SEC

V% Rk, UNITED STATES

" NUCLEAR REGULATORY COMMISSION

C' WASHINGTON, D.C. 20555-0001

April 11, 2012

RETARY COMMISSION VOTING RECORD

DECISION ITEM: SECY-12-0032

TITLE: REPORT TO CONGRESS ON ABNORMAL

OCCURRENCES: FISCAL YEAR 2011

The Commission (with all Commissioners agreeing) approved the subject paper as recorded in

the Staff Requirements Memorandum (SRM) of April 11, 2012.

This Record contains a summary of voting on this matter together with the individual vote

sheets, views and comments of the Commission.

Annette L. Vietti-Cook

Secretary of the Commission

Attachments:

1. Voting Summary

2. Commissioner Vote Sheets

cc: Chairman Jaczko

Commissioner Svinicki

Commissioner Apostolakis

Commissioner Magwood

Commissioner Ostendorff

OGC

EDO

PDR
VOTING SUMMARY - SECY-12-0032

RECORDED VOTES

NOT

APRVD DISAPRVD ABSTAIN PARTICIP COMMENTS DATE

CHRM. JACZKO

COMR. SVINICKI

COMR. APOSTOLAKIS

COMR. MAGWOOD

COMR. OSTENDORFF

x

x

x

x

x

3/13/12

X 3/20/12

X 312/12

X 3/26/12

X 3/20/12
TO:

FROM:

SUBJECT:

NOTATION VOTE

RESPONSE SHEET

Annette Vietti-Cook, Secretary

Gregory B. Jaczko

SECY-12-0032 - REPORT TO CONGRESS ON

ABNORMAL OCCURRENCES: FISCAL YEAR 2011

Approved X Disar

Not Participating

COMMENTS: Below

:)proved Abstain

Attached None X

/1GNATURE

DATE

Entered on "STARS" Yes x No
TO:

FROM:

SUBJECT:

NOTATION VOTE

RESPONSE SHEET

Annette Vietti-Cook, Secretary

COMMISSIONER SVINICKI

SECY-12-0032 - REPORT TO CONGRESS ON

ABNORMAL OCCURRENCES: FISCAL YEAR 2011

Approved XX Disapproved Abstain

Not Participating _

COMMENTS: Below XX Attached XX None

I approve the proposed FY 2011 AO report to Congress, subject to the attached edits.

0317A/12

-W, DATE

Entered on "STARS" Yes _/No
ABSTRACT

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 five events that the NRC identified as AOs during fiscal year (FY) 2011

based on the criteria defined in this report's Appendix A, "Abnormal Occurrence Criteria and

Guidelines for Other Events of Interest." The first event at an NRC-licensed facility involved

radiation exposure to an embryo/fetus, and the second was an event of high safety significance

at a commercial nuclear power plant. The other three events occurred at NRC iccnsced or

NRC-regulated medical institutions and are medical events, as defined in Title 10 of the Code of Federal Regulations (10 CFR) Part 35, "Medical Use of Byproduct Material."

In addition, this report describes 19 events that Agreement States identified as AOs during FY

2011, based on the criteria in Appendix A to this report. Agreement States are those States that

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

Energy Act (AEA), to regulate certain quantities of AEA material at facilities located within their

borders. Currently, there are 37 Agreement States. The first Agreement State event involved

radiation exposure to an embryo/fetus, the second event involved an exposure to the

extremities of a radiographer, and the third event involved a stolen radiography camera. The

other 16 Agreement State events were medical events, as defined in 10 CFR Part 35.

Appendix A to this report presents the NRC's criteria for selecting AOs, as well as the guidelines

for selecting "other events of interest." Appendix B, "Updates of Previously Reported Abnormal

Occurrences," provides updated information for one event reported in the FY 2010 "Report to

Congress on Abnormal Occurrences" regarding the medical event at Providence Hospital in

Novi, Michigan. During FY 2011, three items were identified as meeting the guidelines for

inclusion in Appendix C, "Other Events of Interest." These three events occurred at nuclear

power plants. Appendix D, "Glossary," presents definitions of terms used throughout this report.

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

iii
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) 2011, 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 (AEA) to regulate certain quantities of AEA material at facilities located 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.

Appendix A to this report presents the NRC's criteria for selecting AOs, as well as the guidelines for selecting "other events of interest." Appendix B, "Updates of Previously Reported Abnormal

Occurrences," provides updated information for one event reported in NUREG-0090 Volume 33, "Report to Congress on Abnormal Occurrences-FY 2010," issued June 2011. The update involves the medical event at Providence Hospital in Novi, Michigan. During FY 2011, the NRC

identified three items as meeting the guidelines for inclusion in Appendix C, "Other Events of

Interest." These three events occurred at nuclear power plants. 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 by which the NRC carries out its responsibilities is

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

(10 CFR). Stakeholders are informed and involved, as appropriate, to ensure openness in the

agency's regulatory process, consistent with the NRC's "Strategic Plan for FY 2008-2013

(Updated)" (NUREG-1614, Volume 45, issued February 2-0082012). The NRC regularly conducts licensing reviews, inspections, enforcement, investigations, operating experience evaluations, incident response, and confirmatory research. The NRC also maintains programs

to establish standards and issue technical reviews and studies. In addition, the NRC involves

the public as an essential element in the regulatory process.

The NRC adheres to the philosophy that the health and safety of the public are best ensured by establishing multiple levels of protection. These levels are normally achieved and maintained

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 provide a regulatory framework to ensure compliance with the regulations. In

vii
addition, the NRC is striving to make the regulatory system more risk informed and

performance-based, where appropriate.

REPORTABLE EVENTS

The NRC initially promulgated 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, used by the NRC to define AOs for the report.

Review of and responses to operating experience are essential to ensure that licensed activities

are conducted 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 industry review and evaluate operating experience to identify safety concerns.

The NRC responds to risk-significant issues through licensing reviews, inspections, and

enhancements to regulations. In addition, the agency maintains operational data in computerbased data files for more effective collection, storage, retrieval, and evaluation.

The NRC also routinely disseminates (to the public, industry, and other interested stakeholders)

publicly available information and records regarding reportable events at licensed or regulated

facilities. The agency achieves this dissemination through public announcements and special notifications to licensees and other stakeholders. To widely disseminate information to the

public, the NRC also 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. In addition, the NRC routinely informs Congress of significant events, including AOs,

that occur at licensed or regulated facilities.

AGREEMENT STATES

Section 274 of the AEA, as amended, authorizes the Commission to enter into agreements with

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

byproduct, source, and certain quantities of special nuclear materials in G.Uantities . not ufficieAt

to form a craitica masc. States that enter into such agreements with the NRC are known as

Agreement States. 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 2011, there were 37 Agreement States.

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 has also developed and implemented procedures for evaluating materials

events to identify those that should be reported as AOs. Toward that end, the NRC uniformly

applies the AO criteria (in Appendix A to this report) to events at licensees regulated by either

the NRC or the Agreement States. In addition, in early 1977, the Commission determined that

the annual report to Congress also should include events that meet the criteria for AOs at

viii
ABNORMAL OCCURRENCES IN FISCAL YEAR 2011

The following briefly explains the numbering system used in this section of the report. Appendix

A provides the specific criteria for determining when an event is an abnormal occurrence (AO)

and provides the guidelines for reporting other events of interest which may not meet the AO

criteria, but which the Commission has determined should be in this report. Appendix A

contains four major categories: I. All Licensees, II. Commercial Nuclear Power Plant Licensees,

Ill. Events at Facilities Other Than Nuclear Power Plants and All Transportation Events, and IV.

Other Events of Interest. Category IV events are discussed in Appendix C to this report, and

Categories 1, 11, and Ill are discussed in this section. Categories I and II contain significant

subelements labeled A, B, C, and D, and Category Ill addresses Subelement C. This section of

the report discusses only the specific subelement in Categories 1, 11, and Ill for which an AO was

reported. The identification number for all Agreement State AO reports starts with "AS."

Similarly, the identification number for all U.S. Nuclear Regulatory Commission (NRC) AO

reports starts with "NRC."

I. ALL LICENSEES

During this reporting period, one event at an NRC-licensed or NRC reguldated facilitic facilityI

and three events at Agreement-State-licensed facilities were significant enough to be reported

as AOs based on the criteria in Appendix A to this report. Although two of these events

occurred at a medical facility, they involved unintended exposures of individuals who were not

the patient. Therefore, these events belong under the Criteria I.A, "All Licensees" category, as

opposed to the Criteria Ill.C, "Medical Licensees" category.

NRCII-01 Human Exposure to Radiation at Portsmouth Naval Medical Center in

Portsmouth, Virginia

Criterion I.A.2, "Human Exposure to Radiation from Licensed Material," of Appendix A to this

report provides, in part, 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 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 - January 12, 2011, Portsmouth, Virginia

Nature and Probable Consequences - The Department of the Navy (the licensee) reported that

a female patient at the Naval Medical Center in Portsmouth, Virginia (NMCP), received 3,630

MBq (98 mCi) of iodine-131 for thyroid ablation therapy. On the day of the treatment the patient

informed NMCP staff that she was not pregnant and NMCP staff administered a pregnancy test

as a routine precaution. The pregnancy test yielded a negative result. Based on the negative

pregnancy test results and the patient's interview responses, NMCP staff administered iodine131 to the patient.

On January 27, 2011, the patient became aware that she was pregnant and informed the

physician who had administered the treatment. An obstetrician estimated that conception had

occurred somewhere around January 7-10, 2011, and that a pregnancy test administered on

January 12, 2011, would not have been sensitive enough to produce a positive result. NMCP

estimated the dose to the embryo to be 21.3 cGy (21.3 rem) and notified the Naval Radiation

Safety Committee that the patient may have been pregnant before the therapy. NMCP staff

1
estimated a slight increased risk of early pregnancy failure and this was discussed with the

patient. NMCP staff subsequently refined the dose estimate to 24.7 cGy (24.7 rem). The NRC

contracted with a medical consultant who estimated a fetal/embryo dose of 27 cGy (27 rem) and

stated that embryonic tissue capable of concentrating iodine-131 is not formed until 10 to 12

weeks of gestation; therefore, the tissue had not yet formed at the time of the treatment. The

medical consultant concluded that there was a low possibility of carcinogenesis or

malformations. The pregnancY P.Ogr....d nomally and both the mother and ,hild are doing

weUlCause(s) - The cause of this event was the close proximity of conception, which resulted in a

negative pregnancy test result, to the administration of the iodine-1 31.

Actions Taken to Prevent Recurrence

Licensee - NMCP revised the initial consultation procedures for the prescribing physician to

stress the importance of discussing with the patient the need for sexual abstinence at least 10

days before therapeutic dose administration.

NRC - The NRC conducted an inspection on February 2, 2011 through June 2, 2011, and there

were no violations of NRC requirements associated with this event.

This event is closed for the purpose of this report.

2
AS 1-01 Human Exposure to Radiation at Montefiore Medical Center in New York

City, New York

Criterion I.A.2, "Human Exposure to Radiation from Licensed Material," of Appendix A to this

report provides, in part, 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 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 - September 22, 2006 (reported on April 27, 2011), New York City, New York

Nature and Probable Consequences - Montefiore Medical Center (the licensee) reported that a

female patient received 3,519 MBq (95 mCi) of iodine-1 31 for thyroid ablation therapy. Before

the treatment, the licensee interviewed the patient and ascertained that she was not pregnant.

The licensee's staff administered a pregnancy test as a routine precaution. The pregnancy test

yielded a negative result. Based on the negative pregnancy test results and the patient's

interview responses, the licensee administered iodine-131 to the patient.

On December 22, 2006, the patient returned to the licensee for a followup visit. Following that

visit, the nuclear medicine department staff was informed by another section of the medical

center that the patient was pregnant. The licensee confirmed the pregnancy with the patient's

obstetrician/gynecologist-(OgBGYN). The ultrasound performed by the patient's

obstetrician/gynecologist revealed that the patient was approximately 2-3 weeks pregnant at the

time of the iodine-1 31 treatment. The licensee estimated that the fetus received about 25 cGy

(25 rem) of radiation exposure and stated that embryonic tissue capable of concentrating iodine131 is not formed until 10 to 12 weeks of gestation; therefore, this tissue had not yet fully formed

at the time of the treatment. The patient was advised to see a genetic specialist to discuss the

possible consequences to the fetus from this exposure. Although the licensee claimed that it

had originally reported the event to the New York City Office of Radiological Health in 2006, the

office had no record of the report. The New York City Office of Radiological Health identified the

missing report in April 2011, and subsequently notified the NRC on June 15, 2011. The

licensce rcperted that the child, now 5 yearc old, us normnl anRd moet-;ng al! dcVelop-menta!

Cause(s) - The cause of this event was the close proximity of conception to the iodine-1 31

treatment and a false negative result on a pregnancy test done before the administration of the

treatment.

Actions Taken to Prevent Recurrence

Licensee - The licensee's corrective actions included additions to its Safety Precaution Form

stressing the necessity of sexual abstinence before the treatment and recommending that

patients also take precautions to avoid getting pregnant for 6 months after the treatment.

State - The New York City Office of Radiological Health conducted an inspection on June 16,

2011, and determined that the licensee had followed acceptable protocols before the

administration of iodine-131. Consequently no civil penalties or enforcement action for this

event are warranted.

This event is closed for the purpose of this report.

3
ASll-02 Human Exposure to Radiation at Caribbean Inspection & NDT Services,

Inc., in Port Lavaca, Texas

Criterion I.A. 1, "Human Exposure to Radiation from Licensed Material," of Appendix A to this

report provides, in part, that any unintended radiation exposure to an adult resulting in an

annual shallow dose equivalent to the skin or extremities of 2,500 mSv (250 rem) or more shall

be considered for reporting as an AO.

Date and Place - September 12, 2011, Port Lavaca, Texas

Nature and Probable Consequences - Caribbean Inspection & NDT Services Inc. (the licensee)

reported that a radiographer trainee received an overexposure to his right hand and was

seeking medical attention. The radiographer trainee stated that on September 12, 2011, while

conducting radiography operations in the field, he removed a radiography camera guide tube

from the Amersham 660 D radiography camera. The radiographer trainee stated that he

noticed the 2.7 TBq (73 Ci) iridium-1 92 source was not fully retracted and protruding from the

camera about 2 inches. The radiographer trainee stated that he may have brushed the source

with his hand when he removed the guide tube.

On September 19, 2011, the radiographer trainee presented himself to a Houston, Texas

hospital with observable deterministic effects, which included blistering of the thumb, index and

middle fingers. These types of effects correspond to an exposure range of 20 - 40 Sv (2000 to

4000 rem) to the extremities. His doctors initially conferred with the Radiation Emergency

Assistance Center/Training Site in Oak Ridge, TN regarding his medical treatment. The trainee

is continuing his treatment at the Houston, Texas hospital as an out-patient. The licensee

stated that the results of the trainee's dosimeter indicated that he received 14.1 mSv (1.41 rem)

whole body exposure based on the film badge he was wearing at the time of the event.

Cause(s) - The State of Texas is currently investigating the cause of this event.

Actions Taken to Prevent Recurrence

Licensee - The licensee is conducting an investigation to determine the exact nature and cause

of this event. Pending the results of this investigation the licensee will determine corrective

action and inform the State of the circumstances of the event and the corrective actions.

State -Texas Department of State Health Services, Radiation Control Program is currently

investigating this incident, which includes collecting information from the physicians, the

licensee, and the individuals involved in the event. Pending the results of this investigation and

the depositions performed through the General Counsel, the Texas Department of State Health

Services will determine the probable causes of the event and review the licensee's corrective

actions and consider what, if any, civil penalties and enforcement actions to pursue.

This event is open for the purpose of this report.

4
ASIl-03 Stolen Radiography Camera at Acuren Inspection, Inc., in La Porte, Texas

Criterion I.C.2, "Theft, Diversion, or Loss of Licensed Material, or Sabotage or Security Breach"

of Appendix A to this report provides, in part, that any substantiated case of actual theft or

diversion of licensed, risk-significant radioactive sources, shall be considered for reporting as an

AO.

Date and Place - July 19, 2011, La Porte, Texas

Nature and Probable Consequences - Acuren Inspections Inc. (the licensee) reported the theft

of a radiography camera containing 1.25 GBq (33.7 Ci) of iridium-1 92. On July 19, 2011, the

licensee discovered that their radiography truck had been broken into, and the radiography

camera, associated equipment, and portable generator had been stolen. The alarm system on

the truck was then tested and determined to be operational; however, the alarm had not been

set at the time of the theft. Attempts to locate the camera included the use of portable radiation

detection equipment on vehicles, Austin Police Department/6 Civil Support Team (APDA/6GST

helicopter flyovers of the area, and a Department of Energy fly-over survey between the cities of

Austin and San Antonio, using a fixed wing plane.

It should be noted that at the time this event was reported to the NRC, the radioactive material

in the camera was at a level considered to be risk-significant. However, as of October 1, 2011,

the radioactive material had decayed to a level considered to not be risk-significant. The

radioactive source has not been recovered at the time of this report.

Cause(s) - Licensee failure to use the vehicle alarm system.

Actions Taken to Prevent Recurrence

Licensee - The licensee conducted a company-wide review of the incident with all employees,

inspected all their trucks to verify the alarm systems were operating, and required all employees

to view a video that showed the proper way to lock and secure radioactive material.

State - The Texas Department of State Health Services conducted an inspection on July 21,

2011 and determined that radiographer had failed to activate the alarm system on the truck

containing the radiography camera. The licensee and the radiographers involved were cited for

the violation.

This event is closed for the purpose of this report.

5
II. COMMERCIAL NUCLEAR POWER PLANT LICENSEES

During this reporting period, one event at a commercial nuclear power plants in the United

States was significant enough to be reported as an AO based on the criteria in Appendix A to

this report.

NRCI1-02 Commercial Nuclear Power Plant Event at Browns Ferry Nuclear Plant, Unit

1, in Athens, Alabama

Criterion II.C, "For Commercial Nuclear Power Plant Licensees," of Appendix A to this report

provides, in part, that a commercial nuclear power plant event shall be considered for reporting

as an AO if it results in any reactor conditions or performance indicators that are determined to

be of high safety significance (red findings).

Date and Place - October 23, 2010, Athens, Alabama

Nature and Probable Consequences - The Tennessee Valley Authority (TVA) (the licensee)

reported a commercial nuclear power plant event at Browns Ferry Nuclear Plant, Unit 1, a

boiling-water reactor designed by General Electric. On October 23, 2010 during a refueling

outage, it was discovered that a residual heat removal (RHR) low pressure coolant injection

(LPCI) flow control valve failed while the licensee was attempting to establish shutdown cooling.

The flow control portion of the valve, called the disc, was found stuck in the seat of the valve.

The disc had become separated from the valve stem and could no longer be controlled by the

valve motor operator. The RHR system is primarily used for LPCI during accident conditions

and for cooling while the reactor is shut down. As a result of the flow control valve failure, Loop

II of the RHR system could not have performed its safe shutdown functions and was declared

inoperable. The licensee promptly placed the other loop of the RHR system (Loop I) into

service and, as a result, the failure of the flow control valve did not involve an actual safety

consequence or impact the health and safety of the public.

