July 20, 2011 

Terry Dwelle, M.D., M.P.H.T.M. 

State Health Officer 

North Dakota Department of Health 

State Capitol 

600 East Boulevard Avenue 

Bismarck, ND 58505-0200 

Dear Dr. Dwelle: 

On June 16, 2011, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the North Dakota 

Agreement State Program. The MRB found the North Dakota Agreement State Program 

adequate, but needs improvement, to protect public health and safety, and compatible with the 

U.S. Nuclear Regulatory Commission’s (NRC) program. Because of the significance of the 

findings, the MRB determined that the North Dakota Program should undergo a period of 

Heightened Oversight. Heightened Oversight is an increased monitoring process the NRC 

uses to follow the progress of improvement needed in an Agreement State program. It 

involves preparation of a program improvement plan, bimonthly conference calls, and 

submission of status reports prior to each call with the appropriate North Dakota and NRC 

managers and staff members. 

Section 4.0, page 18, of the enclosed final report contains a summary of the review team’s 

findings and recommendations for the North Dakota Agreement State Program. We request 

that you prepare and submit a program improvement plan as part of your response to the review 

team’s recommendations. I ask that you have your staff discuss the required elements of this 

plan with Mr. Terrence Reis, Acting Director, Division of Materials Safety and State Agreements, 

Office of Federal and State Materials and Environmental Management Programs, to ensure that 

the “get-well” path and measures of success are clearly identified. The plan should be 

submitted within 30 days of receipt of this letter. Upon review of your program improvement 

plan, NRC staff will schedule the first conference call. The initial conference call should be 

scheduled and conducted no later than October 1, 2011. 
T. Dwelle 2 

Based on the results of the current IMPEP review, a Periodic Meeting will be held within 1 year 

to assess the State’s progress in addressing the open recommendations, and a follow-up 

IMPEP review take place approximately 1 year following the Periodic Meeting (2 years from 

current IMPEP). The MRB believes that the performance of a follow-up IMPEP at 

approximately 2 years from the current IMPEP will allow the State sufficient time to correct 

programmatic issues identified during the review. The follow-up review will cover the State’s 

actions in response to the recommendations in the enclosed final report. 

 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

North Dakota Final IMPEP Report 

cc w/encl.: Terry O’Clair, Director 

 Division of Air Quality 
T. Dwelle 2 

Based on the results of the current IMPEP review, a Periodic Meeting will be held within 1 year 

to assess the State’s progress in addressing the open recommendations, and a follow-up 

IMPEP review take place approximately 1 year following the Periodic Meeting (2 years from 

current IMPEP). The MRB believes that the performance of a follow-up IMPEP at 

approximately 2 years from the current IMPEP will allow the State sufficient time to correct 

programmatic issues identified during the review. The follow-up review will cover the State’s 

actions in response to the recommendations in the enclosed final report. 

 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

North Dakota Final IMPEP Report 

cc w/encl.: Terry O’Clair, Director 

 Division of Air Quality 

DISTRIBUTION: EDATS: FSME-0075 

See next page 

ADAMS Accession Number: ML111780525 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME LDimmick DWhite MDelligatti TReis 

DATE 7/1/11 7/1/11 7/5/11 7/9/11 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland CCarpenter 

(RLewis for)

MFWeber 

DATE 7/11/11 7/13/11 07/20/11 

OFFICIAL RECORD COPY 
Letter to Terry Dwelle, M.D. from Michael F. Weber dated: July 20, 2011 

SUBJECT: NORTH DAKOTA FINAL IMPEP REPORT 

DISTRIBUTION: EDATS: FSME-2011-0075 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

JKatanic, FSME/MSSA Commissioner Svinicki 

LDimmick, FSME/MSSA Commissioner Apostolakis 

RBrowder, RIV/RSAO Commissioner Magwood 

Michele Greenwell, KY Commissioner Ostendorff 

RCananio, RIV SECY 

ECollins, RIV 

AHowell, RIV 

KBrock, OEDO 

BJones, OGC 

JBiggins, OGC 

WDean, RI 

Jared Thompson, AR 

DWhite, FSME 

TReis, FSME 

MDelligatti, FSME 

MBeardsley, FSME 

JOlmstead, OGC 

JWeil, OCA (2 copies) 
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NORTH DAKOTA AGREEMENT STATE PROGRAM 

APRIL 4-8, 2011 

FINAL REPORT 
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the North Dakota Agreement State Program. The review was conducted 

during the period of April 4-8, 2011, by a review team composed of technical staff members 

from the U.S. Nuclear Regulatory Commission (NRC) and the Commonwealth of Kentucky. 

The Management Review Board (MRB) met on June 16, 2011, to consider the proposed final 

report. Based on the results of this review, the review team recommended, and the MRB 

agreed, that North Dakota’s performance be found unsatisfactory for one performance indicator 

reviewed; satisfactory, but needs improvement for three performance indicators reviewed; and 

satisfactory for two performance indicators reviewed. 

The review team made 11 recommendations regarding the performance of the North Dakota 

Agreement State Program. These recommendations, which are briefly described below, 

included areas for improvement to correct identified performance deficiencies and weaknesses 

in North Dakota’s Agreement State Program. The review team recommends that the State: (1) 

update its procedures to memorialize the policies and practices of the Agreement State program 

and examine staffing options to effectively implement the program.; (2) ensure that initial 

inspections are performed at the prescribed interval; (3) ensure that inspection findings are 

communicated to licensees in a timely manner; (4) ensure that sufficient information pertaining 

to inspections is appropriately documented and that items of non-compliance are appropriately 

communicated to licensees; (5) obtain additional training to enhance inspection skills; (6) ensure 

that licensing actions are adequately documented and consistent with the regulations and 

licensing guidance; (7) provide additional training regarding the technical review of licensing 

actions and correct deficiencies identified in the licensing casework review; (8) take measures to 

determine and document the basis of confidence that radioactive materials will be used as 

intended and as described in applications or amendment requests; (9) take measures to assure 

that financial assurance requirements are properly implemented; (10) take measures to 

strengthen its incident response program; and (11) take measures to strengthen its allegation 

program. 

The review team recommended, and the MRB agreed, that the North Dakota Agreement State 

Program be found adequate, but needs improvement, to protect public health and safety, and 

compatible with NRC's program. 

Based on the results of the current IMPEP review, the review team recommended, and the MRB 

agreed, that NRC initiate a period of Heightened Oversight for North Dakota. The review team 

further recommended, and the MRB agreed, that a Periodic Meeting be held within 1 year and 

that a follow-up IMPEP review take place approximately 1 year following the Periodic Meeting. 
North Dakota Final IMPEP Report Page 1 

1.0 INTRODUCTION 

Under Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, the U.S. Nuclear 

Regulatory Commission (NRC) has programmatic responsibility to periodically review the 

actions of the Agreement States to comply with the requirements of the AEA to continue to 

maintain adequate and compatible programs. The current review process under the Integrated 

Materials Performance Evaluation Program (IMPEP) is conducted with State staff participation 

under the National Materials Program. 

This report presents the results of the review of the North Dakota Agreement State Program. 

The onsite portion of the review was conducted during the period of April 4-8, 2011, by a review 

team composed of technical staff members from the NRC and the Commonwealth of Kentucky. 

Team members are identified in Appendix A. The review was conducted in accordance with the 

“Implementation of the Integrated Materials Performance Evaluation Program and Rescission of 

Final General Statement of Policy,” published in the Federal Register on October 16, 1997, and 

NRC Management Directive 5.6, “Integrated Materials Performance Evaluation Program 

(IMPEP),” dated February 26, 2004. Preliminary results of the review, which covered the period 

of April 20, 2007, to April 8, 2011, were discussed with North Dakota managers on the last day 

of the review. 

A draft of this report was issued to North Dakota for factual comment on May 2, 2011. The 

State responded by electronic mail dated May 31, 2011, and a revised response dated June 13, 

2011, from Daniel E. Harman, Manager, Division of Air Quality. Copies of the State’s responses 

are included as an Attachment to this report. The Management Review Board (MRB) met on 

June16, 2011, to consider the proposed final report. The MRB found the North Dakota 

Agreement State Program adequate to protect public health and safety, but needs improvement 

and compatible with NRC’s program. 

The North Dakota Agreement State Program is administered by the Radiation and Indoor Air 

Branch (the Branch), in the Division of Air Quality (the Division). The Division is part of the 

North Dakota Department of Health (the Department). Organizational charts for the Branch, the 

Division, and the Department are included as Appendix B. 

At the time of the review, the North Dakota Agreement State Program regulated approximately 

76 specific licenses authorizing byproduct, source, and certain special nuclear materials. The 

review focused on the radioactive materials program as it is carried out under the Section 274b 

(of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of 

North Dakota. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Branch on December 21, 2010. The Branch 

provided its response to the questionnaire via email on March 19, 2011, with supplemental 

information provided on March 21, 2011. A publicly available version of the questionnaire 

response can be found in NRC’s Agencywide Documents Access and Management System 

(ADAMS) using the Accession Number ML110810051. 

The review team's general approach for conduct of this review consisted of: (1) examination of 

the Branch’s response to the questionnaire; (2) review of applicable North Dakota statutes and 
North Dakota Final IMPEP Report Page 2 

regulations; (3) analysis of quantitative information from the Branch’s databases; (4) technical 

review of selected regulatory actions; (5) field accompaniments of two inspectors; and 

(6) interviews with staff and managers. The review team evaluated the information gathered 

against the established criteria for each common and the applicable non-common performance 

indicator and made a preliminary assessment of the North Dakota Agreement State Program’s 

performance. 

Results of the review for the common performance indicators are presented in Section 2.0. 

