Audit of NRC’s

Oversight of Medical Uses 

of Nuclear Material

OIG-16-A-02

October 8, 2015

All publicly available OIG reports (including this report) 

are accessible through NRC’s Web site at

http://www.nrc.gov/reading-rm/doc-collections/insp-gen
UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, D.C. 20555-0001

OFFICE OF THE

INSPECTOR GENERAL

October 8, 2015

MEMORANDUM TO: Mark A. Satorius

Executive Director for Operations

FROM: Stephen D. Dingbaum /RA/

Assistant Inspector General for Audits

SUBJECT: AUDIT OF NRC’S OVERSIGHT OF MEDICAL USES OF 

NUCLEAR MATERIAL (OIG-16-A-02)

Attached is the Office of the Inspector General’s (OIG) audit report titled Audit of NRC’s 

Oversight of Medical Uses of Nuclear Material.

The report presents the results of the subject audit. Following the September 15, 2015, exit 

conference, agency staff indicated they had formal comments for inclusion in this report. 

These comments and OIG’s analysis of the comments are included as report appendixes.

Please provide information on actions taken or planned on each of the recommendations 

within 30 days of the date of this memorandum. Actions taken or planned are subject to OIG 

followup as stated in Management Directive 6.1.

We appreciate the cooperation extended to us by members of your staff during the audit. If 

you have any questions or comments about our report, please contact me at (301) 415-5915 

or Sherri Miotla, Team Leader, at (301) 415-5914.

Attachment: As stated
Office of the Inspector General

U.S. Nuclear Regulatory Commission

Defense Nuclear Facilities Safety Board

Results in Brief

Audit of NRC’s Oversight of Medical Uses of Nuclear 

Why We Did This Review Material

The Nuclear Regulatory Commission 

(NRC) is responsible for overseeing 

the medical uses of nuclear material 

through its licensing, inspection, and 

enforcement programs. The types of 

medical uses regulated by NRC 

include diagnostic, therapeutic, and 

research. NRC issues medical use 

licenses to medical facilities, develops 

guidance and regulations for use by 

licensees, and maintains a committee 

of medical experts to obtain advice 

about the use of byproduct materials 

in medicine.

This committee, the Advisory 

Committee on the Medical Uses of 

Isotopes (ACMUI), is an independent 

committee established by the NRC for 

the express purpose of advising NRC 

staff. ACMUI provides NRC staff with 

advice, technical assistance, 

consulting, and key issues.

When a medical facility has a 

potential problem using radioactive 

material, it may meet NRC’s criteria 

for a medical event. These events 

may involve doses to a patient of the 

wrong amount, the wrong radioactive 

drug, incorrect administration of a 

drug, or dose to the wrong patient or 

wrong part of the body. There are 

about 40 medical events ach year.

The audit objective was to determine 

if NRC’s oversight of medical uses of 

radioactive isotopes adequately 

protects public health and safety.

OIG-16-A-02

October 8, 2015

NRC provides adequate oversight of the medical uses of radioactive isotopes to 

protect public health and safety; however, opportunities for improvement exist

with regard to clarifying NRC’s medical event policy, periodically assessing 

medical event reporting, and providing better feedback to ACMUI.

Medical event reporting requirements are inconsistently understood by licensees 

and NRC staff. This inconsistent understanding is due to a general lack of clarity 

surrounding NRC’s requirements and purpose for reporting medical events. 

Furthermore, NRC provides insufficient medical event data to medical licensees. 

As a result, NRC is not effectively achieving all the possible benefits of medical 

event reporting.

NRC has not conducted a periodic self-assessment of its medical events reporting 

requirements to determine if they are effectively meeting their intended purpose. 

As a result, NRC is not in a position to make any informed conclusions regarding 

the effectiveness of its approach to collecting information on medical events.

NRC does not routinely provide sufficiently detailed feedback to ACMUI despite 

relying on it as a key advisory body. This lack of sufficiently detailed feedback is a 

result of NRC not having current, formalized policies and procedures that clearly 

articulate the expectations for providing feedback to ACMUI. As a result, the 

benefits of having the ACMUI provide expert advice may not be fully realized and 

the potential for miscommunication and misunderstanding remains.

This report makes recommendations to increase clarity in NRC’s regulations, to 

conduct self-assessments of the medical program, and to increase feedback to 

ACMUI. Management stated their general agreement with two of the findings (A 

& C) but not with the third finding (B). The agency’s comments are included in 

Appendix C of this report.

What We Found

What We Recommend
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

ABBREVIATIONS AND ACRONYMS .......................................................... i

I. BACKGROUND ................................................................................1

II. OBJECTIVE......................................................................................7

III. FINDINGS.........................................................................................7

A. Medical Event Reporting is Unclear ......................................7

Recommendations ...............................................................13

B. Event Reporting Process Not Periodically Assessed ..........14

Recommendation.................................................................17

C. Insufficient Feedback Provided to ACMUI ...........................17

Recommendation.................................................................24

IV. CONSOLIDATED LIST OF RECOMMENDATIONS.......................25

V. AGENCY COMMENTS...................................................................26

APPENDIXES 

A. OBJECTIVE, SCOPE, AND METHODOLOGY...............................27

B. REPORT AND NOTIFICATION OF A MEDICAL EVENT...............30

C. AGENCY FORMAL COMMENTS.................................................. 31

D. OIG ANALYSIS OF AGENCY COMMENTS...................................36

TO REPORT FRAUD, WASTE, OR ABUSE .............................................43

COMMENTS AND SUGGESTIONS..........................................................43

 TABLE OF CONTENTS
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

i

10 CFR Title 10 of the Code of Federal Regulations

ACMUI Advisory Committee on the Medical Uses of Isotopes

FSME The Office of Federal and State Materials and 

Environmental Management Programs

NMED Nuclear Materials Events Database

NMSS Office of Nuclear Material Safety and Safeguards

NRC U.S. Nuclear Regulatory Commission

OIG Office of the Inspector General

rem Roentgen equivalent man

Sv Sievert

 ABBREVIATIONS AND ACRONYMS
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

1

Nuclear medicine is the use of radioactive material to provide information 

about the functioning of a person's specific internal organs (diagnostic) or 

to treat a disease (therapeutic). Diagnostic procedures generally use

small amounts of radioactive material to facilitate imaging of certain 

organs to help physicians locate and identify tumors, size anomalies, or 

other physiological or functional organ problems. Therapeutic uses of 

radioactive material are intended to kill cancerous tissue, reduce the size 

of a tumor, or reduce pain. 

There are three main categories of radiation therapy: (1) External beam 

therapy is a beam of radiation directed to the target tissue. Several 

different types of machines provide external beam therapy. Some 

treatment machines contain high-activity radioactive sources that emit 

 I. BACKGROUND

Source: Nuclear Regulatory Commission (NRC)

Gamma Knife uses beams of radiation to treat cancerous brain tumors.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

2

photons to treat the target site; (2) Brachytherapy treatments use sealed 

radioactive sources1 placed near or even directly in cancerous tissue.

The radiation dose is delivered at a distance of up to an inch from the

target area; and (3) Therapeutic radiopharmaceuticals deliver a large 

radiation dose inside the body. Different radioactive material can be given 

to patients and will concentrate in different regions or organ systems.

