June 2, 2009 

Mr. Dee Freeman 

Secretary 

Department of Environment 

 and Natural Resources 

1601 Mail Service Center 

Raleigh, NC 27699-1601 

Dear Mr. Freeman: 

On May 5, 2009, the Management Review Board (MRB) met to consider the proposed final 

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

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

adequate to protect public health and safety and compatible with the U.S. Nuclear Regulatory 

Commission=s (NRC) program. 

Section 5.0, page 12, of the enclosed final report contains a summary of the IMPEP review 

team=s findings and recommendations. Your letter dated April 14, 2009, adequately discusses 

the State’s actions for resolving the review team’s recommendations. No further response is 

requested at this time. 

Based on the results of the current IMPEP review, the next full review of the North Carolina 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for May 2011. During the periodic meeting and at the next IMPEP review, 

NRC will evaluate the effectiveness of your State’s response to the review team’s 

recommendations, as well as the overall implementation of your Agreement State program. 

The MRB recognized that this review was the fourth consecutive IMPEP review in which the 

North Carolina Agreement State Program was found adequate to protect public health and 

safety, compatible with the NRC’s program, and satisfactory for all performance indicators 

reviewed. These are the highest possible ratings for an IMPEP review. I applaud your staff for 

their dedication to excellence in radiation protection. 
D. Freeman - 2 -

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

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

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

Sincerely, 

 /RA Michael Weber Acting For/ 

Martin J. Virgilio 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

North Carolina Final IMPEP Report 

cc w/encl: Manly Wilder, Chief Deputy Secretary 

 North Carolina Department of Environment 

 and Natural Resources 

 W. Lee Cox, III, Acting Chief 

 North Carolina Radiation 

 Protection Section 

 Michael Snee, Ohio 

 Organization of Agreement States 

 Liaison to the MRB 
D. Freeman - 2 - 

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

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

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

Sincerely, 

 /RA Michael Weber Acting For/ 

Martin J. Virgilio 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

North Carolina Final IMPEP Report 

cc w/encl: Manly Wilder, Chief Deputy Secretary 

 North Carolina Department of Environment 

 and Natural Resources 

 W. Lee Cox, III, Acting Chief 

 North Carolina Radiation 

 Protection Section 

 Michael Snee, Ohio 

 Organization of Agreement States 

 Liaison to the MRB 

Distribution: See next page. 

 ML091250337 EDATS: FSME-2009-0017 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA Tech Editor 

NAME ATMcCraw:knm1 ADWhite RJLewis CPoland 

DATE 05/05/09 05/11/09 05/21/09 05/27/09 

OFFICE FSME DEDMRT 

NAME CLMiller (G.Pangburn for) MJVirgilio 

DATE 05/29/09 06/02/09 

OFFICIAL RECORD COPY
Letter to Dee Freeman from Martin J. Virgilio dated: June 2, 2009 

Distribution: EDATS: FSME-2009-0017 

MSSA RF DCD (SP01) 

EDO RF 

RidsEdoMailCenter 

RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

JLynch, RIII Commissioner Lyons 

JKottan, RI/RSAO Commissioner Klein 

GWarren, RIII Commissioner Svinicki 

Cindy Becker, Florida SECY 

TReis, FSME 

ARivera, OEDO 

SBurns, OGC 

JGray, OGC 

BJones, OGC 

ECollins, RIV 

APowell, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NORTH CAROLINA AGREEMENT STATE PROGRAM 

February 23-27, 2009 

FINAL REPORT
North Carolina Final Report Page 1 

1.0 INTRODUCTION 

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

The review was conducted during the period of February 23-27, 2009, by a review team 

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

the States of Florida and Texas. 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 21, 2004, to February 27, 2009, were 

discussed with North Carolina managers on the last day of the review. 

A draft of this report was issued to North Carolina for factual comment on March 26, 2009. The 

State responded by letter on April 14, 2009, from Dee Freeman, Secretary, Department of 

Environment and Natural Resources (the Department). A copy of the State’s response is 

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

5, 2009, to consider the proposed final report. The MRB found the North Carolina Agreement 

State Program to be adequate to protect public health and safety and compatible with NRC’s 

program. 

The North Carolina Agreement State Program is administered by the Radiation Protection 

Section (the Section) within the Division of Environmental Health (the Division). The Division is 

part of the Department. Within the Section, the Radioactive Materials Branch (the Branch) 

administers the radioactive materials program, which performs the majority of responsibilities of 

the Agreement State program. Organization charts for the Department, the Division, and the 

Section are included in Appendix B. 

At the time of the review, the North Carolina Agreement State Program regulated 760 specific 

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

focused on the radioactive materials program as it is carried out under the Section 274b. (of the 

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

Carolina. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Section on September 8, 2008. The Section 

provided its response to the questionnaire on November 20, 2008. A copy of the questionnaire 

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

(ADAMS) using the Accession Number ML083470347. 

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

the Section’s response to the questionnaire, (2) review of applicable North Carolina statutes and 

regulations, (3) analysis of quantitative information from the Branch’s database, (4) technical 

review of selected regulatory actions, (5) field accompaniments of three of the Branch’s 

inspectors, and (6) interviews with staff and managers. The review team evaluated the 

information gathered against the established criteria for each common and applicable noncommon performance indicator and made a preliminary assessment of the North Carolina 

Agreement State Program’s performance. 
North Carolina Final Report Page 2 

Section 2.0 of this report covers the State’s actions in response to recommendations made 

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

are presented in Section 3.0. Section 4.0 details the results of the review of the applicable noncommon performance indicators, and Section 5.0 summarizes the review team's findings and 

recommendations. The review team’s recommendations are comments that relate directly to 

program performance by the State. A response is requested from the State to all 

recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on August 20, 2004, the review team made 

two recommendations regarding program performance. The current status of each 

recommendation is as follows: 

1. The review team recommends that the Branch develop and implement a reliable and 

comprehensive licensing and inspection, and sealed source and device (SS&D) product 

evaluation database that serves as an effective planning, tracking and management tool. 

