Report to Congress on Abnormal 

Occurrences 

Fiscal Year 2015 

United States Nuclear Regulatory Commission 

Washington, DC 20555-0001 

iii 

ABSTRACT 

Section 208 of the Energy Reorganization Act of 1974, as amended (Public Law 93-438), 

defines an “abnormal occurrence” (AO) as an unscheduled incident or event that the 

U.S. Nuclear Regulatory Commission (NRC) determines to be significant from the standpoint 

of public health or safety. The Federal Reports Elimination and Sunset Act of 1995 (Public 

Law 104-66) requires that the NRC report AOs to Congress annually. 

This report describes two medical events involving NRC licensees that the NRC identified as 

AOs during the fiscal year (FY) 2015 based on the criteria in Appendix A, “Abnormal 

Occurrence Criteria and Guidelines for Other Events of Interest.” One event involved radiation 

exposure to an embryo/fetus during treatment of the patient, and the other event was a medical 

event as defined in Part 35 of Title 10 of the Code of Federal Regulations, “Medical Use of 

Byproduct Material.” 

In addition, this report describes fifteen medical events involving Agreement State licensees that 

have been identified as AOs during FY 2015 based on the criteria defined in this report’s 

Appendix A. Agreement States are those States that have entered into formal agreements with 

the NRC, pursuant to Section 274 of the Atomic Energy Act of 1954, as amended (AEA) (Public 

Law 83-703), to regulate certain quantities of AEA material at facilities located within their 

borders. Currently, there are 37 Agreement States. 

It should be noted that the seventeen AOs represent a small fraction of the average number of 

nuclear medicine and radiation therapy procedures conducted annually. In the United States in 

2006, the number of diagnostic nuclear medicine procedures performed was 5,048,231, as 

reported in the National Council on Radiation Protection Report 160 – Ionizing Radiation 

Exposure of the Population of the United States (2009). The number of radiation therapy 

treatment procedures performed in 2013 was 1,016,565, as reported by the IMV Benchmark 

Report for Radiation Therapy (2014). 

Appendix A to this report provides the NRC’s criteria for identifying AOs, as well as the 

guidelines for identifying “other events of interest” (OEI). During FY 2015, the NRC identified no 

events that met the guidelines for inclusion in Appendix B, “Updates of Previously Reported 

Abnormal Occurrences.” During FY 2015, the NRC identified three events that met the 

guidelines for inclusion in Appendix C, “Other Events of Interest,” because these events 

attracted significant public interest. These events were a release of hydrogen fluoride at the 

Honeywell Metropolis Works Facility, a conversion facility located in Metropolis, Illinois; an event 

involving human exposure at International Isotopes Incorporated, Idaho Falls, Idaho; and a dual 

state (Oklahoma-Texas) contamination event from a generator operated by Tracerco at the 

University of Tulsa, Oklahoma. Appendix D, “Glossary,” presents definitions of terms used 

throughout this report. Appendix E, “Conversion Table,” presents conversions commonly used 

when calculating doses.

v 

CONTENTS 

ABSTRACT ...................................................................................................................... iii

CONTENTS ...................................................................................................................... v

EXECUTIVE SUMMARY ................................................................................................ vii

INTRODUCTION ................................................................................................. vii 

THE LICENSING AND REGULATORY SYSTEM ............................................... vii 

REPORTABLE EVENTS ..................................................................................... viii 

AGREEMENT STATES ....................................................................................... viii 

INTERNATIONAL INFORMATION ....................................................................... ix 

UPDATES OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES ....... ix 

OTHER EVENTS OF INTEREST .................................................................................. ix 

ABBREVIATIONS ............................................................................................................ xi

ABNORMAL OCCURRENCES IN FISCAL YEAR 2015 ................................................... 1

I. ALL LICENSEES ....................................................................................... 1 

NRC15-02 Human Exposure to Radiation Event at Department 

of the Army, Womack Army Medical Center in Fort 

Bragg, North Carolina ........................................................ 1 

II. COMMERCIAL NUCLEAR POWER PLANT LICENSEES ........................ 3 

III. EVENTS AT FACILITIES OTHER THAN NUCLEAR POWER PLANTS 

AND ALL TRANSPORTATION EVENTS .................................................. 3 

NRC15-01 Medical Events at University of Michigan in Ann Arbor, 

Michigan ............................................................................. 3 

AS15-01 Medical Event at an Unspecified City, New York ............... 5 

AS15-02 Medical Event at Abington Memorial Hospital in Abington, 

Pennsylvania ...................................................................... 6 

AS15-03 Medical Event at Affiliated Oncologists in Mokena, 

Illinois ................................................................................. 7 

AS15-04 Medical Event at Presence Resurrection Medical 

Center in Chicago, Illinois .................................................. 8 

AS15-05 Medical Event at MedStar Montgomery Medical Center 

(formerly University of Maryland), Helen P. Denit Cancer 

Center in Olney, Maryland ................................................. 9 

AS15-06 Medical Event at Christus St. Vincent Hospital, in 

Santa Fe, New Mexico ..................................................... 10 

AS15-07 Medical Event at an Unspecified City, New York ............. 11 

AS15-08 Medical Events at Legacy Good Samaritan Medical 

Center in Portland, Oregon .............................................. 13 

AS15-09 Medical Event at Abbott Northwestern Hospital in 

Minneapolis, Minnesota ................................................... 14 

AS15-10 Medical Event at Riverside Medical Center in 

Kankakee, Illinois ............................................................. 15 

AS15-11 Medical Event at Radiotherapy Clinics of Georgia, 

Conyers, Georgia ............................................................. 16 

AS15-12 Medical Event at Radiotherapy Clinics of Georgia, 

Snellville, Georgia ............................................................ 17 
vi 

AS15-13 Medical Event at University Hospitals of Cleveland in 

Cleveland, Ohio ................................................................ 18 

AS15-14 Medical Event at Wellstar Kennestone Hospital, 

Marietta, Georgia ............................................................. 19 

AS15-15 Medical Event at Wake Forest Baptist Health, 

Winston-Salem, North Carolina ........................................ 20 

APPENDIX A ABNORMAL OCCURRENCE CRITERIA AND GUIDELINES FOR 

OTHER EVENTS OF INTEREST .......................................................... A-1

APPENDIX B UPDATES OF PREVIOUSLY REPORTED ABNORMAL 

OCCURRENCES ................................................................................... B-1

APPENDIX C OTHER EVENTS OF INTEREST .......................................................... C-1

OEI 15-01 Cesium-137 contamination associated with University 

of Tulsa, Oklahoma ........................................................ C-1 

OEI 15-02 Honeywell Metropolis Works: Uranium Hexafluoride 

Release .......................................................................... C-3 

OEI 15-03 Human Exposure Event at International Isotopes 

Incorporated, Idaho Falls, Idaho .................................... C-5 

APPENDIX D GLOSSARY ........................................................................................... D-1

APPENDIX E CONVERSION TABLE .......................................................................... E-1 
vii 

EXECUTIVE SUMMARY 

INTRODUCTION 

Section 208 of the Energy Reorganization Act of 1974 (Public Law 93-438) defines an 

“abnormal occurrence” (AO) as an unscheduled incident or event that the U.S. Nuclear 

Regulatory Commission (NRC) determines to be significant from the standpoint of public health 

or safety. The Federal Reports Elimination and Sunset Act of 1995 (Public Law 104-66) 

requires that the NRC report AOs to Congress annually. 

This report describes those events that the NRC or an Agreement State identified as AOs 

during fiscal year (FY) 2015, based on the criteria defined in this report’s Appendix A, “Abnormal 

Occurrence Criteria and Guidelines for Other Events of Interest.” Agreement States are those 

States that have entered into formal agreements with the NRC, pursuant to Section 274 of the 

Atomic Energy Act of 1954 (AEA) (Public Law 83-703), to regulate certain quantities of AEA 

material at facilities within their borders. The NRC has determined that, of the incidents and 

events reviewed for this reporting period, only those that are described here meet the criteria for 

being reported as AOs. For each AO, this report documents the date and place, nature and 

probable consequences, cause(s), and actions taken to prevent recurrence. 

Four of the seventeen AOs included in this report occurred in previous fiscal years. The NRC 

completed its evaluation for these AOs in FY 2015. The NRC requires that information about 

AOs be complete to allow for adequate evaluation. Occasionally, all of the required information 

is not available in time to report an AO in the fiscal year of its occurrence. 

It should be noted that the seventeen AOs represent a small fraction of the average number of 

nuclear medicine and radiation therapy procedures conducted annually. In the United States in 

2006, the number of diagnostic nuclear medicine procedures performed was 5,048,231, as 

reported in the National Council on Radiation Protection Report 160 – Ionizing Radiation 

Exposure of the Population of the United States (2009). The number of radiation therapy 

treatment procedures performed in 2013 was 1,016,565, as reported by the IMV Benchmark 

Report for Radiation Therapy (2014). 

Appendix A to this report provides the NRC’s criteria for determining which events are identified 

as AOs, as well as the guidelines for identifying “other events of interest.” Appendix B to this 

report is provided to supply updates of previously reported AOs; however, no events met the 

criteria to be included. During FY 2015, the NRC identified three events that met the guidelines 

for inclusion in Appendix C, “Other Events of Interest,” because they attracted significant public 

interest. Appendix D, “Glossary,” presents definitions of terms used throughout this report. 

Appendix E, “Conversion Table,” presents conversions commonly used when calculating doses. 

THE LICENSING AND REGULATORY SYSTEM

The system of licensing and regulation that the NRC uses to carry out its responsibilities is 

implemented through the rules and regulations in Title 10 of the Code of Federal Regulations. 

The agency informs and involves stakeholders to ensure openness in the agency’s regulatory 

process, consistent with the NRC’s “Strategic Plan: Fiscal Years 2014–2018,” (NUREG-1614, 

Volume 6, dated September 2014, Agencywide Documents Access and Management System 
viii 

(ADAMS) Accession No. ML14246A439). The NRC regularly conducts licensing reviews, 

inspections, enforcement, investigations, operating experience evaluations, incident response, 

and confirmatory research. In addition, the agency involves the public in the regulatory process. 

The NRC adheres to the philosophy that multiple levels of protection best ensure the health 

and safety of the public. The agency achieves and maintains these levels of protection through 

regulations specifying requirements that ensure the safe use of radioactive materials. Those 

regulations contain design, operation, and quality assurance criteria appropriate for the various 

activities regulated by the NRC. Licensing, inspection, investigations, and enforcement 

programs offer a regulatory framework to ensure compliance with the regulations. In addition, 

the NRC strives to make the regulatory system more risk-informed and performance-based, 

where appropriate. 

REPORTABLE EVENTS 

The NRC initially issued the AO criteria in a Commission policy statement published in the 

Federal Register on February 24, 1977 (42 FR 10950), followed by several revisions in 

subsequent years. The most recent revision to the AO criteria was published in the 

Federal Register on October 12, 2006 (71 FR 60198), and became effective on that date. That 

revision established the criteria presented in Appendix A to this report, which the NRC used to 

determine which events are AOs. 

Review of, and responses to, operating experience is essential to ensure that licensees conduct 

their activities safely. Toward that end, the regulations require that licensees report certain 

incidents or events to the NRC. Such reporting helps to identify deficiencies and ensure that 

corrective actions are taken to prevent recurrence. 

