ML20072Q116
| ML20072Q116 | |
| Person / Time | |
|---|---|
| Issue date: | 08/31/1994 |
| From: | NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | |
| References | |
| NUREG-0090, NUREG-0090-V17-N01, NUREG-90, NUREG-90-V17-N1, NUDOCS 9409090134 | |
| Download: ML20072Q116 (33) | |
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NUREG-0090 Vol.17, No.1
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Report to Congress on Abnormal Occurrences January - March 1994 i
U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data p
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NUREG-0090 Vol.17, No.1 Report to Congress on Abnormal Occurrences January - March 1994 Date Published: August 1994 Ollice for Analysis and Evaluation of Operational L)ata U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
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Abnormal Occurrences,1st Otr CY94 Previous Reports in Series NUREG 75/090 (January-June 1975), publ,:. icd October 1975.
NUREG-WM-1 through 10 (.luij-September 1975 through October-December 1977), published March 1976 through March 1978.
NUREG-0090, Vols. I through 16 (January-March 1978 through October-December 1993), published June 1978 through March 1994.
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NUREG-0090, Vol.17, No.1 ii
Abnormal Occurrences,1st Otr CY94 ABSTRACT Section 208 of the Energy Reorganization Act of 1974 therapy misadministrations, one involved a medical tele-idenlifies an abnormal occurrence (AO) as an unsched-therapy misadministration, and one involved four lost ref-uled incident or event that the Nuclear Regulatory Com-erence sources. One AO that was reported by an mission determines to be significant from the standpoint Agreement State is also discussed; the information is cur-of public health or safety and requires a quarterly report rent as of April 25,1994. This event involved a therapeu-of such events to be made to Congress. This report pro-tic radiopharmaceutical misadministration. The repon vides a description of those events that have been deter-also contains updates on seven abnormal occurrences pre-mined to be abnormal occurrences during the period of viously reported by NRC licensees and one abnormal oc-January 1 through March 31,1994.
currence previously reported by an Agreement State li.
censec. For the period January 1 to March 31,1994, no This report addresses seven AOs at NRC-licensed facili-new "Other Events of Interest" were reported but an up-ties. One involved inoperable main steam isolation valves date to a therapeutic misadministration previously re-at a boiling water reactor, four involved medical brachy-ported as an "Other Event of Interest" is included.
t iji NUREG-4X)90, Vol.17, No.1
Abnormal Occurrences,1st Qtr CY94 CONTENTS Page Abstract.....
iii Preface vii IntroduClion...
..........................................Vii The Regulatory System Vii RCportable Occurrences........
vii Agreement States.
viii Foreign Information.
Viii Reopening of Closed Abnormal Occurrences.......
viii Report to Congress on Abnormal Occurrences, January-March 1994..
1 Nuclear Power Plants....
1 94-1 Inoperable Main Steam Line Isolation Valves at Perry Nuclear Power Plant.......
I Fuct Cycle Facilities (Other than Nuclear Power Plants).....
2 Other NRC Licensees (Industrial Radiographers. Medical Institutions, Industrial Users, etc.).........
2 94-2 Medical Brachytherapy Misadministration at Hospital Metropolitano in Rio Piedras, Pu e rt o R ico...................................
2 94-3 Teletherapy Misadministration at THangle Radiation Oncology Associates in Pittsburgh, Pennsylvania 3
94-4 Lost Reference Sources at Brooks Air Force Base in San Antonio, Texas 4
94-5 Medical Brachytherapy Misadministration at the Unhersity of Cincinnati in 5
Cincinnati, Ohio 94-6 Medical Brachytherapy Misadministration at Kecster Medical Center, Kecsler Air 6
Force Base in Biloxi, Mississippi.
94-7 Medical Brachytherapy Misadministration at Alexandria Hospital in Alexandria, Virginia.....
7 Agreement State Licensees........
8 AS 94-1 Therapeutic Radiopharmaceutical Misadministration at North Carolina Baptist ilospital in Winston Salem, North Carolina...
8 10 References......
Appendix A - Abnormal Occurrence Criteria....
11 Appendix B - Update of Previously Reported Abnormal Occurrences...............
15 Other NRC Licensees.........
15 92-16 MedicalTherapy Misadministration at the Lahey Clinic Medical Center in Burlington, Massachusetts.....
15 NUREG-0090, Vol.17, No.1 v
Abnormal Occurrences,1st Qtr CY94 CONTENTS (cont.)
92-17 Medical Therapy Misadministration at Indiana University M.. cal Center in Indianapolis, Indiana 15 92-19 Medical Therapy Misadministration and 'Ibmporary Loss of Brachytherapy Source at Yale-New Ilaven IIospital in New Haven, Connecticut 15 93-3 Medical'Iherapy Misadministration Involving the Use of a Ifigh-Dose-Rate Remote Afterloader Ilrachytherapy Device at Yale-New Haven Hospital in New IIaven, Connecticut..
16 93-13 Medical 13rachytherapy Misadministration at Mountainside Hospital in Montclair, New Jersey..
16 93-14 Exposure to a Nursing Infant at Queen's Hospital in Honolulu, Hawaii 16 93-15 Medical lirachytherapy Misadministration at Good Samaritan Medical Center in Zanesville, Ohio........
17 Agreement State Licensees 17 AS 93-16 Medical 11rachytherapy Misadministration at Richland Memorial Hospital in Columbia, South Carolina 17 Appendix C 19 Misadministration at Veterans Administration Medical Center in Dallas, Texas.....
19 Appendix D.
20 References for Appendices....
21 NUREG-0090, Vol.17, No. I vi
k Abnormal Occurrences,1st Otr CY94 PREFACE Introduction and safety. These events are not reportable as AOs but are provided as "Other Events of Interest."
The Nuclear Regulatory Commission reports to Congress cach quarter, under provisions of Section 2080f the Encr-Appendix D has been added to this report to include gy Reorganization Act of 1974, any abnormal occurrences events submitted by Agreement States that are likely to be categorized as AOs. For these events, insufficient infor-(AOs) involving facilitics and activities regula ted by NR(,
An AO is defmed in Section 208 as an unscheduled inci-mation was available in time to identify them as AOs for dent or event that the Commission determines to be sig-this report.
nificant from the standpoint of public health or safety.
NRCidentifiesan AO for the purpose of this report using The Regulatory System the criteria in Appendix A. These criteria were promul-gated in an NRC policy statement that was published in
.the system of licensing and regulation by which NRC car-the Federal Register on February 24,1977, (Vol. 42, No. 37, rics out its responsibilitics is implemented through the pages 10950-10952),
rules and regulations m Title 100f the Codc offedera/ Reg-ulations. Tins meludes public participation as an element.
.Ihe policy statement was published before licensees were Tb accomplish its objectives, NRC regularly conducts li-required to report medical misadministrations to NRC.
censing proceedings, inspection and enforcement activi-I ew of the examples m the policy statement are applicable tics, evaluation of operating experience, and confirmatory to medical misadministrations. Iherefore, dunng 1984, rescarch, while maintaining programs for establishing NRC developed guidelines for selecting such events for standards and issuing technical reviews and studies.
AO reporting. These guidelines, which have been used since the htter part of 1984, augment the NRC policy in licensing and regulating nuclear power plants and the statement examples and arc summarized in 'Ihble A-1 m uses of byproduct nuclear materials, NRC follows the phi-Appendix A. On January 27,1992, new medical misadmi-losophy that the health and safety of the public are best nistration defimtions became effective. Therefore, re-ensured by establishing multiple levels of protection.
vised guidelines for identifying medical misadmmistra-These levels can be achieved and main tained through reg-tions as AOs are currently being developed. The revised ulations specifying requirements that will ensure the safe guidelines will be published for comment m the Federal use of nuclear materials. The regulations include design
- Register, and quality assurance criteria appropriate for the various activities licensed by NRC. An inspection and enforce-ment program helps ensure compliance with the regula-In order to provide wide dissemination of information to tions.
the public, a Federal Register notice is issued on NRC li-censee AOs. Copics of the notice are distributed to the NRC Public L)ocument Room and all Local Public Docu-Reportable Occurrences ment Rooms. At a minimum, cach notice must contain the date and place of the occurrence and a description ofits nature and probable consequences.
Actual operating experience is an essential input to the regulatory process for assuring that licensed activities are NRC has determmed that, of the events reviewed for this conducted safely. Licensees are required to report certain reporting period, only those that are described in this re-incidents or events to N RC.This reporting helps to identi-fy deficiencies and to ensure that corrective actions are port, meet the en,teria for reporting as AOs. This report taken to prevent recurrence.
covers the penod from January 1 through March 31,1994.
Information reported on each event includes date and place, nature and proba' ale consequences, cause or For nuclear power plants, dedicated groups have been causes, and actions taken to prevent recurrence.
formed, both by th e NRC and by the nuclear power indus-try, for the detailed review of opera ting experience to help identify safety concerns early; to improve dissemination of Appendix Il contains updated information on previously such information; and to feedback the experience into li-reported AOs.
censing, regulations, and operations. In addition, NRC and the nuclear power industry have ongoing ciforts to Appendix C provides descriptions of events that can be improve the operational data systems, which include not perceived as significant but do not involve a major reduc-only the type and quality of reports required to be sub-tion in the level of protection provided for public health mitted, but also the methods used to analy7e the data, in vij NUREG-0090, Vol.17, No.1
Abnormal Occurrences,1st Qtr CY94 order to more effectively collect, collate, store, retrieve, States whereby the Commission relinquishes and the and evaluate operational data, the information is main-States assume regulatory authority over byproduct, tained in computer-based data files.
source, and special nuclear materials (in quantitics not ca-pable of sustaining a chain reaction). Agreement State Three primary sources of operational data are Licensee programs must be comparable to and compatible with the 1
Event Reports (LERs) submitted pursuant to 10 CFR Commission's program for such material.