However, the NRC reviewed this event under its significance determination process and

determined that the licensee's history with regards to this valve performance issue represented

a finding of high safety significance (red finding). The basis for this finding was that the flow

control valve's failure (condition) caused a weakness in the licensee's fire mitigation strategy,

resulting in a significant increase in the core damage frequency. The licensee's fire mitigation

strategy limits the availability of alternative sources of reactor coolant inventory makeup and

both loops of LPCI could potentially be unavailable in some accident scenarios. Automatic

valve function was lost, as well as the ability of plant operators to manually use this loop of the

RHR system.

The public was never actually endangered because no event requiring use of the RHR system

occurred. However, the RHR system is counted on for core cooling during certain accident

scenarios, and the flow control valve failure left it inoperable, which could have led to core

damage had an accident involving a series of unlikely events occurred. The NRC determined

that this event did not represent an immediate safety concern, because the licensee staff had,

as part of its immediate corrective actions, implemented repairs and modifications in

accordance with design requirements that returned the flow control valve to an operational

condition (the red finding was for licensee performance deficiencies resulting in a past

inoperability).

Cause(s) - The immediate cause for this condition was separation of the valve disc from the

6
stem/skirt, with the disc wedged into the seat in the closed position. The licensee determined

that part of the root cause was a valve manufacturing defect that resulted in undersized disc

skirt threads at the disc connection to the valve stem. In addition, the NRC identified several

other performance deficiencies on the part of the licensee. Specifically, the NRC determined

that the licensee's failure to establish adequate programs to ensure that motor-operated valves

continue to be capable of performing their design-basis safety functions was a performance

deficiency. The NRC also concluded that TVA should have foreseen the results of not including

these valves within the scope of the program described in Generic Letter 89-10, "Safety-Related

Motor-Operated Valve Testing and Surveillance," dated June 28, 1989, and should have

corrected the problem. This failure to effectively maintain and inspect these valves within the

program contributed to the performance deficiency. The licensee's corrective action program

and root cause evaluation also did not appear to address the broader issues associated with

programs to ensure the continued capability of motor-operated valves to perform their designbasis safety function.

Actions Taken to Prevent Recurrence

Licensee - TVA reported this condition under 10 CFR 50.73, "Licensee Event Reporting

System," and under 10 CFR Part 21, "Reporting of Defects and Noncompliance Process." In

addition, TVA has presented corrective actions related to the flow control valve failure and

corrective actions that are planned to address long-term fire strategies at the Browns Ferry

Nuclear Power Station. The flow control valve was repaired promptly, and inspections were

performed on all similar valves for Units 1, 2, and 3 to verify their functional capability. TVA

informed the NRC of plans to reduce operator manual actions; implement procedural changes

related to fire strategy; install modifications as a result of its review of National Fire Protection

Association Standard 805, "Performance-Based Standard for Fire Protection for Light Water

Reactor Electric Generating Plants," and continue to reduce fire risk at the station.

NRC - The NRC assessed the performance of Browns Ferry Nuclear Power Station, Unit 1, to

be in the Multiple/Repetitive Degraded Cornerstone Column of the NRC's Action Matrix

beginning in the fourth quarter of calendar year 2010. This finding resulted in increased NRC

oversight at Browns Ferry Nuclear Power Station, including a supplemental inspection to

evaluate safety, organizational, and programmatic issues at the plant. NRC staff initiated the

supplemental inspection at the Browns Ferry Nuclear Power Station beginning on September

12, 2011. This inspection is being conducted in accordance with inspection procedures, and will

include extensive reviews of programs and processes not inspected as part of the NRC's

baseline inspection program. The inspection will also include an assessment of the Browns

Ferry Nuclear Power Station's safety culture. Part 1 of this supplemental inspection was

completed and an inspection report was issued on November 17, 2011 (available at

Agencywide Documents Access and Management System (ADAMS) Accession No.

ML1 13210602). The results of this inspection will be combined with the results from Parts 2 and

3 of the Browns Ferry Inspection Procedure (41P)-95003 (available at ADAMS Accession No.

ML1 02020551), and will assist the NRC in determining the breadth and depth of safety,

organizational, and programmatic issues at Browns Ferry Nuclear Power Station. The NRC will

report on the final supplemental inspection results as part of the FY 2012 AO report to

Congress.

This event is open for the purpose of this report.

7
ASII-05 Medical Event at the University of Pennsylvania in Philadelphia,

Pennsylvania

Criteria III.C.1.b and III.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 21 2010, Philadelphia, Pennsylvania

Nature and Probable Consequences - University of Pennsylvania (the licensee) reported that a

medical event occurred associated with a brachytherapy seed implant procedure to treat

prostate cancer. The patient was prescribed to receive a total dose of 145 Gy (14,500 rad) to

the prostate using 65 iodine-125 seeds. Instead, the seeds were inadvertently placed outside

the intended treatment site (wrong treatment site). The patient received an approximate dose of

161 Gy (16,100 rad) to the penile bulb (glans) (wrong treatment site). The patient and referring

physician were informed of this event.

On January 21, 2010, the iodine-125 seeds were implanted in the patient's prostate using real

time dosimetry under ultrasonic guidance. The written directive called for a therapeutic radiation

dose of 145 Gy (14,500 rad) to the prostate volume, plus 5 mm of margin. On February 23,

2010, the patient returned for a 30 day post implant CT scan, which revealed that the implanted

seeds were "in an appropriate pattern," but outside the intended target volume, which resulted

in unintended dose to the penile bulb (glans). The licensee concluded that the medical event

would not have a significant medical effect on the patient.

Cause(s) - The medical event is presumed to have been caused by misuse of a new ultrasound

unit.

Actions Taken to Prevent Recurrence

Licensee - The licensee's Radiation Oncology Department suspended all prostate

brachytherapy treatments pending an additional quality assurance review. Upon completion of

the quality assurance review, the licensee modified its prostate brachytherapy treatment

procedures. As of January 2012, the licensee has not yet roommencd resumed prostate

brachytherapy treatments after implementation of these modified procedures.

State - The Pennsylvania Department of Environmental Protection investigated the incident on

April 15, 2010 and determined that the licensee's corrective actions were adequate. No

enforcement action was taken and the State forwarded the final update of the event to the NRC

on November 14, 2011.

This event is closed for the purpose of this report.

10
AS 11-0 6 Medical Event at University Community Hospital in Tampa, Florida

Criteria II1.C.1 .b, IIl.C.2.a and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report

provide, in part, 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 or is delivered to the wrong

treatment site.

Date and Place - February 14, 2010, Tampa, Florida

Nature and Probable Consequences - University Community Hospital (the licensee) reported

that two patients were prescribed single-channel HDR brachytherapy treatments of 34 Gy

(3,400 rad). The actual average dose of 17 Gy (1,700 rad) to the first patient, and 26 Gy (2,600

rad) to the second patient, were delivered to the target area of the breast in which some parts of

the planned volume received greater than 700 percent (first patient) and 220 percent (second

patient) of the prescribed dose. In addition, other areas of the breast not in the target region

received up to 136 Gy (13,600 rad) in the first patient and 75 Gy (7,500 rad) in the second

patient. The maximum skin dose was calculated to be 42.5 Gy (4,250 rad) to the first patient

and 75 Gy (7,500 rad) to the second patient. The patients and their referring physicians were

informed of the events.

On February 14, 2010, the licensee noted that the source within the mammosite catheter was

erroneously positioned approximately 2 to 2.5 cm away from the tumor. This was the result of

the operator entering the wrong dwell position into the planning system. The licensee

concluded that no significant adverse health effects to the patients are expected.

Cause(s) - The cause of the medical events was human error involving entering the wrong

position of the reference end of the catheter into the planning system.

Actions Taken to Prevent Recurrence

Licensee - Corrective actions included implementing various quality assurance steps to ensure

that the correct treatment calculations and data are used for future treatments. Additional

procedural guidance will be created with detailed instructions.

State- The Florida Bureau of Radiation Control initiated an inspection on February 18, 2010.

The State completed the inspection on March 1, 2010, and determined that the licensee's

corrective actions were adequate. No enforcement action was taken and the State forwarded

the final update of the event to the NRC on February 1, 2011.

This event is closed for the purpose of this report.

11
AS 11-07 Medical Event at Coral Springs Clinic in Coral Springs, Florida

Criteria II1.C.1.b and IIl.C.2.a, "For Medical Licensees," of Appendix A to this report provide, in

part, that a medical event shall be considered for reporting as an AO if it results in a dose that is

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 - March 11, 2010, Coral Springs, Florida

Nature and Probable Consequences - Coral Springs Clinic (the licensee) reported that a

medical event occurred associated with an HDR brachytherapy treatment for basal cell

carcinoma of the ear; the treatment consisted of 210.9 GBq (5.7 Ci) of iridium-192. The patient

was prescribed 14 fractionated doses of 2.5 Gy (250 rad) to the ear, but instead, the patient

received 22.5 Gy (2,250 rad) on the second fractionated treatment dose. The patient and

referring physician were informed of this event.

On March 11, 2010, the patient being treated for basal cell carcinoma of the ear was to receive

the second fractionated dose 2.5 Gy (250 rad); however, while starting the treatment the

radiation therapist accidentally pushed the incorrect button on the HDR device, which was the

"auto radiography" button rather than the "treatment" button on the machine control console.

This resulted in the patient receiving approximately 9 times the intended dose for that fraction of

the treatment. Further treatments were canceled. The patient and doctor were notified of the

incident. The licensee concluded that no significant health effects to the patient are expected as

a result of this incorrect dose.

I Cause(s) - The medical event was caused by human error in that the radiation therapistiGe.,see

failed to push the correct button on the HDR device.

Actions Taken to Prevent Recurrence

Licensee - The licensee immediately disabled the autoradiograph function on the HDR and

other similar devices. The licensee modified its procedures to include the use of an

independent mechanical timer and provided additional training to its entire clinical staff.

State - The Florida Bureau of Radiation Control initiated an inspection on April 27, 2010 and

determined that the licensee's corrective actions were adequate. No enforcement action was

taken and the State forwarded the final update of the event to the NRC on October 10, 2011.

This event is closed for the purpose of this report.

12
ASIl-08 Medical Event at Rhode Island Hospital in Providence, Rhode Island

Criteria III.C.1 .b and III.C.2.b(i), "For Medical Licensees," of Appendix A to this report provide, in

part, that a medical event shall be considered for reporting as an AO if it results in a dose that is

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 uses the wrong radiopharmaceutical.

Date and Place - April 23, 2010, Providence, Rhode Island

Nature and Probable Consequences - Rhode Island Hospital (the licensee) reported that a

medical event occurred during a thyroid diagnostic uptake scan. The patient was prescribed to

receive 7.4 MBq (200 uCi) of iodine-1 23, but was administered 148 MBq (4 mCi) of iodine-131.

The administration resulted in a dose of approximately 3,108 cGy (3,108 rad) to the patient's

thyroid, rather than the estimated 7 cGy (7 rad) that would have resulted from the iodine-1 23

administration. The patient and referring physician were informed of this event.

The patient's physician handed the patient a written prescription for the iodine-1 23 scan, but the

physician's office faxed an incorrect order to the hospital for an iodine-1 31 scan. On April 23,

2010, the patient presented the correct written prescription slip, for the iodine-123, to the

licensee's admitting receptionist. The receptionist refused the written prescription, because she

thought the hospital already had the correct prescription in its records. The patient was

administered the iodine-131, and the whole body scan was performed. The nuclear medicine

technologist noticed something was wrong based on the scan results. The impact of this event

on the patient was not reported by the licensee.

Cause(s) - The cause of this medical event was human error and failure of the licensee staff to

follow existing written procedures and protocols.

Actions Taken to Prevent Recurrence

Licensee - The licensee reviewed existing written protocols and training procedures used for

the nuclear medicine technologists. The licensee's corrective actions included modifying the

procedures and conducting refresher training for the nuclear medicine technologists. In

addition, the licensee developed a thyroid interview and patient assessment history sheet and

now requires a pathology report for all thyroid cancer patients before iodine-1 31 doses are

administered.

State - The Rhode Island Department of Health, Radiation Control Program, conducted an

investigation of this medical event on April 30 through May 20, 2010, and issued a Netie-ef

Violation (NOV) to the licensee. The Rhode Island Department of Health also issued a

regulatory citation regarding the licensee's failure to follow established procedures and

forwarded the final update of the event to the NRC in September 2011.

This event is closed for the purpose of this report.

13
AS11-12 Medical Event at Cleveland Clinic Foundation in Cleveland, Ohio

Criteria II1.C.1 .b and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 26, 2010, Cleveland, Ohio

Nature and Probable Consequences - The Cleveland Clinic Foundation (the licensee) reported,

to the Ohio Department of Health (ODH) that a medical event occurred associated with a

radioembolization brachytherapy treatment for liver cancer; the treatment consisted of 3.96 GBq

(107 mCi) of yttrium-90. A postprocedure scan of the patient identified significant undesired

activity in the duodenum (wrong treatment site). The licensee estimated that approximately

0.37 GBq (10 mCi) of activity was present in the duodenum, with a dose to the duodenum of

approximately 90 Gy (9,000 rad). The patient and physician were informed of this event.

Approximately 3 weeks before the therapy, the patient was scanned for extra hepatic shunting

by injecting technetium-99m into the hepatic artery. No shunting to the duodenum was

identified during this procedure. On October 26, 2010, the interventional radiologist correctly

inserted the catheter into the patient and its placement was confirmed by a second

interventional radiologist. During the radioembolization treatment, the patient complained of

pain, which resulted in the lirensee-medical staff performing a postprocedure SPECT/CT scan

of the patient. The SPECT/CT scan identified undesired yttrium-90 activity in the duodenum.

The patient was hospitalized for observation and possible intervention as a result of the dose to

the duodenum. Some ulceration of the duodenum bulb was observed, but no evidence of

perforation or bleeding was detected. The licensee is continuing to monitor the patient for

health effects from the radiation exposure.

Cause(s) - The licensee believes-reported that the cause of the medical event was that some

collateral blood vessels became dominant and blood was shunted through them to the

duodenum, allowing movement of the yttrium-90 microspheres. Although the licensee has not

seen this relatively uncommon occurrence in the past 3 years, it has been noted in other

treatment cases.

Actions Taken to Prevent Recurrence

Licensee: - The licensee modified its radioembolization therapy procedure to include

posttreatment imaging of yttrium-90 distribution. This will allow the licensee to respond

appropriately in the event of a recurrence. The licensee's rate of occurrence is approximately

10 times less than is reported in medical literature; therefore, no specific action to prevent a

reoccurrence is proposed.

State: - On November 3, 2010, ODH performed an onsite investigation of the event. ODH

reviewed and approved the licensee's corrective actions and took no enforcement action.

This event is closed for the purpose of this report.

19
ASl1-14 Medical Event at the University of Texas Southwestern Medical Center in

Dallas, Texas

Criteria III.C.1.b and III.C.2.a, "For Medical Licensees," of Appendix A to this report provide, in

part, 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 - July 30, 2010 and September 16, 2010 (reported on February 15, 2011),

Dallas, Texas

Nature and Probable Consequences - The University of Texas Southwestern Medical Center

(the licensee) reported the occurrence of two-a medical events to two young adult patients

prescribed colloidal phosphorus-32 (ranging from 7.4 MBq (0.2 mCi) and 92.5 MBq (2.5 mCi) of

activity) for treatment of cranial cysts. The patients were prescribed to receive a total dose of

300 Gy (30,000 rad) and 200 Gy (20,000 rad) respectively, but instead the patients received an

approximate dose of 565 Gy (56,500 rad) and 506 Gy (50,600 rad) to the cysts. These dosages

were 88 and 153 percent greater than the prescribed dosages. The patients and referring

physicians were informed of these events.

On February 15, 2011, the licensee discovered that two young adult patients were administered

doses of phosphorus-32 greater than 50 percent of the prescribed doses. The incidents were

discovered when the authorized user noticed an area of inflammation surrounding the cysts and

along the track of the drainage catheter. The authorized user discussed these findings with the

staff medical physicist who reviewed the colloidal phosphorus-32 doses supplied by the nuclear

pharmacy. The licensee determined that for both cases, the labels had the correct total activity,

but the incorrect volume and activity per unit volume. Therefore, the doses were incorrectly

labeled, and the concentration was approximately 60 percent higher than indicated on the

labels. The licensee subsequently calculated the doses to the target and surrounding tissues

and does not expect any patient impact or unfavorable outcomes as a result of these events.

Cause(s) - The cause of the medical event was that the two colloidal phosphorus-32

prescriptions provided by the vendor's nuclear pharmacy were incorrectly diluted and labeled.

In addition, the licensee did not perform a verification assay of the doses before their

administration.

Actions Taken to Prevent Recurrence

Licensee - To prevent recurrence, the licensee will obtain future doses that have been

calibrated to a National Institute of Standards and Technology traceable standard. The licensee

also will perform a verification assay at its facility and will assess the dose volume for calculating

the specific activity.

State - On March 1, 2011, the Texas Department of State Health Services conducted an

inspection and reviewed the causes and the licensee's corrective actions. The licensee was

cited for a violation for failing to perform a direct measurement of the dosage taken from a bulk

quantity for medical purposes.

This event is closed for the purpose of this report.

21
ASl1-16 Medical Event at the University of California, Los Angeles in Los Angeles,

California

Criteria IIl.C.1.b and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - Aprl 4, 2011, Los Angeles, California

Nature and Probable Consequences - The University of California, Los Angeles (UCLA) (the

licensee) reported the occurrence of a medical event associated with a brachytherapy seed

implant procedure to treat prostate cancer. The patient was prescribed a dose of 144 Gy

(14,400 rad) to the prostate using 101 iodine-125 seeds. Instead, the iodine-125 seeds were

implanted inferior to the target volume (wrong treatment site), resulting in a dose to this tissue of

144 Gy (14,400 rad). The patient and referring physician were informed of this event.

On May 3, 2011, the patient returned to the UCLA Department of Radiation Oncology for a

routine postimplant CT scan to verify seed placement and final dosimetry endpoints. The

routine postimplant CT scan indicated that of the 101 total seeds implanted, approximately 72

seeds had been placed inferior to the target volume. As a result of the seed misplacements,

approximately 31 cm 3 of normal tissue inferior to the prostate received at least 144 Gy (14,400

rad) instead of the prostate tissue receiving that dose. Rectal and bladder doses were not

significantly impacted by the seed misplacements and remained within typical doses for prostate

implants. The licensee concluded that there was no harm to the patient from doses to the

nontargeted tissue.

Cause(s) - The licensee believes-reported that the cause of the medical event was movement

of the prostate gland during the implantation procedure, coupled with insufficient ultrasound

images needed to identify the movement of the prostate gland during the procedure.

Actions Taken to Prevent Recurrence

Licensee - The licensee temporarily placed the permanent prostate seed implantation program

on hold pending a review of the procedures. Upon completion of the review the licensee

changed the implant procedure to require the verification of the base prostate plane and needle

placement using both axial and sagittal plane ultrasound views. The licensee also did an

internal investigation to determine if any similar incidents of seed misplacements had occurred

in the past and reported that postimplant CT had been performed for at least the previous 5 to 6

years without the detection of any significant seed misplacement events.

State - The California Radiation Control Program investigated the event and issued violations

for failing to have adequate prostate seed implantation procedures, failing to report the medical

event within 24 hours of discovery, failing to provide a written report with all of the required

information for the medical event within 15 days, and failing to have procedures and to

adequately train staff and authorized users for reporting of medical events.

This event is closed for the purpose of this report.