The NRC and its licensees review and evaluate operating experience to identify safety and 

security concerns. The NRC responds to risk-significant issues through licensing reviews, 

inspections, and enhancements to regulations. In addition, the agency maintains operational 

data in computer-based data files for effective collection, storage, retrieval, and evaluation. 

The NRC routinely makes information and records on reportable events at licensed facilities 

available to the public. The NRC also disseminates information through public announcements 

and special notifications to licensees and other stakeholders. The NRC issues a 

Federal Register notice describing AOs that occurred in the previous fiscal year at facilities 

licensed or otherwise regulated by the NRC or Agreement States. The NRC routinely informs 

Congress of significant events, including AOs that occur at licensed facilities or involving 

licensed activities. 

AGREEMENT STATES 

Section 274 of the AEA authorizes the Commission to enter into agreements with States 

whereby the Commission relinquishes and the States assume certain regulatory authority over 

byproduct, source, and certain quantities of special nuclear materials. States that enter into 

such agreements with the NRC are known as Agreement States. Under these agreements, 

Agreement States must maintain programs that are adequate to protect public health and 

safety, and are compatible with the Commission’s program for such materials. At the end of 

FY 2015, there were 37 Agreement States. 
ix 

Agreement States report event information to the NRC in accordance with compatibility criteria 

established by the “Policy Statement on Adequacy and Compatibility of Agreement State 

Programs,” which the agency published in the Federal Register on September 2, 1997 

(62 FR 46517). The NRC also has put procedures into place for evaluating materials events 

to identify those that meet the AO criteria. The NRC uniformly applies the AO criteria (in 

Appendix A to this report) to events at licensee facilities or activities involving use of radioactive 

material regulated by either the NRC or the Agreement States. In addition, in 1977, the 

Commission determined that the annual report to Congress should include events that meet the 

criteria for AOs at licensees regulated by Agreement States. The Federal Register notice that 

the NRC issues to disseminate AO-related information to the public includes those AOs that 

occurred at licensees regulated by the Agreement States. 

INTERNATIONAL INFORMATION 

The NRC exchanges information with various foreign governments that regulate nuclear 

facilities and materials. This international information is reviewed and considered in the NRC’s 

research and regulatory activities, as well as in its assessment of operating experience. 

Although the NRC may occasionally refer to such international information in its AO reports to 

Congress, the agency generally reports only domestic AOs. 

UPDATES OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES 

The NRC supplies updates of previously reported AOs if significant new information becomes 

available. During this fiscal year reporting period, there were no updates to previously reported 

events. 

OTHER EVENTS OF INTEREST 

The NRC provides information concerning other events of interest that are not reportable to 

Congress as AOs but are included in this report based on the Commission’s guidelines, listed in 

Appendix A. During FY 2015, the NRC identified three events that met the guidelines for 

inclusion in Appendix C, “Other Events of Interest,” because they attracted significant public 

interest.

xi 

ABBREVIATIONS 

ADAMS the NRC’s Agencywide Documents Access and Management System 

AEA Atomic Energy Act of 1954, as amended 

AMP authorized medical physicist 

AO abnormal occurrence 

AS Agreement State 

CFR Code of Federal Regulations

cGy centigray(s) 

Ci curie(s) 

cm centimeter(s) 

CT computed tomography 

DNR Department of Natural Resources 

EPIP emergency plan implementing procedure 

ERT emergency response team 

FMB feed materials building 

FR Federal Register

FY fiscal year 

GBq gigabecquerel(s) 

GDC general design criterion/criteria

Gy gray(s) 

HDR high dose rate 

IEP Interim Enforcement Policy 

MBq megabecquerel(s) 

mCi millicurie(s) 

MD management directive 

mm millimeter(s) 

mSv millisievert(s) 

NRC U.S. Nuclear Regulatory Commission 

OEI other events of interest 

rad radiation absorbed dose 

rem roentgen equivalent man 

ROP Reactor Oversight Process 

RSO radiation safety officer 

Sv sievert(s) 

TBq terabecquerel(s) 

TEDE total effective dose equivalent 

TS technical specification 

1 

ABNORMAL OCCURRENCES IN FISCAL YEAR 2015 

Appendix A supplies the specific criteria for determining whether an event is an abnormal 

occurrence (AO) and offers the guidelines for reporting other events of interest that may not 

meet the AO criteria, but which the U.S. Nuclear Regulatory Commission (NRC) has 

determined should be in this report. Appendix A contains four major categories: 

I. All Licensees 

II. Commercial Nuclear Power Plant Licensees 

III. Events at Facilities other than Nuclear Power Plants and All 

Transportation Events 

IV. Other Events of Interest. 

Categories I, II, and III are discussed in this section, and Category IV events are discussed in 

Appendix C to this report. 

I. ALL LICENSEES 

During this reporting period, one event involving an NRC licensee was significant enough to be 

reported as an AO based on Criterion I, “All Licensees,” in Appendix A to this report.1 Although 

the event occurred at a medical facility, it involved unintended exposure of an embryo, not the 

patient. Therefore, this event belongs under the Criterion I.A “Human Exposure to Radiation 

from Licensed Material,” category, as opposed to the Criterion III.C, “Medical Licensees,” 

category. 

NRC15-02 Human Exposure to Radiation Event at Department of the Army, Womack 

Army Medical Center in Fort Bragg, North Carolina 

Criterion I.A.2, of Appendix A to this report provides that any unintended radiation exposure to 

any minor (an individual less than 18 years of age) resulting in an annual total effective dose 

equivalent of 50 millisieverts (mSv) (5 rem) or more, or to an embryo/fetus resulting in a dose 

equivalent of 50 mSv (5 rem) or more, shall be considered for reporting as an AO. 

Date and Place—December 11, 2014, Fort Bragg, North Carolina 

Nature and Probable Consequences—Department of the Army, Womack Army Medical Center 

(the licensee), reported that a pregnant patient received approximately 3.6 gigabecquerels 

(GBq), which equates to 97 millicuries (mCi) of iodine-131 (I-131) for thyroid ablation treatment. 

 

1 In the NRC’s Fiscal Year 2015 Performance and Accountability Report (http://www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1542/v21/) and 2017 Congressional Budget Justification 

(http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1100/v32/), the agency reported two Abnormal 

Occurrences (AOs) involving NRC licensees that met or exceeded “AO Criteria 1.A.1, I.A.2, or I.A.3.” in its 

performance indicators. However, upon further review the staff determined that there was only one event 

that met this AO criteria for 2015. The agency will review its processes to verify the accuracy of the 

performance indicator results reported in all future documents. 
2 

On December 31, 2014, the patient reported to the medical center that it had been determined 

that she was pregnant on the day of the treatment and the gestational age of the embryo was 

determined to be 2 to 4 weeks at the time of the thyroid ablation treatment. The Womack Army 

Medical Center’s radiation safety officer (RSO) was notified of this event on January 5, 2015, by 

the authorizing physician. The licensee calculated an estimated dose of 204.3 milligrays, which 

is the equivalent to 20.43 rad, to the embryo from the procedure. 

The patient and referring physician were informed of this event. The expected effect to the 

embryo was determined to be either miscarriage or no effect. The fetus developed normally and 

was born with no abnormalities noted. 

Cause(s)—The cause of this event was a false negative pregnancy test that the licensee 

performed approximately 1.5 hours before the dosage administration and the patient’s lack 

of awareness that she was pregnant. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee modified its “I-131 Patient Questionnaire” to include a question about 

the status of the patient with regard to pregnancy to help increase the patient’s awareness of 

possible pregnancy. The licensee revised its “Radiation Safety Precautions for the Home After 

Release” to include instructions for the patient to follow if she learns she was pregnant at the 

time of the treatment, which included a specific phone number to call during working hours and 

after working hours. A refresher session was held with all applicable authorized users (AUs) 

about the reporting requirements. 

NRC—The NRC conducted an inspection from January 21, 2015, through March 4, 2015. The 

NRC identified one Severity Level IV violation of Title 10 of the Code of Federal Regulations (10 

CFR) 35.3047(c) for failure to notify the NRC by the next calendar day following the discovery of 

an unintended dose to an embryo/fetus. 

This event is closed for the purpose of this report. 
3 

II. COMMERCIAL NUCLEAR POWER PLANT LICENSEES 

During this reporting period, no events at commercial nuclear power plants in the United States 

were significant enough to be reported as AOs based on Criterion II in Appendix A to this report. 

III. EVENTS AT FACILITIES OTHER THAN NUCLEAR POWER PLANTS AND 

ALL TRANSPORTATION EVENTS 

During this reporting period, one event at an NRC licensee and fifteen events at Agreement 

State licensee facilities were significant enough to be reported as AOs, based on Criterion III in 

Appendix A to this report. 

NRC15-01 Medical Events at University of Michigan in Ann Arbor, Michigan 

Criteria III.C.1.b and III.C.2.a of Appendix A to this report provide that a medical event shall be 

considered for reporting as an AO if it results in a dose equal to or greater than 10 gray (Gy), or 

1,000 rad, to any organ or tissue (other than a major portion of the bone marrow, the lens of the 

eye, or the gonads) and represents a prescribed dose or dosage that is at least 50 percent 

greater than that prescribed. 

Date and Place—November 17, 2006, through January 6, 2010, Ann Arbor, Michigan 

Nature and Probable Consequences—The NRC identified four medical events at the University 

of Michigan (the licensee), which occurred between November 2006 and January 2010 

involving four patients. The events were associated with brachytherapy procedures using 

iodine-125 (I-125) seed mesh implants for lung cancer treatments. Each patient was prescribed 

approximately 100 Gy (10,000 rad) to his or her lung tissue at 5 millimeters (mm) from the 

center of the mesh, but instead the patients were administered doses that were 40 percent, 

74 percent, 99 percent, and 114 percent greater than prescribed. The referring physicians were 

informed of these events. In accordance with 10 CFR 35.3045(e), the licensee did not inform 

the patients of these events because, based on medical judgment, the referring physicians 

determined that telling the patients would be harmful. 

On October 1, 2014, the NRC informed the licensee that all four events met the criteria to be 

reported as medical events. However, in accordance with the Interim Enforcement Policy for 

Permanent Implant Brachytherapy Medical Event Reporting (IEP), dated July 9, 2013 (78 FR 

41125), the NRC did not take enforcement action against the licensee for failure to report the 

events. In the IEP, the Commission authorized the staff to exercise enforcement discretion for 

existing and future violations of the current section 35.3045(a)(1)(i) medical event reporting 

requirement when a treatment site total dose equals or exceeds 120 percent of the prescribed 

dose, provided that the treatment would not have to be reported based on other criteria such as 

the dose exceeding regulatory limits to adjacent, normal tissue. In all four cases, all conditions 

were met to exercise the enforcement discretion granted in the IEP. The licensee determined 

that none of the procedures resulted in harm to the patient or caused excessive dose to an 

unintended treatment site. Further the licensee determined that the doses to tissues other than 

the treatment site did not exceed reportable limits. 
4 

Cause(s)—The licensee determined, and the NRC confirmed, that the cause of the events was 

that the prescribed doses of approximately 100 Gy (10,000 rad) were determined assuming the 

seed mesh lies flat after implantation. However, due to re-inflation of the lung after surgery, the 

mesh curved such that the concave surface of the mesh faced the lung tissue. Because of the 

curved mesh, the I-125 sources contained in the mesh were located closer to the treatment site, 

which resulted in the treatment sites receiving higher doses than prescribed. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee has suspended conduct of this treatment protocol and has no plans in 

the foreseeable future to resume its use. 

