subsequent updated licensees, AgreementStates, AgreementStatelicensees.

information on the abnormal occurrences discussed. (The i

j and other involved parties, such as reactor vendors and update provided generally covers events that took place architect-engineering firms, continued with the during the report period; some updating, however, may be i

implementation of actions necessary to prevent more current as indicated by the associated event dates.)

recurrence of previously reported abnormal occurrences.

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

Nuclear Power Plants 86-15 Differential Pressure Switch BFN, Units 1 and 3 were in an extended shutdown at the time the status of IE Bulletin (IEB) 86-02 closecut was Problem in Safety Systems at issued. These units were shutdown in March of 1985 and La Salle Facility will continue to remain shutdown for some time to come.

Prior to authorizing resumption of power operation, the staff will confirm that the 7bnnessee Valley Authority This abnormal occurrence was originally reported m.

(IVA, the licensee) has adequately resolved staff 4

NUREG-0090, Vol. 9, No. 3, " Report to Congress on concerns regarding the use of SOR switches. TVA's Abnormal Occurrences," July-September 1986. He original response to IEB 86-02 was dated July 20,1987.

g event involved degradation of essential safety-related The staff closed out IEB 86-02 for BFN, Unit 2 in j

switches used to initiate operation of engineered saf Inspection Report 50-260/88-28 dated December 9,1988.

f systems.

I Since only two units are not closed out, and the projected restart dates for BFN, Units 1 and 3 are well into the The im.tial report mvolved problems with reactot future (late 1998 and September 1995, respectively), no f

water level switches at la Salle Unit 2. NRC t' further updates are planned. This completes the Bulletin 86-02 on July 18,1986, which required owners of discussion regarding SOR switches and the item is facilities usmg the affected switches m safety systems t considered closed for the purposes of this report.

i take actions to assure reliability of operation. The i

majority of licensees did not have the switches of concern.

Acceptable actions have been implemented and verified 93-1 Steam Generator 'Ibbe i

at all other operating power reactor facilities. Status of Rupture at Palo Verde Unit 2 the closeout effort for this problem is documented in NUREG/CR-5294, "Closecut of IE Bulletin 86-02:

This abnormal occurrence was originally reported in 4

Static "O"

Ring Differential Pressure Switches,"

NUREG-0090, Vol.16, No.1, " Report to Congress on i

published in October 1989. Closeout was complete at all Abnormal Occurrences," January-March 1993.

I facilities except Oyster Creek and Browns Ferry Nuclear Plant (BFN), Unit 1 and Unit 3.

As previous'y sported, on March 14,1993, at 4:34 a.m.,

I while at 98/s pctcent power, the unit experienced a tube rupture in staasa generator (SG) No. 2. An Augmented The interim response for Oyster Creek was acceptable.

Inspection'Ibam (AIT) was sent by the NRC to investigate 1

I This was documented in NRC Inspection Report the event. The AITidentified weaknesses in the licensee's 50-219/89-14. In a June 11, 1991, letter to NRC, the implementation of emergency plan actions, including licensee stated that the setpoint drift of the static "O" ring event classification, activation of the emergency response

]

(SOR) switches was acceptable and the switches being facilitics, and promptly determining accountability for considered as possible replacements did not offer on-site personnel. Weaknesses were also found in the improved performance. SOR switch performance data procedures, equipment, and training associated with training plans were reviewed by the NRC staff. Adequate responding to a SG tube rupture event. The AIT report, instructions, guidance and compensatory actions in the documented in NRC Inspection Report No.

event of a switch failure were prov ded; therefore, the 50-529/93-14, was issued on April 16,1993.

i staff concluded that the concerns had been adequately addressed. This is documented in Inspection Report On July 22,1993, NRC issued Information Notice 93-56, 50-219/92-19.

" Weakness in Emergency Operating Procedures Found as l

13 NUREG-0090, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 documented in NRC Inspection Report No.

He licensee issued a response to the NRC Confirmatory 50-529/93-14, was issued on April 16,1993.

