January 15, 2013 

MEMORANDUM TO: Charles A. Casto, Regional Administrator 

Region III

FROM: Michael F. Weber /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 REVIEW OF THE 

 REGION III RADIOACTIVE MATERIALS PROGRAM 

On December 17, 2012, 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 (NRC) Region III Radioactive Materials Program. The MRB found the 

program adequate to protect public health and safety. 

Section 3.0, page 9, 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. 

Based on the results of the current IMPEP review, the next full review of the NRC Region III 

program will take place in approximately 5 years, with a periodic meeting tentatively scheduled 

mid-cycle. The program received a 1 year extension based on two consecutive IMPEPs 

resulting in satisfactory ratings for all indicators reviewed. 

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

applaud your staff’s efforts during the IMPEP review period. 

Enclosure: 

Region III Final IMPEP Report 

cc w/ encl: Earl Fordham, WA 

 Organization of Agreement States 

 Liaison to the MRB 

 

 Anne T. Boland, Director 

 Division of Nuclear Materials Safety 

 
January 15, 2013 

MEMORANDUM TO: Charles A. Casto, Regional Administrator 

Region III

FROM: Michael F. Weber /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 REVIEW OF THE 

 REGION III RADIOACTIVE MATERIALS PROGRAM 

On December 17, 2012, 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 (NRC) Region III Radioactive Materials Program. The MRB found the 

program adequate to protect public health and safety. 

Section 3.0, page 9, 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. 

Based on the results of the current IMPEP review, the next full review of the NRC Region III 

program will take place in approximately 5 years, with a periodic meeting tentatively scheduled 

mid-cycle. The program received a 1 year extension based on two consecutive IMPEPs 

resulting in satisfactory ratings for all indicators reviewed. 

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

applaud your staff’s efforts during the IMPEP review period. 

Enclosure: 

Region III Final IMPEP Report 

cc w/ encl: Earl Fordham, WA 

 Organization of Agreement States 

 Liaison to the MRB 

 

 Anne T. Boland, Director 

 Division of Nuclear Materials Safety 

DISTRIBUTION: 

See next page 

 ML12354A437 

OFC MSSA:TL MSSA MSSA MSSA MSSA:D TechEd FSME:D EDO 

NAME JDeCicco LDimmick / 

KMeyer 

DWhite / 

TTaylor 

PHenderson BMcDermott CPoland MSatorius 

/ BHolian 

MWeber 

DATE 12/19/12 12/26/12 12/26/12 12/28/12 01/03/13 01/04/13 01/09/13 01/15/13 

OFFICIAL RECORD COPY 

 
Memo to C. Casto from Michael F. Weber dated: January 15, 2013 

SUBJECT: NRC Region III FY2013 FINAL IMPEP REPORT 

DISTRIBUTION: 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

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RidsOgcMailCenter 

RidsRgn1MailCenter 

RidsRgn3MailCenter 

RidsFsmeDmssa 

RidsSecyCorrespondenceMailCenter Chairman Macfarlane 

MBeardsley, FSME Commissioner Svinicki 

KModes, RI/DNMS Commissioner Apostolakis 

AGaines, RIV/DNMS Commissioner Magwood 

CBecker, FL Commissioner Ostendorff 

JLynch, RIII/RSAO SECY 

PLouden, RIII 

JFoster, OEDO 

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

REVIEW OF THE NRC REGION III PROGRAM 

September 24 - 28, 2012 

FINAL REPORT

Enclosure 
EXECUTIVE SUMMARY 

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

(IMPEP) review of the U.S. Nuclear Regulatory Commission (NRC) Region III materials 

program. The review was conducted during the period of September 24-28, 2012, by a review 

team composed of technical staff members from the NRC and the State of Florida.

Based on the results of this review, Region III’s performance was found satisfactory for all five 

indicators reviewed. The findings for the indicators remain unchanged from the previous two 

IMPEP reviews. 

The review team did not make any recommendations. 

Accordingly, the review team recommended, and the Management Review Board agreed, that 

the NRC Region III materials program is adequate to protect public health and safety. The 

review team recommends that the next IMPEP review take place in approximately 5 years. 

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

24 – 28, 2012, by a review team composed of technical staff members from the NRC and the 

State of Florida. 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 August 31, 2007 to September 28, 2012, were discussed 

with Region III managers on the last day of the review. 

A draft of this report was provided to Region III for factual comment on October 23, 2012. 

