ML20077E698
| ML20077E698 | |
| Person / Time | |
|---|---|
| Issue date: | 10/31/1994 |
| From: | NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | |
| References | |
| NUREG-0090, NUREG-0090-V17-N02, NUREG-90, NUREG-90-V17-N2, NUDOCS 9412130086 | |
| Download: ML20077E698 (41) | |
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NUREG-0090 Vol.17, No. 2 Report to Congress on Abnormal Occurrences f
April - June 1994 U.S. Nuclear Regulatory Commission j
Office for Analysis and Evaluation of Operational Data
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AVAILABILITY NOTICE Availabillty of Reference Materials Cited in NRC Publications l
Most documents cited in NRC publications will be available from one of the following sources:
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Although the listing that follows represents the majority of documents cited in NRC publica-
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A ycar's subscription of this report consists of four quarterly issues.
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Vol.17, No. 2 1
Report to Congress on Abnormal Occurrences i
April - June 1994 Date Published: October 1994 l
Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 i
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Abnormal Occurrences,2nd Otr CY94 Previous Reports in Series NUREG 75/090 (January-June 1975), published October 1975.
NUREG-0090-1 through 10 (July-September 1975 through October-December 1977), published March 1976 through March 197
NUREG-90, Vols. I through 16 (January-March 1978 through October-December 1993), published June 1978 through March 19w.
NUREG-(X)90, Vol.17, No.1 (January-March 1994), published August 1994.
NUREG-0090, Vol.17, No. 2 ii
Abnormal Occurrences,2nd Qtr CY94 ABSTRACT
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Section 208 of the F.ncrgy Reorganization Act of 1974 by the Agreement States as of August 3,1994. Two in-identifics an abnorrial occurrence (AO) as an unsched-volved medical brachytherapy misadministrations, one in-uled incident or ev;nt that the Nuclear Regulatory Com-volved a radiation burn received by an industrial radio-mission determin ;s to be significant from the standpoint grapher, and one involved a lost well logging source.
of public health ar safety and requires a quarterly repmt of such events '.o be made to Congress. This report pro.
The report also contains updates of seven AOs previously vides a descrir tion of those events that have been deter-reported by NRC licensees and five AOs previously re-mined to be abnormal occurrences during the period of ported by Agreement State licensecs. Three "Other April 1 thre.igh June 30,1994.
Events of Interest" are also reported. One involved a de-liberate coverup of an error in a diagnostic radiopharma-This report addresses seven abnormal occurrences (AOs) ceutial administration at an NRC licensee, one involved at NRC-licensed facilities. Five involved medical brachy-an Order Suspending License and Demand for Informa-therapy misadministrations, one involved a medical tele-tion at an NRC licensee, and one involved an overexpo-therapy misadministration, and one involved a medica! so-sure of an industrial radiographer at an Agreement State dium iodide misadministration. Four AOs were reported licensee.
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iii NUREG-0090, Vol.17, No. 2
Abnormal Occurrences,2nd Qtr CY94 CONTENTS Page Abstract...................
iii Preface vii I n t rod uction..............................
vii Th e Regula t ory Syst em.............................................................. vii Reportable Occurrences......................
vii Agreement States.....................
viii Foreign Informa tion..................................................
viii Reopening of CloscJ Abnormal Occurrences........
viii Report to Congress on Abnormal Occurrences, April-June 1994............
1 Nuclear Power Plants.
1 Fuel Cyc!c Facilities (Other than Nuclear Power Plants) 1 Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
I 94-8 Multiple Medical Ilrachytherapy Misadministrations at Deaconess Medical Center in Ilillings, Montana 1
94-9 Medical Ilrachytherapy Misadministration at Memorial Hospital in South Ilend, Indiana..
3 94-10 'Ibletherapy Misadministration at Jewish Ilospital, Washington University Medical Center, in St. Louis, Missouri..
4 94-11 Medicallirachythera;7j Misadministration at The Queen's Medical Center in lionolulu, Hawaii 4
94-12 Medical Sodium Iodide Misadministratior at Stamford llospital in Stamford, Connecticut 5
94-13 Medical Ilrachytherapy Misadministration at lilodgett Memorial llospital in East Grand Rapids, Michigan........
7 94-14 Medicallirachytherapy Misadministration at The William V',ackus llospital in Norwich, Connecticut...
7 Agreement State 1 icensees..........
9 AS 94-2 Medical lirachytherapy Misadmimstration at Memorial Medical Center in Lufkin,'Ibxas 9
AS 94-3 Radiation llurn of an Industrial Radiographer at Illazer Inspection in Texas City, Texas 10 AS 94-4 Lost Well Logging Source at 'Ibcker Wircime Service of Corpur, Christi, Texas........
11 AS 94-5 Multiple lirachytherapy Misadministrations at Cedars Medical Center in Miami. Florida.
12 References..
13 y
NUREG-0090, Vol.17, No. 2
Abnonnal Occurrences,2nd Qtr CY94 Appendix A - Abnormal Occurrence Criteria..........................................................
15 Appendix B - Update of Previously Reported Abnormal Occurrences...................................
19 Other NRC Ucensees 19 86-25 Suspension of License for ServicingTbletherapy and Radiography Units by Advanced Medical Systems in Geneva, Ohio..............................
19 92-18 Oncology Services Corporation in Indiana, Pennsylvania................................. 19 93-13 Medical Brachytherapy Misadministration at Mountainside Hospital in M on t clair, N ew J ersey........................................................... 20 94-2 Medical Brachytherapy Misadministration at Hospital Metropolitano in 20 Rio Picdras. Puerto Rico................
94-3 Thietherapy Misadministration at Triangle Oncology Associates in 21 Pittsburgh, Pennsylvania..................
94-6 Medical Brachytherapy Misadministration at Kecsler Medical Center at Keesler Air Force Base in Biloxi, Mississippi 21
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94-7 Medical Brachytherapy Misadministration at Alexandria Hospital in 22 Alexandria, Virginia................
22 Agreement State Ucensees...............
AS 88-5 MedicalTeletherapy Misadministration at Sacred Heart Hospital in Cumberland, Maryland..............................................
22 AS 88-6 MedicalTeletherapy Misadministration at Sacred Heart Hospital 22 in Cumberland, Maryland...................
AS 93-11 Found Source at Scrap Metal Facility in Magnolia. Arkansas........................ 22 AS 93-13 Lost or Stolen Radiation Source at BPB Instruments, Inc., in Midland. Texas........... 23 AS 93-15 Medical Brachytherapy Misadministration at Mt. Sinai Medical Cent e r in Miami B each, Florida................................................ 23 25 Appendix C - Other Events Of Interest........................
25 O ther N RC Uce nsees................................
1.
Deliberate Coverup of an Error in Diagnostic Radic pha,naceutical Administration at the llospital of the University of Pennsyhania in W1 zielphia, Pennsylvania............... 25 2.
Order Suspending License and Demand fc Wrmation issued to Western Industrial X-Ray Inspection Company, Inc., in Evanston, Wyoming 25 26 Agreement State Licensees 3.
Overexposure of an Industrial Radiographer at BlX Tbsting 26 12beratories ir Baytown, 'Itxas..........
Appendix D - Agreement State Events Being Considered as Abnormal 28 i
Occurrences...............
29 l
References for Appendices.................
NUREG-0090, Vol.17, No. 2 vi
Abnormal Occurrences,2nd Qtr CY94 PREFACE Introduction and safety. These events are not reportable as AOs but are provided as other events of interest.
'Ihe Nuclear Regulatory Commission reports to Congress each quarter, under provisions of Section 208 cf the Ener-Appendix D includes events submitted by Agreement gy Reorgamzation Act of 1974, any abnormal occurrences States that are likely to be cate2orized as ' sos. For these events, insufficient information was available in time to (AOs) involving facilities and activitics regulated by NRC.
An AO is defmed in Section 208 as an unscheduled mci-identify them as AOs for this report.
dent or event that the Commission determines to be sig-nificant from the standpoint of public health or safety.
The Regulatory System NRC identifics an AO for Ihe purpose of this report using
'the system of licensing and regulation by which NRC car-the criteria in Appendix A. 'lhese criteria were promul-rics out its responsibilitics is implemented through the gated in an NRC policy statement that was published in rulesand regulationsin11tle 100f the CodeoffederalReg-the Federal Register on February 24,1977, (Vol. 42, No. 37, ulations. This includes public participation as an element.
pages 10950-1095.')
To accomplish its objectives, NRC regularly conducts li-censing proceedings, inspection and enforcement activi-1hc poh.ey statement was publish jore licenseeswere tics, evaluation of operating experience, and confirmatory required to report medical misadn..mstrations to NRC.
Few of the examples m the policy statement are applicable research, while maintaining programs for establishing standards and issuing technical reviews and studies.
to medical misadmimstrations. 'Iherefore, dunng 1984, NRC developed guidelines for selecting such events for In licensing and regulating nuclear power plants and the AO reporting. 'Ihese guidelines, which have been used uses of byproduct nuclear materials, NRC follows the phi-since the latter part of 1984, augment the NRC policy losophy that the health and safety of the public are best statement examples and are summarized in 1hble A-1 in ensured by establishing multiple levels of protection.
Appendix A. On January 27,1992, new medical misadmi-These levels can be achieved and maintained through reg-nistration definitions became effective. The staf f is cur-ulations specifying requirements that will ensure the safe rently developing a policy statement to revise the AO cri-use of nuclear materials. The regulations include design l
teria for medical misadministrations as well as other and quality assurance criteria appropriate for the various events. In addition, guidelines are being developed for activitics licensed by NRC. An inspection and enforce.
Appendix C items, "Other Events of Interest. After the ment program helps ensure compliance with the regula-Commission's approval, the policy statement will be pub-tions.
lished for comment in the FederalRegister.
In order to provide wide dissemination of information to Reportable Occurrences the public, a Federal Register notice is issued on NRi ~.o censee AOs. Copics of the notice are distributed to the Actual operating experience is an essentialinput to the NRC Public Document Room and all Local Public Docu-regulatory process for assuring that licensed activitics are ment Rooms. At a minimum, cach notice must contain the conducted safely. Licensecs are required to report certain date and place of the occurrence and a description of its inciden ts or events to NRC. This reporting hclps to identi-nature and probable consequences.
fy deficiencies and to ensure that corrective actions are NRC has determined that, of the events reviewed for this reporting period, only those that are described in this rc.
For nuclear power plants, dedicated groups have been port, meet the criteria for reporting as AOs. 'lhis report formed, both by the NRC and by the nuclear powerindus-covers Ihe period from April 1 through J une 30,1994. In-try, for the detailed rcview of operating experience to help formation reported on each event includes date and place, identify safety concerns early; to improve dissemination of nature and probable consequences, cause or causes, and such information; and to feedback the experience into li-1 actions taken to prevent recurrence.
censing, regulations, and operations. In addition, NRC 1
and the nuclear power industry have ongoing efforts to Appendix il contains updated information on preuously improve the operational data systems, which include not reported AOs.
only the type and quality of reports required to be sub-mitted, but also the methods used to analyze the data. In Appendix C provides descriptions of events that can be order to more effectively collect, collate, store, retrieve, perceived as significant but do not involve a major reduc-and evaluate operational data, the information is nnin-tion in the level of protcetion provided for public health tained in computer-based data files.
vii NUREG-0090. Vol.17, No. 2
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Abnormal Occurrences,2nd Otr CY94 Three primary sources of operational data are Licensee sou rce, and special nuclear materials (in quantities not ca.
Event Reports (LERs) submitted pursuant to 10 CFR pable of sustaining a chain reaction). Agreement State 50.73, immediate notifications submitted pursuant to 10 programs m ust be comparable to and compatible with the CFR 50.72, and medical misadministration reports sub-Commission's program for such material.
mitted pursuant to 10 CFR 35.33.
Presently, information on reportable occurrences in Except for records exempt from public disclosure by stat-Agreement State licensed activities is publicly available at ute and/or regulation, information concerning reportoble the State level. For the purpose of developing a nation-occurrences at facilitics licensed or otherwise regulated wide database, Agreement States are encouraged to pro-by NRC is routinely disseminated by NRC to the nuclear vide information to NRC on reportable events.
industry, the public, and other interested groups as these events occur.
In aarly 1977, the Commission determined that AOs hap-pening at facilities of Agreement State licensees should Dissemination includes special notifications to licensees be included in the quarterly reports to Congress.The AO and other affected or interested groups, and public an-criteria included in Appendix A are applied uniformly to nouncements. In addition, information on reportable events at the NRC and thc Agreement State licensce faci-events is routinely sent to the NRC's more than 100 Local litics. Procedures have been developed and implemented, Public Document Rooms throughout the United States and AOs reported by the Agreement States to NRC are and to the NRC Public Document Room in Washington, included in these quarterly reports to Congress.
D.C. Congress is routinely kept informed of reportable events occurring in licensed facilities.
Another source of operational dr.ta is reliability data sub-mitted by licensees under the Nuc! car Plant Reliability N RC participates in an exchange ofinformation with vari.
Data Syst em (NPR DS).The NPRDS is a voluntary, mdus' ous foreign governments that have nuclear facilities.This try-supported system maintamed by the Institute of Nu-foreign information is reviewed and considered in the clear Power Operations (INPO), a nuclear utility organi.
NRC's assessment of operating experience and in its re-7ation, noth engineering and failure data arc submitted by search and regulatory activities. Reference to foreign in-nuclear power plant licensecs for specified plant compo-formation may occasionally be made in these quarterly nents and systems. The Commission considers th AO reports to Congress; however, only domestic AOs are NPRDS to be a useful supplement to the LER system for reported' the collection, review, and feedback of operational expe-tience.
Reopening of Closed Abnormal Agreement States Occurrences s
Section 274 of the Atomic Energy Act, as amended, au-NRC reopens previously closed AOs if significant newin-thorizes the Conimission to enter into agreements with formation becomes available. Similarly, previously re-States whereby the Commission relinquishes and the ported "Other Events of Interest" are updated if signifi-States assume regulatory authority over byproduct, cant new information becomes available.
