July 29, 2010 

MEMORANDUM TO: Marc L. Dapas, Acting Regional Administrator 

 Region I 

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 I RADIOACTIVE MATERIALS PROGRAM 

On July 12, 2010, 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 I radioactive materials program. The MRB found the program 

adequate to protect public health and safety. 

Section 4.0, page 7, 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. 

If you have any questions on the report, please contact Joseph DeCicco at (301) 415-7833. 

I applaud your staff’s efforts during the IMPEP review period and look forward to continued high 

level performance in the future. I would also like to thank Region I for exemplary support during 

the time of the team’s visit. 

Enclosure: Region I Final IMPEP Report 

cc: J. Kinneman, Region I 

CONTACT: Aaron T. McCraw, FSME/MSSA 

 (630) 829-9650 
July 29, 2010 

MEMORANDUM TO: Marc L. Dapas, Acting Regional Administrator 

 Region I 

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 I RADIOACTIVE MATERIALS PROGRAM 

On July 12, 2010, 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 I radioactive materials program. The MRB found the program 

adequate to protect public health and safety. 

Section 4.0, page 7, 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. 

If you have any questions on the report, please contact Joseph DeCicco at (301) 415-7833. 

I applaud your staff’s efforts during the IMPEP review period and look forward to continued high 

level performance in the future. I would also like to thank Region I for exemplary support during 

the time of the team’s visit. 

Enclosure: Region I Final IMPEP Report 

cc: J. Kinneman, Region I 

CONTACT: Aaron T. McCraw, FSME/MSSA 

 (630) 829-9650 

DISTRIBUTION: See next page 

ADAMS Accession No.: ML101950072 EDATS: FSME-2010-0197 

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

NAME ATMcCraw:knm1 ADias TReis RJLewis 

DATE 07/14/10 07/15/10 07/19/10 07/22/10 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland (PTressler for) CLMiller (CCarpenter for) MFWeber 

DATE 07/23/10 07/26/10 07/29/10 

OFFICIAL RECORD COPY 
MEMORANDUM TO MARC L. DAPAS FROM MICHAEL F. WEBER DATED: July 29, 2010 

Distribution: EDATS: FSME-2010-0197 

MSSA RF DCD (SP01) 

MSSA_Technical_Asst Resource 

EDO RF 

RidsEdoMailCenter 

RidsOgcMailCenter 

RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

MBeardsley, FSME/MSSA Commissioner Svinicki 

JDeCicco, FSME/MSSA Commissioner Apostolakis 

SPoy, FSME/MSSA Commissioner Magwood 

CClemons-Webb, FSME/DILR Commissioner Ostendorff 

RTorres, RIV SECY 

Robert Dansereau, NYSDOH 

KBrock, OEDO 

BJones, OGC 

Alice Rogers, TX 

WDean, NSIR 

TRothchild, OGC 

JOlmstead, OGC 

APowell, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE REGION I RADIOACTIVE MATERIALS PROGRAM 

APRIL 26-30, 2010 

FINAL REPORT
Region I Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Region I radioactive materials program. The 

review was conducted during the period of April 26-30, 2010, by a review team composed of 

technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of 

New York. 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 a Final General Statement of Policy,” published in the Federal 

Register on October 16, 1997, and NRC Management Directive (MD) 5.6, “Integrated Materials 

Performance Evaluation Program (IMPEP),” dated February 26, 2004. Preliminary results of the 

review, which covered the period of April 9, 2005, to April 30, 2010, were discussed with 

Region I managers on April 30, 2010. 

A draft of this report was issued to Region I for factual comment on June 1, 2010. Region I 

responded by memorandum dated June 17, 2010, from John D. Kinneman, Director, Division of 

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

Attachment to this report. The Management Review Board (MRB) met on July 12, 2010, to 

consider the proposed final report. The MRB found the NRC Region I radioactive materials 

program adequate to protect public health and safety. 

The Region I radioactive materials program is administered by the Division, which is headed by 

the Division Director. The Division Director reports directly to the Regional Administrator. 

Organization charts for Region I and the Division are included as Appendix B. 

At the time of the review, the Region I radioactive materials program regulated more than 950 

specific radioactive material licenses. In addition, the Division had inspection responsibility for 

four power reactors in decommissioning status, five complex materials decommissioning sites, 

and all independent spent fuel storage installations in Region I. 

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

was sent to Region I on January 14, 2010. The Division provided a response to the 

questionnaire on April 8, 2010. The Division’s response can be found in NRC’s Agencywide 

Documents Access and Management System (ADAMS) using Accession Numbers 

ML100980430 (memorandum) and ML100980461 (questionnaire response). 

