December 12, 2007 

MEMORANDUM TO: James L. Caldwell, Regional Administrator 

 Region III 

FROM: Martin J. Virgilio /RA/

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

SUBJECT: FINAL REPORT OF THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW 

OF THE REGION III RADIOACTIVE MATERIALS PROGRAM 

On November 13, 2007, the Management Review Board (MRB) met to consider the proposed 

final Integrated Materials Performance Evaluation Program (IMPEP) report of the U.S. Nuclear 

Regulatory Commission’s Region III radioactive materials program. The MRB found the 

program to be adequate to protect public health and safety. Based on the results of the review, 

the MRB concluded that the next full IMPEP review of the Region III radioactive materials 

program should take place in approximately 4 years. 

Section 4.0, page 8, of the enclosed final report summarizes the results of the review. The 

review team made no recommendations in regard to program performance by the Region and 

identified two good practices. 

If you have any questions, please contact Aaron McCraw at (301) 415-1277. 

We appreciate your staff’s efforts during the IMPEP review period, especially during the time of 

the team’s visit. We likewise appreciate the performance of the Region III program and look 

forward to our continued interaction. 

Enclosure: 

Region III Final IMPEP Report 

cc: Mark A. Satorius, RIII 

 Steven A. Reynolds, RIII 

 Jared Thompson, Arkansas 

 Organization of Agreement States 

 Liaison to the MRB 
December 12, 2007 

MEMORANDUM TO: James L. Caldwell, Regional Administrator 

 Region III 

FROM: Martin J. Virgilio /RA/

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

SUBJECT: FINAL REPORT OF THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW 

OF THE REGION III RADIOACTIVE MATERIALS PROGRAM 

On November 13, 2007, the Management Review Board (MRB) met to consider the proposed 

final Integrated Materials Performance Evaluation Program (IMPEP) report of the U.S. Nuclear 

Regulatory Commission’s Region III radioactive materials program. The MRB found the 

program to be adequate to protect public health and safety. Based on the results of the review, 

the MRB concluded that the next full IMPEP review of the Region III radioactive materials 

program should take place in approximately 4 years. 

Section 4.0, page 8, of the enclosed final report summarizes the results of the review. The 

review team made no recommendations in regard to program performance by the Region and 

identified two good practices. 

If you have any questions, please contact Aaron McCraw at (301) 415-1277. 

We appreciate your staff’s efforts during the IMPEP review period, especially during the time of 

the team’s visit. We likewise appreciate the performance of the Region III program and look 

forward to our continued interaction. 

Enclosure: 

Region III Final IMPEP Report 

cc: Mark A. Satorius, RIII 

 Steven A. Reynolds, RIII 

 Jared Thompson, Arkansas 

 Organization of Agreement States 

 Liaison to the MRB 

DISTRIBUTION: EDATS: FSME-2007-0037

See next page. 

ML073330366 

OFFICE FSME/DMSSA FSME/DMSSA FSME/DMSSA Tech Editor 

NAME ATMcCraw:kk ADWhite RJLewis CPoland 

DATE 11/30/07 11/30/07 11/30/07 12/04/07 

OFFICE FSME DEDMRT 

NAME GPangburn MJVirgilio 

DATE 12/06/07 12/12/07 

OFFICIAL RECORD COPY 
MEMORANDUM TO J. CALDWELL FROM M. VIRGILIO DATED: December 12, 2007

Distribution: EDATS: FSME-2007-0037 

DMSSA RF DCD (SP01) 

EDO RF 

RidsFsmeOD 

RidsSecyCorrespondenceMailCenter 

KLukes, FSME/DMSSA Chairman Klein 

JLynch, Region III/RSAO Commissioner Jaczko 

SHammann, Region I Commissioner Lyons 

RLeonardi, Region IV SECY 

Robin Rademacher, NC 

DDiaz-Toro, OEDO 

APowell, OCA (2 copies) 

KCyr, OGC 

FCameron, OGC 

CMiller, FSME 

JSchlueter, FSME 
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NRC REGION III RADIOACTIVE MATERIALS PROGRAM 

August 27-30, 2007 

FINAL REPORT

ENCLOSURE 
Region III Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the U.S. Nuclear Regulatory Commission (NRC) 

Region III radioactive materials program. The review was conducted during the period of 

August 27-30, 2007, by a review team comprised of technical staff members from the NRC and 

the State of North Carolina. 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 the February 26, 2004, NRC Management Directive 

5.6, “Integrated Materials Performance Evaluation Program (IMPEP).” Preliminary results of the 

review, which covered the period of March 29, 2003, to August 30, 2007, were discussed with 

Region III managers on the last day of the review. 

A draft of this report was issued to the Region for factual comment on September 25, 2007. 

Region III responded by e-mail on October 22, 2007, from Steven A. Reynolds, Director, 

Division of Nuclear Materials Safety (the Division). A copy of the Region’s response is included 

as the Attachment to this report. The Management Review Board (MRB) met on November 13, 

2007, to consider the proposed final report. The MRB found the Region III radioactive materials 

program to be adequate to protect public health and safety. 