Action Letter on July 18,1993, providing a Unit 2 Steam Generator 'Ibbe Rupture Analysis Report, and the On July 22,1993, NRC issued Information Notice 93-56, licensee's basis for restart of the facility. The report

" Weakness in Emergency Operating Procedures Found as concluded that the damage mechanism for the steam Result of Steam Generator 'Ibbe Rupture," to all generator tubes was-inter-granular attack and pressurized water reactor licensees. Enforcement action inter-granular stress corrosion cracking caused by a resulting from the AIT in the area of emergency caustic-sulfate environment, crevice formation, and preparedness was issued as Severity Level IV (Severity residual and applied stresses. The NRC issued the Safety LevelsI through V range from the most significant to the Evaluation Report, and a Request for Information least significant, respectively) violations by NRC pursuant to 10 CFR 50.54(f), to tie licensee, by letter Inspcetion Report No. 50-529/93-28, dated July 1,1993.

dated August 19,1993, concluding that Unit 2 could safely The heensee responded by letter dated July 30,1993, with resume operation for 6 months before the next steam an admission of the violations and a corrective action plan.

'IWo Severity Level IV violations were issued m, NRC Benerator tube inspection. He licensee restaned the Inspection Report 50-528/529/530/93-29, related to facility on August 27, 1993, and achieved 100 percent chemistry and radiation monitoring concerns following Power on September 6,1993. The licensee has since the SG tube rupture event. In addition, two Severity Level determined that reducing power to 85 percent will IV violations were identified in NRC Inspecti vt Report minimize further tube degradation, pending further 50-528/529/530/93-35, related to the review of SG crack evaluation during a mid-cycle outage scheduled for growth rates and Emergency Operating Procedures January 1994. This item is considered closed for the inadequacies.

purposes of this report.

Other NRC Licensees 91-2 Medical Diagnostic 93-2 Medical Sodium Iodide Misadministration at Hutzel Misadministration at Ingham Hospital in Detroit, Michigan Medical Center in Lansing, Michigan his abnormal occurrence was originally reported in This abnormal occurrence was originally reported in NUREG-0090, Vol.19, No.1, " Report to Congress on NUREG-0090, Vol.16, No.1, " Report to Congress on Abnomal Ocanences: January-March 1993." The Abnormal Occunences," January-March 1991. The a n Na CNnenCC rePon is updated as foHow abnormal occurrence report is updated as follows:

In May 1992 a patiem received a whole body scan using iodine-131 (I-131)instead of a thyroid scan, which uses technetium-99m. The misadministration occurred On January 17, 1991, a patient received a dosage of because of an apparent misunderstanding during a iodine-131 in a diagnostic procedure that was 100 times telephone conversation between the referring physician's greater than the dosage prescribed office and a technologist at Ingham Medical Center.

On September 9,1993, NRC issued a notice of violation and proposed imposition of a fine for $11,250 to the This misadministration was caused by a modification of licensee. The licensee was cited for failing to have the the intended diagnostic procedure as a result of a h

P ysician authorized to use radioactive materials prepare dinussion between the physician's assistant and the a written Sective as required for the dosage of I-131 nuclear medicine technologist. He modification was not inv Ived in a whole body scan and for failing to follow the reviewed or approved by the patient's physician.

hospital's wn,tten mstruction that I-131 whole body sans be used only for patients who had their thyroids removed.

Since the patient in this case had an intact thyroid, the whole body I-131 scan should not have been performed.

No enforcement action was taken.Ris item is considered This item is considered closed for the purpm of this closed for the purpose of this report.

report.

NUREG-0090, Vol.16, No. 3 14

Abnorraal Occurrences,3rd Qtr CY93 l

l i

l Agreement State Licensees AS 88-5 AS 93-3 Medical Brachytherapy and 88-6 Medical'Ibletherapy Misadministration at Maine Misadministrations at Medical Center in Portland, Sacred Heart Hospital in Maine Cumberland, Maryland This abnormal occurrence was originally reported in l

l These abnormal occurrences were originally reported in NUREG-0090, Vol.16, No. 2, " Report to Congress on l

NUREG-0090, Vol.11, No.4, " Report to Congress on Abnormal Occurrences," April-June 1993.The abnormal l

Abnormal Occurrences," October-December 1988.The occurrence is updated as follows:

l abnormal occurrences are updated as follows:

The State of Maine has reviewed and approved the l

corrective actions taken by the licensee as a result of this l

NRC is continuing to work with the State of Maryland to misadministration.The State Agency considers this c' se a

obtain more information regarding these occurrences.

closed.

i i

15 NUREG-0090, Vol.16, No. 3

l Abnormal Occurrences,3rd Qtr CY93 l

i APPENDIX C OTHER EVENTS OF INTEREST Re following items are described because they may in the level of protection provided for public health or I

possibly be perceived by the public to be of health or safety safety; therefore, they are not reportable as abnormal significance. The items did not involve a major reduction occurrences.