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

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

Region’s licensing, inspection, and allegation databases, as well as ADAMS; (3) technical 

review of selected regulatory actions; (4) field accompaniments of five Region I inspectors; and 

(5) interviews with staff and managers. The review team evaluated the information that it 

gathered against the established criteria for each common performance indicator and made a 

preliminary assessment of the Region I radioactive materials program’s performance. 

Section 2.0 of this report covers the Region’s response to recommendations made during 

previous reviews. Results of the current review of the common performance indicators are 

presented in Section 3.0. Section 4.0 summarizes the review team's findings. 
Region I Final Report Page 2 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on April 8, 2005, the review team made no 

recommendations regarding program performance by the Division. 

3.0 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. 

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, interviewed Region I Division of Resource 

Management staff, and considered any workload backlogs. 

The Division is composed of four branches: (1) the Medical Branch, (2) the Commercial and 

R&D Branch, (3) the Materials Security and Industrial Branch, and (4) the Decommissioning 

Branch. The Licensing Assistance Team, managed as part of the Decommissioning Branch, 

consists of a Team Leader and three staff. The Licensing Assistance Team provides 

administrative and records management support for licensing and inspection activities for the 

Division. Including non-technical positions, the Division had 42 staff members on board at the 

time of the review. Funding for technical positions comes from the Nuclear Materials Safety 

Arena (26.9 full-time equivalents (FTE)) and Security and Incident Response Arena (5.1 FTE). 

Since the previous review, the Division’s total number of staff positions has decreased by 10, 

with a corresponding budget change of approximately 7 FTE. This decrease was in parallel with 

a loss of approximately 1,600 licenses that were transferred to 3 new Agreement States during 

the review period. Seven new technical staff members were hired into the Division since the 

last IMPEP review. During the same period, 15 technical staff members departed the program 

(three were among those hired during that time period). The Division had three technical 

vacancies at the time of the on-site review. Two positions have been vacant for approximately 

1 year, while the third position was vacated just prior to the on-site review. The Division is 

addressing these vacancies within the constraints of overall Regional FTE levels. 

The review team examined the Division’s training spreadsheet, sampled some individual 

inspectors’ qualifications, and interviewed managers concerning technical training in 

accordance with the requirements of Inspection Manual Chapter (IMC) 1246, “Formal 

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

review team found a good balance of personnel between licensing and inspecting. Technical 

staff members perform licensing and inspection activities. All staff members in each branch are 

qualified for the work they perform. Three staff members are in the inspector qualification 

process, the remainder of the staff being fully qualified inspectors. Two of the three staff in the 

qualification process are interim-qualified and are expected to complete the process by October 
Region I Final Report Page 3 

2010. The remaining one will complete the process within the time frame contained in IMC 

1246. Of the technical staff members who work on materials and decommissioning licensing 

issues, 12 have full signature authority, 12 have limited signature authority, and 5 have no 

signature authority. Except for training purposes, staff members are assigned licensing work for 

which they have independent signature authority. A senior license reviewer signed out the 

licenses when an unqualified reviewer reviewed the license for training purposes. The Division 

staffing level was adequate for its workload. 

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

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

satisfactory. 

3.2 Status of Materials Inspection Program

The team focused on five factors in reviewing this indicator: inspection frequency, overdue 

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

and performance of reciprocity inspections. The evaluation was based on the Division=s 

questionnaire response relative to this indicator, data from NRC=s Licensing Tracking System 

(LTS), 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,” by cross-checking the inspection frequencies entered in 

LTS for randomly selected licensees with the IMC 2800 frequencies. The review team found, in 

all cases, that the inspection frequencies in LTS matched the IMC 2800 inspection frequencies, 

unless the next inspection date was intentionally reduced by the Division based on licensee 

performance and in accordance with IMC 2800. The review team verified that Increased 

Controls inspections were being performed concurrently with routine safety inspections for 

applicable licensees. 

Region I conducted a total of 1,207 inspections of Priority 1, 2, and 3 licensees during the 

review period. As noted in their response to the questionnaire, the Division identified 35 of 

these inspections that were conducted overdue by more than 25 percent of the inspection 

frequency prescribed by IMC 2800. The review team did not identify any inspections that were 

overdue at the time of the review. The review team found that 10 of the 35 overdue inspections 

were due to LTS data entry errors. During the review period, the Division instituted changes in 

Quality Control and monitoring in order to reduce future errors. 

The review team also evaluated the Division’s timeliness for conducting initial inspections. 

During the review period, Region I issued 395 new licenses. IMC 2800 requires initial 

inspections of new licenses to be conducted within 12 months of license issuance. In the 

questionnaire, the Division self-identified 19 initial inspections that were conducted overdue. 

The review team verified that there were no overdue initial inspections at the time of the review. 