(Sections 3.2 and 4.2 of the 2004 IMPEP report) 

Current Status: In 2005, the Branch began using one operating system (XP-Pro) 

on a single new server for their licensing, inspection, and SS&D database. The 

review team found the current system to be an effective planning, tracking and 

management tool. The Branch expects to upgrade to an Oracle database in the 

near future to further enhance their database capabilities. This recommendation 

is closed. 

2. The review team recommends that the Branch assess their licensing quality control 

process and tools to improve the accuracy and consistency of licensing actions. 

(Section 3.4 of the 2004 IMPEP report) 

 Current Status: Following the 2004 review, the Branch modified its license reviewer 

checklists. The Branch also revised its process to ensure that quality assessments, both 

administrative and supervisory, are performed on each licensing action. Additionally, 

license review timeliness expectations were increased to allow more time for licensing 

actions and allow additional focus on quality. The review team’s evaluation of licensing 

actions identified an overall excellent level of quality. This recommendation is closed. 

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 Branch’s staffing level and staff 

turnover, as well as the technical qualifications and training histories of the staff. To evaluate 
North Carolina Final Report Page 3 

these issues, the review team examined the questionnaire response relative to this indicator, 

interviewed managers and staff, reviewed job descriptions and training records, and considered 

any possible workload backlogs. 

The Radiation Protection Section is headed by the Section Chief. This position is currently 

vacant due to the retirement of the former Section Chief on December 31, 2008. The Deputy 

Section Chief is currently the Acting Section Chief. 

The Section includes the [Radioactive Materials] Branch; the Emergency 

Response/Environmental Monitoring Branch; the Radiology Compliance Branch; the 

Registration, Invoicing, and Tanning Branch; and the Radon Program Branch. The Branch is 

responsible for radioactive materials licensing, inspection, security, low-level radioactive waste, 

general licenses, and SS&D reviews. The Branch consists of 8.5 technical staff positions 

(Health Physicists), an administrative assistant, and the Branch Manager. The Branch Health 

Physicists all perform licensing, inspection, and incident response activities. 

Three staff members left the Branch during the review period. One individual transferred to 

another part of State government, and the other two resigned. Two of the vacated positions 

were filled with the hiring of a Health Physicist Trainee in 2006 and a Health Physicist in 2008. 

One technical staff position was vacant at the time of the review. Since the review all vacant 

positions have been frozen due to the current economic environment. 

The Branch has a documented training and qualification program for technical staff members. 

The training and qualification program is equivalent to NRC Inspection Manual Chapter (IMC) 

1246, “Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program 

Area,” and is consistent with the NRC and Organization of Agreement States Training Working 

Group Recommendations for Agreement State Training Programs. Qualification is achieved 

through a combination of education and experience, formal classroom training, and on-the-job 

training. Staff members are required to have a Bachelor’s degree or equivalent experience in a 

physical or biological science or engineering. 

The review team found that the Branch maintains training and qualification records for each staff 

member. The review team noted that no Branch staff had attended NRC’s irradiator training 

course, although there are four large pool irradiators located in North Carolina. The review 

team observed that licensing and inspection of the irradiators has been adequate and without 

incident; however, the review team believes that attendance at the irradiator training course 

would strengthen the Branch’s regulation of these four licensees. The Acting Section Chief 

agreed that the training course would be beneficial and indicated that he would pursue enrolling 

at least one staff member in the course. Overall, the review team concluded that Section 

management encourages and supports training opportunities, based on program needs and 

funding. 

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

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

was satisfactory. 
North Carolina Final Report Page 4 

3.2 Status of Materials Inspection Program

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

overdue inspections, initial inspections of new licensees, timely dispatch of inspection findings 

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

on the Section’s questionnaire response relative to this indicator, data gathered independently 

from the Branch’s licensing and inspection database, the examination of completed licensing 

and inspection casework, and interviews with managers and staff. 

The review team verified that the Branch’s inspection frequencies for various types of licenses 

are at least as frequent as the inspection frequencies prescribed by IMC 2800, “Materials 

Inspection Program,” for equivalent license types. The Branch’s inspection frequencies mirror 

NRC’s inspection frequencies. 

The Branch conducted 651 inspections of high priority (Priority 1, 2, and 3) licensees and 126 

initial inspections during the review period. The review team determined that, at the time of the 

review, no inspections were overdue and that 9 Priority 1, 2, and 3 inspections and 14 initial 

inspections were completed overdue during the review period. The review team calculated that 

less than 3 percent of the 777 Priority 1, 2, and 3 and initial inspections performed by the 

Branch were performed overdue during the review period. 

The review team evaluated the Branch’s timeliness of issuance of inspection reports to 

licensees. The Branch has an effective and efficient process to ensure that inspection reports 

are completed and that findings are communicated to licensees in a timely manner. Of the 25 

inspection files reviewed, 3 of the inspection reports and findings were completed beyond the 

30-day goal. Two of the late reports were attributed to the training of a new inspector and the 

other was simply an oversight. 

During the review period, the Branch granted 26 reciprocity licenses that were candidates for 

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

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

that the Branch inspected 12 (46 percent) of the candidate reciprocity licensees during the 

review period and exceeded the criterion of inspecting at least 20 percent of candidate 

reciprocity licensees during the review period, as prescribed by IMC 1220. 

The review team determined that the Branch adequately implemented an inspection program for 

Increased Controls licensees, including fingerprinting. All Increased Controls inspections were 

performed in a timely manner, as required by NRC guidance. The review team determined that 

the Branch adequately planned for the initial set of Increased Controls inspections of affected 

licensees. The review team evaluated the Branch’s prioritization methodology and found it 

acceptable. The Branch adopted a 1-year re-inspection frequency for these licensees, which 

represents a conservative approach to meeting the intent of the Increased Controls program. 

