NUREG-0090, SECY-22-0014: Enclosure 1 - NUREG-0090, Volume 44, Report to Congress on Abnormal Occurrences Fiscal Year 2021.docx

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SECY-22-0014: Enclosure 1 - NUREG-0090, Volume 44, Report to Congress on Abnormal Occurrences Fiscal Year 2021.docx
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Text

Report to Congress on Abnormal Occurrences

Fiscal Year 2021

United States Nuclear Regulatory Commission Washington, DC 20555-0001

ABSTRACT

Section 208 of the Energy Reorganization Act of 1974, as amende d (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 t he standpoint of public health or safety. The Federal Reports Elimination and Sunset Act of 1 995 (Public Law 104-66) changed the AO reporting frequency from quarterly to annual.

This report describes six events that were identified as AOs du ring fiscal year 2021. These events were identified based on the criteria in the NRC policy statement Abnormal Occurrence Reports, published in Volume 82 of the Federal Register (FR), page 45907 (82 FR 45907; October 2, 2017). All six AOs were medical events as defined i n Title 10 of the Code of Federal Regulations Part 35, Medical Use of Byproduct Material.

Appendix A, Abnormal Occurrence Criteria, to this report pres ents the NRCs criteria for identifying AOs. In addition, the NRC identified two events du ring fiscal year 2021 that meet the guidelines for inclusion in Appendix B, Other Events of Intere st. The first event was a radiopharmaceutical misadministration due to an erroneous writt en directive. The second was an event at the National Institute of Standards and Technology Center for Neutron research reactor. No events met the guidelines for inclusion in Appendi x C, Updates on Previously Reported Abnormal Occurrences. Appendix D, Glossary, define s terms used throughout this report. Appendix E, Conversion Table, presents conversions c ommonly used when calculating doses.

iii

CONTENTS

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

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

EXECUTIVE

SUMMARY

............................................................................................................ v i i

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

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

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

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

INTERNATIONAL INFORMATION................................................................................. viii

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

UPDATES ON PREVIOUSLY REPORTED ABNORMAL OCCURRENCES................... ix

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

ABNORMAL OCCURRENCES IN FISCAL YEAR 2021............................................................. 1

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

II. COMMERCIAL NUCLEAR POWER PLANT LICENSEES......................................... 1

III. EVENTS AT FACILITIES OTHER THAN NUCLEAR POWER PLANTS AND ALL TRANSPORTATION EVENTS.................................................................................... 1

AS21-01 Medical Event at Stanford University, Stanford, California.................. 1

AS21-02 Medical Event at Columbia Hospital at Medical City Dallas, Dall as, Texas................................................................................................... 3

AS21-03 Medical Event at Ohio State University, Columbus, Ohio.................... 4

AS21-04 Medical Event at Kell West Regional Hospital, Wichita Falls, Te xas... 5

AS21-05 Medical Event at University of California, Irvine, Medical Cent er, Orange, California................................................................................ 6

AS21-06 Medical Event at Moses Cone Health System, Greensboro, North Carolina............................................................................................... 7

APPENDIX A ABNORMAL OCCURRENCE CRITERIA...................................................... A-1

v APPENDIX B OTHER EVENTS OF INTEREST................................................................... B-1

APPENDIX C UPDATES ON PREVIOUSLY REPORTED ABNORMAL OCCURRENCES........................................................................................... C-1

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

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

vi EXECUTIVE

SUMMARY

INTRODUCTION

Section 208 of the Energy Reorganization Act of 1974, as amende d (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 t he standpoint of public health or safety. The Federal Reports Elimination and Sunset Act of 1 995 (Public Law 104-66) changed the AO reporting frequency from quarterly to annual.

This report describes events identified as AOs in fiscal year ( FY) 2021, based on the criteria in the NRC policy statement Abnormal Occurrence Reports (Volume 82 of the Federal Register (FR), page 45907 (82 FR 45907; October 2, 2017)). For each AO, this report documents the date and place, nature and probable consequences, cause or caus es, and actions taken to prevent recurrence.

Appendix A, Abnormal Occurrence Criteria, to this report pres ents the NRCs criteria for identifying AOs. In addition, the NRC identified two events du ring FY 2021 that met the guidelines for inclusion in Appendix B, Other Events of Intere st. During this reporting period, no events met the guidelines for inclusion in Appendix C, Upda tes on Previously Reported Abnormal Occurrences. Appendix D, Glossary, defines terms u sed throughout this report.

Appendix E, Conversion Table, presents conversions commonly u sed when calculating doses.

THE LICENSING AND REGULATORY SYSTEM

The NRC implements its system of licensing and regulation throu gh the regulations in Title 10 of the Code of Federal Regulations. The NRC regularly conducts licensing reviews, inspections, enforcement, investigations, operating experience evaluations, incident response, and confirmatory research. The agency informs and involves stakeho lders and the public to ensure openness and transparency in its regulatory process.

The NRC adheres to the philosophy that multiple levels of protection best ensure public health and safety. The agency achieves and maintains these levels of protection through regulations specifying requirements that ensure the safe use of radioactive materials. Those regulations contain design, operation, and quality assurance criteria for t he various activities regulated by the NRC. Licensing, inspection, investigation, and enforcement programs offer a regulatory framework to ensure compliance with the regulations.

vii REPORTABLE EVENTS

The NRC initially issued the AO criteria in a Commission policy statement published on February 24, 1977 (42 FR 10950), followed by several revisions. The agency published the most recent revision to the AO criteria in the FR on October 2, 2017 (82 FR 45907); the revised criteria became effective on that date. The NRC staff used the se criteria to define AOs for this FY 2021 report.

Reviews of and responses to operating experience are essential to ensure that licensees conduct their activities safely. To that end, NRC regulations require licensees to report certain incidents or events to the NRC. Such reporting helps to identi fy deficiencies and ensure that corrective actions are taken to prevent recurrence.

The NRC and its licensees review and evaluate operating experie nce to identify safety concerns. The NRC responds to ris k-significant issues through licensing reviews, inspections, enforcement, and enhancements to regulations. In addition, the agency maintains operational data in computer-based data files for more effective collection, storage, retrieval, and evaluation of events.

The NRC routinely makes information and records on reportable e vents at licensed facilities available to the public. The agency also disseminates informat ion through public announcements and special notifications to licensees and other stakeholders. The NRC issues an FR notice describing AOs that occurred in the previous FY at facilities licensed or otherwise regulated by the NRC or an Agreement State. In addition, the N RC promptly informs Congress of significant events, including AOs, should they occur.