Overall, the review team calculated that the Division conducted approximately 3 percent of 

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

The review team evaluated the Division’s timeliness for issuing inspection findings during the 

inspection casework reviews. The Division issued inspection findings to the licensees within 30 
Region I Final Report Page 4 

days for 55 of the 57 inspection findings reviewed by the team. The two reports were late due 

to tracking errors. 

During the review period, the team determined that the Division completed the required number 

of reciprocity inspections of candidate licensees for all years covered by the review period, 

except 2005. IMC 1220, “Processing of NRC Form 241 and Inspection of Agreement State 

Licensees Operating Under 10 CFR 150.20,” requires inspection of at least 20 percent of all 

candidate reciprocity licensees per calendar year. In 2005, the Division inspected 3 of 19 

candidate licensees or 16 percent of candidate licensees. The Division self-identified their 

being below the 20 percent criteria in 2005 and instituted programmatic changes to correct this 

issue. After 2005, the Division began requesting their reciprocity licensees to provide dates that 

the licensee would be available for reciprocity inspection visits. This programmatic change 

reduced the number of failed inspection attempts, which is not captured by the reciprocity 

inspections metric. The Division also increased its monitoring of reciprocity activities and was 

then able to meet or exceed the 20 percent criterion in each of the subsequent calendar years 

of the review period. 

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

that Region I=s performance with respect to the indicator, Status of Materials Inspection 

Program, was satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated inspection reports and documentation, enforcement documentation, 

and interviewed inspectors for 29 inspections that were conducted by 25 different inspectors 

during the review period. The casework selected included a cross-section of inspection types. 

These included broad scope medical, high-dose rate remote afterloader (HDR), gamma 

stereotactic radiosurgery, irradiator, industrial radiography, nuclear pharmacy, brachytherapy, 

research and development, portable gauge, well-logging, academic broad scope, waste 

handling/shipping, decommissioning, and medical private practice. Casework also included 

inspections related to reciprocity, decommissioning, events, and security. Appendix C lists the 

inspection files reviewed. 

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

aspects of the licensees’ radiation safety and security programs. The review team noted that 

inspection reports were generally thorough, complete, consistent, and of high quality with 

sufficient documentation to ensure that licensees’ performances with respect to health, safety, 

and security were acceptable. Inspection reports were complete, with sufficient documentation 

to support inspection findings, including escalated enforcement when applicable. 

While on site, the review team evaluated the Division’s handling and storing of sensitive 

information. The review team determined that documents containing sensitive information were 

appropriately marked, stored, and protected in accordance with NRC policy. The review team 

observed outgoing correspondence that was appropriately marked. 

The review team determined that a supervisor accompanied all active inspectors at least once 

per year. 
Region I Final Report Page 5 

Review team members accompanied five Region I radioactive materials inspectors on nine 

inspections. The inspector accompaniments were conducted on the following license types: 

five hospitals, one medical private practice, one industrial radiography site, one research and 

development broadscope license facility, and one self-shielded irradiator. The accompaniments 

are identified in Appendix C. Each accompanied inspector demonstrated appropriate inspection 

methods and exhibited knowledge and understanding of applicable regulations and license 

conditions. The inspectors were trained, prepared, and thorough in their inspections of the 

licensees’ program. Inspectors used good health physics practices, conducted effective 

interviews of licensee personnel, and used a performance-based approach. The review team 

determined that the inspections were adequate to assess radiological health, safety, and 

security. 

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

that Region I’s performance with respect to the common indicator, Technical Quality of 

Inspections, was satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team examined the casework and interviewed license reviewers for 34 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, security requirements, 

operating and emergency procedures, appropriateness of license conditions, and overall 

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

letters and cover letters, reference to appropriate regulations, supporting documentation and 

data, consideration of enforcement history, pre-licensing visits, peer/supervisory review, and 

proper signatures. 

The review team selected licensing casework that provided a representative sample of licensing 

actions completed during the review period. Licensing actions selected for evaluation included: 

8 new licenses, 6 renewals, 10 amendments, 3 terminations, 4 financial assurance reviews, and 

3 decommissioning cases. Casework reviewed included a cross-section of license types: 

decontamination service, academic broadscope, well logging, HDR, irradiator, self-shielded 

irradiator, research and development broadscope, gamma stereotactic radiosurgery, mobile 

medical service, radionuclide production using an accelerator, medical institution broad, 

decommissioning, medical product distribution, fixed and portable gauges, and source material 

military munitions testing. A listing of the licensing casework reviewed, with case-specific 

comments, can be found in Appendix D. 

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

high quality, and properly addressed health, safety, and security issues. The review team found 

that documentation for all of the reviewed licensing cases was complete and well documented in 

ADAMS. 