24
AS11-17 Medical Event at St. Vincent Hospital in Green Bay, Wisconsin

Criteria Ill.C.1.b and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - May 15, 2011, Green Bay, Wisconsin

Nature and Probable Consequences - St. Vincent Hospital (the licensee) reported that a

medical event occurred associated with HDR brachytherapy treatment for breast cancer; the

treatment consisted of 318.2 GBq (8.6 Ci) iridium-192. The patient was prescribed to receive a

total dose of 34 Gy (3,400 rad) over 10 fractionated treatments. Instead, the patient received

8.84 Gy (884 rad) to the tumor site and a dose of 67.5 Gy (6,750 rad) to unintended skin tissue.

The patient and referring physician were informed of this event.

On June 6, 2011, the licensee determined that the applicator catheter lengths measured using

the check rulerwere incorrect during the breast cancer treatment. The licensee ascertained

that the incorrect measurement was the result of the wire being caught at the apex of the curved

catheter, approximately 4.5 cm from of the end of the catheter. Members of the licensee's staff

assumed that this measured length was accurate because they were not aware of the nominal

catheter length. The Wisconsin Department of Health Services verified that the nominal

catheter length was not provided in the manufacturer's written procedure, and the manufacturer

determined that the check wire used by the licensee met all design specifications. The licensee

concluded that there were no observed significant adverse effects to the patient, and no

long-term significant complications are expected.

Cause(s) - The cause of the medical event was human error in the failure to identify that the

check wire was not inserted to the end of the catheter's lumen and failure to identify an incorrect

measurement length.

Actions Taken to Prevent Recurrence

Licensee - Corrective actions include obtaining a new measurement wire whiGh-that has the

same flexible tip as the HDR dummy wire. The treatment protocol was changed to incorporate

the manufacturer's expected applicator treatment distances. In addition, the licensee developed

a new policy and procedure, which emphasizes the due diligence required by the staff before

the first clinical use of new HDR treatment applicators and guide tubes.

State - Based on its investigation conducted on June 14, 2011, the Wisconsin Department of

Health Services cited the licensee for failure to develop, implement, and maintain written

procedures to ensure that each administration is performed according to the provisions of the

written directive.

This event is closed for the purpose of this report.

25
damage in the reactor and the subsequent movement of that hydrogen gas from the drywell into

the secondary containment. Fukushima Dai-ichi Units 1, 2, and 3 experienced severe core

damage; the Unit 4 core had been offloaded to a spent fuel pool before the earthquake. The

source of the explosive gases causing the Unit 4 explosion remains unclear, but may have been

caused by leakage of hydrogen from unit 3. On December 16, 2011. the Japanese government

and TEPCO announced that all of the reactors had achieved a state of cold shutdown.

On March 11, 2011, the NRC fully staffed its 24-7 Operations Center with technical experts and

liaison staff, in order to evaluate potential impacts, if any, on U.S. nuclear facilities from the

tsunami, and monitor and analyze events at the nuclear plants in Japan. At the request of the

Japanese government and through the U.S. Agency for International Development, the NRC

sent a team of its technical experts to provide on-the-ground support to the Japanese

government and U.S. Ambassador. As events at the Fukushima Dai-ichi site became relatively

static over a period of time, the NRC reduced the staffing levels for the Operations Center. The

NRC continued to provide a small technical staff to the U.S. Ambassador in Japan until

February 2012., In addition, the NRC as-well-as still maintains a cadre of key technical

Gempetentstaff members at NRC Headquarters to answer requests from._ the onsfr technical

support or information about actions in response to the Japan nuclear accidentstaff (see

http://www. nrc.gov/iapan/iapan-info.html) .

In response to these events in Japan, as well as questions about the safety and survivability of

similarly designed U.S. plants, the Commission directed the Executive Director for Operations to

establish a senior-level task force to conduct both a short- and long-term analysis of the lessons

that can be learned from the situation in Japan. In addition, the NRC inspected all U.S.

commercial nuclear power plants to evaluate the industry's readiness for a similar event and to

aid in determining whether additional regulatory actions by the NRC are warranted. These

inspections were intended to be a high-level examination of the industry's preparedness for

events that may exceed the design basis of a plant. The senior-level task force reviewed the

results of these inspections.

The NRC's Japan Near-Term Task Force conducted a systematic and methodical review of

NRC processes and regulations to determine whether the agency should make additional

improvements to its regulatory system and to make recommendations to the Commission for its

policy direction, in light of the accident at the Fukushima Dai-ichi Nuclear Power Plant. In

examining the Fukushima Dai-ichi accident for insights for reactors in the United States, the

Task Force addressed protecting against accidents resulting from natural phenomena,

mitigating the consequences of such accidents, and ensuring adequate emergency

preparedness. The Task Force determined that the current re-gulatory approach, and more

importantly, the resultant plant capabilities allow them to conclude that a sequence of events

like the Fukushima accident is unlikely to occur in the United States and some appropriate

mitigation measures have been implemented, reducing the likelihood of core damage and

radiological releases. Therefore, continued operation of the operating nuclear power plants and

continued licensing activities do not pose an imminent threat to public health and safety. The

Task Force also found that the Commission's longstanding defense-in-depth philosophy,

supported and modified as necessary by state-of-the-art probabilistic risk assessment

techniques, should continue to serve as the primary organizing principle of its regulatory

framework. The result of the Task Force's work is a set of 12 recommendations that take a

balanced approach to defense-in-depth as applied to low-likelihood, high-consequence events

such as prolonged station blackout resulting from severe natural phenomena. These

recommendations, taken together, are intended to clarify and strengthen the regulatory

framework for protection against natural disasters, mitigation, and emergency preparedness,

C-2
team identified deficiencies in the licensee's flooding coping strategies for protecting areas vital

to plant safety between 1,009.5 and 1,014 feet MSL. By identifying and having the licensee

address this issue earlier and before the flooding began, the NRC enhanced the safety of the

site. At no time was the health and safety of the public compromised by the actual flooding that

occurred on and subsequent to June 26, 2011.

Other plant performance issues have been identified and are currently under evaluation by the

NRC staff. For example, on June 7, 2011, FCS experienced a fire in a safety-related breaker

and switchgear. The fire resulted in FCS declaring an Alert because the fire impacted safetyrelated equipment. These plant performance issues and their continuing review have resulted

in FCS's extended plant shutdown continuation after termination of the flooding condition.

Additionally as described in NRC letter dated December 13, 2011 (available at ADAMS

Accession No. ML1 13470721), NRC decided to transition te-FCS to oversight under inspection

manual chapter 0350, "Oversight of Reactor Facilities in a Shutdown Condition due to

Significant Performance and/or Operational Concerns."

At this time, the NRC staff continues to evaluate plant performance issues under the NRC's

Accident Sequence Precursor (ASP) Program and Significance Determination Process (SDP).

The ASP Program provides an integrated risk analysis of all deficiencies, equipment failures,

and degraded conditions that were observed during the event. The inspection program

separately assesses the risk associated with each performance deficiency. Therefore, for

events involving multiple licensee performance deficiencies and equipment failures, as in the

FCS event, it is not unexpected that the ASP and inspection programs would assign different

risk-significance levels. As such, the integrated approach used by the ASP Program

complements the inspection program.

If the NRC evaluation for the plant performance issues at FCS results in a SDP finding of high

safety significance (red finding) or if the final ASP analysis of these events results in its

identification as a significant precursor, the NRC will report this event in Section II, "Commercial

Nuclear Power Plant Licensees," of the next fiscal year's AO report and in the FY 2012

"Performance and Accountability Report to Congress."

C-5
On October 3, 2011, a public meeting was held at NAPS to discuss the preliminary results of the

AIT (available at ADAMS Accession No. ML1 1276A024). Subsequently, the NRC released the

final report of the AIT on October 31, 2011 (available at ADAMS Accession No. ML1 13040031).

The NRC and VEPCO conducted a public meeting in Mineral, Virginia on November 1, 2011,

regarding the units' restart readiness inspection findings and the NRC staff's technical review,

available at http://www.nrc.qov/about-nrc/emerg-preparedness/vir-qinia-quake-info.html. On

November 7, 2011, VEPCO submitted its plans for the seismic evaluation of future plant

modifications, including new and replacement equipment. In that letter, VEPCO committed to

include the seismic ground acceleration and derived in-structure response spectra from both the

existing design-basis earthquake and the August 23, 2011, earthquake in any future seismic

analysis to determine the maximum bounding design values for future modifications.

Additionally, VEPCO committed to including the maximum bounding design values in the NAPS

Updated Final Safety Analysis Report.

On November 11, 2011, the NRC issued its Technical Evaluation Related to Plant Restart after

the Occurrence of an Earthquake Exceeding the Level of the Operating Basis and Design Basis

Earthquakes (available at ADAMS Accession No. ML1 1308B406). In that document, the NRC

staff concluded that VEPCO had acceptably demonstrated that no functional damage occurred

to those features necessary for continued operation, and that NAPS could be operated, without

undue risk to the health and safety of the public. Also on November 11, 2011, NRC informed

VEPCO that its commitment for future plant modifications was reasonable and acceptable

(available at ADAMS Accession No. ML1 13088406) and issued VEPCO a Confirmatory Action

Letter (CAL) (ADAMS Accession No. ML11311A201), confirming VEPCO's commitments to

take long term actions in response to the August 23, 2011 earthquake. The CAL requires

VEPCO to inform the NRC when it has fulfilled its commitments and to inform the NRC if any

commitments will not be fulfilled.

NAPS Unit 1 was restarted on November 14, 2011 and restored to full power operation on

November 18, 2011. NAPS Unit 2 was restarted on November 20, 2011 and restored to full

power operation on November 25, 2011. On December 1, 2011, NRC submitted a finalized

INES rating of a below-scale event that received domestic and international attention to the

International Atomic Energy Agency. The Event Rating Form is publicly available at http://wwwnews. iaea.orq/ErfView.aspx?mld=24a1 76aa-6b4c-40ea-9262-e3927eed56db. NRC's

participation in the INES is described in Information Notice 2009-27, dated November 13, 2009

(available at ADAMS Accession No. ML092510055).

C-7
NOTATION VOTE

RESPONSE SHEET

TO:

FROM:

SUBJECT:

Annette Vietti-Cook, Secretary

Commissioner Apostolakis

SECY-1 2-0032 - REPORT TO CONGRESS ON

ABNORMAL OCCURRENCES: FISCAL YEAR 2011

Approved X Disapproved Abstain

Not Participating _

COMMENTS: Below Attached X None

SIGNAT12kE

3//&2/A

DAT=

Entered on "STARS" Yes No No

/
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) 2011, 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 (AEA) to regulate certain quantities of AEA material at facilities located 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.

Appendix A to this report presents the NRC's criteria for selecting AOs, as well as the guidelines for selecting "other events of interest." Appendix B, "Updates of Previously Reported Abnormal

Occurrences," provides updated information for one event reported in NUREG-0090 Volume 33,

"Report to Congress on Abnormal Occurrences-FY 2010," issued June 2011. The update

involves the medical event at Providence Hospital in Novi, Michigan. During FY 2011, the NRC

identified three items as meeting the guidelines for inclusion in Appendix C, "Other Events of

Interest." These three events occurred at nuclear power plants. 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 by which the NRC carries out its responsibilities is

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

(10 CFR). Stakeholders are informed and involved, to ensure _openness in the agency's.

regulatory process, consistent with the NRC's "Strategic Plan for FY 2008-2013"

(NUREG-1614, Volume.5 issued FebruaryO12).- The NRC regularly conducts licensingreviews, inspections, enforcement, investigations, operating experience evaluations, incident

response, and confirmatory research. The NRC also mai.,,tain. PF09F-,M, to octablish standardc

and4issue conducts technical reviews and studies. In addition, the NRC involves the public as

an essential element in the regulatory process.

The NRC adheres to the philosophy that the health and safety of the public are best ensured by

establishing multiple levels of protection. These levels are normally achieved and maintained

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 provide a regulatory framework to ensure compliance with the regulations. In

Deleted, , as appropriate,

Deleted: 4,

Deleted: 2008

Formatted: Strikethrough

vii
addition, the NRC is striving to make the regulatory system more risk informed and

performance-based, where appropriate.

REPORTABLE EVENTS

The NRC initially promulgated 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, used by the NRC to define AOs for the report.

Review of and responses to operating experience are essential to ensure that licensed activities

are conducted 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 industry review and evaluate operating experience to identify safety concerns.

The NRC responds to risk-significant issues through licensing reviews, inspections, and

enhancements to regulations. In addition, the agency maintains operational data in computerbased data files for more effective collection, storage, retrieval, and evaluation.

The NRC also routinely disseminates (to the public, industry, and other interested stakeholders)

publicly available information and records regarding reportable events at licensed or regulated

facilities. The agency achieves this dissemination through public announcements and special

notifications to licensees and other stakeholders. To widely disseminate information to the

public, the NRC also 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. In addition, the NRC routinely informs Congress of significant events, including AOs,

that occur at licensed or regulated facilities.

AGREEMENT STATES

Section 274 of the AEA, as amended, authorizes the Commission to enter into agreements with

States whereby the Commission relinquishes and the States assume certain regulatory

authority over byproduct, source, and special nuclear materials, States that enter into such Deleted: in quantities not sufficient to form a

agreements with the NRC are known as Agreement States. Agreement States must maintain critical mass

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 2011, there were 37 Agreement

States.

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 has also developed and implemented procedures for evaluating materials

events to identify those that should be reported as AOs. Toward that end, the NRC uniformly

applies the AO criteria (in Appendix A to this report) to events at licensees regulated by either

the NRC or the Agreement States. In addition, in early 1977, the Commission determined that

the annual report to Congress also should include events that meet the criteria for AOs at

viii
ABNORMAL OCCURRENCES IN FISCAL YEAR 2011

The following briefly explains the numbering system used in this section of the report. Appendix

A provides the specific criteria for determining when an event is an abnormal occurrence (AO)

and provides the guidelines for reporting other events of interest which may not meet the AO

criteria, but which the Commission has determined should be in this report. Appendix A

contains four major categories: I. All Licensees, II. Commercial Nuclear Power Plant Licensees,

Ill. Events at Facilities Other Than Nuclear Power Plants and All Transportation Events, and IV.

Other Events of Interest. Category IV events are discussed in Appendix C to this report, and

Categories 1, 11, and III are discussed in this section. Categories I and II contain significant

subelements labeled A, B, C, and D, and Category Ill addresses Subelement C. This section of

the report discusses only the specific subelement in Categories 1, 11, and III for which an AO was

reported. The identification number for all Agreement State AO reports starts with "AS."

Similarly, the identification number for all U.S. Nuclear Regulatory Commission (NRC) AO

reports starts with "NRC."

I. ALL LICENSEES

During this reporting period, one event at,@ NRC-regulated facilityand three events at

Agreement-State-licensed facilities were significant enough to be reported as AOs based-on-the

criteria in Appendix A to this report. Although two of these events occurred at a medical facility,

they involved unintended exposures of individuals who were not the patient. Therefore, these

events belong under the Criteria LA, "All Licensees" category, as opposed to the Criteria IlI.C,

"Medical Licensees" category.

NRCII-01 Human Exposure to Radiation at Portsmouth Naval Medical Center In

Portsmouth, Virginia

Criterion I.A.2, "Human Exposure to Radiation from Licensed Material," of Appendix A to this

report provides, in part, 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 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 - January 12, 2011, Portsmouth, Virginia

Nature and Probable Conseauences - The Department of the Navy (the licensee) reported that

a female patient at the Naval Medical Center in Portsmouth, Virginia (NMCP), received 3,630

MBq (98 mCi) of iodine-131 for thyroid ablation therapy. On the day of the treatment the patient

informed NMCP staff that she was not pregnant and NMCP staff administered a pregnancy test

as a routine precaution. The pregnancy test yielded a negative result. Based on the negative

pregnancy test results and the patient's interview responses, NMCP staff administered iodine131 to the patient.

On January 27, 2011, the patient became aware that she was pregnant and informed the

physician who had administered the treatment. An obstetrician estimated that conception had

occurred somewhere around January 7-10, 2011, and that a pregnancy test administered on

January 12, 2011, would not have been sensitive enough to produce a positive result. NMCP

estimated the dose to the embryo to be 21.3 cGy (21.3 rem) and notified the Naval Radiation

Safety Committee that the patient may have been pregnant before the therapy. NMCP staff

Deleted: NRC-licensed or

Deleted: ties

1
estimated a slight increased risk of early pregnancy failure and this was discussed with the

patient. NMCP staff subsequently refined the dose estimate to 24.7 cGy (24.7 rem). The NRC

contracted with a medical consultant who estimated a fetal/embryo dose of 27 cGy (27 rem) and

stated that embryonic tissue capable of concentrating iodine-1 31 is not formed until 10 to 12

weeks of gestation; therefore, the tissue had not yet formed at the time of the treatment. The

medical consultant concluded that there was a low possibility of carcinogenesis or malformations. The p...gna..pr.gr. ,es.d...l n b..o.th, the moethor a-nRd child. a, dp.ng

Cause(s) - The cause of this event was the close proximity of conception, which resulted in a

negative pregnancy test result, to the administration of the iodine-131.

Actions Taken to Prevent Recurrence

Licensee - NMCP revised the initial consultation procedures for the prescribing physician to

stress the importance of discussing with the patient the need for sexual abstinence at least 10

days before therapeutic dose administration.

NRC - The NRC conducted an inspection on February 2, 2011 through June 2, 2011, and there

were no violations of NRC requirements associated with this event.

This event is closed for the purpose of this report.

jFornattd: Stiikethrough

2
ASIl-01 Human Exposure to Radiation at Montefiore Medical Center in New York

City, New York

Criterion I.A.2, "Human Exposure to Radiation from Licensed Material," of Appendix A to this

report provides, in part, 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 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 - September 22, 2006 (reported on April 27, 2011), New York City, New York

Nature and Probable Consequences - Montefiore Medical Center (the licensee) reported that a

female patient received 3,519 MBq (95 mCi) of iodine-1 31 for thyroid ablation therapy. Before

the treatment, the licensee interviewed the patient and ascertained that she was not pregnant.

The licensee's staff administered a pregnancy test as a routine precaution. The pregnancy test

yielded a negative result. Based on the negative pregnancy test results and the patient's

interview responses, the licensee administered iodine-131 to the patient.

On December 22, 2006, the patient returned to the licensee for a followup visit. Following that

visit, the nuclear medicine department staff was informed by another section of the medical

center that the patient was pregnant. The licensee confirmed the pregnancy with the patient's

obstetrician/gynecologist (OB/GYN). The ultrasound performed by the patient's

obstetrician/gynecologist revealed that the patient was approximately 2-3 weeks pregnant at the

time of the iodine-1 31 treatment. The licensee estimated that the fetus received about 25 cGy

(25 rem) of radiation exposure and stated that embryonic tissue capable of concentrating iodine131 is not formed until 10 to 12 weeks of gestation; therefore, this tissue had not yet fully formed

at the time of the treatment. The patient was advised to see a genetic specialist to discuss the

possible consequences to the fetus from this exposure. Although the licensee claimed that it

had originally reported the event to the New York City Office of Radiological Health in 2006, the

office had no record of the report. The New York City Office of Radiological Health identified the

missing report in April 2011, and subsequently notified the NRC on June 15, 2011. Tha e _

licancoo moortod that tho aheid- n c.m 'arar v old. it nrAmal And moo~tina All dAVAloomontAl

Formatted: Strikethrough

A. ........ - o• ......... r. ,

Cause(s) - The cause of this event was the close proximity of conception to the iodine-1 31

treatment and a false negative result on a pregnancy test done before the administration of the

treatment.