NRC—The NRC exercised enforcement discretion via the IEP dated July 9, 2013. The NRC is 

undertaking a rulemaking that will amend 10 CFR Part 35. One element of this rulemaking is an 

amendment to the medical event reporting criteria that will establish criteria for permanent 

implant brachytherapy medical event reporting that are activity-based, because activity-based 

criteria are more appropriate for this treatment method than dose-based criteria. If approved by 

the Commission, these criteria would be effective in 2017 and would supersede the IEP at that 

time. 

This event is closed for the purpose of this report. 
5 

AS15-01 Medical Event at an Unspecified City, New York2

Criterion III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy (1,000 

rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of the 

eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the wrong 

treatment site. 

Date and Place — March 25, 2013, Unspecified Licensee, New York 

Nature and Probable Consequences—The New York State Department of Health reported that 

a medical event occurred associated with an I-125 radioactive seed implantation. During the 

radioactive seed localization procedure, the surgeon successfully removed the tumor and lymph 

node; however, the seed had migrated deeper into tissue (wrong treatment site) and was not 

removed. The surgeon determined that the migrated seed location prevented safe extraction 

due to scarring from previous node removal, mastectomy, and reconstructive surgery. The 

licensee calculated a localized dose at 0.5 cm from the seed of 2,290 centigray (cGy or rad) and 

negligible dose at 6 cm. The patient, referring physician, medical oncologist, and radiologist 

were notified. The State withheld the licensee name and location in accordance with N.Y. Pub. 

Health Law § 2805-m. 

Cause(s) — The New York State Department of Health did not provide the cause of the medical 

event. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee’s corrective actions included discontinuation of radioactive seed 

localization procedure for axillary node lesions. 

State — The New York State Department of Health did not provide the actions taken 

to prevent reoccurrence. 

This event is closed for the purpose of this report. 

 

2 The State of New York Department of Health did not provide the facility name or location for the two AOs 

that it reported and informed the NRC that withholding this information is consistent with New York State 

Public Health Law § 2805-I. 
6 

AS15-02 Medical Event at Abington Memorial Hospital in Abington, Pennsylvania 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, the lens of 

the eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the 

wrong treatment site. 

Date and Place — August 15, 2013, Abington, Pennsylvania 

Nature and Probable Consequences—Abington Memorial Hospital (the licensee) 

discovered and subsequently reported a medical event on March 10, 2014, that occurred on 

August 15, 2013, that was associated with an yttrium-90 microspheres infusion procedure for 

treatment of cancer in the liver. On August 15, 2013, the patient was treated with 

1,339.77 megabecquerels (MBq), the equivalent of 36.21 mCi, with a prescribed dose of 107 Gy 

through the right hepatic artery. On September 6, 2013, the physician noted that the patient 

was experiencing intermittent abdominal pain. On October 10, 2013, the patient was 

administered 188.33 MBq (5.09 mCi) through the proximal left hepatic artery and 179.45 MBq 

(4.85 mCi) through the distal left hepatic artery. On February 24, 2014, the patient was 

admitted because of severe anemia and suspected gastrointestinal bleeding. On 

February 27, 2014, endoscopy revealed a duodenum lesion and an ulcer that had developed 

seemingly because of microspheres migrating to the stomach (wrong treatment site) yielding an 

unknown dose. The licensee determined that the delivered dose was 160 Gy to the liver; 

however, the licensee stated they could not determine the dose to the stomach. A dose greater 

than 10 Gy is required in order for pain and gastrointestinal bleeding, as experienced by this 

patient, to occur. The patient and referring physician were informed of this event. 

Cause(s) — The cause of the medical event was determined to be the migration of 

microspheres through an aberrant hepatic arterial vasculature supplying the stomach. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee reevaluated its procedure with the manufacturer’s guidance. 

State — Pennsylvania performed a full reactive inspection to investigate this event. 

This event is closed for the purpose of this report. 
7 

AS15-03 Medical Event at Affiliated Oncologists in Mokena, Illinois 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy (1,000 

rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of the 

eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the wrong 

treatment site. 

Date and Place – March 10 through March 14, 2014, Mokena, IL 

Nature and Probable Consequences – Affiliated Oncologists of Southland Oncology (the 

licensee) reported that a medical event occurred associated with a high dose rate (HDR) 

brachytherapy treatment for breast cancer using 314.5 GBq (8.5 Ci) of iridium-192. The patient 

was prescribed a total dose of 34 Gy (3,400 rad) in 10 fractionated doses to a treatment volume 

of the left upper quadrant of the breast (treatment site). However, it was determined that the 

skin at the incision site for the catheter (wrong treatment site) received a dose of 100 Gy 

(10,000 rad). The patient and referring physician were informed of this event upon its discovery 

on March 25, 2015. 

On June 24, 2014, the patient returned to the licensee to discuss a non-healing breast wound 

that occurred following the treatment. The patient was referred to her surgeon who excised 

some additional tissue associated with the injury at that time. However, no connection was 

made between a potential medical event and the observed injury at the site until an investigation 

was conducted at another facility that utilized the same HDR equipment and support services. 

From a review of the results of that investigation, it was determined that the same error resulted 

in the dose to the wrong treatment site. This error was a default entry in the treatment planning 

system that was not correctly changed during treatment planning, which led the source 

placement to be rotated 180 degrees along the applicator’s long axis. 

Cause(s) – The medical event was caused by human error. The medical physicist failed to 

change a default entry in the treatment planning system as required by the licensee’s 

procedure. Further, the licensee did not have a procedure in place to independently review the 

prepared plan to ensure with high confidence that the plan would be implemented appropriately. 

Actions Taken to Prevent Recurrence 

Licensee – The licensee has suspended future treatments pending completion of remedial 

actions including establishment of a review plan for all treatment plans by an independent 

authorized medical physicist and the use of a documented pre-treatment checklist.

State – The Illinois Emergency Management Agency conducted an on-site investigation into the 

circumstances surrounding the event and program management. The Agency issued citations 

regarding the failure to ensure adequate testing of the treatment planning system with the 

applicator system and the failure to establish adequate written procedures to ensure 

administrations were in accordance with written directives. 

This event is closed for the purpose of this report. 
8 

AS15-04 Medical Event at Presence Resurrection Medical Center in Chicago, Illinois 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy (1,000 

rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of the 

eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the wrong 

treatment site. 

Date and Place — October 3 through 9, 2014, Chicago, IL 

Nature and Probable Consequences – Presence Resurrection Medical Center (the licensee) 

reported that a medical event occurred associated with an HDR brachytherapy treatment for 

breast cancer using 257 GBq (6.95 Ci) of iridium-192. The patient was prescribed a total dose 

of 34 Gy (3,400 rad) in 10 fractionated doses to a treatment volume of the left breast (treatment 

site). However, it was determined that the skin at the incision site for the catheter (wrong 

treatment site) received a dose of 130 Gy (13,000 rad). The patient and referring physician 

were informed of this event. 

On November 21, 2014, the patient returned to the licensee to discuss a non-healing breast 

wound that occurred following the treatment. The referring physician requested a review of the 

treatment plan. Following an investigation, it was determined that a default entry in the 

treatment planning system was not correctly changed during treatment planning. This led to the 

source reference location being misplaced by 4 cm along the applicator’s long axis. This 

resulted in the dose to the wrong treatment site. A retrospective review of eight other cases at 

the facility revealed similar errors but none meeting the criteria of an AO. The licensee 

recommended that the best course of action was to perform a mastectomy, which was 

completed at another facility after receiving the patient’s consent. 

Cause(s) — The medical event was caused by human error. The medical physicist failed to 

change a default entry in the treatment planning system as required by the licensee’s 

procedure. Further, the licensee did not have a procedure in place to independently review the 

prepared plan to ensure with high confidence that the plan would be implemented appropriately. 

Actions Taken to Prevent Recurrence 

Licensee — The licensee has modified the treatment and planning checklists to include 

verification of catheter orientation by two independent personnel before each fraction, and 

different planning software and hardware systems are now being used. Additionally, services 

have been converted from a third party provider to in-house resources. 

State — The Illinois Emergency Management Agency conducted an on-site investigation into 

the circumstances surrounding the event and the program management. The Agency issued 

citations regarding the failure to ensure adequate testing of the treatment planning system with 

the applicator system and the failure to establish adequate written procedures to ensure 

administrations were in accordance with written directive. 

This event is closed for the purpose of this report. 
9 

AS15-05 Medical Event at MedStar Montgomery Medical Center (formerly 

University of Maryland), Helen P. Denit Cancer Center in Olney, Maryland 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, the lens of 

the eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the 

wrong treatment site. 

Date and Place — December 10, 2014, Olney, Maryland 

Nature and Probable Consequences — MedStar Montgomery Medical Center (formerly 

University of Maryland), Helen P. Denit Cancer Center (the licensee) reported that a medical 

event occurred during a brachytherapy procedure for prostate cancer treatment. The patient 

was prescribed a total dose of 10,800 cGy (rad) to the prostate using 53 iodine-125 (I-125) 

seeds on December 10, 2014. However, on December 10, 2014, the post implant computed 

tomography (CT) revealed that all seeds missed the prostate and were deposited in an 

unintended area of soft tissue at the base of the patient’s penis, not in the prostate, resulting in 

a dose of 10,800 cGy to normal tissue at the base of the penis (wrong treatment site). The 

patient and referring physician were informed of the event. The licensee concluded that there 

were no noted medical effects based on this abnormal occurrence. 

Cause(s) — Before patient treatment, the vendor serviced the licensee’s ultrasound unit, which 

was used to guide the insertion of the prostate seeds. After service and prior to the patient 

treatment, some of the calibration settings were changed. The licensee failed to identify those 

changes and used the improperly calibrated ultrasound unit. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee put procedures into place to ensure efficacy of the ultrasound unit 

after servicing and before use. Additionally, in the future, the licensee will ensure that the 

urologist and oncologist have demonstrated competency in using the ultrasound equipment by 

clearly identifying the prostate gland and the surrounding anatomy before implantation of seeds. 

During the procedure, the ultrasound technologist will also be available to troubleshoot any 

ultrasound equipment issues. 

State — The State conducted an onsite reactive inspection on December 19, 2014. The 

inspection results indicated that several violations occurred that contributed to the event. 

The RSO failed to put adequate procedures into place that would offer a high confidence that 

the prescribed radioactive material (53 I-125 seeds) were implanted as prescribed by the written 

directive. As a result, the licensee failed to establish appropriate procedures, through 

compliance with the written directive, necessary to prevent the occurrence of a medical event. 

The licensee failed to follow appropriate procedures that would offer a high degree of 

confidence that the prescribed radioactive material (53 I-125 seeds) was implanted in the 

intended organ. 