Section 3.0 details the results of the review of the applicable non-common performance 

indicators, and Section 4.0 summarizes the review team's findings and recommendations. The 

review team’s recommendations are comments that relate directly to the Division’s 

performance. A response is requested from the State to all recommendations in the final report. 

2.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review NRC Regional and Agreement State 

radioactive materials programs. These indicators are: (1) Technical Staffing and Training, 

(2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical 

Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities. 

2.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Branch’s staffing level and staff 

turnover, as well as the technical qualifications and training histories of the staff. To evaluate 

these issues, the review team examined the Branch’s questionnaire response relative to this 

indicator; interviewed managers and staff, reviewed job descriptions and training records, and 

considered any workload backlogs. 

When fully staffed, the North Dakota Agreement State Program is composed of a manager and 

two technical staff. The manager and technical staff conduct inspections, perform licensing 

actions, and respond to incidents and allegations based on individual qualifications. The 

manager and technical staff members have at least a bachelor’s degree in a physical or life 

science or engineering. Based on information provided by the Branch, the review team 

estimated that the Division expends approximately 2.8 to 3.0 full-time equivalents (FTE) to 

administer the Agreement State program, which includes support from the Division Director and 

some limited administrative support. 

During the review period, there was a Branch management change as well as several technical 

staff changes. Immediately following the previous IMPEP review, the Branch manager, who 

had several years of radioactive materials experience, left the Division. Within about two 

months, the manager position was filled with the current Branch manager. The current Branch 

manager has many years of experience with the State, but has only been involved with the 

radioactive materials program since becoming the Branch manager approximately four years 

ago, and has limited prior experience with radioactive materials. Furthermore, the technical 

staff experienced significant turnover during the review period. During the review period, the 

Branch has been able to readily fill vacancies but has not been able to retain staff. The two 

technical staff present during the previous IMPEP review both left the Branch. In both cases, 

the vacancies were promptly filled. The two technical staff members that were hired to fill the 
North Dakota Final IMPEP Report Page 3 

vacancies also left the Branch. One individual left after approximately 11 months and the 

second individual left after approximately two and a half years. Both of these vacancies were 

promptly filled. The two current technical staff members have appropriate education and 

background but no prior regulatory experience. One individual has been with the Branch for 

approximately one year and four months and the other individual for approximately eight 

months. The review team explored the reason for the high staff turnover and concluded that 

staff had left the program for varying reasons, including leaving for employment with other 

Agreement State programs, for other higher paying jobs, and for personal reasons. 

During the review period, it was recognized by the Branch that staff turnover and inexperience 

of new staff members could impact the quality of the State’s radioactive materials program. 

Consequently, NRC had coordinated with the State of Minnesota to provide support to North 

Dakota. As a result, experienced staff from the Minnesota Agreement State program provided 

on-the-job training and inspection assistance to North Dakota staff, including the Branch 

manager. Additionally, the Branch manager and one of the former North Dakota technical staff 

traveled to Minnesota to observe inspection activities. Other than the current Branch manager, 

the North Dakota technical staff members who were recipients of this additional training are no 

longer with the Branch. 

Training and qualification requirements for Branch staff had been established in the North 

Dakota Radiation Control Program Administrative Procedures Manual. Training and 

qualification is documented through the use of a “Training Regimen Checklist.” This is 

consistent with the requirements in the NRC/Organization of Agreement States Training 

Working Group Report and NRC’s Inspection Manual Chapter (IMC) 1246, “Formal Qualification 

Programs in the Nuclear Material Safety and Safeguards Program Area.” 

The Branch’s qualification process consists of formal coursework, observations of inspections, 

and supervised inspections. After supervised inspections are performed for different license 

types, there is a “sign-off” that indicates that the individual is authorized to perform inspections 

independently. The Branch manager, who also performs inspections, has completed all formal 

coursework. One current member of the technical staff is making steady progress toward 

completion of formal coursework and was authorized to perform several types of inspections 

independently. The most recent member of the technical staff has begun the qualification 

process by taking formal coursework but has not yet been authorized to perform independent 

inspections.

Given the high rate of turnover in the Branch, the review team discussed with the Branch 

manager and Division Director the value of having some type of knowledge management 

program. Because of staff turnover during the review period, the Branch manager has had to 

spend a significant portion of his time implementing the licensing and inspection program. This 

has not left the Branch manager with sufficient time to “manage” and develop the program. In 

January 2011, the Branch manager began updating some Branch procedures, however there 

remains a significant amount of work necessary to develop a sustained program in the event of 

further staff losses. 

With a small program, the Branch has often relied on verbal communication to implement new 

policies and practices. This practice can be effective in a small program where there is limited 

turnover; however, in a program with a high turnover rate, the documentation of policies and 
North Dakota Final IMPEP Report Page 4 

practices is very important. The review team determined that a majority of the program’s 

knowledge was lost with the departure of the former Branch manager and with other former 

members of the technical staff. Some portion of the program’s knowledge resides in the 

Division Director and the Branch manager. In the event of one of these individuals leaving the 

Division, there is a danger in the further loss of program knowledge. This concern will need to 

be addressed to ensure the long-term health of the Agreement State program. Programmatic 

knowledge retention therefore, is not only dependent on having documented tools to implement 

the program but is also dependent on retaining qualified personnel and/or having sufficient 

depth in staffing to effectively implement the program. The review team recommends that the 

State: (1) update its existing procedures and develop new procedures, as necessary, to 

memorialize the policies and practices of the Agreement State program and to serve as a 

knowledge management tool, and (2) examine options to increase staff retention and/or develop 

sufficient depth in staffing to effectively implement the program. 

The review team discussed the appropriate finding for this indicator. The review team 

considered a finding of satisfactory, but needs improvement, because of the chronic issue of 

staff turnover. In reaching a recommendation for this indicator, the review team recognized that 

the Branch is currently fully staffed with individuals that possess both education and background 

that will serve as a strong base toward becoming fully qualified inspectors and license 

reviewers. The review team believes that if provided with additional training, including on-the 

job training, these individuals can excel and be successful in carrying out the program. The 

team did however identify specific training issues related to the technical quality of inspections 

and technical quality of licensing actions. These are described in Section 2.3, “Technical 

Quality of Inspections” and Section 2.4, “Technical Quality of Licensing Actions,” respectively. 

Because the review team addressed the need for additional training in its review of the other 

indicators, the review team believed that a finding of satisfactory was the more appropriate 

finding for this indicator. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Technical Staffing and Training, 

be found satisfactory. 

2.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely dispatch of inspection findings to 

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 

on the Branch’s questionnaire response relative to this indicator, data gathered from the 

Branch’s database, examination of completed inspection casework, and interviews with the 

Branch manager and current technical staff members. 

The review team verified the Branch’s inspection frequencies for various license types are as 

frequent as those found in NRC’s Inspection Manual Chapter (IMC) 2800, “Materials Inspection 

Program.” During the review period, the Branch corrected the inspection frequency for its highdose rate remote afterloader licensees from every 3 years to every 2 years as found in NRC’s 

IMC 2800. On January 1, 2011, the Branch adopted as policy the recent revision to NRC’s IMC 

2800, which was issued on November 15, 2010. The Branch had originally designated the 

radionuclide production (cyclotron) license to be performed on a 5 year frequency; however to 
North Dakota Final IMPEP Report Page 5 

be consistent with the recent revision to NRC’s IMC 2800, the frequency was recently changed 

by the Branch to every 2 years. 

The Branch’s database had limited capabilities for retrieval of inspection data from the entire 

review period. For most inspections performed by the Branch, the data from the most recent 

inspection could be retrieved, resulting in the review team being able to review data from 

approximately the last 1-3 years of the review period. Therefore, in order to facilitate its review 

of this indicator, the review team not only verified the Branch’s inspection timeliness based on 

the information that could be obtained from the database but also performed interviews with 

staff members and reviewed the inspection case work for determination of Priority 1, 2, 3, and 

initial inspections. As could be determined based on the information provided by the Branch, 

over the review period, the Branch performed 23 Priority 1, 2, and 3 inspections, of which 2 

were performed overdue (i.e. greater than 25% of the assigned inspection frequency) and none 

were overdue at the time of the review. Initial inspections are to be conducted within 12 months 

of license issuance. The review team found that 10 new licenses had been issued during the 

review period but that five were not yet due for inspection at the time of the review. Of the 

remaining five new licenses, three initial inspections were conducted on time, one was 

conducted overdue (i.e. greater than 1 year after issuance of the license), and one was overdue 

at the time of the review. Overall, the review team calculated that the Branch performed 15 

percent of its inspections overdue during the review period. The review team concluded that the 

percent of inspections overdue was caused, in part, due to issues associated with chronic staff 

turnover, deficiencies in the data entered into the Branch’s database, and limitations of the 

Branch’s database to serve as an inspection planning and scheduling tool. 

During the previous IMPEP review, the Branch struggled with this indicator to meet the 

inspection timeliness criteria. This was due, in part, to a practice of setting the inspection due 

date as the end of the 25% window date. During the review period, the Branch corrected this 

practice and set the inspection due date as the inspection date plus 1, 2, or 3 years as 

appropriate. This change helped correct the timeliness issue for Priority 1, 2, and 3 inspections. 

However, the Branch did not identify that initial inspections need to be performed within 1 year 

of the license issue date. Additionally, when new licenses were issued, the Branch did not have 

a routine practice of setting a due date in its database. As a result, in some cases, the due date 

was left blank and the initial inspections never appeared on the due list. The review team 

recommends that the State take measures to ensure that initial inspections are performed at the 

interval prescribed in NRC’s IMC 2800. 