50.73, immediate notifications submitted pursuant to 10 CFR 50.72, and medical misadministration reports sub-Presently, information on reportable occurrences in mitted pursuant to 10 CFR 35.33.
Agreement State licensed activities is publicly available at the State level. For the purpose of developing a nation-Except for records exempt from public disclosure by stat-wide database, Agreement States are encouraged to pro-ute and/or regulation, information concerning reportable vide information to NRC on reportable events, occurrences at facilitics licensed or otherwise regulated by NRC is routinely disseminated by NRC to the nuclear In early 1977, the Commission determined that AOs hap-industry, the public, and other interested groups as these pening at fr.cilities of Agreement State licensees should events occur.
be included in the quarterly reports to Congress.The AO criteria included in Appendix A are applied uniformly to Dissemination includes special notifications to licensees events at the NRC and the Agreement State licensec faci-and other affected or interested groups, and public an-lities. Procedures have been developed and implemented, nouncements. In additior., information on reportable and AOs reported by the Agreement States to NRC are events is routinely sent to the NRC's more than 100 Local included in these quarterly reports to Congress.
Public Document Rooms throughout the United States and to the NRC Public Document Room in Washington, D.C. Congress is routinely kept informed of reportable Foreign Information events occurring in licensed facilitics.
Another source of operational data is reliability data sub-NRC participates in an exchange ofinformation with vari-mitted by licensecs under the Nuclear Plant Reliability ous foreign governments that have nuclear facilitics. This f reign mformation is reviewed and considered m the Data System (NPRDS). The NPRDS is a voluntary, industry-supported system maintained by the Institute of NRC's assessment of operating experience and myts re-Nuclear Power Operations (INPO), a nuclear utility orga-scarch and regulatory activities. Reference to foreign m-nii.ation. Both engineering and failure data are submitted f rm tion may occasionally be made m these quarterly re ris to Congress; however, only domestic AOs are by nuclear power plant licensees for specified plant com-gg ponents and systems. The Commission considers the NPRDS to be a useful supplement to the LER system for the collection, review, and feedback of operational expe-rience.
ReoI>eninE of Closed Abnormal Occur-rences Agreement States NRC reopens previously closed AOs if significant newin-formation becomes available. Similarly, previously re-Section 274 of the Atomic Energy Act, as amended, au-ported "Other Events of Interest" are updated if signifi-thorizes the Commission to enter into agreements with cant new information becomes available.
i NUREG-0090, Vol.17, No. I viii
Abnormal Occurrences,1st Qte CY94 REPORT TO CONGRESS ON ABNORMAL OCCURRENCES JANUARY-MARCH,1994 Nuclear Power Plants There are 109 operating nuclear power plants in the MSIVs are designed to close and limit the release of ra-United States (U.S.). NRC has reviewed all event reports dioactivity to the environment in the unlikely event of an received from these licensees through the first quarter of accident. When the Perry facility was issued an operating 1994. Using the criteria and guidelines in Appendix A of license, there was reasonable assurance that the MSIVs this report, one of the events reviewed for this reporting would operate as intended, and the potential off-site i
period was determined to be significant enough to be re-doses resulting from postulated accidents, which includes
. ported as an abnormal occurrence (AO).
assumptions regarding fuel damage and fission product release, would be below the guideline values for release to the general public. Because of the excessive leakage, the 94-1
. Inoperable Main Steam L,ne NRC staff, using conservative assumptions, calculated the i
Isolation Valves at Perry potential off-site doses to the general public that might re-sult from a postulated loss-of-coolant accident. Using the Nuclear I,ower Plant very conservative licensing basis calculational methodolo-gics, the calculated dose exceeded the guidelines for re-
,Ihc following information pertammg to this event is also lease to the geneml public. A more realistic calculation being reported concurrently m the federal Register Ap' using the new approach presented in draft NUREG-1465, pendix A (sce General Criteria No.2)of this report notes
" Accident Source Terms for Light-Water Nuclear Power that a major reduction m the degree of protection to pub-Plants" (Ref.1) showed that the potential off-site doses lic health and safety from a majordegradation of essential would not exceed the limits for release to the general pub-safety-related equipment can be considered an AO.
lic; however, additional measures would be needed to E# "
Date and Place-March 1992; Perry Nuclear Power Plant, a G eneral Electric-designed boiling water reactor (BWR),
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i ShWsWmmW andlocated about 11 kilometers (7 miles) northeast of Pai-ve friction from oxide buildup, which caused end-
- nesville, Ohio, of-stroke angular misalignment resulting in non-360-Nature and Probable Consequences-The main steam degree seat contact (Ref. 2).The reason for the difficulty of the Perry MSIVs to meet test leakage limits is design isolation, leakage control and outboard drain valves in three of four main steam lines penetrating containment geometry. The MSIVs are "Y pattern valves with the failed to meet the Technical Specifications limiting condi-valve stem at 45 degrecs to the piping axis. 'Ib seat proper-ly, translational motion of the poppet at the moment of tion of operation (LCO) for leak tightness.
impact must change from the direction of the stem to a direction parallel to the axis of the pipe. Seating is made For many BWRs, the LCO for leakage of each main steam m re difficult because of the large size of the valves (66 isolation valve (MSIV) is 0326 standard cubic meters centimeters [26 mches} diameter) and the weights m-(11.5 standard cubic feet) per hour. Because it is difficult to measure the leakage of each valve individually, a maxi-volved (4500 kilograms [10,000 r,ounds]).
mum combined allowed leakage is specified for the in-board and outboard MSIVs, and the associated control Actions Taken to Prevent Recurrence and drain valves.This LCO is 0.71 standard cubic meters (25 standard cubic feet) per hour. During testing at Perry Licensee-In the early 1980s, Atwood & Morrill, suppli-in 1992, the leakages through the MSIVs were approxi-ers of the MSIVs, and the BWR Owners Group recog-mately 12 times allowable. Due to a history of poor per-nized the need for better maintenance and for modifica-formance and multiple main steam line valve leakage, a tion of the MSIVs. Modifications included improved detailed analysis of the 1992 MSIV leakage was per-poppet nose guides to overcome eccentricity during seat-formed. The analysis required obtaining detailed infor-ing and poppet anti-rotation devices. During the 1992 re-f mation from the licensee; a number of calculations, re-fueling outage, these modifications were installed by the l
views, and subsequent reanalyses; and multiple meetings licensee on the six (out of'ght) MSIVs which have had among the staff to determine the impact on safety.
leakage problems (Ref. 2). Based on leakage tests I
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1-NUREG-0090, Vol.17, No.1.
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Abnormal Occurrences,1st Qtr CY94 performed in 1993 and 1994, the modifications were and progress in reducing the leak rate through the MSIVs.
successful in significantly reducing MSIV leakage.
This event is considered closed for the purpose of this re-NRC-NRC is closely monitoring the licensee's program port.
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 first quarter of 1994. Using the criteria and mal occurrence.
Otlier NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
There are approximately 22,000 active materir.1 licenses On December 11,1993, at approximately 7:30 a.m.,(about for the use of byproduct materials in industrial, medical, 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> before the end of the prescribed treatment), the and academic applications in the U.S. 'lWenty-nine States, patient intervened with the procedure by removing the known as Agreement States, have entered into agree-implant containing three Cs-137 sources of approximately ments with NRC to assume regulatory authority for the 730 megabecquerel (20.4 mci) each, and placed it next to use of byproduct materials. NRC is responsible for regu-her thigh. Shortly after removing the implant, the patient lating approximately 7000 of these licensees k>cated in 21 showed the device to the floor nurse. The nurse recog-States, the District of Columbia, and all U.S. territories.
nized the implant and understood the need for concern.
NRC has reviewed all events received from these licens.
She did not take the device from the patient but reported ecs through the first quarter of 1994. Using the criteria the situation to her supervisor.The patient apparently re-andguidelinesin Appendix Aof thisreport,thefollowing turned the device next to her thigh beneath the bed linen, events have been determined to be significant enough to be reported as AOs.
At the time of being informed, Ihe nursing supervisor was experiencing difficulty with another patient, and was in-volved in shift turnover. Due to these distractions, the su-pervisor failed to realize the urgent nature of the situation 94-2 Medical Brachytherapy and did not make required notifications.
Misadministration at Hospital Metropolitano in Rio Piedras, On several occasions that morning, other licensee person-nel entered the patient's room without realizing that the Puerto Rico radioactive source was exposed because it was eovered by bed linen; the patient did not notify any additional staff
,The following information perta..mmg to this event is also members that she had removed the implant. Approxi-being reported concurrently m the Federal Register. Ap-mately 2-1/2 hours after the estimated time of the source pendix A (see Event 'Ippe 3 in 'Ihble A-1) of this report removal, the attending physician atternpted to perform a notes that a therapeutic exposure to any part of the body routine check of the implant and discovered that it had not scheduled to receive radiation can be considered an been removed and placed next to the patient's thigh.
abnormal occurrence.
Aft er properly accounting for and storing the sources, the physician examined and interviewed the patient. Based on Date and Place-December 11,1993; Hospital Met repoli, discussions with the patient and review of the exposure tano; Rio Piedras, Puerto Rico.
received, the attending physician termmated the treat-ment. This decision was based on the physician's determi-nation that the treatment received was clinically adequate Nature and Probable Consequences-On December 9, and his concern that the patient was a threat to herself and 1993, at 5:20 p.m., a patient began a gynecological low-do-others.
se-rate brachytherapy treatment. The patient was pre-scribed a tr eatment of 3000 centigray (cGy)(3000 rad) by a The actual dose delivered to the intended treatment site 48-hour exposure to approximately 2.3 gigabecquerei was calculated to be 2270 cGy (2270 rad).The written di-(61.3 millieurie [ mci]) of cesium-137 (Cs-137).
rective was revised to reflect the lower dose delivered.