AGREEMENT STATES

Agreement States are those States that have entered into formal agreements with the NRC, in accordance with Section 274 of the AEA, to regulate certain qua ntities of AEA material at facilities within the States borders. Agreement States must m aintain programs that are adequate to protect public health and safety and are compatible with the NRCs program for such materials. Currently, there are 39 Agreement States. All Agreement States report event information in accordance with the compatibility criteria in th e NRCs Agreement State Program Policy Statement (82 FR 46840; October 6, 2017). The NRC also has procedures for evaluating materials events and identifying those that meet the AO criteria. The NRC uniformly applies the AO criteria (see Appendix A) to events at licensee facilities or activities involving the use of radioactive material, whether regulated by the NRC or an Agreement State.

INTERNATIONAL INFORMATION

The NRC exchanges information with various foreign governments that regulate nuclear facilities and materials. The agency reviews and considers thi s international information in its research and regulatory activities and in its assessment of ope rating experience. Although the NRC may occasionally refer to such information in its AO report s to Congress, the agency reports only domestic AOs.

viii OTHER EVENTS OF INTEREST

The NRC offers information about events that do not meet the cr iteria for AOs but are of interest based on the criteria in Appendix B to this report. The NRC id entified two such events that occurred during FY 2021.

UPDATES ON PREVIOUSLY REPORTED ABNORMAL OCCURRENCES

Appendix C typically includes updat es on previously reported AOs that remain open during the FY addressed in the report or for which significant new informa tion becomes available.

However, there are no such updates for this reporting period.

ix

ABBREVIATIONS

ADAMS Agencywide Documents Access and Management System AEA Atomic Energy Act of 1954, as amended AO abnormal occurrence CCDP conditional core damage probability CDP change in core damage probability CDPH California Department of Public Health CFR Code of Federal Regulations Ci curie(s)

CT computerized tomography FR Federal Register FY fiscal year GBq gigabecquerel(s)

Gy gray(s)

I iodine KI potassium iodide MBq megabecquerel(s)

µCi microcurie(s) mCi millicurie(s)

MD management directive mSv millisievert(s)

NIST National Institute of Standards and Technology NCNR NIST Center for Neutron Research NRC U.S. Nuclear Regulatory Commission Sv sievert(s)

TEDE total effective dose equivalent Y yttrium

xi

ABNORMAL OCCURRENCES IN FISCAL YEAR 2021

Appendix A, Abnormal Occurrence Criteria, supplies the specif ic criteria for determining whether an event is an abnormal occurrence (AO). Appendix A co ntains criteria for three major categories:

I. All Licensees II. Commercial Nuclear Power Plant Licensees III. Events at Facilities Other than Nuclear Power Plants and A ll Transportation Events

This section of the report includes only the specific events in Categories I, II, and III which met the AO criteria. The identification numbers for the events, wh ich were all reported by Agreement States, start with AS. Similarly, the identificati on numbers for all U.S. Nuclear Regulatory Commission (NRC) licensee AO reports start with NRC.

I. ALL LICENSEES

During this reporting period, no event was identified as an AO based on the criteria under Category I, All Licensees, in Appendix A.

II. COMMERCIAL NUCLEAR POWER PLANT LICENSEES

During this reporting period, no event at any commercial nuclea r power plant in the United States met the criteria for an AO under Category II, Co mmercial Nuclear Power Plant Licensees, in Appendix A.

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

During this reporting period, six events were identified as AOs based on the criteria in Appendix A under Category III, Events at Facilities Other than Nuclear Power Plants and All Transportation Events.

AS21-01 Medical Event at Stanford University, Stanford, Califor nia

Criteria III.C.1(b) and III.C.2(a) in 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 d ose that exceeds, by 10 gray (Gy)

(1,000 rad), the expected dose to any organ or tissue (other th an a major portion of the bone marrow, the lens of the eye, or the gonads) from the administra tion defined in the written directive, and involves a dose or dosage that is at least 50 pe rcent greater than that prescribed.

Date and PlaceOctober 16, 2020, Stanford, CA

Nature and Probable ConsequencesOn October 16, 2020, Stanford University (the licensee) reported that during an yttrium (Y)-90 microsphere treatment, a patient received a dose that was more than 50 percent greater than that prescribed. The patient had been prescribed 7 Gy (700 rad) to the left lobe of the liver and 17.5 Gy (1,750 rad) to the right lobe of the liver. The patients left lobe was treated first and mistakenly received t he higher dosage intended for the right lobe (1,168 megabecquerels (MBq) (31.57 millicuries (mCi) )), resulting in a dose of

1 17.5 Gy (1,750 rad) to the left lobe of the liver (2.5 times th e intended dose). The physician identified his mistake when he went to administer the dosage to the right lobe and realized the prepared dosage was less than he had already administered to th e left lobe. After the physician identified the mistake, the correct dosage was administered to the right lobe. The patient and referring physician were notified.

The licensee reported that it did not anticipate any significan t adverse impact to the patient from this event.

Cause(s)The error occurred for two reasons. First, the techni cian had labeled the containers with the two dosages incorrectly, switching the liver lobes. A ll other labeling information was correct. Second, the physician administering the dosage failed to verify that the dosage on the containers label matched the dosage prescribed in the written directive for the left lobe.

Actions Taken to Prevent Recurrence

LicenseeThe licensee changed its procedures to require a pause after delivery of the dosage to the treatment room, during which all information related to the delivered dosage must be verified to match the written directive prescribing treatment. It also removed the reference to the target organ on the label, to force the comparison of the dosag e with the dosage prescribed in the written directive. Additionally, the licensee incorporated a timeout into the procedure to allow the authorized user and health physicist to verify that e ach dose is identical to that of the written directive. After the timeout, the procedure has the au thorized user sign the written directive before administration of the dose(s).

StateThe California Department of Public Health (CDPH) reviewe d the event and the licensees proposed corrective actions with licensee personnel, and took enforcement action for the failures that led to the event. The effectiveness of the l icensees corrective actions will be reviewed in future inspections.

This event is closed for the purpose of this report.

2 AS21-02 Medical Event at Columbia Hospital at Medical City Dall as, Dallas, Texas

Criteria III.C.1(b) and III.C.2(b)(i) of Appendix A to this rep ort provide, in part, that a medical event shall be considered for reporting as an AO if it results in a dose that exceeds, by 10 Gy (1,000 rad), the expected dose to any organ or tissue (other th an a major portion of the bone marrow, the lens of the eye, or the gonads) from the administra tion defined in the written directive, and involves a prescribed dose or dosage that uses t he wrong radiopharmaceutical or unsealed byproduct material.