The Region III radioactive materials program is administered by the Director of the Division, who 

reports directly to the Regional Administrator. Organization charts for Region III and the 

Division are included as Appendix B. At the time of the review, the Division regulated 

approximately 1,250 specific licenses authorizing the possession and use of radioactive 

materials. 

In preparation for the review, a questionnaire addressing the common performance indicators 

was sent to the Division on April 12, 2007. The Division provided its response to the 

questionnaire on August 10, 2007. A copy of the questionnaire response may be found in the 

NRC’s Agencywide Documents Access and Management System (ADAMS) using Accession 

Number ML072680482. 

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

the Division’s response to the questionnaire; (2) analysis of quantitative information from the 

licensing, inspection, and allegation databases, as well as ADAMS; (3) technical review of 

selected regulatory actions; (4) field accompaniments of four of the Division’s radioactive 

materials inspectors; and (5) interviews with staff and managers to answer questions or clarify 

issues. The review team evaluated the information gathered against the establish ed criteria for 

each common performance indicator and made a preliminary assessment of the Division’s 

performance. 

Section 2.0 of this report covers Region III’s actions in response to any recommendations made 

during the previous review. Results of the current review for the common performance 

indicators are presented in Section 3.0, and Section 4.0 summarizes the review team's findings. 
Region III Final Report Page 2 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on March 28, 2003, the review team made 

no recommendations in regard to program performance. 

3.0 COMMON PERFORMANCE INDICATORS 

IMPEP identifies five common performance indicators to be used in reviewing 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. 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Division’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 Division’s questionnaire response relative to this 

indicator; interviewed Division managers and staff; and reviewed job descriptions, training plans, 

and training records. The review team also considered any possible workload backlogs in 

evaluating this indicator. 

During the 2003 IMPEP review, the Division was composed of four branches: the Materials 

Licensing Branch, the Materials Inspection Branch, the Decommissioning Branch, and the Fuel 

Cycle Branch. During the review period, the NRC’s Regional Fuel Cycle Inspection Program 

was consolidated in the Region II Atlanta Office, effectively eliminating the Division’s Fuel Cycle 

Branch. The Division currently operates with the Materials Licensing Branch, the Inspection 

Branch, and the Decommissioning Branch; each headed by a Branch Chief. 

At the time of the review, the Division was staffed with 23 direct full time equivalents (FTE), a 

reduction of 2.5 direct FTE from the previous IMPEP review. The decrease in FTE can be 

attributed to the transfer of approximately 415 radioactive materials licenses to two States that 

became Agreement States during the review period (Wisconsin in 2003 and Minnesota in 2006). 

Overall, staffing was relatively stable over the review period. The review team noted that there 

was considerable turnover in the Decommissioning Branch Chief position; however, the 

turnover did not appear to affect the Decommissioning Branch’s performance during the review 

period. At the time of the review, the Division had no vacant positions. 

The review team determined that the Division’s Operational Management Information (OMI) 

reports help Division managers efficiently use their staff resources. Despite the reduction in 

direct FTE, the Division has been capable of taking on additional workload, such as Increased 

Controls inspections. The Division is also assisting the Region I radioactive materials program 

by performing inspections in Region I while Region I is focusing its resources on the proposed 

Section 274b. (of the Atomic Energy Act) Agreement with the Commonwealth of Pennsylvania. 

The Division has also been very active in contributing resources to NRC Working Groups and 

IMPEP reviews of other NRC Regional Offices and Agreement State programs. 
Region III Final Report Page 3 

The Division uses Inspection Manual Chapter (IMC) 1246, “Formal Qualification Programs in the 

Nuclear Material Safety and Safeguards Program Area,” and associated procedures as its 

qualification and training program. During the review period, one individual successfully 

completed the Nuclear Safety Professional Development Program (NSPDP) and achieved 

inspector qualification. At the time of the review, one NSPDP participant in the 

Decommissioning Branch was undergoing inspector qualification and training. This individual is 

expected to complete the required qualifications and training by July 2008. Division managers 

are supportive of staff training opportunities. A majority of the Division’s radioactive materials 

inspectors have attended the NRC’s Security Systems and Principles Course. 

To promote knowledge management, the Division takes advantage of mentoring opportunities 

of less experienced staff. New staff is assigned a specific senior technical staff member as a 

mentor. The review team found that all senior technical staff members are willing to provide 

guidance and assist newer staff on their assigned projects. 

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

that Region III’s performance with respect to the indicator, Technical Staffing and Training, was 

satisfactory. 

3.2 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 Division’s questionnaire response relative to this indicator, data gathered from the 

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

Division managers and staff. 