The review team randomly selected five HDR licenses to determine if the licenses had the 

appropriate sensitivity markings in the header and footer of each page in accordance with NRC 

policy. All five licenses had the appropriate sensitivity markings on each page. The review 

team also looked at the possession limits on the license to determine if the Increased Controls, 
Region I Final Report Page 6 

fingerprinting, and National Source Tracking System requirements were needed based on the 

authorized quantities on the license. 

The review team evaluated the Division’s implementation of NRC’s financial assurance 

requirements. The review team looked at 5 of the Division’s 12 self-guarantee instruments and 

determined that all 5 instruments were current as documented by the licensee’s most current 

execution of their annual self test as required by Appendix E of Part 30 of Title 10 of the Code of 

Federal Regulations, “Energy.” 

The review team evaluated the Division’s implementation of the pre-licensing guidance. The 

review team noted that the Licensing Assistance Team an established administrative process in 

which the pre-licensing guidance is automatically added to all licensing actions so the form can 

be completed during the technical review process. The license reviewers consistently screened 

cases and used the pre-licensing guidance, as applicable. The review team verified that the 

Division conducted on-site, pre-licensing visits for each applicant that was identified as an 

“unknown entity” per the pre-licensing guidance. 

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

that Region I’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 in the Nuclear Material Events Database (NMED) in 

Region I’s jurisdiction, and evaluated the casework for 20 radioactive materials incidents. 

A listing of the casework examined can be found in Appendix E. The review team also 

evaluated the Region’s response to 13 allegations involving radioactive materials. 

The incidents selected for review included lost or stolen material, damaged equipment of 

portable gauges, contamination, leaking source, potential overexposure, medical, 

transportation, and equipment failure. The review team determined that the Division’s 

responses to incidents were thorough, complete, and comprehensive. Initial responses were 

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

safety significance. 

The review team’s evaluation of incident casework revealed that all incidents were evaluated 

quickly for the need for on-site investigations, with several special inspections occurring within a 

relative short time (a few days to a week after incident notification). For less significant health 

and safety issues, the Division deferred review of the licensee’s corrective actions until the next 

routine inspection. When appropriate, the Division coordinated radioactive materials incident 

responses with other NRC offices, as well as with other regulatory jurisdictions, such as 

Agreement States. 

In evaluating the effectiveness of the Region's response to allegations, the review team 

evaluated the casework for 13 allegations involving radioactive material. The review team 

concluded that the Region consistently took prompt and appropriate action in response to 
Region I Final Report Page 7 

concerns raised. The review team determined that the Region adequately protected allegers’ 

identities. The Region notified the allegers of the conclusion of their investigation, when 

possible. 

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

that Region l'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 above, Region I’s performance was found satisfactory for all 

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

regarding program performance. Overall, the review team recommended, and the MRB agreed, 

that the Region I radioactive materials program is 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 review take place in approximately 4 years. 
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B Region I Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Attachment June 17, 2010 Memorandum from John D. Kinneman 

 Region I’s Response to the Draft Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Joseph DeCicco, FSME Team Leader 

 Technical Staffing and Training 

 Inspector Accompaniments 

Stephen Poy, FSME Status of Materials Inspection Program 

Robert Dansereau, New York Technical Quality of Inspections 

Roberto Torres, Region IV Technical Quality of Licensing Actions 

Candace Clemons-Webb, FSME Technical Quality of Incidents and Allegation 

 Activities 

 Inspector Accompaniments 

Richard Leonardi, Region IV Inspector Accompaniments
APPENDIX B 

REGION I ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML101520101
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Washington Hospital Center License Nos.: 08-03604-03 