Date and PlaceApril 14, 2021, Dallas, TX

Nature and Probable ConsequencesOn April 14, 2021, Columbia Ho spital, doing business as Medical City Dallas, (the licensee) reported that a patient rec eived the wrong radiopharmaceutical for a thyroid diagnostic procedure. The pa tient had been prescribed 7.4 MBq (200 microcuries (µCi)) of iodine (I)-123, but instead received 5.55 gigabecquerels (GBq) (150 mCi) of I-131. The licensee discovered the error af ter the patient was allowed to leave the hospital but recalled the patient back to the hospita l to receive potassium iodide (KI) treatment. KI is a thyroid blocking agent administered to eith er prevent or minimize the uptake of I-131 in the thyroid. The licensee consulted with the Radia tion Emergency Assistance Center/Training Site at the Oak Ridge Institute for Science and Education and confirmed that its course of KI treatment was best for the circumstances. The pat ient stayed 4 days at the hospital and was discharged on April 18, 2021. The licensee fo llowed radiation safety procedures for the administration of the I-131. The calculated dose to the patients thyroid gland from the intended administration would have been 0.0237 Gy (2.3 7 rad). The final dose to the patients thyroid gland is not known, because of the interventi onal treatment with KI. However, calculations by State regulators using conservative assumptions indicate that the patient likely received a dose over 10 Gy (1,000 rad) above the originally int ended dose. The patient was placed on a thyroid hormone replacement regimen and is expected to remain on this regimen for the remainder of their life.

Cause(s)The licensee identified the cause of the event as huma n error by the nuclear medicine technician preparing the dose. The technician reporte d to the licensee that the dose was measured in the calibrator, but the technican misread the d ose units. The licensee evaluated to determine whether there had been other contributin g factors such as inadequate training or barrier design, but could not identify any addition al contributing factors. The licensee did, however, identify opportunities for procedural enhancement s.

Actions Taken to Prevent Recurrence

LicenseeThe licensee completed a safety event analysis with me mbers from Patient Safety, Nuclear Medicine, Radiology, and Risk Management, and identifie d areas in which to strengthen its procedures. The licensee revised all iodine pro cedures to require verification by two technicians before administration. The licensee also modif ied the iodine treatment checklist to improve its clarity.

StateThe State regulatory authority did not pursue enforcement action against the licensee but referred the incident to the State medical board for review.

This event is closed for the purpose of this report.

3 AS21-03 Medical Event at The Ohio State University, Columbus, O hio

Criteria III.C.1(b) and III.C.2(b)(iii) of Appendix A to this r eport provide, in part, that a medical event shall be considered for reporting as an AO if it results in a dose that exceeds, by 10 Gy (1,000 rad), the expected dose to any organ or tissue (other th an a major portion of the bone marrow, the lens of the eye, or the gonads) from the administra tion defined in the written directive, and involves a prescribed dose or dosage that is del ivered to the wrong treatment site.

Date and PlaceMay 10, 2021, Columbus, OH

Nature and Probable ConsequencesOn May 11, 2021, The Ohio Stat e University (the licensee) reported that during a Y-90 TheraSphere treatment, a patient received a dose to the wrong treatment site. The patient was prescribed to receive 2. 55 GBq (68.92mCi) to the left lobe of the liver for a dose of 130 Gy (13,000 rad). The cathe ter placement was verified by angiography and fluoroscopy before treatment, and the catheter had been locked in place to prevent movement. However, it was discovered during posttreatment imaging that the patient received 2.47 GBq (66.76 mCi) to the right lobe of the liver fo r a dose of 127Gy (12,700 rad).

The licensee believed that the catheter had kicked out during treatment. The patient and referring physician were notified of the incorrect dosage to th e wrong treatment site. The patient had previously received Y-90 microsphere treatment to the right lobe of the liver and is not expected to experience adverse health effects.

Cause(s)The licensee investigated the event, and although it b elieved that the catheter had kicked out during treatment, the cause of the event could not be determined. The licensee verified that all steps in the Y-90 administration procedure we re followed, including the verification of the catheter position prior to treatment.

Actions Taken to Prevent Recurrence

LicenseeThe licensees corrective action was to modify the Y-9 0 administration procedure.

Prior to this event, the licensees procedure required catheter placement imaging prior to the vascular patency test. The licensee changed their procedure so that the vascular patency test would be conducted before verifying catheter position.

StateThe Ohio Department of Health conducted an investigation on June 3, 2021, but identified no definite cause for the incident. It found that t he licensee followed all applicable regulations and internal procedures. As such, no enforcement a ctions were taken.

This event is closed for the purpose of this report.

4 AS21-04 Medical Event at Kell West Regional Hospital, Wichita F alls, Texas

Criteria III.C.1(b) and III.C.2(b)(iii) 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 exceeds, by 10 Gy (1,000 rad), the expected dose to any organ or tissue (other th an a major portion of the bone marrow, the lens of the eye, or the gonads) from the administra tion defined in the written directive, and involves a prescribed dose or dosage that is del ivered to the wrong treatment site.

Date and PlaceMay 10, 2021, Wichita Falls, TX

Nature and Probable ConsequencesOn May 12, 2021, Kell West Reg ional Hospital (the licensee) reported that during a cesium (Cs)-131 prostate seed implant treatment procedure, a patient received a dose to the wrong treatment site. A post-pr ocedure computerized tomography (CT) scan indicated that 63 of the 78 Cs-131 seeds w ere implanted below the prostate, and the remaining 15 were in the prostate treatment s ite. The written directive prescribed an activity of 7.34 GBq (198.38 mCi) to the prostate, but the patient received only 1.41 GBq (38.11 mCi). The perineal region below the prostate r eceived a dose of 115 Gy (11,500 rad) and the patient and prescribing physician were not ified. The patient did not experience any acute symptoms and was scheduled for long-term f ollowup to track their prognosis and any complications.

CausesThe cause of the event was that the ultrasound probe use d to guide the seed implantation was not positioned correctly at the prostate gland.

Actions Taken to Prevent Recurrence

LicenseeThe licensee revised its procedures to require the est ablishment of a frame of reference to identify the base and apex of the prostate on the axial and sagittal planes. The licensee also revised implant procedures to include a timeout t o verify the location of the prostate and bladder. The licensee plans to implement a retrai ning program for the prostate seed program, including, but not limited to, retraining and pro ctoring by a qualified radiation oncology physician and physicist.

StateThe Texas Department of State Health Services, Radiation Control Program, tracked the event and remained in contact with the licensees medical physi cs team during evaluation of the event, and determined an onsite inspection was not necessary an d that the licensee took all appropriate actions immediately upon discovery of the event.

This event is closed for the purpose of this report.

5 AS21-05 Medical Event at University of California, Irvine, Medi cal Center, Orange, California

Criteria III.C.1(b) and III.C.2(b)(iii) of Appendix A to this r eport provide, in part, that a medical event shall be considered for reporting as an AO if it results in a dose that exceeds, by 10 Gy (1,000 rad), the expected dose to any organ or tissue (other th an a major portion of the bone marrow, the lens of the eye, or the gonads) from the administra tion defined in the written directive, and involves a prescribed dose or dosage that is del ivered to the wrong treatment site.