Actions Taken to Prevent Recurrence

Licensee - The licensee's corrective actions included additions to its Safety Precaution Form

stressing the necessity of sexual abstinence before the treatment and recommending that

patients also take precautions to avoid getting pregnant for 6 months after the treatment.

State - The New York City Office of Radiological Health conducted an inspection on June 16,

2011, and determined that the licensee had followed acceptable protocols before the

administration of iodine-1 31. Consequently no civil penalties or enforcement action for this

event are warranted.

This event is closed for the purpose of this report.

3
III. EVENTS AT FACILITIES OTHER THAN NUCLEAR POWER PLANTS AND ALL

TRANSPORTATION EVENTS

During this reporting period, 3 events at NRC-licensed or NRC-regulated facilities and 16 events

at Agreement-State-licensed facilities were significant enough to be reported as AOs, based on

the criteria in Appendix A to this report.

ASI1-04 Medical Event at Western Pennsylvania Hospital in Allegheny,

Pennsylvania

Criteria Ill.C. 1.b and III.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - February 23, 2009, Allegheny, Pennsylvania

Nature and Probable Consequences - Western Pennsylvania Hospital (the licensee) reported

that a medical event occurred associated with a high-dose-rate (HDR) mammosite treatment for

breast cancer; the treatment consisted of 184.2 GBq (4.9 Ci) of iridium-192. The patient was

prescribed to receive 34 Gy (3,400 rad) in 10 fractionated doses, but instead, received a dose of

50 Gy (5,000 rad) to the skin tissue around the catheter entry point (wrong treatment site). The

patient's physicist notified the patient and the referring physician of this event.

Before starting the treatment on February 23, 2009, the operatorperformed a check to verify the

catheter length and treatment calculations. In addition, the treatment procedure required daily

CT scans to verify the treatment site. On February 27, 2009, a different therapy physicist

identified a potential error in the patient's chart and contacted the patient's physicist. On March

3, 2009, the patient's physicist checked the other therapy physicist's findings and discovered

there had been a 3 cm error in the placement of the source during treatment. This incorrect

distance resulted in the intended site receiving only 30 percent of the intended dose and the

skin tissue receiving the full dose. The patient received followup care for erythema of the skin

tissue and the licensee concluded that this medical event would not have a significant medical

effect on the patient.

Cause(s' - The medical event was caused by human error in the placement of the source

during treatment.

Actions Taken to Prevent Recurrence

Licensee - The licensee revised all mammosite policies and procedures to strengthen the

accuracy of measurement, planning, treatment, and quality control. Specifically, the licensee

modified the mammosite worksheet to add the expected catheter length beside the block where

the measured catheter length is recorded, and required that the catheter measurement wire be

kept in place during CT simulation following catheter measurement.

Comment [GAIL]. Staff please check if this was

the operator or the radiation therapist

Deleted: licensee

8
AS11-06 Medical Event at University Community Hospital in Tampa, Florida

Criteria IIl.C.l.b, IIl.C.2.a and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report

provide, in part, 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 or is delivered to the wrong

treatment site.

Date and Place- February 14, 2010, Tampa, Florida

Nature and Probable Consequences - University Community Hospital (the licensee) reported

that two patients were prescribed single-channel HDR brachytherapy treatments of 34 Gy

(3,400 rad). The actual average dose of 17 Gy (1,700 rad) to the first patient, and 26 Gy (2,600

rad) to the second patient, were delivered to the target area of the breast in which some parts of

the planned volume received greater than 700 percent (first patient) and 220 percent (second

patient) of the prescribed dose. In addition, other areas of the breast not in the target region

received up to 136 Gy (13,600 rad) in the first patient and 75 Gy (7,500 rad) in the second

patient. The maximum skin dose was calculated to be 42.5 Gy (4,250 rad) to the first patient

and 75 Gy (7,500 rad) to the second patient. The patients and their referring physicians were

informed of the events.

On February 14, 2010, the licensee notedthat -the source within the mammosite catheter was_

erroneously positioned approximately 2 to 2.5 cm away from the tumor. This was the result of

the operator entering the wrong dwell position into the planning system. The licensee

concluded that no significant adverse health effects to the patients are expected.

Cause(s) - The cause of the medical events was human error involving entering the wrong

position of the reference end of the catheter into the planning system.

Actions Taken to Prevent Recurrence

Licensee - Corrective actions included implementing various quality assurance steps to ensure

that the correct treatment calculations and data are used for future treatments. Additional

procedural guidance will be created with detailed instructions.

State-The Florida Bureau of Radiation Control initiated an inspection on February 18, 2010.

The State completed the inspection on March 1, 2010, and determined that the licensee's

corrective actions were adequate. No enforcement action was taken and the State forwarded

the final update of the event to the NRC on February 1, 2011.

This event is closed for the purpose of this report.

Deleted: that

11
ASI1-07 Medical Event at Coral Springs Clinic in Coral Springs, Florida

Criteria IIl.C. 1.b and IIl.C.2.a, "For Medical Licensees," of Appendix A to this report provide, in

part, that a medical event shall be considered for reporting as an AO if it results in a dose that is

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 - March 11, 2010, Coral Springs, Florida

Nature and Probable Conseauences - Coral Springs Clinic (the licensee) reported that a medical event occurred associated with an HDR brachytherapy treatment for basal cell

carcinoma of the ear; the treatment consisted of 210.9 GBq (5.7 Ci) of iridium-192. The patient was prescribed 14 fractionated doses of 2.5 Gy (250 rad) to the ear, but instead, the patient

received 22.5 Gy (2,250 rad) on the second fractionated treatment dose. The patient and

referring physician were informed of this event.

On March 11, 2010, the patient being treated for basal cell carcinoma of the ear was to receive

the second fractionated dose 2.5 Gy (250 rad); however, while starting the treatment the

radiation therapist accidentally pushed the incorrect button on the HDR device, which was the "auto radiography" button rather than the "treatment" button on the machine control console.

This resulted in the patient receiving approximately 9 times the intended dose for that fraction of

the treatment. Further treatments were canceled. The patient and doctor were notified of the

incident. The licensee concluded that no significant health effects to the patient are expected as

a result of this incorrect dose.

Cause(s) - The medical event was caused by human error in that the radiation therapist, failed

to push the correct button on the HDR device.

Actions Taken to Prevent Recurrence

Licensee - The licensee immediately disabled the autoradiograph function on the HDR and

other similar devices. The licensee modified its procedures to include the use of an independent mechanical timer and provided additional training to its entire clinical staff.

State - The Florida Bureau of Radiation Control initiated an inspection on April 27, 2010 and

determined that the licensee's corrective actions were adequate. No enforcement action was taken and the State forwarded the final update of the event to the NRC on October 10, 2011.

This event is closed for the purpose of this report.

I Deleted: licensee

12
AS11-08 Medical Event at Rhode Island Hospital in Providence, Rhode Island

Criteria IIl.C. 1 .b and III.C.2.b(i), "For Medical Licensees," of Appendix A to this report provide, in

part, that a medical event shall be considered for reporting as an AO if it results in a dose that is

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 uses the wrong radiopharmaceutical.

Date and Place- April 23, 2010, Providence, Rhode Island

Nature and Probable Consequences - Rhode Island Hospital (the licensee) reported that a medical event occurred during a thyroid diagnostic uptake scan. The patient was prescribed to

receive 7.4 MBq (200 JuC )-of iodine-123, but was administered 148 MBq_(_4_mCi) of iodine-1 31.

The administration resulted in a dose of approximately 3,108 cGy (3,108 rad) to the patient's

thyroid, rather than the estimated 7 cGy (7 rad) that would have resulted from the iodine-123

administration. The patient and referring physician were informed of this event.

The patient's physician handed the patient a written prescription for the iodine-1 23 scan, but the

physician's office faxed an order to the hospital for an iodine-131 scan. On April 23, 2010, the

patient presented the correct written prescription slip, for the iodine-123, to the licensee's

admitting receptionist. The receptionist refused the written prescription, because she thought

the hospital already had the correct prescription in its records. The patient was administered

the iodine-1 31, and the whole body scan was performed. The nuclear medicine technologist

noticed something was wrong based on the scan results. The impact of this event on the

patient was not reported by the licensee.

Cause(s) - The cause of this medical event was human error and failure of the licensee staff to

follow existing written procedures and protocols.

Actions Taken to Prevent Recurrence

Licensee - The licensee reviewed existing written protocols and training procedures used for

the nuclear medicine technologists. The licensee's corrective actions included modifying the

procedures and conducting refresher training for the nuclear medicine technologists. In

addition, the licensee developed a thyroid interview and patient assessment history sheet and now requires a pathology report for all thyroid cancer patients, before iodine-131 doses are administered.

State - The Rhode Island Department of Health, Radiation Control Program, conducted an

investigation of this medical event on April 30 through May 20, 2010, and issued a Notice of

Violation (NOV) to the licensee. The Rhode Island Department of Health also issued a regulatory citation regarding the licensee's failure to follow established procedures and

forwarded the final update of the event to the NRC in September 2011.

This event is closed for the purpose of this report.

- Comment [GA2]: Include microcurie in the

abbreviations section

13
ASl1-10 Medical Event at Lancaster General Hospital in Lancaster, Pennsylvania

Criteria III.C.l.b and III.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, that a medical event shall be considered for reporting as an AO if it results in a dose that

is 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 3, 2010, Lancaster, Pennsylvania

Nature and Probable Conseauences - Lancaster General Hospital (the licensee) reported that a

medical event occurred associated with an HDR brachytherapy treatment for ovarian cancer;

the treatment consisted of 310.8 GBq (8.4 Ci) iridium-192. The patient was prescribed to

receive 7.2 Gy (720 rad) in five fractionated doses, but instead during one of the fractionated

treatments received a dose of 19 Gy (1,900 rad) to the small bowel (wrong treatment site). The

patient and referring physician were informed of this event.

On June 15, 2010, before starting the second treatment, the operator/radiation therapisto0ted

that an incorrect target area had been previously entered into the HDR device for the first

treatment on June 3, 2010. The operator/radiation therapis(noted that the intended treatment

area in the written directive differed from the actual area treated by approximately 3 cm. This

error in treatment area resulted in a dose of 19 Gy (1,900 rad) to the small bowel. The licensee

concluded that the medical event would not have a significant medical effect on the patient.

Cause(s) - The medical event was caused by human error in that the licensee entered the

incorrect target area into the HDR device.

Actions Taken to Prevent Recurrence

Licensee - The licensee implemented corrective measures including procedure modifications to

discontinue using the part of the HDR software that allows for treatment offsets to occur.

State - The Pennsylvania Department of Environmental Protection investigated the incident on

June 21,2010 and determined that the licensee's corrective actions were adequate. No

enforcement action was taken and the State forwarded the final update of the event to the NRC

on November 14, 2011.

This event is closed for the purpose of this report.

Comment [.A3]: Please determine the job title

of the human that performed this action

Deleted: licensee

Comment [GA4]: Please determine the job title

of the human that performed this action

Deleted: licensee

15
NRCIl-03 Medical Event at the G.V. (Sonny) Montgomery VA Medical Center in

Jackson, Mississippi

Criteria III.C.1 .b and III.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - August 4, 2008 (reported on September 8, 2010), Jackson, Mississippi

Nature and Probable Conseauences - The U.S. Department of Veterans Affairs (the licensee)

reported that a medical event involving prostate cancer brachytherapy seed implants occurred

at the G.V. (Sonny) Montgomery VA Medical Center in Jackson, Mississippi. The patient was

prescribed to receive a total dose of 145 Gy (14,500 rad) to the prostate using 104 iodine-125

seeds. However, the seed placement resulted in an approximate dose of 233 Gy (23,300 rad)

to the patient's rectum (wrong treatment site). The patient and referring physician were

informed of this event.

In September 2010, the nedical center staff completed a folowup comprehensie external

review and reanalysis of posttreatment dose parameters for all prostate seed implants

performed at the G.V. (Sonny) Montgomery VA Medical Center for the period between February

2005 and August 2008. Upon an evaluation of the updated dose information generated by

external review, medical center staff, working with the National Health Physics Program,

discovered this event. No adverse effect to the patient is expected from the implant procedure,

and the licensee continues to monitor the progress of the patient.

Cause(s). - The cause of the medical event was an anatomical anomaly of the patient. The

patient had an unusually thin tissue layer between the prostate gland and rectum, which

resulted in a small area of the rectum receiving a higher than expected dose.

Actions Taken to Prevent Recurrence

Licensee - The U.S. Department of Veterans Affairs, working with the National Health Physics

Program and the medical center's staff, performed an initial review of all prostate brachytherapy

seed implant procedures for the period between February 2005 and August 2008. The initial

review of this program resulted in the suspension of and eventual termination of the medical

center's prostate brachytherapy implant program in August 2009. The followup comprehensive

external review and reanalysis of the program identified this event, which the medical center

reported to the licensee and the NRC.

NRC - In August 2010, the NRC issued an NOV and Proposed Imposition of Civil Penalties to

the licensee, based on the results of the initial evaluation and analysis of the licensee's prostate

brachytherapy implant program. The licensee was cited for failure to have adequate written

procedures and failure to verify that the administered doses were in accordance with written

directives. The NRC has not taken any additional actions based on the identification of this

event.

This event is closed for the purpose of this report.

Deleted: licensee

17
ASII-12 Medical Event at Cleveland Clinic Foundation in Cleveland, Ohio

Criteria IIl.C.1.b and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 26, 2010, Cleveland, Ohio

Nature and Probable Consequences - The Cleveland Clinic Foundation (the licensee) reported,

to the Ohio Department of Health (ODH) that a medical event occurred associated with a

radioembolization brachytherapy treatment for liver cancer; the treatment consisted of 3.96 GBq

(107 mCi) of yttrium-90. A postprocedure scan of the patient identified significant undesired

activity in the duodenum (wrong treatment site). The licensee estimated that approximately

0.37 GBq (10 mCi) of activity was present in the duodenum, with a dose to the duodenum of

approximately 90 Gy (9,000 rad). The patient and physician were informed of this event.

Approximately 3 weeks before the therapy, the patient was scanned for extra hepatic shunting

by injecting technetium-99m into the hepatic artery. No shunting to the duodenum was identified during this procedure. On October 26, 2010, the interventional radiologist correctly

inserted the catheter into the patient and its placement was confirmed by a second

interventional radiologist. During the radioembolization treatment, the patient complained of pain, which resulted in thernedical staff performin9 a postprocedure SPECT/CT scan of the

patient. The SPECT/CT scan identified undesired yttrium-90 activity in the duodenum. The

patient was hospitalized for observation and possible intervention as a result of the dose to the

duodenum. Some ulceration of the duodenum bulb was observed, but no evidence of

perforation or bleeding was detected. The licensee is continuing to monitor the patient for

health effects from the radiation exposure.

Cause(s) - The licenseereported that the cause of the medical event was that some collateral

blood vessels became dominant and blood was shunted through them to the duodenum, _

allowing movement of the yttrium-90 microspheres. Although the licensee has not seen this

relatively uncommon occurrence in the past 3 years, it has been noted in other treatment cases.

Deleted: licensee

Deleted: believes

Actions Taken to Prevent Recurrence

Licensee: - The licensee modified its radioembolization therapy procedure to include

posttreatment imaging of yttrium-90 distribution. This will allow the licensee to respond

appropriately in the event of a recurrence. The licensee's rate of occurrence is approximately

10 times less than is reported in medical literature; therefore, no specific action to prevent a

reoccurrence is proposed.

State: - On November 3, 2010, ODH performed an onsite investigation of the event. ODH

reviewed and approved the licensee's corrective actions and took no enforcement action.

This event is dosed for the purpose of this report.

19
ASII-16 Medical Event at the University of California, Los Angeles in Los Angeles,

California

Criteria III.C.1.b and III.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - April 4, 2011, Los Angeles, California

Nature and Probable Consequences - The University of California, Los Angeles (UCLA) (the

licensee) reported the occurrence of a medical event associated with a brachytherapy seed

implant procedure to treat prostate cancer. The patient was prescribed a dose of 144 Gy

(14,400 rad) to the prostate using 101 iodine-125 seeds. Instead, the iodine-125 seeds were

implanted inferior to the target volume (wrong treatment site), resulting in a dose to this tissue of

144 Gy (14,400 rad). The patient and referring physician were informed of this event.

On May 3, 2011, the patient returned to the UCLA Department of Radiation Oncology for a

routine postimplant CT scan to verify seed placement and final dosimetry endpoints. The

routine postimplant CT scan indicated that of the 101 total seeds implanted, approximately 72

seeds had been placed inferior to the target volume. As a result of the seed misplacements,

approximately 31 cm3 of normal tissue inferior to the prostate received at least 144 Gy (14,400

rad) instead of the prostate tissue receiving that dose. Rectal and bladder doses were not

significantly impacted by the seed misplacements and remained within typical doses for prostate

implants. The licensee concluded that there was no harm to the patient from doses to the

nontargeted tissue.

Cause(s) - The licensee jeported that the cause of the medical event was movement of the DeIeted: believes

prostate gland during the implantation procedure, coupled with insufficient ultrasound images

needed to identify the movement of the prostate gland during the procedure.

Actions Taken to Prevent Recurrence

Licensee - The licensee temporarily placed the permanent prostate seed implantation program

on hold pending a review of the procedures. Upon completion of the review the licensee

changed the implant procedure to require the verification of the base prostate plane and needle

placement using both axial and sagittal plane ultrasound views. The licensee also did an

internal investigation to determine if any similar incidents of seed misplacements had occurred

in the past and reported that postimplant CT had been performed for at least the previous 5 to 6

years without the detection of any significant seed misplacement events.

State - The California Radiation Control Program investigated the event and issued violations

for failing to have adequate prostate seed implantation procedures, failing to report the medical

event within 24 hours of discovery, failing to provide a written report with all of the required

information for the medical event within 15 days, and failing to have procedures and to

adequately train staff and authorized users for reporting of medical events.

This event is closed for the purpose of this report.

24
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. These include a group of similar events that have resulted in licensed materials

entering the public domain in an uncontrolled manner.

EOI-01 International Nuclear and Radiological Events Scale Level 7 "Major

Accident": Fukushima Dai-ichi Site (Japan) Nuclear Accident

This event is included in this report because it received significant world-wide media coverage

and was of high health and safety significance in Japan. On March 11, 2011, a magnitude 9.0

earthquake occurred at a depth of approximately 25 kilometers (15 miles), 130 kilometers (81

miles) east of Sendai and 372 kilometers (231 miles) northeast of Tokyo off the coast of Honshu

Island. This earthquake resulted in the automatic shutdown of 11 nuclear power plants at four

sites along the northeast coast of Japan (Onagawa 1, 2, and 3; Fukushima Dai-ichi 1, 2, and 3;

Fukushima Dai-ni 1, 2, 3, and 4; and Tokai 2). The earthquake precipitated a large tsunami that

is estimated to have exceeded 14 meters (45 feet) in height at the Fukushima Dai-ichi Nuclear

Power Plant site. The earthquake and tsunami produced widespread devastation across

northeastern Japan, resulting in approximately 20,000 people dead or missing, displacing tens -

of thousands of people, and significantly impacting the infrastructure and industry in the

northeastern coastal areas of Japan.