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

that North Carolina’s performance with respect to the indicator, Status of Materials Inspection 

Program, was satisfactory. 
North Carolina Final Report Page 5 

3.3 Technical Quality of Inspections

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

notes and interviewed the responsible inspectors for 20 radioactive materials inspections 

conducted during the review period. The casework examined included a cross-section of 

inspections conducted by three former and five current inspectors and covered a wide variety of 

inspection types. These included: academic, research and development, industrial 

radiography, pool irradiator, self-shielded irradiator, service provider, high dose-rate remote 

afterloader, medical, nuclear pharmacy, manufacturing and distribution, reciprocity, and 

Increased Controls licensees. Appendix C lists the inspection casework files reviewed and 

includes case-specific comments. 

The Branch’s inspection procedures are consistent with the inspection guidance found in IMC 

2800. After the conclusion of each inspection, inspectors dispatched inspection findings to the 

respective licensees from the office after Branch management review and approval. The 

Branch Manager’s review of each inspection report was appropriately documented and all 

inspection documentation was entered into the Section’s electronic filing system, accessible to 

all staff members. 

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

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

reports were 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 report documentation supported violations, recommendations made to 

licensees, unresolved safety issues, and discussions held with licensees during exit interviews. 

The Branch appropriately required written responses from licensees describing corrective 

actions to address any infractions, deficiencies, or unresolved issues. Escalated enforcement 

was used, as needed. 

The review team determined that documents involving Increased Controls inspections were 

protected and maintained in a locked file cabinet with limited access. Files were held in 

individual color coded folders, identifying each licensee subject to the Increased Controls. 

Documents observed were sufficiently marked as sensitive information to be withheld from 

public disclosure. 

The Branch has a policy to perform supervisory accompaniments of all inspectors annually. 

The review team determined that the Branch Manager conducted formal, announced 

accompaniments of all qualified radioactive materials inspectors in Calendar Years 2004 

through 2008. 

The review team verified that the Branch maintains an adequate supply of appropriately 

calibrated survey instruments to support the inspection program, as well as to respond to 

radioactive materials incidents and emergency conditions. Instruments used to support the 

materials inspection program are sent to either a commercial service provider or the 

manufacturer for calibration. 

The Branch receives laboratory and sample analysis support from the State laboratory, located 

in Raleigh. The State laboratory is a licensee of the Branch and performs sample analysis for 
North Carolina Final Report Page 6 

multiple programs within the Department. The laboratory had a wide array of analytical 

equipment capable of detailed radiochemistry analysis. The Branch also has a mobile 

laboratory for use during reactor exercises and events. The mobile laboratory has a germanium 

detector and a proportional counter for counting environmental samples, as well as a plastic 

scintillator/portal monitor, and extensive communications capabilities. 

The review team accompanied three of the Branch’s inspectors in January 2009. The 

inspectors conducted inspections at a gauge manufacturer, a research and development facility, 

and a hospital brachytherapy program. One of the inspections included a review of the 

licensee’s implementation of the Increased Controls. Appendix C lists the inspector 

accompaniments. The inspectors demonstrated performance-based inspection techniques and 

knowledge of the regulations. The inspectors were well trained, prepared for the inspections, 

and thorough in their audits 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 inspectors held 

entrance and exit meetings with the appropriate level of licensee management. The review 

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

security at the licensed facilities. 

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

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

was satisfactory. 

3.4 Technical Quality of Licensing Actions

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

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

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

equipment, adherence to good health physics practices, financial assurance, 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, consideration of 

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

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

completed during the review period. Licensing actions selected for evaluation included 2 new 

licenses, 3 renewals, and 21 amendments. Files reviewed included a cross-section of license 

types, including: medical diagnostic and therapy, brachytherapy, gamma knife, pool irradiators, 

industrial radiography, research and development, nuclear pharmacy, and manufacturers. The 

casework sample represented work from each of the license reviewers. A listing of the licensing 

casework reviewed, with case-specific comments, can be found in Appendix D. 

All licensing actions in the Branch are assigned a tracking number and logged into a computer 

tracking system. License reviewers use boilerplate licenses specific to the type of licensing 

actions to ensure consistency in standard licenses. If needed, the reviewer generates a 

deficiency letter and produces a draft licensing action upon final resolution of all deficiency 

items. The draft licensing action receives a quality assurance review by the administrative 

assistant and the Branch Manager. 
North Carolina Final Report Page 7 

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

high quality and consistent with the Branch’s procedures, the State’s 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 review team evaluated several license files where financial assurance for decommissioning 

was required. Those licensees had submitted decommissioning funding plans, as required 

under North Carolina’s regulations. The review team’s evaluation revealed that the Branch 

appropriately identified licensees required to maintain financial assurance and had taken 

appropriate steps to ensure that the licensees remained compliant with the financial assurance 

requirements. The review team verified that financial instruments were appropriately protected 

from loss or theft. 

The Branch performs pre-licensing checks of all new applicants and new authorized users. The 

Branch’s methods incorporate the essential elements of NRC’s revised pre-licensing guidance 

to verify that the applicant will use requested radioactive materials as intended that was 

distributed to the Agreement States via Office of Federal and State Materials and Environmental 

Management Programs (FSME) Letter RCPD-08-020, dated September 22, 2008. The Branch 

checks all applicants against records with the North Carolina Secretary of State’s Office for 

proper business registration. Additionally, the Branch uses various on-line search mechanisms 

and interagency communications to verify the identity of individuals. The Branch has a policy of 

hand-delivering all new and renewed licenses. Each applicant is subject to an on-site 

evaluation of their radiation safety and security programs prior to receipt of the initial license. 

This practice ensures that applicants have adequate radiation safety and security programs in 

place prior to taking possession of radioactive material. This practice meets the essential 

objective of a “pre-licensing visit.” 