Region III responded by electronic mail dated November 16, 2012. A copy of the region’s 

response is included as an Attachment to this report. A Management Review Board (MRB) met 

on December 17, 2012, to consider the proposed final report. The MRB found the NRC Region 

III materials program adequate to protect public health and safety. 

The NRC Region III materials program is administered by the Division of Nuclear Materials 

Safety (Division), which is headed by the Division Director. The Division Director reports directly 

to the Regional Administrator. An organization chart for Region III and the Division is included 

as Appendix B. 

At the time of the review, the Region III materials program regulated 1,116 specific licenses 

authorizing possession and use of radioactive materials. The review focused on the radioactive 

materials program as it is carried out under the Atomic Energy Act of 1954, as amended. 

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

was sent to the Division on May 30, 2012. The Division provided its response to the 

questionnaire on September 4, 2012. A copy of the questionnaire response can be found in the 

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

Accession Number ML12297A211. 

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 

Division’s databases, (3) technical review of selected regulatory actions, (4) field 

accompaniments of six inspectors, and (5) interviews with staff and managers. The review 

team evaluated the information gathered against the established criteria for each common 

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

There were no recommendations made during the previous review. 

Results of the current review of the common performance indicators are presented in Section 

2.0. There were no non-common performance indicators reviewed for this IMPEP. Section 3.0 

summarizes the review team's findings. 
Region III IMPEP Final Report Page 2 

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

Considerations 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 managers and staff, reviewed job descriptions and training records, 

and considered workload backlogs. 

The Division is managed by the Director, who reports directly to the Regional Administrator. 

The Division is composed of three branches: the Materials Licensing Branch, the Materials 

Inspection Branch, and the Materials Controls, ISFSI and Decommissioning Branch. Each is 

headed by a Branch Chief. 

At the time of the review, there were 27 technical staff members with various degrees of 

involvement in the radioactive materials program. The Division has a total of approximately 

28.9 full-time equivalents (FTE), an increase of 5.9 FTE since the last review. The Division 

has two vacant positions: a GG-13 health physicist in Materials Licensing and a GG-6 

Materials Processing Assistant. Filling these vacancies is on hold as a review process is 

being conducted to assess the needs of the Division. The review team determined that the 

Division’s Operational Management Information (OMI) reports assist Division managers to use 

their staff resources efficiently. Early in the review period, there was some turnover of senior 

staff, and two inspectors were assigned for almost a year to evaluate a complicated 

enforcement activity. The Division prevented a possible backlog by procuring assistance from 

the other NRC Regions as well as quickly filling the vacant positions. The review team 

determined that staffing levels were adequate for the Region’s materials program. 

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. Staff members are assigned increasingly complex duties as 

they progress through the qualification process. During the review period, three individuals 

successfully completed their qualification boards, one is eligible in November 2012, and two are 

in the Nuclear Safety Professional Development Program. To promote knowledge management 

and succession, the Division takes advantage of mentoring opportunities for less experienced 

staff. The review team found that all senior technical staff members are available and willing to 

provide guidance and assistance to newer staff on their assigned projects as well as guide them 

through their training. The review team concluded that the Division’s training program is 

adequate to carry out its regulatory duties and noted that Division management supports the 

Division training program. 
Region III IMPEP Final Report Page 3 

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, 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 based its evaluation 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 management and 

staff. 

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

2800, “Materials Inspection Program.” The Division continues to implement its broad scope 

inspection initiative as discussed in previous IMPEP reports. The broad scope inspection 

initiative allows several partial inspections of major broad scope licensees to be conducted 

within the inspection cycles, as long as all inspection objectives are met through the aggregation 

of the partial inspections. 

The review team determined that the Division conducted 797 inspections of Priority 1, 2, and 3 

licensees during the review period. Twelve inspections were performed overdue by more than 

25 percent of the inspection frequency listed in IMC 2800. Five of the overdue inspections were 

identified in 2011 based on an extensive self-assessment conducted to validate inspection and 

licensing tracking data in the Licensing Tracking System database. The Division conducted 196 

initial inspections of new radioactive materials licenses during the review period. Of the 196 

initial inspections, 3 were performed greater than 12 months after license issuance. These 

three were identified during a 2012 effectiveness review of corrective actions from the 2011 

validation effort. Overall the review team calculated that the Division performed 1.5 percent of 

all Priority 1, 2, and 3 inspections and initial inspections overdue during the review period. 

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

the inspection casework reviews and the OMI reports. The review indicated that inspection 

reports were issued to the licensee consistently within 30 days following the conclusion of the 

inspection. 