On March 12, 2011, the Nuclear and Industrial Safety Agency (NISA) of Japan provided the first

provisional rating as a Level 3 (serious incident) on the International Atomic Energy Agency's

International Nuclear and Radiological Event Scale (INES). As conditions of the multiple

reactors became known, both NISA and the Japanese Nuclear Safety Commission, in

cooperation with the Japan Atomic Energy Agency, revised their initial provisional rating based

on the radiation monitoring data and aerial dispersion analysis and, on April 12, 2011, issued

the final rating as a Level 7 (major accident) on the INES. This final INES rating considers the

events that occurred at Fukushima Dai-ichi Units 1, 2, and 3 as a single event on the INES.

NISA notes that while an INES rating of 7 is the same as the rating for the Chernobyl accident,

this is the first time INES has been used during a declared emergency, and the radioactive

materials released in this case are only about 10 percent of the estimated amount released from

the 1986 Chernobyl accident.

The Tokyo Electric Power Company and NISA reported that as a result of the earthquake, the

operating reactors at all of the operating units appeared to experience a normal reactor trip

within the capability of the design specifications of the plants. The ensuing tsunami resulted in

extensive damage to site facilities and a complete loss of alternating current electrical power at

Units 1 through 5, a condition known as "station blackout." Unit 6 retained the function of one of

its diesel generators. Despite the actions of the operators following the earthquake and

tsunami, cooling was lost to the fuel in the Unit I reactor after several hours, the Unit 2 reactor

after about 71 hours, and the Unit 3 reactor after about 36 hours, resulting in damage to the

nuclear fuel shortly after the loss of cooling. Units 1, 2, and 3 experienced explosions caused

by the buildup of hydrogen gas within primary containment, which was produced during fuel

f Deleted: many

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damage in the reactor and the subsequent movement of that hydrogen gas from the drywell into

the secondary containment. Fukushima Dai-ichi Units 1, 2, and 3 experienced severe core

damage; the Unit 4 core had been offloaded to a spent fuel pool before the earthquake. The source of the explosive gases causing the Unit 4 explosion remains unclear, but may have been

caused by leakage of hydrogen from unit 3. On December 16, 2011 the Japanese government

and TEPCO announced that all of the reactors had achieved a state of cold shutdown.

On March 11, 2011, the NRC fully staffed its 24-7 Operations Center with technical experts and

liaison staff, in order to evaluate potential impacts, if any, on U.S. nuclear facilities from the

tsunami, and monitor and analyze events at the nuclear plants in Japan. At the request of the

Japanese government and through the U.S. Agency for International Development, the NRC

sent a team of its technical experts to provide on-the-ground support to the Japanese

government and U.S. Ambassador. As events at the Fukushima Dai-ichi site became relatively

static over a period of time, the NRC reduced the staffing levels for the Operations Center. The

NRC continued to provide a small technical staff to the U.S. Ambassador in Japan until

February 2012, as well as maintaina cadre of key technical staff members at NRC

Headquarters to answer requests from the onsite technical support staff (see

htto://www.nrc.,ov/iapan/iaoan-infohtml).

In response to these events in Japan, as well as questions about the safety and survivability of

similarly designed U.S. plants, the Commission directed the Executive Director for Operations to

establish a senior-level task force to conduct both a short- and long-term analysis of the lessons

that can be learned from the situation in Japan. In addition, the NRC inspected all U.S.

commercial nuclear power plants to evaluate the industry's readiness for a similar event and to

aid in determining whether additional regulatory actions by the NRC are warranted. These

inspections were intended to be a high-level examination of the industry's preparedness for

events that may exceed the design basis of a plant. The senior-level task force reviewed the

results of these inspections.

The NRC's Japan Near-Term Task Force conducted a systematic and methodical review of

NRC processes and regulations to determine whether the agency should make additional

improvements to its regulatory system and to make recommendations to the Commission for its

policy direction, in light of the accident at the Fukushima Dai-ichi Nuclear Power Plant. In

examining the Fukushima Dai-ichi accident for insights for reactors in the United States, the

Task Force addressed protectior, against accidents resulting from natural phenomena,

mitigation of the consequences of such accidents, and/mergencyThpreparedness. Te Task

Force found that the current regulatory approach and the resultant plant capabilities let to a

conclusion that a sequence of events like the Fukushima accident is unlikely to occur in the U.S.

and some appropriate mitigation measures have been implemented, reducing the likelihood of core damage and radiological releases. Therefore, continued operation of the operating nuclear

power plants and continued licensing activities do not pose an imminent threat to public health

and safety. The Task Force found that the Commission's longstanding defense-in-depth

philosophy, supported and modified as necessary by state-of-the-art probabilistic risk

assessment techniques, should continue to serve as the primary organizing principle of its

regulatory framework. The result of the Task Force's work is a set of 12 recommendations that

take a balanced approach to defense-in-depth as applied to low-likelihood, high-consequence

events such as prolonged station blackout resulting from severe natural phenomena. These

recommendations, taken together, are intended to clarify and strengthen the regulatory

framework for protection against natural disasters, mitigation, and emergency preparedness,

and to improve the effectiveness of the NRC's programs. The Task Force concluded that the

application of the defense-in-depth philosophy can be strengthened by including explicit

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*D Deleted: eleted: ngng

Deleted: ensuring adequate

C-2
team identified deficiencies in the licensee's flooding coping strategies for protecting areas vital

to plant safety between 1,009.5 and 1,014 feet MSL. By identifying and having the licensee

address this issue earlier and before the flooding began, the NRC enhanced the safety of the

site. At no time was the health and safety of the public compromised by the actual flooding that

occurred on and subsequent to June 26, 2011.

Other plant performance issues have been identified and are currently under evaluation by the

NRC staff. For example, on June 7, 2011, FCS experienced a fire in a safety-related breaker

and switchgear. The fire resulted in FCS declaring an Alert because the fire impacted safetyelated equipnment. Theseplant performance issues and their continuing revieqwhave resulted

in FCS's extended plant shutdown continuation after termination of the flooding condition.

Additionally as described in NRC letter dated December 13, 2011 (available at ADAMS

Accession No. ML1 13470721), NRC decided to transition to FCS oversight under inspection

manual chapter 0350, "Oversight of Reactor Facilities in a Shutdown Condition due to

Significant Performance and/or Operational Concerns."

At this time, the NRC staff continues to evaluate plant performance issues under the NRC's

Accident Sequence Precursor (ASP) Program and Significance Determination Process (SDP).

The ASP Program provides an integrated risk analysis of all deficiencies, equipment failures,

and degraded conditions that were observed during the event. The inspection program

separately assesses the risk associated with each performance deficiency. Therefore, for

events involving multiple licensee performance deficiencies and equipment failures, as in the

FCS event, it is not unexpected that the ASP and inspection programs would assign different

risk-significance levels. As such, the integrated approach used by the ASP Program

complements the inspection program.

If the NRC evaluation for the plant performance issues at FCS result in a SDP finding of high

safety significance (red finding) or if the final ASP analysis of these events result in its

identification as a significant precursor, the NRC will report this event in Section II, "Commercial

Nuclear Power Plant Licensees,' of the next fiscal year's AO report and in the FY 2012

"Performance and Accountability Report to Congress."

f Deleted:

C-5
EOI-03 North Anna Power Station: Alert Due to Seismically Induced Loss of

Offsite Power with Emergency Diesel Generator Failure

On August 23, 2011, a magnitude 5.8 earthquake occurred in the United States, with its

epicenter located in Mineral, VA, at a depth of 3.7 miles and approximately 11 miles

south-southeast from the North Anna Power Station (NAPS). This event received significant

local and national media coverage and caused the NRC to increase its attention to and

oversight of a program area. Additionally, the Virginia Electric and Power Company (VEPCO)

(the licensee) maintained plant safety, and the NRC maintained oversight of licensee response.

NAPS is located on Lake Anna in Louisa, VA, and consists of two Westinghouse-designed

three-loop PWRs. VEPCO declared an Alert (the next to lowest NRC emergency classification

for plant events) at NAPS because of significant seismic activity on site with the loss of offsite

power. The NRC entered monitoring mode. The two PWRs experienced automatic reactor trips

from 100 percent power, and the facility experienced a loss of offsite power. The station's four

EDGs automatically started, loaded, and provided power to the emergency buses. While NAPS

was receiving power from the EDGs, one EDG experienced a coolant leak and was

subsequently shut down. All control rods were inserted into the core during the reactor trips,

and plant decay heat was removed via the steam dumps to the atmosphere. The station's three

remaining EDGs continued to provide power to the station's safety systems until offsite power

was restored approximately 3 hours later.

On August 24, 2011, NAPS downgraded the Alert to an NOUE based on equipment alignments

and safety equipment inspection results. Later that same day, NAPS completed walkdowns and

plant inspections and subsequently exited the NOUE. The NRC exited monitoring mode based on its understanding of the event and the licensee's priorities. The NRC's resident inspectors at

the facility observed the licensee's activities and provided firsthand information to the agency.

On August 29, 2011, the NRC dispatched a seismic expert and another structural expert to

assist the agency's resident inspectors on site. Further reviews indicated that additional

inspections were warranted, and the NRC inspection team was officially classified as an

Augmented Inspection Team (AIT).

On September 8, 2011, the licensee provided the NRC with a detailed presentation about the

event (available at ADAMS Accession No. ML1 1252A006). The licensee reported that the

operating-basis earthquake and design-basis earthquake criteria were exceeded; however, the

cumulative absolute velocity, a concept used by the Electric Power Research Institute to

address exceedance calculations for the operating-basis earthquake, indicates that significant

damage would not be expected. The licensee undertook extensive actions to inspect, evaluate,

test, and repair, if necessary, any systems, structures, or components to ensure that they were,_

capable of performing their required design-basis functions. The licensee reported that no significant equipment damage to safety-related systems (including Class I structures) had, been -

identified through site walkdowns, nor had equipment degradation been detected through plant

performance and surveillance testing following the earthquake. In addition, the Lake Anna Dam

was also inspected with no damage noted. On September 30, 2011, NRC issued Confirmatory

Action Letter (CAL) No. 2-2011-001, "Confirmatory Action Letter - North Anna Power Station

Unit Nos. 1 and 2, Commitments to Address Exceeding Design Bases Seismic Event (TAC Nos.

ME7050 and ME7051)," to VEPCO (available at ADAMS Accession No. ML1 1273A078),

confirming NAPS' commitment that, Units 1 and 2,,would not enter Modes 1-4 (as defined in the

facility technical specifications), until the Commissionhd completed r its review of the request

for restart, performed confirmatory inspections, and completed its safety evaluation review.

j Deleted: are

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C-6
Commissioner Apostolakis' edits SECY-1 2-0032

The Honorable John Boehner

Speaker of the United States

House of Representatives

Washington, DC 20515

Dear Mr. Speaker:

On behalf of the U.S. Nuclear Regulatory Commission (NRC), I am forwarding the enclosed

"Report to Congress on Abnormal Occurrences: Fiscal Year (FY) 2011." This submission is in

accordance with Section 208 of the Energy Reorganization Act of 1974 (Public Law 93-438) and

the Federal Reports Elimination and Sunset Act of 1995 (Public Law 104-66), which require the

NRC to identify and report abnormal occurrences (AOs) to Congress on an annual basis. An

AO is an unscheduled incident or event that the Commission determines to be significant from

the standpoint of public health or safety.

The NIRC iiilyPFrmuigatod tho AQ critoria ina peorgy~ Statement that tho Comm~ission

published in the Federal Reqstaon Fcbrwairy 24, 1977, followed by sovoral Feiiasi

subsequent years. The- MoGt recAn8t rc':isiAo to thA AO criteria, publishod in the F;odarp

RoeiSteFR on Otobe 12. 2006. cc-tablichcd- the crFitofi-a that the ANRC 1669- to- dofinoA AQ for tho

purpoSSef ohe me ncioed Fepo~t, asA sot roan in A ppendix A to that FoP9ot.

The enclosed AO report for FY 2011 describes 5 events at NRC-regulatedacilities and 19

events at Agreement-State-licensed facilities. The first event at an NRC-licensed facility --

involved radiation exposure to an embryo/fetus, and the second involved an incident of high

safety significance at a commercial nuclear power plant. The other three NRC-licensed events were medical events as defined in NRC regulations. The first Agreement-State-licensed event

involved radiation exposure to an embryo/fetus, the second event involved an exposure to the

extremities of a radiographer, and the third event involved a stolen radiography camera. The

other 16 Agreement-State-licensed events were medical events as defined in NRC regulations.

Additionally three events occurred at nuclear power plants that are not AOs but have received

significant attention by Congress or the public, these events can be found in an Appendix C to

the AO report

Deleted: licnsed

Deleted:

Sincerely,

Gregory B. Jaczko

Enclosure:

As stated
TO:

FROM:

SUBJECT:

NOTATION VOTE

RESPONSE SHEET

Annette Vietti-Cook, Secretary

COMMISSIONER MAGWOOD

SECY-12-0032 - REPORT TO CONGRESS ON

ABNORMAL OCCURRENCES: FISCAL YEAR 2011

Approved E

Not Participating

COMMENTS: Below

)isapproved Abstain

Attached _X None

SIGNATURE

DATE

Entered on "STARS" Yes _ No
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) 2011, 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 (AEA) to regulate certain quantities of AEA material at facilities located 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.

Appendix A to this report presents the NRC's criteria for selecting AOs, as well as the guidelines

for selecting "other events of interest." Appendix B, "Updates of Previously Reported Abnormal

Occurrences," provides updated information for one event reported in NUREG-0090 Volume 33,

"Report to Congress on Abnormal Occurrences-FY 2010," issued June 2011. The update

involves the medical event at Providence Hospital in Novi, Michigan. During FY 2011, the NRC

identified three items as meeting the guidelines for inclusion in Appendix C, "Other Events of

Interest." These three events occurred at nuclear power plants. 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 by which the NRC carries out its responsibilities is

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

(10 CFR). Stakeholders are informed and involved, " ...... e...-,e to ensure openness in the

agency's regulatory process, consistent with the NRC's "Strategic Plan for FY 2008-2013"

(NUREG-1614, Volume 4 5, issued February 2008 2012). The NRC regularly conducts

licensing reviews, inspections, enforcement, investigations, operating experience evaluations,

incident response, and confirmatory research. The NRC also maintains programs to establish

standards and issue technical reviews and studies. In addition, the NRC involves the public as

an essential element in the regulatory process.

The NRC adheres to the philosophy that the health and safety of the public are best ensured by

establishing multiple levels of protection. These levels are normally achieved and maintained

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 provide a regulatory framework to ensure compliance with the regulations. In

vii
estimated a slight increased risk of early pregnancy failure and this was discussed with the

patient. NMCP staff subsequently refined the dose estimate to 24.7 cGy (24.7 rem). The NRC

contracted with a medical consultant who estimated a fetal/embryo dose of 27 cGy (27 rem) and

stated that embryonic tissue capable of concentrating iodine-131 is not formed until 10 to 12

weeks of gestation; therefore, the tissue had not yet formed at the time of the treatment. The

medical consultant concluded that there was a low possibility of carcinogenesis or

malformations. The pregnar, ......... " ... a ,t b' ,,d the ÷h,•, ." de4Rg

Cause(s) - The cause of this event was the close proximity of conception, which resulted in a

negative pregnancy test result, to the administration of the iodine-1 31.

Actions Taken to Prevent Recurrence

Licensee - NMCP revised the initial consultation procedures for the prescribing physician to

stress the importance of discussing with the patient the need for sexual abstinence at least 10

days before therapeutic dose administration.

NRC - The NRC conducted an inspection on February 2, 2011 through June 2, 2011, and there

were no violations of NRC requirements associated with this event.

This event is closed for the purpose of this report.

2
ASl 1-01 Human Exposure to Radiation at Montefiore Medical Center in New York

City, New York

Criterion I.A.2, "Human Exposure to Radiation from Licensed Material," of Appendix A to this

report provides, in part, 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 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 - September 22, 2006 (reported on April 27, 2011), New York City, New York

Nature and Probable Consequences - Montefiore Medical Center (the licensee) reported that a

female patient received 3,519 MBq (95 mCi) of iodine-131 for thyroid ablation therapy. Before

the treatment, the licensee interviewed the patient and ascertained that she was not pregnant.

The licensee's staff administered a pregnancy test as a routine precaution. The pregnancy test

yielded a negative result. Based on the negative pregnancy test results and the patient's

interview responses, the licensee administered iodine-131 to the patient.

On December 22, 2006, the patient returned to the licensee for a followup visit. Following that

visit, the nuclear medicine department staff was informed by another section of the medical

center that the patient was pregnant. The licensee confirmed the pregnancy with the patient's

obstetrician/gynecologist (OB/GYN). The ultrasound performed by the patient's

obstetrician/gynecologist revealed that the patient was approximately 2-3 weeks pregnant at the

time of the iodine-1 31 treatment. The licensee estimated that the fetus received about 25 cGy

(25 rem) of radiation exposure and stated that embryonic tissue capable of concentrating iodine131 is not formed until 10 to 12 weeks of gestation; therefore, this tissue had not yet fully formed

at the time of the treatment. The patient was advised to see a genetio specialist to discuss the

possible consequences to the fetus from this exposure. Although the licensee claimed that it

had originally reported the event to the New York City Office of Radiological Health in 2006, the

office had no record of the report. The New York City Office of Radiological Health identified the

missing report in April 2011, and subsequently notified the NRC on June 15, 2011. The

lircensee reported that thc child, noW 5 yearseold, is normal and mneeting all developmental

molesternes.

Cause(sj - The cause of this event was the close proximity of conception to the iodine-131

treatment and a false negative result on a pregnancy test done before the administration of the

treatment.

Actions Taken to Prevent Recurrence

Licensee - The licensee's corrective actions included additions to its Safety Precaution Form

stressing the necessity of sexual abstinence before the treatment and recommending that

patients also take precautions to avoid getting pregnant for 6 months after the treatment.

State - The New York City Office of Radiological Health conducted an inspection on June 16,

2011, and determined that the licensee had followed acceptable protocols before the

administration of iodine-1 31. Consequently no civil penalties or enforcement action for this

event are warranted.

This event is closed for the purpose of this report.

3
AS1 1-07 Medical Event at Coral Springs Clinic in Coral Springs, Florida

Criteria II1.C.1.b and IIl.C.2.a, "For Medical Licensees," of Appendix A to this report provide, in

part, that a medical event shall be considered for reporting as an AO if it results in a dose that is

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 - March 11, 2010, Coral Springs, Florida

Nature and Probable Consequences - Coral Springs Clinic (the licensee) reported that a

medical event occurred associated with an HDR brachytherapy treatment for basal cell

carcinoma of the ear; the treatment consisted of 210.9 GBq (5.7 Ci) of iridium-192. The patient

was prescribed 14 fractionated doses of 2.5 Gy (250 rad) to the ear, but instead, the patient

received 22.5 Gy (2,250 rad) on the second fractionated treatment dose. The patient and

referring physician were informed of this event.

On March 11, 2010, the patient being treated for basal cell carcinoma of the ear was to receive

the second fractionated dose 2.5 Gy (250 rad); however, while starting the treatment the

radiation therapist accidentally pushed the incorrect button on the HDR device, which was the

"auto radiography" button rather than the "treatment" button on the machine control console.