NUREG-0090, Vol.17. No. 2 viii
Abnormal Occurrences,2nd Qtr CY94 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES APRIL-JUNE,1994 Nuclear Power Plants There are 109 operating nuclear power plants in the of this report, none of the events reviewed for this report-United States (U.S.). NRC has reviewed all event reports ing period was determined to be significant enough to be.
received from these licensees through the second quarter reported as an abnormal occurrence (AO).
of 1994. Using the criteria and guidelines in Appendix.A Fuel Cycle Facilities (Other than Nuclear Power Plants)
There are 41 active licenses for the milling. processing, guidelines in Appendix A of this report, none of the and fabrication of nuclear fuel in the U.S. NRC has re-events reviewed for this reporting period were deter-viewed all event reports received from these licensees mined to be significant enough to be reported as an abnor-during the second quarter of 1994. Using the criteria and mal occurrence.
Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
There are approximately 22,000 awve material licenses This report documents two misadministrations involving for the use of byproduct materials in industrial, medical, brachytherapy procedures performed at the licensee's fa-and academic applications in the U.S.'lkenty-nine States, cility in September and November 1993, which are related known as Agreement States, have entered into agree-to nine other events identified at another NRC-licensed ments with NRC to assume regulatory authority for the medical facility, because the events are the result of a use of byproduct materials. NRC is responsible for regu-common root cause.
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lating approximately 7000 of these licensees located in 21 States, the District of Columbia, and all U.S. territories.
Date and Place-September and November 1993; Dea-NRC has reviewed all events received from these licens-coness Medical Center; Billings, Montana.
ces through the second quarter of 1994. Using the criteria and guidelinesin Appendix A of this report, the following Nature and Probable Consequences-On March 22, events have been determined to be significant enough to 1994, representatives from Northern Rockies Cancer be reported as AOs.
Center (NRCC), Deaconess Medical Center (DMC), and St. Vincent Hospital and Health Center (SVHHC) noti-fied the NRC Region IV office of a misadministration in-volving a brachytherapy treatment performed at DMC on 94-8 Multiple Medical-September 24,1993 (Ref.1).The event was not discovered Bracllytherapy until March 20,1994, during the course of a thorough re-view of a select group of treatments performed at DMC Misadnu.. frattons at nis and SVHHC under treatment plans developed at NRCC.
Deaconess Medical Center The three licensees participated in the telephonic notifi-
)
in BillinEs' Montana cation because NRCC provides brachytherapy planning services to both DMC and SVHHC, and the potential cause of the misadministrations involved errors in treat-The following information pertaining to the events is also ment plans developed at NRCC. (NRCC is jointly owned being reported concurrently in the Federal Register. Ap-by DMC and SVHH C.) The licensees reported that based pendix A(see Event'Iype 5[d]in'able A-1)of thisreport upon initialinformation developed by the physics staff at notes that a therapeutic exposure which aff, as two or NRCC, it appeared likely that additional brachytherapy more patients at the same facility (regardless of any health treatment errors had occurred at both DMC and effects) can be considered an abnormal occurrence.
SVHHC.
1 NUREG-0090, Vol.17, No. 2
- Abnormal Occurrences,2nd Qtr CY94 The following day, March 23,1994, the licensees reported independent (manual) verification checks of treatment an additional brachytherapy misadministration at DMC, plans that were adequate to determine the accuracy of and nine other incidents due to the same error that re-computer-generated dose tables (Ref. 3, Ref. 4). Several sulted in administered doses greater than prescribed (one factors involving clarity of instructions provided in the at DMC and eight at SVHilC)(Ref. 2). The misadminis-Theraplan user's manual, and in prompts and data pres-trations reported by DMC involved administration of ra-ented to treatment planning system users in printed for-diation such that the doses received by the patients ex-mat and at the system console, were identified as contrib-cceded the prescribed doses by 21 and 24 percent. In cach uting factors to the inadvertent entry of and failure to case, the patient had received radiation by external beam detect the erroneous data entered in program software as well as " boost" doses administered via brachytherapy.
for linear Cs-137 sources.
The overdoses noted above pertain only to the brachy-therapy component of each treatment.
The inspection also disclosed significant weaknesses in DMC's implementation of its quality managcment pro-During the initial telephonic report, NRCC staff ex-gram (QMP) for brachytherapy procedures. In addition, plained that during a recent routine treatment setup a several apparent violations of NRC rcquirements relating new staff member identified errors in a dose table gener-to DMC's QMP and its implementation were identified.
ated by a Theratronics 'lheraplan L treatment planning One apparent violation involved a failure to establish a system. Following considerable review of treatment plans QMP in January 1992, as required, although the inspec-and data generated using the treatment planning system, tion confirmed that DMC later established a QMP in May the physics staff at NRCC, with assistance from 'Ihcra-1992. Ilowever, the QMP established by DMC failed to tronics, concluded that the data in a software file used to meet the following requirements: (1) that written direc-compute dose tables for ccsium-137 (Cs-137) sources tives are signed by authorized users and completed in ac-were deleted and were later replaced with data
- hich did cordance with NRC regulations; (2) that final plans of not properly characterize the Cs-137 sov~
used by treatment are in accordance with the respective written DMC and SVI11IC.The computer-genet...Mose tables directive; and (3) that each administration of radiation is that were computed using erroneous data were in error by in accordance with the applicable written directive. Other as much as 20 to 25 percent.The errors were not detceted apparent violations included failures to (1) conduct an an-because an incorrect reference dose table was used to nual revic,v of the QMP during the calendar years 1992 verify and adjust the output of Ihe treatment planning al-and 1993, (2) train all individuals working under the super-gorithm and individual patient treatment plans.
vision of DMC's authorized users in the provisions of its QMP, (3) train nursing personnel who cared for patients An NRC inspection was conducted at the facility on undergoing brachytherapy treatment in accordance with March 28 through April 1 and April 5 through 29,1994. In Ihe conditions of DMC's license, and (4) record all re-addition, the events were reviewed by regional and head-quired information in survey reords related to brachy-quarters NRC staff accompanied by personnel from the therapy and in brachytherapy r.,urce usage records.
Idaho National Engineering Laboratory on April 6 through 8,1994, to examine generic aspects of the root Actions Taken to Prevent Recurrence causes and contributing factors.
Licensee-DMC voluntarily suspended its brachytherapy "1he physics staff at N RCC promptly corrected the data in program until certain corrective measures could be im-the Theraplan L software and recalculated the doses re-plemented. However, because the findings of the inspec-ceived by 1he patients. Ilased upon a rcview of the recalcu-tion indicated significant, programmatic weaknesses in lated doses conducted by the authorized users and an in-DMC's QMP and its implementation, the NRC sought to dependent medical consultant contracted by NRCC, the confirm with DMC staff the specific actions planned for authorized users have determined that no long-term ad-completion prior to resuming brachytherapy treatments.
verse health effects beyond those normally expected for The licensee's proposed corrective actions were docu-this form of treatment are anticipated for the patients.
mented in a Confirmatory Action Letter (CAL) issued by The licensee has been informed that an NRC medical the NRC on May 3,1994 (Ref. 5). As of the date of this consultant will review each case in order to provide an in-report, the licensee has not yet completed each of the ac-dependent assessment of the potential consequences of tions described in the CAL and has continued suspension the overdoses.
of its brachytherapy program.
The patients involved in the misadministrations were no-NRC-An enforcement conference was held with the li-tified both orally and in writing.
censee on J u ne 28,1994, to discuss the apparent violations described above and to review the corrective actions taken Cause or Causesulhe inspection disclosed that the root by the licensee. NRC is continuing its deliberations re-cause of the misadministrations was a failure to conduct garding any proposed enforcement action.
NUREG4)090, Vol.17, No. 2 2
Abnormal Occurrences,2nd Otr CY94 An NRC Information Notice has been drafted to inform afterloader in the applicator was empty and that the other licensees of the particulars of this case and of the Cs-137 source had not been placed in the applicator.'lhe importance of conducting adequate checks of computer-source was then placed in the afterloader and loaded into generated treatment plans. NRC has also discussed con-the applicator to continue the patient's treatment.
cerns related to the'lheraplan treatment planning system software, and related instructions provided by the man-The first treatment was then completed, giving the pa-ufacturer, with representatives from the U. S. Food and tient a dose to the treatment site of 13.83 Gy (1383 rad),
Drug Administration (FDA). FDA has recently cleared which was 8 percent less than the intended dose. The sec-the software for the treatment planning system to allow ond treatment was then performed on April 27 and 28, modifications of existing software to be imported into the 1992, without incident.
United States.
The licensee investigated the incident and concluded that A medical consultant will review each misadministration the source had fallen on the floor while it was being placed and provide NRC with an independent assessment of the in the afterloading device by the dosimetrist.The incident overdoses and the potential adverse health effects to pa.
was not reported to NRC because the radiation dose to tients.
the treatment site differed by only 8 percent from the in-tended dose.This variance would not require reporting as This event will be updated when additional information a misadministration.
becomes available.
During an NRC inspection on May 4 and 5,1994, the in-spector reviewed the circumstances surrounding the 94-9 Medical lirachytherapy treatment incident. The inspector evaluated the routine Misadministration at radi don mcys f the padenfs mom that wm donc ab ter the radiation sources were placed in the applicator.
Memorial Hospital in
'lhe surveys showed that it was unlikely that there was an unshicided Cs-137 source on the floor of the room.
South Bend, Indiana Further inquity by the inspector led to the determination
'lhe following information pertaining to the event is also that the source likely fell from the afterloader while it was being reported concurrently in the Federal Register. Ap-bemg placed m the applicator. 'lle physician reported pendix A (see Event 'lype 3 in 'Ihble A-1) of this report havmg difficulty m placmg the afterloader m the apphca-notes that a therapeutic dose that results in any part of the tor, and, according to the treatment chart, the patient had body receiving unscheduled radiadan can be considered mp rted that she felt a small metal object fall next to her an abnormal occurrence.
skin during the somcc placement.
Date and Place-April 13, 1992; Memorial Hospital; As a result, the source may have been next to the skin of South llend, Indiana.
the patient's thigh for about 7.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> resulting in a radi-ation dose of up to 10.34 Gy (1034 rad), according to the Nature and Probable Consequences-On April 13,1992, licensce's calculation, the first of two brachytherapy treatments was begun. Each of the treatments was to deliver 15 gray (Gy)(1.500 rad) to An NRC medical consultant was retained to evaluate the the patient's cerm. For the first treatment, five cc-case and concluded that the radiation dose to the patient's sium-137 (Cs-137) sources were to be loaded into a treat-thigh could result in some later damage to the tissue of the ment device, known as a Fletcher-suit applicator, which patient's thigh.
was placed in the patient's vagina. 'lhe sources were placed into afterloaders by a dosimetrist in preparation llecause this incident resulted in a radiation dose to the for placement in the applicator. The afterloaders were wrong treatment site, this constitutes a misadministra-then placed in the applicator by the treating physician.
tion.
About eight hours later, the patient's care provider dis-The licensec notified the patient and the patient's physi-covered a Cs-137 source on the floor near the foot of the cian of the misadministration on May 6.1994. However, patient's bed.The source was found after the care provid-the licensec did not provide a written report to the patient er had changed the patient's bed linen. The care provider until June 27,1994, after NRC inquired about patient no-recovered the source wah long handled forceps and tification.
placed it in a shielded container.
Cause or Causes-The incident apparently was the result
'the treating physician and the licensee's Radiation Safety of the source falhng out of the afterloader as it was being Officer (RSO) were notified. They determined that one placed in the applicator. The physician reported some 3
NUREG-0090, Vol.17, No. 2
Abnormal Occurrences,2nd Qtr CY94 difficulty in placing the sources and apparently did not ob-fractions.The radiation therapist was verbally instructed serve the source when it fell.
of the change, but the written directive was not changed.
J The first portion of the second treatment was properly de-Actions Taken to Present Recurrence livered using the modified treatment plan. Ilowever, the i
j radiation therapist erroneously changed the treatment Licensee-Ilhe licensee has revised its procedures for angle for the second portion of the treatment.The error placing the radiation sources, including use of a pillow un-meant that the left eye orbit received the radiation dose der a patient's pelvis in difficult situations. Its investiga, instead of the right eye orbit. Consequently, the left cyc tion of any future incidents will also include an evaluation orbit erroncously received a dose of approximately 150 of radiation doses to unintendcd treatment sites.
cGy (150 rad)and the right eye orbit Icccived 150 cGy (150 rad) less than intended. The licensee stated that the pa-NRC dihe NRC inspection during May 4 and 5,1994, tient received an explanation of the event and that the er-identified two violations of NRC requirements. They ror did not affect the treatment.The entire treatment was were (1) failure of the licensec's Radiation Safety Corn.
completed on May 6,1994, without further incident.The mittee and RSO to adequately investigate a possible mis.
administration to include consideration of possible radi.
patient subsequently died as a result of the cancer.The NRC consultant determined that the misadministration ation doses to the w rong treatment sites; and (2) failure to provide a written report to the patient within 15 days of had no impact on the patient's death.
the discovery of a misadministration. A Notice of Viola-Cause or Causes-Failure of the authorized physician to tion (Ref. 6) was issued to the licensee on July 15,1994.
prepare a change in the written directive, and fsilure to lhere was no Livil Penalty mvolved.
effectively supervise the administration of the treatment.
This item is considered closed for the purpose of this re-Action Taken To Prevent Recurrence port.
Licensee-The licensce's corrective actions included (1) policy changes to clarify the radiation therapists
- responsi-94-]()
Teletherapy Misadministration bility when treatment plan changes are made: (2) retrain-ing staff on quality management program (QMP) procc-at Jew. h IIosp tal, dures;(3) requiring that on the first day of treatment the is i
Washington University setup is supervised by a physician: (4) modifying the writ-ten directiv f rm used f r d cumenting written direc-Medical Center, in tives and subsequent revisions; and (5) reviewing and re-St. Lou,s, M,issourt vising the current QMP and submitting the changes to i
NRC for review.