The review team verified the Branch’s performance of all initial inspections of licensees subject 

to the Increased Controls no later than three years after the date of implementation of the 

Increased Controls. When the Increased Controls were issued, the Branch had eight licensees 

subject to the Increased Controls. At the time of the review, the Branch had 11 licensees 

subject to the Increased Controls. The State implemented the Increased Controls requirements 

through license conditions and all initial inspections of the Increased Controls were to be 

completed before the end of 2008. The review team found that one licensee subject to the 

initial round of Increased Controls inspections had two locations subject to the requirements. 

The review team found that the Branch’s database did not allow for the tracking of inspection 

information for licenses that have multiple locations of use/storage. The review team conducted 

a search of the Branch’s hard copy inspection records for the licensee in question, and found 

that one of the locations had been inspected against the Increased Controls but there was no 
North Dakota Final IMPEP Report Page 6 

record of any kind that the second location had been inspected by the Branch since 1999, prior 

to the issuance of the Increased Controls. Further review and follow-up by the review team 

found evidence, some of which was anecdotal, that the second location had been inspected in 

2007 and again in 2008. However, the results of these inspections were not documented and it 

is not clear whether the inspections addressed the Increased Controls requirements or if they 

only addressed health and safety requirements. None of the individuals who were associated 

with performing the missing inspections were with the Branch at the time of the review. This 

matter was discussed with the Branch manager, who acknowledged that there was no record of 

the inspections having been performed or any documentation of the results of the inspections. 

As a result, the Branch manager made a plan to conduct an inspection of the location, including 

the licensee’s implementation of the Increased Controls, for the week following the review. 

The review team evaluated the Branch’s timeliness in issuing inspection findings. The Branch 

generally communicates these findings to licensees by issuing a “Letter of Compliance” or a 

“Letter of Apparent Non-Compliance.” The review team found that, based on the information 

provided from the Branch’s database 21 of 55 of the Branch’s inspection findings were issued 

greater than 30 days following the date of the inspection. This was further supported by a 

review of the inspection case files. The review team found that inspection findings related to 

one inspection that identified significant health and safety issues were not issued by the Branch 

until 38 days following the inspection. The review team discussed with the Branch manager the 

need to document the reasons for any delays in issuing inspection findings to licensees, 

especially when matters important to health and safety or security are being addressed. The 

review team recommends that the State take measures to ensure that inspection findings are 

communicated to licensees within 30 days of the date of the inspection. 

During the review period the Branch granted approximately 42 reciprocity requests that that they 

identified as candidates for inspection as described in NRC’s IMC 1220 “Processing of NRC 

Form 241 and Inspection of Agreement State Licensees Operating under 10 CFR 150.20.”

Based on the Branch’s questionnaire response and review of documents provided during the 

review, the review team found that the Branch was unable to consistently perform inspections of 

20 percent of the reciprocity licensees annually. During one year of the review period, the 

Branch was unable to perform any inspections of licensees operating under reciprocity. During 

each of the other years of the review period, the Branch performed inspections of: 30 percent, 

11 percent, and 18 percent of licensees operating under reciprocity. Historically the Branch has 

had difficulty achieving the 20 percent described in NRC’s IMC 2800 due, in large part, to the 

geographical location of reciprocity activities (e.g. well logging activities are prevalent in the far 

north and western portions of the State), and challenges presented by weather conditions. 

During the review period, an additional challenge in performing reciprocity inspections was also 

due in part to staff turnover. 

Many of the issues identified above (e.g. timeliness of initial inspections, performance of 

inspections of multiple use locations, timeliness of issuance of inspection findings) could be 

attributed, in part, to deficiencies associated with the Branch’s database. The review team 

found several errors associated with the information contained in the Branch’s database. In 

some cases, the inspection due date was blank and therefore the inspection never appeared on 

the “to do” list of inspections. If the quality of the information in the database was improved and 

some features were enhanced, it could be a very useful tool for the Branch. Another matter that 

contributed to the issues identified above is lack of management oversight. Due to the technical 
North Dakota Final IMPEP Report Page 7 

staff turnover issues described in Section 2.1, the Branch manager has been filling a more 

technical staff-type role and has had to spend substantial time either performing or assisting 

with inspections and training of new staff members. As a result, the Branch manager has not 

been able to sufficiently oversee the Branch activities from a management perspective (e.g. 

plan and track Branch inspection activities). The Branch manager indicated that there are plans 

to review the information contained in the database and develop additional useful features to 

prevent recurrence of some of the identified problems. The Branch manager believes that with 

the current stability of the technical staff, he will be able to devote more time to planning and 

overseeing Branch activities. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota's performance with respect to the indicator, Status of Materials Inspection 

Program, be found satisfactory, but needs improvement. 

2.3 Technical Quality of Inspections

The review team evaluated 13 inspection reports that included inspection records, enforcement 

documentation and letters to licensees, and interviewed the Branch manager and technical staff 

members who were responsible for some of the radioactive materials inspections conducted 

during the review period. The casework reviewed covered a wide variety of inspection types, 

including academic broad scope, radionuclide production (cyclotron), industrial radiography, 

self-shielded irradiators, and medical-written directives required, and also included inspections 

conducted by the current Branch manager and one technical staff member as well as 3 former 

technical staff members. Appendix C lists the inspection casework files reviewed as well as the 

results of the inspector accompaniments performed by the review team. 

Based on the review of casework, the review team noted that some inspections did not address 

all aspects of the licensees’ radiation safety programs. Based on the evaluation of casework, 

the review team determined that inspection reports were frequently not thorough, were 

incomplete, inconsistent, and did not contain sufficient documentation to ensure that licensees’ 

performance with respect to health, safety, and security were acceptable. Additionally, 

inspection documentation did not always address review by the current inspector of items of 

non-compliance that were identified during previous inspections. 

If potential non-compliance items are identified during an inspection, the Branch issues a Letter 

of Apparent Non-Compliance. The letters are dispatched to licensees after the Branch manager 

reviews the inspection record and the accompanying letter. Such letters are submitted to the 

Division Director for signature and issuance to the licensee. The review team found that some 

Letters of Apparent Non-Compliance did not address items of non-compliance that were 

documented in the inspection records. Additionally, some letters did not provide sufficient detail 

to facilitate appropriate licensee corrective actions. The review team found that some 

inspection documentation did not always support identified items of non-compliance. When 

items of non-compliance are not well supported in the inspection record, it is difficult to follow-up 

on these items during future inspections. The review team recommends that the State: (1) take 

measures to ensure that sufficient information pertaining to inspection observations and 

identified non-compliances is documented in inspection records and in letters to licensees and 

that these documents be appropriately reviewed by management, prior to issuance, for 

thoroughness and consistency, and (2) develop and implement a plan to address comments 
North Dakota Final IMPEP Report Page 8 

noted in Appendix C related to identified items of non-compliance that were not included in 

findings that were dispatched to licensees. 

The Branch’s written policy was that at least 10% of all field inspections include the Branch 

manager or Division Director. The review team found that during the review period, the Branch 

manager had accompanied all qualified staff performing radioactive materials inspections on an 

annual basis. During some accompaniments, the Branch manager participated in inspection 

activities as well as reviewed inspector performance. 

The review team noted that the Branch maintained appropriately calibrated survey instruments 

to support the inspection program. The Branch possessed two kits that each contained a 

survey meter with several detector/probe types for performing surveys of various radiological 

conditions. The instrumentation is calibrated by an outside vendor according to the 

manufacturer’s recommendations. The Branch manager noted that additional survey meters 

were going to be acquired concurrent with the replacement of some older out-of-service 

instrumentation. 

A review team member accompanied the Branch manager and one member of the technical 

staff during inspections the week of January 31, 2011. Because performance issues were 

identified by the review team member during the accompaniments, a second week of 

accompaniments was performed the week of March 14, 2011. In accordance with the State’s 

training program, the Branch manager is a fully qualified inspector. The other individual that 

was accompanied was not a fully qualified inspector but was qualified to independently perform 

inspections of most license types. The inspections selected were in areas the inspector was 

qualified to inspect. The license types inspected as part of the accompaniments included a 

facility that produced radionuclides with a cyclotron, academic broad scope, industrial 

radiography, and medical facilities that performed various diagnostic and therapeutic 

procedures, including activities involving radioiodine therapy, permanent implant brachytherapy, 

and high dose-rate remote afterloader brachytherapy. Two of the inspections included a review 

of the licensee’s implementation of the Increased Controls. The accompaniments and 

associated comments are identified in Appendix C. 

In January 2011, the Branch moved from a more compliance-driven inspection procedure to a 

performance-based inspection procedure. During the accompaniments, the inspectors made a 

strong effort to incorporate interviews with appropriate personnel and performance observations 

into their inspection activities. However, the inspectors often did not adequately follow-up on 

potential items of non-compliance that were observed during the performance reviews. For 

some areas inspected, the inspectors did not have sufficient familiarity with the regulations or 

with certain regulatory requirements. These areas included regulatory requirements related to 

procedures requiring written directives, patient release criteria, and the Increased Controls. 

Both inspectors had done some level of preparation prior to the inspections, but in some cases, 

the prior review of authorized activities, license conditions, and inspection history was not 

adequate. Although both inspectors have attended formal training courses, due to staff turnover 

issues neither has received much on-the-job training or mentoring by experienced inspectors. 

During the observed inspections, the inspectors did not understand the importance of 

performing independent radiation surveys of licensed activities. When independent radiation 

surveys were performed, the inspectors did not use appropriate techniques. Furthermore, the 
North Dakota Final IMPEP Report Page 9 

inspectors did not have an adequate understanding of proper operation of their radiation 

detection and measurement instrumentation. There was a lack of understanding of how to 

source-check the Branch’s instrumentation to verify operability, a lack of understanding of the 

efficiencies of the Branch’s instrumentation associated with the detection of various 

radionuclides, and there were general issues with basic operation of the equipment. 