Date and PlaceJune 15, 2021, Orange, CA

Nature and Probable ConsequencesOn June 15, 2021, the Universi ty of California, Irvine, Medical Center (the licensee) reported a medical event that inv olved a patient treated for liver metastases with Y-90 microspheres. The treatment plan prescrib ed between 0.29 and 0.83 GBq (7.84 and 22.43 mCi) to the left lobe of the liver. T he treatment plan specified that the microcatheter be placed in the left hepatic artery near to the branching point with the right artery to ensure that some of the Y-90 microspheres are infused into a small side branch off the left artery. During the treatment, it was discovered that the micro catheter had moved and the right liver lobe received an unintended dose of approximately 20 Gy ( 2,000 rad). The right lobe had been treated separately with Y-90 microspheres 2 weeks earlier. The patient and prescribing physician were notified. The patient is not expected to experi ence adverse health effects.

Cause(s)The licensee determined that the cause was a movement of the microcatheter during the administration due to patient respiration and vascul ar pulsation.

Actions Taken to Prevent Recurrence

LicenseeThe licensee concluded that the movement of the microc atheter had been unavoidable, since it had been necessary to place the microcath eter near the arterial branching point for the two lobes of the liver, but that the movement cou ld have been discovered earlier, which would have reduced the unintended dose to the right lobe. In future cases where patient physiological functions may cause the microcatheter to move, mo re attention will be directed to detecting such movement. The licensee held a meeting of oncolo gy staff to emphasize the need for such increased attention.

StateThe CDPH reviewed the event and the licensees proposed c orrective actions with licensee personnel. Future inspections are planned to verify t he effectiveness of the licensees corrective actions.

This event is closed for the purpose of this report.

6 AS21-06 Medical Event at Moses Cone Health System, Greensboro, North Carolina

Criteria III.C.1(b) and III.C.2(b)(iii) of Appendix A to this r eport provide, in part, that a medical event shall be considered for reporting as an AO if it results in a dose that exceeds, by 10 Gy (1,000 rad), the expected dose to any organ or tissue (other th an a major portion of the bone marrow, the lens of the eye, or the gonads) from the administra tion defined in the written directive, and involves a prescribed dose or dosage that is del ivered to the wrong treatment site.

Date and PlaceJuly 26, 2021, Greensboro, NC

Nature and Probable ConsequencesOn July 26, 2021, Moses Cone H ealth System (the licensee) reported that during a prostate seed implant treatmen t, a patient received a dose to the wrong treatment site. The treatment plan was to insert 54 I-125 seeds into the prostate, for a total activity of 1.013 GBq (27.38 mCi), achieving a prescrib ed dose of 145 Gy (14,500 rad) to the prostate. On August 18, 2021, a followup CT scan showed th at all 54 I-125 seeds had inadvertently been implanted into the penile bulb. A dose to t he penile bulb of approximately 145 Gy (14,500 rad) was received where no dose was intended. T he patient and prescribing physician were notified, and the clinical impacts to the patien t included severe rectal and perineal pain, the inability to sit upright, and confinement to a bed. The patient received a nerve block for pain from the implantation procedure and all the pati ents clinical impacts have been resolved.

Cause(s)The cause of the event was determined to be human erro r. After interviews with the medical physicist and radiation safety officer, the inspector r uled out the possibility of a malfunction of the ultrasound unit. The medical physicists re trospective review indicated that if the catheter was not clearly visible on the ultrasound images, then this could have caused seed implantation in a location other than the prostate.

Actions Taken to Prevent Recurrence

LicenseeThe licensees corrective actions include the addition of a step to the prostate brachytherapy protocol to ensure that personnel clearly identif y the prostate gland and the surrounding anatomy.

StateThe North Carolina Department of Health and Human Service s performed an inspection on August 18, 2021. The investigation found no violations.

This event is closed for the purpose of this report.

7

APPENDIX A ABNORMAL OCCURRENCE CRITERIA

Abnormal Occurrence General Statement of Policy

The U.S. Nuclear Regulatory Commission (NRC) will apply the fol lowing policy in determining whether an incident or event at a facility or involving an acti vity that is licensed or otherwise regulated by the Commission or an Agreement State is an abnorma l occurrence (AO):1

An incident or event is considered an AO if it involves a major reduction in the protection of public health or safety. The incident or event h as a moderate or severe impact on public health or safety and could include, but need not be limited to, the following:

(1) Moderate exposure to, or release of, radioactive material l icensed by or otherwise regulated by the Commission or Agreement State;

(2) Major degradation of essential safety-related equipment;

(3) Major deficiencies in design, construction, or use of, or m anagement controls for, facilities or radioactive material licensed by or otherwise regulated by the Commission or Agreement State; or

(4) Substantiated case of actual loss, theft, or diversion of r isk-significant radioactive material licensed by or otherwise regulated by the Commission or Agreement State.

The NRC provided the criteria below for identifying AOs, as wel l as the guidelines for other events of interest, in a policy statement published in Volume 82 of the Federal Register, page 45907 (82 FR 45907; October 2, 2017).

Abnormal Occurrence Criteria

The following presents the criteria, by types of events, used t o determine which events will be considered for reporting as AOs.

I. All Licensees2

A. Human Exposure to Radiation from Licensed Material

1 Events reported to the NRC by Agreement States that reach the threshold for reporting as AOs will be reported as such by the Commission.

2 Medical patients and human research subjects are excluded from consideration under these criteria, and these criteria do not apply to medical events defined in § 35.3045 of Title 10 of the Code of Federal Regulations (10 CFR), Report and notification of a medical event, which are considered in AO Criteria III.C.

A-1

1. Any unintended radiation exposure to an adult (any individua l 18 years of age or older) resulting in:

(a) An annual total effective dose equivalent (TEDE) of 250 millisieverts (mSv) (25 rem) or more;

(b) An annual sum of the deep dose equivalent (external dose) a nd committed dose equivalent (intake of radioactive material) to a ny individual organ other than the lens of the eye, the bone marro w, and the gonads of 2,500 mSv (250 rem) or more;

(c) An annual dose equivalent to the lens of the eye of 1 sieve rt (Sv)

(100 rem) or more;

(d) An annual sum of the deep dose equivalent and committed dos e equivalent to the bone marrow of 1 Sv (100 rem) or more;

(e) A committed dose equivalent to the gonads of 2,500 mSv (250 rem) or more; or

(f) An annual shallow dose equivalent to the skin or extremitie s of 2,500 mSv (250 rem) or more.

2. Any unintended radiation exposure to any minor (an individua l less than 18 years of age) resulting in an annual TEDE of 50 mSv (5 rem) or more, or to an embryo/fetus resulting in a dose equivalent of 50 mSv (5 rem) or more.
3. Any radiation exposure that has resulted in unintended perma nent functional damage to an organ or a physiological system as dete rmined by an independent physician3 deemed qualified by the NRC or Agreement State.