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

Database to the review team. The Division independently developed this database to gain 

efficiency in the inspection planning process. The Inspection Planner Database is populated 

and updated by a monthly download from Web-Based Licensing (WBL) database. Information 

provided from WBL, such as a licensee’s address and inspection dates, is entered automatically 

into the respective fields on the planning form, saving the inspector time from 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, and after supervisory review, the administrative 

staff enters the completed inspection data to update WBL. In addition, the Division utilizes an 

electronic Inspection Book, which is populated and updated by a monthly download from the 
Region III IMPEP Final Report Page 4 

WBL database. Information provided from the WBL, such as a licensee’s address and 

inspection dates, is entered automatically into the respective fields in the Inspection Book. The 

frequent monthly updates have allowed steady progress regarding inspections in the plus 25 

percent category and the Inspection Planner allows current inspections to be included with the 

plus 25 percent category for travel and time efficiency. This focus also helps lower the plus 25 

percent category. The review team believes that the Division’s database and Inspection Book 

could be a beneficial tool for the other NRC Regional Offices in planning their inspection 

activities. The database is also capable of generating the inspection information for the monthly 

OMI reports. 

During the review period, the Division granted 45 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 Division exceeded the 

NRC’s criteria of inspecting 20 percent of candidate licensees operating under reciprocity in 

each of the five years covered by the review period with an overall inspection average of 54.5 

percent. On August 6, 2012, the Division issued “DI IMC-1200 Processing, Approving and 

Tracking Reciprocity Requests,” to specify the criteria for determining whether a reciprocity 

licensee is a candidate for inspection and what actions to take when a reciprocity notification is 

received from another Region. Reciprocity candidates now include Priority 1 through 3 

licensees, from Region I and IV Agreement States, working at temporary job sites in Region III, 

as notified from Region I or IV. This change is expected to significantly increase the number of 

candidates for reciprocity inspection. 

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, be found satisfactory. 

2.3 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, 

inspection field notes, and interviewed inspectors for 20 radioactive materials inspections 

conducted during the review period. The casework reviewed included inspections 

conducted by 12 Region III inspectors and covered inspections of various license types: 

medical broad scope, academic broad scope, medical diagnostic, medical therapy 

including high dose rate remote after loader, unsealed radioiodine therapy, and 

permanent implant brachytherapy, portable and fixed gauges, industrial radiography, selfshielded irradiators, nuclear pharmacy, and Increased Security Controls for Radioactive 

Materials Quantities of Concern (Increased Controls). Appendix C lists the inspection 

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

Based on the evaluation of casework, the review team noted that inspections covered all 

aspects of the licensee’s radiation safety program. The review team found that inspection 

reports were thorough, complete, consistent, and of high quality, with sufficient documentation 

to ensure that a licensee’s performance with respect to health and safety was acceptable. The 

documentation supported violations, recommendations made to licensees, unresolved safety 

issues, the effectiveness of corrective actions taken to resolve previous violations and 

discussions held with licensees during exit interviews. 
Region III IMPEP Final Report Page 5 

The inspection procedures utilized by Region III are consistent with the inspection guidance 

outlined in IMC 2800. An inspection report is completed by the inspector which is then reviewed 

and signed by the Branch Chief. All inspectors received annual supervisory accompaniments. 

The review team determined that the inspection findings were appropriate, and prompt 

regulatory actions were taken as necessary. All inspection findings were clearly stated and 

documented in the reports and sent to the licensees with the appropriate letter detailing the 

results of the inspection. Region III issues to the licensee either an NRC Form 591 indicating a 

clear inspection, an NRC Form 591 with Severity Level IV violations, or a Notice of Violation 

(NOV), in letter format, which details the results of the inspection. The Branch Chief reviews all 

findings. When Region III issues an NOV, the licensee is required to provide, within 30 days, 

written corrective actions, based on the violations cited. 

The review team noted that Region III has an adequate supply of survey instruments to support 

its inspection program. Appropriate, calibrated survey instrumentation, such as 

Geiger-Mueller meters, scintillation detectors, ion chambers, micro-R meters, and neutron 

detectors, were available. Region III’s Radiation Safety Officer tracks calibration due dates. 

Instruments are calibrated at least annually, or as needed, by a commercial vendor with 

National Institute of Standards and Technology traceable sources. 

Two IMPEP team members conducted accompaniments with six Region III inspectors 

during the weeks of July 16, July 23, and September 10, 2012. The IMPEP team members 

accompanied the inspectors during health and safety and security inspections of industrial 

radiography, self-shielded irradiators, portable and fixed gauges, medical broad scope, 

academic broad scope, medical diagnostic and medical therapy, including high dose rate 

remote after loader, unsealed radioiodine therapy, and permanent implant brachytherapy 

licenses. The accompaniments are identified in Appendix C. During the accompaniments, 

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 inspections of the licensees’ radiation 

safety programs. 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 security 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, be 

found satisfactory. 