This event is closed for the purpose of this report. 
10 

AS15-06 Medical Event at Christus St. Vincent Hospital, in Santa Fe, New Mexico 

Criteria III.C.1.b and III.C.2.b of Appendix A to this report provide that a medical event shall be 

considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy (1,000 

rad) to any organ or tissue (other than a major portion of the bone marrow, the lens of the eye, 

or the gonads) and represents a dose delivered to the wrong individual or human research 

subject. 

Date and Place — December 17, 2014, Santa Fe, New Mexico 

Nature and Probable Consequences — Christus St. Vincent Hospital (the licensee) reported 

that a medical event occurred during a radioiodine thyroid ablation procedure on 

December 17, 2014. The patient was prescribed 1.1 GBq (30 mCi) of I-131 resulting in a dose 

of 80 Gy (8,000 rad) to the thyroid. The wrong dose vial was selected from the cart and the 

patient received 5.3 GBq (143.2 mCi) of I-131 resulting in a dose of 379 Gy (37,900 rad) to the 

thyroid. This delivered dosage was approximately 400 percent greater than the prescribed 

dosage to the patient. The administering individual identified the medical event immediately and 

notified the patient and referring physician of this event. The licensee concluded there were no 

adverse health effects expected because of the medical event. 

Cause(s) — The cause of the medical event was the selection of a dose vial prescribed for 

another patient and the failure to review the written directive as required by the licensee’s 

quality management program before administering the dosage. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee’s corrective actions included revision of the policy used for patient 

ID and written directive for radiopharmaceutical administration to ensure that a patient’s identity 

is verified before administering the dose. Additionally, the licensee informed its staff of the 

event and put corrective actions put into place. 

State — The State is currently reviewing all information. Once all information is compiled and 

reviewed, the State’s Radiation Control Bureau will meet with its Office of General Counsel for 

disposition. 

This event is closed for the purpose of this report. 
11 

AS15-07 Medical Event at an Unspecified City, New York

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy (1,000 

rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of the 

eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the wrong 

treatment site. 

Date and Place — January 7, 14, and 19, 2015, Unspecified City, NY 

Nature and Probable Consequences—The New York State Department of Health reported that 

a medical event occurred associated with a high dose rate brachytherapy treatment using an 

iridium-192 source for endometrial cancer. The patient was prescribed three fractional doses of 

700 cGy (rad) each to a vaginal treatment volume. Following the completion of treatment, the 

patient reported bilateral labial itch, dryness, and tingling around the treatment area. The 

patient was referred to a dermatologist who identified a radiation reaction. A review of the films 

that had been taken to confirm the placement of the Ir-192 source revealed that the source was 

placed inferior to the treatment site and exterior to the opening of the vagina for all three 

fractions, resulting in a total dose of 2,100 cGy to the outer vaginal mucosa and upper thigh 

(wrong treatment site) and minimal dose to the intended treatment site. The patient and 

referring physician were notified. 

Physical examination showed signs of radiation exposure in the vulvar area and on the skin of 

the upper inner thigh. Potential short term effects include progression of these skin reactions 

and possible urinary and rectal irritation. Long term effects may include thickening of the skin 

and the mucosa, development of scar tissue and urinary track and rectal issues. This patient 

continues care under a gynecological oncologist, a dermatologist, and a radiation oncologist as 

needed. The State withheld the licensee name and location in accordance with N.Y. Pub. Health 

Law § 2805-m. 

Cause(s) — The causes of the medical event were determined to be the incorrect assembly of 

the applicator by nursing staff who were not trained for the task and the Authorized User’s (AU) 

lack of experience with this type of applicator. The AU failed to verify the positioning of the 

applicator by visual inspection and to detect the incorrect positioning of the applicator in the 

patient on the verification image, attributing the poor image quality to the patient’s obesity. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee’s corrective actions included providing training to AUs on the correct 

assembly and insertion of the applicator; adding a bead dummy source to the end of the tandem 

and obtaining orthogonal images for verification for every treatment session; ensuring that the 

full length of the vaginal cylinder is visible on every image; having the verification images 

reviewed and approved by both the AU and a New York State licensed/registered Radiation 

Therapy Technologist or an authorized medical physicist (AMP) prior to treatment; and having 

the AU sign and date a written statement that the cylinder and tandem positioning was verified 

and found to be in accordance with the approved treatment plan that will go into the patient’s 

medical record. 
12 

State — The New York State Department of Health required a root cause analysis, held a 

conference call with the licensee, and conducted a site visit that included interviews of staff, 

review of the quality assurance program, and training. The State determined that the licensee’s 

root cause analysis, corrective action and preventive measures were acceptable. The 

Department of Health will continue to monitor the licensee’s implementation of the corrective 

actions during subsequent inspections. 

This event is closed for the purpose of this report. 
13 

AS15-08 Medical Events at Legacy Good Samaritan Medical Center in Portland, 

Oregon 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy (1,000 

rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of the 

eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the wrong 

treatment site. 

Date and Place — January 7, 2015, to February 12, 2015, in Portland, OR 

Nature and Probable Consequences — Legacy Good Samaritan Medical Center (the licensee) 

reported eight medical events associated with a gamma knife (Elekta’s Perfexion unit), which 

contained 244,200 GBq (6,600 Ci) of cobalt-60 at the time of treatments. Five of these events 

exceeded the 10 Gy (1,000 rad) dose threshold in the abnormal occurrence criterion listed 

above. The medical events involved gamma knife therapy treatment for acoustic neuromas and 

metastatic brain tumors for the eight patients. All eight patients received the prescribed dose, 

ranging from 7 to 24.9 Gy (700 – 2490 rad), to the wrong location due to manufacture 

misalignment of the patient positioning system. The misalignment of the patient positioning 

system occurred during an Elekta’s (maintenance provider) maintenance that was performed on 

the gamma knife unit between December 13, 2014 and January 1, 2015. As a result, the 

positioning system was off-target by 1.87 mm, which resulted in delivering the following doses to 

the patients to the wrong treatment site (normal tissue) (January 7 to February 12, 2015): 

patient 1 – 5 fields, maximum 24.9 Gy (2490 rad); patient 2 – 6 fields, maximum 24.6 Gy (2460 

rad); patient 3 – 2 fields, maximum 16.8 Gy (1680 rad); patient 4 – 3 fields, maximum 19.1 Gy 

(1910 rad); patient 5 – 3 fields, maximum 23.1 Gy, (2310 rad); patient 6 – right acoustic 

neuroma, maximum 7 Gy,(700 rad); patient 7 – right acoustic neuroma, maximum 9.1 Gy (910 

rad); and patient 8 – left acoustic neuroma, maximum 9.3 Gy, (930 rad). All patients and 

referring physicians were notified of the events. Patients were informed of the results 

associated with their individual cases. Effects from the resulting doses to the patients are still to 

be determined. 

Cause(s) — The medical events were caused by human error. According to Elekta, this 

adjustment was made without following the correct service procedures, which would have 

detected the error. 

Actions Taken to Prevent Recurrence 

Licensee — The licensee is in the process of establishing a new set of tests, with the 

cooperation of Elekta. After any form of service, the absolute output of the unit will be checked 

and “pin prick” films will be taken to verify positioning. The licensee has permanently instituted 

a weekly “pin prick” film and focus precision check at the end of the day prior to the first gamma 

knife procedure of each week. In addition, the licensee also has added a consistency check as 

part of its monthly quality assurance routine. 

State — The Oregon Health Authority is requesting information from Elekta (maintenance 

provider) to complete their investigation of the events. 

This event is open for the purpose of this report. 
14 

AS15-09 Medical Event at Abbott Northwestern Hospital in Minneapolis, Minnesota 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, the lens of 

the eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the 

wrong treatment site. 

Date and Place — May 29, 2015, Minneapolis, Minnesota 

Nature and Probable Consequences—Abbott Northwestern Hospital (the licensee) reported that 

a medical event occurred associated with a yttrium-90 (Y-90) microsphere procedure to treat 

liver cancer. The licensee prescribed a dose of 130 Gy (13,000 rad) from 1 GBq (27 mCi) of 

Y-90 TheraSpheres to a portion of the left lobe of the liver (the treatment site). A post-delivery 

scan revealed that the microspheres were delivered to the right lobe of the liver (wrong 

treatment site) rather than the left lobe, resulting in a dose of 43.7 Gy (4,370 rad) to the right 

lobe from 0.87 GBq (23.5 mCi) of Y-90. The patient and referring physician’s partner were

informed of this event; the referring physician was not available the day of the event. The 

licensee indicated that treatment of the right lobe of the liver was planned for an unspecified 

time in the future. Because of this event, the patient received a dose to the right lobe of the 

liver, but less than would have been given during the planned future treatment. The licensee 

will monitor the patient and offer additional therapy to the right lobe if necessary. Treatment will 

be given to the left lobe as originally planned. The licensee expects that the clinical outcome for 

the patient will not change because of this incident. 

Cause(s) — The catheter delivering the microspheres was placed in the wrong artery because 

of a lack of clarity due to the fact that the patient’s vessels were small and similar in 

appearance. 

Actions Taken To Prevent Recurrence 

Licensee — For future procedures, the licensee will have an image available from the planning 

angiogram with the vessels clearly labeled to refer to during placement of the catheter during 

microsphere delivery. 

State — An onsite investigation was performed on June 11, 2015. The Minnesota Department 

of Health accepted the licensee’s corrective actions. 

This event is closed for the purpose of this report. 
15 

AS15-10 Medical Event at Riverside Medical Center in Kankakee, Illinois 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy (1,000 

rad) to any organ or tissue (other than a major portion of the bone marrow, the lens of the eye, 

or the gonads) and represents a prescribed dose or dosage that is delivered to the wrong 

treatment site. 

Date and Place — June 2, 2015, Kankakee, IL 

Nature and Probable Consequences — Riverside Medical Center (the licensee) reported that a 

medical event occurred associated with a yttrium-90 microsphere procedure treatment for 

metastatic cancer lesions in the liver; the treatment consisted of 1,302 MBq (35.2 mCi) of 

yttrium-90. On June 2, 2015, the patient was administered 1,302 MBq (35.2 mCi) of yttrium-90 

microspheres through the wrong infusion site (the renal artery). Due to the error, the patient 

received an unintentional dose of 1,345 Gy (134,500 rad) to the right kidney (wrong treatment 

site). 

The patient was informed of the error and consented to receive a second administration of 

1,300 MBq (35 mCi) of yttrium-90 microspheres through the correct infusion site (the hepatic 

artery) to deliver the prescribed dose to the liver (the correct treatment site) that same day. The 

referring physician was also informed of this event. The patient was subsequently hospitalized 

for observation with no adverse complications noted. The patient has received regular 

monitoring since the event and no renal dysfunction or clinically significant radiation nephritis 

has been observed. The patient has received a second treatment to the liver for cancer. 

Cause(s) — The cause of the medical event was determined to be human error. Due to the 

patient’s unusual anatomy and poor imaging, the accessory right renal artery was mistaken for 

the hepatic artery. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee has amended administration procedures to require that mapping 

images as well as CT images are available to the physician in the treatment room and these 

images will be compared with contrast images taken pre-dose administration to ensure 

treatment of the correct target site. Additionally, the licensee has amended procedures to 

require a review and verification of correct catheter placement by a second physician, and will 

develop a formal written checklist to be completed prior to each patient administration.