B. Discharge or Dispersal of Radioactive Material from Its Inte nded Place of Confinement

The release of radioactive material to an unrestricted area in concentrations that, if averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 5,000 times the v alues specified in Table 2 of Appendix B, Annual Limits on Intake (ALIs) and Deri ved Air Concentrations (DACs) of Radionuclides for Occupational Exposur e; Effluent Concentrations; Concentrations for Release to Sewerage, to 10 CFR Part 20, Standards for protection against radiation, unless the licens ee has demonstrated compliance with §20.1301, Dose limits for indivi dual members of the public, using §20.1302(b)(1) or §20.1302(b)(2)(ii). Thi s criterion does not apply to transportation events.

3 Independent physician is defined as a physician not on the licensees staff and who was not involved in the care of the patient involved.

A-2 C. Theft, Diversion, or Loss of Licensed Material; Sabotage; or Security Breach4,5,6

1. Any stolen, diverted, abandoned, or unrecovered lost radioac tive material that meets or exceeds the thresholds listed in Appendix A, Cat egory 1 and Category 2 Radioactive Materials, to 10 CFR Part 37, Phys ical protection of category 1 and category 2 quantities of radioacti ve material.

Excluded from reporting under this criterion are those events i nvolving sources that are lost or abandoned under the following conditio ns:

sources that have been lost and for which a reasonable attempt at recovery has been made without success, or irretrievable well l ogging sources as defined in §39.2, Definitions. These sources are only excluded if there is reasonable assurance that the doses from t hese sources have not exceeded, and will not exceed, the reporting t hresholds specified in AO Criteria I.A.1 and I.A.2 and the agency has det ermined that the risk of theft or diversion is acceptably low.

2. An act that results in radiological sabotage as defined in § 73.2.
3. Any substantiated7 case of actual theft, diversion, or loss of a formula quantity of special nuclear material, 8 or an inventory discrepancy of a formula quantity of special nuclear material 8 that is judged to be caused by theft or diversion.

4 Information pertaining to certain incidents may either be classified or under consideration for classification because of national security implications. Classified information will be withheld when formally reporting these incidents in accordance with Executive Order 13526, Classified National Security Information, as amended (75 FR 707; January 5, 2010), or any predecessor or successor order to require protection against unauthorized disclosures. Any classified details about these incidents would be available to Congress upon request, under appropriate security arrangements.

5 Information pertaining to certain incidents may be Safeguards Information as defined in §73.2 because of safety and security implications. The AO report would withhold specific Safeguards Information in accordance with Section 147 of the Atomic Energy Act of 1954, as amended. Any safeguards details regarding these incidents would be available to Congress upon request, under appropriate security arrangements.

6 Reporting lost or stolen material is based on the activity of the source at the time the radioactive material was known to be lost or stolen. If, by the time the AO report is due to Congress, the radioactive material has decayed below the thresholds listed in Appendix A to 10 CFR Part 37, the report will clarify that the radioactive material has decayed below the thresholds.

7 Substantiated means a situation in which there is an indication of loss, theft, or unlawful diversion, such as an allegation of diversion, report of lost or stolen material, or other indication of loss of material control or accountability that cannot be refuted following an investigation, and requires further action on the part of the agency or other proper authorities.

8 Formula quantity of special nuclear material is defined in §70.4, Definitions.

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4. Any substantial breakdown 9 of physical security, cyber security, or material control and accountability programs that significantly weakens the protection against loss, theft, diversion, or sabotage.
5. Any significant unauthorized disclosures (loss, theft, and/o r deliberate disclosure) of classified information that harms national secur ity or of Safeguards Information that threatens public health or safety.

D. Initiation of High-Level NRC Team Inspection 10

II. Commercial Nuclear Power Plant Licensees

A. Malfunction of Facility, Structures, or Equipment

1. Exceeding a safety limit of a license technical specificatio n (§50.36(c)).
2. Serious degradation of fuel integrity, primary coolant press ure boundary, or primary containment boundary.
3. Loss of plant capability to perform essential safety functio ns so that a release of radioactive materials that could result in exceeding the dose limits of 10 CFR Part 100, Reactor site criteria, or five tim es the dose limits of General Design Criteria (GDC) 19, Control Room, in Appendix A, General Design Criteria for Nuclear Power Plants, to 10 CFR Part 50, Domestic licensing of production and utilizati on facilities, could occur from a postulated transient or acciden t (e.g., loss of emergency core cooling system, loss of control rod system).

B. Design or Safety Analysis Deficiency, Personnel Error, or Pr ocedural or Administrative Inadequacy

1. Discovery of a major condition not specifically considered i n the safety analysis report or technical specification that requires immedi ate remedial action.
2. Personnel error or procedural deficiencies that result in th e loss of plant capability to perform essential safety functions such that a re lease of radioactive materials exceeding the dose limits of 10 CFR Part 100 or five times the dose limits of GDC 19 in Appendix A to 10 CFR Part 50, could

9 A substantial breakdown is defined as a red finding under the Reactor Oversight Process (ROP) in the physical security inspection program or any plant or facility determined to have overall unacceptable performance.

10 This item addresses the initiation of any incident investigation teams, as described in NRC Management Directive (MD) 8.3, NRC Incident Investigation Program (Agencywide Documents Access and Management System (ADAMS) Accession No. ML13175A294), or initiation of any accident review groups, as described in MD 8.9, Accident Investigation (ADAMS Accession No. ML13319A133).

A-4 occur from a postulated transient or accident (e.g., loss of em ergency core cooling system, loss of control rod drive mechanism).

C. Any operating reactor events or conditions evaluated by the NRC ROP to be the result of or associated with licensee performance issues of hig h safety significance11

D. Any operating reactor events or conditions evaluated by the NRC Accident Sequence Precursor (ASP) program to have a conditional core dam age probability (CCDP) or change in core damage probability (CDP) of greater than or equal to 1 x 10312

E. Any operating reactor plants that are determined to have ove rall unacceptable performance or are in a shutdown condition as a result of signi ficant performance problems and/or operational event(s) 13

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

A. Events Involving Design, Analysis, Construction, Testing, Op eration, Transport, Use, or Disposal

1. An accidental criticality.
2. A major deficiency in design, construction, control, or oper ation having significant safety implications that require immediate remedial action.
3. A serious safety-significant deficiency in management or pro cedural controls.

11 The NRC ROP uses four colors to describe the safety significance of licensee performance. As defined in NRC MD 8.13, Reactor Oversight Process (ADAMS Accession No. ML17347B670), green is used for very low safety significance, white is used for low to moderate safety significance, yellow is used for substantial safety significance, and red is used for high safety significance. Reactor conditions or performance indicators evaluated to be red are considered AOs.