Other NRC Licensees Medical Misadministration at directive. The NRC inspector noted that the written directive associated with this case differed from all other Veterans Administratm.n Medical written directives completed by the licensee's authorized Center in Dallas, Texas users in that the dose to be administered to the tumor site was apparently not specified and that the treatment was the first of this type completed by the licensee's staff. Due On February 11,1992, a misadministration occurred at the to the fact that key individuals involved with this case were Department of Veterans Affairs, Veterans Administra-n I nger available at the licensee,s facility and the tion Medical Center in Dallas,'Ibxas.

licensee was unable to contact them regarding the case, the licensee was unable to contribute further information ne misadministration involved administration of which may have assisted in determining the direct cause.

radiation using a cobalt-60 teletherapy unit for a During the interval between May 1992 and August 1993, treatment which was mitiated on February 11,1992, for the licensee developed a new Quality Management (QM) the lower extremities. The total treatment dose Program which was reviewed during the inspection. The admm, istered to the patient, as calculated during the NRC new QM Program was an improvement over the program inspection, was 18 percent greater than the prescribed which existed at the time of the misadministration, and dose for the legs, and 4 to 6.5 percent less than the appeared to have incorporated policies and procedures prescribed dose for the anterior and posterior feet. The that would be more easily implemented by the staff and difference

• if etween the admmistered total dose and the which included additional controls to ensure that prescribed total dose for each treatment field did not radiation was administered in accordance with a written meet the criteria defined in 10 CFR 35.2 for a directive. In addition, during this interYal, the licensee misadmuu,stration. However, the dose admimstered to experienced changes in managers, authorized users, and the lower legs during the third week of treatment was physicists involved with the teletherapy program and the approximately 209 percent of the prescribed weekly dose individuals in place at the time of the inspection appeared (626 centigray [cGy] [626 rad] versus the prescribed 300 to be more closely involved with the program.

cGy [300 rad]). The difference between the administered dose for the legs during the third week of treatment and the prescribed weekly dose met the criteria defined in 10 Following the inspection, NRC requested that a medical CFR 35.2 for a misadministration in that the calculated consultant review the case to evaluate the potential weekly administered dose.was more than 30 percent consequence (s) to the patient.The consultant is currently greater that the prescribed weekly dose.

coatinuing his review. NRC also conducted an enforcement conference with the licensee on September The direct cause of the misadministration could not be 22, 1993, to review the findings of the inspection, determined during NRC inspection because the licensee's including a substantial failure to implement the QM physicist and physician were no longer employed by the program. NRC also discussed with the licensee patient licensee and were unavailable for interview. In addition, notification requirements and requested that the licensee there was insufficient information recorded in the provide notification regarding this issue as requested in 10 patient's treatment chart about the physician's specific CFR 35.33. NRC staff is still reviewing information intentregardingtreatmentsetup Onecontributingfactor provided by the licensee during the enforcement in this case appeared to be an inconsistency in the format conference to determine the apprcpriate enforcement used for prescribing radiation treatment in the written action and the status of patient notification.

NUREG-0090, Vol.16, No. 3 16 1

i Abnormal Occurrences,3rd Qtr CY93 Agreement Stata Licensees Medical Misadministration at and it was not anticipated that there would be two

'"PS"' **'

Roger Williams Medical Center in Providence, Rhode Island b.