State — The Illinois Emergency Management Agency conducted an on-site investigation into 

the circumstances surrounding the event, patient follow-up, and the program management. The 

Agency’s investigation revealed that the matter was sufficiently addressed by the licensee’s 

corrective actions and the event warranted no citations. 

This event is closed for the purpose of this report. 
16 

AS15-11 Medical Event at Radiotherapy Clinics of Georgia, Conyers, Georgia 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of 

the eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the 

wrong treatment site. 

Date and Place — June 8, 2015, Conyers, Georgia 

Nature and Probable Consequences—Radiotherapy Clinics of Georgia/Vantage Oncology (the 

licensee) reported that a medical event occurred during a patient treatment for endometrium 

cancer using a vaginal cylinder applicator. The treatment was delivered in three fractions from 

June 8 to June 17, 2015. The licensee used two different HDR Varian GammaMed Plus 

brachytherapy units, each containing a separate iridium-192 (Ir-192) source of 370 GBq (10 Ci) 

during the course of treatment. The three fractions were delivered with the first two fractions 

being performed using the same HDR unit and the third fraction being performed using a 

different HDR unit. Each fraction was prescribed to deliver 600 cGy (rad), for a total of 

1,800 cGy (rad) to the treatment site. However, on a follow up exam the patient revealed 

two small sores on the skin of both her upper thighs. The radiation oncologist believed the 

marks were consistent with radiation dermatitis. The licensee discovered the incident on 

July 20, 2015, and determined that the third fraction was not administered as prescribed. 

Computer reconstruction of the event revealed that the dose delivered to the patient’s skin was 

4,000 cGy (rad) at a depth of 0.2 cm. The patient also received 33 percent less dose to the 

intended site than prescribed by the written directive. 

Cause(s) — The cause of the medical event was determined to be incorrect assembly of the 

vaginal cylinder applicator. The physicist failed to inspect the applicator before administration. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee’s corrective actions included putting procedures into place with 

specific requirements for the HDR simulation process to ensure that applicators are inspected 

for integrity before and after HDR procedures, requiring physicists to inspect all applicators 

before insertion, and requiring application of position verification marks on patient and 

inspection of marks before and after treatment. The licensee also expanded annual HDR 

training to include applicator handling, patient safety considerations, and review of current 

policies and procedures. 

State — The Georgia Department of Natural Resources (DNR) conducted a reactive inspection 

on July 24, 2015. After interviewing personnel and reviewing documentation supplied by the 

licensee, the department determined that a reportable medical event occurred. The DNR 

issued violations in accordance with Rule 391-3-17-.05(20)(a) and (b)(2) and -.05(31)(d). 

This event is closed for the purpose of this report. 
17 

AS15-12 Medical Event at Radiotherapy Clinics of Georgia, Snellville, Georgia 

Criteria III.C.1.b and III.C.2.a of Appendix A to this report provide that a medical event shall be 

considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of 

the eye, or the gonads) and represents a dose or dosage that is at least 50 percent greater than 

that prescribed. 

Date and Place — June 9, 2015, Snellville, Georgia 

Nature and Probable Consequences — Radiotherapy Clinics of Georgia (the licensee) reported 

that the dose administered to a patient treated for skin cancer on the nose exceeded the 

prescribed dose by more than 50 percent. The patient was treated using an HDR GammaMed 

Plus Varian brachytherapy unit with a 370-GBq (10-Ci) Ir-192 source. The physician’s written 

directive specified a dose to the tumor volume and a maximum tumor dose of 130 percent of 

that prescribed. The total dose was delivered in eight fractions using a skin applicator from 

June 9 to July 2, 2015. The prescribed dose was 500 cGy/fraction (rad/fraction) for a total dose 

of 4,000 cGy (rad), with a maximum dose of 650 cGy/fraction (rad/fraction) for a total maximum 

dose of 5,200 cGy (rad). On a follow-up exam, the patient’s skin reaction was more drastic than 

anticipated. The estimated dose received by the patient’s target was 950 cGy (rad) for 

five fractions and 700 cGy (rad) for three fractions, for a total of 6,850 cGy (rad). The incident 

resulted in the patient receiving a dose 71.25 percent greater than prescribed. 

Cause(s) — The cause of the medical event was determined to be a deficient treatment plan 

developed by a junior medical physicist. The licensee did not have documented procedures 

for the treatment plan in accordance with the written directive. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee’s corrective actions included developing, documenting, and training 

personnel on specific procedures for verification of the physician’s written directive and for the 

review of treatment plans before patient treatment. The licensee also put into place an HDR 

physics peer review to include review of prescription and treatment plans, evidence of 

appropriate quality assurance checks at each step, and appropriate documentation of 

HDR procedures. 

State — The Georgia DNR conducted a reactive inspection on July 20, 2015, and, upon 

interviews with personnel involved and reviews of documentation pertaining to this report 

provided by the licensee, it was determined that a reportable medical event occurred. The State 

issued the violations in accordance with GA Rules 391-3-17-.05(20(a) & (b)(2) and 391-3-17-

.05(31)(d). 

This event is closed for the purpose of this report. 
18 

AS15-13 Medical Event at University Hospitals of Cleveland in Cleveland, Ohio 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, the lens of 

the eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the 

wrong treatment site. 

Date and Place — July 14, 2015, Cleveland, Ohio 

Nature and Probable Consequences — University Hospitals of Cleveland (the licensee) 

reported that a medical event occurred associated with a yttrium-90 (Y-90) microsphere 

procedure to treat liver cancer. The licensee prescribed a dose of 78 Gy (7,800 rad) from 

758.5 MBq (20.5 mCi) of Y-90 SIR-Spheres® to the right lobe of the liver (the treatment site). 

During the microsphere treatment, the procedure was discontinued because the administering 

physician, who was also the referring physician, determined that the dose was not being 

delivered to the liver. A post-delivery CT scan revealed that the microspheres were delivered to 

an area of 20 to 30 cm of the small bowel (wrong treatment site), resulting in a dose of 36 Gy 

(3,600 rad) from 288.2 MBq (7.79 mCi). 

The patient was informed of this event on July 14, 2015. The patient experienced some 

abdominal pain approximately 3 weeks after the procedure. The patient was examined and 

admitted to a local hospital. A CT scan of the patient’s abdomen and pelvis identified abnormal 

inflammation to a short segment of the small bowel, but no acute perforation or ulcers. The 

patient was discharged, and the licensee spoke to the patient on August 10, 2015. At that time, 

the patient presented with some abdominal discomfort or pain, which was relieved by prescribed 

pain medications. 

Cause(s) — The cause of the medical event was determined to be that the fluoroscopy table 

may have been moved during the procedure, causing the microcatheter used to administer the 

Y-90 to change positions from the hepatic artery to the superior mesenteric artery. After the 

table and consequently the microcatheter were moved, a fluoroscopy of the patient was not 

performed, resulting in the licensee not identifying the relocated microcatheter in the patient’s 

arteries before Y-90 SIR-Sphere administration. 

Actions Taken To Prevent Recurrence 

Licensee — Licensee staff members reviewed this event to emphasize the critical steps of 

radioembolization, “hard stop” times, and verification of microcatheter location for future Y-90 

administrations. The licensee communicated to staff the importance of using intermittent 

fluoroscopy throughout Y-90 microsphere administrations. 

State — The State investigated on July 30, 2015, to gather the facts surrounding the incident 

and to confirm the licensee followed required regulations, guidance, and procedures. A notice 

of violation was issued on August 26, 2015. An adjudication order and administrative penalty 

order were issued on September 16, 2015. 

This event is closed for the purpose of this report. 
19 

AS15-14 Medical Event at Wellstar Kennestone Hospital, Marietta, Georgia 

Criteria III.C.1.b and III.C.2.a of Appendix A to this report provide that a medical event shall be 

considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of 

the eye, or the gonads) and represents a dose or dosage that is at least 50 percent greater than 

that prescribed. 

Date and Place — August 5, 2015, Marietta, Georgia 

Nature and Probable Consequences — Wellstar Kennestone Hospital (the licensee) reported 

that a patient received 900 cGy (rad) instead of the prescribed 300 cGy (rad) during one fraction 

of the treatment. Equipment used during the patient’s cervical cancer treatment used a 

185-GBq (5-Ci) Ir-192 source in a cervical applicator. The patient received 300 cGy (rad) during 

the first and second fractions. The source dwell time during the third fraction was 

1,128 seconds instead of the correct time of 350 seconds. The patient received a total dose of 

1,500 cGy (rad) during the three fractions instead of the intended 900 cGy (rad), which is a 

66-percent increase over the prescribed dose. The patient was informed of the event on 

August 8, 2015. 

Cause(s) — The cause of the medical event was determined to be software discrepancies, 

miscommunication between staff members, and failure to verify the treatment plan. The 

physicist used the wrong treatment plan (one that had been developed earlier for the patient) 

during the third fraction. 

Actions Taken To Prevent Recurrence 

Licensee — Licensee has implemented the following: Standardized language to include dose 

per fraction and total dose for radiation prescription; added “Verification of treatment plan” to the 

existing checklist; investigated Flexitron’s missing safety feature and possible recall with vendor; 

evaluated adding MOSAIQ interface module to Flexitron; and started daily meetings within 

Radiation Oncology. All disciplines within the department will attend the meeting, which 

includes an assessment of staffing. 

State —The State conducted an inspection on August 7, 2015. After interviewing personnel and 

reviewing documentation supplied by the licensee, the State determined that a reportable 

medical event did occur. The State did not issue any violations for this event. 

This event is closed for the purpose of this report. 
20 

AS15-15 Medical Event at Wake Forest Baptist Health, Winston-Salem, North 

Carolina 

Criteria III.C.1.b and III.C.2.b(iii) of Appendix A to this report provide that a medical event shall 

be considered for reporting as an AO if it results in a dose equal to or greater than 10 Gy 

(1,000 rad) to any organ or tissue (other than a major portion of the bone marrow, or the lens of 

the eye, or the gonads) and represents a prescribed dose or dosage that is delivered to the 

wrong treatment site. 

Date and Place — October 1, 2015, Winston-Salem, North Carolina 

Nature and Probable Consequences — Wake Forest Baptist Health (the licensee) reported that 

a patient with trigeminal neuralgia received a gamma knife treatment to the wrong site on 

October 1, 2015. The patient was prescribed 8,500 cGy (rad) to a site in the right side of the 

brain at the 100-percent isodose line, but instead received the treatment to the left side of the 

brain. The 80-percent isodose line was approximately 33.5 cubic mm and was prescribed 

6,800 cGy (rad). The incident was identified as patient treatment was completed. Medical 

personnel involved in the treatment reviewed, discussed, and confirmed the incident. The 

licensee determined that the isocenter was positioned incorrectly because of human error. 

The RSO was contacted and he notified the North Carolina Department of Health and Human 

Services. The patient was notified of the event by the attending neurosurgeon and then 

received the correct treatment that same day. The attending radiation oncologist notified the 

referring physician later the same day. 

Cause(s) — The cause of the medical event was determined to be that the isocenter was 

positioned incorrectly because of human error. The incorrect side was targeted during 

treatment planning. 