2.4 Technical Quality of Licensing Actions

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

22 specific licensing actions. 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, operating and 

emergency procedures, appropriateness of license conditions, and overall technical quality. 

The casework was also reviewed for timeliness, use of appropriate deficiency and cover letters, 
Region III IMPEP Final Report Page 6 

use of appropriate reference to regulations, supporting documentation, consideration of 

enforcement history, pre-licensing visits, peer/supervisory review, and proper signatures. 

The review team selected licensing casework to provide a representative sample of licensing 

actions completed during the review period. Licensing actions selected included four new 

licenses, four renewals, three terminations, ten amendments, and one void decommissioning 

case. Files reviewed included a cross-section of license types: medical (e.g., broad-scope, high 

dose rate remote afterloader, gamma knife, and teletherapy), radionuclide production using an 

accelerator, nuclear pharmacy, research and development, industrial radiography, fixed gauges, 

manufacturers and distributors, panoramic irradiators, and special nuclear materials. The 

casework sample represented work from 14 license reviewers. A list of the licensing casework 

evaluated with case-specific comments is provided 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 and were supported by information contained in the file. 

Requests for additional information contained clearly stated regulatory positions, were used at 

the proper time, and identified substantive deficiencies in the licensees’ documents. Terminated 

licensing actions were well documented, showing appropriate transfer and survey records, as 

well as environmental assessments when needed. License reviewers use the Region III’s 

certification checklists and the NUREG-1556 series guidance documents, policies, and license 

conditions specific to the type of licensing actions to ensure consistency in licenses. The 

certification checklists are highly adaptable by each license reviewer and may range from a few 

pages to over 60 pages because the list may include the results of the previous inspection and 

many reference documents. Region III also forwards non-conforming financial assurance 

documents to the Division of Waste Management and Environmental Protection for review via 

the technical assistance request process. 

The Materials Licensing Branch is composed of 10 personnel who primarily work on licensing 

actions, a records management clerk, and a branch chief. Six of the ten license reviewers have 

full signature authority for licensing actions. License reviewers are responsible for reviewing the 

license actions before issuance to the licensee. Licenses are issued for a 10 year period under 

a timely renewal system. As of August 2012, Region III has 1,116 specific licensees - 15 

Priority 1, 125 Priority 2, 212 Priority 3, and 764 Priority 5 licensees. The Materials Licensing 

Branch completes approximately 930 licensing actions per fiscal year (FY). 

The review team found that incoming licensing action requests are scanned into ADAMS as a 

non-public document by a representative from Region III Division of Resource Management. 

The license action is then provided to the Chief of the Materials Licensing Branch who performs 

a preliminary review and has a staff member check WBL for any other pending actions. The 

Branch Chief then assigns the action to a license reviewer. A contractor generates a deemed 

timely letter for renewals, a postcard receipt with the mail control number listed for new licenses 

and amendments, and enters the milestones into the WBL system. Once the license reviewer’s 

action is complete and the license is signed, the license action is provided to the Records 

Management Clerk who date stamps and processes the action for mailing. The contractor 

performs the final update to WBL. 
Region III IMPEP Final Report Page 7 

The Chief of the Materials Licensing Branch manages the oversight of the licensing program. 

Until FY12, self-assessments of the licensing process were performed quarterly; as of FY12, the 

self-assessments are performed semi-annually. The self-assessments are critical and are used 

to improve staff performance and efficiency. 

 

Based on the casework evaluated, the review team concluded that the licensing actions were of 

high quality and consistent with the Branch licensing procedures and/or NUREG-1556 guidance 

documents, NRC regulations, and good health physics practices. The review team attributed 

the consistent use of templates and quality assurance reviews to the overall quality noted in the 

casework reviews. 

The Program performs pre-licensing checks of all new applicants, unless the applicant has a 

valid Agreement State license in good standing and the license reviewer obtains verification 

from the Agreement State regarding this particular licensee. The pre-licensing review methods 

incorporate the essential elements of NRC’s revised pre-licensing guidance to verify that the 

applicant will use requested radioactive materials as intended. All pre-licensing site visits 

include an evaluation of the applicant’s radiation safety and security programs prior to receipt of 

the initial license. 