Federal Regulations

The Atomic Energy Act of 1954 authorizes the Nuclear Regulatory 

Commission (NRC) to issue licenses for those using nuclear material for 

medical, commercial, industrial, and research and development purposes. 

The act also states the production and use of source,2 byproduct,3 and 

special nuclear material4 must be regulated in order to protect the health 

and safety of the public.

 

1 A sealed radioactive source (or sealed source) is any radioactive or byproduct material encased in a 

capsule designed to prevent leakage or escape of the material.

2 Source material is natural uranium or thorium or depleted uranium that is not suitable for use as reactor 

fuel.

3 Byproduct material, in general, is nuclear material (other than special nuclear material) that is produced 

or made radioactive in a nuclear reactor or a particle accelerator.

4 Special nuclear material consists of uranium-233 or uranium-235, enriched uranium, or plutonium.

Post-operation image of a prostate brachytherapy patient

Source: NRC
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

3

Title 10 of the Code of Federal Regulations (10 CFR), Part 35, contains 

the requirements and provisions for the medical use of byproduct material 

and for issuance of specific licenses authorizing the medical use of this 

material. These requirements and provisions provide for the radiation

safety of workers, the general public, patients, and human research 

subjects.

NRC Oversight 

In addition to its regulatory authority over the medical use of radiation,

NRC has authority over the possession and use of byproduct, source, and

special nuclear material in medicine. NRC is responsible for overseeing 

the medical uses of nuclear material through its licensing, inspection, and 

enforcement programs. NRC issues medical use licenses to medical 

facilities, develops guidance and regulations for use by licensees, and 

maintains a committee of medical experts and health care professionals

that provides advice about the use of byproduct material in medicine. 

The Office of Nuclear Material Safety and Safeguards (NMSS), through 

the Medical Safety and Events Assessment Branch, is responsible for the 

programmatic direction and development of policy for the medical use of 

radioactive material. The Medical Safety and Events Assessment Branch

also provides support and technical assistance to NRC’s regional offices 

for licensing and inspection. The branch is responsible for maintaining, 

revising, and updating medical licensing guidance, inspection procedures, 

internal NRC guidance, regulations, and policy statements related to the 

medical use of radioactive material. 

The NRC regional offices ensure protection of public health and safety 

and the environment through the licensing, inspection, event response, 

enforcement, and allegations activities for NRC-licensed medical users in 

the United States, Puerto Rico, and the Virgin Islands where NRC has 

jurisdiction.5

Advisory Committee on the Medical Uses of Isotopes (ACMUI)

ACMUI is an independent committee established by the NRC for the 

express purpose of advising NRC staff. ACMUI provides advice that helps 

staff create medical regulations that are meant to be useful, realistic, 

 

5 Region I oversees Region II’s materials program.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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practical, not overly burdensome, and not intrusive in the practice of 

medicine. ACMUI further assists NRC staff by providing technical 

assistance in licensing, inspection, and enforcement cases; providing

consulting services when necessary; and by bringing key issues to the 

attention of NRC staff for appropriate action. 

ACMUI is a 13-member committee consisting of medical experts and 

health care professionals from various disciplines.

6

 Membership in 

ACMUI is gained through a formal nomination and selection process. 

ACMUI members are appointed to 4-year terms and, with approval from 

NRC, may elect to serve up to two consecutive terms, for a maximum term 

of 8 years.

Other Regulators

Agreement States

NRC has relinquished its authority to regulate certain radioactive material, 

including some radioisotopes, to a majority of the States. These States, 

which have entered into an agreement assuming this regulatory authority

 

6 ACMUI is composed of the following: a nuclear medicine physician, a nuclear cardiologist, a medical 

physicist in nuclear medicine unsealed byproduct material, a medical physicist in radiation therapy, a 

radiation safety officer, a nuclear pharmacist, two radiation oncologists, a patients' rights advocate, a

Food and Drug Administration representative, an Agreement State representative, a health care 

administrator, and a diagnostic radiologist.

Figure 1: Map of NRC Agreement States

Source: NRC
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

5

from NRC, are called Agreement States. Agreement States, like NRC,

regulate reactor-produced radioisotopes within their borders and must 

provide at least as much health and safety protection as NRC. There are

currently 37 Agreement States that have regulatory authority over medical 

licensees, and these States oversee approximately 86 percent of all 

medical licensees. 

Food and Drug Administration

The NRC and the Food and Drug Administration have a Memorandum of 

Understanding that coordinates existing NRC and Food and Drug 

Administration regulatory programs for medical devices, drugs, and 

biological products utilizing byproduct, source, or special nuclear material. 

The Food and Drug Administration is responsible for regulating the 

manufacture and marketing of machines that generate radiation, such as 

x-rays, as well as devices, drugs, and biologics containing radioactive 

material. NRC has responsibility for overseeing the manufacture, 

distribution, and use of byproduct material and the machines that use this 

material.

Medical Events

NRC regulations aim to assure radioactive material is used properly in 

medical diagnosis, treatment, and research. The regulations are also 

meant to assure the safety of patients, medical workers, and the public, as 

well as to protect the environment. These regulations require licensees to 

report any event which fits the definition of a medical event. 

Medical events refer to a potential problem with how a medical facility 

uses radioactive material. These events may involve doses to a patient of 

the wrong amount, the wrong radioactive drug, incorrect administration of 

a drug, or dose to the wrong patient or wrong part of the body. Appendix 

B of this report provides the complete medical event definition located in 

10 CFR Part 35.3045.

Per 10 CFR Part 35.3045, licensees are required to report medical events 

within 1 calendar day, by telephone, to the NRC Operations Center. 

Licensees are also required to submit a written report to the appropriate 

NRC regional office within 15 calendar days of discovering the medical 

event.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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NRC analyzes each event to see if further action is needed. If there is a 

violation, NRC may take enforcement action. NRC also searches for

trends to see if something in NRC's regulations or guidance may need to 

be clarified. While a medical event may indicate a potential problem in a 

facility's use of radioactive material, it does not necessarily result in harm 

to a patient or a safety violation for the medical facility.

On average, there are approximately 40 reported medical events per year 

out of hundreds of thousands of medical procedures involving radioactive 

material.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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The audit objective was to determine if NRC’s oversight of medical uses of 

radioactive isotopes adequately protects public health and safety. 

Appendix A of this report contains information on the audit’s scope and 

methodology.

NRC provides adequate oversight of the medical uses of radioactive 

isotopes to protect public health and safety; however, opportunities for 

improvement exist with regard to

 Clarification of NRC’s medical event reporting requirements.

 Periodic self-assessment of medical event reporting.

 Providing better feedback to ACMUI.

A. Medical Event Reporting Is Unclear

Medical event reporting requirements are inconsistently understood by 

licensees and NRC staff. According to NRC’s Principles of Good 

Regulation, regulations should be readily understood and easily applied. 

However, this inconsistent understanding is due to a general lack of clarity 

surrounding NRC’s requirements and purpose for reporting medical 

events. Furthermore, NRC provides insufficient access to medical event 

data to medical licensees. As a result, NRC is not effectively achieving all

the possible benefits of medical event reporting.

 II. OBJECTIVE

 III. FINDINGS
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

8

NRC Requirements Should Be Clear

NRC’s Principles of Good Regulation states that regulations should be 

coherent, logical, and practical. There should be a clear nexus between 

regulations and agency goals and objectives. Furthermore, agency 

positions should be readily understood and easily applied.