The vial label was not read carefully by the technologist reparing the dose, ne label on the On May 27,1992, a patient was scheduled to receive a 0.26 vial stated that tu capsules were contained in the vial.

gigabecquerel (GBq) (7.0 millicuric [ mci]) therapy dose l

of iodine-131 orally in a capsule. He order was received The dose, calibrator check was done with the two l

c.

from a radiopharmacy on May 27,1992, and was assayed while still in the vial as 0.26 GBq (7.0 mci). One capsule capsules m the shipping vial before dispensing the dose.

was administered to the patient. He lead vial containing the capsule was placed in the storage area.

d.

Since one capsule was wedged between the vial wall and a desiccant packet, only one capsule came out On July 10, while disposing of lead containers, it was when the vial was inverted.

i discovered (by the sound of something rattling around in the container) that a capsule remained in the vial. The The licensee stated that the referring physician will order capsule was assayed, and by decay corrections it was a diagnostic test to determine if the dose delivered to the determmed that the prescribed dosage was originally tobe patient was adequate to perform the treatment desired.

delivered as two capsules, each being 0.13 GBq (3.5 mci).

The licensee added that there would be no harm to the The referring physician was notified.

patient due to receiving only 50 percent of the prescribed l

dose, and the referring physician assured the Radiation On July 13, the hospital's Radiation Protection Office was Safety Office that he will continue to assess the treatment notified of this situation by a Radiation incident Report.

efficacy

• The Radiation Safety Officer (RSO) investigated the cvent, and determined on July 29 that the event met the The authorized user instructed the Nuclear Medicine criteria for a misadmmistration. On July 29,1992, the staff to a) read all labels carefully to check the dosage by RSO called the State Radiation Control Agency,but was volume and the number of capsules, b) label the top of the not successful in communicatmg with officers m that v al with the dosage and number of capsules, and c) assay agency. On July 30, notification of this misadministration the vial in the dose calibrator immediately after was made by telephone to the Radiation Control Agency.

administration to determine if the entire dose was administered. Administering physicians were instructed This misadministration was determined to have occurred to double check the labels.

for four reasons:

The patient was not notified of this misadministration a.

The capsule activity ordered (0.26 GBq [7.0 mci])

because it was felt that the dose administered would be had always been delivered in one capsule in the past sufficient to accomplish the planned treatment.

17 NUREG4X)90, Vol.16, No. 3

Abnormal Occurrences,3rd Qtr CY93 APPENDIX D AGREEMENT STATE EVENTS BEING CONSIDERED AS ABNORMAL OCCURRENCES For this report, NRC is considering two events subnnsted The entire applicator system was then unloaded and by Agreement States as abnormal occurrences.

returned to the brachytherapy vault where all of the Information on these events that was provided by the sources were accounted for. A radiation survey of the Agreement States as of November 1, 1993, was patient's room after the unloading showed na additional i

insufficient to positively identify them as abnormal sources in the patient's room.

occurrences. When the necessary information becomes available they will be included in future reports.

In an effort to determine the length of time that the source was out of place, several people were interviewed.

The patient was asked and did not know how the source cald have gotten out of the appHeatorme nurse, who 2 PAS 93-1 Medical Brach)' therapy days earlier loaded the Cs-137 sources into the patient's Misadministration at applicators, said that there was nothing unusual about Richland Memorial Hospital that loading and that she was confident that she had loaded the applicator properly.

in Columbia, South Carolm, a The patient's radiation oncologist said that he had checked the applicator after the insertion and each The necessary information to determine if a misadministration and/or an abnormal occurrence had morning and evening of the treatment and had noticed occurred was not discussed in the event description nothing unusual or any loose sources. His most recent provided by the State. NRC has asked the State of South visit was at 8:00 a.m., on the morning of September 24, Carolina for the necessary information to determine if 1992. The attending nurse said that she had checked the this event is a' misadministration and/or an abnormal Patient and noticed nothing until the morning of occurrence.