12 Results from the NRC Accident Sequence Precursor program are used to monitor agency performance against the agencys strategic safety goal (e.g., ensure the safe use of radioactive materials) and objectives (e.g., prevent and mitigate accidents and ensure radiation safety). A precursor event with a CCDP or CDP of greater than or equal to 1 x 103 is used as a performance indicator for the strategic safety goal by determining that there have been no significant precursors of a nuclear reactor accident and that there have been no more than one significant adverse trend in industry safety performance.

13 Any plants assessed by the ROP to be in the unacceptable performance column, as described in NRC Inspection Manual Chapter (IMC) 0305, Operating Reactor Assessment Program (ADAMS Accession No. ML19256A191), or under NRC IMC 0350, Oversight of Reactor Facilities in a Shutdown Condition Due to Significant Performance and/or Operational Concerns (ADAMS Accession No. ML17116A273). This assessment of safety performance is based on the number and significance of NRC inspection findings and licensee performance indicators.

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4. A series of events (in which the individual events are not o f major importance), recurring incidents, or incidents with implication s for similar facilities (generic incidents) that raise a major safety concer n.

B. Fuel Cycle Facilities14

1. Absence or failure of all safety controls (engineered and hu man) such that conditions were present for the occurrence of a high-conse quence event involving an NRC-regulated hazard (radiological or chemic al).15
2. An NRC-ordered safety-related or security-related immediate remedial action.

C. Events Involving the Medical Use of Radioactive Materials in Patients or Human Research Subjects16

1. A medical event, as defined in §35.3045, which results in a dose that:

(a) Is equal to or greater than 1 gray (Gy) (100 rad) to a majo r portion of the bone marrow or to the lens of the eye; or equal to or gr eater than 2.5 Gy (250 rad) to the gonads; or

(b) Exceeds, by 10 Gy (1,000 rad), the expected dose to any oth er organ or tissue from the administration defined in the written directive; and

2. A medical event, as defined in §35.3045, which involves:

(a) A dose or dosage that is at least 50 percent greater than t hat prescribed, or

(b) A prescribed dose or dosage that:

14 Criterion III.A also applies to fuel cycle facilities.

15 High-consequence events for facilities licensed under 10 CFR Part 70, Domestic licensing of special nuclear material, are those that could seriously harm the worker or a member of the public in accordance with §70.61, Performance requirements. The integrated safety analysis conducted and maintained by the licensee or applicant of 10 CFR Part 70 fuel cycle facilities identifies such hazards and the safety controls

(§70.62(c)) applied to meet the performance requirements in accordance with §70.61(b) through (d).

Fuel cycle facilities licensed under 10 CFR Part 40, Domestic licensing of source material, or certified under 10 CFR Part 76, Certification of gaseous diffusion plants, have licensing basis documents that describe facility specific hazards, consequences, and those controls used to prevent or mitigate the consequences of such accidents. For these facilities, a high-consequence event would be a release that has the potential to cause acute radiological or chemical exposures to a worker or a member of the public similar to that defined in Appendix A to Chapter 3, Section A.2, of NUREG 1520, Revision 2, Standard Review Plan for Fuel Cycle Facilities License ApplicationsFina l Report, issued June 2015, under Consequence Category 3 (High Consequences) (ADAMS Accession No. ML15176A258).

16 Criteria III.A.2, III.A.3, and III.A.4 also apply to medical licensees.

A-6 (i) Uses the wrong radiopharmaceutical or unsealed byproduct material; or

(ii) Is delivered by the wrong route of administration; or

(iii) Is delivered to the wrong treatment site; or

(iv) Is delivered by the wrong treatment mode; or

(v) Is from a leaking source or sources; or

(vi) Is delivered to the wrong individual or human research subject.

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APPENDIX B OTHER EVENTS OF INTEREST

This appendix discusses other events of interest that do not me et the criteria for abnormal occurrences (AOs) in Appendix A, Abnormal Occurrence Criteria, to this report. The U.S. Nuclear Regulatory Commission (NRC) may determine that eve nts other than AOs may be of interest to Congress and the public and should be included i n an appendix to the AO report as Other Events of Interest. Such events may include, but ar e not necessarily limited to, events that do not meet the AO criteria but that have been perc eived by Congress or the public to be of high health or safety significance, have received sign ificant media coverage, or have caused the NRC to increase its attention to or oversight of a p rogram area. They may also include groups of similar events through which licensed materia ls have entered the public domain in an uncontrolled manner.

OEI 21-01 Avera McKennan Nuclear Medicine

The NRC is including this event in this report because the even t received significant attention and oversight from the NRC and had health consequences comparab le to those of an AO.

Date and PlaceDecember 15, 2020, Sioux Falls, SD

On December 23, 2020, Avera McKennan notified the NRC of a medi cal event that had occurred on December 15, 2020. A physician had referred a pati ent to Avera McKennan (the licensee) for a thyroid scan and uptake study. Such studies ge nerally use approximately 7.4 MBq (0.2 mCi) of I-123. Errors by the licensees central s cheduling and authorized users resulted in the generation of an erroneous written directive th at called for administration of a therapeutic dose to the thyroid using 555 MBq (15 mCi) of I-131. The administered amount was 584.6 MGq (15.8 mCi) of I-131, which was sufficient to complete ly ablate the patients thyroid gland.

Criteria III.C.1(b) and III.C.2(a) 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 d ose that exceeds, by 10 Gy (1,000 rad), the expected dose to any organ or tissue (other th an a major portion of the bone marrow, the lens of the eye, or the gonads) from the administra tion defined in the written directive, and involves a dose or dosage at least 50 percent gr eater than that prescribed. In this case, the administered dose to the patients thyroid was approx imately 9,000 times the dose that would have been administered by the diagnostic test reques ted by the physician, and it was administered using the wrong radiopharmaceutical; however, beca use it was administered in accordance with the written directive, it did not meet Criterio n III.C.1(b).

The licensee performed a detailed review of all I-131 administr ations performed in the 6 months preceding the medical event to determine any similar occurrence s. The licensee concluded that the event appeared to be isolated in nature. The licensee also revised written procedures to require that, before creating a written directive, the authoriz ed user physically verify the prescribing physicians order for the treatment and also review the patients electronic medical record, instead of simply relying on the electronic order sent from centralized scheduling to the nuclear medicine department. Finally, the licensee revised the procedure for ordering doses for therapeutic administrations to require an assigned nuclear medi cine worker to collect

B-1 information on the order. This assigned worker would then crea te a hard-copy folder containing this information and provide it to the authorized user, who wou ld use it to verify that the written directive conforms to the original physicians order.