Medical Event Reporting Requirements Inconsistently Understood

Medical event reporting requirements are inconsistently understood by

licensees and NRC staff. Specifically, the Office of the Inspector General 

(OIG) learned that several licensees either underreported, or reported and 

later retracted, medical events. Furthermore, a specific interim guidance 

document had to be written to help address some of the confusion. 

Inaccurate Reporting of Medical Events

According to several NRC staff, there is a belief that medical events are 

underreported. Although many inspectors agreed that finding medical 

events during safety inspections is difficult and is not the focus of the 

inspection, it is not uncommon for inspectors to discover medical events 

during inspections.

7

 For example, one senior inspector estimated having

identified roughly half of the medical events incurred by licensees that the 

inspector had inspected. Another senior inspector surmised having found 

approximately 10 medical events during the inspector’s career. A former 

inspector claimed to have identified “a number of medical events” while 

working as an inspector.

In addition to NRC inspectors, an ACMUI member reported questioning 

the accuracy of medical event reporting when reviewing the annual

 

7 This applies to routine safety inspections. In the case of “reactive” inspections, inspectors contact or 

visit licensees specifically to inspect a medical event.

What Is Required

What We Found
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

9

medical events reports, as the events seemed to represent a “very, very, 

very, small number.” An Agreement State representative questioned the 

number of medical events reported for a specific medical procedure. This 

representative said one of the expected risks of this procedure is that nontargeted organs could be affected, yet events associated with this 

procedure are rarely reported.

Conversely, some inspectors have stated that licensees often report 

events that are eventually retracted because the events do not meet the

medical event criteria established in NRC regulations. For example, one 

inspector said that many licensees seem to take a conservative approach 

to reporting medical events. The inspector thinks that licensees may 

actually overreport events. Another inspector echoed this sentiment, 

saying most licensees would rather report an event and then later retract 

it, as opposed to having NRC discover it. Meanwhile, a regional 

inspection manager explained that while certain events seem to be 

obvious medical events, NRC headquarters may take the position that 

they are not actually medical events. 

NRC does not keep official records of how a medical event was identified. 

Specifically, NRC does not track how many medical events were selfreported – and later retracted – by licensees, or if the medical event was 

discovered by an NRC or Agreement State inspector during an inspection. 

In an attempt to identify such data, OIG conducted general searches of 

NRC’s public material events database and the Nuclear Material Events 

Database (NMED)8for the period of July 2005 to July 2015. Of 

approximately 600 medical events recorded in NMED, OIG identified 30 

medical events that were not reported by licensees but were discovered 

by NRC or Agreement State inspectors.9 Additionally, OIG identified 44 

medical events self-reported by licensees that were eventually retracted 

because it was determined that the events did not meet the criteria of a 

medical event.10 

 

8 NMED contains records of all materials events reported to NRC by NRC licensees, Agreement States, 

and non-licensees. This database may be accessed only by NRC staff, Agreement State staff, and other 

users authorized by NRC.

9 These figures indicate only what was discovered by inspectors. They do not represent the total number 

of events that may not have been reported by licensees.

10 The events that are eventually retracted do not necessarily indicate confusion over medical event 

reporting requirements in all cases. In some cases, the retractions may be due to the complexity of 

treatment planning and the post-treatment assessment of the medical event against NRC reporting 

criteria.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

10

Interim Enforcement 

Another example that illustrates the 

confusion surrounding medical 

events involved NRC’s issuance of 

a medical event interim enforcement 

policy.11 In July 2013, NRC issued 

an interim enforcement policy to 

provide regulatory relief and further 

clarification to the medical event 

reporting requirements for 

permanent implant brachytherapy. 

The regulation had previously 

required licensees to report medical 

events for this particular procedure 

even when the treatment may have 

been medically appropriate. Furthermore, the policy was created, in part,

to offer clarification on reporting requirements that were being interpreted 

and enforced differently by two NRC regional offices. The interim 

enforcement policy will remain in place until the implementation of the new 

Part 35 rule.

Part 35 Rulemaking

The concerns surrounding medical events have been ongoing for several 

years and NRC has taken notice. The regulation that addresses the 

medical uses of radioactive material, Part 35, is currently in the rulemaking 

process. The proposed rule contains several regulatory changes including 

some regarding medical event reporting. NRC staff is currently reviewing 

all public comments and anticipates submitting the final proposed rule to 

the Commission in March 2016. In addition to the final rule, new guidance 

documents that correspond with the rule will be developed. An NMSS 

manager believes the proposed changes to medical event reporting will 

“help NRC tremendously.”

 

11 NRC-2013-0114, “Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event 

Reporting,” July 3, 2013.

Source: NRC

Permanent brachytherapy “seeds” 

containing Iodine-125
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

11

In summary, OIG identified several illustrative examples that support 

stakeholders’ view that the medical event reporting requirements can be 

confusing. Specifically, the instances of underreporting and retracting

medical events, NRC’s issuance of an interim enforcement policy to 

address inconsistent application of regulatory requirements, and the 

substantive proposed revisions to Part 35 corroborate the confusion 

surrounding medical event reporting requirements.

Medical Event Reporting Requirements Unclear

There is a general lack of clarity to NRC’s requirements and purpose for 

reporting medical events. Not only do medical events pose a challenge to 

licensees, but there is confusion surrounding the medical event reporting

requirements from a regulatory and advisory perspective as reflected in 

the following comments:

 “NRC has incredibly complicated, contorted medical event 

regulations. Not only is it difficult for licensees to interpret, 

sometimes it is difficult for NRC.” – NMSS staff member

 “It [medical event] is a complicated definition.” – NMSS manager

 “Medical events can be confusing to me too, so I can see how it’s 

confusing to a licensee.” – NRC inspector

 “The medical event definition especially causes issues...” –

Agreement State representative 

 “Medical event criteria...[are] a bit ambiguous.” – ACMUI member

Many NRC staff believe that the majority of unreported medical events are 

due to licensees not understanding they even incurred an event. As one 

NRC inspector summarized, the medical event reporting requirements can 

be effective only “if the licensees understand what they’re supposed to 

report.”

Purpose Not Stated for Licensees

The purpose of reporting medical events is not listed in NRC regulations 

or licensee guidance. Specifically, OIG was unable to locate an

explanation for medical event reporting in Part 35 or any guidance 

Why This Occurred
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

12

documentation. When questioned about the purpose of reporting medical 

events, several NRC staff provided various responses but could not 

identify where the purpose was located. 

While performing documentary review for this audit, OIG was able to 

locate the importance of medical event reporting in an internal procedure 

document.

12

 The document stated that medical event information “is 

invaluable in assessing trends or patterns, identifying generic issues or 

generic concerns, and recognizing any inadequacies or unreliability of 

specific equipment and procedures.” Further, it stated that medical event 

information “will significantly aid in understanding why the event occurred 

and identifying any actions necessary to improve the effectiveness of NRC 

and Agreement State regulatory programs.” 

However, an explicit purpose for the reporting of medical events was not 

identified by OIG in any external, publicly available document that is

readily accessible to licensees.13 As one medical team member said, “It 

would make sense to have it in the regulations because that’s what 

licensees read to see what they are required to do.”

Limited Sharing of Medical Event Data

NRC does not proactively share the majority of medical event information 

with licensees. For example, NRC typically provides medical event 

information to licensees only if a trend is detected. When this occurs, 

NRC will send out a generic communication to licensees. This has 

occurred on two occasions over the past 5 years. 