The review team verified that the Division adheres to the inspection priorities prescribed in IMC 

2800, “Materials Inspection Program.” The Division appropriately modified inspection schedules 

in response to revisions to IMC 2800 during the review period. The review team noted that the 

Division continues to implement its broad scope inspection initiative as discussed in the 1999 

and 2003 IMPEP reports. This initiative allows several partial inspections of major broad scope 

licensees to be conducted within the inspection cycle, as long as all inspection objectives are 

met through the aggregation of the partial inspections. 

The review team determined that the Division conducted 752 inspections of Priority 1, 2, and 3 

licensees during the review period. The review team identified five of these inspections as 

performed overdue by more than 25 percent of the inspection frequency listed in IMC 2800. 

Three of the overdue inspections can be attributed to input errors into the Licensing Tracking 

System (LTS). For these three cases, the inspection priorities changed because of program 

code changes; however, the dates of the next inspections were not modified in LTS, thereby 

causing the inspections to be performed based on their previous inspection priority. The review 

team determined that the Division conducted 207 initial inspections of new radioactive materials 

licenses during the review period. Of the 207 initial inspections, two were performed greater 

than 12 months after license issuance. Overall, the review team calculated that the Division 

performed 0.7 percent of all Priority 1, 2, and 3 inspections and initial inspections overdue 

during the review period. 
Region III Final Report Page 4 

During the on-site portion of the review, the Division demonstrated its Inspection Planner 

Database to the review team. This database was independently developed by the Division to 

gain efficiency in the inspection planning process. The database is populated and updated by 

monthly downloads from LTS. Information provided from LTS, such as a licensee’s address 

and inspection dates, can be automatically entered into the respective fields on the planning 

form when a licensee’s name or license number is selected, saving the inspector time by not 

having to look up or hand-write the information. After the inspections are entered, the database 

produces a hard copy of the inspector’s proposed inspection trip for approval from his or her 

supervisor. Following the inspection and/or report issuance, the inspector can input the 

completion data to generate an update for LTS. At this time, the database cannot automatically 

update LTS. Any changed information must be manually entered into LTS. With the ability to 

automatically update LTS, the Division’s database would be a more powerful, time-saving tool. 

The review team believes that the Division’s database could be a beneficial tool for the other 

NRC Regional Offices. The database is also capable of generating the inspection information 

for the monthly OMI reports. 

The review team evaluated the timeliness of issuance of inspection findings to licensees using 

the inspection casework reviews and the Division’s monthly OMI reports. Inspection reports 

were generally issued to the licensee within 30 days, with the majority of findings being issued 

at the conclusion of the inspection via NRC Form 591. 

During the review period, the Division granted 36 reciprocity permits to candidate licensees 

based upon the criteria in IMC 1220, “Processing of NRC Form 241 and Inspection of 

Agreement State Licensees Operating Under 10 CFR 150.20.” The review team determined 

that the Division exceeded the NRC’s goal of inspecting 20 percent of candidate licensees 

operating under reciprocity in each of the four years covered by the review period. 

The review team determined that the Division adequately planned for the initial set of Increased 

Controls inspections of the affected licensees. The Division’s prioritization methodology was 

consistent with the prioritization methodology provided by NRC Headquarters. The Division has 

80 licensees that are implementing the Increased Controls. At the time of the review, the 

Division had performed 48 Increased Controls inspections, including all 18 inspections that were 

to be completed in the first year of implementation. Division managers were confident that all 

Increased Controls inspections would be completed within the Commission’s allotted time 

frame. 

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

that Region III’s performance with respect to the indicator, Status of Materials Inspection 

Program, was satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, inspection field 

notes, and interviewed inspectors for 21 radioactive materials inspections conducted during the 

review period. The casework reviewed included inspections conducted by 12 of the Division’s 

inspectors and covered inspections of various license types, including: medical broad scope, 

medical institutions requiring written directives, mobile medical, fixed and portable gauges, 

industrial radiography, research and development broad scope, irradiator, medical therapy, 
Region III Final Report Page 5 

nuclear pharmacy, manufacturer and distribution broad scope, exempt distribution, special 

nuclear material, decommissioning, Increased Controls, and reciprocity. Appendix C lists the 

inspection casework files reviewed, as well as the results of the inspector accompaniments. 

The review team found that inspection reports were generally thorough, complete, consistent, 

and of high quality, with sufficient documentation to ensure that a licensee’s performance with 

respect to health, safety, and security was acceptable. Inspection findings led to appropriate 

and prompt regulatory action, when necessary. Based on the review of casework, the review 

team concluded that routine inspections covered all aspects of the licensees’ radiation safety 

programs commensurate with licensed activities. 

The inspection procedures utilized by the Division are generally consistent with the inspection 

guidance outlined in IMC 2800 and other NRC inspection procedures. The most notable 

deviation is the Division’s broad scope inspection initiative. This initiative increases the 

communication with several large licensees and provides the Division some flexibility in 

scheduling and completing inspections of these facilities. 