This resulted in the patient receiving approximately 9 times the intended dose for that fraction of

the treatment. Further treatments were canceled. The patient and doctor were notified of the

incident. The licensee concluded that no significant health effects to the patient are expected as

a result of this incorrect dose.

Cause(s) - The medical event was caused by human error in that the liGensee radiation

therapist failed to push the correct button on the HDR device.

Actions Taken to Prevent Recurrence

Licensee - The licensee immediately disabled the autoradiograph function on the HDR and

other similar devices. The licensee modified its procedures to include the use of an

independent mechanical timer and provided additional training to its entire clinical staff.

State - The Florida Bureau of Radiation Control initiated an inspection on April 27, 2010 and

determined that the licensee's corrective actions were adequate. No enforcement action was

taken and the State forwarded the final update of the event to the NRC on October 10, 2011.

This event is closed for the purpose of this report.

12
AS1 1-12 Medical Event at Cleveland Clinic Foundation in Cleveland, Ohio

Criteria II1.C.1.b and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 26, 2010, Cleveland, Ohio

Nature and Probable Consequences - The Cleveland Clinic Foundation (the licensee) reported,

to the Ohio Department of Health (ODH) that a medical event occurred associated with a

radioembolization brachytherapy treatment for liver cancer; the treatment consisted of 3.96 GBq

(107 mCi) of yttrium-90. A postprocedure scan of the patient identified significant undesired

activity in the duodenum (wrong treatment site). The licensee estimated that approximately

0.37 GBq (10 mCi) of activity was present in the duodenum, with a dose to the duodenum of

approximately 90 Gy (9,000 rad). The patient and physician were informed of this event.

Approximately 3 weeks before the therapy, the patient was scanned for extra hepatic shunting

by injecting technetium-99m into the hepatic artery. No shunting to the duodenum was

identified during this procedure. On October 26, 2010, the interventional radiologist correctly

inserted the catheter into the patient and its placement was confirmed by a second

interventional radiologist. During the radioembolization treatment, the patient complained of

pain, which resulted in the li•eeee medical staff performing a postprocedure SPECT/CT scan

of the patient. The SPECT/CT scan identified undesired yttrium-90 activity in the duodenum.

The patient was hospitalized for observation and possible intervention as a result of the dose to

the duodenum. Some ulceration of the duodenum bulb was observed, but no evidence of

perforation or bleeding was detected. The licensee is continuing to monitor the patient for

health effects from the radiation exposure.

Cause(s) - The licensee believes reported that the cause of the medical event was that some

collateral blood vessels became dominant and blood was shunted through them to the

duodenum, allowing movement of the yttrium-90 microspheres. Although the licensee has not

seen this relatively uncommon occurrence in the past 3 years, it has been noted in other

treatment cases.

Actions Taken to Prevent Recurrence

Licensee: - The licensee modified its radioembolization therapy procedure to include

posttreatment imaging of yttrium-90 distribution. This will allow the licensee to respond

appropriately in the event of a recurrence. The licensee's rate of occurrence is approximately

10 times less than is reported in medical literature; therefore, no specific action to prevent a

reoccurrence is proposed.

State: - On November 3, 2010, ODH performed an onsite investigation of the event. ODH

reviewed and approved the licensee's corrective actions and took no enforcement action.

This event is closed for the purpose of this report.

19
ASII-16 Medical Event at the University of California, Los Angeles in Los Angeles,

California

Criteria III.C.1.b and III.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - April 4, 2011, Los Angeles, California

Nature and Probable Consequences - The University of California, Los Angeles (UCLA) (the

licensee) reported the occurrence of a medical event associated with a brachytherapy seed

implant procedure to treat prostate cancer. The patient was prescribed a dose of 144 Gy

(14,400 rad) to the prostate using 101 iodine-1 25 seeds. Instead, the iodine-125 seeds were

implanted inferior to the target volume (wrong treatment site), resulting in a dose to this tissue of

144 Gy (14,400 rad). The patient and referring physician were informed of this event.

On May 3, 2011, the patient returned to the UCLA Department of Radiation Oncology for a

routine postimplant CT scan to verify seed placement and final dosimetry endpoints. The

routine postimplant CT scan indicated that of the 101 total seeds implanted, approximately 72

seeds had been placed inferior to the target volume. As a result of the seed misplacements,

approximately 31 cm 3 of normal tissue inferior to the prostate received at least 144 Gy (14,400

rad) instead of the prostate tissue receiving that dose. Rectal and bladder doses were not

significantly impacted by the seed misplacements and remained within typical doses for prostate

implants. The licensee concluded that there was no harm to the patient from doses to the

nontargeted tissue.

Cause(s) - The licensee believes reportedthat the cause of the medical event was movement of

the prostate gland during the implantation procedure, coupled with insufficient ultrasound

images needed to identify the movement of the prostate gland during the procedure.

Actions Taken to Prevent Recurrence

Licensee - The licensee temporarily placed the permanent prostate seed implantation program

on hold pending a review of the procedures. Upon completion of the review the licensee

changed the implant procedure to require the verification of the base prostate plane and needle

placement using both axial and sagittal plane ultrasound views. The licensee also did an

internal investigation to determine if any similar incidents of seed misplacements had occurred

in the past and reported that postimplant CT had been performed for at least the previous 5 to 6

years without the detection of any significant seed misplacement events.

State - The California Radiation Control Program investigated the event and issued violations

for failing to have adequate prostate seed implantation procedures, failing to report the medical

event within 24 hours of discovery, failing to provide a written report with all of the required

information for the medical event within 15 days, and failing to have procedures and to

adequately train staff and authorized users for reporting of medical events.

This event is closed for the purpose of this report.

24
damage in the reactor and the subsequent movement of that hydrogen gas from the drywell into

the secondary containment. Fukushima Dai-ichi Units 1, 2, and 3 experienced severe core

damage; the Unit 4 core had been offloaded to a spent fuel pool before the earthquake. The

source of the explosive gases causing the Unit 4 explosion remains unclear, but may have been

caused by leakage of hydrogen from unit 3. On December 16, 2011 the Japanese government

and TEPCO announced that all of the reactors had achieved a state of cold shutdown.

On March 11, 2011, the NRC fully staffed its 24-7 Operations Center with technical experts and

liaison staff, in order to evaluate potential impacts, if any, on U.S. nuclear facilities from the

tsunami, and monitor and analyze events at the nuclear plants in Japan. At the request of the

Japanese government and through the U.S. Agency for International Development, the NRC

sent a team of its technical experts to provide on-the-ground support to the Japanese

government and U.S. Ambassador. As events at the Fukushima Dai-ichi site became relatively static over a period of time, the NRC reduced the staffing levels for the Operations Center. The

NRC continued to provide a small technical staff to the U.S. Ambassador in Japan until

February 2012, as well as maintains a cadre of key technical Ge•,petent-staff members at NRC

Headquarters to answer requests from the onsite technical support staff (see

http://www. nrc.gov/iapan/*apan-info. html).

Following the nuclear accident at Fukushima, the NRC chartered a Near-Term Task Force

(NTTF) to review insights from the event and provide recommendations for enhancing reactor

safety in the United States. On July 12, 2011, the NTTF issued its report, entitled, "Near-Term

Report and Recommendations for Agency Actions Following the Events in Japan." This report

is available in the NRC's Agencywide Documents Access and Management System (ADAMS)

at Accession No. ML1 11 86A950. The NTTF concluded that continued U.S. plant operation and

NRC licensing activities present no imminent risk to public health and safety. While the NTTF

also concluded that the current regulatory system has served the Commission and the public well, it found that enhancements to safety and emergency preparedness are warranted and

made a dozen general recommendations for Commission consideration.

On October 3, 2011, the NRC staff proposed to the Commission a three-tiered prioritization of

the NTTF recommendations (ADAMS Accession No. ML1 1272A1 11). The Tier 1

recommendations are those actions that should be implemented without unnecessary delay.

The Tier 2 recommendations are those actions that need further technical assessment or critical

skill sets to implement. The Tier 3 recommendations are longer-term actions that depend on

the completion of a shorter-term action or need additional study to support a regulatory action.

On December 15, 2011, the Commission approved the staff's recommended prioritization

(ADAMS Accession No. ML1 13490055).

The Conference Report on the Fiscal Year (FY) 2012 Energy and Water Development

Appropriations Act (P.L. 112-74), signed by the President on December 23, 2011, states in part:

The conferees recognize the progress that the Nuclear Regulatory Commission

has made on the recommendations of the Near Term Task Force. Commission

staff has proposed a prioritized list of the Task Force recommendations that

reflects the order regulatory actions are to be taken. The conferees direct the

Commission to implement these recommendations consistent with, or more

expeditiously than, the "schedules and milestones" proposed by NRC staff on

October 3, 2011.

In response to the conferees' request and the input it received from stakeholders, the NRC

C-2
accelerated the schedule originally proposed in its October 3, 2011, paper. On February 17,

2012, the NRC staff proposed orders and a request for information to the Commission in

SECY-12-0025, "Proposed Orders and Requests for Information in Response to Lessons

Learned From Japan's March 11, 2011, Great T6hoku Earthquake and Tsunami" (ADAMS

Accession No. ML12039A103). SECY-12-0025 also discussed the disposition of

recommendations from the Commission's Advisory Committee on Reactor Safeguards (ACRS),

as well as six additional recommendations identified after the NTTF report was issued, that the

NRC staff has determined may also warrant additional action.

On March 12, 2012, the NRC issued three immediately effective orders and the request for

information. These regulatory actions are discussed in more specific detail in the following

section.

To ensure the NRC made well-informed decisions on the Tier 1 regulatory actions, the NRC

staff conducted over a dozen public meetings with stakeholders to better understand the

public's point of view, as well as the industry's views on the NRC's proposed actions. The staff

also established an e-mail box so that members of the public could send input on the NRC's

resolution of the Tier 1 recommendations. The NRC staff considered this input when

developing the orders and request for information.

By letter dated December 16, 2011 (ADAMS Accession No. ML1 1353A008), the Nuclear

Energy Institute, the policy organization for the nuclear industry, presented its plans to respond

to Fukushima-like events. The industry developed a concept of a diverse and flexible mitigation

capability called "FLEX." The NRC staff has considered this industry approach and is generally

encouraged by the actions the industry is taking in this area. The NRC staff envisions that

many elements of FLEX may satisfy the requirements of the order to mitigate challenges to key

safety functions resulting from beyond-design-basis natural phenomena hazards.

On March 12, 2012, the NRC issued three immediately effective orders. The first two orders

were issued to all power reactor licensees, including holders of construction permits and

combined licenses. The third order was issued to licensees operating boiling water reactors

(BWRs) with Mark I and Mark II containment designs. The following is a summary of each of

the orders:

1. Licensees are ordered to develop strategies to mitigate the effects of

beyond-design-basis natural phenomena that address both multiunit events and

reasonable protection of equipment identified to implement such strategies.

This order requires development of strategies to deal with beyond-design-basis

external events resulting in simultaneous loss of all alternating current (ac) power

and loss of normal access to the ultimate heat sink. The strategies and guidance

developed and implemented by licensees in response to the requirements imposed

by this order will provide the necessary capabilities to supplement those of the

permanently installed plant structures, systems, and components that could be

unavailable following beyond-design-basis external events. These strategies and

guidance will enhance the safety and preparedness capabilities established following

the events of September 11, 2001, and codified in Title 10 of the Code of Federal

Regulations (10 CFR) 50.54(hh)(2). To address the potential for more widespread

effects of beyond-design-basis external events, this order requires licensees to have

increased capabilities to implement multiple strategies concurrently at multiple units

on a site. The strategies shall be developed to add multiple ways to maintain or

C-3
restore core cooling, containment and spent fuel pool (SFP) cooling capabilities in

order to improve the defense in depth of licensed nuclear power reactors. The order

also requires that the equipment needed to implement the strategies be reasonably

protected.

2. Licensees are ordered to install enhanced SFP instrumentation.

This order requires enhanced, reliable SFP instrumentation. During the events at

Fukushima, responders were without reliable instrumentation to determine the water

level in the SFP. This caused concerns that the pool may have boiled dry, resulting

in fuel damage, but in fact the spent fuel had remained covered at all times.

Fukushima demonstrated that confusion and misapplication of resources may result

from beyond-design-basis external events when adequate instrumentation is not

available. The instrumentation installed at U.S. nuclear power plants is typically only

for a narrow range of SFP level and, therefore, only capable of monitoring normal

and slightly off-normal conditions in the pool. Although the likelihood of a

catastrophic event affecting U.S. nuclear power plants and their associated SFPs

remains very low, beyond-design-basis external events could challenge the ability of

existing SFP instrumentation to provide emergency responders with reliable

information on the condition of SFPs. Reliable and available indication is essential to

ensure that plant personnel can effectively prioritize emergency actions.

3. Licensees with BWR Mark I and Mark II containments are ordered to have reliable,

hardened vents.

This order requires reliable, hardened vents in BWR Mark I and Mark II

containments. At Fukushima, limitations in time and the unpredictable conditions

associated with the accident significantly challenged the attempts by responders to

preclude core damage and containment failure. In particular, the operators were

unable to successfully operate the containment venting system. The inability to

reduce containment pressure inhibited efforts to cool the reactor core. Had

additional backup or alternate sources of power been available to operate the

containment venting system remotely, or had certain valves been more accessible to

allow manual operation, the operators at Fukushima might have been able to

depressurize the containment earlier. This, in turn, could have allowed operators to

implement strategies using low-pressure water sources. Thus, the events at

Fukushima demonstrate that reliable hardened vents at BWR facilities with Mark I

and Mark II containment designs are important to maintain core and containment

cooling.

The NRC has concluded that the orders on mitigation strategies and reliable, hardened vents

are necessary to ensure adequate protection of public health and safety under the provisions of

the backfit rule, 10 CFR 50.109(a)(4)(ii). The NRC has concluded that the order on SFP

instrumentation represents a significant enhancement to the protection of public health and

safety and is an appropriate response to the insights from the Fukushima Dai-ichi accident. The

NRC believes that continued operation under existing regulations does not pose an imminent

threat to public health and safety but that the events at Fukushima highlighted the need for

these additional capabilities to mitigate the effects of beyond-design-basis external events.

The NRC plans to prepare guidance for implementation of the technical requirements of the

orders by August 2012. Licensees will then be required, by February 28, 2013, to submit to the

C-4
Commission an integrated plan, including a description of how compliance with the orders will

be achieved. After reviewing the licensee submittals, the NRC plans to issue facility-specific

orders, as necessary, imposing license conditions that address the requirements of the orders.

Each licensee will be required to achieve full compliance within two refueling outages after

submittal of its integrated plan, or by December 31, 2016, whichever comes first.

On March 12, 2012, the NRC issued a request for information to power reactor licensees

pursuant to 10 CFR 50.54(f), which requires a written response. The request for information

asked licensees to do the following:

" Reevaluate seismic and flooding hazards at each site using present-day information,

guidance, and methodologies.

" Perform seismic and flooding walkdowns to identify and address plant-specific

degraded, nonconforming, or unanalyzed conditions.

* Assess current communication systems and equipment under conditions of onsite and

offsite damage and prolonged station blackout (SBO).

" Perform a staffing study to determine the number and qualifications of staff required to

fill all necessary positions to respond to a multiunit event.

Protection from natural phenomena is critical for continued safe operation of nuclear power

plants. Given that new information has been developed on natural phenomena hazards since

the licensing basis of currently operating plants was established, the NRC found it necessary to

confirm the adequacy of the hazard assumptions for U.S. plants, and their ability to protect

against them. These hazards include earthquakes, local intense precipitation, floods of streams

and rivers, storm surges, seiches, tsunamis, and dam failures. Further, the NRC found that the

accident at Fukushima highlighted a need to verify the adequacy of emergency planning,

including communications infrastructure and staffing levels of response personnel, to address a

prolonged SBO and multiunit event.

The NRC will evaluate each licensee's response to the request for information and take

additional regulatory action, if necessary.

The NRC staff's October 3, 2011, paper included two Tier 1 recommendations that were not

addressed by the orders or request for information. One was a recommendation to enhance

SBO mitigation capability, and the other was to strengthen and integrate onsite emergency

response procedures, training, and exercises. Both of these recommendations remain Tier 1

priority issues and are being actively implemented through the NRC's rulemaking process. The

NRC expects to complete the SBO rule in 2014 and the emergency response enhancements

rule in 2016. The NRC will publish an advance notice of its proposed rulemaking on SBO in

March 2012.

The Conference Report on the Consolidated Appropriations Act, 2012 (P.L. 112-74), stated in

part:

The conferees direct the Commission to maintain an implementation schedule

such that the remaining recommendations (not identified as Tier I priorities) will

be evaluated and acted upon as expeditiously as practicable.

C-5
The NRC will address Tier 2 recommendations consistent with the milestone schedule set forth

in its October 3, 2011, paper. The NRC staff is developing a Commission paper, currently

scheduled for July 2012, where it will propose schedules and milestones for Tier 3

recommendations. Furthermore, the NRC has established a process to assess additional

issues as they are identified, applying the same three-tiered prioritization process used for the

NTTF recommendations. In its October 3, 2011, paper, the NRC staff identified six additional

issues with a clear connection to the Fukushima event that may warrant regulatory action but

were not included with the original NTTF recommendations. The detailed assessment can be

found in Enclosure 2 to SECY-12-0025 (ADAMS Accession No. ML12039A118).

In accordance with Section 402 of the Consolidated Appropriations Act, 2012, the NRC will also

consider external natural phenomena hazards. The request for information issued on March 12,

2012, addresses seismic, tsunami, and flooding hazards, which the NRC believes will

encompass the dominant, albeit low, risks to operating plants. The NRC intends to address

other external hazards, such as wind and missile loads from tornadoes and hurricanes, and

snow and ice loads from winter weather, as a Tier 2 activity that will be initiated as soon as

sufficient resources become available.

On October 13, 2011, and on November 8, 2011, the ACRS provided recommendations to the

Commission based on its review of the NRC staffs priortization of the NTTF recommendations

(ADAMS Accession Nos. ML1 1284A136 and ML1 131 1A264, respectively). The NRC staff s

evaluation of the ACRS recommendations can be found in Enclosure 3 to SECY-1 2-0025

(ADAMS Accession No. ML12039A121). By letter dated February 15, 2012, the ACRS provided

a third letter (ADAMS Accession No. ML12046A145).

The NRC staff continues to evaluate ongoing stakeholder recommendations, and it plans to

make the results available on the NRC's public website.

in response to those events in japan, as well as questions about the safety and GUr~iVability of

siMilarly designed U.S. plants, the Commmission di-rectd the Executive Director forOperations to

establish a senior leyel tack force to conduc bo hth a Short and long termA analysis of the lessons

that c-an bhe learned fromn the situation in~ japan. In; addition, the NRC inspected all UJ.S-.

commercia nuclear power plants to evaluate the inductrc readinesrs foria similar event an~d to

aid in detemining whether additional rogulator,' actions by the NRC are Warranted. These

inspections Wore intended to be a high level ex~amination of the industir,"s preparedness for

events that may exceeed the design basis of a plant. The ecRnir. level tack force reviewed the

results of there inspectio.