The NRC performed a reactive inspection from January 11, 2021, through August 3, 2021, to gather additional information on the event. The report from th at inspection documented numerous deficiencies in the licen sees safety program with respect to the receipt, documentation, and transmission of physician requests for patie nt treatment requiring a written directive. The inspector discussed his findings with the licen see during the inspection, which informed the licensees corrective actions described above. Th e inspection did not identify any violations of NRC regulations.

B-2 OEI 21-02 National Institute of Standards and Technology

The NRC is including this event in this report because the even t received significant attention and oversight from the NRC, as well as significant interest fro m Federal, State, and local officials and the general public.

Date and PlaceFebruary 3, 2021, Gaithersburg, MD

On February 3, 2021, the National Institute of Standards and Te chnology (NIST) Center for Neutron Research (NCNR) test reactor experienced an automatic s cram in response to indications of high exhaust stack radiation levels, while opera tors were performing a startup after a 6-week outage for reactor refueling. Consequently, NIS T (the licensee) declared an Alert in accordance with NIST emergency instructions and notified the NRC as required by its emergency plan. The reactor confinement building and control r oom were evacuated once the reactor was secured. NCNR personnel who were externally contam inated were decontaminated and cleared to go home that day. Monitoring of the contaminated personnel found no significant internal contamination. Later in the day, the licensee downgraded the event to a Notification of Unusual Event in accordance with its emerg ency instructions. NIST exited the event that evening when samples of effluent gases in the re actor stack met the criteria in the emergency instructions. All response procedures were followed and safety systems functioned as designed.

The NRC monitored the licensees i mmediate response to the event to ensure that there was no threat to public health and safety. The NRC also began a speci al inspection on February 9, 2021, to examine the licensees response. The lice nsee held a public meeting on February 10, 2021, with NRC participation, to inform the local community and officials about the event and the NRCs regulatory actions. NIST assessed the rele ase of radioactive material to the environment, and the NRC independently analyzed the same in formation as part of its special inspection. Both concluded that during the event, pote ntial radiation doses beyond NIST property would have been less than 0.01 millisievert (mSv) (1 m illirem (mrem)), which is a very small fraction of the regulatory annual public dose limit of 1 mSv (100 mrem) (a limit roughly equivalent to several chest x-rays) established in 10 CFR 20.13 01.

Based on remote visual inspection and radiation conditions in t he facility, the licensee notified the NRC on March 2, 2021, that it had exceeded the fuel tempera ture safety limit in the NCNR technical specifications during the event, causing damage to a fuel element. The fuel element was not fully seated in its normal position and a small amount of melted fuel was deposited on the lower grid plate surfaces near the displaced fuel element n ozzle. NIST submitted the written report to the NRC on March 5, 2021. On October 1, 2021, NIST s ubmitted to the NRC a request to restart the NCNR test reactor following completion o f corrective actions. NIST also submitted root cause and corre ctive actions reports to the NRC. In accordance with the requirements of 10 CFR 50.36, Technical specifications, the licensee cannot resume operation until authorized by the NRC.

The NRC Special Inspection Team will continue to inspect and wi ll issue a report. The NRC will take appropriate enforcement actions after evaluating all poten tial violations.

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APPENDIX C UPDATES ON PREVIOUSLY REPORTED ABNORMAL OCCURRENCES

During this reporting period, there were no updates on previous ly reported abnormal occurrences.

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APPENDIX D GLOSSARY

AEAthe Atomic Energy Act of 1954 (Public Law 83-703), including a ny amendments.

Authorized useras defined in Title 10 of the Code of Federal Regulations (10 CFR) 35.2, Definitions, a physician, dentist, or podiatrist who (1) meet s the requirements in 10 CFR 35.59, Recentness of training, and 10 CFR 35.190(a), 10 CFR 35.290(a ), 10 CFR 35.390(a),

10 CFR 35.392(a), 10 CFR 35.394(a), 10 CFR 35.490(a), 10 CFR 35.590(a), or 10 CFR 35.690(a), or (2) is identified as an authorized user on (i) a Commission or Agreement State license that authorizes the medical use of byproduct mate rial, (ii) a permit issued by a Commission master material licensee that is authorized to permi t the medical use of byproduct material, (iii) a permit issued by a Commission or Agreement St ate specific licensee of broad scope that is authorized to permit the medical use of byproduct material, or (iv) a permit issued by a Commission master material license broad scope permittee t hat is authorized to permit the medical use of byproduct material.

Brachytherapyas defined in 10 CFR 35.2, a method of radiation therapy in wh ich sources are used to deliver a radiation dose at a distance of up to a f ew centimeters by surface, intracavitary, intraluminal, or interstitial application.

Brachytherapy seed implantation for prostate cancer 1a form of radiation therapy for prostate cancer. The radioactive seeds are loaded into the des ignated number of needles in a specific order, and each needle is inserted through the skin in the perineum and into the prostate, using continuous ultrasound guidance. Once accurate needle placement is confirmed, the seeds in that needle are released. This process is continu ed until all of the radioactive seeds have been implanted.

Brachytherapy sourceas defined in 10 CFR 35.2, a radioactive source or a manufacturer-assembled source train or a combination of these s ources that is designed to deliver a therapeutic dose within a distance of a few centimete rs.

Catheter1 A flexible tube used to deliver fluids into or withdraw fluids from the body.

CDPincrease in core damage probability for a time period during w hich one or more components are deemed unavailable or degraded.

Conditional core damage probabilityconditional probability that a core damage state is reached given the occurrence of the observed initiating event ( and any subsequent equipment failure or degradation).

Deep dose equivalentas defined in 10 CFR 20.1003, the external whole-body exposure dose equivalent at a tissue depth of 1 centimeter (1,000 millig rams per square centimeter).

1. These terms are not defined in Title 10 of the Code of Federal Regulations or a U.S. Nuclear Regulatory Commission (NRC) management directive, inspection procedure, or policy statement. Rather, these definitions are based on those on the National Institutes of HealthNational Cancer In stitute Web site (see https://www.cancer.gov/about-cancer).

D-1 Dose equivalent (HT)as defined in 10 CFR 20.1003, the product of the absorbed dose in tissue, quality factor, and all other necessary modifying facto rs at the location of interest; the units of dose equivalent are the rem and sievert (Sv).

Effective dose equivalent (HE)as defined in 10 CFR 20.1003, the sum of the products of the dose equivalent to the organ or tissue (H T) and the weighting factors (W T) applicable to each of the body organs or tissues that are irradiated.

Exposureas defined in 10 CFR 20.1003, being exposed to ionizing radiat ion or to radioactive material.

External doseas defined in 10 CFR 20.1003, that portion of the dose equival ent received from radiation sources outside the body.

Fluoroscopy2an x-ray procedure that makes it possible to see internal orga ns in motion.