Supervisory accompaniments were generally conducted annually for all inspectors. The Branch 

Chiefs made a total of 144 accompaniments during the review period. Two inspectors each had 

one annual accompaniment which was missed; however, both of these inspectors have many 

years’ experience inspecting radioactive materials licensees. Inspectors receive verbal 

feedback at the time of the accompaniments, and a portion of the inspectors’ annual 

performance appraisals address their inspection skills, as demonstrated during the 

accompaniments. 

The review team observed that the Division maintains an adequate supply of survey instruments 

to support their inspection program. Appropriate, calibrated survey instrumentation, such as 

Geiger-Mueller (GM) meters, scintillation detectors, ion chambers, and micro-R meters, was 

observed to be available. Instruments are calibrated annually through a commercial calibration 

service. The Division uses a contract laboratory for radioanalysis of samples taken during 

inspections. 

Accompaniments of four Division inspectors were conducted by two IMPEP team members 

during the weeks of July 30, August 6, and August 20, 2007. The inspectors were accompanied 

during health and safety inspections of medical institutions and Increased Controls inspections. 

The accompaniments are identified in Appendix C. During the accompaniments, all of the 

inspectors demonstrated appropriate inspection techniques, knowledge of the regulations, and 

conducted performance-based inspections. The inspectors were trained, well-prepared for the 

inspection, and thorough in their audits of the licensees’ radiation safety programs and 

implementation of the Increased Controls orders. The inspectors conducted interviews with 

appropriate personnel, observed licensed operations, conducted confirmatory measurements, 

and utilized good health physics practices. The inspections were adequate to assess 

radiological health and safety and Increased Controls at the licensed facilities. 

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

that Region III’s performance with respect to the indicator, Technical Quality of Inspections, was 

satisfactory. 
Region III Final Report Page 6 

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license reviewers for 

22 specific licenses. Licensing actions were reviewed for completeness, consistency, proper 

radioisotopes and quantities, qualifications of authorized users, adequate facilities and 

equipment, adherence to good health physics practices, financial assurance, operating and 

emergency procedures, appropriateness of the license conditions, Increased Controls, and 

overall technical quality. The casework was also reviewed for timeliness, use of appropriate 

deficiency letters and cover letters, reference to appropriate regulations, product certifications, 

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

supervisory review as indicated, and proper signatures. The casework was checked for 

retention of necessary documents and supporting data. 

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

completed during the review period. The review team evaluated 30 licensing actions, covering 

the work of 11 license reviewers. Licensing actions selected for evaluation included 6 new 

licenses, 2 renewals, 19 amendments, 2 terminations, and 1 reciprocity request. The sampling 

included the following license types: research and development broad (master material 

license), research and development, medical (broad, private practice - no written directive, 

gamma knife, and high dose-rate remote afterloader), industrial radiography, portable gauge, 

fixed gauge, panoramic irradiator, decommissioning, manufacturing and distribution, and 

nuclear pharmacy. A listing of the licensing casework evaluated can be found in Appendix D. 

The review team found that the licensing actions were thorough, complete, consistent, and of 

high quality, with health, safety, and security issues properly addressed. License tie-down 

conditions were stated clearly, backed by information contained in the file, and auditable. 

Licenses and correspondence are generated using standardized conditions and formats. 

Licensing staff appropriately used licensing guides, policies, and standard license conditions. 

Licensees’ compliance histories were taken into account when reviewing all renewal 

applications and major amendments. At the time of the review, the Division had no licensing 

actions pending beyond the established acceptable turnaround times. Licenses are issued for a 

10-year period. 

Each licensing action is given a technical review by a license reviewer. All license reviewers 

have signature authority. The Licensing Branch Chief performs a technical and supervisory 

review on files in accordance with established policy. Regular meetings of licensing staff allow 

opportunity for managers to introduce, implement, and provide and gather feedback on new or 

ongoing initiatives. Licensing actions selected by the Licensing Branch Chief are peer reviewed 

as part of quarterly meetings to augment the Division’s other quality assurance and quality 

control measures. 

The review team evaluated the Division’s reciprocity licensing activities. Requests for 

reciprocity from Agreement State licensees and other NRC Regions are processed promptly. 

Expiration dates on Agreement State licenses are verified. For Agreement State licenses 

expiring within the current calendar year, authorization for reciprocal work in Region III 

terminates on the date of expiration unless the licensee can provide an updated license, which 

would extend their reciprocal recognition through the end of the calendar year. 
Region III Final Report Page 7 

The review team evaluated the Division’s financial assurance and decommissioning activities. 

Ongoing financial assurance reviews are tracked through LTS, including milestones. Review of 

the files and milestones reported for open files revealed applicant/licensee turnaround times to 

be the source of delays in issuance. The review team found that terminations and amendments 

to remove or release locations for either controlled or uncontrolled use were well-documented, 

showing appropriate material transfer and survey records. The review team identified no 

performance issues with the Division’s financial assurance and decommissioning activities. 