The NRC's Japan Near TcA-M T_ ackForce comned-uted a system-atic and- methodical reyfiew of

NRC processes6 and- regulatiene to determ~ine whether the agency sho-uld- make additionial

impovmets to itc regulator,' system and to make reco-emmendationc to the Commission69- fo-r its

policy direction, in light of the acietat the Fukushima Daio ichi NucleG-19ar Powcr Plant. In

examningthe Fukuchima Dai ichi accOident for inSights for reactFSorin the United States, the

Ta- ForcVe ad~dffesed protec~ting protection agafinct acc~idents resulting from natura

phenomena, mitigation of the consequences of such accaidents, and ensuring adequat

emercgency preparadness. The Task Force foun-,Fd that the current rogU~atGr; approach and the

resultant plant capab:!:ties led to a Genclusion that a sequence of events like the Fukushima

C-6
acient is unlikely to occur in the U.S. an~d som prpiate mitigation moauentcmt haye been

implemented redUcing the likelihood of corme ddamageadrdooi eoaces. T-herefore,

continued operation of the operating nuclear power plante and continued 1-Gensing activitiec, do

not pace an imminent threat to public- health and safety. The Task Force found that the

rCom.m.iscc-ion's longstadg deene in depth philocophy, cupportod and moedified as n~ececcar; by state of the art probabilictic Fisk assessmtent technigues, should continue to sew.e as the

primr; oganizing principle of its regulator; framnework. The recult of the Task Frme's work i

ct ra of 12 rocommoandations that take a balanced approach to defense in depth as applied to

low likelihood, high consoguence eyonte cuch as prolonged station blackout reculting from

ceyore natural phenomena. These Frveommendations, taken together, are intended to clarify and strengthon the regulator; framnework for protoction against n~atural dicactere, mitigation,an em~ergencGy preparednece, and to imAprove the effectivonesec of the- NIRC'c prOgrame. The Tack

ForcoP- concluded that the application of the defense in depth philocophy can be streRgthened by including explicit regufiFromontc for beyond design basis events. The Tack Force com~pleted its

repo..... toth Cmicin, SECY 11 0093, "The Near T-erm Tac~k Force ReViewF Of Ineighte from

the Fkuchima W Dai ichi Accident," on July 12, 201 o oedetailp on the Tack or=e'

report, cs te NR eb page "Rcmedtoeof the akFre," maa available at

On October 3, 2011, the NRC Staff propoced to the Comm'cio roMmeRd-atiaene for the

PrGiortiZatiGR of the japan Near TermA Tack For~e recommend-ations in SECY 11 0)137,_

"Prieritization of Recomme~nded Antione to be T~aken in Recponse to Fukuchima Lessens

Learned," _availamble a-t-httlD:!!#"A. nrc..aov/iaoaniiaoan; activitiec. html. The Comm~w.iccio

approved the staffsc propoced piOritizAainof the japan Near TermA Tack Forc~e

r~ecemmenda.tione Ac eadi the Stf egieeneMmoandum (SRM) to SECY 11

013, Stff Reguirements SECY 11 013:7 PF*8Ort;Zat*on of Recommended Actione to be T-aken in Roeponce to Fu kiuchomI maLcona Lewarned," datedDcme 5 01,aalbea

h#P;:WWW.RF.ne~pviaFpani;aiqaR act*ivitiec. htmlAditinly the NRC maintains a publi webpage providing updated details related to the japan oarthguakeftcunami reactor events

avaiablt:hUD/!W.nRcG.povaiqaRpanvap nfhtl

C-7
NOTATION VOTE

RESPONSE SHEET

TO: Annette Vietti-Cook, Secretary

FROM: COMMISSIONER OSTENDORFF

SUBJECT: SECY-1 2-0032 - REPORT TO CONGRESS ON

ABNORMAL OCCURRENCES: FISCAL YEAR 2011

Approved X Disapproved Abstain

Not Participating _

COMMENTS: Below X Attached X None

I approve submitting to Congress the "Report to Congress on Abnormal Occurrences:

Fiscal Year 2011" subject to the attached edits. I also support the edits of Commissioner

Apostolakis and Commissioner Svinicki except as indicated by the attached edits.

SIGNATURE

DATE

Entered on "STARS" Yes X No
addition, the NRC is striving to make the regulatory system more risk informed and

performance-based, where appropriate.

REPORTABLE EVENTS

The NRC initially promulgated 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, used by the NRC to define AOs for the report.

Review of and responses to operating experience are essential to ensure that licensed activities

are conducted 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 industry review and evaluate operating experience to identify safety concerns.

The NRC responds to risk-significant issues through licensing reviews, inspections, and

enhancements to regulations. In addition, the agency maintains operational data in computerbased data files for more effective collection, storage, retrieval, and evaluation.

The NRC also routinely disseminates (to the public, industry, and other interested stakeholders)

publicly available information and records regarding reportable events at licensed or regulated

facilities. The agency achieves this dissemination through public announcements and special

notifications to licensees and other stakeholders. To widely disseminate information to the

public, the NRC also 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. In addition, the NRC routinely informs Congress of significant events, including AOs,

that occur at licensed or regulated facilities.

AGREEMENT STATES

Section 274 of the AEA, as amended, authorizes the Commission to enter into agreements with

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

byproduct, source, and certain quantities of special nuclear materials in quantities not sufficient

to form a critical mass. States that enter into such agreements with the NRC are known as

Agreement States. 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 2011, there were 37 Agreement States.

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 has also developed and implemented procedures for evaluating materials

events to identify those that should be reported as AOs. Toward that end, the NRC uniformly

applies the AO criteria (in Appendix A to this report) to events at licensees regulated by either

the NRC or the Agreement States. In addition, in early 1977, the Commission determined that

the annual report to Congress also should include events that meet the criteria for AOs at

viii
ABNORMAL OCCURRENCES IN FISCAL YEAR 2011

The following briefly explains the numbering system used in this section of the report. Appendix

A provides the specific criteria for determining when an event is an abnormal occurrence (AO)

and provides the guidelines for reporting other events of interest which may not meet the AO

criteria, but which the Commission has determined should be in this report. Appendix A

contains four major categories: I. All Licensees, I1. Commercial Nuclear Power Plant Licensees,

Ill. Events at Facilities Other Than Nuclear Power Plants and All Transportation Events, and IV.

Other Events of Interest. Category IV events are discussed in Appendix C to this report, and

Categories 1, 11, and Ill are discussed in this section. Categories I and II contain significant

subelements labeled A, B, C, and D, and Category Ill contains addresse, sSubelements labeled

A. B. and C. This section of the report discusses only the specific subelement in Categories I,

II, and Ill for which an AO was reported. The identification number for all Agreement State AO

reports starts with "AS." Similarly, the identification number for all U.S. Nuclear Regulatory

Commission (NRC) AO reports starts with "NRC."

I. ALL LICENSEES

During this reporting period, one event at an NRC liconcod or NRC-regulated facilityies and

three events at Agreement-State-licensed facilities were significant enough to be reported as

AOs based on the criteria in Appendix A to this report. Although two of these events occurred at

a medical facility, they involved unintended exposures of individuals who were not the patient.

Therefore, these events belong under the Criteria I.A, "All Licensees" category, as opposed to

the Criteria IllI.C, "Medical Licensees" category.

NRC11-01 Human Exposure to Radiation at Portsmouth Naval Medical Center in

Portsmouth, Virginia

Criterion I.A.2, "Human Exposure to Radiation from Licensed Material," of Appendix A to this

report provides, in part, 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 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 - January 12, 2011, Portsmouth, Virginia

Nature and Probable Consequences - The Department of the Navy (the licensee) reported that

a female patient at the Naval Medical Center in Portsmouth, Virginia (NMCP), received 3,630

MBq (98 mCi) of iodine-131 for thyroid ablation therapy. On the day of the treatment the patient

informed NMCP staff that she was not pregnant and NMCP staff administered a pregnancy test

as a routine precaution. The pregnancy test yielded a negative result. Based on the negative

pregnancy test results and the patient's interview responses, NMCP staff administered iodine131 to the patient.

On January 27, 2011, the patient became aware that she was pregnant and informed the

physician who had administered the treatment. An obstetrician estimated that conception had

occurred somewhere around January 7-10, 2011, and that a pregnancy test administered on

January 12, 2011, would not have been sensitive enough to produce a positive result. NMCP

estimated the dose to the embryo to be 21.3 cGy (21.3 rem) and notified the Naval Radiation

Safety Committee that the patient may have been pregnant before the therapy. NMCP staff

1
II. COMMERCIAL NUCLEAR POWER PLANT LICENSEES

During this reporting period, one event at a commercial nuclear power plants in the United

States was significant enough to be reported as an AO based on the criteria in Appendix A to

this report.

NRC11-02 Commercial Nuclear Power Plant Event at Browns Ferry Nuclear Plant, Unit

1, in Athens, Alabama

Criterion ll.C, "For Commercial Nuclear Power Plant Licensees," of Appendix A to this report

provides, in part, that a commercial nuclear power plant event shall be considered for reporting

as an AO if it results in any reactor conditions or performance indicators that are determined to

be of high safety significance (red findings).

Date and Place - October 23, 2010, Athens, Alabama

Nature and Probable Consequences - The Tennessee Valley Authority (TVA) (the licensee)

reported a commercial nuclear power plant event at Browns Ferry Nuclear Plant, Unit 1, a

boiling-water reactor designed by General Electric. On October 23, 2010 during a refueling

outage, it was discovered that a residual heat removal (RHR) low pressure coolant injection

(LPCI) flow control valve failed while the licensee was attempting to establish shutdown cooling.

The flow control portion of the valve, called the disc, was found stuck in the seat of the valve.

The disc had become separated from the valve stem and could no longer be controlled by the

valve motor operator. The RHR system is primarily used for LPCI during accident conditions

and for cooling while the reactor is shut down. As a result of the flow control valve failure, Loop

II of the RHR system could not have performed its safe shutdown functions and was declared

inoperable. The licensee promptly placed the other loop of the RHR system (Loop I) into

service and, as a result, the failure of the flow control valve did not involve an actual safety

consequence or impact the health and safety of the public.

However, the NRC reviewed this event under its significance determination process and

determined that the licensee's history with regards to this valve performance issue represented

a finding of high safety significance (red finding). The basis for this finding was that the flow

control valve's failure (condition) caused a weakness in the licensee's fire mitigation strategy,

resulting in a significant increase in the core damage frequency. The licensee's fire mitigation

strategy limits the availability of alternative sources of reactor coolant inventory makeup and

both loops of LPCl could potentially be unavailable in some accident scenarios. Automatic

valve function was lost, as well as the ability of plant operators to manually use this loop of the

RHR system.

The public was never actually endangered because no event requiring use of the RHR system

occurred. However, the RHR system is counted on for core cooling during certain accident

scenarios, and the flow control valve failure left it inoperable, which could have led to core

damage had an accident involving a series of unlikely events occurred. The NRC determined

that this event did not represent an immediate safety concern, because the licensee staff had,

as part of its immediate corrective actions, implemented repairs and modifications in

accordance with design requirements that returned the flow control valve to an operational

condition (the red finding was for licensee performance deficiencies resulting in a past

inoperability).

Cause(s) - The immediate cause for this condition was separation of the valve disc from the

6
AS1 1-06 Medical Event at University Community Hospital in Tampa, Florida

Criteria III.C.1 .b, III.C.2.a and III.C.2.b(iii), "For Medical Licensees," of Appendix A to this report

provide, in part, 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 or is delivered to the wrong

treatment site.

Date and Place - February 14, 2010, Tampa, Florida

Nature and Probable Consequences - University Community Hospital (the licensee) reported

that two patients were prescribed single-channel HDR brachytherapy treatments of 34 Gy

(3,400 rad). Te-An__actual average dose of 17 Gy (1,700 rad) to the first patient, and 26 Gy

(2,600 rad) to the second patient, were delivered to the target area of the breast, and4***-w h

some parts of the planned volume received greater than 700 percent (first patient) and 220

percent (second patient) of the prescribed dose. In addition, other areas of the breast not in the

target region received up to 136 Gy (13,600 rad) in the first patient and 75 Gy (7,500 rad) in the

second patient. The maximum skin dose was calculated to be 42.5 Gy (4,250 rad) to the first

patient and 75 Gy (7,500 rad) to the second patient. The patients and their referring physicians

were informed of the events.

On February 14, 2010, the licensee noted that the mammosite catheter was erroneously

positioned approximately 2 to 2.5 cm away from the tumor. This was the result of the operator

entering the wrong dwell position into the planning system. The licensee concluded that no

significant adverse health effects to the patients are expected.

Cause(s) - The cause of the medical events was human error involving entering the wrong

position of the reference end of the catheter into the planning system.

Actions Taken to Prevent Recurrence

Licensee - Corrective actions included implementing various quality assurance steps to ensure

that the correct treatment calculations and data are used for future treatments. Additional

procedural guidance will be created with detailed instructions.

State -The Florida Bureau of Radiation Control initiated an inspection on February 18, 2010.

The State completed the inspection on March 1, 2010, and determined that the licensee's

corrective actions were adequate. No enforcement action was taken and the State forwarded

the final update of the event to the NRC on February 1, 2011.

This event is closed for the purpose of this report.

11
ASIl-07 Medical Event at Coral Springs Clinic in Coral Springs, Florida

Criteria II1.C.1 .b and IIl.C.2.a, "For Medical Licensees," of Appendix A to this report provide, in

part, that a medical event shall be considered for reporting as an AO if it results in a dose that is

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 - March 11, 2010, Coral Springs, Florida

Nature and Probable Consequences - Coral Springs Clinic (the licensee) reported that a

medical event occurred associated with an HDR brachytherapy treatment for basal cell

carcinoma of the ear.; the troatmnt conci.tod of 210.0 GBq (•5.7 Ci) of ir-idium, 19-2.• The patient

was prescribed 14 fractionated doses of 2.5 Gy (250 rad) to the ear, but instead, the patient

received 22.5 Gy (2,250 rad) on the second fractionated treatment dose. The patient and

referring physician were informed of this event.

IOn M~arch 11, 2010, the pationt being troa-to-d for -basal c8il carcinomi of thA oar was to rocA

the Rene f•ractonatod doc 2.5 Gy (250 Fad); howo.... Wwhile starting the treatment the

radiation therapist accidentally pushed the incorrect button on the HDR device, which was the

"auto radiography" button rather than the "treatment" button on the machine control console.

This resulted in the patient receiving approximately 9 times the intended dose for that fraction of

the treatment. Further treatments were canceled. The patient and doctor were notified of the

incident. The licensee concluded that no significant health effects to the patient are expected as

a result of this incorrect dose.

Cause(s) - The medical event was caused by human error in that the licensee failed to push the

correct button on the HDR device.

Actions Taken to Prevent Recurrence

Licensee - The licensee immediately disabled the autoradiograph function on the HDR and

other similar devices. The licensee modified its procedures to include the use of an

independent mechanical timer and provided additional training to its entire clinical staff.

State - The Florida Bureau of Radiation Control initiated an inspection on April 27, 2010 and

determined that the licensee's corrective actions were adequate. No enforcement action was

taken and the State forwarded the final update of the event to the NRC on October 10, 2011.

This event is closed for the purpose of this report.

12
ASI1-11 Medical Event at the Greater Baltimore Medical Center in Baltimore,

Maryland

Criteria II1.C.1 .b and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - July 9, 2010, Baltimore, Maryland

Nature and Probable Consequences - The Greater Baltimore Medical Center (the licensee)

reported that a medical event occurred associated with an HE)R-manual brachytherapy

treatment for cervical cancer. The patient was prescribed to receive 35 Gy (3,500 rad) to the

cervix over the course of 73 hours using 1.635 GBq (44.2 mCi) of cesium-137. While the

sources were being inserted into the patient, one of the cesium-1 37 sources fell out of the

Fletcher-Suit applicator and into the patient's hospital gown. Consequently, the skin tissue on

the patient's buttocks received a dose of 10.5 Gy (1,050 rad) from the errant source. The

patient and referring physician were informed of this event.

Sometime after the sources had been inserted into the patient, the patient removed the hospital

gown, folded it, placed it with the trash, and donned a clean gown. On July 9, 2010, the

oncologist and medical physicist removed the sources from the patient and discovered that one

of the six sources was missing. The oncologist and radiation safety officer subsequently located

the source wrapped in the soiled hospital gown in a bag designated for radioactive waste. The

source was retrieved and transported back to the Radiation Oncology Department's source

storage room. The licensee noticed no erythema of the patient's skin and concluded that no

clinically significant side effects would be expected from the radiation exposure to the skin.

Cause(s) - The cause of the medical event was the failure of the source attachment to the

applicator, coupled with failure of the licensee to establish appropriate procedures to prevent the

occurrence of the medical event.

Actions Taken to Prevent Recurrence

Licensee - The licensee plans to discontinue the use of the Fletcher-Suit applicator used during

this treatment and exclusively use the Fletcher-Suit-Delclos applicator. The licensee also plans

to revise procedures for brachytherapy applicators and provide improved training to the staff.

State - The Maryland Department of the Environment, Radiological Health Program conducted

an investigation on July 27, 2010 and August 18, 2010. On October 18, 2010, the Department

issued a letter and NOV to the licensee and forwarded the final update of the event to the NRC

in July 2011.

This event is closed for the purpose of this report.

16
NRCl 1-03 Medical Event at the G.V. (Sonny) Montgomery VA Medical Center in

Jackson, Mississippi

Criteria IIl.C.1.b and IIl.C.2.b(iii), "For Medical Licensees," of Appendix A to this report provide,

in part, 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 - August 4, 2008 (reported on September 8, 2010), Jackson, Mississippi

Nature and Probable Consequences - The U.S. Department of Veterans Affairs (the licensee)

reported that a medical event involving prostate cancer brachytherapy seed implants occurred

at the G.V. (Sonny) Montgomery VA Medical Center in Jackson, Mississippi. The patient was

prescribed to receive a total dose of 145 Gy (14,500 rad) to the prostate using 104 iodine-125

seeds. However, the seed placement resulted in an approximate dose of 233 Gy (23,300 rad)

to the patient's rectum (wrong treatment site). The patient and referring physician were

informed of this event.

In September 2010, the licensee completed a followup comprehensive external review and

reanalysis of posttreatment dose parameters for all prostate seed implants performed at the

G.V. (Sonny) Montgomery VA Medical Center for the period between February 2005 and

August 2008. Upon an evaluation of the updated dose information generated by external

review, medical center staff, working with the National Health Physics Program, discovered this

event. No adverse effect to the patient is expected from the implant procedure, and the

licensee continues to monitor the progress of the patient.

Cause(s) - The cause of the medical event was an anatomical anomaly of the patient. The

patient had an unusually thin tissue layer between the prostate gland and rectum, which

resulted in a small area of the rectum receiving a higher than expected dose.

Actions Taken to Prevent Recurrence

Licensee - The U.S. Department of Veterans Affairs, working with the National Health Physics

Program and the medical center's staff, performed an initial review of all prostate brachytherapy

seed implant procedures for the period between February 2005 and August 2008. The initial

review of this program resulted in the suspension of and eventual termination of the medical

center's prostate brachytherapy implant program in August 2009. The followup comprehensive

external review and reanalysis of the program identified this event, which the medical center

reported to the licensee and the NRC.

NRC - In August 2010, the NRC issued an NOV and Proposed Imposition of Civil Penalties to

the licensee, based on the results of the initial evaluation and analysis of several events

associated with the licensee's prostate brachytherapy implant program. The licensee was cited

for failure to have adequate written procedures and failure to verify that the administered doses

were in accordance with written directives. The NRC has not taken any additional actions

I based on the identification of this event.