The following information pertaining to the event is also NRC-NRC Region 111 conducted an inspection from being reported concurrently in the &deral Register. Ap-May 2 through June 9,1994, to review the misadministra-pendix A (see Event 'lype 3 in 'lable A-1) of this report tion. NRC also contacted a medical consultant to review indicates that a therapeutic exposure to a part of the body the incident. Significant violations of NRC requirements not scheduled to receive radiation can be considered as an were identified during the inspection. The violations in-abnormal occurrence.
cluded (1) failure to make a written revision to a written Date and Place-April 22,1994;.fewish llospital, Wash.
directive prior to administering a revised teletherapy dose ington University Medical Center; St. Louis, Missouri.
to a patient; (2) failure to review the written prescription; (3) failure to verify that details of the administration of the Nature and Probable Consequences-A' patient was be.
verbally revised dose were in accordance with the written ing treated for uncer of the brain.The written prescrip.
directive and plan of treatment; (4) failure to follow the tion directed that a 3000 centigray (cGy)(3000 rad) total written QMP procedures established by the licensce; and absorbed dose be delivered in a series of 10 treatments of (5) failu re to include in written directives the overall treat-300 cGy (300 rad) each. Each treatment was to consist of ment period. On July 11,1994, NRC Region nl issued a Notice of Violation (NOV) with a Severity Level In viola-150 cGy (150 rad) from the left side, and 150 cGy (150 rad) tion with no fine assessed (Ref. 7). The NOV requires the from the right side.The eyes were tobe shielded during licensee to document the specific actions taken and any the treatments.The patient's first treatment on April 21, 1994, was delivered without incidet.t in accordance with additional actions planned to prevent recurrence.
the prescription.
'Ihis item is considered closed for the purpose of this "I
On April 22,1994, the licensee informed NRC that after administering the first treatment to the patient, the physi-94-11 Medical I3rach)theraE}-
cians decided to mclude the patient s right eye orbit into Misadministration at The the whole brain treatment field for subsequent treatment NUREG-0090, Vol.17, No. 2 4
Abnormal Occurrences,2nd Qtr CY94
=
Queen's medicai center in medicai consesucnces of the misadministration wouid be ne8 8H M e.
IIOn0 lulu, llawaii Cause or Causes-Part 35 of Title 10 of the Code offeder-
,the following information pertaining to this event is also al Regulations states that licensees must establish and being reported in the Federal Register. Appendix A (see maintain a written quality managetrunt program (QhiP)
Event'lype 1[a]in'Ihble A-1)of this report notes that ad-to provide high confidence that each administration is in mimstering a therapeutic radiation dose greater than 1.5 accordance with the written directive. liowever, at the times that intended from a scaled source should be con' time of the treatment, the licensee did not have a written sidered an abnormal occurrence.
procedure to require that staff members confirm that the planned administration will be as specified in the written Date and Place-May 2,1994;The Queen's Medical Cen-directive. Consequently, neither the physician nor the on-ter; Ilonolulu, Hawaii.
cology nurse referred to the written directive, nor did they discuss the procedure before it took place. Inconsistent Nature and Probable Consequences-A patient was pre-training given to the oncology nurses in the method of scribed to receive two treatments of 1000 centigray (cGy) timing treatments was also a contributing factor.
(l(XX) rad) to the patient's right eye using a strontium-90 (Sr-90) cye applicator. The treatment plan called for the Actions Taken to Prevent Recurrence two treatments to be scheduled one week apart. 'lhe first treatment was properly delivered on April 25,1994,by 1,icensee-The licensee revised the QMP procedures to keeping the source in contact with the patient's right eye prevent recurrence of similar misadministrations. The for 18 seconds. On May 2,1994, when the patient returned new procedure specifies that prior to the procedure, the for the second treatment, the same physician treated the staff will determine that the eye appheator is as specified patient, but a different oncology nurse assisted.The phy-in the written directive. It also states that the staff must sictan did not refer to the written directive or to the dose-seek guidance prior to continuing if they do not under-rate information available with the eye applicator, al-stand any aspect of the written directive.
though he had used other applicators in the past. He also did not discuss the procedure with the oncology nurse NRC-NRC Region IV conducted an inspection at The prior to the second treatment. At the end of the desired Queen's Medical Center on May 16-17, 1994, to review 18-second period, the nurse raised her voice and paused the circumstances associated with the misadministration at the count of "18"(as she had been trained) without say-and its probable causc(s). The NRC staff is currently re-ing "stop" as the physician expected. As a result, the treat-viewing the inspection results for possible violations, and ment continued until 32 seconds had passed, when the enforcement action is pending.
l physician realized that the desired time must have clapsed. As a result, the patient received 1778 cGy (1778 rad) to the right cyc during the second treatment, rather Future reports will be made as appropriate.
than the prescribed 1000 cGy (1000 rad).
94-12 Medical Sodium 10dide The lladiation Safety Officer reported the misadministra.
tion to the NRC Operations Center at 8:37 p.m. on May 2, Misadministration at 1994. The referring physician was also notified on the Stamford Il0SE tal in i
same day. lhe patient was notified of the event during follow-up examinations by the referring physician on May Stamford, Connecticut 5 and May 14,1994. No clinical damage was observed by the referring physician, and none is expected. The patient The following information pertaining to the event is also will be examined during subsequent follow-up visits to the being reported concurrently in the rederal Register. Ap-medical center.
pendix A (see Event 'lype 1 in Table A-1) of this report notes that administering a radiopharmaceutical other The NRC staff retained a medical consultant to evaluate than the one intended which results in any part of the body the potential medical effects on the patient as a result of receiving unscheduled diagnostic radiation, and the ac-the misadministration.The medical consultant stated that tual dose to the wrong body part, is five times the upper dosimetry for Sr-90 cyc applicators is difficult, due to cal.
limit of the normal range of exposures prescribed for diag-bration factors, clinical factors, and treatment technique.
nostic procedures involving that body part, can be consid-cred an abnormal occurrence.
'the consultant will send an update on the dosimetry and calibration in the near future. 'lhe medical consultant stated that the increased unintended dose is within the Date and Place-May 17,1994; Stamford Hospital: Stam-range of normal treatments. He indicated that the ford, Connecticut.
5 NUREG-0090, Vol.17, No. 2
Abnormal Occurrences,2nd Otr CY94 Nature and Probable Consequences-On May 19,1994, 1.11 MBq (30 Ci)which would require written directives the licensee notified the NRC Operations Center that on and failed to instruct supervised individuals in NRC re-May 17,1994, a patient was administered 37 megabec-quirements of a QMP.
querel (MHg) (1 millicuric [ mci]) of sodium iodide io-dine-131 (1-131) for a whole txxty scan Cien no such study Actions Taken to Prevent Recurrence was prescribed. Ihc licensee identified this misadmmis-tration during review of the scan by the authorized user.
Licensee /Ihe licensee now requires that (1) all requests for diagnostic or therapeutic procedures be in writing and A patient was scheduled by a referring physician to have a sent via facstmile transmission from the referring physi-
"whole bh>od red cell mass" test, correctly known as a " red cian's office; (2) all administrations above 1.11 MBq (30 blood cell volume" test.This test involves withdrawing an Ci) f I-131 be done only by written order from the AU/
amount of bhxx.! from the patient, and labeling the pa-RSO or other AU's authonzed to do so;(3)all diagnostic tient's red blood cells in vitro with the radionuclide chro-and therapy requisitions will be reviewed by a radiologist, mium-51 having a nominal activity of 1.02 to 3.7 MHg and designated as approved or not approved; (4) all tech-(30-100 microcuric [ Cij). This is followed by reinjection nologists will be tramed m regard to the chmcal diagnosis of the labeled red blood cells into the patient, and mea-for which each test is applicable; (5) the central bookina surement of radioactivity in blood sampics withdrawn staff will meet with the RSO and will be mformed that the from the patient 10 to 30 minutes later.The referring phv-sician contacted the patients's licalth Maintenancc Org'a.
clmical diagnosis must match the test being requested, and that any deviation from the match or any diagnosis nization (IIMO), as the IIMO requires that it place the that they don't understand must be challenged and order with Stamford llospital. The llMO wrongly con.
brought to the attention of the radiologist; and (6) the tacted the central booking area for Nuclear Medicine at RSO and physicist wdl review the QMP annually and dis.
Stamford llospital, rather than the Clinical Laboratory cuss it at the Radiation Safety Committee meeting and which performs this test as authorized in Part 35.100 of with the entire nuclear medicme staff.
Title 10 of the Code of Federal Regulations. 'lhe central booking secretary, and the iIMO secretary, in an attempt to fit the procedure into one of those listed under Nuclear NRC-NRC Region I conducted a special inspection on Medicine, converted the prescribed "Whole Blood Red May 23 and 24, and June 1 and 6,1994, to investigate the Cell Mass" test into"Whole Body 1-131 Scan,"a scan that circumstances of the misadministration. An NRCinspec-uses 37 MHg (1 mci) of I-131.The central booking secre-tion report (Ref. 8) was issued June 15,1994, and identi-tary then printed the name of the referring physician at ficd the following five apparent violations: (1) failure to the bMtom of the form for " Consultation for Nuclear establish a QMP for amounts of I-125 and 1-131 greater MedAine," and sent it to the Nuclear Medicine Depart-than 1.11 MHg (30 Ci);(2) failure to conduct annual re-ment where it was received on May 13,1994. A nuclear views of the QMP; (3) failure to have records specifying medicine technologist (NMT) looked at the form and saw the methods used to verify patient identity which can be that it was for " total red cell mass," but since the NMT audited;(4) failure to have written directives signed by the knew the referring physician, the NMT assumed that this authorized uscr; and (5) failure to instruct individuals in was a new test using 1-131 to determine " total red cell the QMP. An NRC medical consultant reviewed the infor-mass " The NMTordered the requested 37 MHg(1 mci) mation in the NRC's inspection report, the licensce's 1-131 capsule, which was administered on May 16,1994.
15-day misadministration report, and the preliminary no-The patient was scanned on May 17,1994, and May 18, tification, and conducted telephone interviews with the 1994, the authorized user (AU), who is also the Radiation RSO/AU.'
rnedical consultant concluded that without Safety Officer (RSO), rcad the films.The AU immediate-an actual measurement of the thyroid uptake of I-131 ly notiecd the error and notified the referring physician, there was a moderate uncertainty in the estimate of the who notified the patient.
radiation dose to the thyroid, and estimated a radiation absorbed dose of approximately 530-to-1600 cGy The licensee estimated that the patient received a whole (530-to-1600 rad). The medical consultant further stated tuly dose equivalent of 4.7 millisievert (470 millirem)and that it is unlikely that the misadministration will result in a a thyroid absorbed dose of 800 centigray [cGy) (800 rad).
clinically detectable effect on the patient's thyroid. The NRC was notified within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the discovery of the impact on the patient's health should be negligib!c, with misadministration. The licensee submitted a written re.
no expected long-tenn disability.
port of the misadministration to NRC Region I on May 31, 1994.
An enforcement conference was held with the licensee on June 24,1994. The five violations were classified as a Se-Cause or Causes 'the licensee had failed to establish a verity Level IH problem and a Notice of Violation and quahty management program (OMP) for administering Proposed imposition of Civil Penalty (Ref. 9) for $1,250 quantities of 1-131 and iodine-125 (1-125) greater than was issued on July 11,1994.
NURIIG-009(1, Vol.17, No. 2 6
Abnormal Occurrences,2nd Qtr CY94
'Ihis event will be further updated when additional infor-Action Taken To Prevent Recurrence rnation becomes available.
Licensee-The licensee reported that in the future the brachytherapy quality management program (QMP) will 94-13 Medical Brachytherapy be strictly adhered to when performing eye applications, Misadministration at Blodgett and a physics check will be done before each treatment i
fraction. In addaion, a souwe activity decay chart for Memorial Hosp tal in East Sr-90 will be provided to the physicians for immediate rei-j Grand Rapids, Michigan erence.
The following information pertaining to the event is also NRC-NRC Region HI conducted an inspection from being reported concurrently in the Fedeml Register. Ap.
June 28 through July 6,1994, to review the circumstances pendix A (see Event 'lype 5 in Thble A-1) of this report of the misadministration. An NRC medical consultant, notes that a therapeutic dose that is greater than 1.5 times retained to review the case, concluded that chances are fa-the prescribed dose can be considered an abnormal vorable that the patient will suffer no health complica-l occurrence.
tions, but the risk of future complications is not zero.
Date and Place-June 14,1994;111odutt Memorial Medi.
On August 18, Region Ill issued a Notice of Violation cal Center; East Grand Rapids, Michigan.
.(Ref.10) to the licensee for the following violations: (1) treating a patient with the Sr-90 cye applicator without Nature and Probable Consequences-On June 15,1994, preparation of a written directive; (2) failure to establish the li:ensee notified NRC that a misadministration oc.
and use a written QMP for the Sr-90 eye applicator; (3) curred on June 14,1994, during the second of a series of investigation of the misadministration by the Radiation three treatments to an eye surface lesion using a stron.
Oncology Department instead of the Radiation Safety Of-
)
tium-90 (Sr90) cyc applicator. The misadministration re.
ficer as required; (4) failure to maintain required records sulted in the patient receiving a total dose that was 53.6 of the Sr-90 source usage;(5) failure to maintain the man-percent above the intended total dose.
ufact urer's instruct ~ons for the eye applicator as required.
There was no Civil Penalty assessed for the violations.
The pitient was to receive 25.5 gray (Gy)(2550 rad)in a
'lh.s item is considered closed for the purpose of the serics of three cquat treatments.The intended treatment time for each of the three treatments was 19.1 seconds.
"PUfl-The first treatment was performed as intended. During the second treatment, the treatment time was misread and the patient received treatment for 1 minute and 9 sec-onds.The second treatment dose was 30.68 Gy (3068 rad) 94-14 Medical Brachytherapy instead of the intended 8.5 Gy (850 rad).The third treat-Misadmimstration at The ment was not administered. 'Iherefore, the patient's cyc received a total dose of 39.18 Gy (3918 rad).