September 24,1992, when she went to help the patient with the bed pan. Upon discovery of the sources, she then contacted radiation oncology. She said that the patient Date and Place-September 24,1992; Richland Memorial had been on the bed pan several times during her Hospital; Columbia, South Carolina.

treatment, and that she had checked under the patient and did not see any sources. The chief resident of Nature and Probable Consequences-A radiation gynecological services checked the patient during oncology nurse notified the Radiation Safety Officer that treatment but did not manipulate the applicator, she retrieved a 1.1 gigahecquerel (GBq) (30 millicurie

[ mci]) cesium-137 (Cs-137) source from a female NRC has asked the State of South Carolina to determine patient's bed. The patient eventually developed an the exposures to the attending and oncology nurses, to ulceration beneath her right thigh as a result of being identify the dose to the wrong treatment site, and to verify exposed to this source.

that the referring physician and patient were notified of the misadmtmstration.

The oncology nurse stated that the attending nurse was Since the nurse who inserted the Cs-137 sources insisted putting the patient on a bed pan when she discovered the that she inserted them properly, and that the physician source and contncted the oncology nurse. The licensee had just checked the patient that morning and saw stated that the patient was undergoing a 42-hour Cs-137 nothing, the time of source removal was estimated to be brachytherapy treatment using an applicator. The about 8:00 a.m.

applicator contained three sources of 1.39,0.93, and 0.93 GBq (37.5,25, and 25 mci) of Cs-137. Each of the two This was to be the patient's first of two treatments, and the ovoids were to have one 1.39 GBq (37.5 mci) source.

dose deficit could be made up with the subsequent However, one ovoid applicator was found empty. NRC treatment.

has asked the State of South Carolina to provide clarification and additional details on the treatment plan The licensee stated that this event does not meet the including the sources used, the planned exposure time, State's criteria for a misadministration because if the l

the planned dose schedule, the intended dose, and the source was removed sometime after 8:00 a.m. the dose dose received up to the time of the incident.

could be corrected with the subsequent treatment.

NUREG-0090, Vol.16, No. 3 18

Abnormal Occurrences,3rd Otr CY93 However, NRC does not have sufficient and accurate After the administration, the technologist measured the information to verify this and to complete an analysis, residual activity in the syringe and found it to be 3.70 MBq (0.100 mci). which is approximately 10 percent of the Cause or Causes-The licensee stated that either the reported drawn dose. In a final statement on the dose source fell out of the applicator as it was being inserted received by the patient, the State indicated that the and it was not noticed, or a person on the staff opened the dosage administered was estimated to be 29.75 MBq applicator out of curiosity and improperly reinserted the (0.804 mci) of I-131 MIBG. NRC has asked the State of source in a loose manner.

Arizona to provide a clarification on the estimated dosage administered to the patient.

Actions Taken to Prevent Recurrence The report, provided by the State, also explained that the Licensee 'Ib prevent recurrence of this event, the, technologist involved in the procedure assumed that the nursing staff was given refresher radiation safety vial containing MIBG contained only the prescribed instruction regarding the use of radioactive sources for dosage and drew-up the entire volume of the vial. The cancer treatment, patient's name and clinic number were also verified with the written directive.

State Agency-Insufficient information is available on the action (s) taken by the State Agency to prevent The, patient was administered Lugol's solution the recurrence. NRC has asked the State of South Carolina to previous day and again on the day of the procedure to provide additional information regarding the State minimize thyroid exposure. The patient was also agency's action (s).

instructed to complete a bowel preparation procedure to minimize exposure to the abdominal area. The lead This event will be further evaluated when additional technologist and the Radiation Safety Officer were information becomes available.

notified of this incorrect administration.He exposure to the thyroid was not discussed. NRC has asked the State of Arizona to provide additional information regarding PAS 93-2 Mev... cal Misadnu.. trat. ion exposure to the thyroid.He State was also asked to verify nis at Mayo Clinic in Scottsdale, that the referring physician and patient were notified.

Arizona Cause or Causes-%e cause for administering an incorrect dose was not discussed in the description of the A dose of iodine-131 (1-131) meta-nodo-benzyl guanidm.e event provided by the Agreement State. NRC has asked (MIBG), suspected to be at least 60 percent greater than the State of Arizona to provide additional information the prescribed dose, was reported to be admmistered to a regarding the cause(s) of this event.

patient. If this dosage was admimstered for therapeutic purposes, it would exceed the criteria in Appendix A, Actions Taken to Prevent Recurrence Event Type 5, the administration of a therapeutic dose greater than 1.5 times the prescribed dose. NRC has asked Licensee-ne actions tal:n by the licensee to prevent the State of Arizona for the necessary information to recurrence of a similar event as described above were not determine if this event is an abnormal occurrence.

discussed in the event description provided by the Agreement State. NRC has asked the State of Arizona for Date and Place-September 8,1992; Mayo Clinic; this information regarding licensee's action (s).