08-03604-05 

Inspection Type: Routine Priority: 2 

Inspection Dates: 11/16-18/09 Inspectors: PL, JN 

File No.: 2 

Licensee: Concrete Imaging, Inc. License No.: 19-31213-03 

Inspection Type: Special Priority: 1 

Inspection Date: 4/30/08 Inspector: DC 

File No.: 3 

Licensee: All Heart Medical Center License No.: 08-31224-01 

Inspection Type: Routine Priority: 5 

Inspection Date: 10/22/07 Inspector: DL 

File No.: 4 

Licensee: Pharmalogic WV, Ltd. License No.: 47-25375-01 

Inspection Type: Routine Priority: 2 

Inspection Dates: 8/28/09, 9/2/09 Inspectors: SC, TJ 

File No.: 5 

Licensee: Tracewell Services, Inc. License No.: 47-25480-01 

Inspection Type: Routine Priority: 3 

Inspection Date: 10/8/08 Inspector: SL 

File No.: 6 

Licensee: Radiac Research License No.: 31-17528-01 

Inspection Type: Routine Priority: 5 

Inspection Date: 7/9/07 Inspector: OMB 

File No.: 7 

Licensee: University of Connecticut License No.: 06-01450-47 

Inspection Type: Routine Priority: 3 

Inspection Dates: 1/24-25/08 Inspector: TT 

File No.: 8 

Licensee: Baxter Healthcare of Puerto Rico License No.: 52-21175-01 

Inspection Type: Routine Priority: 2 

Inspection Date: 7/27/09 Inspector: MR 
Region I Final Report Page C.2 

Inspection Casework Reviews 

File No.: 9 

Licensee: Department of the Army License No.: 29-01022-07 

Inspection Type: Initial Priority: 5 

Inspection Dates: 11/20-21/06 Inspector: BU 

File No.: 10 

Licensee: Chemtura Corporation License No.: 06-00221-08 

Inspection Type: Special Priority: 5 

Inspection Date: 8/26/09 Inspector: DL 

File No.: 11 

Licensee: Applied Technical Services, Inc. License No.: 45-25477-01 

Inspection Type: Routine Priority: 1 

Inspection Dates: 7/30/08, 11/4-5/08, 1/14/09 Inspectors: CG, JJ 

File No.: 12 

Licensee: Quality Inspection Services, Inc. License No.: 31-30187-01 

Inspection Type: Routine Priority: 1 

Inspection Dates: 3/13-14/07, 4/5/07, 8/30/07 Inspector: CG 

File No.: 13 

Licensee: MedStar Georgetown Medical Center License No.: 08-30577-01 

Inspection Type: Routine Priority: 2 

Inspection Dates: 8/9/07, 9/4/08 Inspector: PL 

File No.: 14 

Licensee: Puerto Rico Highway and Transportation License No.: 52-24903-01 

 Authority Materials Testing Lab 

Inspection Type: Routine Priority: 5 

Inspection Dates: 12/15-16/08 Inspector: CG 

File No.: 15 

Licensee: Megan LLC, dba Fairfield Testing Laboratory License No.: 06-19279-01 

Inspection Type: Routine Priority: 5 

Inspection Date: 12/1/09 Inspector: CG 

File No.: 16 

Licensee: Roberto Buxedo Decri, M.D. License No.: 52-11897-01 

Inspection Type: Routine Priority: 3 

Inspection Date: 8/12/08 Inspectors: TW, LR 

File No.: 17 

Licensee: Yale-New Haven Hospital License No.: 06-30445-01 

Inspection Type: Routine Priority: 2 

Inspection Dates: 1/25-28/10 Inspectors: SG, LT 
Region I Final Report Page C.3 

Inspection Casework Reviews 

File No.: 18 

Licensee: Huntington Testing and Technology, Inc. License No.: 47-23076-01 

Inspection Type: Special Priority: 1 

Inspection Dates: 9/10-12/08 Inspector: KM 

File No.: 19 

Licensee: Department of the Army License No.: 01-02861-05 

Inspection Type: Special Priority: D 

Inspection Dates: 9/27/05, 11/10/05, 11/14-15/05 Inspector: OMB 

File No.: 20 

Licensee: Stepan Company License No.: STC-1333 

Inspection Type: Special Priority: 2 

Inspection Dates: 12/8/09, 3/2/10 Inspector: MR 

File No.: 21 

Licensee: Concrete Imaging, Inc. License No.: 19-3123-02 

Inspection Type: Special Priority: 1 

Inspection Dates: 6/15-17/07 Inspector: MR 

File No.: 22 

Licensee: Battelle National License No. 19-31362-01 

Inspection Type: Special Priority: 5 

Inspection Date: 5/27/09 Inspector: LK 

File No.: 23 

Licensee: Varian Medical Systems License No.: 45-30957-01 

Inspection Type: Special Priority: 5 

Inspection Date: 1/27-29/09 Inspectors: PL, KM, SP 

File No.: 24 

Licensee: SAIC-Frederick License No.: 19-21091-01 

Inspection Type: Routine Priority: 3 

Inspection Dates: 2/27-28/07, 3/15/07 Inspectors: SH, JJ 

File No.: 25 

Licensee: Tidewater, Inc. License No.: MD-27-087-02 

Inspection Type: Reciprocity Priority: 5 

Inspection Date: 6/17/09 Inspector: KM 

File No.: 26 

Licensee: Puerto Rico Medical Service Authorization License No.: 52-31281-02 

Inspection Type: Routine Priority: 2 

Inspection Dates: 3/23-25/10 Inspectors: LT, RR 
Region I Final Report Page C.4 

Inspection Casework Reviews 

File No.: 27 

Licensee: ABB, Inc. License Nos.: 06-00217-06 

SNM-1067 

Inspection Type: Routine Priorities: D, 2 

Inspection Dates: 12/2-3/08 Inspector: JN 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Danbury Hospital License No.: 06-08544-01 