The inspectors were not adequately prepared for the inspection of the radionuclide production 

(cyclotron) facility. The inspectors did not have familiarity with the licensed cyclotron operations 

or with radiation safety and health physics issues associated with cyclotron operations. As a 

result, the inspection did not identify several health physics and radiation safety issues 

associated with these risk-significant operations. As an example, the inspector accepted the 

licensee’s explanation that an alarm condition on an in-line monitor was due to it malfunctioning. 

However, the alarm condition was likely due to irradiated targets being stored improperly in the 

vicinity of the radiation monitor. Had the inspectors been performing appropriate independent 

radiation surveys, they would have identified this condition and the resulting radiation safety 

hazard. 

During the observed inspections of the Increased Controls and Fingerprinting requirements, the 

inspectors did not have an adequate understanding of the requirements and therefore had 

difficulty assessing licensee compliance with the requirements. In one case, the inspector did 

not identify or understand the security significance of an item of non-compliance. During the 

exit meeting with licensee management, the inspector was unable to clearly articulate the 

applicable requirements and was unable to explain to the licensee what actions could be taken 

to correct the identified deficiencies. 

The review team member’s observations were shared with the inspectors throughout the 

accompaniment process. Additionally, the review team member’s observations were discussed 

with the Division Director. When notified of these observations, the Division Director indicated 

that past issues related to staff turnover had likely contributed to the issues observed during the 

inspections. The review team member noted that the quality of inspections had somewhat 

improved from the first week of observed inspections to the second week, and that the 

inspectors had learned from the earlier discussions with the review team member and had 

incorporated some changes to their inspections. 

The review team recommends that the State obtain additional training (formal and on-the-job, as 

appropriate) for the Branch manager and members of the technical staff to enhance inspection 

skills, particularly with regards to: (1) radiation safety issues associated with cyclotron 

operations, and (2) proper operation and use of radiation survey and measurement 

instrumentation. 

At the conclusion of the review, the review team discussed with the Division Director and 

Branch manager that their preliminary recommendation was that this indicator be found 

satisfactory, but needs improvement. However, upon further review of the totality of information 

gathered during the review (e.g. inspection case files, inspector accompaniments), the review 

team re-evaluated the criteria in MD 5.6 and believes that a finding of unsatisfactory is more 

appropriate for this indicator. In particular, the inspection case files that were reviewed 

indicated problems with completeness, technical quality, consistency, attention to health and 

safety/security, and management review throughout the review period and across former 
North Dakota Final IMPEP Report Page 10 

inspectors as well as current inspectors. Additionally, the inspector accompaniments indicated 

problems with completeness, technical quality, and attention to health and safety/security. One 

individual that was accompanied has been with the program for 4 years and was partially 

responsible for training other inspectors during the review period. Based on the review team 

member’s observations during the inspector accompaniments, it was evident that the observed 

inspection deficiencies have existed throughout the review period and are indicative of a 

programmatic and chronic problem rather than an isolated occurrence or a periodic decline in 

performance. Therefore, based on the review of the inspection case files and the inspector 

accompaniments, the review team believes that the issues with respect to inspection 

completeness, technical quality, consistency, attention to health and safety/security, and 

management review, are chronic and have existed throughout the review period rather than 

being periodic or limited to portions of the review period. On April 28, 2011, this matter was 

discussed with the Division Director, who acknowledged the review team’s decision to revise its 

recommendation for this performance indicator. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Technical Quality of Inspections, 

be found unsatisfactory. 

2.4 Technical Quality of Licensing Actions

The review team examined completed casework and interviewed license reviewers for 

17 licensing actions covering 13 specific licenses. Licensing actions were reviewed for 

completeness, consistency, proper radioisotopes and quantities, qualifications of authorized 

users, adequacy of facilities and equipment, adherence to good health physics practices, 

financial assurance, security requirements, operating and emergency procedures, 

appropriateness of license conditions, and overall technical quality. The casework was also 

reviewed for use of appropriate correspondence, reference to appropriate regulations, 

supporting documentation, consideration of enforcement history, pre-licensing visits, peer and 

supervisory review, and proper signatures. 

The licensing casework was selected to provide a representative sample of licensing actions 

completed during the review period. There were 126 licensing actions completed during the 

review period. Licensing actions selected for evaluation included four new licenses, four 

renewals, eight amendments, and one license termination. Casework reviewed included a 

cross-section of license types, including: industrial radiography, radionuclide production 

(cyclotron), academic broad scope, medical institution-written directive required, fixed gauge, 

and mobile nuclear medicine. The licensing casework selected also represented licensing 

actions that were performed by one current license reviewer and three previous license 

reviewers. A listing of the licensing casework reviewed can be found in Appendix D. 

Licensing actions were received by the Branch via mail, fax, or electronic mail. The Branch 

assigned the licensing action to a reviewer and subsequently updated the status and 

assignment of the licensing action in the Branch’s database. The licensing staff used formal 

correspondence for technical notices or deficiencies. On some occasions, the staff used 

electronic mail to follow up with deficiency notices. 

The review team identified several licensing actions which had incomplete evaluations of the 
North Dakota Final IMPEP Report Page 11 

health and safety issues and a lack of technical quality. In one case, the Branch issued a 

license for a complex, highly safety-significant technology without a thorough technical review 

that conformed with the licensing guidance and ensured health and safety of the workers and 

the environment. Other case files reviewed indicated instances where licensee’s or applicant’s 

operating & emergency procedures did not completely address health and safety issues for 

unsealed radioactive materials, or which allowed different survey frequencies and different 

dosimetry calibration ranges than what is allowed by the regulations. In addition, there were two 

case files reviewed where radiography cameras were authorized for a quantity of radioactive 

material that exceeded the activity specified in the Sealed Source & Device Registry. 

The review also identified several instances where licensing actions for medical use licensees 

were authorized with incomplete documentation of the training and experience of an Authorized 

User. These instances included two different physicians who were authorized for 10 CFR 

35.200 and 10 CFR 35.400 modalities. In one case, the authorization for the 10 CFR 35.200 

modality was granted by the Branch based on a specialty board certification that was not 

recognized by the NRC. In another case, the authorization for the 10 CFR 35.400 modality was 

granted by the Branch based on a specialty board certification that was dated prior to the date 

that the specialty board certification was recognized by the NRC for 10 CFR 35.400. The 

review team recommends that the State: (1) take measures to ensure that the Branch’s review 

of licensing actions are adequately documented and that licensing actions are thorough and 

consistent with the regulations and appropriate licensing guidance, and (2) take measures to 

address the licensing deficiencies that were identified in the comments in Appendix D. 

The review team observed that the Branch did not typically review the enforcement history 

during the license renewal process. Since there has been a significant staff turnover during the 

review period, the review team expressed to the Branch that license renewals are opportunities 

for the staff to review the licensee’s history and to evaluate the historical licensing and 

inspection documentation and perform a quality assurance assessment of the license file. 

The review team discussed the identified licensing deficiencies with the Branch manager and in 

part, suggested additional technical licensing training for the staff as an adjunct to any licensing 

training already received. The Branch manager acknowledged that the types of deficiencies 

identified would likely be corrected and resolved with additional technical training. The review 

team recommends that the State provide additional training to the Branch manager and 

technical staff members regarding technical review of licensing actions, including training to 

ensure that the staff acquires increased familiarity with: (1) the regulations under North 

Dakota’s equivalent to 10 CFR Parts 30 through 39, and (2) applicable licensing guidance 

documents for use authorization and license conditions. 

The Branch has initiated the process to address maximum possession limits on radioactive 

materials licenses as requested by Office of Federal and State Materials and Environmental 

Management Programs (FSME) Letter RCPD-10-007, “Requesting Implementation of a Policy 

on Maximum Possession Limits for Radioactive Material Licenses” dated June 21, 2010. The 

Branch was addressing this action as licensees requested amendments or renewals to their 

licenses. 

The review team assessed the Branch’s implementation of NRC’s pre-licensing guidance issued 

on September 22, 2008, and transmitted to the Agreement States via FSME Letter RCPD-08-
North Dakota Final IMPEP Report Page 12 

020, “Requesting Implementation of the Checklist to Provide a Basis for Confidence That 

Radioactive Material Will Be Used as Specified on a License and the Checklist for RiskSignificant Radioactive Material.” Based on the licensing casework reviewed, the Branch had 

not consistently implemented the essential elements of the pre-licensing guidance under the 

previous staff members. In the more recent cases that were reviewed, the Branch had 

performed the pre-licensing visits; however, there was inconsistent documentation of the prelicensing checklist and pre-licensing visits. The review team recommends that the Branch take 

measures to determine and document the basis of confidence, through consistent use of the 

pre-licensing checklist and guidance, that radioactive materials will be used as intended and as 

described in the application or amendment request, prior to authorizing the material on the 

license. 

Based on the licensing and inspection casework reviewed, the review team identified three 

licenses that potentially required financial assurance. The Branch had previously identified one 

of these licenses as requiring financial assurance; however, at the time of the review, the 

Branch was not able to locate the financial assurance instrument or documentation. The 

remaining two licenses identified by the review team did not have financial assurance 

instruments issued. One of the identified licenses did not properly authorize the incidental 

activated products and therefore financial assurance had not been evaluated by the Branch. 

The Branch indicated they would review the respective license to evaluate the maximum 

amount of incidental activated radioactive material for any possible financial assurance 

requirements. The second license authorized unsealed byproduct material in a quantity amount 

that would potentially require a decommissioning funding plan. Regarding financial assurance, 

the review team recommends that the State: (1) develop a procedure or policy to assess 

financial assurance requirements as part of significant licensing actions and during licensing 

renewals; (2) review all North Dakota licenses to determine whether licensees require financial 

assurance, and either request financial assurance for licenses that are authorized to possess 

the applicable quantities or revise the license conditions to ensure clear quantity limits that will 

not require provision of financial assurance; and (3) take measures to ensure that any financial 

assurance instruments received by the Branch are maintained and stored in accordance with 

State requirements. 