- NUREG-0090, Vol.17, No. I 2
Abnormal Occurrences,1st Otr CY94 The licensee's evaluation of the incident indicated that as-roundmg Ihe misadministration and the licensce's Quali-suming the implant remained in the same location for ty Management program. A Confirmatory Action Letter three hours, the maximum dose to the skin of the patient's (CAL) was issued to the licensee on December 30,1993 thigh (the wrong treatment site) was 572 cGy (572 rad).
(Ref 4). The CAL confirmed that the licensee would re.
The licensee reported that no adverse effects to the pa-vise its emergency procedures and implement a training tient are expected.
program, based on new procedures, for all licensec em-ployces who may handic patients undergoing radiation
'Ihe patient was notified verbally at the time the misadmi-therapy. An NRC medical consultant has been retained to nistration was discovered and then notified in writing on perform a clinical assessment of this misadministration.
January 13,1994.
The medical consultant's report is expected to be avail-able in time to discuss his findings in the second quarter Cause or Causes AO Report. As of the issuance of this report, NRC is pur-suing escalated enforcement action against the licensec.
The initial cause of the misadministration was the pa-tient's removal of the implant which was compounded by 1his report will be further updated when additional infor-the failure of the two nurses to follow emergency proce-mation becomes available.
dures.1hc nurses' failure to respond to the emergency re-suited in approximately 2-U2 hours of unnecessary exp+
94-3 Teletherapy Misadministration surc' at 'Riangle Radiation Oncology Actions Taken to Prevent Recurrence Associates in Pittsburgh, Licensee-The licensee determmed that the nursing su-Pennsylvania pervisor's failure to makc the required notification:; was lhe following information pertaining to this event is also due to the lack of famth.arity with established radiation safety procedures to which he/she had been trained.The being reported concurrently in the Federal Register. Ap-licensce's investigation of the event revealed that the lack pendix A (see Event lype 5 in 1hble A-1) of this report notes that a therapeutic misadministration that affects of familiarity with radiation safety procedures was caused two or more patients at the same facility, regardless of any by the infrequent handling of patients undergoing therapy health effects, can be considered an abnormal occur-with licensed materials (Ref. 3).The licensee held a Radi-rence.
ation Safety Committee meeting in which the incident and corrective actions to prevent recurrence were dis-Date and Place-December 20,1993; Triangle Radiation cussed.
Oncology Associates; Pittsburgh, Pennsylvania.
The licensee decided to dedicate one floor of the hospital Nature and Probable Consequences-On December 20, for all therapies involving NRC-licensed materials. This 1993, Triangle Radiation Oncology Associates in llcaver, will provide additional controls to allow the licensec to Pennsylvania, notified NRC of two potential teletherapy better ensure that nurses assigned to the floor are kept misadministrations that occurred between December 13 current and familiar with operating and emergency proce-and 17,1993, at the licensce's Pittsburgh, Pennsylvania, dures.The licensee is also evaluating the need to increase facility. The potential misadministrations were identified patient awareness regarding non-intervention of procc-during a review of patient records on December 17,1993, dures.
when the licensee observed calculation errors involving 1hc licensee is revising its procedures for responding to radiological emergencies involving patients undergoing Iloth cases involved breast treatments where the original radiopharmaceutical or scaled source therapy. As a mini-treatment plan prescribed 28 treatments of 180 centigray mum, the procedures will define what is a radiological (cGy)(180 rad) from a cobalt-60 t eletherapy sourec (using emergency and will provide examples of situations which 2 parallel opposed fielJs) for a total absorbed dose of 5040 must be considered radiological emergencies or which cGy (5040 rad). The primary breast treatments were con-could result in misadministrations.The licensec also com-cluded on December 10,1993.1he physician wrote sepa-mitted to developing and implementing a retraining pro-rate written directives for each patient to receive an addi-gram based on the revised emergency procedures for all tional 1000 cGy (1000 rad) to the scar in 5 treatments of hospital employees who may be involved in handling pa-200 cGy (200 rad) per day. One of the written directives tients receiving radiation therapy.
indicated that the absorbed dose was to be delivered at dmu, the maximum extension of the teletherapy unit, NRC-A special inspection was conducted on Decem-which, as stated by the physicist, is typically a depth of 0.5 ber 15 and 17,1993, to review the circumstara sur-centimeter (cm)(0.2 inch).The other written directive did 3
NUREG-0090. Vol.17, No.1
Abnormal Occurrences 1st Otr CY94 not indicate a depth; however, the physician stated that consultant's report is expected to be completed in time to the intended depth was dman.
update tnis writeup in the next AO report to Congress.
As described above, such a treatment plan would typic;dly The referring physician was notified and determined that, have been cidculated by the teletherapy technologist at based on medical judgment, informing the patients of the the Pittsburgh facility and communicated by telephone to misadministrations would be harmful.
the teletherapy physicist at the Heaver facility to be Cause or Causesalhe technologist incorrectly trans-checked. liowever, this procedure changed when the computer at the Pittsburgh facility was taken out of ser.
posed the treatment depth on the facsimile used to pre-vice on December 1,1943.
pare the treatment plan. 'lhe technologist failed to make reference to dmaxand entered the depth value incorrectly On December 9,1993, the teletherapy technologist hand as 5.0 cm (2 inch)instead of the intended 0.5 cm (0.2 inch).
wrote a paraphrased request of the written directive for Actions Taken to Present Recurrence the two breast. treatment patients needing scar luoster dose calculations. ltather than writing dmax, the technolo-Limm e di he l censce implemented a rcquirement for a gist 5.tated the tumor dose at a depth of 5 cm (2 inch) and stamp to be placed on all written directives that prompts a sent the request, via facsimile transminsion, to the tele-clear documentation of key treatment parameters such as therapy physicist at the Heaver facility. Iland calculations site, met hod, daily dose, fractions, total dose, depth of cal.
were performed for 200 cGy (2(X) rad) treatments at a 5 cm culation, spinal blocks, other blocks, and date. Previously, (2 mch) depth, checked by a certified physicist, and sent key parameters had been informally handwritten direc-back to the technologist, via facsimile transmission, on lives on patients' treatment charts. The licensee also for-December 9,1993.
malized its requirement to include the written directive for all dosimetry c:dculation requests from the Heaver fa-The patients were treated from December 13 to 17,1993, cility, and revised its " weekly chart check" procedure to
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and received dos.es of 13(X) and 1320 cGy (1300 and 1320 increase chart reviews from once a week to twice a week,
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rad) respectively, rather than the 100() cGy (1000 rad)in-as was the practice prior to December 1,1993.
tended. 'lhis resulted m misadministrations of 30 and 32 percent greater than the intended dose. The licensce's NitC--NRC is reviewing the licensec's April 7,1994, mis-physician stated that no adverse clinical effects are ex-administration report and the findings of the Decem-pected as a result of the overexposures.
ber 28 to 29,1993, NRC inspection. Once the NI(C medi.
cal consultant's report is received, enforcement action After the initial report, the licensec told NRC in subsc-will be considered.
quent telephone conversations that a recalculation of the dose averaged over the entire tumor volume did not ex-
'lhis report will be further updated when additional infor-cced 30 percent and, therefore, the licensee no longer mation becomes availabic, thought the definition of a misadministration applied in this me.
94-4 Lost Reference Sources at NRC performed a special inspection on December 28 and llrooks Air Force llase in San 29,1993, to review the potential misadministrations. In" Antonio, Texas formation gathered durmg this mspection, mcludmg the calculations of the administered doses, was given to an
'Ihe following information pertaining to this event is also NRC scientific consultant to evaluate. The scientific con-being reported concurrently in the Itdcrad Register Ap-sultant, in his report to NRC, stated that "the dose pre-pendix A (see Event 'lype 11 from Examples For All Li.
scription was to dmax (i.e.,0.5 cm [0.2 inch] depth on the censecs)of this report notes that any serious deficiencyin central axis) and a misadministration can only be judged management or procedural controls in a majorarea can be by considering the dose given to this point... clearly in considered an abnormal occurrence, both cases a misadministration has taken place." On March 25,1994, the licensec was informed that the doses Date and Place-1993: Armstrong Laboratory, Brooks to both patients were deemed to be misadministrations-Air Force Base (AFH); San Antonio, Texas.
'Ihc licensee submitted its report of misadministrations in a letter dat.d April 7,1994.
Nature and Probable Consequences-As prescribed by the licensees *s Compliance Accountability and Control After recuving the scientific consultant's report, an NRC Procedures, in 1993, t he licensee performed an audit of all medical consultant was retained to perform a clinical eval-licensed sources at Armstrong Laboratory. During this uation of the patients 'lhe medical c(msultant is still re-audit, the licensee identified four missing strontium-90 viewing the potential health effects to the patients.'Ihe (Sr-90) reference sources of approximately 14.8 megabec-NUREG-0090, Vol. l' N.1 4
i'
Abnormal Occurrences,1st Qtr CY94 querel (400 microcuric) each. The licensec conducted an Actions Taken to Prevent Recurrence extensive physical search for the sources and reviewed all radioactive material permits issued to other organizations Licensee-In 1991, Armstrong Laboratorywas placed un-at Brooks AFil. When the disposition of the Sr-90 scaled der a new Air Force Command. The Command com-sources could not be determined, the licensee reported mitted to increased management oversight of the radi-thc loss of the four scaled sources to NRC by telephonc on ation safety programs. Additionally, physical inventory September 22,1993. 'the licensee informed NRC that the procedurcs were revised.
United States Air Force (USAF) Inspector General would review this incident. The licensee suspected that NRC-NRC conducted an inspection (Ref. 5) at Brooks the sources had been inadvertently discarded and trans.