Inspection Type: Routine Priority: 2 

Inspection Date: 3/16/10 Inspector: RM 

Accompaniment No.: 2 

Licensee: Bridgeport Hospital License No.: 06-01060-10 

Inspection Type: Routine Priority: 2 

Inspection Date: 3/18/10 Inspector: RM 

Accompaniment No.: 3 

Licensee: St. Mary's Hospital License No.: 06-00679-01 

Inspection Type: Routine Priority: 3 

Inspection Date: 3/17/10 Inspector: RM 

Accompaniment No.: 4 

Licensee: Hospital Perea License No.: 52-19984-01 

Inspection Type: Routine Priority: 3 

Inspection Date: 4/20/10 Inspector: LT 

Accompaniment No.: 5 

Licensee: Mayaguez Nuclear Medicine License No.: 52-25507-01 

Inspection Type: Routine Priority: 3 

Inspection Date: 4/21/10 Inspector: LT 

Accompaniment No.: 6 

Licensee: Bella Vista Hospital License No.: 52-25223-01 

Inspection Type: Routine Priority: 3 

Inspection Date: 4/21/10 Inspector: LT 

Accompaniment No.: 7 

Licensee: Testing Technologies, Inc. License No.: 45-25007-01 

Inspection Type: Reciprocity Priority: 1 

Inspection Date: 3/23/10 Inspector: MR 
Region I Final Report Page C.5 

Inspection Casework Reviews 

Accompaniment No.: 8 

Licensee: SAIC-Frederick License No.: 19-21091-01 

Inspection Type: Routine Priority: 3 

Inspection Date: 3/24/10 Inspector: DL 

Accompaniment No.: 9 

Licensee: Alfred I. DuPont Hospital for Children License No.: 07-16199-03 

Inspection Type: Routine Priority: 5 

Inspection Date: 3/10/10 Inspector: LK
APPENDIX D 

LICENSING CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Defense Logistics Agency License No.: STC-133 