Scottsdale, Arizona.

State Agency -The actions taken by the appropriate State Nature and Probable Consequences-The report r.nency to prevent recurrence of a similar event as submitted by the State of Arizona stated that a patient was described above was not discussed in the event description administered approximately 44.4 megabecquerel (MBq) provided by the Agreement State. NRC has asked the (1.2 millicurie (mci]) of I-131 MIBG, instead of the State of Arizona to provide additional information prescribed 18.5 MBq (0.500 mci) dosage of I-131 MIBG.

regarding the State agency's action (s).

(MIBG is a radiopharmaceutical that can also be used for diagnosis.) The State also said that the amount drawn in This event will be further evaluated when additional the syringe was estimated to be 33.5 MBq (1.04 mci).

information becomes available.

19 NUREG-0090, Vol.16, No. 3

.=

~.

NRC FORM 335 U.S. NUCLEAR REGULATORY COMMistlON

1. REPORT NUMBER (r.am

' (Assigned by NRC, Add Vol.,

NRCM 1102, Supp., R3v., ted Addendum Num-320s 32o2 BIBLIOGRAPHIC DATA SHEET b* ' " 5"Y4 (See instructions on th. rev.rse)

NUREG-0090 Vol.16, No. 3

2. TITLE AND SUBTITLE

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

Report to Congress on Abnormal Occurrences:

July - September 1993 MONTH YEAR March 1994

4. FIN OR GRANT NUMBER 6, AU'lHOR(S)

6. TYPE OF REPORT Quarterly

7. PERIOD COVERED (inclusive Dates)

April-June 1993

8. PERFORMING ORGANLZATION ~ NAME AND ADORESS (if NRC, prov6de Division, Offlee or Replan, U.6. Nuclear Regulatory Cornmission, and malling address; if contractor, provido name and mailing address.)

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

9. SPONSORING ORGANIZATION - NAME AND ADDRESS (tf NRC, type 'Same as above*[ if contractor, provide NRC Divis6an. Office or Region.

U.S. Nuclear Regulatory Commission, and malling address.)

Same as 8., above 10, SUPPLEMENTARY NOTES l

11. ABSrRACT (200 words or less)

Section 208 of the Energy Reorganization Act of 1974 identifies an abnormal occarrence as an unscheduled incident or event that the Nuclear Regulatory Commission determines to be significant from the standpoint of public health or safety and requires a quarterly report of such events to be made to Congress. This report covers the period from July 1 through September 30,1993.

This report discusses two abnormal occurrences at NRC-licensed facilities. One involved a medical sodium iodide misad-ministration and one involved a 1981 fatal radiation exposure of a radiographer. One industrial radiographer overexpo-sure event and four medical misadministrations that were reported by the Agreement States are also discussed, based on information provided by the Agreement States as of November 1,1993. The report also contains information updating j

four previously reported abnormal occurrences at NRC-licensed facilities and three reported by the Agreement States, j

j and includes information on two other events of interest.

Appendix D has been added to this report which includes events submitted by Agreement States that are likely to be categorized as abnormal occurrences. For these events, insufficient information was available as of November 1,1993, to j

positively identify them as abnormal occurrences.

l

72. KEY WORDS/DESCRIPTORS (List words or phrases that vall assist researcher 4 in locating the report.)

13. AVAILABluTY STATEMENT Unlimited 3

}

14. SECURITY CLASCIFICATION Medical Therapy Misadministrations (m. rase)

)

Research Reactor Unclassified Safety Systems (1,i,,,po,,)

{

Industrial Radiographer Overexposure Unclassified Reactor Scrams is. NUuBER OF PAGES 3

k

16. PRICE 1

a NRC FORM 335 (2-89)

'\\

l Printed on recycled paper Federal Recycling Program o

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< CAR REGULATORY COMMISSION POSTAGE AND FEES PAID

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