The Division developed a decommissioning guidance website through Region III’s internal 

website. The decommissioning guidance website contains links to pertinent information and 

guidance documents for decommissioning, such as NUREGs, and also includes a number of 

out-of-print and hard-to-find documents. Maintenance of the website is performed in-house by 

the Division, and as additional useful documents are identified or suggested, the webmaster 

adds them to the website. The review team recommended, and the MRB agreed, that the 

Division’s decommissioning guidance web site be identified as a good practice. 

The review team examined the list of licensees that were determined to meet the criteria for the 

Increased Controls. The review team determined that the appropriate licensees were issued 

Orders that required implementation of the Increased Controls. While no new licenses requiring 

the Increased Controls have been issued since May 2006, the Division has a process in place 

for evaluating new license applications’ subjectivity to the Increased Controls. During the 

amendment process, the Division reviews requested authorization limits and works with the 

licensees to either impose the Increased Controls via license condition or to cap authorization 

limits to eliminate the need for the Increased Controls. 

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

that Region III’s performance with respect to the indicator, Technical Quality of Licensing 

Actions, was satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

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

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

this indicator, evaluated selected incidents reported for Region III in the Nuclear Material Events 

Database (NMED) against those contained in the Division’s files, and evaluated the casework 

for 20 radioactive materials incidents. A listing of the incident casework examined can be found 

in Appendix E. The review team also evaluated the Division’s response to 13 allegations 

involving radioactive materials. 

The review team identified 202 radioactive materials incidents in NMED for Region III during the 

review period, of which 166 were reportable under NRC criteria. The incidents selected for 

review included the following categories: medical, lost/stolen material, exposure to 

embryo/fetus, and equipment failure. The review team discussed incident and allegation 

procedures, file documentation, NMED, and the role of the NRC Headquarters Operations 

Center with Division staff and managers. The Division is responsible for initial response and 

followup actions to radioactive materials incidents. The review team determined that the 

Division’s response to incidents was complete and comprehensive. Initial responses were 

prompt and well-coordinated, and the level of effort was commensurate with the health and 
Region III Final Report Page 8 

safety significance. The Division dispatched inspectors for on-site investigations in a majority of 

the cases reviewed and took suitable enforcement and followup actions. 

The Division has created a picture gallery of radioactive material-related photographs. The 

gallery, which is organized by types of use and modality, contains photographs and schematic 

diagrams of devices, sources, and facilities. The gallery provides the Division with the ability to 

include pictures and diagrams in incident briefings to enhance the effectiveness of the briefings 

to individuals that may not be knowledgeable of such sources, devices, or facilities. The gallery 

also provides the Division with an excellent source of visual aids for inclusion in non-incidentrelated discussions and presentations, such as in-house training courses or topical seminars. 

The gallery can also be used to educate new staff members on the appearance and use of such 

devices, sources, and facilities. The review team recommended, and the MRB agreed, that the 

Division’s picture gallery be identified as a good practice. 

In evaluating the effectiveness of the Division's actions in response to allegations, the review 

team evaluated the casework for 13 allegations. The review team held interviews with the 

Regional Allegations Coordinators, Division managers, and Division technical staff regarding the 

handling of allegations, as well as reviewed the Division’s response to the questionnaire relative 

to this indicator. The Division adheres to NRC Management Directive 8.8, “Management of 

Allegations,” in the handling of allegations. The review team’s evaluation of casework, 

associated documentation, and interviews with staff and managers revealed that the Division 

has an effective and efficient program for managing radioactive materials allegations. The 

casework review indicated that the Division took prompt and appropriate action in response to 

all concerns raised. All of the allegations reviewed were appropriately closed, and appropriate 

parties were notified of the actions taken. 

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

that Region III’s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, was satisfactory. 

4.0 SUMMARY 

As noted in Section 3.0, Region III’s performance was found satisfactory for all performance 

indicators reviewed. The review team made no recommendations regarding program 

performance and identified two good practices. Accordingly, the review team recommended, 

and the MRB agreed, that the NRC Region III radioactive materials program was adequate to 

protect public health and safety. Based on the results of the current IMPEP review, the review 

team recommended, and the MRB agreed, that the next full IMPEP review of the NRC Region 

III radioactive materials program take place in approximately 4 years. 
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B Region III Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Attachment October 22, 2007, E-mail from Steven Reynolds 

 Region III’s Response to Draft IMPEP Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Aaron McCraw, FSME Team Leader 

 Technical Staffing and Training 

 Status of Materials Inspection Program 

Stephen Hammann, Region I Technical Quality of Inspections 

 Inspector Accompaniments 

Robin Rademacher, NC Technical Quality of Licensing Actions 

Richard Leonardi, Region IV Technical Quality of Incident and Allegation 

 Activities 

 Inspector Accompaniments 
APPENDIX B 

REGION III ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML072680567 
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Mallinckrodt, Inc. License No.: 24-04206-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 9/18-22/06 Inspectors: DW, BH 