The review team verified that the Branch used license conditions to require licensees to follow 

Increased Controls and Fingerprinting requirements. The review team determined that 

documents containing sensitive security-related information were appropriately controlled and 

maintained in a manner to limit access. Specifically, the Branch maintained documents that 

contained sensitive security-related information in a locked file cabinet; access to the key for the 

file cabinet was limited to persons who had been granted access by the Branch manager. The 

review team found that some of the documents that contained sensitive security-related 

information were marked in a header and footer as containing sensitive information but others 

had not been marked. This matter was discussed with the Branch manager. Based on this 

discussion, the review team determined that when the Increased Controls were first issued, the 

Branch marked all the licenses using appropriate header and footer markings. However, there 

was no Branch policy or procedure to maintain these markings. As a result, during subsequent 

licensing actions the headers and footers were inadvertently not retained. When this was 

further discussed with the Branch manager, the Branch manager immediately developed a 

written policy and procedure for the technical staff and administrative support staff to follow 

when processing documents that contain sensitive security-related information. The Branch 
North Dakota Final IMPEP Report Page 13 

manager indicated that the technical staff members and administrative support staff would be 

briefed on the new policy and procedure. The review team did not identify any instances of 

improper release of information. 

The review team determined that during the latter part of the review period, the Branch had 

begun to develop licensing templates and follow the NRC NUREG-1556 licensing guidance 

more diligently. The review team recognized that the current members of the technical staff are 

still considered in-training for several of the licensing types; however, the licensing actions 

appeared to be more thorough, complete and consistent. As licensing questions arise, the 

current technical staff members have been reaching out to NRC for additional guidance in 

appropriately processing licensing actions. Although many deficiencies were noted in the 

licensing casework review, the review team did not believe that a finding of unsatisfactory was 

warranted for this indicator but rather a finding of satisfactory, but needs improvement, was 

more appropriate for this indicator. The review team’s finding was based on several factors, 

including that the identified deficiencies, other than the radionuclide production (cyclotron) 

license, indicated examples where health and safety concerns were not fully addressed, rather 

than a failure to address health and safety concerns. The radionuclide production license did 

fail to address potentially important health and safety concerns, but this was an isolated 

example of a unique and complex licensing action, rather than being indicative of a 

programmatic licensing breakdown. Additionally, the review of licensing casework indicated that 

licensing deficiencies appeared to be more prevalent in licensing actions completed by former 

staff members rather than during the latter part of the review period. The current staff members, 

who have been present during the latter part of the review period, appear to have a more 

questioning attitude regarding processing licensing actions, leading to better quality license 

reviews. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Technical Quality of Licensing 

Actions, be found satisfactory, but needs improvement. 

2.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Branch’s actions in responding to incidents and 

allegations, the review team examined the Branch’s response to the questionnaire relative to 

this indicator, evaluated selected incidents reported for North Dakota in the Nuclear Material 

Events Database (NMED) against those contained in the Branch’s files, and evaluated the 

casework for 9 reported radioactive materials incidents. A listing of the casework examined, 

with case-specific comments, can be found in Appendix E. The review team also evaluated the 

Branch’s response to 2 allegations that were received by the Branch during the review period. 

The NRC did not refer any allegations to the Branch during the review period. 

The incidents selected for review included incidents related to: damaged equipment, equipment 

failure, overexposure, contamination, and lost radioactive material. The review team found that 

when incidents were reported to the Branch by licensees, the Branch in turn reported the events 

to NRC Headquarters Operations Center as appropriate and in a timely manner. Updates to 

information regarding reported incidents were found to have been promptly provided by the 

Branch to the contractor administering the Nuclear Material Events Database (NMED). The 

review team identified that a few NMED entries for North Dakota events still needed a final 
North Dakota Final IMPEP Report Page 14 

closeout in NMED. This was discussed with the Branch manager so that the events can be 

closed in NMED as appropriate. 

The review team’s evaluation of selected incident case files found that the Branch’s responses 

to incidents was often not well coordinated, was inconsistent, and in several cases, not 

thorough. Based on a review of Branch procedures and discussions with the Branch manager 

and technical staff, it was revealed that the Branch did not have any formal or informal 

procedures to respond to radioactive materials incidents. Although the Division has procedures 

for responding to large-scale events involving radioactive materials, such as a dirty bomb, there 

were no similar procedures for responding to routine radioactive materials incidents, such as 

reports of overexposures or equipment failures. 

Due to the lack of incident evaluation and response processes or procedures, when the Branch 

received notification of an incident, there was no consistent approach to perform an initial 

evaluation of the safety or security significance of an incident to determine the type or level of 

Branch response. In most cases, on-site inspections or evaluation of incidents were not 

performed by the Branch and the incidents were instead reviewed in-office through an 

evaluation of licensee reports. The review team found that the Branch’s review of licensee 

incident reports was inconsistent. In some cases, licensee reports did not contain corrective 

actions as required by regulation and it did not appear that this was recognized by the Branch 

so that further information could be obtained from the licensee. In other cases, when corrective 

actions were described in licensee reports, the Branch’s review did not appear to be thorough in 

that in a few cases it was not recognized by the Branch that the described corrective actions 

would not be adequate to prevent recurrence of the incident. 

For two of the nine incidents examined by the review team, the Branch responded on-site to 

gather additional information and interview individuals involved in the incident. The review 

team’s evaluation of the case files for the two incidents found that information gathered by the 

Branch during the on-site visit was not formally documented. The lack of appropriate 

documentation of the review by the Branch does not provide for knowledge management of the 

information gathered to facilitate future follow-up. Consequently, on-site reviews did not result 

in any documented independent review or analysis of the incidents. In both cases, Branch 

members involved in the on-site incident response were no longer with the Branch at the time of 

the review and therefore were not available for interview or to provide any formal 

documentation. 

 

The review team recommends that the State strengthen its incident response program and take 

measures to ensure that: (1) reported incidents are consistently evaluated to determine the 

appropriate type and level of Branch response; (2) licensee event reports are reviewed by the 

Branch for completeness and appropriate corrective actions; and (3) the Branch’s evaluation of 

licensee events, whether based on a review of licensee reports, on-site reviews, or inspection 

follow-up, is properly documented to facilitate future follow-up. 

In evaluating the effectiveness of the Branch's response to allegations, based on a review of 

Branch procedures and discussions with the Branch manager and technical staff, it was 

identified that during most of the review period, the Branch did not have a formal procedure to 

respond to allegations involving licensed activities. Although the Branch had a policy to 

evaluate allegations on a case-by-case basis, based on the immediate danger to health and 
North Dakota Final IMPEP Report Page 15 

safety, the Branch did not have specific guidance to achieve this. In January 2011, the Branch 

“adopted” NRC Management Directive 8.8, “Management of Allegations.” Although this NRC 

Management Directive was adopted by the Branch, it referred to NRC policies, processes, and 

procedures. The manner in which NRC Management Directive 8.8 was adopted by the State 

did not provide any practical guidance for Branch implementation (no how-to’s for receipt, 

processing, and documentation of allegations). Furthermore, NRC Management Directive 8.8 

had not been adopted by the State in a manner that would make it consistent with State laws for 

protecting an alleger’s identity or open records requirements. 

The review team discussed the Branch’s actions taken in response to two allegations. The 

Branch manager indicated that although both allegations involved licensed activity, the concerns 

were vague, with little specificity, and therefore the Branch was unable to perform any follow-up. 

Neither concern nor actions taken to address the concern were documented by the Branch. 

Although NRC did not formally forward any allegations to the Branch during the review period, 

there was however, an informal concern involving licensed activities that was discussed by the 

NRC State Agreements Officer with the Branch manager for potential follow-up. In this case, 

the Branch manager and a member of the technical staff performed some on-site review of the 

concern and were unable to substantiate the concern. The results of this review were not 

formally documented although the matter was discussed with the NRC State Agreements 

Officer. 

Due to the lack of Branch-specific processes or procedures for the evaluation of, and response 

to allegations or concerns, when the Branch received notification of a concern, there was no 

consistent approach to perform an initial evaluation of the safety or security significance of the 

concern to determine the type or level of Branch response. Likewise, Branch actions taken in 

response to concerns were not documented. 

The review team recommends that the State strengthen its allegation program and take 

measures to ensure that: (1) allegations are promptly evaluated to determine the appropriate 

type and level of Branch response; (2) the Branch’s evaluation of allegations and any actions 

taken in response to allegations is properly documented to facilitate future follow-up; and (3) 

processes are in place to provide a response to allegers as appropriate. 

The Branch manager checked with the Department’s legal staff and was informed that there is 

no State statute that would protect the identity of an alleger or concerned individual from being 

disclosed unless confidentiality had been requested in writing and granted. The Branch’s policy, 

however, is to make all reasonable efforts to protect the identity of allegers. North Dakota 

Century Code Article 23-20 provides the specific situations under which confidentiality can be 

granted. 

In reaching a finding for this indicator, the review team considered that the State appropriately 

notified NRC of reportable events in a timely manner. However, because incident response and 

allegation procedures were not in place, the State’s performance was marginal in terms of 

identifying, reviewing, and resolving potential health and safety issues associated with incidents 

and allegations. The State’s incident response and allegation review activities were often not 

well coordinated, not complete, not of high technical quality, and sometimes not documented. 