The review team examined the Branch’s licensing practices in regard to the Increased Controls 

and Fingerprinting Orders. The review team noted that the Branch added legally binding license 

conditions to the licenses that met the criteria for implementing the Increased Controls, including 

fingerprinting, as appropriate. The review team analyzed the Section’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. 

The review team evaluated the Branch’s efforts to implement the National Source Tracking 

System (NSTS) requirements for certain licensees. The Branch amended all subject licenses 

with legally binding license conditions, which were approved by NRC in June 2008. Most 

sealed source inventories were loaded into the system by the January 31, 2009 deadline. 

The review team identified that one licensee, a newly licensed pool irradiator, did not have the 

appropriate NSTS license condition and, therefore, was not added to the system. During the 

on-site review, the license was appropriately amended to include the NSTS license condition. 

The Acting Section Chief stated that the licensee’s sealed source inventory would be promptly 

entered into NSTS. 

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

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

Actions, was satisfactory. 
North Carolina Final Report Page 8 

3.5 Technical Quality of Incident and Allegation Activities

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

team examined the Section’s response to the questionnaire relative to this indicator, evaluated 

selected incidents reported for North Carolina in the Nuclear Material Events Database (NMED) 

against those contained in the Branch’s files, and evaluated the casework for 14 of 57 

reportable radioactive materials incidents. A listing of the casework examined, with casespecific comments, can be found in Appendix E. The review team also evaluated the Branch’s 

response to 10 allegations involving radioactive materials reported to the State during the 

review period, including 5 that the NRC referred to the State. 

When notified of an incident or an allegation, the Branch Manager and staff discuss the initial 

response and the need for an on-site investigation, based on the safety significance. 

The Branch maintains a database for tracking the status of all incidents and allegations. 

The incidents selected for review included medical events, lost radioactive material, an 

overexposure, damaged equipment, leaking sources, and equipment failures. The review team 

determined that the Branch’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 Branch immediately dispatched 

inspectors to a site when the possibility of an immediate threat to public health and safety 

existed. When no immediate threat was present and the Branch determined that the licensee 

had qualified, competent individuals investigating the incident, the Branch generally responded 

telephonically with an on-site followup at a later date. The review team noted that, at the 

conclusion of investigations, inspectors generated narrative reports that thoroughly documented 

the investigations. Records were stored in the Section’s electronic filing system and in hard 

copy. The review team confirmed that all records containing sensitive information were 

appropriately marked and protected. 

Of the 14 incidents evaluated by the review team, nine had not been reported to the NRC 

Headquarters Operations Center within the required time frame due to a misunderstanding of 

the timeliness requirement in FSME Procedure SA-300 “Reporting Material Events.” This lack 

of timely reporting had no safety significance. When notification of an incident was received, the 

incident response procedure required an assessment to determine if immediate notification to 

the NRC was required. The procedure did not, however, contain additional guidance for other 

frequencies of reporting, such as 24-hour reports. There was a misunderstanding by staff that 

timely NMED reporting met these notification requirements. During the review, the Branch 

Manager provided training to the staff to reflect the requirements of FSME Procedure SA-300. 

The Branch Manager stated that the incident response procedure would be modified 

appropriately to avoid future misunderstandings. All of the reportable incidents had been 

properly characterized in NMED. The NMED contractor commented to the review team that 

North Carolina’s participation in the database was exemplary. The review team recommends 

that the State strengthen its incident response process to ensure that incidents will be reported 

to the NRC as required by FSME Procedure SA-300. 

In assessing the effectiveness of the Branch’s response to allegations, the review team 

evaluated the casework for ten allegations. The review team concluded that the Branch 

consistently took prompt and appropriate action in response to concerns raised. The review 
North Carolina Final Report Page 9 

team noted that the Branch thoroughly documented the investigations and retained all 

necessary documentation to appropriately close the allegations. The Branch notified the 

allegers of the conclusion of their investigation. The review team determined that the Branch 

adequately protected the identity of allegers. 

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

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

Allegation Activities, was satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State programs: (1) 

Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) Low-Level 

Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. NRC’s Agreement 

with the State of North Carolina does not relinquish the authority to regulate uranium recovery 

activities; therefore, only the first three non-common performance indicators were applicable to 

this review. 

4.1 Compatibility Requirements

4.1.1 Legislation

North Carolina became an Agreement State in 1964. The authority under which the Section 

administers the Agreement is granted in the General Statutes of North Carolina, Chapter 104E, 

North Carolina Radiation Protection Act. The Department is designated as the State’s radiation 

control agency. 

The review team noted that, at the time of the review, a bill was before the 2009 Legislative 

Session to amend the General Statutes to broaden the language for establishing annual fees 

and to collect fees from operators and users of low-level radioactive waste facilities. The bill 

would eventually allow the Section to increase fee supported funding. The Section currently is 

two-thirds supported by fees and receipts. It also would allow recovery of actual costs incurred 

during event response. 

4.1.2 Program Elements Required for Compatibility

The North Carolina Regulations for Control of Radiation, found in the North Carolina 

Administrative Code, Title 15A, Chapter 11, “Regulations for Protection Against Radiation,” 

apply to all ionizing radiation, whether emitted from radionuclides or machines. North Carolina 

requires a license for possession and use of all radioactive material. 

The review team examined the State’s rulemaking process and found that the process takes 

approximately 4 to 14 months from the developmental stage to final rule adoption. The Section 

identifies the need for new regulations or changes to existing regulations to the North Carolina 

Radiation Protection Commission. After receiving approval from the North Carolina Radiation 

Protection Commission, the Section drafts proposed regulations for discussion with the 

regulated community and concerned citizens, including a minimum 60-day comment period. 