AFil on December 21,1993, to review the circumstances ported to a sanitary landfill, associated with the loss of licensed material, after receiv-ing a written report from the licensee on December 10, 1993. NRC also held an Enforcement Conference with
'lhe licensee evaluated possible radiation exposure to members of the pencral public and concluded that unless the licensee on February 3,1994, to review the findings of the sources were removed from the container, the radi-the inspection and to determine enforcement action.
ation levels from the sources would be near background On February 11,1994, NRC issued a Notice of Violation level. Furthermore, unless a dcliberate effort was made to (Ref. 6) for violations involving (1) a failure to secure li-open the source capsules, an individual handling the censed material and (2) failure to include in one USAF sources would receive less exposure than allowed by regu-permit a requirement to conduct a periodic physical in-latory limits for the general pubhc.
ventory of all licensed materials.
Cause or Causes-During 1991, the timeframe during These violations were categorized as a Severity Level HI which the sources were apparently lost, a number of indi-and a Severity Level IV, respectively (Severity Level I viduals were responsible for the radiation safety program through V range from the most significant to the least sig-at Brooks AFB. These individuals were temporary or nificant, respectively). No civil penalty was assessed be-part-time Radiation Safety Officers (RSOs), and had ex-cause of the Air Force's discovery of this violation and the tensive, temporary dutics at other siter,.
promptness and comprehensiveness of the corrective ac-tions. 'Ihe licensee has responded in writing to the Notice The results of the USAF krpector General's investiga-of Violation and no additional actions are required.
tion determined that " programmatic issues started to plague radiation safety at arooks AFB after the disman.
This event is considered closed for the purpose of this re-tling of the base / clinic program and the inception of addi.
port.
tional duty RSOs." The report explained that in 1986, the radiation safety function and respesibility was trans-94-5 Medical Brachytherapy ferred to the base clinic at Brooks AFB, Almost simulta-neously, a jomt Military Medical Command (JMMC) was MISadnlintStration at the established and the base clinic became a part of JMMC.
University of Cincinnati in JMMC was a medical command established to service all Cineinnati' Ohio branches of the Armed Forces m the San Antomo, Texas, area. With this action, the radiation safety program was
.Ihc following information pertaining to this event is also managed by an organization that was not responsible t being reported concurrently in the Federal Register. Ap-any management level at Brooks AFB. Furthermore, the pendix A (see Event 'lype 3 in 'lkble A-1) of this report report stated that JM MC dismantled the clinic's radiation notes that a therapeutic exposure to a part of the body not safety program, and " requested that all organizations pre-scheduled to receive radiation can be considered an ab-viously under the clinic's program establish and run their normal occurrence.
own radiation safety program. Exacerbatmg the problem was the appointment of the additional duty RSOs, who Date and Place-January 7,1994; University of Cincinna-had " limited to general knowledge of radiation safety,"
ti: Cincinnati, Ohio.
and no directives or other guidance to assist them. Addi-tionally, "the additional duty RSOs received little man-Nature and Probable Consequences-On January 14, agement oversight after they had been appointed to the 1994, NRC was notified by telephone of a misadministra-RSO position."
tion involving a leaking iodine-125 (I-125) brachytherapy implant seed. On January 7,1994,16 I-125 seeds, each
'the investigation concluded that from 1986 through 1991, ranging from 370 to 1110 megabecquerel (M Bq)(10 to 30 there had been a lack of commitment to management milheuric [ mci]) activity, were implanted in the brain of a oversight, and a serious disregard for radiation safety is-30-year-old male patient. Following the crplant procc-sues.
dure on January 14,1994, the licensee identified radioac-5 NUREG-0090. Vol.17, No.1
Abnormal Occurrences,1st Otr CY94 tive contamination in the surgical room and bathroom NitC also obtained the services of a medical consultant to used by the patient. personnel from the licensee's radi-review the medical implications of the incident. A follow-ation safety office identified the contamination to be up NitC inspection (Ref. 7) was conducted from Febru-1-125 and confirmed that at least one seed was leaking.
my 7 to 11,1994. On March 16, 1994, NltC held a tele-Further analysis by the 2nsee determined that one seed phone Enforcement Conference with the licensee to was damaged during i e implant procedure by a surgical discuss the safety inspections conducted in January and staple. The seed originally contained 758 Mlly (20.5 mci)
February 1994, at the University of Cincinnati.
of I-125 and, based on an assay of the explanted source, the licensee estimated that the loss was approximately 74 A Notice of Violation was issued by NitC on March 25, Mity (2.0 mci).
1994, which imposed a fine of $5(XX) for a violation not as-sociated with this misadministration. In the Notice of Vio-Thyroid monitoring of the patient's visitors and hospital lation, NitC determined that the inadvertent opening of employees involved in the care of the patient was per-the I-125 scaled source did not constitute a violation of formed by the licensee. One of the licensee's employees the University of Cincinnati's license.
was determ med to have received a committed dose equiv-alent to the thyroid of 50 microsievert ( Sv)(5 millirem This event is considered closed for the purpose of this re-Imrem]). In addition, a visitor was determined to have re-port.
ceived a committed dose equivalent to the thyroid of 540 Sv (54 rnrem), or a total effective dose equivalent of 160 pSv (1.6 mrem), which is less than the annual limit for 94-6 Medical llraellyllieraI)Y members of the general public of 1(XX) Sv (100 mrem).
MISadininiStration at Keesler
.Through patient monitoring, the licensee estimates that Medical Center at Kecsler Air approximately 5 percent of the free 1-125 was taken up in l',Orce llaSe in Ilil0XI, the patient's thyroid. (In a normally functioning, un-bh>cked thyroid, approximately 25 percent of the free io-Mjgsjssippj dine would be taken up in an individuars thyroid.)The li-The following information pertaining to this event is also censee estimates that the uptake would result in a radiation dose to the thyroid of approximately 300 centi-being reported concurrently in the Fedeml Register. Ap-gray (300 rad). The licensee does not expect any adverse pendix A (see Event Type 5 in bble A-1) of this report notes that a therapeutic exposure to a part of the body medical effects to the patient as a result of the misadmi-scheduled to receive radiation such that the actual dose nistration. An NltC medical consultant concluded that received is greater than 1.5 times the prescribed dose c m the non radioactive iodinated contrast agent used during be considered an abnormal occurrence.
an imaging procedure performed on the patient prior to the implant bhicked the absorption of the I-125. He also Date and Place-January 13,1944; Kecsler Medical Cen-concluded that exposure lo the radiation levels described ter, Kecsler Air Force liase; Hiloxi, Mississippi.
has resulted in an increased probability of developing thy-roid tumor (s)in the future.
Nature and Probable Consequences-A patient was pre-scribed a lung brachytherapy treatment delivered by an The licensee notified the referring physician, the patient, Omnitron 2(XX) high-dose-rate (I IDll) remote afterloader and the patient's family of the misadministration.
system. The prescribed tumor treatment plan included 1(XX) centigray (cGy)(100() rad) absorbed doses at 5 treat-Cause or Causes-The seed leaked after being inadver-ment positions using a 144.3 gigabecquerel (3.9 curic) tently crushed by a surgical staple used to secure the cath-iridium-192 source within a special needle. At the end of i
eters during the implant procedure.
fifth and last treat ment, the source wire retracted 0.5 cen-timeter (cm)(0.2 inch) and stopped. Alarms immediately Actions Taken to Prevent itecurrence alerted Kecsler staff that the source remained inside the patient's body. Licensee personnel followed emergency Licensee-For future procedures, the licensee plans to procedures, entered the therapy mom and removed the i
ensure that the implanted seeds are located further down the catheter in order to reduce the likelihood of seed needle from the patient. Once outside the patient's body, the radioactive source retracted to the stored position.
damage from surgical staples. The licensee also plans to examine cach I-125 seed for leakage following each ex-The licensee determined that the source remained stuck plant procedure.
at 0.5 cm (0.2 inches) above the fifth position for approxi-mately 2-1/2 minutes. The treatment plan called for the NitC-NitC dispatched two inspectors on January 16, delivery of IfXX) centigray (cGy) (10(X) rad) at I cm from 1994, to monitor the licensee's decontamination efforts each of the 5 treatrnent positions. As a result of the addi-and to obtain more details on the misadministration.
tional 2-1/2 minutes exposure, tne last treatment position NUllEG-0090, Vol.17, No.1 6
I
Abnormal Occurrences,1st Qtr CY94 received 1732 cGy (1732 rad) absorbed dose, or 73.2 per-This report will be updated when additionalinformation cent over the prescribed dose. The treatment plan also becomes available, predicted an 8(X1 cGy (8(X1 rad) absorbed dose at 0.5 cm (0.2 inch) from cach of the 5 treatment positions. The 94-7 Medical Brach)theraI>7 pomt 0.5 cm (0.2 inch)above the last treatment position, where the movement of the source stopped, received ap-Misadministration at proximately 14(X) cGy (14(X) rad), or 75 percent greater Alexandria llospital in than the absorbed dose stipulated in the prescribed treat-c.
ment plan.'Ihe failure of the source to retract resulted in Alexandria, Virginia a single overexposu re, causing an overall absorbed dose of 75 percent greater than that prescribed, for all the tissue
.lhe following information pertaining to this event is also surrounding the position 0.5 cm (0.2 inch) above the last being reported concurrently m the FederalRegister. Ap.
treatment site.
pendix A (see Event 'lype 3 m,lhble A-1) of this report notes that a therapeutic exposure to a part of the body not The licensee reported that no adverse health effects to scheduled to receive radiation can be considered an ab-the patient are expected. 'the patient was immediately no_
normal occurrence.
tified of the misadministration.
Date and Place-January 27,1994; Alexandria Hospital; Cause or Causes Alexandria, Virginia.