The review team examined Region III’s licensing practices regarding the Increased Controls and 

Fingerprinting Orders. The review team noted that Region III uses legally binding license 

conditions that meet the criteria for implementing the Increased Controls Orders, including 

fingerprinting, as appropriate. The review team analyzed Region III’s methodology for 

identifying those licenses and found the rationale was thorough and accurate. The review team 

confirmed that license reviewers evaluated new license applications and license amendments 

using the same criteria. Region III ensures an applicant or licensee’s full implementation of the 

Increased Controls prior to issuance of a new license or license amendment authorizing 

radionuclides in quantities of concern. 

The review team examined Region III’s implementation of its procedure for the control of 

sensitive information. This procedure addresses the identification, marking, control, handling, 

preparation, transportation, transmission, and destruction of documents that contain sensitive 

information related to the Increased Controls. The review team noted that the licensing files are 

maintained in the NRC’s ADAMS which is password protected. Hard copy files that contained 

sensitive information were further secured in locked file cabinets. 

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, be found satisfactory. 

2.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of Region III 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 Materials Events Database 

(NMED) against those contained in the Division’s files, and evaluated the casework for 20 

radioactive materials incidents. A list of the incident casework examined, with case-specific 
Region III IMPEP Final Report Page 8 

comments, may be found in Appendix E. The review team also evaluated Region III’s response 

to 14 allegations involving radioactive materials licenses. 

The review team identified 384 radioactive materials incidents in NMED for Region III during the 

review period, of which 165 were reportable under the NRC regulations. Incidents included 

eight abnormal occurrences. Reviewed incidents included the categories of medical events, lost 

material, equipment failure, contamination, and transportation. The review team discussed 

incident contents, procedures, documentation, incorporation of followup information to the 

NMED database, and the role of NRC Headquarters Operations Center with Division staff. A 

routine, monthly Division level review of open NMED documented incidents facilitates efforts for 

timely closure of incidents. Inspector reviews of NMED facilitate scheduling follow-up visits 

when site visits are deemed necessary. The review team determined that the Division’s 

responses to incidents were complete and comprehensive. Initial responses were prompt and 

well-coordinated, and the level of effort was commensurate with the health and safety 

significance. The Division dispatched inspectors for on-site investigations in 13 of the 20 cases 

reviewed and took suitable enforcement and followup actions. Documentation shows that 

followup to the incidents was performed and was well documented in licensee report reviews, 

investigation inspections, enforcement actions when required, and followup inspections. 

If the Division determines that an immediate onsite inspection is not warranted, via 

communications with the licensee and review of licensee’s report, a Division instruction 

includes a process for closing out NMED items by preparing a letter to the licensee 

acknowledging receipt of the licensee’s written report. 

In evaluating the Division’s actions in response to allegations, the review team evaluated 14 

casework files. The review team noted that the allegation files are maintained by the 

Enforcement and Investigation Coordination Staff (EICS) of the Regional Office, which 

coordinates very well with the Division of Nuclear Materials Safety in addressing materials 

licensee allegations. The review team found records with allegations and supporting 

information well documented. The chronologically filed, well organized documentation makes 

files easy to follow from initial allegation, Allegation Review Board (ARB) meeting notes, 

communications with concerned individuals (CI) and licensees, and final resolution and closeout 

correspondence. Processes are timely, with timeliness goals being met. The ARB schedules 

its meetings every Monday, so that the ARB is addressing all new allegations in a timely 

manner. The Program notified the concerned individuals of the conclusion of their 

investigations when the CI is known. The review team determined that the Program adequately 

protected the identity of concerned individuals. The EICS performs a final file review against a 

multi-page verification list prior to closure of the allegation to assure completeness of the record. 

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, be found satisfactory. 

 
Region III IMPEP Final Report Page 9 

3.0 SUMMARY 

As noted in Section 2.0 above, the Region III’s performance was found satisfactory for all of the 

performance indicators reviewed. The review team did not make any recommendations. 