William W. BackUs Hospital in Norwich, Connecticut The patient and referring physician were notified of the incident by the licensee. 'lhe licensee and the referring physician do not anticipate any serious health conse.
The following information pertaining to the event is also quences to the patient and have conducted follow-up be ng reported concurrently in the Federal Register. Ap.
medical examinations.
pendix A (see Event Type 5 in ihble A-1) of this report notes that a therapeutic dose that results in an actual dose Cau e or Causes-The heensee reported that when the greater than 1.5 times the prescribed dose can be consid-first treatment fraction was performed on June 7,1994, cred an abnormal occurrence.
the treatment time of 191 seconds was erroneously re-corded on the medical chart as 1.91 seconds. When it Date and Place-June 21,1994; The William W. Ilackus came time for the second treatment fraction to be admin-llospital: Norwich, Connecticut.
istered, the therapist made the assumption that the treat-ment time was 1 minute 9 seconds. The physician did not Nature and Probable Consequences-NRC Region I was verify the specific details of the administration prior to ad-notified by the licensee on June 21,1994, of a therapeutic ministering the brachytherapy dose, and did not confirm misadministration that had occurred at its facility earlier the treatment time. In addition, the licensee failed to es-that day. The misadministration involved a patient who tablish a written Quality Management Program (OMP) was prescribed to receive a prostate implant of 112 io-for the SrA0 cyc application eye application, and the dine-125 (I-125) seeds having a radionuclide activity per therapist was not instructed in the licensce's QMP.
seed of between 15.9 and 17.0 megabecqu erel (Milq)(0.43 7
NUREG-0090, Vol.17, No. 2
Abnormal Occurrences,2nd Otr CY94 and 0.46 millicuric [ mci]), but who instead was implanted at the time of receipt of the package, and those made by with 1121-125 seeds having an activity of 166 hillq (4.49 himself earlier that morning. The dosimetrist assumed that these were clerical errors, and therefore " corrected" mci) each.
two of the three sets of entries in the log book by drawing i ollowing the preplanning dosimetry performed at Yale-lines across them and entering the " correct" figures as New Ilaven llospital (YNiill), a written directive was 16.6 Mllq (0.449 mci) per seed and 1860 Mllq (50.288 prepared by an authorized user and was sent via facsimile mci) total, respectively.
transmission to The William W. Backus Ilospital on June 16,1994, by the dosimetrist from YNilll. (YNiill is un-The dosimetrist realized the possibility of an error when it der contract with The William W. llackus llospital to pro-was noted that the packing slip also indicated that cach vide radiation oncologists, dosimetrists and health physi-seed had an activity of 166 MBq (4.49 mci). 'lhe dosimet-cists, and two of the physicians from YNiill are listed as rist contacted the Chief NMT, and together they both authorized users on The William W. llackus 11ospital's called Mcdi-Physics to verify the activity of the seeds.
NRC license).The Chief Nuclear Medicine'Ibchnologist Upon confirmation by Medi-Physics that each seed had (Nhil) received the directive and called Mcdi-Physics in an activity of 166 MBq (4.49 mci), the surgeon was noti-Arlington iIcights, Illinois, to place the order for the re-ficd of the error. (Ihe surgeon was also the patient's ref-quired 1-125 seeds.The package containing the seeds ar-crring physician.) Unable to contact the authorized user rived at The William W. llackus 11ospital on J une 17,1994, who had supervised the implant procedure, the surgeon and was received by one of the Nhrit, who was not the consulted with a second authorized user (also from same individual who had ordered the seeds. The NMT YNIlli) and the two agreed that a surgery to explant as opened the package after making the required radiation many seeds as possible was the most appropriate approach surveys. In accordance with the licensce's established pro-under the circumstances.This involved removal of the pa-cedure, information on the packing slip that accompanied tient's prostate gland where a majority of seeds were 10-the package was compared with the information that was cated. The patient and his family were informed of the posted on the lead " pig" that contained the seeds. The misadministration, and the patient was brought back to verified information included the number of seeds (112),
the operating room and prostatectomy was completed at activity per seed (166 Mllq 14.49 mci] per seed), and total approximately 4:00 p.m.
activity (18,600 Mlly [502.88 mCil), and was entered into acensee was able to explant 69 of the 112 seeds that the scaled source inventory log book by the NMT.
Th were implanted,1 caving 43 seeds still remaining inside the On June 21,1994, the dosimetrist from YNI11I arrived at patient's body. During the explanting procedure, one of The William W. llackus llospital to assist in the implant the I-125 seeds was ruptured. The patient was adminis-procedure.The same dosimetrist had performed the pre-tered prophylactic potassium iodide to block the possible danning dosimetry, and had prepared the written direc-uptake of I-125 by the patient's thyroid.The licensec also tive that was signed by the authorized user.The dosimet-collected the fluids and the tissue that may have been con-rist took the package after reviewing the documentation, taminated. Approximately 5 liters (5.28 quarts) of fluid but failed to notice that the activity of the seeds was 10 were collected and appeared to be contaminated with ap-times higher than the prescribed activity.The dosimetrist proximately 1.85 MBq (0.050 mci) of I-125.1he person-made entries into the log book before removing the con-nel who were present in the operating room during the tainer from the nuclear medicine hot lah, and the entries surgery were also monitored for possible uptake, and the documented that 112 seeds with activity of 166 Ml3q (4.49 results indicated no internal contamination of these mci) cach were taken to the operating room.
personnel.
The implant procedure was completed between 10 and 11
'lhe patient was transferred to YNHil on June 23,1994,in a.m. on June 21,1994, in the presence of the authorized order that a more precise localization of the remaining user, who at the completion of the procedure documented seeds could be made by the use of equipment available at that 1121-125 seeds with total activity of 1840 Mllq (49.73 that facility. At YNHH three-dimensional scans were mci) were implanted. Following the implant procedure, taken, and on June 27,1994, the patient was again oper-the required radiation surveys were made by the dosimet-ated on and an additional 15 seeds were explanted.'Ihis rist and the dose rate of 1 microcoulomb per kilogram (4 left 28 seeds still remaining in the patient.'Ihe remaining millirr gen) per hour at 1 meter (39 inch) from the pa-seeds appeared to be scattered in the lower pcMc region and the licensee decided that funher mitigating surgeryat tient >
ecorded by the dosimetrist.
this time was not warranted.The patient appeared to be in The patient was moved to the recovery area, and the dosi-stable condition. Preliminary dose calculations by the li-metrist returned to the nuclear medicine department to censee indicated that the remaining seeds would cause complete the documentation required by the licensce's the body tissue to receive a radiation dose of the same or-procedure. At this time, the dosimetrist noted discrepan-der of magnitude as would have been received by the sur-cies between the ent ries made in the log book by the N MT rounding organs and tissue if the originally planned seeds NUREG-0090, Vol.17, No. 2 g
Abnormal Occurrences,2nd Qtr CY94 were permanently implantedflhe patient was discharged implantation, and that the implant sources be ordered in from YNiill on July 4,1994.
writing from the supplier.
Cause or Causes-There was a misunderstanding in com.
NRC-NRC Region I dispatched an inspection team, munication between the Chief Nhfr who ordered the which arrived at the facility at approximately 2:00 p.m. on seeds, and the representative of Mcdi-Physics who re.
June 22,1994, to review the circumstances surrounding the misadministration. An NRC medical consultant was ceived the order.The Chief NMTand the NMTwcre not familiar with the magnitude of the radionuclide activities engaged to assess the effects of the misadministration on that are used in prostate implant procedures. The NMT the patient. The medical consultant reviewed the events did not inform the Chief NMT as to the activity received.
and the mitigating actions that the licensec had taken to The Chief NMT was confused by the two telephone calls mim,mize the impact of the misadministration on the pa-tient. The consultant advised NRC that the licensec's ac-that were received from Medi-Physics subsequent to placing of the order, but failed to act to clear the confu.
tions appeared appropriate. On June 23,1994, NRC Re-sion. The licensee did not have any procedure that re.
gion 1. in consultation with the NRC Office for Nuclear quired a comparison of the material ordered and the ma.
Material Safety and Safeguards (NMSS)and the NRC Of-terial received. 'lhe YNIIH dosimetrist failed to notice fice for Analysis and Evaluation of Operational Data, up-that the activity of the seeds was 10 times higher when he graded its inspection effort to an Augmented Inspection logged out the seeds.The bcensee did not have a procc-Team (Aff). NMSS contacted the U.S. Department of dure that required an independent verification of the ac-Energy's Idaho Na tional Engineering Laboratory (INEL),
tivity that was being loaded into the implant needles.'the W> formed a team of consultants to provide technical authorized user relied totally on the dosimetrist and did suprt to the Arr. The AIT and INEL support consul-tai. returned to The %illiam W. Backus Hospital on not verify the actwity of the seeds. Dual control (by the licensee and YNHH) of the radiation safety program re, J une 28,1994, and also to YNH1I. NRC Region I issued a lated to brachytherapy procedures caused the YNHH to press release on June 23,1994, and the AIT held a public assume that the Chief NNfr was familiar with the order-exit meeting with the licensee at The William W.13ackus ing of the radioactive material and did not need additional Hospital on July 7,1994. NRC has received the informa-tion gathered on the incident by INEL support team and training.
incorporated this information in the AIT report issued to the licensee on August 4,1994 (Ref.12). !n a letter to the Actions Taken to Present Recurrence licensee dated August 10,1994, NRC indicated that its re-view of the AIT report noted two apparcru violations:(1) 1.icensee-The licensee made a commitment to volun-10 CFR 35.32(a); and (2) 10 CFR 35.25(a)(Ref.13). NRC tarily suspend its brachytherapy program until written au-will discuss these apparent violations at an Enforcement thorization is granted by NRC to resume the program.
Conference scheduled for August 24,1994.
This comnntment was documented in a Confirmatory Ac-tion Letter (Ref. I1).The licensee was considering a re-This event will be further updated when additional infor-quirement that radioactise sources be assayed prior to mation becomes available.
Agreement State Licensees The 29 Agreement States have approximately 15,000 ac-Appendix A(see EventType3in'lhble A-1)of thisreport tive material licenses for the use of byproduct materials in indicates that a therapeutic exposure to a part of the body industrial, medical, and academic applications. Proce-not scheduled to receive radiation can be considered as an dures have been developed for Agreement States to AO.
screen events using the same criteria and guidelines as NRC, and to report those events that have been deter.
Date and Place-August 4,1993: Memorial Medical Cta-mined to be significant enough to be considered as abnor-ter; Lufkin Texas, mal occurrences (AOs). During this period, the Agree-ment States reported four AOs as of August 3,1994.
Nature and Probable Consequences-On August 4,1993, brachytherapy treatment began on an obesc 90-year-old patient using a Delclos vaginal cylinder implant. Two ce-sium-137 implw sources of 25 milligram radium-equi.
AS 94-2 h1edical Hrachytherapy valent strength (2323.6 megabecquerel [62.8 millicuric])
h1isadministration at were h3ade J at 2:40 p.m. for a 20-hour treatment of 3000 blemorial hledical Center in centigray (cGy)(3000 rad).Thc estimated dose to the ab-domen due to the prescribed procedure would be 20 cGy Luth,n,,l'exas (20 rad).
i 9
NUREG-0090, Vol 17, No. 2
Abnormal Occurrences,2nd Otr CY94 The implant was secured at the implant site with surgical Appendix A (see Example 11 of "For All Licensees")of tape. During the treatment period, the patient became this report notes that serious deficiencyin management or distressed and was repositioned to ease her breathing.
procedural controls in major areas can be considered an
'lhe implant placement was last verified nt 6.00 a.m. on AO.
August 5.1993. At 10:30 a.m. that day, the doctor termi-nated the treatment. At the time he noted that one im-Date and Place-February 23,1994: Illa 7er Inspection; plant was positioned on the patient's abdomen. The doc-Texas City, Texas.
torbelieves that the repositioning of the patient may have dislodged the implant and the tape pulled the implant Nature and Possible Consequences-On February 23, onto the patient's abdomen.The doctor indicated that the 1994, a radiography crew was radiographing welds on a tape was the only method used to secure the implant be-30.5-centimeter (cm) (12-inch) diameter pipe line in a cause of the design and location.
1.5-meter (5-feet) dcep ditch at Amoco Pipeline, using a 3552 gigabecquerel (96 curie) iridium-192 source. They The hospital's radiation physicist calculated that the skin had experienced difficulty with the source exiting from dose rate from the implant was 150 cGy (150 rad) per hou r.
and retracting into the camera carlier in the day. In trying if the implant was on the patient's abdomen for 4.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />, to retract the source to the shielded position after a radio-the unintended doses would have been 675 cGy (675 rad) graph, it was apparent from the survey meter readings to the abdomen and 2325 cGy (2325 rad) to the tumor.
that the source was in an unshicided position. In working This is a 655 cGy (655 rad) unintended to the abdomen and the crank-outs, the source was pushed from the camera a 675 cGy (675 rad) underdose to the tumor. A review of but would not retract into the camera which indicated a personnel monitoring records for the doctor and nurses source disconnect. The radiographer got a 2.5-cm caring for the patient indicated there were no elevated ra-(1-inch) thick lead sheet from the radiography truck and diation exposures.The patient was informed of the inci-covered the source in the guide tube. He then sent his dent.
helper to get the Amoco inspector, but by that time it was dark.
On September 2,1993, the patient was examined by her doctor and no evidence of radiation damage to the abdo-
'lhe radiographer had his helper rope off a larger area and men was noted.The patient has since died. (Ihe misadmi-stay at a distance from the source. He then asked the nistration did not contribute to the patient's death.)