NRC is provided drafts of the proposed regulations for review and comment around the time 
North Carolina Final Report Page 10 

they are published for public comment. Approximately 2 weeks after the rule is published, a 

public hearing is held to allow the public and other interested parties to comment on the 

proposed regulations. The State Rules Review Commission reviews and approves regulations 

promulgated by all State agencies. Unless significant numbers of comments are received, the 

regulations become effective the next month after approval by the State Rules Review 

Commission. The Department’s rules and regulations are not subject to “sunset” laws. The 

Department has the authority to issue legally binding requirements, such as orders or license 

conditions, in lieu of regulations. 

The review team evaluated the Section’s response to the questionnaire relative to this indicator, 

reviewed the status of regulations required to be adopted by the State under NRC’s adequacy 

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

State Regulation Status Sheet that FSME maintains. 

Since the previous IMPEP review, the State adopted nine rule packages. With these adoptions, 

North Carolina is up to date on regulation development; however, two of those rule packages 

resulted in comments from NRC that have not yet been resolved. The first package, submitted 

to NRC in 2006, involved general license regulation. NRC’s comment letter, dated 

August 15, 2006, identified five comments regarding regulations that were less restrictive than 

NRC’s regulations. The second package, submitted to NRC in 2008, involved medical use and 

transportation of radioactive materials. NRC’s comment letter, dated June 30, 2008, identified 

seven comments that need to be addressed for compatibility. The Acting Section Chief 

explained that the Section lost its regulatory coordinator in 2008 and, due to competing 

priorities, regulation development was temporarily put on hold. The regulation development 

process is now assigned to the Branch Manager, who recently began the regulatory process by 

communicating the needed compatibility changes to the North Carolina Radiation Protection 

Commission. The review team recommends that the State, to maintain compatibility with the 

NRC, make appropriate regulatory changes to resolve NRC-generated comments as noted in 

regulation review letters. 

The review team identified the following NRC amendments that the State will need to address in 

the future. The Acting Section Chief related that the amendments would be addressed in 

upcoming rulemakings or through the adoption of alternate legally binding requirements: 

● “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40 and 70 amendment 

(71 FR 15005), that is due for Agreement State adoption by March 27, 2009. 

● “Medical Use of Byproduct Material – Minor Corrections and Clarifications,” 10 CFR 

Parts 32 and 35 amendment (72 FR 45147 and 72 FR 54207), that is due for Agreement 

State adoption by October 29, 2010. 

● “Requirements for Expanded Definition of Byproduct Material,” 10 CFR Parts 20, 30, 31, 

32, 33, 35, 61, and 150 amendment (72 FR 55864), that is due for Agreement State 

adoption by November 30, 2010. 

● “Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: 

Licensing and Reporting Requirements,” 10 CFR Parts 30, 31, 32 and 150 amendment 

(72 FR 58473), that is due for Agreement State adoption by December 17, 2010. 
North Carolina Final Report Page 11 

● “Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent,” 

10 CFR Parts 19 and 20 amendment (72 FR 68043), that is due for Agreement State 

adoption by February 15, 2011. 

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

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

was satisfactory. 

4.2 Sealed Source and Device Evaluation Program

In reviewing this indicator, the review team used three subelements to evaluate the Branch’s 

performance regarding the Sealed Source and Device (SS&D) Evaluation Program. These 

subelements were: (1) Technical Staffing and Training; (2) Technical Quality of the Product 

Evaluation Program; and (3) Evaluation of Defects and Incidents Regarding SS&Ds. 

In assessing the Branch's SS&D evaluation activities, the review team examined information 

contained in the Section’s response to the IMPEP questionnaire for this indicator. The review 

team evaluated seven SS&D evaluations and supporting documents processed during the 

review period. The review team noted the staff's use of guidance documents and procedures, 

interviewed staff members involved in SS&D evaluations, and verified the use of regulations and 

inspections to enforce commitments made in the applications. 

4.2.1 Technical Staffing and Training

The Branch has two reviewers who are qualified to perform safety evaluations of SS&D 

applications. Both have degrees in a physical science or engineering and have attended NRC’s 

SS&D Workshop. 

The review team interviewed staff members involved in the reviews and determined that they 

were familiar with the procedures used in the evaluation of sources and devices. The review 

team confirmed that all applicable and pertinent American National Standards Institute 

standards, NUREG-1556 Series guides, NRC Regulatory Guides, and applicable references 

were available and used appropriately in performing the SS&D reviews. The Branch also 

retains the services of a Professional Engineer to supplement staff efforts in specialized areas 

such as material science/analysis and system safety evaluations. The review team determined 

that the Branch’s staffing level for SS&D reviews is adequate for the current workload. 

4.2.2 Technical Quality of the Product Evaluation Program

The review team evaluated a cross section of the SS&D actions issued during the review 

period. The casework reviewed represented the efforts of the two current SS&D reviewers and 

two former SS&D reviewers. The actions included one new device and six amendments to 

existing device registries. A list of SS&D casework examined can be found in Appendix F. 

Analysis of the casework and interviews with staff members confirmed that the Branch follows 

the recommended guidance from the NRC’s SS&D Workshop and NUREG-1556, Volume 3, 

Revision 1, “Consolidated Guidance About Materials Licenses – Applications for Sealed Source 

and Device Evaluation and Registration.” Registrations clearly summarized the product 
North Carolina Final Report Page 12 

evaluations to provide license reviewers with adequate information to license the possession 

and use of the products. Deficiency letters clearly stated regulatory positions and all health and 

safety issues were addressed. The review team determined that the product evaluations were 

thorough, complete, consistent, of acceptable technical quality, and adequately addressed the 

integrity of the products during use and under accident conditions. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

No incidents related to SS&D defects involving sources or devices registered by the State of 

North Carolina were reported during the review period. Incident procedures are in place should 

an SS&D-related incident occur. The Branch Manager was aware of the need to look at such 

incidents as potentially generic in nature with possible wide-ranging effects. 

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

that North Carolina’s performance with respect to the indicator, Sealed Source and Device 

Evaluation Program, was satisfactory. 