File No.: 2 

Licensee: Hayes Testing Laboratory License No.: KY-201-168-05 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 7/27/07 Inspector: GP 

File No.: 3 

Licensee: Holland Community Hospital License No.: 21-18502-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/21/05 Inspectors: SM, EK 

File No.: 4 

Licensee: Capital Pharmacy License No.: 21-26597-01MD 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 1/19/06 Inspector: GP 

File No.: 5 

Licensee: Mathy Construction Company License No.: 48-18722-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 4/16/07 Inspector: EK 

File No.: 6 

Licensee: Lone Star Industries, Inc. License No.: 13-12374-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 11/30/05 Inspector: TG 

File No.: 7 

Licensee: Centocor Biologics, LLC License No.: 24-32396-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 3/28/06 Inspector: ML 

File No.: 8 

Licensee: University of Minnesota License No.: 22-00187-46 

Inspection Type: Special Priority: N/A 

Inspection Dates: 1/31-2/23/05 Inspectors: ML, SB 
Region III Final Report Page C.2 

Inspection Casework Reviews

File No.: 9 

Licensee: MTI Industries, Inc. License No.: 12-23905-01E 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 5/25/05 Inspector: SM 

File No.: 10 

Licensee: Jackson Community College License No.: SNM-1171 

Inspection Type: Special, Announced Priority: N/A 

Inspection Date: 7/13/05 Inspector: GW 

File No.: 11 

Licensee: Mid-Michigan Diagnostic License No.: 21-32601-01 

Inspection Type: Initial, Announced Priority: 3 

Inspection Date: 5/11/06 Inspector: KL 

File No.: 12 

Licensee: Indiana University School of Medicine License No.: 13-18384-01 

Inspection Type: Special, Unannounced Priority: 5 

Inspection Dates: 8/22/06, 10/25/06 Inspector: JM 

File No.: 13 

Licensee: JANX Integrity Group License No.: 21-16560-01 

Inspection Type: Special, Announced Priority: 2 

Inspection Dates: 1/17-19/07 Inspector: BH 

File No.: 14 

Licensee: Michigan State University License No.: 21-00021-30 

Inspection Type: Special, Announced Priority: 2 

Inspection Dates: 2/26-28/07 Inspector: DW 

File No.: 15 

Licensee: Bronson Methodist Hospital License No.: 21-13125-01 

Inspection Type: Special, Announced Priority: 2 

Inspection Dates: 8/23-24/07 Inspector: DP 

File No.: 16 

Licensee: DBI, Inc. License No.: NE-02-46-01 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 2/15/07 Inspector: GW 
Region III Final Report Page C.3 

Inspection Casework Reviews

File No.: 17 

Licensee: Hennepin County Medical Center License No.: 22-11070-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/11/05 Inspector: DP 

File No.: 18 

Licensee: U.S. Steel Corporation License No.: 21-10459-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 2/12/07 Inspector: SB 

File No.: 19 

Licensee: Sigma-Aldrich Company License No.: 24-16273-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 9/29-30/05 Inspector: DP 

File No.: 20 

Licensee: University of Michigan License No.: 21-00215-04 

Inspection Type: Routine, Announced Priority: 2 

Inspection Dates: 8/29-9/2/05 Inspectors: DW, SB 

File No.: 21 

Licensee: University of Michigan License No.: 21-00215-04 

Inspection Type: Routine, Announced Priority: 2 

Inspection Dates: 1/22-25/07 Inspector: DW 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: Bloomington Hospital License No.: 13-10408-02 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/9/07 Inspector: GW 

Accompaniment No.: 2 

Licensee: Henry Ford Hospital License No.: 21-04109-16 

Inspection Type: Special, Announced Priority: 1 

Inspection Dates: 8/23-24/07 Inspector: ML 

Accompaniment No.: 3 

Licensee: Heart Care Group, The License No.: 24-32625-01 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 7/23/07 Inspector: DP 
Region III Final Report Page C.4 

Inspection Casework Reviews

Accompaniment No.: 4 

Licensee: SSM DePaul Health Center License No.: 24-02490-03 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/23/07 Inspector: DP 

Accompaniment No.: 5 

Licensee: Army, Department of License No.: 24-32221-01 

Inspection Type: Special, Announced Priority: 3 

Inspection Dates: 7/24-25/07 Inspector: DP 

Accompaniment No.: 6 

Licensee: Army, Department of License No.: 24-15095-01 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 7/24/07 Inspector: DP 

Accompaniment No.: 7 

Licensee: St. Luke’s Hospital License No.: 24-01570-03 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/26/07 Inspector: DP 

Accompaniment No.: 8 

Licensee: Community Memorial Hospital License No.: 21-20250-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/8/07 Inspector: KL 

Accompaniment No.: 9 

Licensee: Schoolcraft Memorial Hospital License No.: 21-16542-03 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 8/8/07 Inspector: KL 