Actions Taken To Prevent Recurrence 

Licensee — The licensee’s corrective actions included modifying the target identification 

procedure followed for identifying major anatomical features. This target designation process 

will be signed by the AMP performing treatment and the AU who prescribed the treatment. This 

will be followed by an independent timeout and target verification before treatment is performed. 

The AMP will perform a visual examination of the patient’s position immediately before 

irradiation. The AMP’s visual observation of patient’s positioning will be recorded in writing. 

State — The State conducted an onsite investigation of this event on October 5, 2015. The 

licensee agreed to conduct an internal root cause analysis of this event and to report the basic 

findings of the analysis to North Carolina upon completion. Furthermore, the licensee agreed to 

immediately put into place three changes to its procedures for gamma knife treatment of 

trigeminal neuralgia. 

This event is closed for the purpose of this report. 
A-1 

APPENDIX A 

ABNORMAL OCCURRENCE CRITERIA AND 

GUIDELINES FOR OTHER EVENTS OF INTEREST 

An incident or event will be considered an abnormal occurrence (AO) if it involves a major 

reduction in the degree of protection of public health or safety. This type of incident or event 

would have a moderate or severe impact on public health or safety and could include, but need 

not be limited to, the following: 

(1) moderate exposure to, or release of, radioactive material licensed by or otherwise 

regulated by the Commission; 

(2) major degradation of essential safety-related equipment; or 

(3) major deficiencies in design, construction, use of, or management controls for facilities 

or radioactive material licensed by or otherwise regulated by the Commission. 

The U.S. Nuclear Regulatory Commission (NRC) identified the following criteria for determining 

an AO and the guidelines for “other events of interest” in a policy statement published in the 

Federal Register on October 12, 2006 (71 FR 60198). 

Abnormal Occurrence Criteria 

The NRC uses the following criteria to determine whether to consider events for reporting as 

AOs: 

I. For All Licensees 

A. Human Exposure to Radiation from Licensed Material 

1. Any unintended radiation exposure to an adult (any individual 18 years of 

age or older) resulting in an annual total effective dose equivalent (TEDE) 

of 250 millisievert (mSv) [25 roentgen equivalent man (rem)] or more; or 

an annual sum of the deep dose equivalent (external dose) and 

committed dose equivalent (intake of radioactive material) to any 

individual organ other than the lens of the eye, the bone marrow, and the 

gonads of 2,500 mSv (250 rem) or more; or an annual dose equivalent to 

the lens of the eye of 1 sievert (Sv) (100 rem) or more; or an annual sum 

of the deep dose equivalent and committed dose equivalent to the bone 

marrow of 1 Sv (100 rem) or more; or a committed dose equivalent to the 

gonads of 2,500 mSv (250 rem) or more; or an annual shallow-dose 

equivalent to the skin or extremities of 2,500 mSv (250 rem) or more. 

2. Any unintended radiation exposure to any minor (an individual less than 

18 years of age) resulting in an annual TEDE of 50 mSv (5 rem) or more, 

or to an embryo/fetus resulting in a dose equivalent of 50 mSv (5 rem) or 

more. 
A-2 

3. Any radiation exposure that has resulted in unintended permanent 

functional damage to an organ or a physiological system as determined 

by a physician. 

B. Discharge or dispersal of radioactive material from its intended place of 

confinement, which results in the release of radioactive material to an 

unrestricted area in concentrations which, if averaged over a period of 

24 hours, exceeds 5,000 times the values specified in Table 2 of 

Appendix B, “Annual Limits on Intake (ALIs) and Derived Air 

Concentrations of Radionuclides for Occupational Exposure; Effluent 

Concentrations; Concentrations for Release to Sewerage,” to Part 20 of 

Title 10 of the Code of Federal Regulations (10 CFR), “Standards for 

Protection against Radiation,” unless the licensee has demonstrated 

compliance with 10 CFR 20.1301, “Dose Limits for Individual Members of 

the Public,” using 10 CFR 20.1302(b)(1) or 10 CFR 20.1302(b)(2)(ii). 

This criterion does not apply to transportation events. 

C. Theft, Diversion, or Loss of Licensed Material, or Sabotage or Security Breach1,2

1. Any unrecovered lost, stolen, or abandoned sources that exceed the 

values listed in Appendix P to 10 CFR Part 110, “Category 1 and 2 

Radioactive Material.” Excluded from reporting under this criterion are 

those events involving sources that are lost, stolen, or abandoned under 

the following conditions: sources abandoned in accordance with the 

requirements of 10 CFR 39.77(c); sealed sources contained in labeled, 

rugged source housings; recovered sources with sufficient indication that 

doses in excess of the reporting thresholds specified in AO criteria I.A.1 

and I.A.2 did not occur while the source was missing; and unrecoverable 

sources (sources that have been lost and for which a reasonable attempt 

at recovery has been made without success) lost under such conditions 

that doses in excess of the reporting thresholds specified in AO 

criteria I.A.1 and I.A.2 are not known to have occurred and the agency 

has determined that the risk of theft or diversion is acceptably low. 

 

1. Information pertaining to certain incidents may be either classified or under consideration for classification 

because of national security implications. Classified information will be withheld when formally reporting 

these incidents in accordance with Section 208 of the Energy Reorganization Act of 1974, as amended. Any 

classified details regarding these incidents would be available to the Congress, upon request, under 

appropriate security arrangements. 

2. Due to increased terrorist activities worldwide, this report does not disclose specific classified information 

and sensitive information, the details of which are considered useful to a potential terrorist. Classified 

information is defined as information that would harm national security if disclosed in an unauthorized 

manner. 
A-3 

2. A substantiated3 case of actual theft or diversion of licensed, 

risk-significant radioactive sources or a formula quantity4

 of special 

nuclear material; or act that results in radiological sabotage.5

3. Any substantiated3 loss of a formula quantity4

 of special nuclear material 

or a substantiated3 inventory discrepancy of a formula quantity4

 of special 

nuclear material that is judged to be caused by theft or diversion or by a 

substantial breakdown6

 of the accountability system. 

4. Any substantial breakdown6

 of physical security or material control 

(i.e., access control containment or accountability systems) that 

significantly weakened the protection against theft, diversion, or 

sabotage. 

5. Any significant unauthorized disclosures (loss, theft, and/or deliberate) of 

classified information that harms national security or safeguards 

information that harms the public health and safety. 

D. Initiation of High-Level NRC Team Inspection.7

II. For Commercial Nuclear Power Plant Licensees 

A. Malfunction of Facility, Structures, or Equipment 

1. Exceeding a safety limit of license technical specification (TS) 

[10 CFR 50.36(c)]. 

2. Serious degradation of fuel integrity, primary coolant pressure boundary, 

or primary containment boundary. 

 

3. “Substantiated” means a situation where an indication of loss, theft, or unlawful diversion such as: an 

allegation of diversion, report of lost or stolen material, statistical processing difference, or other indication of 

loss of material control or accountability cannot be refuted following an investigation; and requires further 

action on the part of the agency or other proper authorities. 4. A formula quantity of special nuclear material is defined in 10 CFR 70.-4, “Definitions.” 5. Radiological sabotage is defined in 10 CFR 73.-2, “Definitions.” 6. A substantial breakdown is defined as a red finding in the security inspection program, or any plant or facility 

determined to have overall unacceptable performance, or in a shutdown condition (inimical to the effective 

functioning of the nation’s critical infrastructure) as a result of significant performance problems and/or 

operational events. 7. Initiation of any Incident Investigation Teams, as described in NRC Management Directive (MD) 8.3, “NRC 

Incident Investigation Program,” or initiation of any accident review groups, as described in MD 8.9, 

“Accident Investigation.” 
A-4 

3. Loss of plant capability to perform essential safety functions so that a 

release of radioactive materials which could result in exceeding the dose 

limits of 10 CFR Part 100, “Reactor Site Criteria,” or 5 times the dose 

limits of 10 CFR Part 50, “Domestic Licensing of Production and 

Utilization Facilities,” Appendix A, “General Design Criterion for Nuclear 

Power Plants,” General Design Criterion (GDC) 19, “Control Room,” could 

occur from a postulated transient or accident (e.g., loss of emergency 

core cooling system, loss of control rod system). 

B. Design or Safety Analysis Deficiency, Personnel Error, or Procedural or 

Administrative Inadequacy 

1. Discovery of a major condition not specifically considered in the safety 

analysis report (SAR) or TS that requires immediate remedial action. 

2. Personnel error or procedural deficiencies that result in loss of plant 

capability to perform essential safety functions so that a release of 

radioactive materials which could result in exceeding the dose limits of 

10 CFR Part 100 or 5 times the dose limits of 10 CFR Part 50, 

Appendix A, GDC 19, could occur from a postulated transient or accident 

(e.g., loss of emergency core cooling system, loss of control rod drive 

mechanism). 

C. Any reactor events or conditions that are determined to be of high safety 

significance.8

D. Any operating reactor plants that are determined to have overall unacceptable 

performance or that are in a shutdown condition as a result of significant 

performance problems and/or operational event(s).9

III. Events at Facilities Other Than Nuclear Power Plants and All Transportation Events 

A. Events Involving Design, Analysis, Construction, Testing, Operation, Transport, 

Use, or Disposal of Licensed Facilities or Regulated Materials 

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

 

 

8. The NRC reactor oversight process (ROP) uses four colors to describe the safety significance of licensee 

performance. As defined in NRC Management Directive 8.13, “Reactor Oversight Process,” green is used 

for very low safety significance, white is used for low to moderate safety significance, yellow is used for 

substantial safety significance, and red is used for high safety significance. Reactor conditions or 

performance indicators evaluated to be red are considered abnormal occurrences. Additionally, 

Criterion II.C also includes any events or conditions evaluated by the NRC ASP program to have a 

conditional core damage probability (CCDP) or change in core damage probability (∆CDP) of greater than 

1x10-3. 9. Any plants assessed by the ROP to be in the unacceptable performance column, as described in NRC 

Inspection Manual Chapter 0305, “Operating Reactor Assessment Program.” This assessment of safety 

performance is based on the number and significance of NRC inspection findings and licensee performance 

indicators. 
A-5 

2. A major deficiency in design, construction, control, or operation having 

significant safety implications that require immediate remedial action. 

3. A serious safety-significant deficiency in management or procedural 

controls. 

4. A series of events (in which the individual events are not of major 

importance), recurring incidents, or incidents with implications for similar 

facilities (generic incidents) that raise a major safety concern. 

B. For Fuel Cycle Facilities 

1. Absence or failure of all safety-related or security-related controls 

(engineered and human) for an NRC-regulated lethal hazard (radiological 

or chemical) while the lethal hazard is present. 

2. An NRC-ordered safety-related or security-related immediate remedial 

action. 

C. For Medical Licensees 

 A medical event that: 

1. Results in a dose that is 

a. Equal to or greater than 1 gray (Gy) (100 rad) to a major portion of 

the bone marrow or to the lens of the eye; or equal or greater than 

2.5 Gy (250 rad) to the gonads; or 

b. Equal to or greater than 10 Gy (1,000 rad) to any other organ or 

tissue; and 

2. Represents either 

a. A dose or dosage that is at least 50 percent greater than that 

prescribed, or 

b. A prescribed dose or dosage that 

(i) Uses the wrong radiopharmaceutical or unsealed 

byproduct material; or 

(ii) Is delivered by the wrong route of administration; or 

(iii) Is delivered to the wrong treatment site; or 

(iv) Is delivered by the wrong treatment mode; or 

(v) Is from a leaking source or sources; or 
A-6 

(vi) Is delivered to the wrong individual or human research 

subject. 