Accordingly, the review team recommended, and the MRB agreed, that the Region III Program 

be found adequate to protect public health and safety. Based on the results of the current 

IMPEP review, the review team recommends that the next IMPEP review take place in 

approximately 5 years. 
LIST OF APPENDICES 

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 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Joseph DeCicco, FSME Team Leader 

 Technical Quality of Incident 

 and Allegation Activities 

Cynthia Becker, Florida Technical Staffing and Training 

 Status of Materials Inspection Program 

Kathy Modes, Region I Technical Quality of Licensing Actions 

 Inspection Accompaniments 

Anthony Gaines, Region IV Technical Quality of Inspections 

 Inspection Accompaniments 
APPENDIX B 

REGION III ORGANIZATION CHART 

ADAMS ACCESSION NO.: ML12283A358 
 

 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Indiana State University License No.: 13-09639-05 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 11/6/08 Inspector: SM 

File No.: 2 

Licensee: Metaltek International Carondelet Division License No.: 24-26136-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/21/09 Inspector: KN 

File No.: 3 

Licensee: University of Notre Dame du Lac License No.: 13-01983-15 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 8/4-6/09 Inspector: ML 

File No.: 4 

Licensee: Allied Inspection Services, Inc. License No.: 21-18428-01 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 8/20/09 Inspector: DP 

File No.: 5 

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

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 10/29/09 Inspector: GW 

File No.: 6 

Licensee: City of South Bend, Department of Public Works License No.: 13-15423-03 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 1/19/10 Inspector: EK 

File No.: 7 

Licensee: ArcelorMittal Burns Harbor LLC License No.: 13-32670-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 2/18-19/10 Inspector: RG 

 

File No.: 8 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 2/22-25/10 Inspector: KL 

File No.: 9 

Licensee: De Backer and Sons, Inc. License No.: N/A 

Inspection Type: Special, Announced Priority: N/A 
REGION III IMPEP Final Report Page C.2 

Inspection Casework Reviews 

Inspection Date: 3/16/10 Inspector: RH 

File No.: 10 

Licensee: Wabash College License No.: 13-07419-02 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/7/10 Inspector: ML 

File No.: 11 

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

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 6/7/10 Inspector: EK 

File No.: 12 

Licensee: Oakwood Hospital and Medical Center License No.: 21-04515-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 6/10/10 Inspector: DP 

File No.: 13 

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

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 8/2-6/10 and 8/9-10/10 Inspector: RG 

File No.: 14 

Licensee: St. Luke’s Hospital of Kansas City License No.: 24-00889-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 8/9-11/11 Inspector: GW 

File No.: 15 

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

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 11/16-18/11 Inspector: RG 

File No.: 16 

Licensee: Midwest Testing, Inc. License No.: 24-24619-02 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 1/31/12 Inspector: RH 

File No.: 17 

Licensee: Bayer CropScience LP License No.: 24-03830-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 2/27/12 Inspectors: KL, BL 

File No.: 18 

Licensee: Alpena Regional Medical Center License No.: 21-17754-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/28-29/12 Inspector: AB 

 
REGION III IMPEP Final Report Page C.3 

Inspection Casework Reviews 

File No.: 19 

Licensee: Allied Inspection Services, Inc. License No.: 21-18428-01 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 7/24/12 Inspector: BL 

File No.: 20 

Licensee: PETNET Solutions, Inc. License No.: 41-32720-02MD 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/24/12 Inspectors: KL, MH 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Dunn Paper License No.: 21-26777-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 7/18/12 Inspector: EK 

Accompaniment No.: 2 

Licensee: Marathon Petroleum Company LP License No.: 21-32842-01 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 7/18/12 Inspector: EK 

Accompaniment No.: 3 

Licensee: Washington University License Nos.: 24-00167-11 and 24-00167-14 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/17, 19, and 20/12 Inspector: RG 

Accompaniment No.: 4 

Licensee: Washington University License Nos.: 24-00167-11 and 24-00167-14 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/17, 19, and 20/12 Inspector: RH 

Accompaniment No.: 5 

Licensee: Allen Park Cardiology, P.C. License No.: 21-26792-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 7/23/12 Inspector: BL 

Accompaniment No.: 6 

Licensee: Allied Inspection Services, Inc. License No.: 21-18428-01 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 7/24/12 Inspector: BL 

 
REGION III IMPEP Final Report Page C.4 

Inspection Casework Reviews 

Accompaniment No.: 7 

Licensee: Southeast Missouri Hospital License No.: 24-00128-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/25-26/12 Inspector: AB 

Accompaniment No.: 8 

Licensee: Mercy Hospital License No.: 21-02187-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/10/12 Inspector: AM 

Accompaniment No.: 9 

Licensee: McLaren – Greater Lansing License No.: 21-04073-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/11/12 Inspector: AM 
 

APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

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

Type of Action: Amendment Amendment No.: 49 

Date Issued: 8/2/12 License Reviewer: KN 

File No.: 2 

Licensee: Spectron mrc, LLC License No.: 13-32726-02 

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

Date Issued: 5/7/11 License Reviewer: KN 

File No.: 3 

Licensee: Franciscan St. Anthony Health-Crown Point License No.: 13-15933-01 

Type of Action: Renewal Amendment No.: 28 

Date Issued: 4/27/12 License Reviewer: CF 

File No.: 4 

Licensee: Crane Army Ammunition Activity License No: 13-18235-01 

Type of Action: Termination Amendment No.: 18 

Date Issued: 7/20/12 License Reviewer: CF 

File No.: 5 

Licensee: Solutia, Inc. License No.: 21-05103-02 

Type of Action: Bankruptcy/Termination Amendment No.: 41 

Date Issued: 10/14/09 License Reviewer: LH 

File No.: 6 

Licensee: Hidden Water, Inc. License No.: 48-32822-01 

Type of Action: New & Corrected Copy Amendment No.: N/A 

Date Issued: 2/8/12 and 9/27/12 License Reviewer: TS 

File No.: 7 

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

Type of Action: Amendment Amendment No.: 45 

Date Issued: 11/28/11 License Reviewer: CC 

File No.: 8 

Licensee: IRISNDT, Inc. License No.: 42-32791-01 

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

Date Issued: 7/6/10 License Reviewer: TS 

 
REGION III IMPEP Final Report Page D.2 

License Casework Reviews 

File No.: 9 

Licensee: University of Evansville License No.: SNM-995 

Type of Action: Renewal Amendment No.: 7 

Date Issued: 5/4/11 License Reviewer: WR 

File No.: 10 

Licensee: Reuter-Stokes, Inc. License No.: SNM-1826 

Type of Action: Amendment Amendment No.: 22 

Date Issued: 2/22/12 License Reviewer: CF 

File No.: 11 

Licensee: U.S. Environmental Protection Agency License No.: 12-10243-01 

Type of Action: Termination Amendment No.: 28 

Date Issued: 10/6/09 License Reviewers: KS, GM 

File No.: 12 

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

Type of Action: Amendment Amendment No.: 77 

Date Issued: 7/9/12 License Reviewer: SF 

 

File No.: 13 

Licensee: Indiana University Medical Center License No: 13-02752-08 

Type of Action: Renewal w/ license condition exemptions Amendment No.: 32 

Date Issued: 7/24/12 License Reviewer: SF 

File No.: 14 

Licensee: Aptuit, LLC License No.: 24-15595-01 

Type of Action: Void w/ two-part Amendment (change of control) Amendment No.: 33 

Date Issued: 9/22/11 & 1/4/12 License Reviewer: WR 

File No.: 15 

Licensee: Aptuit, LLC License No.: 24-15595-01 

Type of Action: Void - Decommissioning Plan Amendment No.: N/A 

Date Issued: 5/11/12 License Reviewer: LR 

File No.: 16 

Licensee: St. Anthony’s Medical Center License No: 24-01041-04 

Type of Action: Amendment w/ safety culture paragraph Amendment No.: 54 

Date Issued: 9/4/12 License Reviewer: FT 

File No.: 17 

Licensee: Providence Hospital License No.: 21-02802-03 

Type of Action: Amendment w/ safety culture paragraph Amendment No.: 74 

Date Issued: 9/4/12 License Reviewer: FT 

 
REGION III IMPEP Final Report Page D.3 

License Casework Reviews 

File No.: 18 

Licensee: Hot Shots Nuclear Medicine License No.: 21-26597-02MD/21-32778-01MD 

Type of Action: New & Corrected Copies Amendment No.: N/A 

Date Issued: 1/15/10, 1/16/10, and 1/22/10 License Reviewer: CC 

File No.: 19 

Licensee: ArcelorMittal Burns Harbor, LLC License No: 13-32670-01 

Type of Action: Amendment Amendment No.: 3 

Date Issued: 9/22/10 License Reviewer: MH 

File No.: 20 

Licensee: Cardinal Health License No.: 34-29200-01MD 

Type of Action: Amendment w/ safety culture paragraph Amendment No.: 39 

Date Issued: 6/21/12 License Reviewer: BP 

File No.: 21 

Licensee: Sigma-Aldrich Company License No.: 24-16607-03 

Type of Action: Renewal w/safety culture paragraph Amendment No.: 8 

Date Issued: 8/30/12 License Reviewer: BP 

File No.: 22 

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

Type of Action: Amendment & Corrected Copy in-progress Amendment No.: 76 

Date Issued: 3/11/11 License Reviewer: JM 
 APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Karmanos Cancer Center License No.: 21-04127-06 

Date of Incident: 10/24/07 NMED No.: 070672 

Investigation Date: 10/29/11-12/14/11 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 2 

Licensee: Providence Hospital License No.: 21-02802-03 

Date of Incident: 8/30/10 NMED No.: 100448 

Investigation Date: 9/16/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 3 

Licensee: Deaconess Hospital License No.: 13-00142-02 

Date of Incident: 3/5/12 NMED No.: 120480 

Investigation Date: To be determined Type of Incident: Medical Event 

 Type of Investigation: To be determined 

Comment: The 3/5/12 event was not reported to NRC until 8/16/12, with the licensee’s written 

report letter received 8/31/12. Region is pursuing medical consultant assistance. 