However, the review team did not believe that the criteria for considering the indicator 

unsatisfactory were met given that events were properly reported to NRC by the State and the 
North Dakota Final IMPEP Report Page 16 

review team did not identify any situations where the State’s performance resulted in the 

persistence of health and safety problems associated with event response or allegation 

activities. Taking all of these factors into consideration, the review team believes that a finding 

of satisfactory, but needs improvement, is more appropriate for this indicator. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory, but needs improvement. 

3.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State Programs: 

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) Lowlevel Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The NRC’s 

Agreement with the State of North Dakota does not relinquish authority to regulate a sealed 

source and device evaluation program, or a uranium recovery program, so only the first and 

third non-common performance indicators were applicable to this review. 

3.1 Compatibility Requirements

3.1.1 Legislation

North Dakota became an Agreement State on September 1, 1969. Legislative authority to 

create an agency and enter into an Agreement with NRC is granted in the North Dakota Century 

Code Chapter 23-20. Century Code Chapter 23-20.1, “Ionizing Radiation Development,” 

designates that the North Dakota Radiation Control Program is administered by the North 

Dakota Department of Health. The North Dakota Century Code is sufficiently broad to provide 

authority for the regulation byproduct, source, special nuclear materials, and other radioactive 

materials. 

One rulemaking action affecting the Radiation Control Program was approved during the review 

period. Prior to the review period, the Radiation Control Program was funded through license 

fees as well as obtaining approximately 30-40% of its funding from the State’s General Fund. 

During the past year, the proposed rules were adopted that puts in place a 6-year 

implementation period for the Radiation Control Program to become fully fee funded. This 

matter went through the State rulemaking process including a public comment period. During 

the implementation period, licensees will receive a fee increase every year for six years. At the 

end of six years, the Radiation Control Program will be fully fee funded. 

3.1.2 Program Elements Required for Compatibility 

The review team examined the Branch’s response to the questionnaire, reviewed the status of 

regulations required to be adopted by the State under the Commission’s adequacy and 

compatibility policy, and verified the adoption of regulations with data obtained from the State 

Regulation Status Sheet that is maintained by FSME. 

North Dakota’s regulations for control of radiation are located in the North Dakota Administrative 

Code, Article 33-10, and apply to all persons who receive, possess, use, transfer, own, or 
North Dakota Final IMPEP Report Page 17 

acquire any source of radiation. North Dakota requires a license for the processing, generation, 

disposal, use, manufacture, production, acquisition, ownership, receipt, possession, or transfer 

byproduct, source, certain quantities of special nuclear material, and other radioactive materials 

occurring naturally or produced artificially or devices or equipment utilizing such materials. 

The review team verified that the State’s rulemaking process offers the public and other 

interested parties an opportunity to comment on proposed regulation changes. The rulemaking 

process begins with the Branch drafting the proposed rules, which are submitted to NRC for a 

compatibility review. Concurrently, a public notice is then submitted for publication and public 

comment in the official newspaper of each of the 53 counties in the State. After a public hearing 

wherein additional comments can be submitted, any received comments will be evaluated and 

any necessary changes are made. The proposed rules are then submitted to the State Attorney 

General for a legal opinion. After the Attorney General’s legal opinion is received, the legal 

opinion and rulemaking package are submitted to the State Health Council for adoption. The 

package is then submitted to the State’s Legislative Council. The Legislative Council submits 

the package to the Legislative Rules Committee for final approval. After final approval is 

received, the Legislative Council publishes the rules. The rules become effective on the date 

they are published. The Branch Manager indicated that this rulemaking process typically takes 

9-12 months. 

After North Dakota regulations are published as final, they are not subject to a sunset review or 

other administrative reviews. 

During the review period, the State significantly revised its radiation control program regulations 

to provide for NRC regulations to be adopted by reference. The North Dakota regulations were 

revised to reflect the NRC regulations that were in place on January 1, 2010. The revised 

regulations became effective on January 1, 2011. Because the North Dakota regulations are 

“fixed” to NRC’s regulations as of January 1, 2010, future revisions or amendments to NRC’s 

regulations will require that North Dakota follow their rulemaking process to revise or amend 

their regulations. 

Current NRC policy requires that Agreement States adopt certain equivalent regulations or 

legally binding requirements no later than 3 years after the effective date of NRC’s regulations. 

At the time of the review, North Dakota had no overdue regulations and had completed all 

outstanding regulation changes through the last NRC final rulemaking which was issued in 

2009. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Compatibility Requirements, be 

found satisfactory. 

3.2 Low-Level Radioactive Waste (LLRW) Disposal Program

In 1981, NRC amended its Policy Statement, “Criteria for Guidance of States and NRC in 

Discontinuance of NRC Authority and Assumption Thereof by states Through Agreement,” to 

allow a State to seek an amendment for the regulation of LLRW as a separate category. Those 

States with existing Agreements prior to 1981 were determined to have continued LLRW 

disposal authority without the need of an amendment. Although North Dakota has such 
North Dakota Final IMPEP Report Page 18 

authority to regulate a LLRW disposal facility, NRC has not required States to have a program 

for licensing a disposal facility until such time as the State has been designated as a host State 

for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of 

the need to regulate a LLRW disposal facility, it is expected to put in place a regulatory program 

that will meet the criteria for an adequate and compatibility LLRW program. There are no plans 

for a commercial LLRW disposal facility in North Dakota. Accordingly, the review team did not 

review this indicator. 

4.0 SUMMARY 

As noted in Sections 2.0 and 3.0 above, the review team recommends that North Dakota’s 

performance be found unsatisfactory for the performance indicator Technical Quality of 

Inspections, and satisfactory, but needs improvement, for the performance indicators: Status of 

the Materials Inspection Program, Technical Quality of Licensing Actions, and Technical Quality 

of Incident and Allegation Activities. The review team found North Dakota’s performance to be 

satisfactory for the other indicators reviewed. The review team made 11 recommendations 

regarding the performance of the State. Overall, the review team recommended, and the MRB 

agreed, that the North Dakota Agreement State Program be found adequate, but needs 

improvement, to protect public health and safety, and compatible with NRC's program. 

Based on the results of the current IMPEP review, and in accordance with the criteria in NRC 

Management Directive 5.6, the review team recommended, and the MRB agreed, that a period 

of Heightened Oversight be initiated for North Dakota. Heightened Oversight may be used in 

cases where one or more performance indicators are found unsatisfactory. Heightened 

Oversight is a formal process that allows the NRC to maintain an increased level of 

communication with an Agreement State program. The review team believes that Heightened 

Oversight will be a useful tool in assessing the State’s progress toward addressing the 

programmatic issues and deficiencies identified during the review. 

The review team further recommended, and the MRB agreed, that a Periodic Meeting be held 

within 1 year to assess the State’s progress in addressing the open recommendations, and that 

a follow-up IMPEP review take place approximately 1 year following the Periodic Meeting (2 

years from current IMPEP). The review team believes that the performance of a follow-up 

IMPEP at approximately 2 years from the current IMPEP will allow the State sufficient time to 

correct programmatic issues identified during the review. However, the follow-up IMPEP should 

be coordinated with the State to provide for the date of the follow-up IMPEP to be offset from 

the State’s biennial legislative cycle. 

Below are the review team’s recommendations, as mentioned in the report, for evaluation and 

implementation by the State: 

1. The review team recommends that the State: (1) update its existing procedures and 

develop new procedures, as necessary, to memorialize the policies and practices of the 

Agreement State program and to serve as a knowledge management tool, and (2) 

examine options to increase staff retention and/or develop sufficient depth in staffing to 

effectively implement the program. (Section 2.1) 

2. The review team recommends that the State take measures to ensure that initial 
North Dakota Final IMPEP Report Page 19 

inspections are performed at the interval prescribed in IMC 2800. (Section 2.2) 

3. The review team recommends that the State take measures to ensure that inspection 

findings are communicated to licensees within 30 days of the date of the inspection. 

(Section 2.2) 

4. The review team recommends that the State: (1) take measures to ensure that sufficient 

information pertaining to inspection observations and identified non-compliances is 

documented in inspection records and in letters to licensees and that these documents 

be appropriately reviewed by management, prior to issuance, for thoroughness and 

consistency, and (2) develop and implement a plan to address comments noted in 

Appendix C related to identified items of non-compliance that were not included in 

findings that were dispatched to licensees. (Section 2.3) 

5. The review team recommends that the State obtain additional training (formal and onthe-job, as appropriate) for the Branch manager and members of the technical staff to 

enhance inspection skills, particularly with regards to: (1) radiation safety issues 

associated with cyclotron operations, and (2) proper operation and use of radiation 

survey and measurement instrumentation. (Section 2.3) 

6. The review team recommends that the State: (1) take measures to ensure that the 

Branch’s review of licensing actions are adequately documented and that licensing 

actions are thorough and consistent with the regulations and appropriate licensing 

guidance, and (2) take measures to address the licensing deficiencies that were 

identified in the comments in Appendix D. (Section 2.4) 

7. The review team recommends that the State provide additional training to the Branch 

manager and technical staff members regarding technical review of licensing actions, 

including training to ensure that the staff acquires increased familiarity with: (1) the 

regulations under North Dakota’s equivalent to 10 CFR Parts 30 through 39, and (2) 

applicable licensing guidance documents for use authorization and license conditions. 

(Section 2.4) 

8. The review team recommends that the Branch take measures to determine and 

document the basis of confidence, through consistent use of the pre-licensing checklist 

and guidance, that radioactive materials will be used as intended and as described in the 

application or amendment request, prior to authorizing the material on the license. 