IV. Other Events of Interest 

The Commission may determine that events other than AOs may be of interest to Congress and 

the public and should be included in an appendix to the AO report as “Other Events of Interest.” 

Such events may include, but are not necessarily limited to, events that do not meet the AO 

criteria but that have been perceived by Congress or the public to be of high health and safety 

significance, have received significant media coverage, or have caused the NRC to increase its 

attention to or oversight of a program area, or a group of similar events that have resulted in 

licensed materials entering the public domain in an uncontrolled manner. 
B-1 

APPENDIX B 

UPDATES OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES 

During this reporting period, no events met the guidelines for inclusion in Appendix B, “Updates 

of Previously Reported Abnormal Occurrences,” as an update to previous years’ “Report to 

Congress on Abnormal Occurrences.” 

C-1 

APPENDIX C 

OTHER EVENTS OF INTEREST 

This appendix discusses other events of interest that do not meet the abnormal occurrence 

(AO) criteria in Appendix A but have been perceived by Congress or the public to be of high 

health and safety significance, have received significant media coverage, or have caused the 

U.S. Nuclear Regulatory Commission (NRC) to increase its attention to or oversight of a 

program area. This appendix includes updates to other events of interest (OEI) reported in 

previous AO reports to Congress. 

There are three other events of interest that meet the above criteria to report for FY 2015. 

OEI 15-01 Cesium-137 contamination associated with University of Tulsa, Oklahoma 

The NRC included this event in this report as an Other Event of Interest because it involved 

radioactive material contamination in an area accessible by members of the public. It received 

a moderate amount of local media coverage. 

Radioactive contamination occurred in a process building at the University of Tulsa (TU) from 

about October 14 through October 17, 2014, when technicians breached the containment of a 

Cesium-137/Barium-137(m) isotope generator used to elute radioactive material for injection 

into a closed pipeline research apparatus. Technicians for Tracerco, a Texas licensee working 

in Oklahoma under a reciprocity filing, modified a malfunctioning generator they were using. 

Their modifications caused the release of an estimated 3.7MBq (0.1mCi) of cesium-137 (Cs137) that contaminated the process building area during their four day test. 

Tracerco technicians returned to TU on two other occasions in November and December 2014 

and used the same generator to elute radioactive material for flow studies. The breach of the 

generator’s containment was undetected until May 2015, when Tracerco detected radioactive 

contamination at its Texas facility. The modified generator was identified as the contamination 

source. A Tracerco technician returned to TU on June 10, 2015, to survey for possible 

contamination; however, he did not survey the process building where the contamination existed 

due to the presence of workers there who were performing a system upgrade. 

On August 24, 2015, after Tracerco’s investigation revealed the breach had occurred in the 

process building, Tracerco personnel returned to TU, surveyed the process building and 

discovered the radioactive contamination. They also identified small levels of radioactive 

contamination in some other locations near the process building. Tracerco performed a partial 

decontamination of the process building area and reported the contamination event to the 

Oklahoma Department of Environmental Quality (OKDEQ), the Agreement State regulatory 

authority. 

OKDEQ conducted a reactive inspection on August 27, 2015, and verified elevated radiation 

readings at some locations in and near the process building. OKDEQ calculated that one 

member of the public may have exceeded the regulatory limit of 100 mrem/year. OKDEQ’s 

inspection activity for this event was ongoing as of the compilation of this report. 
C-2 

TU identified 51 individuals who were potentially exposed to the Cs-137 contamination. 

Urinalysis testing was performed on a majority of these individuals. None of the urinalysis tests 

identified any detectable uptakes of Cs-137. Eleven University employees underwent additional 

whole body radiation scanning. Whole body scans for all eleven individuals did not identify any 

detectable Cs-137.

Tracerco contracted with an environmental remediation service to characterize and remediate 

the site. The contractor arrived on-site on August 31, 2015, and located several other areas of 

contamination both at TU and off-site at a private residence. As of the compilation of this report, 

site remediation was nearly complete. 

 
C-3 

OEI 15-02 Honeywell Metropolis Works: Uranium Hexafluoride Release 

The NRC included this event in this report because of the media attention the event received 

and increased attention by the NRC. Specifically, the visible leak of hydrogen fluoride outside1

the Honeywell Metropolis Works process buildings (which resulted from a leak of uranium 

hexafluoride (UF6) within the plant) and the migration of the plume toward the site boundary 

fence. Furthermore, the event received a significant level of media attention because videos of 

the release were recorded by bystanders and posted on social media. The event was of further 

interest because members of the public notified the NRC of the event before Honeywell 

supplied such notification. The event did not pose a public safety hazard and did not require 

any protective actions for members of the public. 

On October 26, 2014, at approximately 7:20 p.m. CST, in Metropolis, Illinois, Honeywell 

identified a leak of UF6 from a heated cold trap inside the feed materials building (FMB). The 

leak occurred during a routine sublimation and draining of a cold trap. A cold trap is a large tank 

where UF6 accumulates, is cooled and solidified, and can be later heated and drained during 

normal plant operations. Operators noticed a haze in the FMB, and an operator confirmed the 

leak by donning a respirator and observing the conditions on the fourth floor of the FMB. 

Honeywell emergency responders followed established emergency procedures, which included 

sounding the plant emergency alarm, shutting down all processes, declaring a plant emergency, 

and accounting for all personnel. Honeywell identified the cause of the leak as a crack in a weld 

between the body and head of the cold trap. Honeywell declared an “all clear” at 2:16 a.m. CST 

on October 27, 2014, and reported no significant injuries. 

NRC inspectors followed up on the event and determined that Honeywell’s emergency response 

team (ERT) members performed their roles and responsibilities to mitigate the leak. However, 

the ERT did not properly classify the event as an “Alert.”2 NRC inspectors determined that any 

UF6 that may have traveled beyond the Honeywell fence line would have been of such low 

concentration that it would not pose a public safety hazard and would not require any protective 

actions. 

Because the event was not properly classified, Honeywell failed to notify the NRC Operations 

Center within 1 hour. The NRC Operations Center was initially made aware of the UF6 release 

by calls from the public. The Operations Center received cellphone videos from local residents 

on social media and phone calls from local government agencies the following morning. 

On November 7, 2014, the NRC issued a Confirmatory Action Letter EA-14-183 (Agencywide 

Documents Access and Management System (ADAMS) Accession No. ML14311A670). 

Honeywell determined the cause of the misclassification of the UF6 release to be inadequate 

visual observation and deficiencies in the emergency plan implementing procedures (EPIPs) 

regarding event classification. Honeywell agreed to review and revise its emergency 

preparedness procedures and conduct appropriate training to ensure that events will be 

 

1 When UF6 is released, the UF6 reacts with water vapor in the air to form hydrogen fluoride and uranyl 

fluoride. 2 Section 3.2.2 of the Honeywell Emergency Response Plan defines an “Alert,” in part, as “an event that 

deviated from normal operating conditions creating a hazardous environment requiring an emergency 

response to mitigate a hazardous situation that either initiates or migrates outside of plant buildings and 

stays within the restricted area or inner fence line.”
C-4 

classified correctly and that appropriate emergency response actions are put into place. NRC 

inspectors reviewed Honeywell’s revised EPIPs and observed the conduct of its emergency 

exercise on November 12, 2014. NRC inspectors concluded that Honeywell effectively put into 

place corrective actions, and Honeywell resumed licensed operations on November 13, 2014. 

On January 30, 2015, the NRC issued an Inspection Report 40-3392/2014-005 

(ADAMS Accession No. ML15030A166) with an apparent violation for the failure to declare 

an Alert during the release. The NRC subsequently issued a Severity Level III violation on 

April 20, 2015 (ADAMS Accession No. ML15110A228). 

 
C-5 

OEI 15-03 Human Exposure Event at International Isotopes Incorporated, Idaho Falls, 

Idaho 

The NRC included this event in this report because of the unusual human exposure and the 

media attention the event received. 

International Isotopes Incorporated (the licensee), located in Idaho Falls, Idaho, reported to 

NRC Region IV on August 20, 2015, that an occupational whole body overexposure and an 

occupational extremity overexposure occurred earlier that morning during a routine cobalt-60 

(Co-60) source drawer transfer procedure. A technician was transferring a Co-60 source 

drawer from a shielded cask to a medical therapy head. The technician attempted to withdraw 

the Co-60 source drawer from the cask slightly to remove a handling tool that was attached to 

the drawer. The technician inadvertently withdrew the drawer fully from the shielded cask, 

exposing the Co-60 source. He caught the falling source by its extension and quickly reinserted it into the cask. It has been determined that human error, due to poor coordination and 

control of the task, caused the event. 

The technician was briefly exposed (for approximately 4 seconds) to a very high activity Co-60 

source containing 135.57 terabecquerel (3,664 Ci). The technician was exposed to a peak 

exposure rate of 37.39 Gy/hr (3,739 rad/hour) from the Co-60 source. The calculated 

occupational whole body dose to the technician was 56.2 mSv (5.62 rem) and the calculated 

occupational extremity maximum dose was 384 mSv (38.4 rem). The event was not considered 

to be a clinically significant exposure. 

The incident was reported as an International Nuclear and Radiological Event Scale level 3 

event.3

The technician has not exhibited and is not expected to have any observable medical effects 

from either the whole body or the extremity dose. 

The licensee corrective actions included personnel training and procedure modification. NRC 

Region IV dispatched inspectors to the facility on August 21, 2015, and again on September 14, 

2015. 

 

3 According to the International Nuclear and Radiological Event Scale (INES) User’s Manual 2008 Edition, an 

INES level 3 incident is the minimum level for events that result in: (1) “The occurrence or likely occurrence 

of a non-lethal deterministic effect or (2) Exposure leading to an effective dose greater than ten times the 

statutory annual whole body dose limit for workers.” 

D-1 

APPENDIX D 

GLOSSARY 

Acoustic Neuroma1—a benign tumor that may develop on the hearing and balance nerves 

near the inner ear.

Act—the Atomic Energy Act of 1954 (Public Law 83-703), including any amendments. 

Authorized User—as defined in Section 35.2 of Title 10 of the Code of Federal Regulations

(10 CFR), “Definitions,” a physician, dentist, or podiatrist who: (1) meets the requirements in 

10 CFR 35.59, “Recentness of Training,” and 10 CFR 35.190(a), 10 CFR 35.290(a), 

10 CFR 35.390(a), 10 CFR 35.392(a), 10 CFR 35.394(a), 10 CFR 35.490(a), 10 CFR 35.590(a), 

or 10 CFR 35.690(a); or (2) is identified as an authorized user on: (i) a Commission or 

Agreement State license that authorizes the medical use of byproduct material, (ii) a permit 

issued by a Commission master material licensee that is authorized to permit the medical use of 

byproduct material, (iii) a permit issued by a Commission or Agreement State specific licensee 

of broad scope that is authorized to permit the medical use of byproduct material, or (iv) a 

permit issued by a Commission master material license broad scope permittee that is 

authorized to permit the medical use of byproduct material. 