'lhe patient had made a sudden move near the end of the Nature and Probable Consequences-On January 27, treatment causing the special needle to bend at the point 1994, a patient was scheduled to receive a 500 centigray where it extended beyond the biopsy needic. 'lhe bend (cGy)(500 rad) brachytherapy treatment to the trachea using a Nucletron high-dose-rate (llDR) remote after-prevented the radioactive source from retracting to the loader system. A single catheter was used for this endo-stored position, causing the misadministration.
bronchial treatment and the licensee performed a routine Act.mns Taken to Present Recurrence simulated treatment. During this simulation, the oncolo-gist established a 3 centimeter (cm)(1.2 inch) tumor treat-la,censee.lhe licensec immediately stopped the use of ment site and added a 1 cm (0.4 inch) margin on both ends of the tumor site.
the HDR device pending a complete check of the system by the manufacturer (Ref. 8, Ref. 9). The licensee also Normally, at this point the medical physicist and the dosi-evaluated the practice of extending special needles be-metrist plot distances, measured in centimeters along the yond biopsy needics and the probability of patient move-length of the catheter shown in the simulation film,in or-ment causing damage, and decided to discontinue this der to program the 1IDR for precise treatment at the pre-practice (Ref.10. Ref. I!).
scribed treatment site. This step was not performed and the procedure was initiated without the HDR beingprop-NRC-A special inspection was conducted from Janu-crly programmed. The unprogrammed source was al-ary 19 to 21,1994, to review the circumstances surround-lowed to travel beyond the treatment site into the left ing the misadministration and the licensee's Quality Man-lung area where the catheter ended. The treatment re-agement program. A representative of the U.S. Tbod and sulted in the prescribed 500 cGy (500 rad) effective dose Drug Administration (FDA) also participated in this in-equivalcnt being delivered to the left lung instead of the spection. No violations of regulatory requirements were trachca tdrget site. Prior to administering the dose, the identified during the inspection, but NRC initiated the treatment plan and treatment console printout were re-following actions:(1)a Confirmatory Action Letter (Ref.
viewed by the dosimetrist, the medical physicist, and the
- 12) was issued to the licensec on January 18,1994, which oncologist. All three individuals failed toidentify the fail-prohibited the use of the llDR unit until serviced by the ure to plot the treatment site.
manufacturer; (2) a medical consultant was contracted to evaluate the clinical effects and to assess the events that immediately following the treat ment, the licensce's med-led to this misadministration; (3) the manufacturer was ka! physicist realized that the plotting and programming asked to analyze the source wire involved in the misadmi-of the treatment site were not performed. Afterdiscovery nistration for damage as a result of the stresses experi-of the treatment error, the oncologist determined that the enced during this event: (4) Sout hwest Research Institute patient should be treated again using the correct treat-was contracted to analyze the special needle for mechani-ment parameters, c:d failure; (5) a generic communication is being devel-oped to notify other HDR users of the results of the The licensee has advised NRC that no adverse effects to inspection and related research;and (6)NRC is coordinat-the patient are anticipated as a result of this misadminis-ing with FDA an evaluation of the generic implications tration.The licensee hasinformed the patient of the mis-surrounding this event, administration.
7 NUREG-0090, Vol.17, No.1
)
Abnormal Occurrences,1st Otr CY94 Cause or Causes 'lhe licensee's radiation therapy staff card generated by the planning computer to program the failed to follow the licensec's normal protocol for treat-IIDR rather than programming the llDR treatment pa-ment with the llDR remote afterloader. The failure to rameters manually.
administer the treatment as prescribed resulted from per-forming the treatment planning and independent verifi' NRC-NRC conducted a special inspection from Febru-cation m the vicinity of the HDR console, where there ary 2 to 4.1994, to review the circumstances associated were a number of distractions.
with the misadministration, the licensec's Quality Man-Actions Taken to Prevent Recurrence agement program, and the licensee's immediate correc-tive actions. In addition, on February 25,1994, NRL 1.icensee- 'Itc licensee's corrective actions included im-emphiyed a medical consultant to provide an assessment mediate retraining of all personnel involved in brachy-of the potential clinical effects of this misadmmistration and the events that led to it.
therapy treatmentsand the addition of a checklist foreach step in the treatment process. 'lhe licensee also added steps to its Quality Management program for 1IDR bra-The inspection report, medical consultant's assessment, chytherapy.These steps now require the use of the treat-and enforcement actions for the misadministration are ment planning computer with manual verification of the being completed.This report will be updated when addi-input parameter and the use of the treatment parameter tional information becomes available.
Agreement State Licensees The 29 Agreement States have approximately 15,000 ac-nostic dose of thallium-201 for a myocardial perfusion live material licenses for the use of byproduct materials in scan. Upon entering the next room to administer the dos-industrial, medical, and academic applications. Proce-age to the second patient, the technologist discovered the dures have been developed for Agreement States to error.
screen events using the same criteria and guidelines as NRC, and to report those events that have been deter-NRC was notified of this event on August 10,1993. Imme-mined to be significant enough to be considered as abnor-diate action taken by the licensec included notifying the mal occurrences. During this period, the Agreement referring physician and patient. An approved iodine con-States reported one abnormal occurrence, and informa-trast agent was injected into the patient, hemodialysis was tion relat mg to this occurrence provided by April 25,1994, initiated, and daily doses of potassium iodine were started has been included in this report.
and con tin ued for 2 weeks.The patient was also held over-night for observation. No thyroid uptake was performed.
AS 94-1 Therapeutic Radiopharma-
.lhe Radiation Safety Officer concluded that without up-ceutical Misadministration take data only rough estimates of the patient's exposure at North Carolina Baptist can be made. According to thc International Commission on Radiological Protection, publication 53, " Radiation IIOSpital,il WinSton saiem, Dose to Patients from Radiopharmaccuiicais, 300 pcr.
t North Carolina cent blocking of the thyroid would resuh in all organ doses being less than 50 millisievert (mSv)(5 rem), and the ef-Appendix A(see Event'lypc 2inLble A-1)of this report fcctive dose equivalent would be approximately 43 mSv notes that administering any therapeutic dose to the (4.3 rem). Assummg incomplete blockage, some parts of wrong patient should be considered an abnormal occur.
the gastrointestinal (GI) tract, the bladder wall, and the rence.
thyroid would have significantly higher doses.
Date and Place-June 17, 1993; North Carolina Baptict in addition, the National Council on Radiation Protection Hospital in Winston Salem, North Carolina.
and Measurements Report No. 80, " Induction of Thyroid Cancer by Ionizing Radiation," states that a significantly Nature and Probable Consequences-The nuclear medi-increased risk of thyroid cancer has not been detected in cine technologist had prepared dosages for two different several studies on humans at the dose level misadminis-patients and then prepared both patients for injection, tered to the patient. However, due to the likelihood ofin-The technologist was temporarily sidctracked and then complete thyroid bhickage, the patient will need to be returned to complete administration of the prepared dos-monitored for signs of hypothyroidism.
ages. 'lhe first patient received a 592 megabecquerel (MHg) (16 millicuric [ mci]) therapeutic dose of Cause or Causes-This misadministration occurred due iodine-131 instcad of the prescribed 37 MHq (1 mci) diag-to personnel error during a time of heavy workload.
NUREG-0090, Vol.17, No. I g
Abnormal Occurrences,1st Otr CY94 l
Actions Taken to Prevent Recurrence licensed activities by the North Carolina Division of Radi-ation Protection.
Licensee-A new policy to color-code prepared dosages The patient has been contacted several times for follow-was implemented to more clearly and easily distinguish up observations; however, the patient lives out of town i
between therapeutic and diagnostic dosages.
and has not been willing to cooperate.Therefore, no addi-tional actions are expected.
State Agency 'lhe licensee's corrective and preventative This event is considered closed for the purpose of this re-
)
actions will be reviewed during the next inspection of the port.
1 B
9 NUREG-0090, Vol.17. No.1
Abnormal Occurrences,1st Qtr CY94 REFERENCES 1.
U.S. NucIcar Regulatory Commission NUREG-son, M.D., Senior Vice President and Provost for 1465, " Accident Source Terms for Light-Water Nu-11calth Affairs, University of Cincinnati, fonvarded clear Power Plants," Draft Report for Comment, Inspection Report No. 030-02764/94001, Docket June 1992.*
No. 030-02764, License No.34-06903-05, dated March 10,1994.*
2.
Licensec Event Report 50-440/92-006- 01, " Local Leak Rate 'Icst Results Exceed Allowable Primary 8.
Letter from Omnitron International, Inc. to NRC Containment Leakage for Main Steam Lines A,11, Document Control Desk, forwarding a Report of and D," August 14, 1992.*
IIDR misadministration, Part 21-Reporting of De-fccts and Noncompliance, Omnitron Report No.
3.
Letter from Ilospital Metropolitano, to Ilector fler-102, datcd January 19,1994, Docket No. 030-26841, m udez, Senior inspector, NMI Section, NRC Region License No. 42-23539-01 AE' 11, Forwarding a Misadministration Report dated December 29,1993, and an Addendum to the Misad-9.
Letter from Omnitron International,Inc. to John W.
ministration Report dated January 11,1994, Docket Lubinski, Mechanical Engineer, Nuclear Material No. 030-11155, License No. 52-16033-01.*
Safety and Safeguards, NRC Washington, D.C., for-warding a report of Inspection of Source Wire, dated 4.
Letter from J. Philip Stohr, Director, Division of Ra-April 6,1994, Docket No.030-26841, License No.
diation Safety and Safeguards, NRC Region II, to 42-23539-01 AE' flospital Metropolitano, Attn: Mr. Victor Marrero, Administrator, forwarding a Confirmatory Action
- 10. Letter from Department of the Army, 11 0 Letter, CAL No. 2-93-14, Docket No. 030-11155, AFMOA/SGPR,13 rooks AFil, TX to NRC Region License No. 52-16033-01, dated December 30, IV, forwarding the 15-Day Report of Misadministra-1993.*
tion at Kecsler AFil, MS, dated February 1,1994, Docket 030-26841, License No. 42-23539-01 AE" 5.