Accompaniment No.: 10 

Licensee: Dickinson County Memorial License No.: 21-18889-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/9/07 Inspector: KL 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Saint Joseph’s Hospital License No.: 13-32277-01 

Type of Action: Termination Amendment No.: 11 

Date Issued: 5/7/07 License Reviewer: WR 

File No.: 2 

Licensee: Heart & Wellness Institute, PC License No.: 21-32654-01 

Type of Action: New Amendment No.: N/A 

Date Issued: 6/22/07 License Reviewer: JM 

File No.: 3 

Licensee: William Beaumont Hospital License No.: 21-01333-02 

Types of Action: New, Amendments Amendment Nos.: 0-2 

Dates Issued: 12/13/06, 4/4/07, 7/30/07 License Reviewer: TS 

File No.: 4 

Licensee: William Beaumont Hospital License No.: 21-01333-01 

Type of Action: Amendments Amendment Nos.: 81, 82 

Dates Issued: 10/10/06, 12/13/06 License Reviewer: TS 

File No.: 5 

Licensee: Gateway Constructors License No.: 24-32656-01 

Type of Action: New Amendment No.: N/A 

Date Issued: 6/27/07 License Reviewers: KN, JM 

File No.: 6 

Licensee: St. Mary’s University of Minnesota License No.: 22-00027-06 

Type of Action: Termination Amendment No.: 21 

Date Issued: 10/13/05 License Reviewer: KN 

File No.: 7 

Licensee: Goshen General Hospital License No.: 13-18845-01 

Type of Action: Amendment Amendment No.: 35 

Date Issued: 6/27/07 License Reviewer: TS 

File No.: 8 

Licensee: Warner-Lambert, LLC License No.: 21-01443-06 

Type of Action: Amendment Amendment No.: 60 

Date Issued: 12/19/06 License Reviewer: WS 
Region III Final Report Page D.2 

License Casework Reviews

File No.: 9 

Licensee: American Radiolabeled Chemicals License No.: 24-21362-01 

Type of Action: Amendment Amendment No.: 37 

Date Issued: 7/28/06 License Reviewers: KN, PL 

File No.: 10 

Licensee: Warner-Lambert, LLC License No.: 21-01443-06 

Type of Action: Amendment Amendment No.: N/A 

Date Issued: Pending License Reviewer: WS 

File No.: 11 

Licensee: Missouri Baptist Medical Center License No.: 24-11128-02 

Type of Action: Amendment Amendment No.: 64 

Date Issued: 1/26/07 License Reviewer: JM 

File No.: 12 

Licensee: Battelle Memorial Institute License No.: SNM-7 

Type of Action: Renewal Amendment No.: 33 

Date Issued: 6/7/07 License Reviewer: MM 

File No.: 13 

Licensee: Michigan Cardiology, P.C. License No.: 21-32468-01 

Types of Action: New, Amendments Amendment Nos.: 0-3 

Dates Issued: 8/25/03, 10/9/03, 6/30/05, 3/7/06 License Reviewers: CC, JM 

File No.: 14 

Licensee: Kraft Foods, Inc. License No.: 12-32496-01 

Types of Action: New, Amendment Amendment Nos.: 0, 1 

Dates Issued: 5/17/04, 2/8/06 License Reviewers: LH, WR 

File No.: 15 

Licensee: Radiopharmacy of Indianapolis License No.: 13-32637-01MD 

Type of Action: New Amendment No.: N/A 

Date Issued: 4/3/07 License Reviewer: TS 

File No.: 16 

Licensee: Testing Engineers & Consultants, Inc. License No.: 21-18668-01 

Type of Action: Renewal Amendment No.: 17 

Date Issued: 1/17/07 License Reviewer: LH 

File No.: 17 

Licensee: Midwest Research Institute License No.: 24-02564-02 

Type of Action: Amendment Amendment No.: 59 

Date Issued: 6/12/07 License Reviewer: KN 
Region III Final Report Page D.3 

License Casework Reviews

File No.: 18 

Licensee: Whitney & Associates, Inc. License No.: IL-01683-01 

Type of Action: Reciprocity Amendment No.: N/A 

Date Issued: 8/29/07 License Reviewer: GP 

File No.: 19 

Licensee: Department of Veteran Affairs License No.: 03-23853-01VA 

Type of Action: Amendments Amendment Nos.: 5, 6 

Dates Issued: 6/8/07, 8/28/07 License Reviewer: CF 

File No.: 20 

Licensee: SSM DePaul Health Center License No.: 24-02490-03 

Type of Action: Amendment Amendment No.: 51 

Date Issued: 3/2/07 License Reviewer: CC 

File No.: 21 

Licensee: 3M Company License No.: 22-00057-61 

Type of Action: Amendment Amendment No.: 38 

Date Issued: 5/14/07 License Reviewer: CC 

File No.: 22 

Licensee: Elite Inspection Service Co., Inc. License No.: 13-26712-01 

Type of Action: Amendment Amendment No.: 10 

Date Issued: 5/2/07 License Reviewer: KN 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: University of Michigan License No.: 21-00215-04 