(Section 2.4) 

9. Regarding financial assurance, the review team recommends that the State: (1) develop 

a procedure or policy to assess finance assurance requirements as part of significant 

licensing actions and during licensing renewals; (2) review all North Dakota licenses to 

determine whether licensees require financial assurance, and either request financial 

assurance for licenses that are authorized to possess the applicable quantities or revise 

the license conditions to ensure clear quantity limits that will not require provision of 

financial assurance; and (3) take measures to ensure that any financial assurance 

instruments received by the Branch are maintained and stored in accordance with State 

requirements. (Section 2.4) 
North Dakota Final IMPEP Report Page 20 

10. The review team recommends that the State strengthen its incident response program 

and take measures to ensure that: (1) reported incidents are consistently evaluated to 

determine the appropriate type and level of Branch response; (2) licensee event reports 

are reviewed by the Branch for completeness and appropriate corrective actions; and (3) 

the Branch’s evaluation of licensee events, whether based on a review of licensee 

reports, on-site reviews, or inspection follow-up, is properly documented to facilitate 

future follow-up. (Section 2.5) 

11. The review team recommends that the State strengthen its allegation program and take 

measures to ensure that: (1) allegations are promptly evaluated to determine the 

appropriate type and level of Branch response; (2) the Branch’s evaluation of allegations 

and any actions taken in response to allegations is properly documented to facilitate 

future follow-up; and (3) processes are in place to provide a response to allegers as 

appropriate. (Section 2.5) 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B North Dakota Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Janine Katanic, FSME Team Leader 

 Technical Staffing and Training 

Inspector Accompaniments 

Technical Quality of Incident and 

 Allegation Activities 

Compatibility Requirements 

 

Rachel Browder, Region IV Technical Quality of Licensing Actions 

 

Michele Greenwell, Kentucky Status of Materials Inspection Program 

 Technical Quality of Inspections 
APPENDIX B 

NORTH DAKOTA ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML110810045
 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Bismarck Cancer Center License No.: 33-41919-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/8/09 Inspector: LR 

File No.: 2 

Licensee: Medcenter One Health System License No.: 33-00043-05 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 1/29/08 Inspectors: LR, CS 

Comment: 

The documented inspection record identified an apparent non-compliance item that was 

not included in the inspection findings that were dispatched to the licensee. 

File No.: 3 

Licensee: Medcenter One Health System License No.: 33-00043-05 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 1/27-28/11 Inspectors: DH, DS 

Comment: 

The inspection findings were dispatched to the licensee approximately 40 days after the 

inspection date. 

File No.: 4 

Licensee: DMS Imaging License No.: 33-11325-01 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 12/8/10 Inspectors: DS, LR 

File No.: 5 

Licensee: University of North Dakota License No.: 33-48922-01 

Inspection Type: Initial, Announced Priority: 2 

Inspection Date: 1/31-2/1/11 Inspectors: DS, DH 

Comments: 

a) Using a previous version of IMC 2800, the Branch had identified this as a Priority 5 

inspection. Based on the Branch’s adoption of the revised IMC 2800, the Branch 

revised the inspection priority to Priority 2. 

b) Some health and safety issues identified during the inspection were not documented 

in the inspection findings issued to the licensee. 

c) The inspection findings, which addressed significant health and safety issues, were 

issued 38 days after the date of the inspection. 
North Dakota Final IMPEP Report Page C.2 

Inspection Casework Reviews 

File No.: 6 

Licensee: Sanford Medical Center-Fargo License No.: 33-10227-02 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 6/18/09 Inspectors: LR, DH 

Comments: 

a) The inspection report did not document if a review was performed related to items of 

non-compliance that were identified during the previous inspection. 

b) The inspection findings were dispatched to the licensee over 90 days after the date 

of the inspection. 

File No.: 7 

Licensee: Sanford Medical Center-Fargo License No.: 33-10227-02 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 2/2/11 Inspectors: DS, DH 

Comment: The inspection record did not document a review of the licensee’s compliance 

related to procedures requiring written directives. 

File No.: 8 

Licensee: University of North Dakota License No.: 33-12827-01 

Inspection Type: Routine, Special, Announced Priority: 3 

Inspection Date: 2/1/08 Inspectors: CS, LR 

Comments: 

a) The inspection record did not document if a review was performed related to items of 

non-compliance that were identified during the previous inspection. 

b) An inspector from the State of Minnesota participated in this inspection. 

File No.: 9 

Licensee: University of North Dakota License No.: 33-12827-01 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 1/31-2/1/11 Inspectors: DH, DS 

Comment: 

The database indicated that the inspection findings were dispatched to the licensee 38 

days after the date of the inspection. However, the dispatched inspection record could 

not be located for review. 

File No.: 10 

Licensee: Braun Intertec Corporation License No.: 33-48303-01 

Inspection Type: Initial, Special, Announced Priority: 1 

Inspection Date: 2/3/11 Inspectors: DS, DH 
North Dakota Final IMPEP Report Page C.3 

Inspection Casework Reviews 

File No.: 11 

Licensee: Midwest Industrial X-Ray License No.: 33-14907-01 

Inspection Type: Routine, Special, Announced Priority: 1 

Inspection Date: 11/17/10 Inspectors: DS, DH 

File No.: 12 

Licensee: Weatherford International, LTD License No.: 33-46901-01 

Inspection Type: Initial, Announced Priority: 3 

Inspection Date: 2/2/10 Inspectors: DS, LR 

File No.: 13 

Licensee: Trinity Health License No.: 33-04608-01 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 1/28/10 Inspectors: LR 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: University of North Dakota License No.: 33-48922-01 

Inspection Type: Initial, Announced Priority: 2 

Inspection Date: 1/31-2/1/11 Inspector: DH, DS 

Comments: 

a) The inspector did not have familiarity with the licensed cyclotron operations or with 

radiation safety and health physics issues associated with cyclotron operations. As a 

result, the inspector did not identify several apparent health physics and radiation 

safety issues associated with these risk-significant operations. 

b) The inspection was unable to be completed and as a result, certain higher risk 

significance activities were not reviewed. A follow-up inspection was scheduled to 

be performed within approximately 6 months. 

c) The inspector did not have a thorough understanding of the proper use and 

operation of radiation detection and survey instrumentation. 

Accompaniment No.: 2 

Licensee: University of North Dakota License No.: 33-12827-01 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 1/31-2/1/11 Inspector: DH, DS 

Comments: 

a) The inspection was unable to be completed and as a result, certain higher risk 

significance activities were not reviewed. A follow-up inspection was scheduled to 

be performed within approximately 6 months. 
North Dakota Final IMPEP Report Page C.4 

Inspection Casework Reviews 

b) Issues regarding licensed activities that were raised during the inspector’s 

performance observations were not adequately followed up by the inspector. 

c) The inspector did not review the licensee’s corrective actions related to a previously 

identified non-compliance. 

Accompaniment No.: 3 

Licensee: Sanford Medical Center - Fargo License No.: 33-10227-02 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 2/2/11 Inspector: DS, DH 

Comments: 

a) The inspector did not identify an issue related to the security of unattended 

radioactive materials. 

b) The inspector did not adequately review licensee compliance related to various 

therapeutic modalities requiring written directives. 

c) The inspector did not have a thorough understanding of the proper use and 

operation of radiation survey instrumentation. 

Accompaniment No.: 4 

Licensee: Braun Intertec Corporation License No.: 33-48303-01 

Inspection Type: Special, Initial, Announced Priority: 1 

Inspection Date: 2/3/11 Inspector: DS, DH 

Comments: 

a) The inspector did not perform a thorough initial inspection in that it only addressed 

issues related to security requirements and did not address the licensee’s radiation 

safety program related to radiographic operations. The inspector was unable to 

describe what plans, if any, were being made to inspect the remainder of the 

licensee’s program. 

b) An initial inspection of licensee implementation of security requirements warranted a 

more detailed review than what was performed by the inspector. The inspector did 

not have a thorough understanding of the security requirements, leading to confusion 

regarding the adequacy of licensee compliance. 

Accompaniment No.: 5 

Licensee: North Dakota State University License No.: 33-06769-06 

Inspection Type: Special, Announced Priority: 3 

Inspection Date: 3/14-16/11 Inspector: DH, DS 

Comments: 

a) The inspector did not adequately review several apparent security-related issues. 

The inspector did not identify or did not understand the security significance of a noncompliance related to security requirements and therefore did not promptly notify the 

licensee of the need to take immediate corrective actions. The inspector did not 

have a thorough understanding of the security requirements and could not clearly 

explain to the licensee what actions were necessary to achieve compliance. 

b) The inspector did not have a thorough understanding of the proper use and 
North Dakota Final IMPEP Report Page C.5 

Inspection Casework Reviews 

operation of radiation survey instrumentation. 

c) The inspector did not identify evidence of the consumption of food and the storage of 

personal medication in areas where radioactive materials were used or stored so that 

these issues could be promptly corrected. 

d) The inspector did not identify an issue involving the storage of portable gauges. 

Accompaniment No.: 6 

Licensee: Innovis Health, LLC License No.: 33-02604-01 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 3/16-17/11 Inspector: DS, DH 

Comment: 

The inspector did not have a thorough understanding of the proper use and operation of 

radiation survey instrumentation. 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Institute of Diagnostic Imaging License No.: 33-39805-01 

Type of Action: Termination Previous Amendment No.: 05 

Date Issued: 2/22/11 License Reviewer: DS 

File No.: 2 

Licensee: University of North Dakota License No.: 33-48922-01 

Type of Action: New Amendment No.: New 

Date Issued: 9/22/10 License Reviewer: DS 

Comments: 

a) This license was split from the University of North Dakota Broad Scope license and 

therefore some of the tie-downs were still contained under the Broad Scope license 

and should have been resubmitted for this cyclotron license. 

b) The license reviewer did not request the activated products for the cyclotron model 

from the licensee and therefore did not authorize the material on the license. 

c) The license reviewer did not calculate financial assurance for the activated products. 

d) The design/drawings, including the conduits and tubing of the material transfer, were 

not included as part of the submittal. 

e) The detailed health and safety elements as described in NUREG-1556, Volume 21, 

were not submitted as part of the application, including: radioactive waste, 

ventilation, contamination controls, packaging and transportation. 