NRC conducts an annual trending analysis of medical events, but this 

report is only provided to ACMUI and Agreement States. There is also a 

publicly available annual report on material events provided by an NRC 

contractor. However, this report provides only limited information on a 

small number of medical events that are considered to be significant. 

Finally, there is an “events database” on NRC’s public Web site, but this

database provides very limited search functions.

 

12 FSME Procedure Approval SA-300, Reporting Material Events, March 27, 2013.

13 NRC management noted that the purpose of medical event reporting is located in Federal Register 45 

FR 31701, published on May 14, 1980.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

13

A licensee stated that they do not receive effective feedback on medical 

events from NRC. The licensee noted that it is the licensees who incur

the medical events, yet they only have limited access to medical event

data. An NRC regional manager opined that NRC could do a better job of 

sharing medical event information and that NRC expects licensees to take 

their own initiative in obtaining this information. The manager added that 

NRC should make sure licensees are getting the message of how other 

medical events could impact their programs.

NRC Not Achieving Possible Benefits of Reporting

NRC is not effectively achieving all the possible benefits of medical event 

reporting. As it currently stands, medical event reporting is unreliable due 

to the underreporting and retracting of events by licensees who do not 

consistently understand the requirements. In the cases where events are 

retracted, an extra burden is created as licensees must expend time and 

resources to complete paperwork and address the event with NRC and 

other parties. NRC must then send an inspector to the licensee site within 

5 days to inspect the event, in addition to involving regional management 

and NRC headquarters staff to further assess the event. 

There is an ongoing effort between the American Society for Radiation 

Oncology and the American Association of Physicists in Medicine to 

create a database that would allow the medical community to 

anonymously share information and learn from mistakes. A licensee 

suggested that it may be helpful if NRC approached the reporting of 

medical events in a similar manner. OIG concludes that if the purpose of 

medical event reporting is to collect data to prevent future events, the 

information collected could be used in a more effective way that enhances

its benefit as a learning tool.

Recommendations

OIG recommends that the Executive Director for Operations

1. Clearly define the purpose of medical event reporting in a publicly 

available document and clarify the reporting requirements.

Why This Is Important
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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2. Proactively provide all medical licensees with medical event 

tracking/trending information for lessons-learned purposes.

B. Event Reporting Process Not Periodically Assessed

To date, NRC has not conducted a periodic self-assessment of its medical 

events reporting requirements to determine if they are effectively meeting 

their intended purpose. Conducting periodic self-assessments of a 

reporting process and associated requirements is a recognized best 

practice in the nuclear regulatory community. This programmatic 

deficiency exists because there is no requirement that a thorough and 

periodic review of the medical event reporting process be conducted. 

As a result, NRC is not in a position to make any informed conclusions 

regarding the effectiveness of its approach to collecting information on 

medical events.

Self-Assessment of Reporting Process Recognized Best Practice

Conducting periodic self-assessments of a reporting process and 

associated requirements is a recognized best practice in the nuclear 

regulatory community. Self-assessments are intended to provide an 

opportunity to determine whether (1) the issues identified are being 

reported in a timely manner, (2) reporting is strongly encouraged, and (3) 

reporting activities are consistent among licensees. Furthermore, 

performing a self-assessment of a reporting process can identify

significant weaknesses, recommend remedial measures to address those 

weaknesses, and provide an opportunity to measure current reporting 

requirements against licensee experience and recognized good practices.

What Is Required
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

15

No Self-Assessment of Reporting Process

NRC’s approach to medical event reporting requirements is found to be 

confusing and, therefore, controversial by some stakeholders. However, 

to date, NRC has not conducted an internal review or assessment of its 

medical event reporting requirements to determine if the requirements are 

appropriate or effective in meeting their intended purpose.

For example, there are industry concerns about the way NRC handles

medical event reporting. Some stakeholders noted that NRC’s approach 

to medical event reporting is perceived to be punitive in nature. 

Specifically, stakeholders opined that the associated reporting 

requirements are actually a deterrent to self-reporting medical events. 

Examples that support the stakeholders’ perception of NRC’s current 

approach to medical event reporting as punitive include the following: 

 Licensees must report medical events to NRC, the referring 

physician, and the patient, even if the event had no negative effect 

on the patient.14

 A physician can perform a procedure perfectly, but if the results are 

different than what was intended due to the patient’s unique 

physiology, NRC requirements may dictate that a medical event be 

reported despite there being no medical negligence. 

 Medical events are public information and can adversely affect a 

medical practice.

 NRC inspectors may occasionally take a confrontational approach 

towards licensees that report medical events.

As one ACMUI member said,

How do you ensure various medical facilities are honest in 

reporting medical events without having the fear that NRC 

will come down hard on them? It is a very delicate balance 

because you want everyone to report [medical events], but 

 

14 Per 10 CFR Part 35, the referring physician has the authority to inform the patient, or based on medical 

judgment, withhold the information if telling the patient would be considered harmful.

What We Found
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

16

at the same time, if the people involved feel it will be a big 

deal and create a ruckus within their career or organization, 

maybe they won’t report it.

No Policy Requiring Periodic Assessment

NRC has never conducted a self-assessment of its approach to reporting 

medical events. This programmatic deficiency exists because there is no 

requirement that a thorough and periodic review of the medical event 

reporting process be conducted to determine if

 The intended purpose of reporting requirements is being met. 

 The thresholds of the reporting requirements are appropriate.

No Assurance That Medical Event Reporting Approach Is Effective

Confusion and contention will likely continue to surround NRC’s approach 

to medical event reporting if the agency does not periodically assess and 

make appropriate improvements to its medical reporting requirements. 

Specifically, NRC is not in a position to draw any conclusions regarding 

the effectiveness of its approach to collecting information on medical 

events. Additionally, NRC is not able to proactively address programmatic 

weaknesses or stakeholder concerns in a timely manner. 

There have also been some industry claims that medical event reporting 

may negatively affect the practice of medicine.

15

 The reasoning is that 

some physicians do not want to perform specific procedures that tend to 

have a higher occurrence of medical events due to the perceived punitive 

nature of the reporting requirements. While there may be some truth to 

these claims, OIG was unable to obtain data from any sources that could

 

15 NRC’s Medical Policy Statement states that NRC will not intrude into medical judgments affecting 

patients, except as necessary to provide for the radiation safety of workers and the general public.

Why This Occurred

Why This Is Important
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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support or verify the statement. However, several NRC staff agreed this

consequence was theoretically possible and NRC must be cognizant of 

how it handles medical event reporting. An Agreement State 

representative said it is up to the regulators to treat medical events as they 

should be treated – that licensee event identification and reporting is “a 

good thing.” 

By establishing a periodic self-assessment of the medical events program, 

NRC can more readily address the program’s weaknesses. This would 

also help solidify NRC’s position that medical event reporting is about 

public safety and not about punishing licensees for their mistakes.

Recommendation

OIG recommends that the Executive Director for Operations

3. Develop and implement policy and procedures that require periodic 

assessments of NRC’s approach to medical event reporting. These 

assessments should include whether

i. The intended purpose of the reporting requirements is being 

met.

ii. The thresholds of the reporting requirements are 

appropriate.