Letter from Dwight D. Chamberlain, Acting Direc-tor, Division of Radiation Safety and Safeguards,
- 11. Letter from Department of the Army, 11Q NRC Region IV, to Lt. Colonel Joseph J. Donnelly, AFMOA/SGPR, Ilrooks AFil, TX to NRC Region Chief of USAF Radioisotope Committec Secretari-IV, responding to a NRC Confirmatory Action Let-at, forwarding Inspection Report No 030-28641/93-ter (dated January 18, 1994), dated March 8,1994, 10, Docket No. 030-28641, License No. 42-23539-Docket 030-26841, License No. 42-23539-01 AE" Ol AF, dated January 19,1994.*
- 12. Letter from James L Milhoan, Regional Adminis-6.
Letter from L J. Callan, Regional Administrator, trator, Region IV, to Dep^.rtment of the Army, NRC Region IV, to Department of the Air Force, USAF Radioisotope Committ m, HQ AFMOA/
USAF Radioisotope Committee, forwarding Notice SG PR, llrooks AFI), TX, forwarc.ng a C anfirmatory of Violation, Docket No. 030-28641, License No.
Action Letter, CAL No. 4-94 31, Docket No.
42-23539-01 AF, dated February 11, 1994.*
030-28641, License No. 42-23539-01 AF, dated Janu-ary 18,1994.*
7.
Letter from W.L Axelson, Director, Division of Radiation Safety and Safeguards, to Donald liarri-
'A copy is available for insNction.or b. wer !xvel), Washington,
" A cobs available for in etion.or cobing for a fee. in the NRC
{
~ for a fee, in the NRC Pub-i he Ibcument Room. 21 L Street Pubbe eument Room.6 Ryan Plaza rive. Suite 400, Arlington, DC 20555-0001.
Texas 76011.
NUREG-0090, Vol.17, No.1 10 L__________
Abnormal Occurrences,1st Qtr CY94 APPENDIX A AllNORMAL OCCURRENCE CRITERIAI The following critcria used to determine abnormal occur-package containing the radioactive material, or (b) rence (AO) were set forth in an NRC policy statement release of radioactive material from a package in I
published in th e /cdcru/ Register on February 24,1977 (Vol.
amounts greater than the regulatory limit.
42, No. 37, pages 10950-1(N52).
l 5.
Any loss of licensed material in such quantities and
)
An event will be considered an AO if it involves a major under such circumstances that substantial hazard reduction in the degree of protection of the public health may result to persons in unrestricted areas.
or safety. Such an event would involve a moderate or more severe impact on the public health or safety and 6.
A substantiated case of actual or attempted theft or could include but need not be limited to:
diversion of licensed material or sabotage of a facil-ity.
1.
Moderate exposure to, or release of, radioactive ma-terial licensed by or otherwise regulated by the Com.
7.
Any substantiated loss of special nuclear material or mission; any substantiated inventory discrepancy that is judged to be significant relative to normally expected 2.
Major degradation of essential safety-related equip-performance and that is judged to be caused by theft ment; or or diversion or by substantial breakdown of the ac-countability system.
3.
Major deficiencies in design, construction, use of, or management controls for licensed facilitics or mate, 8.
Any substantial breakdown of phys.ical security or rial.
to terial control (i.e., access control, contamment, or accountability systems) that significantly weak-Examples of the types of events Ihat are evaluated in de-ened the protection against theft, diversion, or sabo-tait using these criteria are:
tage.
For All Licensees 9.
An accidental criticality l10 CFR 70.52(a)].
1.
Exposure of the whole body of any individual to 25 A major deficiency in design, construction, or opem-rem or more of radiation: exposure of the skin of the non having safety implications requiring immediate whole Imdy of any individual to 150 rem or more of remedial action.
radiation; or exposure of the feet, ankles, hands or
- 11. Serious deficiency in management or procedural forearms of any individual to 375 rem or more of ra~
diation [10 CFR 20.403(a)(1)], or equivalent expo-controls in major areas.
sures from internal sources.
- 12. Series of cycnts (where individual events are not of 2.
An exposure to an mdividual in an unrestricted arca major importance), recurring incidents, and inci-such that the whole body dose received exceeds 0.5 dents with implications for similar facilitics (generic rem in one calendar year [10 CFR 20.105(a)].
incidents) that create major safety concern.
3.
The release of radioactive material to an unre-stricted arca in concentrations which, if averaged 1.
Exceeding a safety limit of license Technical Specifi-over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. cxceed 500 times the regu-cations [10 CFR 50.36(c)].
latory limit of Appendix II,'lable 11,10 CFR 1hrt 20 l
(CFR 20.403(b)(2)).
2.
Major degradation of fuel integrity, primary coolant pressure boundary, or primary containtnent bound-4.
Radiation or contamination levels in excess of design ary.
values on packages, or loss of confinement of radio-active material such as (a) a radiation dose rate of 3.
Loss of plant capability to perform essential safety 1,000 mrem per hour three feet from the surface of a functions such that a potential release of
'On January 1,1994, changes to'Utle 10 of the Calc ofIcdcra/Repdatiorn Part 20 were promulgated. At the Commission's directwe, the staff iscurrently developing a policy staicment revising entena for various types of AOs. The changes pertinent to the 10 CI'R 2u revisions will also be included in that draf t pohn statement. Upon Commission's appioval. the appropriate changes to this Appendix will be published.
1I NUREG-0090, Vol.17, No. I
Abnormal Occurrences,1st Qtr CY94 radioactivity in excess of 10 CFR lbrt 100 guidelines 2.
A major condition not specifically considered in the could result from a postulated transient or accident safety analysis report orTechnical Specifications that (e.g., loss of emergency core cooling system, loss of requires immediate remedial action.
control rod system).
3.
4.
Discovery of a major condition not specifically con-An event that seriously compromised the ability of a sidered in the Safety Analysis Report (SAR) orTech-c nfinement system to perform its designated func-tion.
nical Specifications that requires immediate reme-dial action.
Medical Misadministrations 5.
Personnel error or procedural deficiencies that re-sult in loss of plant capability to perform essential safety functions such that a potential release of ra-As discussed in the Preface to this report, the NRC policy statement on AOs was published before licensecs were dioactivity in excess of 10 CFR 15rt 100 guidehnes required to report medical misadministrations to the could result from a postulated transient or accident NRC.Therefore, during 1984, NRC developed guidelines (c.g., loss of emergency core cooling system, loss of for selecting such events for AO reporting. These guide-control rod system).
lines, which are summarized in 'lkble A-1, augment the For Fuel Cycle Licensees NRC policy statement.
1.
A safety limit of license Technical Specifications is As noted in the Preface, revised guidelines are currently execeded and a plant shutdown is required * 'l CFR being developed because new medical misadministration 50.36(c)].
definitions became effective on January 27,1992.
t i
4 NUREG-0090, Vol.17, No. I 12
Abnormal Occurrences,1st Otr CY94 Table A 1 NRC Guidelines for Selecting Medical Misadministration Events for Abnormal Occurrence (AO) Reporting AO Reporting Threshold Event Type Diagnostic Exposure Therapeutic Exposure (1) Administering a radiopharma-If the improper administration If the improper administration ceutical or radiation from a results in any part of the results in any part of the body sealed source other than the body receiving unscheduled receiving unscheduled radiation, an one intended.
radiation, an AO report should AO report should be proposed for be proposed if:
any such event.
(a) the actual dose to the if the parts of the body wrong body part is receiving radiation 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 I art, or (b) there are clinical (a) the actual dose is greater indications of any than 1.5 times that intended adverse health effects to the above described body to the wrong body pan.
parts, or, If the parts of the body (h) the actual dose is less than receiving radiation 0.5 times that intended to the improperly would have above described body parts, or, received radiation anyway, had the proper administration (c) the above described body parts been used, an AO repod should show signs of adverse health be proposed if:
effects greater than expected had the properadministration been used, or (a) the actual dose is greater (d) the event (regardless of any than five times that intended health effects) affects two or to the above described body more patients at the same parts, or, facility.
(b) the above described body parts show signs of adverse health effects greater than expected had the proper administration l
been used.
(2) Administering a radio-An AO report should be An AO report should be pharmaccutical or radiation proposed if:
proposed for any such event.
to the wrong patient.
(a) the actual dose to the wrong patient exceeds five times the prescribed dose for the intended patient, or (b) the event results in any adverse health effects.
(3) Administering a radiophar-Same guidelines as for Same guidelines as for maceutical or radiation by a Event Type 1.
Event 'lype 1.
13 NU R EG-0090, Vol.17, No.1 2
m.
Abnormal Occurrences,1st Otr CY94 Table A 1 (Cuatinued)
AO Reporting Threshold Es ent '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 than 50 percent.
greater than five times the prescribed dose, or, (b) the event results in adverse health effects worse than expected for the normal range of exposures prescribed for the diagnostic procedure.
(5) Administering a Not applicable.
An AO report should be therapeutic dose of proposed if:
a radiopharmaceutical differing from the prescribed (a) the actual dose is greater dose by more than 10 percent:
than 1.5 times the prescribed or administering a therapeutic dose, or, radiation dose from a 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 facilitics involved).
public health or safety concern.
(7) Generic events.
For either diagnostic or therapeutic cxposures, an AO report should be 9
proposed for misadministratim with generic implications that create a significtmt public health or safety concern.