Amoco inspector to call the radiography Radiation Safety Officer (RSO), to tell him that everything was undercon-Cause or Causes-Repositioning of the patient to reh. eve trol and that the radiographer could handic the situation.
breathing distress was the probable cause of the implant The radiographer then disconnected the guide tube and
'CIUC"II""-
the source fell into the mud at the bottom of the ditch. In picking up the source from the mud with channel-lock pli-Actions Taken to Prevent a Recurrence ers the source shpped, and reaching to straighten the pig-ita tail with his hand he apparently touched the source in the l.icensee.lhe hosp. l increased nursm.g m-semce process. Ile placed the pigtail into the camera, intending training with emphasis (m source and implant apparatus to place the source capsule in first, but the survey meter identification, and the importance of verilymg implant ndicated that the source was still extending from the cam-placement during each patient check. The doctors are re-cra.
j viewing different means to secure these devices in pa-I' " lS-The radiographer then removed the pigtail and placed it under the lead sheet.1Ic removed the lock-box from the State Agency 'the State agency investigated the incident camera, inserted the source end of the pigtail, replaced and reviewed care procedures for radiation therapy pa-tients for violations. No violations were noted. 'the State the lock-box, and locked it.,ihe source was now secured in the shicided position.The barricades were taken down, agency also reviewed the subject matter covered during the equipment was loaded on the truck, and the crew re-the nurses increased in-service training.
turned to the office.The company did not notify the State agency of the disconnect.
This event is considered closed for the purpose of this report.
About 10 days later, the radiographer started experienc-ing discomfort in his left thumb and index finger and vis-ited a doctor for treatment on March 9,1994, and again on Radiat,on Burn of an March 14, and April 1,1994. On April 11,1994, the RSO AS 94-3 i
Industrial Radiographer at and the radiographer visited the State agency office and Olazer InSIlection in Texas "iW ** ia*a* **te "sc"cr ia*8 "
- t meident at this time, and found that the film badge read-City, Texas ing was 10.5 millisievert (1.05 rem) whole body.
NUREG-0090, Vol 17, No. 2 10
Abnormal Occurrences,2nd Qtr CY94 An inspection of the camera was performed by the radiog-AS 94-4 Lost Well Logging Source at raphy company's RSO the day after the incident. The
,IhCker Wirch.ne Service of.
company had ordered two model number 22 pigtails and sources from Industrial Nucicar Co., Inc. (INC), for the Corpus Christi, Texas company's Gamma Century radiography cameras. INC inadvertently sent the radiography company a model Appendix A (sce Exampic 11 of "For All Licensecs")of number 22 and a model number 23 pigtail, instead of the this report notes that serious deficiencyin management or two model number 22 pigtails that were ordered.'lhe two procedural cc'ntrols in major areas can be considered an models appeared similar but close examination revealed AO.
two differences. The model number 22 is manufactured with a 0.32-cm (0.13-inch) aircraft cable and a 1.9-cm Date and Place-April 19,1994; a job outside of Freer,
- Tbxas, (0.75-inch)conncetor, while the model number 23 is man.
ufactured with teleflex cable, which is the same as the Nature and Possible Consequences-On April 19,1994, a drive cable, and a 2.5-cm (binch) connector. 'lhe model well logging crew with Tucker Wircline Services com-number 23 is not made to be used in the Gamma Century pleted a job for Amoco Production Company at the Los camera."Ihe radiography company assumed that the two Lom s Ranch, Peters Estate, Well Number 1, which is 16 pigtails sent to it were cach a model number 22. The mod-miles south of Freer, Texas. They loaded all tools and el number 23 was mistakenly placed in the Gamma Centu-equipment onto their truck along with a 111 gigabecquer-ry camera being used at Amoco Pipeline and is apparently el (3 cune) americium /berylhum-214 source and its the cause of the disconnect. The radiography company shield, which were chamed in a left rear compartment.
thought it was placing a model number 22 in the Gamma
,The shield is a 36-centimeter (14-mch) diameter cylinder, Century camera. The California Radiation Control Pro-which is pamted purple and weighs 347 newtons (78 gram (INC is licensed in California) was informed of the pounds).
incident and investigated INC's mistake in sending the two different pigtails to the radiography company.
'Ihe well logging crew stopped in Frect to report to the office and noticed that the compartment was open.They checked the compartment and found that the source and Cause or Causes-The manufacturer's mistaken delivery shic!d were missing. They called the office and reported of a pigtail model number,different than the one ordered, the source missmg.
and the radiography company's assumption that the pig-tails received were the models ordered, resulted in a pig-The crew then back-tracked to the job site and attempted tail being used in a camera for which it was not manufac-to locate the source. The office also sent four people to turd.
help find the source. He source was not found, but a de-pression in the road with purple paint indicated the spot where the source and shield fell from the truck. It was ap-Also, the radiographer knowing he was not authorized to parent that someone had found and taken possession of do so, attempted to recover the disconnected source. He the source.
stated that due to the darkness and the mud in the ditch, he felt the circumstances warranted his attempt to recov-On April 20,1994, the State agency and licensee person-er the source. ihe radiographer was not tramed in source nel searched from ranch to ranch attempting to locate the recovery and had no previous experience with source dis' indhidual who had taken possession of the source. The connects.
source as not located and the licensee issued a formal press release to the arca newspapers and television sta-tions offering a reward.
Actions Taken to Present a Recurrence On April 21,1994, the Texas Board of Health issued a State Agency-The licensee and radiographer were cited press release.That afternoon a ranch owner called and re-for violations of the 'Ibxas Regulations for Control of Ra.
ported that he had found the source, and had placed it in diation and are being called in for an escalated Enforce.
his barn thinking it was a tool box. He agreed to meet the ment Conference.
next morning and return the source to the licensee.
On April 22,1994, the State agency and licensee person-Licensee-- Actions will be given at the Enforcement Con.
nel met with the ranch owner who returned the source to the licensee. The ranch owner had found the source be-ference.
side the road, and placed it in the back of his truck. He drove it to his barn and kicked the source off the back of This event will be updated when additional information his truck. State agency calculations indicated the ranch becomes available.
owner received less than 50 microsievert (5 millirem) 11 NUREG-0090, Vol.17, No. 2
Abnormal Occurrences,2nd Otr CY94 cxposure during the handling of the source.The required The licensee reported Ihat the misadministrations for all labelmg information was not on the shield.
seven patients w etc of similar magnitude. Possible conse-quences apply uniformly to the patients, and will be due to Cause or Causes 'Ihe source and shield were not prop-the dose received to organs near the implants.The licens-crly secured against accidental loss from the truck. Al-ce stated that all of the organs may have had similar com-though the well logging crew indicated they chained and plications even if there had been no overdose, and the locked the source and shield to the truck, circurnstances risks for complications have increased even though the do not support that contention.
possibility for cure has also increased.The referring physi-cians and patients have been notified, and patient follow-up has been implemented to include routine examina-l Actions Taken to Present a Recurrence
,tions.
Agency--The State agency cited the licensee for failure to Cause or Causes-The misadministrations were caused secure the source against accidental loss and violations of by a calculation error when the physicist entered the l
labeling recuirements. 'lhe licensee has been called in for wrong gamma constant when he edited the computer pro-l an escalated Enforcement Conference.
gram on March 29,1994.The physicist was attempting to convert from " milligram radium equivalent" to "millicu-Licenseedihe licensee will address the incident at its rie" and entered 3.256 " radium" instead of "millicurie,"
Enforcement Conference-resulting in an crror ratio that was 2.5 times greater than expected. (Ihe treatment planning system was developed
'lhis event is considered closed for the purpose of this by Computeriicd Medical System of St. Louis, Missouri.)
report.
The initial error was confirmed by another physicist who performed independent calculations utilizing a computer treatment planning system at another facility. A third Multi ile Brachytheral)y physicist has independently confirmed the calculations on AS 94-5 l
MISadniinistrations at all patients involved. An extensive record review was per-formed to ensure that no other patients were mvolved.
Cedars Medical Center in Actions Taken to Prevent Recurrence Mianli, Florida Ib prevent any possibility of a repeat of this oc-censee Appendix A (see Events 'Ippe [5}laj and [5][dl in 'labic currence, the licensee discussed the meident with the A-1)of this report notes that a therapeutic exposure to a manufactmu of the treatment planning system. The h-part of the body scheduled to receive radiation such that ansee aho mstituted more thorough training and super-the actual dose received is greater than 1.5 times the pre-vision of personnel in brachytherapy calculational meth-scribed dose, or the event (regardless of any health ef-ods, which includes mdependent hand calculations of at fccts) affects two or more patients at the same facility, can ast one key point for confirmation of dose.
be considered an AO.
State Agency-. 'Ihe State agency performed an on-site Date and Place-May 17,1994; Cedars Medical Center; visit on May 17,1994, to confirm the cause of the error, to Miami, I'lorida.
verify that appropriate corrective actions were being tak-en, and that proper review was taking place to determine Nature and Probable Consequences-On May 17,1994, if other patients were involved. An additional on-site visit an er ror was discovered in the treatment of seven patients was conducted on May 26,1994, to further investigate the with low dose rate cesium-137 (Cs-137) brachytherapy incident and to assure that proper patient notification and sources. One patient was treated with three Cs-137 follow.-up was taking place. The investigation found that sources during a gynecological implant procedure, during the cause of the event appeared to be as stated by the li-the period of May 4 through 8,1994Jlhe patient received censee. An independent medical consultant has been re-approximately 9130 centigray (9130 rad) to the treatment tained by the State to review the incident and advise on area, which was about 238 percent greater than pre-the appropriateness of all findings, conclusions, and pa-scribed. Further investigation of the incident revealed tient follow-up.
that the error involved six additional patients, with the pa-tients cach receiving doses ranging from 37 percent to l44 This event is considered closed for the purpose of this percent in excess of their intended doses.
report.
NUR EG-fXNO, Vol.17. No. 2 12
Abnormal Occurrences,2nd Qtr CY94 REFERENCES 1.
Preliminary Notification of Event or Unusual Occur-llospital forwarding Inspection Report No.
rence PNO-IV-94-010; March 23,1994; Docket No.
030-01265/94-001, Docket No. 030-01265, License 0304)2389.*
No. 06-06697-02, dated Junc 15,1994*
2.
Preliminary Notification of Event or Unusual Occur-9.
Letter from 'Ihomas T. Martin, Regional Administra-rence PNO-IV-94-010A; March 24, 1994; Docket tor, to Andrew I1. Hanoff, Vice President, Ambulato-No. 030-02339.*
ry Services, Stamford llospital forwarding Notice of Violation and Proposed Imposition of Civil Penalty -
3.
Letter from Leonard J. Callan, Regional Administra-
$ 1,250, Docket No. 030-01265, License No.
tor, NRC Region IV, to Lane Hasso, Chief Executive 06-06697-02, dated July 11, 1994.*
Officer, Deaconess Medical Center, Docket No.
030-02389, License No. 25-01051-01, dated May 26,
- 10. Letter from John 11. Martin, Regional Administrator, 1994.*
NRC Region III, to Randy Oostra, Assistant Vice President, lik>dgett Memorial Medical Center, for-4.
Letter from Samuel J. Collins, Director, Division of warding Notice of Violation, NRC Inspection Report Radiation Safety and Safeguards, to Mr. Lane Hasso, No. 030- 0200S/94001, Docket No. 030-02008, Li-Chief Executive Officer, Deaconess Medical Center, cense No. 21-411424-03, dated August 18, 1994.*
forwarding NRC Inspection Rcport 030-02389/94-01, Docket No. 0304)2389, License No. 25-01051-01,
- 11. Letter from Charles W. Ilehl, Director Division of dated June 10, 1994.*
Radiation Safety and Safeguards, to Brian J. Smith-wick, Vice President and Chief Executive Officer, 5.
Letter from by Leonard. J. Callan, Regional Admin-The William W. Backus Ilospital, forwarding Confir-istrator, N RC Region IV, to Lane Hasso, Chief Execu-matory Action Letter 1-94-010, Docket No.
tive Of ficer, Deaconess Medical Center forwarding 030-01287, License No. 06-11734-02, dated J une 23, Confirmatory Action Letter, Docket No. 030-02389, 1994.*
License No. 25-01051-01, dated May 3,1994.*
- 12. Letter from Charles W. licht Director, Division of 6.
Letter from Roy J. Caniano, Chief, Nuclear Materi-Radiation Safety and Safeguards, to Michael T.
als Safety Branch, NRC Region III, to George Soper, Moore, President and Chief Executive Officer, The Senior Vice President, Memorial llospital, forward-William W. Backus liospital, forwarding NRC Aug-ing Notice of Violation and Inspection Report mented Inspection Team (AIT) Report No.
030-17335/94001, Docket Nos. 030-17335 and 030-01287/94-001, Docket No. 030-01287, License 030-191173, License Nos. 13-18881-01 and 13-No. 06-11734-02, dated August 4,1994.*
18881-02, dated July 15, 1994.*
- 13. Letter from Charles W. Ilehl, Director, Division of 7.
Letter from W.L Axelson. Director, Division of Ka-Radiation Safety and Safeguards, to Michael T.
diation Safety and Safeguards, to Walter Davis, Jr.,
Moore, President and Chief Executive Officer, The Assistant Dean and Chief Facilitics Officer, Washing-William W. Backus Ilospital, forwarding NRC In-ton University Medical Center, forwarding inspec-spection Report No. 030-01287/944)01, Docket No.
tion Report No. 030-15101/94001, Docket No.
030-01287, License No. Ofr11734-02, dated August 030-15101, License No. 244X)063-10, dated July 11, 10, 1994.*
1994.*
8.
Letter from Charles W. licht, Director, Division of
- A m nailable for inspection, or cwying for a fee,in the NRC Radiation Safety and Safeguards, to Andrew I1. Han-Public Document Room. 21201. Street NW4Lmer I eveh. Washing-off, Vice President, Ambulatory Services, Stamford ton, DC 20037.
13 NUREG4)090. Vol.17 No. 2
Abnormal Occurrences,2nd Otr CY94 APPENDIX A ABNORMAL OCCURRENCE CRITERIA 1 1
The following criteria used to determine abnormal occur-5.
Any loss of licensed material in such quantities and rence (AO) were set forth in an NRC policy statement under such circumstimces that substantial hazard publish ed in the Rdera/ Register on February 24,1977 (Vol.
may result to persons in unrestricted areas.