C. Insufficient Feedback Provided to ACMUI

NRC does not routinely provide sufficiently detailed feedback to ACMUI 

despite relying on it as a key advisory body. This is inconsistent with 

NRC’s Principles of Good Regulation as well as NRC’s commitment to the 

Open Government initiative, both of which require transparency in 

decisionmaking. This lack of sufficiently detailed feedback is a result of 

NRC not having current, formalized policies and procedures that clearly 

articulate the expectations for providing feedback to ACMUI. As a result, 

the benefits of having ACMUI provide expert advice may not be fully 

realized and the potential for miscommunication and misunderstanding 

remains.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Independence, Openness, and Collaboration Required in NRC’s 

Regulatory Process

NRC’s Principles of Good Regulation identify key organizational values 

that guide the agency’s regulatory actions. Among these values are 

independence and openness. Independence requires that final decisions 

be documented with the reasons explicitly stated while openness requires 

that NRC appropriately inform and involve stakeholders in the regulatory 

process. Additionally, NRC’s Commitment to Open Government 

reinforces the need for transparency and collaboration in its operations so 

that stakeholders can participate meaningfully in the regulatory process.

NRC Provides Insufficient Feedback to ACMUI

NRC does not provide sufficiently detailed feedback to ACMUI on 

proposed recommendations despite relying on it for expert advice and to 

inform regulatory decisionmaking. Currently, the agency provides ACMUI 

with marginal feedback on its proposed recommendations by means of a 

spreadsheet and corresponding memorandum that is provided to each 

Committee member during the semi-annual meetings held each year. The 

following table shows the type of information the spreadsheet provides 

concerning ACMUI recommendations submitted to NRC.

What Is Required

What We Found
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ACMUI receives feedback from NRC staff on recommendations and the 

regulatory basis for the staff’s acceptance or denial of proposed 

recommendations via the spreadsheet and Response to Actions 

memorandum. However, the spreadsheet is designed primarily to be a 

tracking tool and therefore provides minimal information regarding the 

basis for the staff’s decision on a particular recommendation. For 

example, some entries for recommendations that were “not accepted,” or 

“partially accepted,” state the basis for the staff’s decision simply as, “This 

is outside of the scope of this rulemaking,” “Current Expanded 

Rulemaking,” or “Majority of comments were accepted.” Other 

recommendations in “pending” or “acknowledged” status provide no basis 

or explanation for the staff’s determination.

The Response to Actions memorandum is intended to be the formal 

method by which ACMUI recommendations and subsequent actions are 

reviewed and staff’s response to them is recorded. However, like the 

spreadsheet, the memorandum provides only minimal information on what 

actions NRC is required to take in response to an ACMUI 

recommendation or activity. The memorandum does not provide feedback 

or a regulatory basis for any decisionmaking in response to ACMUI 

recommendations. 

 

16 Status of the recommendation refers to whether the recommendation was “accepted,” “partially 

accepted,” “pending,” “not accepted,” or “acknowledged” by the NRC staff. “Accepted” means the 

recommendation was accepted by NRC staff and forwarded for consideration. “Partially accepted” 

means that part of the recommendation was accepted. “Pending” means that the staff has not made a 

decision on the recommendation and is waiting for more information from ACMUI before making a 

determination. “Not accepted” means that the recommendation was not accepted and will not be 

forwarded for consideration. “Acknowledged” means that the staff is aware of the intended purpose of the 

recommendation but the recommendation pertains to a non-medical subject such as resource constraints.

Advisory Committee on the Medical Use of Isotopes Recommendations (2007 to Present)

Date Subject Subcommittee 

Report

(N, Y & title)

Discussion Status16 Open vs. Closed Additional Notes

Date 

recommendation 

submitted by 

ACMUI.

Subject of 

recommendation.

Did ACMUI draft 

a subcommittee 

report on the 

recommendation?

If yes, note title 

of report.

Did an ACMUI 

hold a discussion/ 

presentation on 

the 

recommendation?

If yes, note title of 

discussion or 

presentation.

Is the 

recommendation 

“accepted,” 

“partially 

accepted,” 

“pending,” “not 

accepted,” or 

“acknowledged” 

by the NRC staff?

Is the 

recommendation 

“open” or 

“closed?” If 

“closed,” note 

date of closure. 

Notes on basis for 

the NRC’s 

decision on the 

recommendation.

Source: OIG

Generic Example of ACMUI Recommendation Tracking Spreadsheet
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Multiple ACMUI members opined that the current way they receive 

information on the Committee’s proposed recommendations does not 

provide sufficient detail to clearly articulate or completely understand 

NRC’s position. One ACMUI member cited two examples where the 

reason given for NRC staff’s decisionmaking was “frustrating” and seemed 

“arbitrary.” Another ACMUI member stated that NRC “is vague in its

explanation” for not accepting an ACMUI recommendation. An additional 

ACMUI member opined that it would be helpful if ACMUI received more 

feedback from NRC on the decisions regarding proposed 

recommendations. 

To learn how ACMUI understands and recognizes the method by which 

NRC provides feedback, OIG posed the following question to all ACMUI 

members: “How is feedback given?” Of the seven responses received, 

none of the respondents identified the recommendation spreadsheet or 

Response to Actions memorandum as a means of receiving feedback. 

Additionally, none of the respondents identified a different method by 

which written feedback was provided. In fact, most respondents indicated 

that the feedback was verbal and provided informally during meetings with 

staff. The varied responses were indicative that ACMUI members have an 

inconsistent recognition of when and how NRC provides feedback. 

2014 ACMUI briefing with NRC Commission

Source: NRC
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Despite the lack of sufficient feedback and recognition of a common 

feedback process, ACMUI members stated that, in general, 

communication and coordination between NRC staff and the Committee 

has improved significantly in recent years. Committee members are 

provided the opportunity to ask questions and discuss any of the 

highlighted topics at their semiannual meetings with NRC. An ACMUI 

member noted, “Right now, there is a great sense of mutual respect 

between the ACMUI and NRC staff. There is a feeling of understanding of 

how each has work to do and we each appreciate the need to work 

together. The working relationship has been very effective in injecting 

ACMUI input into NRC regulations and guidance.” 

The expertise and commitment of NRC staff is also recognized by ACMUI. 

For example, one Committee member noted, “the staff ACMUI encounters 

is bright, professional, and well-intentioned... the staff is genuinely 

concerned with formulating rules that meet their mandate but are not 

intrusive to medical practice and are reasonable.” Formalizing the 

feedback process between NRC and ACMUI will help develop a mutual 

understanding and expectation for feedback and therefore will further 

improve this valuable working relationship.

NRC Lacks Policy and Procedures Guiding Feedback

The lack of sufficient feedback is a result of not having a current, 

formalized policy and operating procedures that clearly articulate the 

expectations and process for providing feedback to ACMUI. In contrast to 

ACMUI, the Advisory Committee on Reactor Safeguards, another NRC 

Federal advisory committee, has a current, formalized Memorandum of 

Understanding with the agency that provides specific instructions to guide 

staff’s provision of timely and appropriately detailed feedback.

While conducting fieldwork, the audit team identified two documents that 

addressed, in part, communication and coordination between NRC and 

ACMUI. However, these documents lack specific instructions on the 

provision of feedback and are outdated. 