File No.: 4 

Licensee: Calumet Testing Services, Inc. License No.: 13-16347-01 

Date of Incident: 7/22/08 NMED No.: 080416 

Investigation Date: 9/29/08 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

File No.: 5 

Licensee: Walmart License No.: General 

Date of Incident: 9/9/08 NMED No.: 080839 

Investigation Date: 12/9/08 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 

File No.: 6 

Licensee: NUCOR Steel License No.: 13-25975-01 

Date of Incident: 2/8/12 NMED No.: 120098 

Investigation Date: 9/26/12 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

 
REGION III IMPEP Final Report Page E.2 

Incident Casework Reviews 

File No.: 7 

Licensee: Department of the Army License No.: 12-007220-06 

Date of Incident: 1/4/11 NMED No.: 110016 

Investigation Date: 2/21/11 Type of Incident: Equipment Damage 

 Type of Investigation: Licensee Report 

File No.: 8 

Licensee: Department of Veteran Affairs License No.: 03-23852-01VA 

Date of Incident: 2/6/12 NMED No.: 120095 

Investigation Date: 2/6/12 Type of Incident: Contamination Event 

 Type of Investigation: Licensee Report 

File No.: 9 

Licensee: Janx License No.: 21-16560-01 

Date of Incident: 1/15/09 NMED No.: 090080 

Investigation Date: 11/16/12 Type of Incident: Transportation 

 Type of Investigation: Licensee Report 

File No.: 10 

Licensee: Westinghouse Electric Company, LLC License No.: SNM-0033 

Date of Incident: 3/26/09 NMED No.: 090479 

Investigation Date: 8/24/09 – 8/26/09 Type of Incident: Release of RAM 

 Type of Investigation: Site 

File No.: 11 

Licensee: 3M Company License No.: 22-00057-03 

Date of Incident: 5/21/12 NMED No.: 120332 

Investigation Date: 8/24/12 Type of Incident: Equipment Failure 

 Type of Investigation: Licensee Report 

File No.: 12 

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

Date of Incident: 4/27/11 NMED No.: 110193 

Investigation Date: 5/2/11 – 5/5/11 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 13 

Licensee: Liberty Hospital License No.: 24-16178-01 

Date of Incident: 10/6/10 NMED No.: 100507 

Investigation Date: 10/13/10 – 10/14/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 14 

Licensee: Mid-America Isotopes, Inc. License No.: 24-26241-01MD 

Date of Incident: 5/20/12 NMED No.: 120409 

Investigation Date: 5/23/12 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 
REGION III IMPEP Final Report Page E.3 

Incident Casework Reviews 

File No.: 15 

Licensee: Evonik DeGussa Corp. License No.: General 

Date of Incident: 8/13/10 NMED No.: 100528 

Investigation Date: 10/26/10 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Licensee report 

File No.: 16 

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

Date of Incident: 2/13/11 NMED No.: 110094 

Investigation Date: 4/2/12 – 4/6/12 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 

File No.: 17 

Licensee: Westinghouse Electric Company, LLC License No.: SNM-033 

Date of Incident: 0/4/08 NMED No.: 080288 

Investigation Date: 3/10/08 Type of Incident: Release of RAM 

 Type of Investigation: Site 

 

File No.: 18 

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

Date of Incident: 10/6/10 NMED No.: 100506 

Investigation Date: 10/18/10 – 10/20/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 19 

Licensee: Indiana Department of Transportation License No.: 13-26341-01 

Date of Incident: 9/10/07 NMED No.: 070567 

Investigation Date: 9/18/07 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 

File No.: 20 

Licensee: ATC Associates, Inc. License No.: 13-17732-01 

Date of Incident: 8/9/09 NMED No.: 090660 

Investigation Date: 8/25/09 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 
 

ATTACHMENT 

November 16, 2012 email from Anne Boland 

Region III’s Response to the Draft Report 

ADAMS Accession No.: ML12323A00