4.3 Low-Level Radioactive Waste Disposal Program

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

Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through 

Agreement” to allow a State to seek an amendment for the regulation of low-level radioactive 

waste (LLRW) as a separate category. Those States with Agreements prior to 1981 were 

determined to have continued LLRW disposal authority without the need of an amendment. 

Although the North Carolina Agreement State Program has LLRW disposal authority, NRC has 

not required States to have a program for licensing a LLRW disposal facility until such time as 

the State has been designated as a host State for a LLRW disposal facility. When an 

Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal 

facility, it is expected to put in place a regulatory program that will meet the criteria for an 

adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal 

facility in North Carolina. Accordingly, the review team did not review this indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0, North Carolina’s performance was found satisfactory for all 

seven performance indicators reviewed. The review team made two recommendations 

regarding program performance by the State. Accordingly, the review team recommended, and 

the MRB agreed, that the North Carolina Agreement State Program is adequate to protect 

public health and safety and compatible with NRC's program. Based on the results of the 

current IMPEP review, the review team recommended, and the MRB agreed, that the next full 

IMPEP review of the North Carolina Agreement State Program take place in approximately 4 

years. 
North Carolina Final Report Page 13 

Below are the review team’s recommendations, as mentioned in earlier sections of the report, 

for evaluation and implementation, as appropriate, by the State. 

RECOMMENDATIONS 

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

process to ensure that incidents will be reported to the NRC as required by FSME 

Procedure SA-300. (Section 3.5) 

2. The review team recommends that the State, to maintain compatibility with the NRC, 

make appropriate regulatory changes to resolve NRC-generated comments as noted 

in regulation review letters. (Section 4.1.2) 
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B North Carolina Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source & Device Casework Reviews 

Attachment April 14, 2009 Letter from Dee Freeman 

 North Carolina’s Response to Draft IMPEP Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

James Lynch, Region III Team Leader 

 Technical Quality of Licensing Actions 

 Compatibility Requirements 

 Inspector Accompaniments 

James Kottan, Region I Technical Staffing and Training 

Technical Quality of Incident and Allegation 

 Activities 

Geoffrey Warren, Region III Technical Quality of Inspections 

Cynthia Becker, Florida Status of Materials Inspection Program 

D. Ray Jisha, Texas Technical Quality of Licensing Actions 

 Sealed Source and Device Evaluation Program 
APPENDIX B 

NORTH CAROLINA ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML082520670 
 

APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: JANX Integrity Group Inc. License No.: 085-1117-1 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 3/13/07 Inspector: SJ 

File No.: 2 

Licensee: Cardinal Health License No.: 025-0794-10 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/1/05 Inspector: GA 

File No.: 3 

Licensee: Duke University License No.: 032-0247-1 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 7/17/06 Inspectors: SJ, et al. 

Comment: 

Inspection report included information copied from the previous inspection report, 

including the description of a violation that had since been corrected. 

File No.: 4 

Licensee: Research Triangle Institute License No.: 032-0131-1 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 2/13/07 Inspector: SJ 

File No.: 5 

Licensee: North Carolina State University License No.: 092-0090-3 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 2/14/07 Inspector: GM 

File No.: 6 

Licensee: Gaston Memorial Hospital License No.: 036-0203-2 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 8/21/07 Inspector: JA 

File No.: 7 

Licensee: New Hanover Regional Medical Center License No.: 065-0037-4 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/26/08 Inspector: RC 
North Carolina Final Report Page C.2 

Inspection Casework Reviews

File No.: 8 

Licensee: Albemarle Hospital, Inc. License No.: 070-0126-1 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 4/4/07 and 5/7/07 Inspector: JA 

File No.: 9 

Licensee: Raleigh Medical Group License No.: 092-1457-1 

Inspection Type: Pre-Licensing Site Visit Priority: 5 

Inspection Date: 6/20/08 Inspector: JA 

File No.: 10 

Licensee: Sterigenics U.S., Inc. License No.: 060-0974-1 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 6/24/08 Inspector: SJ 

File No.: 11 

Licensee: Wake Radiology Oncology Services License No.: 092-1086-1 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 2/11/08 Inspector: CH 

File No.: 12 

Licensee: Baker Testing Services Inc. License No.: 049-1441-1 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 12/3/07 Inspector: GM 

File No.: 13 

Licensee: Digirad Imaging Solutions License No.: 065-1014-5 

Inspection Type: Initial, Unannounced Priority: 3 

Inspection Date: 6/7/07 Inspectors: CH, RC 

File No.: 14 

Licensee: North Carolina Baptist Hospital License No.: 034-0158-1 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 9/13/06 Inspector: JA 

File No.: 15 

Licensee: Diabetes and Endocrinology Consultants, PC License No.: 016-1316-1 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/6/08 Inspector: RC 

File No.: 16 

Licensee: Humboldt Scientific License No.: 092-0750-1 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 7/17/07 Inspectors: CH, RC 
North Carolina Final Report Page C.3 

Inspection Casework Reviews

File No.: 17 

Licensee: Cleveland County Healthcare System License No.: 023-0219-1 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/3/05 Inspector: GS 

File No.: 18 

Licensee: H&H X-Ray Services License No.: 111-0322-R 

Inspection Type: Reciprocity, Unannounced Priority: 1 

Inspection Date: 7/31/08 Inspector: CH 

Comment: 

Licensee’s response to a Notice of Violation was not in the file. 

File No.: 19 

Licensee: Hospira, Inc. License No.: 064-0969-1 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/20/07 Inspector: JA 

File No.: 20 

Licensee: Siemens Medical Solutions USA, Inc. License No.: 092-0895-1 

Inspection Type: Special, Announced Priority: 5 

Inspection Date: 12/12/05 Inspector: ME 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Duke Raleigh Hospital License No.: 092-0582-4 

Inspection Type: Initial, Announced Priority: 3 

Inspection Date: 1/6/09 Inspector: JA 

Accompaniment No.: 2 

Licensee: InstroTek, Inc. License No.: 092-1073-1 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 1/7/09 Inspector: RC 

Accompaniment No.: 3 

Licensee: GlaxoSmithKline License No.: 032-1029-2 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 1/8/09 Inspector: GM 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Becton Dickinson and Company License No.: 032-0369-3 

Type of Action: Amendment Amendment No.: 2 

Date Issued: 7/3/08 License Reviewer: GM 

Comment: 

 License was missing required license condition. 