Why This Occurred
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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The first document, NUREG BR 0309, “Serving on the Advisory 

Committee on the Medical Use of Isotopes (ACMUI): A Members Guide,” 

dated 2004, addresses the general methods of interaction among NRC, 

ACMUI, and the Commission. Specific information on the process and 

procedures for providing feedback to ACMUI on its recommendations is 

not provided. Rather, the NUREG simply states ACMUI recommendations 

will be reviewed and considered by NRC staff and that NRC staff will 

provide a basis for its decision. 

The second document, “[Office of Federal and State Materials and 

Environmental Management Programs] FSME Policy and Procedures, 2-

5, Revision 0,” dated 2011, defines and documents staff guidance and 

procedures for interfacing with ACMUI during the development of major 

medical policy issues. However, this document does not provide specific 

instructions on the process for providing feedback to ACMUI. Rather the 

information is focused on what type of information should be included in 

staff correspondence to the Commission regarding ACMUI 

recommendations.

The agency is aware of the need to develop updated guidance that 

provides specific instructions for giving feedback to ACMUI. At present, 

the agency is in the process of drafting an internal policy and procedures 

document that outlines the roles, responsibilities, and administrative duties 

of NRC staff who support ACMUI. This document is expected to include 

detailed instructions on providing feedback to ACMUI, including how and 

when feedback is to be provided.

Benefits of Employing ACMUI Not Fully Realized

There are multiple effects of not having a current, formalized policy and 

subsequent operating procedures that clearly articulate the expectations 

and process for providing feedback to ACMUI. Generally, the benefits of 

having ACMUI provide expert advice to NRC may not be fully realized,

and there is greater risk of miscommunication and misunderstanding 

between NRC and ACMUI. This can lead to a perception that NRC is not 

being transparent in its regulatory processes.

Why This Is Important
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Since ACMUI members are not experts in regulatory matters, the 

committee members are at a disadvantage when trying to understand the 

NRC’s regulatory approach to reviewing recommendations and the 

subsequent decisionmaking process. Having a consistent understanding 

of how recommendations are reviewed and considered by the agency and 

being provided detailed and timely feedback would help ACMUI be more 

effective in providing appropriate assistance to NRC. 

Additionally, without a formalized, clearly understood process by which 

feedback is provided to ACMUI, there is potential for misunderstandings to 

occur between ACMUI and the agency. Such an instance occurred on 

ACMUI’s proposed recommendation on medical event reporting 

compatibility.

17

 Specifically, ACMUI recommended that current 

regulations be revised such that only medical event reporting for 

permanent implant brachytherapy be changed from Compatibility C to 

Compatibility B. ACMUI did not recommend any additional medical event 

reporting changes to Compatibility B. However, the Commission’s 

notational vote indicated its support for changing medical event reporting 

for all medical procedures to Compatibility B. This issue was brought to 

the attention of ACMUI by a Committee member during the March 2015 

semiannual meeting, 14 months after the Commission vote. An ACMUI 

member characterized this occurrence as "a significant process 

breakdown” among ACMUI, NRC staff, and the Commission. 

A lack of regulatory knowledge, coupled with the potential for 

misunderstandings, further reinforces the desire by some ACMUI 

members that NRC conduct business more transparently. To maximize 

the benefits of employing an advisory committee, NRC must provide 

timely and sufficiently detailed feedback so that input provided by ACMUI 

continues to be useful, and the working relationship between ACMUI and 

NRC remains effective.

 

17 An Agreement State radiation control program is compatible with NRC’s regulatory program when its 

program does not create conflicts or gaps that would jeopardize orderly regulation of agreement-related 

material on a nationwide basis. Compatibility B signifies an NRC regulation that should be identically 

adopted by Agreement States; Compatibility C signifies an NRC regulation of which Agreement States 

should simply adopt the “essential objectives.”
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Recommendation

OIG recommends that the Executive Director for Operations

4. Develop and implement policy and procedures to guide provision of 

sufficiently detailed and timely feedback to ACMUI from NRC staff.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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OIG recommends that the Executive Director for Operations

1. Clearly define the purpose of medical event reporting in a publicly 

available document and clarify the reporting requirements.

2. Proactively provide all medical licensees with medical event 

tracking/trending information for lessons-learned purposes.

3. Develop and implement policy and procedures that require periodic 

assessments of NRC’s approach to medical event reporting. These 

assessments should include whether

i. The intended purpose of reporting requirements is being 

met.

ii. The thresholds of the reporting requirements are

appropriate.

4. Develop and implement policy and procedures to guide provision of 

sufficiently detailed and timely feedback to ACMUI from NRC staff.

 IV. CONSOLIDATED LIST OF RECOMMENDATIONS
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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On August 25, 2015, OIG provided the agency with a discussion draft of 

this report prior to the exit conference which has held on September 15, 

2015. Subsequently, agency management provided supplemental 

information via informal written and verbal comments that have been 

incorporated into this report, as appropriate. 

On September 30, 2015, agency management provided formal comments 

to the draft report that indicated general agreement with two findings and 

disagreement with one finding contained in the audit report. Appendix C

contains a copy of the agency’s formal comments. Appendix D contains 

OIG analysis of the agency’s formal comments. 

 V. AGENCY COMMENTS
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Appendix A

Objective

The audit objective was to determine if NRC’s oversight of medical uses of 

radioactive isotopes adequately protects public health and safety.

Scope

The audit focused on reviewing current NRC oversight processes for 

medical uses of radioactive isotopes. We conducted this performance 

audit at NRC headquarters (Rockville, MD) from February 2015 through 

July 2015. Internal controls related to the audit objective were reviewed 

and analyzed. Throughout the audit, auditors were aware of the possibility 

of fraud, waste, or abuse in the program.

Methodology

OIG reviewed relevant criteria, such as Federal regulations including the 

Federal Advisory Committee Act, NRC’s Medical Use of Byproduct 

Material Policy Statement, and Title 10 of the Code of Federal 

Regulations, particularly 10 CFR Part 35 Medical Use of Byproduct 

Material. 

OIG also reviewed NRC guidance documents such as 

 NUREGs.

1. BR-0217 Rev. 1 “The Regulation and Use of Radioisotopes in 

Today's World” April 2000.

2. 1556 Vol. 9 “Consolidated Guidance About Material Licenses, 

Program-Specific Guidance About Medical Use Licenses” 

January 2008.

3. 1925 Rev. 2 “Research Activities FY 2012-2014” August 2013.

 Management Directives.

1. 8.1 “Abnormal Occurrence (AO) Reporting Procedure”

September 2011.

 OBJECTIVE, SCOPE, AND METHODOLOGY
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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2. 8.10 “NRC Assessment Program for a Medical Event or an 

Incident Occurring at a Medical Facility” March 2014.

3. 8.3 “NRC Incident Inspection Program” June 2014.

 Inspection Manual Chapters.

1. 1360 “Use of Physician and Scientific Consultants in the 

Medical Consultant Program” November 2006.

2. 2800 “Material Inspection Program” November 2010.

 Inspection Procedures.

1. 87103 "Inspection of Material Licensees Involved in an Incident 

or Bankruptcy Filing" November 2000.

2. 87130 "Nuclear Medicine Programs, Written Directive Not 

Required" October 2002.

3. 87131 "Nuclear Medicine Programs, Written Directive Required" 

August 2011. 

4. 87132 "Brachytherapy Programs" April 2012.

5. 87133 " Medical Gamma Stereostatic Radiosurgery and 

Teletherapy Programs " August 2011.