File No.: 3 

Licensee: University of North Dakota License No.: 33-12827-01 

Type of Action: Renewal Amendment No.: 32 

Date Issued: 9/29/10 License Reviewer: DS 

Comments: 

a) The license reviewer did not ensure that the broad scope licensee submitted 

adequate procedures for approval of users and facilities that gave the Branch a basis 

of confidence that the authorizations would be protective of health and safety of the 

public and environment. 

b) The license reviewer did not ensure that special radiation safety protocols were in 

place for handling unsealed radioactive material such as P-32. 

c) The license reviewer did not ensure that adequate instrument calibration procedures 

and the individual’s training and experience for who would be performing the 

calibration was included in the license application. If instrument calibration activity 

was performed as a service to other licensees, this activity should be authorized as a 

service activity. 

 
North Dakota Final IMPEP Report Page D.2 

License Casework Reviews 

File No.: 4 

Licensee: DMS Health Technologies License No.: 33-11325-01 

Type of Action: Amendment Amendment No.: 52 

Date Issued: 9/20/10 License Reviewer: DS 

File No.: 5 

Licensee: DMS Health Technologies License No.: 33-11325-01 

Type of Action: Renewal Amendment No.: 51 

Date Issued: 2/25/09 License Reviewer: LR 

File No.: 6 

Licensee: Medcenter One Health Systems License No.: 33-00043-01 

Type of Action: Amendment Amendment No.: 54 

Date Issued: 4/17/09 License Reviewer: JR 

Comment: 

The license reviewer authorized an individual on the license who was not qualified for 

the 10 CFR 35.200 modality under the regulations. 

File No.: 7 

Licensee: Medcenter One Health Systems License No.: 33-00043-05 

Type of Action: Amendment Amendment No.: 58 

Date Issued: 11/5/10 License Reviewer: LR 

File No.: 8 

Licensee: Braun Intertec Corporation License No.: 33-48303-01 

Type of Action: New Amendment No.: New 

Date Issued: 3/4/10 License Reviewer: JR 

Comment: 

The license reviewer incorrectly authorized a radiography camera with greater activity 

than what is authorized under the Sealed Source & Device Registry. 

File No.: 9 

Licensee: St. Alexis Medical Center License No.: 33-11320-01 

Type of Action: Amendment Amendment No.: 39 

Date Issued: 6/9/09 License Reviewer: LR 

Comment: 

The license reviewer authorized an individual on the license who was not qualified for 

the 10 CFR 35.400 modality under the regulations. 

File No.: 10 

Licensee: Medcenter One Health System License No.: 33-00043-05 

Type of Action: Amendment Amendment No.: 49 

Date Issued: 8/10/07 License Reviewer: CS 
North Dakota Final IMPEP Report Page D.3 

License Casework Reviews 

File No.: 11 

Licensee: Midwest Industrial X-Ray, Inc. License No.: 33-14907-01 

Type of Action: Amendment Amendment No.: 18 

Date Issued: 11/30/10 License Reviewer: DS 

File No.: 12 

Licensee: Midwest Industrial X-Ray, Inc. License No.: 33-14907-01 

Type of Action: Renewal Amendment No.: 16 

Date Issued: 8/29/08 License Reviewer: LR 

Comments: 

a) The license reviewer incorrectly authorized a radiography camera with greater 

activity than what is authorized under the Sealed Source & Device Registry. 

b) The license reviewer approved a permanent radiography facility without adequate 

drawings, dose rates, and roof access information. 

c) The license reviewer incorrectly authorized Operating & Emergency procedures 

which granted the pocket dosimeter range to exceed the range provided in the 

regulations and granted the alarming ratemeter accuracy range to exceed the range 

provided in the regulations. 

File No.: 13 

Licensee: Minot State University License No.: 33-45808-01 

Type of Action: New Amendment No.: New 

Date Issued: 1/9/09 License Reviewer: LR 

Comment: 

a) The license reviewer did not complete the Pre-Licensing checklist. 

b) The license reviewer did not ensure that special radiation safety protocols were in 

place for handling unsealed radioactive material such as P-32. 

File No.: 14 

Licensee: Weatherford International, Inc. License No.: 33-46901-01 

Type of Action: New Amendment No.: New 

Date Issued: 12/2/08 License Reviewer: JR 

File No.: 15 

Licensee: Schlumberger Technology License No.: 33-10108-01 

Type of Action: Amendment Amendment No.: 22 

Date Issued: 6/14/08 License Reviewer: CS 

File No.: 16 

Licensee: Midwest Radiation Physicists, Inc. License No.: 33-09908-01 

Type of Action: Renewal Amendment No.: 13 

Date Issued: 5/17/10 License Reviewer: DS 

 
North Dakota Final IMPEP Report Page D.4 

License Casework Reviews 

File No.: 17 

Licensee: Sanford Medical Center - Fargo License No.: 33-10227-02 

Type of Action: Amendment Amendment No.: 51 

Date Issued: 9/13/10 License Reviewer: DS 

Comment: 

a) The license reviewer did not authorize a medical physicist for decay correction of the 

Sr-90 eye plaque, as required by the regulations. 

b) While most of the line-listed radionuclides had sealed source model numbers 

authorized on the license, there was one radionuclide that did not specify the sealed 

source model number(s). 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Northern Technologies, Inc. License No.: 33-32112-01 

Date of Incident: 10/21/10 NMED No.: 100526 

Investigation Date: 10/21/10 Type of Incident: Damage to Equipment 

Type of Investigation: Licensee Report 

File No.: 2 

Licensee: Weatherford International, Inc. License No.: 33-46901-01 

Date of Incident: 5/21/10 NMED No.: 100270 

Investigation Date: 5/21/10 Type of Incident: Overexposure 

Type of Investigation: Licensee Report 

Comment: 

 The licensee’s final report providing their final dosimetry analysis and corrective actions 

was not in the case file during the review and had to be requested from the licensee by 

the Branch manager. 

File No.: 3 

Licensee: T&K Inspection, Inc. License No.: 33-22313-01 

Date of Incident: 5/10/10 NMED No.: 100251 

Investigation Date: 5/10/10 Type of Incident: Equipment Failure/Overexposure 

Type of Investigation: Licensee Report 

File No.: 4 

Licensee: Team Industrial Services, Inc. License No.: 42-32219-01 

Date of Incident: 5/18/09 NMED No.: 090504 

Investigation Date: 5/18/09 Type of Incident: Damage to Equipment/Equipment Failure 

Type of Investigation: Licensee Report, Site Visit 

Comments: 

a) The licensee was operating under reciprocity in North Dakota. 

b) Two members of the technical staff performed a site visit. However, information 

gathered during the site visit was not formally documented. The case file only 

contained hand-written “scratch” notes from the technical staff which were hard to 

decipher and provided no documentation of an independent review or analysis of the 

incident. 

File No.: 5 

Licensee: Midwest Industrial X-Ray, Inc. License No.: 33-14907-01 

Date of Incident: 7/8/08 NMED No.: 080382 

Investigation Date: 7/8/08 Type of Incident: Equipment Failure/Overexposure 
North Dakota Final IMPEP Report Page E.2 

Incident Casework Reviews 

Type of Investigation: Licensee Report, Site Visit 

Comments: 

a) The licensee’s final report providing their corrective actions, as required by 

regulation, could not be located in the case file. 

b) The Branch manager and a member of the technical staff performed a site visit. 

However, information gathered during the site visit was not formally documented. 

The case file only contained hand-written “scratch” notes from the technical staff 

which were hard to decipher and provided no documentation of an independent 

review or analysis of the incident. 

File No.: 6 

Licensee: Dakota Gasification Company License No.: 33-15327-01 

Date of Incident: 2/16/10 NMED No.: 100088 

Investigation Date: 2/16/10 Type of Incident: Equipment Failure 

Type of Investigation: Licensee Report/Email 

File No.: 7 

Licensee: Sanjel Corporation License No.: 33-42824-01 

Date of Incident: 3/13/11 NMED No.: 110136 

Investigation Date: 3/13/11 Type of Incident: Damage to Equipment and Facility 

Type of Investigation: Licensee Report/Telephone 

Comment: 

 The State is awaiting final disposition of the damaged equipment before closing the 

incident case file. 

File No.: 8 

Licensee: University of North Dakota License No.: 33-12827-01 

Date of Incident: 10/15-11/14/07 NMED No.: 070754 

Investigation Date: 12/10/07 Type of Incident: Overexposure/Contamination Event 

Type of Investigation: Licensee Report 

Comments: 

a) The contamination event occurred during the period from 10/15-11/14/07 and was 

reported to the State on 12/10/07. 

b) The dosimetry analysis indicated that the incident was not a true overexposure but 

rather the result of a contaminated dosimeter. The State did not identify that the 

licensee’s report did not address any probable causal factors or corrective actions 

related to the contamination event. 

File No.: 9 

Licensee: Wal-Mart License No.: General License 

Date of Incident: 1/8/09 NMED No.: 090060 

Investigation Date: 1/8/09 Type of Incident: Loss of Radioactive Material 

Type of Investigation: Licensee Report 
ATTACHMENT 

May 31, 2011 Letter from Daniel E. Harman 

North Dakota Response to the Draft Report 

ADAMS Accession No.: ML111511081 

June 13, 2011 Letter from Daniel E. Harman 

North Dakota Revised Response to the Draft Report 

ADAMS Accession No.: ML111660475 

NRC Comment Resolution to May 31, 2011 Letter 

ADAMS Accession No.: ML111580527