File No.: 2 

Licensee: Research Triangle Institute License No.: 032-0131-1 

Type of Action: Renewal Amendment No.: 91 

Date Issued: 8/3/05 License Reviewer: CH 

Comment: 

Licensee renewal application was not in the file. 

File No.: 3 

Licensee: Hospira, Inc. License No.: 064-0969-1 

Type of Action: Renewal Amendment No.: 12 

Date Issued: 11/10/08 License Reviewer: RC 

File No.: 4 

Licensee: Sterigenics U.S., Inc. License No.: 060-0974-1 

Type of Action: Amendment Amendment No.: 30 

Date Issued: 10/29/08 License Reviewer: GS 

File No.: 5 

Licensee: JANX integrity Group License No.: 068-1117-1 

Type of Action: Amendment Amendment No.: 13 

Date Issued: 10/29/08 License Reviewer: WT 

File No.: 6 

Licensee: Cumberland Cardiology License No.: 026-1460-1 

Type of Action: New Amendment No.: 0 

Date Issued: 7/30/08 License Reviewer: JA 

File No.: 7 

Licensee: Troxler Electronic Laboratories License No.: 032-0182-1 

Type of Action: Amendment Amendment No.: 4 

Date Issued: 4/11/08 License Reviewer: ME 
North Carolina Final Report Page D.2 

Licensing Casework Reviews

File No.: 8 

Licensee: Cardinal Health License No.: 025-0794-11 

Type of Action: Amendment Amendment No.: 9 

Date Issued: 12/8/06 License Reviewer: JA 

File No.: 9 

Licensee: Catawba Valley Medical Center License No.: 018-0292-1 

Type of Action: Amendment Amendment No.: 112 

Date Issued: 8/22/07 License Reviewer: GM 

File No.: 10 

Licensee: Pitt County Memorial Hospital License No.: 074-0296-9 

Type of Action: Amendment Amendment No.: 15 

Date Issued: 1/28/09 License Reviewer: HB 

File No.: 11 

Licensee: MACTEC Engineering & Consulting, Inc. License No.: 060-0082-1 

Type of Action: Amendment Amendment No.: 37 

Date Issued: 12/5/08 License Reviewer: GM 

File No.: 12 

Licensee: Wake Radiation Oncology License No.: 092-1086-1 

Type of Action: Amendment Amendment No.: 8 

Date Issued: 10/29/08 License Reviewer: GS 

Comment: 

Generic license condition authorizing a fictitious device was left on license instead of 

being updated to be specific to this facility. 

File No.: 13 

Licensee: Presbyterian Hospital License No.: 060-0019-1 

Type of Action: Amendment Amendment No.: 28 

Date Issued: 3/13/05 License Reviewer: JA 

File No.: 14 

Licensee: University of North Carolina License No.: 068-0565-1 

Type of Action: Renewal Amendment No.: 43 

Date Issued: 11/24/08 License Reviewer: GS 

File No.: 15 

Licensee: Moses Cone Regional Cancer Center License No.: 041-0021-3 

Type of Action: New Amendment No.: 10 

Date Issued: 1/6/09 License Reviewer: HB 
North Carolina Final Report Page D.3 

Licensing Casework Reviews

File No.: 16 

Licensee: Alamance Cancer Center License No.: 001-0117-2 

Type of Action: Amendment Amendment No.: 9 

Date Issued: 1/15/09 License Reviewer: LC 

File No.: 17 

Licensee: High Point Regional Hospital License No.: 041-0119-2 

Type of Action: Amendment Amendment No.: 25 

Date Issued: 1/15/09 License Reviewer: LC 

File No.: 18 

Licensee: North Carolina Baptist Hospital License No.: 034-0158-9 

Type of Action: Amendment Amendment No.: 8 

Date Issued: 2/9/09 License Reviewer: HB 

File No.: 19 

Licensee: Cape Fear Valley Health System License No.: 026-0173-2 

Type of Action: Amendment Amendment No.: 30 

Date Issued: 1/28/09 License Reviewer: HB 

File No.: 20 

Licensee: Wayne Radiation Oncology License No.: 096-0186-2 

Type of Action: Amendment Amendment No.: 21 

Date Issued: 1/28/09 License Reviewer: GS 

File No.: 21 

Licensee: Gaston Memorial Hospital License No.: 036-0203-2 

Type of Action: Amendment Amendment No.: 14 

Date Issued: 1/28/09 License Reviewer: HB 

File No.: 22 

Licensee: Moore Regional Hospital License No.: 063-0585-1 

Type of Action: Amendment Amendment No.: 52 

Date Issued: 2/11/09 License Reviewer: HB 

Comment: 

A license condition did not specify make and model of device. 