Brachytherapy—as defined in 10 CFR 35.2, a method of radiation therapy in which sources 

are used to deliver a radiation dose at a distance of up to a few centimeters by surface, 

intracavitary, intraluminal, or interstitial application. 

Brachytherapy Seed Implantation for Prostate Cancer 1—Radioactive seed implants are 

a form of radiation therapy for prostate cancer. The radioactive seeds are loaded into the 

designated number of needles, in a specific order, and each needle is inserted through the skin 

in the perineum and into the prostate using continuous ultrasound guidance. Once accurate 

needle placement is confirmed, the seeds in that needle are released. This process is 

continued until all of the radioactive seeds have been implanted. 

Brachytherapy Source—as defined in 10 CFR 35.2, a radioactive source or a 

manufacturer-assembled source train or a combination of these sources that is designed to 

deliver a therapeutic dose within a distance of a few centimeters. 

Catheter 1—a tubular medical device for insertion into canals, vessels, passageways, or body 

cavities for diagnostic or therapeutic purposes to permit injection or withdrawal of fluids or to 

keep a passage open. 

Cervical Cancer 1—cancer of the cervix, the narrow neck at the lower part of a woman’s uterus, 

just above the vagina. 

Dose Equivalent (HT)—as defined in 10 CFR 20.1003, “Definitions,” the product of the 

absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location 

of interest; the units of dose equivalent are the roentgen equivalent man (rem) and sievert (Sv). 

 

1. These terms are not defined in 10 CFR, an MD, an inspection procedure, or an NRC policy statement. 

Rather, they are defined based on definitions in MedicineNet’s “Online MedTerms Medical Dictionary.” 

MedicineNet is an online service part of WebMD (see http://www.medterms.com). 
D-2 

Effective Dose Equivalent (HE)—as defined in 10 CFR 20.1003, the sum of the products of the 

dose equivalent to the organ or tissue (HT) and the weighting factors (wT) applicable to each of 

the body organs or tissues that are irradiated. 

Endometrial Cancer—cancer of the womb (uterus).

Exposure—as defined in 10 CFR 20.1003, being exposed to ionizing radiation or to 

radioactive material. 

External Dose—as defined in 10 CFR 20.1003, that portion of the dose equivalent received 

from radiation sources outside the body. 

Gray (Gy)—as defined in 10 CFR 20.1004, “Units of Radiation Dose,” the international system’s 

unit of absorbed dose; 1 gray is equal to an absorbed dose of 1 joule/kilogram (100 rad). 

Interstitial 2—situated within, but not restricted to or characteristic of, a particular organ or 

tissue; used especially of fibrous tissue. 

Manual Brachytherapy—as defined in 10 CFR 35.2, a type of brachytherapy in which the 

brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either 

into the body cavities that are close to a treatment site or directly into the tissue volume. 

Medical Event—as defined in 10 CFR 35.2, an event that meets the criteria in 

10 CFR 35.3045(a) or (b). Regulations in 10 CFR 35.3045(a) state that a licensee shall report 

any event, except for an event that results from patient intervention, in which the administration 

of byproduct material or radiation from byproduct material results in: 

(1) a dose that differs from the prescribed dose or dose that would have resulted from 

the prescribed dosage by more than 0.05 Sv (5 rems) effective dose equivalent, 0.5 Sv 

(50 rems) to an organ or tissue, or 0.5 Sv (50 rems) shallow dose equivalent to the skin 

and: (i) the total dose delivered differs from the prescribed dose by 20 percent or more; 

(ii) the total dosage delivered differs from the prescribed dosage by 20 percent or more 

or falls outside the prescribed dosage range; or (iii) the fractionated dose delivered 

differs from the prescribed dose, for a single fraction, by 50 percent or more; 

(2) a dose that exceeds 0.05 Sv (5 rems) effective dose equivalent, 0.5 Sv (50 rems) to an 

organ or tissue, or 0.5 Sv (50 rems) shallow dose equivalent to the skin from any of the 

following: (i) an administration of a wrong radioactive drug containing byproduct 

material; (ii) an administration of a radioactive drug containing byproduct material by the 

wrong route of administration; (iii) an administration of a dose or dosage to the wrong 

individual or human research subject; (iv) an administration of a dose or dosage 

delivered by the wrong mode of treatment; or (v) a leaking sealed source; 

 

2. This term is not defined in 10 CFR, an MD, an inspection procedure, or an NRC policy statement. Rather, it 

is defined based on definitions in Merriam-Webster’s “MedlinePlus Online Medical Dictionary.” MedlinePlus 

is a service of the U.S. National Library of Medicine and the National Institutes of Health (see

http://www.nlm.nih.gov/medlineplus/mplusdictionary.html). 
D-3 

(3) a dose to the skin or an organ or tissue other than the treatment site that exceeds by 

0.5 Sv (50 rems) to an organ or tissue and 50 percent or more of the dose expected 

from the administration defined in the written directive (excluding, for permanent 

implants, seeds that were implanted in the correct site but migrated outside the 

treatment site). 

Regulations in 10 CFR 35.3045(b) state that a licensee shall report any event resulting from 

intervention of a patient or human research subject in which the administration of byproduct 

material or radiation from byproduct material results or will result in unintended permanent 

functional damage to an organ or a physiological system, as determined by a physician. 

Prescribed Dosage—as defined in 10 CFR 35.2, the specified activity or range of activity of 

unsealed byproduct material as documented (1) in a written directive or (2) in accordance with 

the directions of the authorized user for procedures performed pursuant to 10 CFR 35.100, “Use 

of Unsealed Byproduct Material for Uptake, Dilution, and Excretion Studies for Which a Written 

Directive Is Not Required,” and 10 CFR 35.200, “Use of Unsealed Byproduct Material for 

Imaging and Localization Studies for Which a Written Directive Is Not Required.” 

Prescribed Dose—as defined in 10 CFR 35.2; (1) for gamma stereotactic radiosurgery, the 

total dose as documented in the written directive; (2) for teletherapy, the total dose and dose 

per fraction as documented in the written directive; (3) for manual brachytherapy, either the total 

source strength and exposure time or the total dose, as documented in the written directive; or 

(4) for remote brachytherapy afterloaders, the total dose and dose per fraction as documented 

in the written directive. 

rad—as defined in 10 CFR 20.1004, the special unit of absorbed dose; 1 rad is equal to an 

absorbed dose of 100 ergs/gram or 0.01 joule/kilogram (0.01 gray). 

Radiation (Ionizing Radiation)—as defined in 10 CFR 20.1003, alpha particles, beta particles, 

gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles 

capable of producing ions; radiation, as used in 10 CFR Part 20, “Standards for Protection 

against Radiation,” does not include nonionizing radiation, such as radio waves or microwaves, 

or visible, infrared, or ultraviolet light. 

Radiation Oncologist 3—a specialist in using radiation therapy as a treatment for cancer. 

Radiation Therapy (Radiotherapy)3—treatment in which high-energy rays are used to damage 

cancer cells and stop them from growing and dividing. A specialist in radiation therapy is called 

a “radiation oncologist.” 

Reactive Inspection—as defined in U.S. Nuclear Regulatory Commission (NRC) Inspection 

Procedure 43003, “Reactive Inspections of Nuclear Vendors,” an inspection performed for the 

purpose of obtaining additional information or verifying adequate corrective actions on reported 

problems or deficiencies. 

 

3. These terms are not defined in 10 CFR, an MD, an inspection procedure, or an NRC policy statement. 

Rather, they are defined based on definitions in MedicineNet’s “Online MedTerms Medical Dictionary.” 

MedicineNet is an online service part of WebMD (see http://www.medterms.com). 
D-4 

rem—as defined in 10 CFR 20.1004, the special unit of any of the quantities expressed as dose 

equivalent; the dose equivalent in rem is equal to the absorbed dose in rad multiplied by the 

quality factor (1 rem = 0.01 sievert). 

Shallow Dose Equivalent (HS)—as defined in 10 CFR 20.1003, which applies to the external 

exposure of the skin of the whole body or the skin of an extremity, the dose equivalent at a 

tissue depth of 0.007 centimeter (7 milligrams/square centimeter). 

Sievert (Sv)—as defined in 10 CFR 20.1004, the international system’s unit of any of the 

quantities expressed as dose equivalent; the dose equivalent in sieverts is equal to the 

absorbed dose in grays multiplied by the quality factor (1 Sv = 100 rems). 

Source Material—as defined in 10 CFR 40.4, “Definitions”; (1) uranium or thorium, or any 

combination thereof, in any physical or chemical form; or (2) ores that contain by weight 

one-twentieth of one percent (0.05 percent) or more of: (i) uranium, (ii) thorium, or (iii) any 

combination thereof. Source material does not include special nuclear material. 

Special Nuclear Material—as defined in 10 CFR 70.4, “Definitions”; (1) plutonium, 

uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material 

that the Commission, pursuant to the provisions of Section 51, “Special Nuclear Material,” of the 

Atomic Energy Act, determines to be special nuclear material, but not including source material; 

or (2) any material artificially enriched by any of the foregoing but not including source material. 

Therapeutic Dose—as defined in 10 CFR 35.2, a radiation dose delivered from a source 

containing byproduct material to a patient or human research subject for palliative or 

curative treatment. 

Thyroid Ablation Treatment—deactivate thyroid tissue using radioactive iodine.

Trigeminal Neuralgia 4—inflammation of the trigeminal nerve (the fifth cranial nerve) that most 

commonly causes paroxysms of very intense lightning pain in the areas of the face the nerve 

supplies—the lips, eye, nose, scalp, forehead, gums, cheek, and chin—on the involved side of 

the face. A less common “atypical” form of the disease causes a more constant, dull, burning, 

or aching pain.

Treatment Site—as defined in 10 CFR 35.2, the anatomical description of the tissue intended 

to receive a radiation dose, as described in a written directive. 

Written Directive—as defined in 10 CFR 35.2, an authorized user’s written order for the 

administration of byproduct material or radiation from byproduct material to a specific patient 

or human research subject, as specified in 10 CFR 35.40, “Written Directives.” 

 

4 This term is not defined in 10 CFR, an MD, an inspection procedure, or an NRC policy statement. Rather, it 

is defined based on definitions in MedicineNet’s “Online MedTerms Medical Dictionary.” MedicineNet is an 

online service part of WebMD (see http://www.medterms.com). 
E-1 

APPENDIX E 

CONVERSION TABLE 

Radioactivity and Ionizing Radiation 

QUANTITY FROM METRIC UNITS TO NON-SI UNITS DIVIDE BY 

 

(Radionuclide) 

Activity 

megabecquerel (MBq) curie (Ci) 37,000 

 terabecquerel (TBq) Ci 0.037 

 gigabecquerel (GBq) Ci 37 

Absorbed dose gray (Gy) rad 0.01 

 centigray (cGy) rad 1.0 

Dose equivalent sievert (Sv) roentgen equivalent 

man (rem) 

0.01 

 centisievert (cSv) rem 1.0 

 millisievert (mSv) rem 10 

 mSv millirem (mrem) 0.01 

 microsievert (μSv) mrem 10