NUREG-WX), Vol.17, No.1
[4
Abnormal Occurrences. Ist Qtr CY94 APPENDIX B UPDATE OF PREVIOUSIX REPORTED AllNORMAL OCCURRENCES During January through March 1994, NRC licensees, discussed b-low contain a summary of information pre-Agreement States, Agreement State licensecs, and other sented in previous reports and any subsequent updated in-involved parties, such as reactor vendors and architect-formation provided during the reporting period. 'those engineering 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 occurrences Other NRC Licensees 92-16 Medical Therapy 1his event is considered closed for the purpose of this re-Misadministration at the P""'
Lahey Clinic Medical Center 92-17 Medical Therapy 1
in llurlington, Massachusetts Misadministration at Indiana University Medical Center in
'llis abnormal occurrence was originally reported in NUREG-0090, Vol.15, No. 4. " Report to Congress on Ind.ianapoh.s, Indiana Abnormal Occurrences," October December 1992. 'lhe mformation pertaimng to this abnormal occurrence is up-
'lhis abnormal occurrence was originally reported in dated as follows.
NUREG-4X)90, Vol.15, No, 4 " Report to Congress on Abnormal Occurrences," October-December 1992. 'lhe information pertaming to this abnormal occurrence is up-dated as follows.
At the Lahey Clinic Medical Center in Hurlington, Mas-sachusetts, a patient was scheduled to receive brachyther-On November 13 and 14,1992, a 30-month-old patient re-apy treatment to the right mainstem bronchus in three fractions using a Gamma Med high-dose-rate (IIDR) re-ceived a radiation dose of 600 centigray (cGy)(600 rad)in-stead of the intended dose of 300 cGy (300 rad) as treat-mote afterloader. Each fraction was to deliver 700 centi-gray (700 rad) to the targeted tumor site. On October 7, ment for a brain tumor. 'the error was caused by 1992, the patient was administered the first treatment as crroneous calculations by the dosimetrist and by an appar-ently inadequate review by the physician before the treat-prescribed. On October 14,1992, the therapist incorrectly ments began.
entered 7 millimeters (0.28 inch), versus the prescribed 7 centimeters (2.8 inch), for the offset distance into the On October 7,1993, NRC proposed a $5000 Civil Penalty treatment computer, 'this error resulted in the second against the medical center for failing to have procedures fraction delivering 90 percent of the prescribed fraction-to assure that the written directive had all the necessary ated radiation dose to unintended tissues away from the treatment information and to verify that the dose calcula-tumor site and underdosing the tumor site. 'lhe under-tions in the treatment plan conformed to the written di-dose was made up during the administration of the third rective.'lhe medical center protested the penalty and the and final fraction on October 22,1992.
NRC staff subsequently issued an Order imposing the
$5000 Civil Penalty on January 18,1994. The medical cen-ter has requested a hearing on the issue and the hearing is On January 21,1993, NRC held an open Enforcement pending.
Conference to discuss the apparent violations and their causes, and th e licensce's corrective actions. After consid-
'lhis report will be further updated when additionalinfor-eration of the information presented by the licensec and mation becomes available.
the application of the mitigation / esc 2dation factors, a No-tice of Violation was issued to the licensee on August 4, 92-19 Medical rrherapy 1993. In a letter dated November 11.1993, the licensec provided its corrective actions for each siolation. A rou-Misadministration and line inspection, including followup review of the licens-ec's corrective action was performed on February 1 and 2, Temporary Loss of 1994. No additional violations were identified.
Isracllytherapy Source at 15 NUREG4)090. Vol.17, No. I
Abnormal Occurrences,1st Otr CY94 Yale-New Ilaven llospital in This abnormal occurrence was originally reported in NUREG-41090, Vol.16, No. 4, " Report to Congress on New Ilaven, Connecticut Abnormal Occurrences," October-December 1993. The information pertaining to this abnormal occurrence is up-
'this abnormal occurrence was originally reported in dated as follows.
NUREG4XML Vol.15 No. 4, " Report to Congress on Abnor mal Occurrences," October-December 1992. It was On J uly 1,1993, a patient was administered a therapeutic updated in Vol.16. No. 4, of NUREG4090, October-dose to a part of the body not scheduled to receive expo-December 1993. The information pertaining to this ab-sure. The patient was prescribed 3 brachytherapy treat-normal occurrence is updated as follows.
ments of 700 centigray (cGy)(700 rad) to the right mains-tem bronchus using a Nucletron Micro-Selectron HDR On December 3,1992, NRC was notified by the licensee remote afterloader, During the last treatment, a longer that a 39-year-old female patient received a 33 percent than required catheter was used preventing the source undertreatment during a brachytherapy treatrnent to the from reaching the target site. A negligible dose was deliv-cervix and an unplanned 260 centigray (260 rad) exposure cred to the tumor site. It also resulted in a surface dose to to her leg. One of the sources that was prescribed was ci-the lens of the eyes of 1.97 cGy (1.97 rad), a dose to the ther never inserted or was removed from the applicator chin of 4.56 cGy (4.56 rad), and a dose lo the thyroid of 3.07 during treatment, and left in her bedding, cGy (3.07 rad).
Actions taken by the NRC include the followingactivities:
This event is considered closed for the purpose of this re-(1) a special safety inspection, limited to gathering adds
- pgn, tionalinformation on the licensee's Quality Management program, was performed on March 8,1994; (2) an open Enforcement Conference to discuss the apparent viola-93-3 hiedical TlieraI)),
tions identified in the December 1,1993, and the March 8.
SliSadnlinistration Involving 1994, inspections, its causes and the licensec's corrective actions held on March 11,1994: and (3) a Notice of Viola-ille use or a Iligh-nose-nate tion was issued to the licensee on March 31,1994.The li-Reinote Afterloader censee responded to the Notice of Violation and has ad-Israchytherapy Device at rnitted to three of the violations.The NRC is evaluating the hanwis demal of the founh violation.
Yale-New Ilaven Ilospital in New IInven, Connecticut This report will be funher updated when additional infor-mation becomes available.
~1his abnormal occurrence was originally reporte'J in NUREG41090 Vol.16, No.1. " Report to Congress on 93-M Ihposure to a Nursing Infant Abnormal Occurrences," January-March 1993. It was up-dated in Vol.,16, No. 4, of NUREG-0090. October-at Queen'S IloSpital in December 1993. The information pertaining to this ab-lionolulu, llawaii normal occurrence is updated as follows.
'lhis abnormal occurrence was originally reported in On January 21,1993, NRC was notified by the licensee N UREG-0090, Vol.14, No. 4," Report to Congress on Ab-that a female patient received a 50 percent undertreat.
normal Occurrence," October-December 1993. The in-ment during a brachytherapy procedure to the vagina and formation pertaining to this abnormal occurrence is up-an unplanned 700 centigray (700 rad) exposure to h'er ree-dated as follows.
tum when the physician mistakenly inserted the HDR applicator into the rectum instead of the vagina.
On December 2,1991, a breastfeeding patient was admin-istered 0.56 megabecquerel (15 microcuric) of iodine-131 This event is consid,acd closed for the purpose of this re-for a diagnostic sc:m, because the technologist failed to notice the notation on a hospital form that the patient was port.
breastfeeding. As a result, her infant received an ab-sorbed thyroid dose in the range of 160 to 650 millisievert (16 to 65 rem).
93-13 51edical I!rachytherapy 51isadministration at An NRC inspection was conducted on September 28, and hlountainSide lloSpital in Ocgber 25 to 27,1993. This incident was discussed during the mspection. On December 29,1993, a Notice of Vmla-h1ontcla,r, New Jersey tion was issued because the technician administered a i
NUREG4X)oo, Vol.17, No. I 16
Abnormal Occurrences,1st Qtr CY94 dose to a breastfeeding mother in violation of the licens-His abnormal occurrence was originally reported in ec's procedures. This item was classified as a Severity Lev-NUREG41099, Vol.16, No. 4, " Report to Congress on el IV item and no Civil Penalty imposed.
Abnormal Occurrences," October-December 1993. The information relating to this abnormal occurrence is up-The licensee respeded to the Notice of Violation on Jan-dated as follows.
uary 25,1994.The licensee stated that the Radiation Safe-ty Officer reminded the staff in a memorandum, dated A therapeutic misadministration occurred November 10, November 19, 1993, to be diligent in the breastfeeding 1993, at Good Samaritan Hospital in Zanesville, Ohio, screening procedure. Further, the procedure has been when a crimp m a catheter prevented iridium-192 seeds documented and reviewed by each technologist.The pro, contained in a ribbon from being fully inserted to the cedure was also incorporated into the clinical procedure treatment positL. As a result, the patient's throat area manual and will be reviewed at the annual safety inservice received an unintended radiation exposure. The seeds training.
were subsequently placed in their correct position to de-liver the intended dose to the patient's lung.
NRC accepted the licensee's response to this item in a let-ter dated February 10,1994.
An NRC inspection on January 19,1994, identified three violations associated with this misadmmistration. These adons wem 0) fauure to instruct the medical technol-This event is considered closed for the purpose of this re-ogist and medical physicist in proper implanting procc-port.
dure; (2) failure to review radiographs to confirm the sou rce location until three hours after the implant; and (3) f Hm t pr vid the required radiation safety instruc-93-15 Medical Ilrach}theraEY tions. A Notice of Violation was issued on February 28, Misadministration at Good 1994, but no Civil Penalty was proposed.
Samaritan Medical Center in
,this event is considered closed for the purpose of this re-Zanesville, Ohio port.
Agreement State Licensees AS 93-16 Medical tirachytherapy through the use of implants and an external beam irradia-tor. After finding the source out of place, the second in-Misadm.. trat. ion at mis tracavitary insertion was cancelled. The remaining de-Richland Memorial llospital sired doses to the pertinent points of treatment were in Columbia' South Carolina btained by additional external beam irradiation. The Point A dose was 8752 cGy (8752 rad)on the left, and 8271 cGy (8271 rad) on the right.
This abnormal occurrence was originally reported in NUREG-0(yX), Vol.14, No. 4, " Report to Congress on Efforts were taken to determine the length of time that Abnormal Occurrences," October-December 1993. The the source was out of place; however, no conclusive deter-mformation pertaining to this abnormal occurrence is up' minations could be made. Days after the treatment, the dated as follows.
patient developed an ulceration beneath the right thigh.