File No.: 23 

Licensee: New Hanover Radiation Oncology License No.: 065-0860-1 

Type of Action: Amendment Amendment No.: 13 

Date Issued: 11/7/08 License Reviewer: ME 

File No.: 24 

Licensee: 21st Century Oncology License No.: 011-1276-1 

Type of Action: Amendment Amendment No.: 36 

Date Issued: 1/8/09 License Reviewer: GS 
North Carolina Final Report Page D.4 

Licensing Casework Reviews

File No.: 25 

Licensee: NC Radiation Therapy Management Services License No.: 044-1276-2 

Type of Action: Amendment Amendment No.: 12 

Date Issued: 10/29/08 License Reviewer: GS 

File No.: 26 

Licensee: Carolina Radiation Medicine License No.: 074-1276-4 

Type of Action: Amendment Amendment No.: 5 

Date Issued: 2/5/09 License Reviewer: GS 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Charlotte-Mecklenburg Hospital License No.: 060-0014-3 

Date of Incident: 1/27/09 NMED Log No.: 090151 

Investigation Date: Ongoing Type of Incident: Medical Event 

 Type of Investigation: Site 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 

File No.: 2 

Licensee: Charlotte-Mecklenburg Hospital License No.: 060-0014-3 

Date of Incident: 1/20/09 NMED Log No.: 090102 

Investigation Date: 1/21/09 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 

File No.: 3 

Licensee: ECS Carolinas License No.: 041-0253-4 

Date of Incident: 1/19/09 NMED Log No.: 090100 

Investigation Date: 1/19/09 Type of Incident: Lost Material 

 Type of Investigation: Telephone/Site Visit 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 

File No.: 4 

Licensee: QSL License No.: 090-1058-1 

Date of Incident: 1/13/09 NMED Log No.: 090077 

Investigation Date: Ongoing Type of Incident: Overexposure 

 Type of Investigation: Telephone/Site Visit 

File No.: 5 

Licensee: Flowserve License No.: 092-0121-1 

Date of Incident: 8/6/08 NMED Log No.: 080559 

Investigation Date: 8/7/08 Type of Incident: Equipment Failure 

 Type of Investigation: Telephone 
North Carolina Final Report Page E.2 

Incident Casework Reviews

File No.: 6 

Licensee: Froehling & Robertson License No.: 092-0353-6 

Date of Incident: 6/27/08 NMED Log No.: 080378 

Investigation Date: 6/27/08 Type of Incident: Damage to Equipment 

 Type of Investigation: Telephone 

File No.: 7 

Licensee: S & ME, Inc. License No.: 092-0922-1 

Date of Incident: 4/10/08 NMED Log No.: 080310 

Investigation Date: 5/5/08 Type of Incident: Equipment Failure 

 Type of Investigation: Telephone 

File No.: 8 

Licensee: Virginia Mason Medical Center License No.: 060-0014-3 

Date of Incident: 3/11/08 NMED Log No.: 080170 

Investigation Date: 3/14/08 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 

File No.: 9 

Licensee: Memorial Mission Hospital License No.: 011-0091-4 

Date of Incident: 1/29/08 NMED Log No.: 080071 

Investigation Date: 1/30/08 Type of Incident: Lost Material 

 Type of Investigation: Telephone 

File No.: 10 

Licensee: Carolinas Medical Center License No.: 060-0014-1 

Date of Incident: 10/12/07 NMED Log No.: 070640 

Investigation Date: 10/16/07 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 

File No.: 11 

Licensee: Memorial Mission Hospital License No.: 011-1203-1 

Date of Incident: 4/24/07 NMED Log No.: 070263 

Investigation Date: 4/26/07 Type of Incident: Medical Event 

 Type of Investigation: Telephone/Site 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 
North Carolina Final Report Page E.3 

Incident Casework Reviews

File No.: 12 

Licensee: Carolinas Medical Center License No.: 060-0014-3 

Date of Incident: 1/17/06 NMED Log No.: 060049 

Investigation Date: 1/18/06 Type of Incident: Medical Event 

 Type of Investigation: Telephone 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 

File No.: 13 

Licensee: DuPont License No.: 026-1851-0G 

Date of Incident: 6/1/05 NMED Log No.: 050615 

Investigation Date: 8/31/05 Type of Incident: Loss of Control 

 Type of Investigation: Telephone 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 

File No.: 14 

Licensee: Duke University License No.: 032-0247-4 

Date of Incident: 11/15/04 NMED Log No.: 040859 

Investigation Date: 11/16/04 Type of Incident: Medical Event 

 Type of Investigation: Telephone 

Comment: 

The Branch did not report this event to the NRC Operations Center in a timely manner. 
APPENDIX F 

SEALED SOURCE & DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: NC-646-D-130-S SS&D Type: Portable Gauge 

Applicant Name: Troxler Electronics Laboratories Type of Action: Amendment 

Date Issued: 6/12/06 Reviewers: SJ, GS 

File No.: 2 

Registry No.: NC-646-D-128-S SS&D Type: Portable Gauge 

Applicant Name: Troxler Electronics Laboratories Type of Action: Amendment 

Date Issued: 3/20/08 Reviewers: ME, GS 

File No.: 3 

Registry No.: NC-1252-D-101-G SS&D Type: Chemical Agent Vapor Detector 

Applicant Name: General Dynamics Type of Action: New 

Date Issued: 6/14/06 Reviewers: SJ, ME 

File No.: 4 

Registry No.: NC-585-D-103-G SS&D Type: Self-Lighting Sign 

Applicant Name: SRB Technologies, Inc. Type of Action: Amendment 

Date Issued: 2/19/07 Reviewers: GS, ME 

File No.: 5 

Registry No.: NC-585-D-105-G SS&D Type: Self-Luminous Fixed Marker 

Applicant Name: SRB Technologies, Inc. Type of Action: Amendment 

Date Issued: 7/26/07 Reviewers: GS, ME 

File No.: 6 

Registry No.: NC-585-S-102-S SS&D Type: Self-Luminous Tritium Lamp 

Applicant Name: SRB Technologies, Inc. Type of Action: Amendment 

Date Issued: 2/19/07 Reviewers: GS, ME 

File No.: 7 

Registry No.: NC-585-D-801-E SS&D Type: Self-Lighting Sign 

Applicant Name: SRB Technologies, Inc. Type of Action: Amendment 

Date Issued: 1/11/05 Reviewers: SJ, GA 
ATTACHMENT 

April 14, 2009, Letter from Dee Freeman 

North Carolina’s Response to Draft IMPEP Report 

ADAMS Accession No.: ML091110161