6. 87134 "Medical Broad-Scope Programs" August 2011.

2. Previous OIG Investigations.

1. “NRC Oversight of Requirements Pertaining to the Release of 

Patients Treated with Medical Isotopes” August 2011.

2. “NRC Regulatory Oversight of the Pennsylvania Veterans 

Affairs Medical Center Brachytherapy Program” January 2014.

OIG conducted searches in NRC’s material events public database as well 

as the Nuclear Material Events Database. OIG also reviewed the 

proposed Part 35 rule and each of the public comments.

OIG traveled to Region I, King of Prussia and also observed two medical 

inspections at licensee facilities located in Washington, D.C., including a 

broad scope licensee and a nuclear medicine office. 

OIG conducted interviews with management and staff from the NMSS 

Medical Safety and Event Evaluation Branch, in addition to various safety 

inspectors and license reviewers from Regions I, III and IV during the 

course of this audit. OIG interviewed several ACMUI members, 

Agreement State representatives, and industry representatives/licensees. 

Finally, OIG attended a monthly NMSS/Regions Part 35 meeting and the 

semi-annual ACMUI/NMSS and ACMUI/NRC Commission meetings.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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We conducted this performance audit in accordance with generally 

accepted government auditing standards. Those standards require that 

we plan and perform the audit to obtain sufficient, appropriate evidence to 

provide a reasonable basis for our findings and conclusions based on our 

audit objectives. We believe that the evidence obtained provides a 

reasonable basis for our findings and conclusions based on our audit 

objectives. 

The audit was conducted by Sherri Miotla, Team Leader; Mike Blair, Audit 

Manager; Jacki Storch, Audit Manager; Kevin Nietmann, Senior Technical 

Advisor; George Gusack, Auditor; Meredith Johnson, Management 

Analyst; and Connor McCune, Student Intern.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Appendix B

(a) A licensee shall report any event, except for an event that results from patient 

intervention, in which the administration of byproduct material or radiation from 

byproduct material results in—

(1) A dose that differs from the prescribed dose or dose that would have resulted 

from the prescribed dosage by more than 0.05 Sv (5 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

(i) The total dose delivered differs from the prescribed dose by 20 percent 

or more;

(ii) The total dosage delivered differs from the prescribed dosage by 20 

percent or more or falls outside the prescribed dosage range; or

(iii) The fractionated dose delivered differs from the prescribed dose, for a 

single fraction, by 50 percent or more.

(2) A dose that exceeds 0.05 Sv (5 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 

from any of the following—

(i) An administration of a wrong radioactive drug containing byproduct 

material;

(ii) An administration of a radioactive drug containing byproduct material 

by the wrong route of administration;

(iii) An administration of a dose or dosage to the wrong individual or 

human research subject;

(iv) An administration of a dose or dosage delivered by the wrong mode of 

treatment; or

(v) A leaking sealed source.

(3) A dose to the skin or an organ or tissue other than the treatment site that 

exceeds by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more of the 

dose expected from the administration defined in the written directive (excluding, 

for permanent implants, seeds that were implanted in the correct site but 

migrated outside the treatment site).

(b) A licensee shall report any event resulting from intervention of a patient or human 

research subject in which the administration of byproduct material or radiation from 

byproduct material results or will result in unintended permanent functional damage to an 

organ or a physiological system, as determined by a physician.

 § 35.3045 REPORT AND NOTIFICATION OF A MEDICAL EVENT
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Appendix C

 AGENCY FORMAL COMMENTS
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Appendix D

The Office of the Inspector General’s (OIG’s) Finding A: Clarification of the 

U.S. Nuclear Regulatory Commission’s (NRC’s) medical event reporting 

requirements 

Agency Comment

The staff agrees with most aspects of this finding. The issue highlighted in 

this finding has existed for decades. Staff has been working with the 

medical community and other stakeholders to clarify what constitutes a 

medical event when it comes to permanent implant brachytherapy. To 

remedy this, as approved by the Commission, staff developed an Interim 

Enforcement policy to help licensees identify medical events for this 

particular medical procedure, and to maintain consistency in the 

enforcement of these events. This is an interim solution while the agency 

pursues a long-term solution. The proposed Title 10 of the Code of 

Federal Regulations (10 CFR) Part 35 rule changes, when finished, will 

address the confusion over the requirements that the medical community 

has shared with the NRC over the years. Staff worked with the Advisory 

Committee on the Medical Uses of Isotopes (ACMUI), the medical 

community, and other stakeholders, along with the Agreement States, on 

this proposed rule change, and it is generally understood that the changes 

will provide the clarity the medical community needs. Staff agrees that the 

purpose of medical event reporting has not been clearly and succinctly 

described. Thus, some clarification is needed. For these reasons staff

agrees that we will take action on Recommendation 1, “Clearly define the 

purpose of medical event reporting in a publicly available document and 

clarify the reporting requirements.”

Although the staff agrees with Finding A, the staff disagrees with 

Recommendation 2, “Proactively provide all medical licensees with 

medical event tracking/trending information for lessons learned purposes.” 

The basis for this recommendation is that there is limited sharing of 

medical event data. However, as stated in the report, the frequency of 

medical events is very low when considered in the context of the 

 OIG ANALYSIS OF AGENCY COMMENTS
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

37

magnitude of the procedures. The staff has not seen significant trends 

that haven’t been already identified in the annual Nuclear Materials Event 

Database (NMED) reports. In addition, the staff does not have new 

information to share on any past trends or events to form the basis for 

more generic communications. When significant new situations or trends 

are identified, staff responds accordingly and develops a new generic 

communication. The NRC presents its annual trending analysis to ACMUI 

each year, and the ACMUI provides their analysis back to the NRC. This 

is done during the fall and spring ACMUI public meetings, and the slides 

and information presented are available on the NRC’s public Web site. 

The NRC also publically shares the NMED annual report that identifies 

high level issues and trends in medical events. Staff devotes a 

reasonable and justified level of resources to accomplish these efforts, 

and openly shares this information with licensees and other stakeholders 

as requested. Finally, medical events involving NRC licensees are 

frequently followed up by NRC inspections, which result in publically 

available inspection reports. States update events in NMED, and if there 

are lessons to be learned from the causes, this information is then 

highlighted in presentations to ACMUI, and possibly incorporated in the 

NMED annual report.

OIG Response

During the course of the audit, several individuals – both industry and 

NRC staff – agreed that medical event information was not always shared 

in a proactive, productive way. OIG maintains that medical event 

information should be openly shared with licensees, and this information 

should be shared before the events become a trend. 

OIG is aware of the medical event report provided to ACMUI each year; 

however, the public meeting slides covering this report contain only

general information on medical events and do not address the details of 

each medical event. Likewise, the annual NMED report addresses only

Abnormal Occurrences, which compose a small number of medical 

events. 

While OIG does not deny that medical event information is available to 

licensees, the only way to gain access to all medical event information is 

to conduct a tedious search in NRC’s Event Notification Report Web page. 

With an extremely limited search function and the inability to run reports, 
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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the Event Notification Report Web page limits accessibility and does not 

provide any guarantee that the appropriate medical event information will

be identified. Therefore, NRC should proactively provide this information 

at regular intervals. If the intent of medical event reporting is to identify 

potential problems and prevent their reoccurrence, then licensees should 

have easier access to this information for their own lessons learned 

purposes. 