Action: Renewal Amendment No.: 34 

Date Issued: 2/17/10 License Reviewer: DL 

File No.: 2 

Licensee: Terranearpmc, LLC License No.: 37-31379-02 

Action: New Amendment No.: N/A 

Date Issued: 3/8/10 License Reviewer: SH 

File No.: 3 

Licensee: The Catholic University of America License No.: 08-02075-03 

Action: Financial Assurance Amendment No.: N/A 

Date Issued: 3/8/10 License Reviewer: DL 

File No.: 4 

Licensee: Tracewell Services, Inc. License No.: 47-25480-01 

Action: Renewal Amendment No.: 01 

Date Issued: 2/3/10 License Reviewer: SW 

File No.: 5 

Licensee: Tomé & Ubiñas RadioOncology License No.: 52-25487-01 

Action: Renewal Amendment No.: 09 

Date Issued: 3/23/10 License Reviewer: JN 

File No.: 6 

Licensee: Battelle National Biodefense Inst. License No.: 19-31362-01 

Action: New Amendment No.: N/A 

Date Issued: 6/25/09 License Reviewer: LK 

File No.: 7 

Licensee: Protometrix License No.: 06-30693-01 

Action: Termination Amendment No.: 06 

Date Issued: 5/29/09 License Reviewer: TT 

File No.: 8 

Licensee: Puerto Rico Medical Services Adm. License No.: 52-31281-02 

Action: New Amendment No.: N/A 

Date Issued: 6/4/09 License Reviewer: PL 
Region I Final Report Page D.2 

Licensing Casework Reviews 

File No.: 9 

Licensee: RCOA Imaging Services License No.: 09-31351-01 

Action: New Amendment No.: N/A 

Date Issued: 2/23/09 License Reviewer: DL 

File No.: 10 

Licensee: Lantheus Medical Imaging License No.: 52-25361-02 

Action: New Amendment No.: N/A 

Date Issued: 11/17/09 License Reviewer: EU 

File No.: 11 

Licensee: Marshall University License No.: 47-05972-02 

Action: Financial Assurance Amendment No.: N/A 

Date Issued: 3/8/06 License Reviewer: SH 

File No.: 12 

Licensee: Entergy Nuclear Operations License No.: 20-07626-04 

Action: Termination Amendment No.: 08 

Date Issued: 8/21/08 License Reviewer: KM 

File No.: 13 

Licensee: Hotwell Services, Inc. License No.: 42-31298-01 

Action: Termination Amendment No.: 03 

Date Issued: 4/21/09 License Reviewer: JJ 

File No.: 14 

Licensee: Hotwell Services, Inc. License No.: 37-31365-01 

Action: New Amendment No.: N/A 

Date Issued: 4/21/09 License Reviewer: JJ 

File No.: 15 

Licensee: Washington Hospital Center License No.: 08-03604-03 

Action: Amendment Amendment No.: 47 

Date Issued: 4/7/08 License Reviewer: PL 

File No.: 16 

Licensee: URS Corporation Infrastructure License No.: 06-31214-01 

Action: New Amendment No.: N/A 

Date Issued: 2/1/07 License Reviewer: JS 

File No.: 17 

Licensee: All Heart Medical Center License No.: 08-31224-01 

Action: New Amendment No.: N/A 

Date Issued: 3/20/07 License Reviewer: DJ 
Region I Final Report Page D.3 

Licensing Casework Reviews 

File No.: 18 

Licensee: Clearon Corporation License No.: 47-24837-01 

Action: Renewal Amendment No.: 07 

Date Issued: 2/20/07 License Reviewer: SL 

File No.: 19 

Licensee: Department of the Navy License No.: 45-23645-01 

Action: Financial Assurance Amendment No.: N/A 

Date Issued: 3/15/06 License Reviewer: OMB 

File No.: 20 

Licensee: Astenjohnson, Inc. License No.: 39-32137-01 

Action: Amendment Amendment No.: 08 

Date Issued: 8/2/07 License Reviewer: TS 

File No.: 21 

Licensee: AstraZeneca Pharmaceuticals, LP License No.: 07-03990-01 

Action: Amendment Amendment No.: 44 

Date Issued: 4/3/07 License Reviewer: N/A 

File No.: 22 

Licensee: Department of the Army License No.: 29-01022-07 

Action: Amendment Amendment No.: 35 

Date Issued: 9/15/06 License Reviewer: EU 

File No.: 23 

Licensee: University of Connecticut License No.: 06-01450-47 

Action: Financial Assurance Amendment No.: N/A 

Date Issued: 11/25/08 License Reviewer: SC 

File No.: 24 

Licensee: Biocompatibles, Inc. License No.: 06-30764-01 

Action: Amendment Amendment No.: 11 

Date Issued: 8/25/06 License Reviewer: DL 

File No.: 25 

Licensee: Union Carbide Corporation License No.: 47-00260-02 

Action: Amendment Amendment No.: 50 

Date Issued: 6/20/06 License Reviewer: DL 

File No.: 26 

Licensee: ABB, Inc. License No.: 06-00217-06 

Action: Decommissioning Amendment No.: 62 

Date Issued: 7/8/09 License Reviewers: JS, JN 
Region I Final Report Page D.4 

Licensing Casework Reviews 

File No.: 27 

Licensee: Defense Intelligence Agency License No.: 01-25316-01 

Action: Renewal Amendment No.: 08 

Date Issued: 9/22/08 License Reviewer: TT 

File No.: 28 

Licensee: Defense Logistics Agency License No.: STC-133 

Action: Decommissioning Amendment No.: 28 

Date Issued: 2/21/07 License Reviewer: DL 

File No.: 29 

Licensee: Department of the Army License No.: SUB-834 

Action: Decommissioning Amendment No.: 31 

Date Issued: 9/14/06 License Reviewer: EU 

File No.: 30 

Licensee: Divine Providence Hospital License No.: 37-16101-02 

Action: Amendment Amendment No.: 41 

Date Issued: 11/7/07 License Reviewer: SG 

File No.: 31 

Licensee: Tomé & Ubiñas RadioOncology License No.: 52-25487-01 

Action: Renewal Amendment No.: 09 

Date Issued: 3/23/10 License Reviewer: PL 

File No.: 32 

Licensee: New Milford Hospital License No.: 06-17892-01 

Action: Amendment Amendment No.: 26 

Date Issued: 1/11/10 License Reviewer: HB 

File No.: 33 

Licensee: Sentara CarePlex Hospital License No.: 45-09087-01 

Action: Amendment Amendment No.: 50 

Date Issued: 10/28/08 License Reviewer: SG 

File No.: 34 

Licensee: University of Pennsylvania License No.: 37-00118-07 

Action: Amendment Amendment No.: 69 

Date Issued: 10/16/06 License Reviewer: TW 
APPENDIX E 

INCIDENT CASEWORK REVIEWED 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Regional Nuclear Pharmaceuticals License No.: 29-30867 