Gray (Gy)as defined in 10 CFR 20.1004, Units of radiation dose, the i nternational systems unit of absorbed dose; 1 Gy is equal to an absorbed dose of 1 j oule per kilogram (100 rad).

Interstitial3situated within, but not restricted to or characteristic of, a particular organ or tissue; used especially of fibrous tissue.

Manual brachytherapyas defined in 10 CFR 35.2, a type of brachytherapy in which th e brachytherapy sources (e.g., seeds, ribbons) are manually place d topically on a treatment site or inserted either into body cavities close to a treatment site or directly into the tissue volume.

Medical eventas defined in 10 CFR 35.2, an event that meets the criteria in 10 CFR 35.3045(a) or (b). Regulations in 10 CFR 35.3045(a) sta te that a licensee shall report any event as a medical event, except for an event that results from patient intervention, in which

(1) The administration of byproduct material or radiation from byproduct material, except permanent implant brachytherapy, results in

(i) A dose that differs from the prescribed dose or dose that w ould have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin and (A) The total dose delivered differs from the prescribed dose b y 20 percent or more; (B) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or (C) The fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 p ercent or more.

2. Id.
3. Id.

D-2 (ii) A dose that exceeds 0.05 Sv (5 rem) effective dose equival ent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shall ow dose equivalent to the skin from any of the following: (A) An administration of a wrong radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedur e; (B) An administration of a radioactive drug containing byproduc t material by the wrong route of administration; (C) An administration of a dose or dosage to the wrong individual or human research subject; (D) An administration of a dose or dosage delivered by the wrong mode of treatment; or (E) A leaking sealed source.

(iii) A dose to the skin or an organ or tissue other than the t reatment site that exceeds by (A) 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revi sed before administration; and (B) 50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revi sed before administration.

(2) For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding source s that were implanted in the correct site but migrated outside the treatmen t site) that results in

(i) The total source strength administered differing by 20 perc ent or more from the total source strength documented in the post-implantation portion of the written directive;

(ii) The total source strength administered outside of the trea tment site exceeding 20 percent of the total source strength document ed in the post-implantation portion of the written directive; or

(iii) An administration that includes any of the following: (A ) The wrong radionuclide; (B) The wrong individual or human research subject; (C) Sealed source(s) implanted directly into a locatio n discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or (D) A le aking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

Regulations in 10 CFR 35.3045(b) state the following:

A licensee shall report any event r esulting from intervention of a patient or human research subject in which the administration of byproduct mater ial or radiation from byproduct material results or will result in unintended pe rmanent functional damage to an organ or a physiological system, as determined by a physician.

D-3 Prescribed dosageas defined in 10 CFR 35.2, the specified activity or range of activity of unsealed byproduct material as documented (1) in a written dire ctive or (2) in accordance with the directions of the authorized user for procedures performed pursuant to 10 CFR 35.100, Use of unsealed byproduct material for uptake, dilution, and excret ion studies for which a written directive is not required, and 10 CFR 35.200, Use of unsealed byproduct material for imaging and localization studies for which a written directive is not r equired.

Prescribed doseas defined in 10 CFR 35.2, (1) for gamma stereotactic radiosur gery, the total dose as documented in the written directive, (2) for tele therapy, the total dose and dose per fraction as documented in the written directive, (3) for ma nual brachytherapy, either the total source strength and exposure time or the total dose, as documen ted in the written directive, or (4) for remote brachytherapy afterloaders, the total dose and d ose per fraction as documented in the written directive.

Radas defined in 10 CFR 20.1004, the special unit of absorbed dos e; 1 rad is equal to an absorbed dose of 100 ergs/gram or 0.01 joule/kilogram (0.01 Gy).

Radiation (ionizing radiation)as defined in 10 CFR 20.1003, alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. Radiation, as used in 10 CFR Part 2 0, Standards for Protection against Radiation, does not include nonionizing radiation, suc h as radio waves or microwaves, or visible, infrared, or ultraviolet light.

Radiation therapy (radiotherapy) 4the treatment of disease with radiation (such as x-rays).

Reactive inspectionas defined in NRC Inspection Manual Chapter 2800, Materials Inspection Program, and Management Directive 8.10, NRC Assess ment Program for a Medical Event or an Incident Occurring at a Medical Facility, an inspection performed in response to an event to obtain additional information.

Remas defined in 10 CFR 20.1004, the special unit of any of the q uantities expressed as dose equivalent; the dose equivalent in rem is equal to the abs orbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

Shallow dose equivalent (HS)as defined in 10 CFR 20.1003, for the external exposure of the skin of the whole body or the skin of an extremity, the dose eq uivalent at a tissue depth of 0.007 centimeter (7 milligrams/square centimeter).

Sievert (Sv)as defined in 10 CFR 20.1004, the international systems unit of any of the quantities expressed as dose equivalent; the dose equivalent in Sv is equal to the absorbed dose in Gy multiplied by the quality factor (1 Sv = 100 rems).

Source materialas defined in 10 CFR 40.4, Definitions, (1) uranium or thori um, or any combination thereof, in any physical or chemical form, or (2) o res that contain by weight 1/20th of 1 percent (0.05 percent) or more of (i) uranium, (ii) thoriu m, or (iii) any combination thereof.

Source material does not include special nuclear material.

4. Id.

D-4 Special nuclear materialas defined in 10 CFR 70.4, Definitions, (1) plutonium, uranium-233, uranium enriched in the isotope 233 or in the isot ope 235, and any other material that the Commission, pursuant to the provisions of Section 51, Special Nuclear Material, of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but not including source material, or (2) any material artificially enr iched by any of the foregoing, but not including source material.

Therapeutic doseas defined in 10 CFR 35.2, a radiation dose delivered from a s ource containing byproduct material to a patient or human research su bject for palliative or curative treatment.

Treatment siteas defined in 10 CFR 35.2, the anatomical description of the t issue intended to receive a radiation dose, as described in a written directive.

Vascular patency5the degree to which blood vessels are not blocked or obstructe d.

Written directiveas defined in 10 CFR 35.2, an authorized users written order for the administration of byproduct material or radiation from byproduc t material to a specific patient or human research subject, as specified in 10 CFR 35.40, Writt en directives.

5. This definition is based upon the National Library of Medicines controlled vocabulary thesaurus (see https://www.ncbi.nlm.nih.gov/mesh/?term=vascular+patency).

D-5

APPENDIX E CONVERSION TABLE

Radioactivity and Dose

QUANTITY FROM METRIC UNITS TO NON-INTERNATIONAL DIVIDE BY SYSTEM UNITS

Radioactivity megabecquerel (MBq) curie (Ci) 37,000

gigabecquerel (GBq) Ci 37

Absorbed dose gray (Gy) rad 0.01

Dose equivalent sievert (Sv) rem 0.01

millisievert (mSv) rem 10

mSv millirem (mrem) 0.01

E-1

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