42, No. 37, pages 1ff)50-10952).
6.
A substantiated case of actual or attempted theft or An event will be considered an AO if it involves a major diversion of licensed material or sabotage of a facil-reduction in the degree of protection of the public health ity.
or safety. Such an event would involve a moderate or 7.
Any substantiated loss of special nuclear material or more severe impact on the public health or safety and could include but need not be limited to:
any substantiated inventory discrepancy that 6 judged to be significant relative to normally expected 1.
Moderate exposure to, or release of, radioactive ma.
performance and that is judged to be caused by theft terial licensed by or otherwise regulated by the Com.
or diversion or by substantial breakdown of the ac-mission; countability system.
8.
Any substantial breakdown of physical security or 2.
Major degradation of essential safety-related equip, material control (i.e., access control, contamment, ment; or or accountability systems) that significantly weak-ened the protection against theft, diversion, or sabo-3.
Major deficiencies in design, construction, use of, or tage management controls for licensed facilitics or mate-9.
An accidental criticality [10 CFR 70.52(a)].
Examples of the types of events that are evaluated in de'
- 10. A major deficiency in design, construction, or opera-tail using these criteria are:
tion having safety implications requiring immediate remedial action.
For All Licensees
- 11. Serious deficiency in management or procedural 1.
Exposure of the whole body of any individual to 25 controls in major areas.
rem or more of radiation; cxposure of the skin of the whole body of any individual to 150 rem or more of
- 12. Series of events (v.hcre individual events are not of radiation; or exposure of the feet, ankles, hands or major importarice), recurring incidents, and inci-forearms of any individual to 375 rem or more of ra-dents with implications for similar facilitics (generic diation l10 CFR 20.403(a)(1)]. or equivalent expo-incidents) that create major safety concern.
sures from internal sources.
For Commercial Nuclear Power Plants 2.
An exposure to an individual in an unrestricted area such that the whole body dose received exceeds 0.5 1.
Execeding a safety limit of license Technical Specifi-rem in one calendar year [10 CFR 20.105(a)].
cations [10 CFR 50.36(c)].
3.
'lhe release of radioactive material to an unre.
2.
Major degradation of fuel integrity, primary coolant stricted area in concentrations which, if averaged pressure boundary, or primary containment bound-over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 500 times the regu.
ary.
latory limit of Appendix II,'lable II,10 CFR Part 20 3.
Loss of plant capability to perform essential safety
[CFR 20.403(b)(2)].
functions such that a potential release of 4.
Radiation or contamination levels in excess of design radioactivity in excess of 10 CFR l' art 100 guidelines values on packages, or loss of confinement of radio-active material such as (a) a radiation dose rate of
'On January 1.1994. changes toTitle 10 of the Code offedera/Regula-1,000 mrem per hour three feet from the surface of a thms Part 20 were promulgated. At the Commission's directive, the P ng a policy statement revising eriteria for vari-
"affis eurtently devel i
package containing the radioactive material, or (b) ous types of AOs. He changes pertment to the 10 CFR 20 revisions will release of radioactive material from a package in abo be included in that draf t polig statement. Upon Commission's ap-amounts prcater than the regulatory limit.
proval, the appropriate changes to this Appendix witl be published.
15 NUREG-0090, Vol.17, No. 2 l
Abnormal Occurrences,2nd Otr CY94 could result from a postulated transient or accident 2.
A major condition not specifically considered in the (e.g., loss of emergency core cooling system, loss of safety analysis report orTechnical Specifications that c(mtrol rod system).
requires immediate remedial action.
4.
Discovery of a major condition not specifically con-3.
An event that seriously compromised the ability of a sidered in the Safety Analysis Report (SAR) orTech-confinement system to perform its designated func-nical Specifications that requires immediate reme-tion.
dial action.
Medical Misadministrations 5.
Personnel error or procedural deficiencies that re-sult in loss of plant capability to perform essential As discussed in the Preface to this report, the NRC policy safety functions such that a potential release of ra.
statement on AOs was published before licensees were dioactivity in excess of 10 CFR Part 100 guidelines required to report medical misadministrations to the could result from a postulated transient or accident N RC.Therefore, during 1984, N RC developed guidelines (e.g., loss of emergency core cooling system, loss of for selecting such events for AO reporting. These guide-control axi system).
lines, which are summarized in 'lable A-1, augment the NRC policy statement.
For l'uct Cycle Licensees 1.
A safety ilmit of license Technical Specifications is As noted in the Preface, revised guidelines are currently exceeded and a plant shutdown is required [10 CFR being developed because new medical misadministration 5036(c)].
definitions became effective on January 27,1992.
I t
l l
I NUREG-0090, Vol 17, No. 2 16
Abnormal Occurrences,2nd Otr CY94
=
Table A 1 NRC Guidelines for Selecting Medical Misadministration Events for Abnormal Occurrence (AO) Reporting l
AO Heporting Threshold j
Event Type Diagnostic Exposure Therapeutic Exposure (1) Administering a radiopharma-If the improper administration if the improper administration i
ceutical or radiation from a results in any part of the results in any part of the body i
scaled source other than the body receiving unscheduled receiving unscheduled radiation, an one intended.
radiation, an AO report should AO report should be proposed for l
be proposed if:
any such event.
l (a) the actual dose to the If the parts of the body wrong body part is receiving radiation 5
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 Gose 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 i
receiving radi ttion 0.5 times that intended to the improperly would have above described body parts, or, received radiation anyway, had the proper administration (c) the above described body parts been used, an AO report should show signs of adverse health be proposed if:
effects greater than expected had the proper administration been used, or (a) the actual dose is greater (d) the event (regardless of any than five times that intended health effects) affects two or to the atx)ve 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 pharmaecutical 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 he_ith effects.
(3) Administering a radiophar-Same guidelines as for Same guidelines as for maceutical or radiation by a Event 'I}pe 1.
Event 'l}pe 1.
17 NUREG-0090, Vol.17, No. 2
Abnormal Occurrences,2nd Qtr CY94 Table A.1 (Continued)
AO Reporting Threshold Event 'I)pe Diagnostic Exposure Therapeutic Exposure route of administration other than that intended by the pre-scribing physician.
(4) Administering a diagnostic An AO report should be Not applicable.
dose of a radiopharma-proposed if:
ceutical differing from the prescribed dose by more (a) the actual dose is I
than 50 percent.
greater than five times the prescribed dose, or, (b) the event results in adverse health effects wo'rse than exoccted for the normal range of exposures prescribed for j
the diagnostic procedure.
(5) Administering a Not applicable.
An AO report should be therapeutic dose of proposed if:
a radiopharmaceutical I
differing from the prescribed (a) the actual dose is greater dose by more than 10 percent; than 1.5 times the prescribed or administering a therapeutic dose,or, radiation dose from a 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 of For either diagnostic or therapeutic exposures, an AO report should be events (regardless of the proposed for recurring events or a series of events (in which each individual number of patients or misadministration is not of major importance) that create a significant facilities involved).
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.
NUREG-0090, Vol.17, No. 2 is
Abnormal Occurrences,2nd Otr CY94 APPENDIX H UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES During Apal through June 1994, NRC licensees, Agree-discussed below contain a summary of information pres-ment States, Agreement State licensecs, and other in-ented in previous reports and any subsequent updated in-volved parties, such as reactor vendors and architect-en-formation provided during the reporting period. Those gineering firms, continued with the implementation of updated events which still require additional information actions necessary to prevent recurrence of previously re-will be discussed in future reports.
ported abnormal occurrences. 'the abnormal occu rrences Other NRC Licensees 86-25 Suspension of License for of potential criminal prosecution of the company. In the interim, the company took actions to resolve the issues Servicing Teletherapy and which led to the Order. The Order was revoked by the Radiography Units by NRC staff in 1987. 'Ihc Hearing proceedings, however, C""ti"" d-Advanced Medical Systems in Geneva, Ohio The DOJ determined not to undertake prosecution in the case, and the Stay on the Hearing proceedings was lifted
'l his abnormal occurre nce (AO) was originally report ed in in 1988. In 1990, the Atomic Safety and Licensing Board NUREG-0090, Vol. 9, No. 4," Report to Congress on Ab-(ASLAll) issued a summary disposition decision in the normal Occurrences," October-December 1986, under case, affirming the issuance of the Order.
the title " Suspension of License for ServicingTeletherapy and Radiography Units." At that time it was reported that The company appealed that decision. The Appeal was on October 10, 1986, the NRC Office of Inspection and considered initially by the ASLAB and, subsequently, by Enforcement issued an order suspending certain NRC-li-the Commission. On June 9,1994, the Commission de-l censed service activitics of Advanced Medical Systems, nied the company's Appeal, determining that the NRC l
Inc., of Geneva, Ohio. This action was taken after NRC staff had acted reasonably and had a substantial basis to determined that the firm had been using untrained and issue an Order effective immediately.
unqualified employees to senice cobalt-60 teletherapy This item is considered closed for the purpose of this re-units.The event was reported as an AO because:(1)it in-volved a moderate or more severe impact on public health port.
or safety; and (2)it involved a serious deficiency in man-apement or procedural controls.
92-18 Oncology Services Corporation in Indiana, Pennsylvania The AO report is updated and closed out as follows:
This abnormal occurrence (AO) was originally reported in On October 10,1986, the NRC staff issued an Order Sus-NUREG-0090, Vol.15, No. 4, " Report to Congress on pending license (Order)immediately suspending certain Abnormal Occurrences," October-December 1992, un-N RC-licensed senicc activitics of Advanced Medical Sys-der the title " Loss of Iridium-192 Source and Medical tems, Inc., of Geneva, Ohio. This action was taken after Therapy Misadministration at Indiana Regional Cancer the NRC staff determined that the licensec's empicyces Center in Indiana, Pennsylvania "
had been performing senice and maintenance on radi-ation therapy equipment at various medical facilitics, At that time, it was reported on November 16,1992, On-even though:(1)the employees lacked required training; cology Senices Corporation had lost a 159,000 gigabec-(2) did not have radiation deicction and monitoring equip-querel (4.3 curic) scaled iridium-192 source from a high ment or the required senice manuals; and (3) had ob-dose rate (HDR) remote afterloader brachytherapy unit jected to performing maintenance without proper train-at its Indiana Regional Cancer Center in Indiana, Penn-ing.
sylvania.The source had:(1) broken off of the HDR unit w hile in senice; (2) subsequently killed a patient with a
(
Advanced Medical Systems fded a request for a Hearing 1,600.000 centigray (1,600,000 rad) absorbed dose, after on the Order,'lhe ilearing was delayed at the request of remaining on the patient's body for almost 4 days; and (3) the U.S. Department of J ustice (DOJ) pending evaluation caused 94 other people to receive radiation ranging from 19 NUREG-0090, Vol.17, No. 2
i Abnormal Occurrences,2nd Otr CY94 400 microsievert to 220 millislevert (40 millirem to 22 The AO report is updated as follows:
rem). %e source was eventually mixed by accident with medical biohazard waste and was subsequently found and NRC conducted a special safety inspection limited to recovered at the site of a company that had been con, gathering additional information on thc licensee's Quality tracted to dispose of biological waste material.
Management Program (QMP) on March 8,1994. An Open Enforcement Conference to discuss the apparent The event was reported as an AO because:(1)it involved a vio!ations identified in the December 1,1993, and the therapeutic dose that was greater than 1.5 times the pre-March 8,1994, inspections, their causes, and the licens-scribed dose; and (2) it involved exposure to an individual ee's corrective actions was held on March 11,1994. After in an unrestricted area such that the whole body dose re-consideration of the information presented by the licens-ceived exceeded 0.5 rem in one calendar year, ec, a Notice of Violation (NOV) was issued to the licensee on March 31,1994. The licensee has 30 days to respond to the NOV.
his AO report is updated as follows:
'lhe licensee responded with corrective actions by letter He licensee provided information to NRC Region I dated April 21,1994. The licensec admitted three of the which provided a basis to relax the Order Suspending Li-mlations and presented corrective actions acceptable to cense (Order) in full for its Pittsburgh and Ilarrisburg, C. %c licensee demed a fourth violation of Part Pennsyivania, facilitics. All other locations authorized by 35.32(a) of,ritte 10 of the Code of Federal Regulations, the license remain under suspension. The licensee re-which mvolved establishment of a QMP having written quested and was granted a IIcaring on the Order. Inter-pobey and procedures requiring that the final treatment rogatories have been answered by the NRC staff, and pl n and related calculations be done m comphance with members of the NRC staff have been deposed by the li-the written directive. liowever, the licensee did present censec's counsel.
modifications toits OMP to ensure an mdependent verifi-cation of patient treatmer~ wtup in the future. NRC is On May 31,1994, NRC Region I, after consultation with evaluatmg the hcensce's + nse.
the Commission, issued a Notice of Violation (NOV) and Proposed imposition of Civil Penaltics for $280.000. nc His item is corsidered closed for the purpose of this re-NOV was based on the N1(C Incident Investigation Team port.
Report (NUR EO-1480), which was published in February 1993, and NRC Inspection Report 030-31765/92 01, which was sent to the licensee on December 23,1992.7 94-2 Medical Ilrach}'theraE7 The NOV classified two violations in Section I and two viola-Misadministration at Hospital tions in Section H as Severity Level I problems, and the 17 Metropolitano in Rio Piedras, violations m its Section HI as a Severity Level H probicm.
Puerto Rico This event will be further up< lated when additionalinfor-
,This abnormal occurrence ( AO) was on..gmally reported m.
mation becomes availabic.
NUREG-0090, Vol.17, No.1, " Report to Congress on Abnormal Occurrences," January-March 1994. At that 93-13 Mcdical Ilrachytherapy time it was reported that on December 11,1993, a patient interv ned during brachytherapy treatment by removing Misadministration at an implant and then mtormmg the nurse of her action.