The licensee estimated the dose to the wrong treatment A paticnt was prescribed a 41.5-hour brachytherapy treat-sit e to bc 20(X) to 4000 cGy (2000 to 4000 rad), based on the ment utilizing cesium 137 (Cs-137) for insertion with tan-degree and severity of ulceration.The licensee indicated dem and ovoid applicators. The tandem applicator had that there would be no way to determine a more specific three sources, and each of the ovoid applicators were to dose since it is not known when the source came out of the havc one source. At 10:00 a.m.. on September 24,1992, applicator, and the proximity of the sourec to the patient's nursing personnel discovered a 1.11 gigabecquerel (30 thigh was also unknown.The licensee stated that no long-millicurie) source in the patient's bed. 37 hours4.282407e-4 days <br />0.0103 hours <br />6.117725e-5 weeks <br />1.40785e-5 months <br /> into the term health effects other than scarring arc expected.
treatment.The entire system was unloaded and returned to the brachytherapy vault. The sources were inventoried The patient and her family were notified of the misadmin-and certified that none was missing.
istration.
The licen,ee stated that ideal doses for the treatment of
% prevent recurrence, the following actions have been stage 11-11 carcinomas of the cervix call for 8500 centigray taken: (1) the Gynecology / Oncology nursing staff has (cGy)(8500 rad) to Point A and 5500 cGy (5500 rad) to the been given refresher radiation safety instruction regard-external iliac nodes. His dose was to be administered ing the use of, and treatment with, radiative Cs-137;(2) 17 NUREG4)D90, Vol.17, No.1
?
Abnormal Occurrences,1st Qtr CY94 the presence of two individuals during Ihe insertion of and approved the procedures requiring the licensee to use i
Iow-dose-rate brachytherapy sources is requir ed as well as tamper resistant tape, have Iwo individ uals present du ring the loading to be reviewed afterwards by a physician; and source loading, and have independent review of allloads (3) tamper resistant tape will be used to seal the tandem by qualified physicians.
and ovoid applicators.
The State agency staff has also reviewed the circum.
This event is considered closed for the purpose of this re-stances of the misadministration. The staff has reviewed port.
1 1
I I
i Y
?
1 NUREG-0090, Vol.17, No.1 is si e.-.
Abnormal Occurrences,1st Otr CY94 APPENDIX C During January through March 1994, no new "Other to the licensee's QMP. The inspection also found that the Events of Interest" were reported. An update of a pre-licensec had not trained members of its technical staff viously reported "Other Event of Interest" is updated as who were responsible for administering radiation therapy fellows.
treatments in the provisions of the QMP. The inspection findings were documented in NRC Inspection Report Misadm.. tration at Veterans 030-00503/93-0I, dated September 3,1993 (Ref. C-1).
inis Administration Medical Center in On September 30,1993, NRCissued a Notice of Violation Dallas, Texas and Proposed Imposition of Civil Penalty (Ref. C-2) for viola tions involving (1) failure to t rain individuals working
'!his abnormal Occurrence was previously reported in under the supervision of a physici:n authorized user in the NUREG-0090, Vol.16, No. 3, " Report to Congress on provisions of the licensee's QMP; (2) failure to prepare Abnormal Occurrences" July-September 1993, Appendix written directives in accordance with NRC regulations; C, "Other Events of Interest." The information relating and (3) multiple examples of failures to follow the licens-to this event of interest is updated as follows.
ec's QMP. These violations were jointly categorized as a Severity Level III problem and assessed a Civil Penalty of The misadministration involved cobalt-60 teletherapy
$3.750. In addition, fou r additional violations were catego-treatment that was initiated on February 11,1992, for rized as Severity Level IV violations, and a fifth violation
. Kaposi' sarcoma affecting ihe patient's lower extremities.
was categorized as a Severity Level V. The latter viola-The physician prescribed the radiation be administered in tions were not assessed a Civil Penalty, several fractional doses to the patient's lower extremitics over the course of several weeks. 'lhe misadministration A medic d consultant was requested to review the misad.
involved administration of radiation in excess of 1he dose ministration discussed above and to provide an asses-prescribed by the physician during the last week of the sment of the potential consequences of the misadminis-treatment. Th: crror in treatment was identified by an tration. The physician consultant determined that the NRC inspector during a routine radiation safety inspec.
misadministration did not result in adverse consequences
- tion, beyond those expected for this form of treatment. The li-censee has paid the Civil Penalty and has responded to the The misadministration appeared to have been the result Notice of Violation (Ref. C-3),
of the licensce's failure to effectivelyimplement its Quali-ty Management Program (QMP). In addition, the inspec-This event is considered closed for the purpose of this re-tor identified several other examples of failures to adhere port.
19 NUREG-0090, Vol.17, No. I
Abnormal Occurrences,1st Qtr CY94 APPENDIX D During anuary through March 1994, NRC has reviewed a at the time of publication of this report, none of these j
number of events reported by the Agreement States. For events has been identified as a likely abnormal occur-several of them, additional information has been pro-
- rence, vided. Our evaluation of these events contiuucs, however, l
i l
NUREG-0090, Vol.17, No.1 20
Abnormal Occurrences,1st Qtr CY94 i
REFERENCES FOR APPENDICES 1
C-1 Letter from L J. Callan, Director, Division of Radi-030-00503, License No. 42-00220-08, dated Sep-ation Safety and Safeguards, to Alan G. Harper, tember 30,1993.*
Medical Center Director, Veterans Administration Medical Center, Dallas, Texas, forwarding NRC In-C-3 Letter from Melvin L Griem, M.D., NRC Medical spection Report 030-00503/93-01, Docket No.
Consultant, to James L Milhoan, Regional Admin-030-00503, License No. 42-00220-08, dated Sep-istrator, resp (mding to a request from the NRC i
tember 3,1993.*
Region IV office to conduct a review of a misadmi-nistration which occurred at the Veterans Adminis-tration Medical Center, Dallas,7bxas, Docket No.
C-2 Letter from James L Milhoan, Regional Adminis-030-00503, License No. 42-00220-08, dated Febru-trator, to Alan G. Harper, Medical Center Direc-ary 7,1994.*
tor, Veterans Administration Medical Center, Dal-las, Texas, forwarding a Notice of Violation and lic Document Room. 21N L Strect Nh.$ ora fee,in the NRC Pub-
- ,,y,;
9,;
,o
. f r Level), Washington, Proposed Imposition of Civil Penalty, Docket No.
DC 20555-0001.
21 NUREG-0090, Vol.17, No. I
POIC FORM 335 U.S. NUCLEAR REGULATORY COMMISSION
- 1. REPORT NLATER (2-80)
(Assigned by NRC. Add Vol.
NRCM 1102, Supp., Rev., and Addendum Num-aa n 3202 BIBLIOGRAPHIC DATA SHEET b"' ' - " *"Y 3 (see instructions on the rev.rsei NUREG-0090 zT e e SUsTi m Vol.17, No.1
- 3. DATE REPORT PUBUSHED Report to Congress on Almormal Occurrences:
yog7g l
yg,g January-March 1994 i
August 1994
- 6. AUTHOR (6)
- 6. TYPE OF REPORT Quarterly
- 7. PERIOD COVERED (inclusive Dates)
January-March 1994
- 8. PERFORMING ORGANIZATION - NAME AND ADDRESS (if NRC, provide Divlsson, Office or Region, U.S Nuc6 ear Regulatory Commiss60n, and malling address; if contractor, provide name and mailing address.)
Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
- 9. SPONSORING ORGANIZATION - NAME AND ADDRESS (if NRC, type "Same as above*; if contractor, provgle NRC Division, Office or Region, U.S. Nuc6 ear Regulatory Commission, and malling address.)
Same as 8., above.
- 10. SUPPLEMENTARY NOTES
- 11. ABSTRACT (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 January 1 through March 31,1994.
This report addresses seven AOs at NRC-licensed facilities. One involved inoperable main steam isolation valves at a boiling water reacter, four involved medical brachytherapy misadministrations, one involved a medical teletherapy misad-ministration, and one involved four lost reference sources. One AO that was reported by an Agreement State is also discussed; t.he information is current as of April 25,1994. This event involved a therapeutic radiopharmaceutical misadmi-nistratior. The report also contains updates on seven abnormal occurrences previously reported by NRC licensees and one abncermal occurrence previously reported by an Agreement State license. For the period January 1 to March 31,1994, ao new "Other Events ofInterest" were reported but an update to a therapeutic misadministration previously reported as an "Other Event of Interest" is included.
- 12. KEY WORDS/DESCRIPTORS (Ust words or phrases that will assist researchers in locating the report.)
- 13. AVAILABluTY STATEMENT Unlimited Medical; Misadministration; Brachytherapy;'Ibletherapy; Exposure to Nursing Infant; Imst Source; Inoperable Main Steam Isolation Valves at Perry Nuclear Power Plant Unclassified (This Report)
Unclassified
- 15. NUMBER OF PAGES
- 16. PRICE NRC FORM 336 (2-80)
l l
Printed on recycled paper 1
i Federal Recycling Program
NUREG-0090, %I.17, Nil REPORT TO CdESS ON ABNORMAL OCCURRENCES AUGUST 1994 JANUARY - MARCH 1994 UNITED STATES NUCLEAR REGULATORY COMMISSION nRST CLASS MAIL POSTAGE AND FEES PAfD WASHINGTON, D.C. 20555-0001 USNRC PERMIT NO. G 67 OFFICIAL BUS! NESS PENALTY FOR PR!VATE USE, $300 120555139531 1 1ANICC1CY1CV1 US NRC-0ADM DIV FnIA & PUBLICATIONS SVCS TPS-PDR-NUREG 2WFN-6E7 WASHINGTCN OC 20555 i
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