Date of Incident: 4/1/03 Incident Log No.: NMED 030267 

Investigation Date: 4/9/03 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 2 

Licensee: Washington University/Medical Center License No.: 24-00167-11 

Date of Incident: 7/9/03 Incident Log No.: NMED 030564 

Investigation Date: 7/22/03 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 3 

Licensee: Lakeland Medical Center License No.: 21-04177-01 

Date of Incident: 11/11/03 Incident Log No.: NMED 030921 

Investigation Date: 11/19/03 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 4 

Licensee: Indiana University Medical Center License No.: 13-02752-03 

Date of Incident: 9/15/04 Incident Log No.: NMED 040819 

Investigation Date: 11/3/04 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Licensee Report 

File No.: 5 

Licensee: Imaging Subsurface, Inc. License No.: 21-32050-01 

Date of Incident: 11/2/04 Incident Log No.: NMED 040798 

Investigation Date: 11/4/04 Type of Incident: Unsecured RAM 

 Type of Investigation: Site 

File No.: 6 

Licensee: William Beaumont Hospital License No.: 21-01333-01 

Date of Incident: 6/8/04 Incident Log No.: NMED 040415 

Investigation Date: 6/10/04 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 7 

Licensee: University of Minnesota License No.: 22-00187-46 

Date of Incident: 1/25/05 Incident Log No.: NMED 050065 

Investigation Date: 1/31/05 Type of Incident: Medical 

 Type of Investigation: Site 
Region III Final Report Page E.2 

Incident Casework Reviews 

File No.: 8 

Licensee: St. John’s Mercy Medical Center License No.: 24-00794-03 

Date of Incident: 3/9/05 Incident Log No.: NMED 050143 

Investigation Dates: 3/15-16/05 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 9 

Licensee: Porter Valparaiso Hospital Campus License No.: 13-17073-01 

Date of Incident: 2/16/05 Incident Log No.: NMED 050098 

Investigation Date: 2/23/05 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 10 

Licensee: Saint Mary’s Health Care License No.: 21-01078-01 

Date of Incident: 2/16/06 Incident Log No.: NMED 060123 

Investigation Date: 2/28/06 Type of Incident: Contamination 

 Type of Investigation: Licensee Report 

File No.: 11 

Licensee: Southeast Missouri State University License No.: 24-09296-02 

Date of Incident: 2/17/06 Incident Log No.: NMED 060124 

Investigation Date: 2/21/06 Type of Incident: Contamination 

 Type of Investigation: Site 

File No.: 12 

Licensee: Indiana University Medical Center License No.: 13-02752-03 

Date of Incident: 3/29/06 Incident Log No.: NMED 060216 

Investigation Dates: 4/3-4/06 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 13 

Licensee: Indiana University Medical Center License No.: 13-02752-03 

Date of Incident: 3/29/06 Incident Log No.: NMED 060219 

Investigation Dates: 4/3-4/06 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 14 

Licensee: Saint Joseph Health Center License No.: 24-15159-01 

Date of Incident: 6/28/06 Incident Log No.: NMED 060430 

Investigation Dates: 7/10-11/06 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 15 

Licensee: University of Missouri License No.: 24-09296-02 

Date of Incident: 10/3/06 Incident Log No.: NMED 060124 

Investigation Date: 10/4/06 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Licensee Report 
Region III Final Report Page E.3 

Incident Casework Reviews 

File No.: 16 

Licensee: Hackley Hospital License No.: 21-04125-01 

Date of Incident: 1/8/07 Incident Log No.: NMED 070024 

Investigation Dates: 1/11-12/07 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 17 

Licensee: Community Hospitals of Indiana, Inc. License No.: 13-06009-01 

Date of Incident: 4/18/07 Incident Log No.: NMED 070235 

Investigation Date: 4/25/07 Type of Incident: Medical 

 Type of Investigation: Site 

File No.: 18 

Licensee: Washington University in St. Louis License No.: 24-00167-11 

Date of Incident: 5/29/07 Incident Log No.: NMED 070339 

Investigation Date: 6/5/07 Type of Incident: Overexposure 

 Type of Investigation: Site 

File No.: 19 

Licensee: Lester E. Cox Medical Center License No.: 24-01143-06 

Dates of Incidents: 7/10,17,24/07 Incident Log No.: NMED 070471 

Investigation Date: 8/2/07 Type of Incidents: Medical 

 Type of Investigation: Site 

File No.: 20 

Licensee: Soil & Materials Engineers, Inc. License No.: 21-17158-02 

Date of Incident: 6/25/07 Incident Log No.: NMED 070387 

Investigation Date: 6/26-27/07 Type of Incident: Equipment Failure 

 Type of Investigation: Site 
ATTACHMENT 

October 22, 2007, E-mail from Steven Reynolds 

Region III’s Response to Draft IMPEP Report 

ADAMS: ML072970853