Mountainside ilospital in owe nurse informcd iac supc< visor who faiicd to reaiize Montclair, New Jersey the urgent nature of the situation.) The patient then re-turned the implant to a location next to her thigh beneath the bed l'nen, where it lay for 2 and l/2 hours before being This abnormal occu rrence (AO) was originally reported in discovered by the attending physician. De event was re-NUREG4X)90, Vol.16, No. 4, " Report to Congress on Abnormal Occurrences," October-December 1993. At p rted as an AO because it mvolved a therapeutic expo-surc to a part of the body not scheduled to receive rads-that time it was reported that on December 1,1993, during ation.
a routine inspection. NRC identified a therapeutic misad-ministration involving a high dose rate remote afterloader He AO report is updated and closed out as follows:
which occurred on July 1,1993. Because of an error m se-
. lecting the wrong transfer tube, the source delivered a The NRC's medical consultant reviewed the events sur-negligible dose to the tumor but exposed the face, the rounding the misadministration and concluded that the lenses of the eyes, the thyroid, and the wholebody to un-dose delivered to the intended treatment site was suffi-scheduled radiation.The event was reported as an AO be-cient to treat the carcinoma. The consultant also con.
cause it involved a therapeutic dose that resulted in a part cluded that acute or late effects are not expected as a re-of the body receiving unscheduled radiation.
sult of the unplanned dose to the normal tissue.
NUREG41090, Vol.17, No. 2 20 l
Abnormal Occurrences,2nd Qtr CY94 NitC held an Enforcement Conference with the licensee neither patient suffered clinical side effects from the dose on May 20,1994, to discuss the inspection findings and ac-received.
tions taken by the licensee in response to the misadminis-tration. On J une 13,1994, N RC Region 11 issued a Notice On June 16,1994, an enforcement conference was con-of Violation with a Severity Level IV violation for failure ducted by telephone with the licensce's representatives.
of the licensee to implement procedures for emergency Representatives of North Hills Passavant llospital were action w hen control of byproduct rnaterial was lost, and a also in attendance by telephone because the licensed ma-Severity I evel V violation for failure of the licensee to terial (cobalt-60 in a teletherapy unit) had been trans-submit a written misadministration report to the NRC ferred to them and the licensec requested termination of within 15 days of the discovery of the misadministration its license. As a result, NRC Region I issued a Notice of (Severity Levels I through V range from the most signifi-Violation (NOV) on June 21,1994, classifying the three cant to the least significant). No civil penalty was assessed violations cited in the aggregate as a Severity Level HI for the violations. The licensee's corrective and preven-problem. No Civil Penalty was assessed due to the licens-tive actions will be reviewed during the next NRC inspec-ec identifying the misadministration and the associated tion of the licensed program, violations, its prompt and comprehensive corrective ac-tions, and past good enforcement history. The licensec This item is considered closed for the purpose of this re-has 30 days to respond to the NOV.
port.
'lhe licensee responJed with its corrective actions which were reviewed and found acceptable to the NRC. The li-94-3 Teletherapy 51isadministration cense will be terminated by Region i.
at Triangle Oncology This item is considered closed for the purpose of th.is Assoc. tes in Pittsburgh, report.
ia Pennsylvania 94-h1cdical ilrachytherapy This ahnormal occurrence ( AO)was originally reported in NUREG4090, Vol.17, No.1, " Report to Congress on bliSadministration at KeeSlcr Abnormal Occurrences," January-March 1994. At that hiedical Center at Keesler Air time it was reported that between December 13 and 17, 1993, two therapeutic misadmimstrations occurred be.
F,orce Isase in 11iloxi, cause of calculation errorsinvolving the depth of the dose h]jsgiggjppj gis en to each of two patients.The event was a therapeutic misadministration that af fected two or more patients at This abnormal occurrence (AO) was originally reported in the same facihty regardless of any health effects.
NUREG4)090, Vol.17, No.1, " Report to Congress on Abnormal Occurrences," January-March 1994. At the
'lhe AO report is updated as follows:
time it was report that on January 13,1994, the failure of a high dose rate remote afterloader brachytherapy source
'lhe licensee implemented and required the use of a to retract resulted in a sing!c overexposure. The overex-stamp to be placed on the written directive that includes a posure resulted in an absorbed dose that was 75 percent prompt to write in the site. methal, daily dose, fractions, greater than prescribed.The event was reported as an AO total dose, depth of calculation, spinal blocks, other because it was a therapeutic exposure to a part of the body bh>cks, and date, Previously boost fields had been infor-scheduled to receive radiation such that the actual dose mal hand written directives on the patients treatment received was greater than 1.5 times the prescribed dose.
chart. The licensee also formalized in writing its previous informal requirement to include the written directive
'the AO report is updated and closed out as follows:
with all requests for dosimetry calculations from the llea-ver facility. Finally the licensee revised its weekly chart The NRC medical consultant reviewed the events sur-check procedure to include checks of charts twice per rounding the misadministration and concluded that no week as was previously performed prior to December 1, harm is to be expected from the excess dose received by 1993.
the patient as a result of the misadministration.
NRC is teviewing the ticensee's April 7,1994 misadminis-The equipment manufacturer evaluated the equipment tration report and the findings of the December 28 and 29, used in the administration of the treatment and found 1993, NRC inspection. The NRC medical consultant re-that there were no equipment malfunctions. In addition, view ed the circumstances surrounding the misadministra-the equipment manufacturer evaluated the stresses the tion and concluded that in both cases there was no evi-source wire was subjected to during the event and found dence of adverse radiation reaction in the breast, and no abnormalitics. Southwest Research Institute 21 NUREG4)090, Vol.17, No. 2
_----._.__-____m____
Abnormal Occurrences,2nd Otr CY94 performed a mechanical failure analysis of the source wire
'Ihis abnormal occurrence (AO) was originally reported in and needic configuration, and found no evidence of radi-NUREG-0090, Vol.17, No.1, " Report to Congress on ation-induced embrittlement of the needle or any other Abnormal Occurrences," January-March 1994. At the
)
abnormalities in the needle.
time it was reported that on January 27,1994, an unpro-grammed high dose rate remote afterloader brachythera-On May 27,1994, NRC issued Information Notice 94-37 py source was allowed to travel beyond the treatment site alerting NRC licensees of the incident.
into the left lung area.'Ihe treatment resulted in the pre-scribed 500 centigray (500 rad) effective dose equivalent On July 5,1994, NRC Region IV issued a Notice of Viola-being delivered to the left lung instead of the trachea tar-l tion with a Severity Level IV violation for failure of the get site.The event was reported as an AO because it was a licensee to notify the patient in writing within 15 days of therapeutic exposure to a part of the body not scheduled the misadministration. (Severity Levels I through V range to receive radiation.
j from the most significant to the least significant.) 'the li-censee's corrective and preventive actions will be re.
The AO report is updated as follows:
viewed during the next NRC inspection of the facility.
The NRC medical consultant reviewed the events sur-r unding the misadministration and concluded that there This item is considered closed for the purpose of this should be no nsk of delayed complications secondary to repod.
l this misadministration and that the patient is receiving ap-propriate follow-up care for her illness.
94-7 Medical tirachytherapy NRC Region 11 has scheduled an Enforcement Confer-Misadministration at ence to discuss the inspecticn findings with the licensee.
Alexandria IIospital in 1his event will be funher up ated when additionalinfor-Alexandria, Virginia mation becomes availabic.
Agreennent State Licensees AS 88-5 Medical Teletherapy This abnormal occurrence (AO) was originally reported in Misadministrat. ion at Sacred NUREG-0090, Vol.11 No. 4, " Report to Congress on Abnormal Occurrences," October-Dece?, Der 1988. At IIcart Ilospital in the time it was reported that over a 13-month period 33 Cumberland, Maryland patients undergoingbrain cancer treatments had received i
therapeutic radiation exposures from a cobalt-60 tele-therapy machine that exceeded 10 percent of the pre-l 1his abnormal occurrence (AO) was eriginally reported in scribed dose in each case. The event was reported as an j
NUREG-0090, Vol. I1, No. 4, " Report to Congress on AO because it involved a moderate or more severe impact Abnormal Occurrences," October-December 1988. At on public health or safety.
I the time it was reported that on September 2,1988, an 81-year-old patient received a therapeutic dose of 1400 The AO report is updated as follows:
centigray (1400 rad) to a part of the body not scheduled to receive radiation.1he event was reported as an AO be-NRC is continuing to work with the State of Maryland to i
cause it involved a moderate or more severe impact on obtain more information regarding these occurrences.
public health or safety.
AS 93-11 Found Source at Scrap 1he AO report is updated as follows:
Metal Fac.lity in Magnolia, i
NRC is continuing to work with the State of Maryland to Arkansas obtain more information regarding thue occurrences.
'Ihis abnormal occurrence (AO) was originally reported m.
NUREG-0090, Vol.16, No. 4, " Report to Congress on Abn nn 1 Ocumnces, Oct bu-Duembu M3." At AS 88-6 Medical TeletheraE},
that time it was reported that on March 24,1993, a ce-Misadministration at Sacred sium-137 source was found at the 'nliman Scrap Yard in IIcart IlosIlital in Magnolia. Arkansas. The source had an activity of 148 gi-gabecquerel (4 cune), and was part of a Texas Nuclear Cumberland, Maryland Model 5176 gage. 'lhe event was reported as an AO be-NUREG4X)90. Vol.17, No. 2 22
Abnormal Occurrences,2nd Otr CY94 cause it involved the loss of licensed material in such length as intended. The events were reported as an AO quantities and under such circumstances that substantial because they involve therapeutic doses that resulted in hazard may result to persons in unrestricted areas, any part of the body receiving unscheduled radiation.
It was determined that the owner of the source was the The following update and closcout information was Elk Roofing Company of Stevens, Arkansas, and that Elk supplied in a fmal AO report that was issued by the State of Florida.
Roofing Company would pay for the final disposal of the source by Texas Nuclest who manufactured the Model
'Ihis mis dministration was originally selected for abnor-5176 gage.The Model 5176 gage and its source were prop-mal ecurrence (AO) reporting because it met the guide-erly disposed of by Texas Nuclear. This item is considered lines given in Appendix A (see Event Vpe 3 in 'Iable A-1) closed for the purpose of this report.
of this report, wherem it is noted that a therapeutic expo-sure that results in any part of the body receiving unsched-AS 93-13 Lost or Stolen Radiation uled radiation can be considered an AO. As a conse-quence of more information becoming available, the Source at BI,B Instruments, criteria have been expanded to include that given in Ap-Inc., in Midland, Texas pendix A (see Event Vpe 5[dj inihble A-1) wherein it is noted that a therapeutic exposure that affects two or more This abnormal occurrence (AO) was originally reported in patients at the same facility (regardless of any health ef-NUREG-0090, Vol.16, No. 4, " Report to Congress on fccts) can be considered an abnormal occurrence.
Abnormal Occurrences, October-December 1993." At Date and Place-Between September 28 and November the time it was reported that a 555 gigabecquerel (15 cu.
24, 1993; Mt. Sinai Medical Center; Miami Beach, rie) americium / beryllium source was not located during Florida.
an inventory and may have been lost or stolen.The event was reported as an AO because it involved a loss of li-Nature and Probable Consequences-The Mt. Sinai censed material m such quantities and under such circum-Medical Center in Miami Beach, Florida, initiated a gyne-stances that a substantial hazard may result.
cological high dose rate (HDR) brachytherapy treatment program M @cmbu W. A % cts Wohe-The State of1 bras has since reported that the source is tron device containing a 300 gigabecquerel (8.1 curic) still missing, and is believed to be stolen. The State is at-seaW soum was M A numbu of accesso&s tempting to involve its Attorney General's office in the in.
used for these treatments were also purchased. These ac-vestigation.
cessones meluded gynecological applicators and transfer tubes used to connect the patient applicator to the treat-This report will be updated when additional information becomes available.
During the period September 28 to November 24,1993, eight patients with a variety of gynecological cancers were AS 93-15 Medical Brach)'theraIU treated with a total of 23 separate HDR brachytherapy m-Misadministration at Mt.
sertions. / discrepancy between the length of the transfer Sinai Medical Center in tube, used to connect the patient applicator to the treat-ment machm, e, and the length of travel indicated in the M,lan11 BeacII, Flor,da software program was discovered.
i This abnormal occurrence (AO) was originally reported in
'Ihe transfer tubes that connect the applicator in the pa-NUREG-0090, Vol.16, No. 4, " Report to Congress on tient to the treatment machine can be ordered in either Abnormal Occurrences, October-December 1993" using 74-centimeter (cm) (29-inch) or 120-cm (47-inch) length.
information supplied in an interim AO report issued by The 74-cm (29-inch) length is most commonly used.The the State of Florida. At that time it was reported that be-applicator, plus the 74-cm (29-inch) transfer tube, togeth-tween September 28 and November 24, 1993, eight pa-er, allow for a maximum source extension of 100 cm (40 tients had received therapeutic exposures to parts of the inch). The applicator, plus the 120-cm (47-inch) transfer body not scheduled to receive radiation during 22 treat-tube, together, allow for a maximum source extension of ments.The exposures were delivered by a high dose rate 150 cm (59 inch).The computer treatment planning soft-remote afterloader brachytherapy unit using an iridi.
ware programs the source extension to a maximum of 100 um-192 (Ir-192) scaled source of approximatcly 300 giga.
cm (40 inch) or 150 cm (59 inch).The correct combination becquerel (8.1 curic) activity. 'Ihe cause of the misadmi-of transfer tube length and software indexing for 100 cm nistrations was the use of a 1.5 meter (4.9 foot)
(40 inch) or 150 cm (59 inch) source extension must be obstetrical / gynecological (OB/Gyn) transfer tube /appli.
combined to achieve correct source placement in the cator combination length instead of a 1.0 meter (3.3 f(xit) patient.