Date of Incident: 12/13/04 NMED No.: 050057 

Investigation Date: 1/26/05 Type of Incident: Lost/stolen material 

 Type of investigation: Licensee report 

File No.: 2 

Licensee: Fox Chase Cancer Center License No.: 37-02766-01 

Date of Incident: 2/24/05 NMED No.: 050125 

Investigation Date: 2/28/05 Type of Incident: Lost/stolen material 

 Type of Investigation: Licensee report 

File No.: 3 

Licensee: Oconee Unit 1 License No.: DPR-0038 

Date of Incident: 4/11/05 NMED No.: 050226 

Investigation Date: 4/12/05 Type of Incident: Transportation 

 Type of Investigation: Event notification 

File No.: 4 

Licensee: University of Uniformed Services License No.: 19-08330-03 

Date of Incident: 6/6/05 NMED No.: 050382 

Investigation Date: 6/6/05 Type of Incident: Equipment failure 

 Type of Investigation: Licensee report 

File No.: 5 

Licensee: Quaker Sales Corp License No.: 37-23351-02 

Date of Incident: 6/20/06 NMED No.: 060403 

Investigation Date: 6/20/06 Type of Incident: Damaged equipment 

 Type of Investigation: Licensee report 

File No.: 6 

Licensee: Windsor Service License No.: 37-18494-01 

Date of Incident: 7/10/06 NMED No.: 060440 

Investigation Date: 8/22/06 Type of Incident: Damaged equipment 

 Type of Investigation: Site 

File No.: 7 

Licensee: Pennoni Associates License No.: 37-17637-02 

Date of Incident: 8/19/06 NMED No.: 060526 

Investigation Date: 11/17/06 Type of Incident: Lost/stolen material 

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

Incident Casework Reviews 

File No.: 8 

Licensee: Grandview Hospital License No.: 37-13187-02 

Date of Incident: 8/28/06 NMED No.: 060577 

Investigation Date: 8/28/06 Type of Incident: Contamination 

 Type of Investigation: Licensee report 

File No.: 9 

Licensee: Agilent Technologies License No.: 07-28762-01 

Date of Incident: 9/22/06 NMED No.: 060708 

Investigation Date: 9/22/06 Type of Incident: Equipment failure 

 Type of Investigation: Licensee report 

File No.: 10 

Licensee: Camden Iron and Metal License No.: 45-00131-02 

Date of Incident: 1/22/07 NMED No.: 070049 

Investigation Date: 1/22/07 Type of Incident: Lost/stolen material 

 Type of Investigation: Licensee report 

File No.: 11 

Licensee: Schlumberger PTC License No.: 29-08636-02 

Date of Incident: 2/14/07 NMED No.: 070130 

Investigation Date: 3/5/07 Type of Incident: Lost/stolen material 

 Type of Investigation: Site 

File No.: 12 

Licensee: Sibley Memorial Hospital License No.: 08-07398-03 

Date of Incident: 3/12/07 NMED No.: 070230 

Investigation Date: 3/12/07 Type of Incident: Medical 

 Type of Investigation: Licensee report 

File No.: 13 

Licensee: Hudson Global Resource Management License No.: 37-27891-01 

Date of Incident: 11/1/05 NMED No.: 070348 

Investigation Date: 1/5/06 Type of Incident: Potential overexposure 

 Type of Investigation: Licensee report 

File No.: 14 

Licensee: Blazosky Associates, Inc. License No.: 37-28507-01 

Date of Incident: 6/25/07 NMED No.: 070385 

Investigation Date: 6/25/07 Type of Incident: Damaged equipment 

 Type of Investigation: Licensee report 

File No.: 15 

Licensee: Department of the Army License No.: 32-04054-04 

Date of Incident: 8/30/08 NMED No.: 080546 

Investigation Date: 9/11/08 Type of Incident: Contamination 

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

Incident Casework Reviews 

File No.: 16 

Licensee: Froehling and Robertson, Inc. License No.: 45-08890-02 

Date of Incident: 10/16/08 NMED No.: 080677 

Investigation Date: 10/17/08 Type of Incident: Transportation 

 Type of Investigation: Site 

File No.: 17 

Licensee: Construction Testing & Engineering License No.: 45-25554-01 

Date of Incident: 1/22/09 NMED No.: 090096 

Investigation Date: 1/22/09 Type of Incident: Damaged equipment 

 Type of Investigation: Site 

File No.: 18 

Licensee: Department of Homeland Security License No.: 08-17447-01 

Date of Incident: 10/1/07 NMED No.: 090133 

Investigation Date: 10/1/07 Type of Incident: Lost/stolen material 

 Type of Investigation: Site 

File No.: 19 

Licensee: Inova Fairfax Hospital License No.: 45-17128-01 

Date of Incident: 1/8/09 NMED No.: 090476 

Investigation Date: 1/8/09 Type of Incident: Leaking source 

 Type of Investigation: Licensee report 

File No.: 20 

Licensee: Langan Engineering License No.: 29-15786-02 

 & Environmental Services 

Date of Incident: 6/29/09 NMED No.: 090569 

Investigation Date: 6/30/09 Type of Incident: Damaged equipment 

 Type of Investigation: Site 
ATTACHMENT 

June 17, 2010 Memorandum from John D. Kinneman 

Region I’s Response to the Draft Report 

ADAMS Accession No.: ML101680279