This event is closed for the purpose of this report.

17
ASII-14 Medical Event at the University of Texas Southwestern Medical Center in

Dallas, Texas

Criteria II1.C.1 .b and IIl.C.2.a, "For Medical Licensees," of Appendix A to this report provide, in

part, 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 - July 30, 2010 and September 16, 2010 (reported on February 15, 2011),

Dallas, Texas

Nature and Probable Conseauences - The University of Texas Southwestern Medical Center

(the licensee) reported the occurrence of two medical events to two young adult patients

prescribed colloidal phosphorus-32 (ranging from 7.4 MBq (0.2 mCi) a;W-to 92.5 MBq (2.5 mCi)

of activity) for treatment of cranial cysts. The patients were prescribed to receive a total dose of

300 Gy (30,000 rad) and 200 Gy (20,000 rad) respectively, but instead the patients received an

approximate dose of 565 Gy (56,500 rad) and 506 Gy (50,600 rad) to the cysts. These dosages

were 88 and 153 percent greater than the prescribed dosages. The patients and referring

physicians were informed of these events.

On February 15, 2011, the licensee discovered that two young adult patients were administered

doses of phosphorus-32 greater than 50 percent of the prescribed doses. The incidents were

discovered when the authorized user noticed an area of inflammation surrounding the cysts and

along the track of the drainage catheter. The authorized user discussed these findings with the

staff medical physicist who reviewed the colloidal phosphorus-32 doses supplied by the nuclear

pharmacy. The licensee determined that for both cases, the labels had the correct total activity,

but the incorrect volume and activity per unit volume. Therefore, the doses were incorrectly

labeled, and the concentration was approximately 60 percent higher than indicated on the

labels. The licensee subsequently calculated the doses to the target and surrounding tissues

and does not expect any patient impact or unfavorable outcomes as a result of these events.

Cause(s) - The cause of the medical event was that the two colloidal phosphorus-32

prescriptions provided by the vendor's nuclear pharmacy were incorrectly diluted and labeled.

In addition, the licensee did not perform a verification assay of the doses before their

administration.

Actions Taken to Prevent Recurrence

Licensee - To prevent recurrence, the licensee will obtain future doses that have been

calibrated to a National Institute of Standards and Technology traceable standard. The licensee

also will perform a verification assay at its facility and will assess the dose volume for calculating

the specific activity.

State - On March 1, 2011, the Texas Department of State Health Services conducted an

inspection and reviewed the causes and the licensee's corrective actions. The licensee was

cited for a violation for failing to perform a direct measurement of the dosage taken from a bulk

quantity for medical purposes.

This event is closed for the purpose of this report.

21
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. These include a group of similar events that have resulted in licensed materials

entering the public domain in an uncontrolled manner.

EOI-01 International Nuclear and Radiological Events Scale Level 7 "Major

Accident": Fukushima Dai-ichi Site (Japan) Nuclear Accident

This event is included in this report because it received significant world-wide media coverage

I and was perceived to be of high health and safety significance in Japan. On March 11, 2011, a

magnitude 9.0 earthquake occurred at a depth of approximately 25 kilometers (15 miles),

130 kilometers (81 miles) east of Sendai and 372 kilometers (231 miles) northeast of Tokyo off

the coast of Honshu Island. This earthquake resulted in the automatic shutdown of 11 nuclear

power plants at four sites along the northeast coast of Japan (Onagawa 1, 2, and 3; Fukushima

Dai-ichi 1, 2, and 3; Fukushima Dai-ni 1, 2, 3, and 4; and Tokai 2). The earthquake precipitated

a large tsunami that is estimated to have exceeded 14 meters (45 feet) in height at the

I Fukushima Dai-ichi Nuclear Power Plant site.-- The earthquake and tsunami produced

widespread devastation across northeastern Japan, resulting in approximately 20,000 people

dead or missing, displacing many tens of thousands of people, and significantly impacting the

infrastructure and industry in the northeastern coastal areas of Japan.

On March 12, 2011, the Nuclear and Industrial Safety Agency (NISA) of Japan provided the first

provisional rating as a Level 3 (serious incident) on the International Atomic Energy Agency's

International Nuclear and Radiological Event Scale (INES). As conditions of the multiple

reactors became known, both NISA and the Japanese Nuclear Safety Commission, in

cooperation with the Japan Atomic Energy Agency, revised their initial provisional rating based

on the radiation monitoring data and aerial dispersion analysis and, on April 12, 2011, issued

the final rating as a Level 7 (major accident) on the INES. This final INES rating considers the

events that occurred at Fukushima Dai-ichi Units 1, 2, and 3 as a single event on the INES.

NISA notes that while an INES rating of 7 is the same as the rating for the Chernobyl accident,

this is the first time INES has been used during a declared emergency, and the radioactive

materials released in this case are only about 10 percent of the estimated amount released from

the 1986 Chernobyl accident.

The Tokyo Electric Power Company and NISA reported that as a result of the earthquake, the

operating reactors at all of the operating units appeared to experience a normal reactor trip

within the capability of the design specifications of the plants. The ensuing tsunami resulted in

extensive damage to site facilities and a complete loss of alternating current electrical power at

Units 1 through 5, a condition known as "station blackout." Unit 6 retained the function of one of

its diesel generators. Despite the actions of the operators following the earthquake and

tsunami, cooling was lost to the fuel in the Unit 1 reactor after several hours, the Unit 2 reactor

after about 71 hours, and the Unit 3 reactor after about 36 hours, resulting in damage to the

nuclear fuel shortly after the loss of cooling. Units 1, 2, and 3 experienced explosions caused

by the buildup of hydrogen gas within primary containment, which was produced during fuel

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damage in the reactor and the subsequent movement of that hydrogen gas from the drywell into

I the secondary containment. Fukushima Dai-ichi Units 1, 2, and 3 experienced seVeee-core

damage; the Unit 4 core had been offloaded to a spent fuel pool before the earthquake. The

source of the explosive gases causing the Unit 4 explosion remains unclear, but may have been

caused by leakage of hydrogen from U44nit 3. The Unit 4 spent fuel remained intact and was

covered with water during the entire accident, contrary to media reports that the spent fuel pool

had gone dry. On December 16, 2011 the Japanese government and TEPCO announced that

all of the reactors had achieved a state of cold shutdown.

On March 11, 2011, the NRC fully staffed its 24-7 Operations Center with technical experts and

liaison staff, in order to evaluate potential impacts, if any, on U.S. nuclear facilities from the

tsunami, and monitor and analyze events at the nuclear plants in Japan. Shortly after March 11.

2011. the NRC concluded that there was no significant risk to U.S facilities and minimal health

risk to citizens in the United States. At the request of the Japanese government and through

the U.S. Agency for International Development, the NRC sent a team of its technical experts to

provide on-the-ground support to the Japanese government and U.S. Ambassador. As events

at the Fukushima Dai-ichi site became relatively static over a period of time, the NRC reduced

the staffing levels for the Operations Center. The NRC continued to provide a small technical

staff to the U.S. Ambassador in Japan until February 2012, as well as maintains a cadre of key

technical competent staff members at NRC Headquarters to answer requests from the onsite

technical support staff (see http:/lwww.nrc.gov/iapan/iapan-info.html).

In response to these events in Japan, as well as questions about the safety and survivability of

similarly designed U.S. plants, the Commission directed the Executive Director for Operations to

establish a senior-level task force to conduct both a short- and long-term analysis of the lessons

that can be learned from the situation in Japan. In addition, the NRC inspected all U.S.

commercial nuclear power plants to evaluate the industry's readiness for a similar event and to

aid in determining whether additional regulatory actions by the NRC are warranted. These

inspections were intended to be a high-level examination of the industry's preparedness for

events that may exceed the design basis of a plant. The senior-level task force reviewed the

results of these inspections.

The NRC's Japan Near-Term Task Force conducted a systematic and methodical review of

NRC processes and regulations to determine whether the agency should make additional

improvements to its regulatory system and to make recommendations to the Commission for its

policy direction, in light of the accident at the Fukushima Dai-ichi Nuclear Power Plant. In

examining the Fukushima Dai-ichi accident for insights for reactors in the United States, the

Task Force addressed protecting against accidents resulting from natural phenomena,

mitigating the consequences of such accidents, and ensuring adequate emergency

preparedness. Therefore, continued operation of the operating nuclear power plants and

continued licensing activities do not pose an imminent threat to public health and safety. The

Task Force found that the Commission's longstanding defense-in-depth philosophy, supported

and modified as necessary by state-of-the-art probabilistic risk assessment techniques, should

continue to serve as the primary organizing principle of its regulatory framework. The re,-t ef

tThe Task Force~s Work is a sot o9frovided 12 overarching recommendations that take a

bncdapproach to doAfonco9_iR ~dpha plied to low likolihood, high GOncoquonco ovents

.uch as prol..god .tation blackout ..... n frmo ratural .mo... ph.. . -These

recommendations, taken together, are intended to clarify and strengthen the regulatory

framework for protection against natural disasters, mitigation, and emergency preparedness,

and to improve the effectiveness of the NRC's programs. The Task Force concluded that the

application of the defense-in-depth philosophy can be strengthened by including explicit

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requirements for beyond-design-basis events. The Task Force completed its report to the

Commission, SECY-1 1-0093, "The Near-Term Task Force Review of Insights from the

Fukushima Dai-ichi Accident," on July 12, 2011. For more details on the Task Force's report,

see the NRC Web page "Recommendations of the Japan Task Force," available at

http://lbadupws.nrc.gov/docs/ML1 1 18/ML1 1 1861807.pdf.

On October 3, 2011, the NRC staff proposed to the Commission recommendations for the

prioritization of the Japan Near-Term Task Force recommendations in SECY-1 1-0137,

"Prioritization of Recommended Actions to be Taken in Response to Fukushima Lessons

Learned," available at http://www.nrc.qov/liapan/iapan-activities.html. The Commission

approved the staffs proposed prioritization of the Japan Near-Term Task Force

recommendations as detailed in the Staff Requirements Memorandum (SRM) to SECY-1 1-

0137, "Staff Requirements - SECY-1 1-0137 - Prioritization of Recommended Actions to be

Taken in Response to Fukushima Lessons Learned," dated December 15, 2011, available at

http://www.nrc.,ov/mapan/iapan-activities.html. Additionally, the NRC maintains a public

webpage providing updated details related to the Japan earthquake/tsunami reactor events

available at: http://www.nrc.ciov/iapan/lapan-info.html.

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EOI-02 Fort Calhoun Station, Unit 1, Nuclear Power Plant: Unusual Event Due to

High River Level

This event is included in this report because it received significant media coverage and public

attention. Local and national media also perceived it to be of high health and safety

significance. However, as described below, the 2011 flooding of the Missouri River and the

subsequent high water levels surrounding the Fort Calhoun Station (FCS) did not dieetIy-impact

plant safetsa,"ct .ovatod .quipmot . Additionally, the Omaha Public Power District (OPPD)

(the licensee) maintained plant safety, and the NRC maintained oversight of licensee response.

FCS, located approximately 19 miles north of Omaha, NE on the Missouri River, consists of a

single pressurized-water reactor (PWR) designed by Combustion Engineering. On

June 6, 2011, FCS declared a Notification of Unusual Event (NOUE) in anticipation that the

Missouri River level at the plant would reach 1,004 feet mean sea level (MSL). By design, the

plant is protected to a river level elevation of 1,014 feet MSL. Record snowfall totals during the

winter, followed by a rapid snowpack melt and significant rainfall during the spring caused this

rise in the Missouri River System. FCS had been shut down since April 9, 2011 for a planned

refueling outage and remained shut down during the entire period of flooding. Although some

plant equipment was impacted by the flooding, FCS maintained their emergency response

capability and the physical security of the plant. The NRC also established 24-hour onsite

inspector coverage during a significant portion of the event.

FCS personnel implemented many steps in advance of high water conditions including use of a

large water-filled tube (water berm) around the facility to Provide ease of access for site

personnel and to protect additional plant assets beyond what was necessary for Plant safety..

They also erected additional earthen berms and other structures to protect specific plant

structures and systems. On June 26, 2011, OPPD reported the failure of the water berm. The

failure of the water berm flooded open areas of the plant's Protected Area to a depth of

approximately 2.5 feet and allowed floodwaters to surround the concrete dams of the main

electrical transformers, prompting OPPD to take the precautionary measure of temporarily

transferring from offsite power to onsite emergency diesel generators (EDGs). Reactor

I shutdown cooling,-afR spent fuel pool cooling-, and other -plant safety systems were unaffected

during the transfer of power to the onsite EDGs. The NRC entered the Monitoring Mode of

agency response for four days with the Region IV Incident Response Center having the

response lead. On August 29, 2011, the licensee terminated the NOUE for flooding when the

Missouri River level receded to less than 1,004 feet MSL. The highest river level reported at

FCS was 1,006 feet, 10 inches MSL on June 25, 2011.

On August 10, 2011, OPPD provided the NRC with a Post-Flooding Recovery Action Plan,

which called for extensive reviews of plant systems, structures, and components to assess the

impact of the floodwaters (available at Agencywide Documents Access and Management

System (ADAMS) Accession No. MLl 12231755). The NRC issued a confirmatory action letter

(CAL 4-11-003) on September 2, 2011 (available at ADAMS Accession No. ML1 12490164),

which described various commitments made by OPPD for site restoration, plant systems and

equipment status, equipment reliability, design and licensing basis, emergency planning and

security impacts, and the recovery actions that would occur before the unit proceeds to startup.

NRC review and approval in accordance with CAL 4-11-003 are required before startup of the

FCS reactor.

In addition, some of the media attention related to this FCS flooding issue referenced an earlier

NRC inspection finding issued to FCS that involved flooding issues. On October 6, 2010, the

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NRC issued a final finding of substantial safety significance (yellow finding), which was identified

during a 2009 NRC inspection (available at ADAMS Accession No. ML1 02800342). The NRC

team identified deficiencies in the licensee's flooding coping strategies for protecting areas vital

to plant safety between 1,009.5 and 1,014 feet MSL. By identifying and having the licensee

address this issue earlier and before the flooding began, the NRC enhanced the safety of the

site. At no time was the health and safety of the public compromised by the actual flooding that

occurred on and subsequent to June 26, 2011.

Other plant performance issues have been identified and are currently under evaluation by the

NRC staff. For example, on June 7, 2011, FCS experienced a fire in a safety-related breaker

and switchgear. The fire resulted in FCS declaring an Alert because the fire impacted safety

related equipment. These plant performance issues and their continuing review have resulted

in FCS's extended plant shutdown continuation after termination of the flooding condition.

Additionally as described in NRC letter dated December 13, 2011 (available at ADAMS

Accession No. ML1 13470721), NRC decided to transition to FCS oversight under inspection

manual chapter 0350, "Oversight of Reactor Facilities in a Shutdown Condition due to

Significant Performance and/or Operational Concerns."

At this time, the NRC staff continues to evaluate plant performance issues under the NRC's

Accident Sequence Precursor (ASP) Program and Significance Determination Process (SDP).

The ASP Program provides an integrated risk analysis of all deficiencies, equipment failures,

and degraded conditions that were observed during the event. The inspection program

separately assesses the risk associated with each performance deficiency. Therefore, for

events involving multiple licensee performance deficiencies and equipment failures, as in the

FCS event, it is not unexpected that the ASP and inspection programs would assign different

risk-significance levels. As such, the integrated approach used by the ASP Program

Semplements -supplements the inspection program.

If the NRC evaluation for the plant performance issues at FCS result in a SDP finding of high

safety significance (red finding) or if the final ASP analysis of these events result in its

identification as a significant precursor, the NRC will report this event in Section II, "Commercial

Nuclear Power Plant Licensees," of the next fiscal year's AO report and in the FY 2012

"Performance and Accountability Report to Congress."

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EOI-03 North Anna Power Station: Alert Due to Seismically Induced Loss of

Offsite Power with Emergency Diesel Generator Failure

On August 23, 2011, a magnitude 5.8 earthquake occurred in the United States, with its

epicenter located in Mineral, VA, at a depth of 3.7 miles and approximately 11 miles

south-southeast from the North Anna Power Station (NAPS). This event received significant

local and national media coverage and caused the NRC to increase its attention to and

oversight of a program area. Additionally, the Virginia Electric and Power Company (VEPCO)

(the licensee) maintained plant safety, and the NRC maintained oversight of licensee response.

NAPS is located on Lake Anna in Louisa, VA, and consists of two Westinghouse-designed

three-loop PWRs. VEPCO declared an Alert (the next to lowest NRC emergency classification

for plant events) at NAPS because of significant seismic activity on site with the loss of offsite

power. The NRC entered monitoring mode. The two PWRs experienced automatic reactor trips

from 100 percent power, and the facility experienced a loss of offsite power. The station's four

EDGs automatically started, loaded, and provided power to the emergency buses. While NAPS

was receiving power from the EDGs, one EDG experienced a coolant leak and was

subsequently shut down. All control rods were inserted into the core during the reactor trips,

and plant decay heat was removed via the steam dumps to the atmosphere. The station's three

remaining EDGs continued to provide power to the station's safety systems until offsite power

was restored approximately 3 hours later.

On August 24, 2011, NAPS downgraded the Alert to an NOUE based on equipment alignments

and safety equipment inspection results. Later that same day, NAPS completed walkdowns and

plant inspections and subsequently exited the NOUE. The NRC exited monitoring mode based

on its understanding of the event and the licensee's priorities. The NRC's resident inspectors at

the facility observed the licensee's activities and provided firsthand information to the agency.

On August 29, 2011, the NRC dispatched a seismic expert and another structural expert to

assist the agency's resident inspectors on site. Further reviews indicated that additional

inspections were warranted, and the NRC inspection team was officially classified as an

Augmented Inspection Team (AIT).

On September 8, 2011, the licensee provided the NRC with a detailed presentation about the

event (available at ADAMS Accession No. ML1 1252A006). The licensee reported that the4he

earthquake was beyond what the plant was designed for in certain earthquake vibration

frequencies, but only minor damage was anticipated based on siubstantial safety margin in the

plant's desig oper.ating basis earthquake •a.thquako and design basis , cROitoa Wer81ecde;•9 

howovor, the cumulati.e absol ute v.elity, a concept used by tho E.ectric P.wor R968ar..

Instiute o addess xceodnce aRIcu-la~tions16 for the operzating basis earthquakeidctsht

significant damage wou.ld not b" oxpec•. d. The licensee undertook extensive actions to

inspect, evaluate, test, and repair, if necessary, any systems, structures, or components to

ensure that they are capable of performing their required design-basis functions. The licensee

reported that no significant equipment damage to safety-related systems (including Class I

structures) has been identified through site walkdowns, nor had equipment degradation been

detected through plant performance and surveillance testing following the earthquake. In

addition, the Lake Anna Dam was also inspected with no damage noted. On September 30,

2011, NRC issued Confirmatory Action Letter (CAL) No. 2-2011-001, "Confirmatory Action

Letter - North Anna Power Station Unit Nos. 1 and 2, Commitments to Address Exceeding

Design Bases Seismic Event (TAC Nos. ME7050 and ME7051)," to VEPCO (available at

ADAMS Accession No. ML1 1273A078), confirming NAPS' commitment that, Units 1 and 2, will

not enter Modes 1-4 (as defined in the facility technical specifications), until the Commission has

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