Agency Comment

For staff to take further action to provide proactively medical licensees

with tracking/trending data would require significant resources, with a 

small benefit compared with the information available publicly now. This 

would also be a burden on each State, because they may have to spend 

resources to redact information in accordance with applicable State law. 

Staff has also recently pursued the feasibility of making a version of 

NMED publically available. Staff solicited information from the states and 

members of the general public and held a public meeting in October 2014 

(Agencywide Documents Access and Management System (ADAMS) 

Accession Number ML15036A526). There was no attendance from any 

medical licensees or medical community representatives at the public 

meeting. The high costs of creating and maintaining a public NMED 

coupled with the perceived lack of interest among stakeholders, does not 

support further efforts in this area. Staff recognizes the importance of 

ensuring information is accessible by members of the public. Additional 

efforts to address this recommendation would have minimal benefits but 

increase resource requirements during a period of flat or decreasing 

budgets. 

OIG Response

OIG is not advocating for the creation of a public NMED with this 

recommendation. OIG believes sending licensees a report similar to what 

is provided annually to ACMUI, for example, would be more effective than 

NRC’s current method of providing medical event information (as 

described above). This should also minimize the amount of resources 

needed since the annual report has already been generated by NRC. 

Furthermore, there should be little (if any) extra burden on States because 

the information is already available in the Event Notification Report. 
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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OIG Finding B: Periodic self-assessment of medical event reporting

Agency Comment

Though staff generally agrees that improvement in this area could be 

pursued, a process is already in place to assess event reporting on an 

annual basis. This process looks for trends to identify any abnormalities 

or discrepancies in event reporting. Staff conducts this annual trend 

review, which includes a 5 and 10-year trending analysis, as part of 

preparations for the Agency Action Review Meetings (AARM) each year. 

Event reporting has remained relatively consistent from year to year. No 

trends or indications have been identified that indicate concerns with 

reporting. This information is communicated to the Commission in the 

annual paper on the AARM (see SECY-15-0058). Staff also analyzes all 

medical events that are reported throughout the year on a real-time basis, 

to help identify any adverse trends or corrective actions that need to be 

shared immediately with the medical community through generic 

communications.

OIG Response

The premise of this finding centers on the assessment of the overall 

medical event reporting program. In other words, keeping medical event 

reporting as-is and reviewing the results/trends does not fix any potential 

fundamental issues of the program itself. 

Agency Comment

Recommendation 3 states that staff should “Develop and implement policy 

and procedures that require periodic assessments of NRC’s approach to 

medical event reporting.” These assessments should include whether: 

the intended purpose of reporting requirements is being met, and whether 

the thresholds of the reporting requirements are appropriate. As stated 

above, the NRC does assess medical events, along with all material 

events on a continuous basis and annually. The staff and ACMUI do this 

each year, and staff conducts another broader review to look at long term 

trends in support of the annual AARM meetings. 

OIG Response

As mentioned above, the issue is not with the reported medical events – it 

is with the medical event reporting process as a whole. Specifically, the 

recommendation aims to address issues such as (A) how NRC 
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

40

determines the effectiveness of medical event reporting, (B) if any of 

NRC’s policies potentially discourage licensee event reporting, (C) if any 

of NRC’s policies affect the practice of medicine, and (D) if the purpose of 

medical event reporting is truly being met, etc. A self-assessment of the 

program would help answer these types of questions. 

It should be noted that OIG encountered a significant number of questions 

and complaints, from both industry and NRC staff, about medical event 

reporting. This served as an indication that an internal review of the 

program should be conducted.

Agency Comment

The intended purpose of reporting medical events is to identify causes in 

order to correct and prevent recurrence of significant and adverse events.

Through generic communications, licensees and Agreement States are 

notified if there is a possibility or likelihood that the same errors could 

recur. In addition, the NRC did an evaluation of the appropriateness of the 

medical event reporting requirements with ACMUI assistance as a result 

of an ACMUI briefing to the Commission. This is documented in Staff 

Requirements Memorandum (SRM) - M04032B (ADAMS Accession 

Number ML040760566), dated March 16, 2004. The SRM directed the 

staff to provide the Commission with recommendations concerning the 

current definition of medical events. The staff involved ACMUI in the 

development of these recommendations. The result was to make changes 

to the rule involving medical events for permanent brachytherapy, 

changing the dose based criteria for reporting and defining medical 

events. These changes have been included in the proposed rule change 

to 10 CFR Part 35 published earlier this year. The underlying intent of this 

recommendation is already being accomplished through current staff 

activities. Further analysis or assessment would require additional 

resources (both the NRC and Agreement State) with little benefit. 

OIG Response

While the rulemaking is a potentially positive step, the rulemaking primarily

involves the medical event definition and changes to permanent 

brachytherapy medical event reporting. Further, this process was initiated 

over 11 years ago. The SRM did not address assessing NRC’s medical 

event reporting requirements as a whole. 
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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FSME Policy and Procedure 6-11, published in January 2014, states

Self-assessments are designed to serve as a critical and 

diagnostic evaluation of an organization’s processes and 

activities associated with the implementation of various 

programs. Periodic self-assessments are a proactive 

initiative to ensure compliance with applicable guidance and 

requirements. Specifically, self-assessments serve to 

identify strengths and weaknesses within FSME activities, 

processes, and programs, which will allow for improved 

efficiency and effectiveness. 

FSME plans to conduct self-assessments scheduled in an 

annual self-assessment plan. In addition, FSME will 

occasionally conduct reactive self-assessments in response 

to current issues, such as identifying reasons for out-ofstandard performance, capture lessons-learned from a 

particular activity, prepare for an external assessment, or 

evaluate significant changes to a program. 

While FSME has since merged with NMSS, NRC management informed 

OIG that FSME policy is still relevant and used by NMSS staff today. 

OIG maintains that self-assessments should provide significant value as 

NRC has no comparable program currently in place. While this may 

require additional resources, NRC – not OIG – is ultimately responsible for 

determining the periodicity of the assessments. Therefore, resource 

limitations may be taken into account when determining the periodicity. 

OIG Finding C: Providing better feedback to ACMUI

Agency Comment

Staff agrees it can improve on the feedback to ACMUI. Recommendation 

5 states “Develop and implement policy and procedures to guide provision 

of sufficiently detailed and timely feedback to ACMUI from NRC staff.” 

Updated internal policies and procedures for staff who work with ACMUI 

are currently under revision. Some of the anticipated changes include 

adding additional requirements to provide feedback to ACMUI on what 

staff sends to the Commission, including the committee’s unfettered

opinions, as well as providing additional information to ACMUI with 
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

42

reasons why staff does not agree or does not plan to take action on their 

recommendations. These changes will help to better inform ACMUI 

members of the rationale behind staff’s proposed actions and allow for 

greater dialogue between the NRC and ACMUI.

OIG Response

OIG looks forward to the agency’s efforts in addressing the 

recommendations in this report.
Audit of NRC’s Oversight of Medical Uses of Nuclear Material

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Please Contact:

Email: Online Form

Telephone: 1-800-233-3497

TDD 1-800-270-2787

Address: U.S. Nuclear Regulatory Commission

Office of the Inspector General

Hotline Program

Mail Stop O5-E13

11555 Rockville Pike

Rockville, MD 20852

If you wish to provide comments on this report, please email OIG using this link.

In addition, if you have suggestions for future OIG audits, please provide them using 

this link.

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