23 NUREG-0090, Vol.17, No. 2 1
Abnorrnal Occurrences,2nd Otr CY94 The transfer tubes used for the first 23 treatments were Actions Taken to Prevent Recurrence 120 cm (47 inch)long. When combined with the applica-tor, the length of maximum source travel was 150 cm (59 la,censee,Ihe licensee took immediate corrective ac-inch). Ilowever, the computer software used for planning tions as described in the m, terim abnormal occurrence re-the !!Dit treatment indicated that the maximum source travel could only be 100 cm (40 inch). Therefore, during p rt.'lhe license is still on a " storage only" status until all issues of concern are addressed.
these treatmen ts, the source stopped 50 cm (20 inch)short of the applicator inside the patient.'lhis placed the radio-active source approximately at each patient's knees.
State Agency 'Ihe State agency retained an independent medical consultant who reviewed the gynecological iIDR
'lWo of the patients sustained third-degree skin inj.ury at procedures and the management of the patients involved the site where the iridium source resided in the long trans-in the misadministration. 'the consultant's report verified fer tube. Five of the patients had no physical manifesta-the initial findings and confirmed that appropriate patient tions as a result of the misadministration. Follow-up eval-follow-up occurred. The State will assure that the find-
-~- ~ ^
uations continue to be made.
ings of the investigation are properly addressed prior to the licensee resuming its HDR brachytherapy treatment Cause or Causes-The misadministrations were caused by program. Enforcement action has been proposed by the treatment unit difficulties as well as the licensee s proce-State due to several regulatory violations found during dural weaknesses. The transfer tubes were not easily dif' the investigation.
ferentiated and the software was not programmed to ac-count for the correct transfer tube length. In addition, the complete treatment procedure was not simulated which This item is considered closed for the purposes of this would have revealed the problem.
report.
h i
t l
NURL G 4090, Vol.17, No. 2 24
Abnormal Occurrences,2nd Otr CY94 APPENDIX C OTHER EVENTS OF INTEREST The following items are described because they may possi-occurrences.
bly be perceived by the public to be of health or safety sig-nificance. The items did not involve a major reduction in the level of protection provided for public health or safe-During the period April through June 1994, three "Other ty; therefore they are not reportable as abnormal Events of Interest" were reported.
Other NRC Licensees
- 1. Deliberate Coverup of an Error in NRC inspector, (2) took prompt and comprehensive disci-Diagnostic Radiopharmaceutical plinary actions against the involved individuals and other corrective actions to prevent recurrence, and (3) the li-Administration at the llospital of censee has had an overall good enforcement history. In the Um.versity of Pennsylvam.a in recognition of the N RC's understanding of the actions the Philadelphia, Pennsylvania licensee had taken, no further information wa9 requested from the licensec and no response was required to the NRC's letter of June 21,1994. The CNMT involved in the lhe NRC staff has consulted with the Commission re-willful violation of 10 CFR 35.53 was issued a letter dated garding a proposed Notice of Violation (NOV) to the 11os-June 21,1994, informing him that similar deliberate mis-pital of the University of Pennsylvania (HUP), and is.
conduct in the future could resud in significant enforce-suar cc of a letter to an unlicensed IlUP cmployee for deliberate violations of an NRC regulation. Consultation ment action being taken against hi n as an individual as with Ihe Commission is required because the enforce.
provided in 10 CFR 30.10 and 10 CFR Part 2, Appendix C, ment action is being proposed more than 18 months after and that violations of 10 CFR 30.10 also i. ay lead to crimi-the referral.,f the matter to the NRC's Office ofInvesti.
nal pra cution.
gations (01).
This event is included as an "Other Events of Interest' be-cause it was seriously considered by one ar more of the On October 1,1992, NRC's 01 initiated an investigation NRC staff offices for ab normal occurrence (AO) apphea-in response to information received durNg a routine in-bility, but it was subsequently found that this ncident did spection at the IIUP on September 14,195 2.1he licensee n tmeetthecritcriain 10CFR35.2tobeang dmmtstra-staff inforn ed the inspector that on Febri ary 20,1992, a tion or an AO.
Certified Nuclear Medicine TechnologQt (CNhfr) at IlUP failed to record the measuremenu (assays) of two
- 2. Order SusI>cndinE License and Demand radiopharmac eutical dosages, as required by NRC regula-For Information Issued to Western tions, in an attempt to cover up an incident. The incident occurred when a nuclear medicine patient was injected Industrial LRay Inspection with the wrong diagnostic technetium-99m radiopharma-Company, Inc.. in Evanston, Wyoming.
ceutical, which was actually intended for another patient.
As a result of this error, two new dossa had to be drawn, On June 16,1994, an Order Suspending License (Effec-one for each patient.
tive immediately) and Demand for Information (Order) was issued to Western Industrial X-Ray inspection Com-
'lhe licensee performed its own investigation and conse-pany, Inc. (WlX), in Evanston, Wyoming, because NRC quently terminated the CNMT, allowed another technol-inspections and investigations revealed a pattern of willful ogist to resign, and took disciplinary action against other and repetitive noncompliance. T: e violations included:
involved technologists. The terminated CNMT is in-(1) failure to perform an evaluai. ". of a radiographer as-1 i
volved in NRC-licensed activitics at another facility.
sistant's radiation exposure following an incident; (2) fail-ure to perform a radiation survey of a radiography device On June 21,1994, after consultation with the Commis-followirig each radiographic exposure; (3) failure to super-sion, a NOV was issued to the licensee for a willful viola-vise assistant radiographers performing radiographic op-tion of litrt 35.53 of Title 10 of the Code of federalRegtda-crations: (4) failure to provide tha NRC a report of an in-tions (10 CFR 35.53). at a Severity Level 111. !!owever, no dividual's radiation exposure following the individual's Civil Penalty was assessed because the licensec (1)identi-termination of employment; and (5) failure to ensure that fied the incident and brought it to the attention of the alarm ratemeters worn by radiography personnel were 25 NUREG-0090, Vol.17, No. 2 l
Abnormal Occurrences,2nd Otr CY94
=
calibrated at the required frequencies. Several other vio-exposure devke, was probably not turned on at the time of lations, some of which were repetitive, were identified the incident.
which further ir dicate that the licensec's program had not been conducted in accordance with requirements.
Both the radiographer and radiographer's assistant pro-vided written reports of the incident to the comp:
presi-dent and RSO shortly after the incident. However, the re-Many of the violations are related to a July 31,1993,inci-p rts contained false information regarding the level of dent involving a WIX radiographer and radiographer's as-supervisi n pr vided to the radiographer's assistant and sistant who were performing radiography on a pipeline.
the fact that radiation surveys of the exposure device were
'Ihe incident occurred while the radiographer's assistant n t performed as required.
was performing radiography without supervision by the radiographer, contrary to NRC rcquirements.While mov-In response to requests made by NRC during its inspec-ing the radiographic exposure device from one lowtion to tions and investigations, the licensee's RSO conducted an another, the radiographer s assistant noticed that her sur-cvaluation to determine the radiation dose received by vey mstrument was " pegged, and that her self-reading the assistant.The licensee subsequently reported that the pocket dosimeter was offscale, both mdications that the assistant had received a whole body dose equivalent of 60 device's radioactive source had not been returned to its millisievert (6 rem) during the incident.
fully shielded position or had been jostled from its shielded position when the device was moved.
Other viclations identified during NRC's inspections and investigations included failures to: (1) ensure that pocket The radiographer's assistant later admitted that she had dosimeters worn by radiography personnel were checked not performed a radiation survey of the device following for correct response at 12-month intervals; (2) perform the last exposure and that she had failed to k)ck the source and record qtnrterly audits of radiography personnel (3) in its shicided position prior to moving the device. In addi-maintain constant surveillance and immediate control of tion, the radiographer's assistant also admitted that her licensed material;(4) submit to NRC a quality assurance alarm ratemeter, a device which could h9ve alerted her to program for use of shipping containers; and (5) leak test the fact that she war in a radiation field while moving the scaled sources.
Agreement State Licensees
- 3. Overexposure of an Industrial camera, set new film, and performed a radiograph. After Radiographer at BlX Testing cranking in the source, the trainee waited for the trainer t return fr m developing the film.
Laboratories in Haytown, Texas When the trainer returned, he noticed that the survey me-This event is being reported as an "Other Event of Inter-ter was reading full scale. The trainer then turned the est" because it was a non-routine event which resulted in cr nk-out handle approximately threefourth of a turn, exposure to plant personnel, but which was below the ab-placing the source in the shicided position.
normal occurrence threshold.
Date and Place-March 23,1994; IHX 'Ibsting Laborato_
rhe trainer then set up for another shot and the trainee checked his pocket dosimeter, finding it to be off-scale.
ries; llaytown, 'lexas, The job was shut down and the office was called. An indi-Nature and Possible Consequences-On the morning of vidual at the office (not the Radiation Safety Officer)
March 23,1994, an industrial radiography trainer and asked how much work was needed to complete the job, trainee were working at Merichem in llouston, Texas.
and that someone would replace the trainee. lf he could
'ihey were radiographing pipe welds on a 3.8-centimeter not be replaced, the trainee was to remain in the dark (1.5-inch) thick pipe with two elliptical shots per weld.
room and finish the job.The trainer and trainec ate junch, They were using a 2220 gigabecquerel (60 curic) iridi.
returned to the job site to finish the job, and then returned um-192 radiography source in a Gulf Nuclear 20VS radi-to the office. It was subsequently determined that the ra-ography camera, diography trainee received a whole body cxposure of 213.6 mdlisievert (21.36 rem).
Upe, reaching the work site, the trainer and trainee set up ior rdocraphy. After taking initial radiographs, the Cause and Causes-The rad;ography trainee failed to fol-trainer took tne film to a remote location to develop.The low trainer instructions and failed to use or observe the trainct told the trainee that he was going to develop the survey meter after performing radiographs. Alarming ra-film and that the trainee was to remain and watch the temeters were available, but were not required for use by camera. After the trainer left, the trainec moved the the company's radiographers. They are now required.
NUREG-M)0, Vol.17, No. 2 26
Abnormal Occurrences,2nd Qtr CY94 Actions Taken to Prevent a Reoccurrence State Agency-The licensee and the trainer were cited for violations of the Texas Regulations for Control of Radi-ation and the case has been referred for Escalated En-Licensee-The trainee was restricted from conducting ra-forcement.
diation work. llecause of reduced work loads, the number of radiographic personnel was reduced to enable better
'this event is considered closed for the purpore of this control of radiation work and radiographic training.
report.
27 NUREG-0090, Vol.17, No. 2
Abnormal Occurrences,2nd Otr CY94 APPENDIX D AGREEMENT STATE EVENTS BEING CONSIDERED AS ABNORMAL OCCURRENCES During the period April through June 1994, NRC at she deadline for publication of this report, none of reviewed a number of events reported by the Agreement these events was identified as a potential abnormal States. For several of them, additional information was occurrence.
provided. Evaluation of these events continues; however, i
NUREG4XNO, Vol.17. No. 2 28
Abnormal Occurr;nces,2nd Otr CY94 REFERENCES FOR APPENDICES For the period April through June 1994, 'here were no references for the Appendices.
l 29 NUREG-0090, Vol.17, No. 2 m
,k NRC FORM 335 U.S. NUCLEAR REGULATORY COMMISSION
- 1. REPORT NUMBER i
(240)
(Assigned by NRC, Add Vol..
NRCM 1102, Supp., Rev., and Addendurn Num-mi, m2 '
BIBLIOGRAPHIC DATA SHEET b* - itany.)
(se instructions on the reverset NUREG-0090.
Vol.17, No. 2
- 2. DTLE AND SUBTITLE
- ' ^"'" "'""""*"' ~
Repmt to Congress on Abnormal Occurrences:
April-June 1944 MONTH YEAR October 1994
' l
- 6. AUIHOh(b)
- 6. TYPE OF REPORT Ouarterly
- 7. PERIOD COVEHED (inclusive Dates)
April-June 1994 j
\\
- 8. PLRFORMING ORGANIZATION - NAME AND ADDRESS (if NRC, provide Olvision, Office or Region, U.S. Nuclear Regulatory Commission, and i
mailing address; if contractor, provide name and maillng address.)
Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 W. SPONSOHANG ORGANtZAllON - NAME AND ADDRESS (if NRC, type "Same as above*; if contractor, provide NRC Division, Ottice or Region, O,S. Nuclear Regulatory Commission, and mailing address.)
Same as 8., above l
l
- 10. SUPPLEMENT ARY NOTES
-I i
- 11. ADSTRACT (200 words or less).
Section 208 of the Energy Reorganization Act of 1974 identifies an abnormal occurrence (AO) 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 provides a description of those events that have been determined to be abnormal occurrences during the period of April 1 through June 30,1994.
(
This report addresses seven abnormal occurrences (AOs) at NRC-licensed facilities. Five involved medical brachythera-s py misadministrations, one involved a medical teletherapy misadministration, and one involved a medical sodium iodide misadminisation. Four AOs were reported by the Agreement States as of August 3,1994. Two involved medical brachy.
therapy misadministrations, one involved a radiation burn received by an industrial radiographer, and one involved a lost well logging source.
"Ihe report also contains updates of seven AOs previously reported by NRC licensees and five AOs previously reported by Agreement State licensees.Three "Other Events of Interest" are also reported. One involved a dehberate coverup of an error in a diagnostic radiopharmaceutical administration at an NRC licensee, one involved an Order Suspending License and Demand for Information at an NRC licensee, and one involved an overexposure of an industria' radiographer at an Agreement State licensee.
- 12. KEY WORDS/DESCRIPTORS (Ust words or phrases that will assist researchers in locating the report.)
- 13. AVAILABIUTY STATEMENT Unlimited Medical: Misadmmistration: Brachytherapy; 'Ibletherapy; Sodium Iodide; Radiation M, SECN CLASSIRCADON Burn; Industrial Radiographer, Lost Source: Deliberate Coverup of Error; Radiophar-maceutical; Willful and Repetitive Noncompliance.
- * "***)
Unclassified i
(This Report)
Unclassified
- 16. NUMBER OF PAGES
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- 16. PRICE 6
NRC rORM 335 (2-89)
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NUREG-0090, Vol.17, No. 2 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES OCTOBER 1994.
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