August 6, 2012 

Shari Meghreblian, Ph.D. 

Deputy Commissioner 

Tennessee Department of Environment 

 and Conservation 

401 Church Street 

1st Floor, L&C Annex 

Nashville, TN 37243 

Dear Dr. Meghreblian: 

On July 10, 2012, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Tennessee 

Agreement State Program. The MRB found the Tennessee Agreement State Program adequate 

to protect public health and safety and compatible with the Nuclear Regulatory Commission’s 

program. 

Section 5.0, page 14 of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the Tennessee 

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

tentatively scheduled mid-cycle. 

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

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

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

 Sincerely, 

/RA/ 

 Michael F. Weber 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Tennessee Final IMPEP Report 

cc w/ encl: Debra Shults, Director 

 Division of Radiological Health 

 

 Bill Dundulis, Rhode Island 

 Organization of Agreement States 

 Liaison to the MRB 
August 6,2012 

Shari Meghreblian, Ph.D. 

Deputy Commissioner 

Tennessee Department of Environment 

 and Conservation 

401 Church Street 

1st Floor, L&C Annex 

Nashville, TN 37243 

Dear Dr. Meghreblian: 

On July 10, 2012, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Tennessee 

Agreement State Program. The MRB found the Tennessee Agreement State Program 

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

Commission’s program. 

Section 5.0, page 14 of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the 

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

meeting tentatively scheduled mid-cycle. 

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

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

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

 Sincerely, 

/RA/ 

 Michael F. Weber 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Tennessee Final IMPEP Report 

cc w/ encl: Debra Shults, Director 

 Division of Radiological Health 

 

 Bill Dundulis, Rhode Island 

 Organization of Agreement States 

 Liaison to the MRB 

DISTRIBUTION: EDATS: FSME-2012-0021 

See next page 

ADAMS Accession Number: ML12194A239 

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

NAME LDimmick DWhite CEinberg / BJM for BMcDermott 

DATE 07/19/12 07/19/12 07/25/12 07/25/12 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland / PNT MSatorius / KSW MWeber 

DATE 07/30/12 07/31/12 08/06 /12 

OFFICIAL RECORD COPY
Letter to S. Meghreblian, Ph.D., from Michael F. Weber dated: August 6, 2012 

SUBJECT: Tennessee 2012 FINAL IMPEP REPORT 

DISTRIBUTION: EDATS: FSME-2012-0021 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsRgn1MailCenter 

RidsRgn3MailCenter 

RidsFsmeDmssa 

RidsSecyCorrespondenceMailCenter Chairman Macfarlane

JLynch, RIIII Commissioner Svinicki 

DJanda, RI/RSAO Commissioner Apostolakis 

BUrllrich, RI Commissioner Magwood 

SMack, AR Commissioner Ostendorff 

SPoy, FSME SECY 

RLorson, RI 

DCollins, RI 

ABoland, RIII 

MKotzalas, OEDO 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE TENNESSEE AGREEMENT STATE PROGRAM 

April 23–27, 2012 

FINAL REPORT
EXECUTIVE SUMMARY 

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

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

during the period of April 23–27, 2012, by a review team composed of technical staff members 

from the U.S. Nuclear Regulatory Commission (NRC) and the State of Arkansas.

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

seven performance indicators. In addition, the review team determined that the 

recommendations from the 2008 IMPEP review regarding staffing and training, and the sealed 

source and device evaluation program, should be closed. 

Accordingly, the review team recommended, and the Management Review Board (MRB) 

agreed, that the Tennessee Agreement State Program is adequate to protect public health and 

safety and is compatible with NRC's program. The review team recommended, and the MRB 

agreed, that the next IMPEP review take place in approximately four years. 
Tennessee Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Tennessee Agreement State Program. The 

review was conducted during the period of April 23–27, 2012, by a review team composed of 

technical staff members from the NRC and the State of Arkansas. 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” dated 

February 26, 2004. Preliminary results of the review, which covered the period of April 25, 

2008, to April 27, 2012, were discussed with Tennessee managers on the last day of the review. 

A draft of this report was provided to Tennessee for factual comment on May 25, 2012. The 

State responded by letter dated June 18, 2012. A copy of the State’s response is included as an 

Attachment to this report. An MRB met on July 10, 2012, to consider the proposed final report. 

The MRB found the Tennessee Agreement State Program adequate to protect public health and 

safety, and compatible with the NRC’s program. 

The Tennessee Agreement State Program is administered by the Division of Radiological 

Health (the Division). The Division is located in the Bureau of Environment, which is in the 

Department of Environment and Conservation (the Department). The Division Director reports 

to the Deputy Commissioner for Environment and Conservation, who in turn reports to the 

Commissioner of the Department. Organization charts for the Department and the Division are 

included as Appendix B. 

At the time of the review, the Tennessee Agreement State Program regulated 576 specific 

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

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

Act of 1954, as amended) Agreement between the NRC and the State of Tennessee. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Division on January 5, 2012. The Division 

provided its response to the questionnaire on April 9, 2012. A copy of the questionnaire 

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

(ADAMS) using the Accession Number ML121010376. 

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

the Division’s response to the questionnaire, (2) review of applicable Tennessee statutes and 

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

review of selected regulatory actions, (5) field accompaniments of nine inspectors, and 

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

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

indicators and made a preliminary assessment of the Tennessee Agreement State Program’s 

performance. 

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

during previous reviews. Results of the current review of the common performance indicators 
Tennessee Final IMPEP Report Page 2 

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. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the 2008 IMPEP review, which concluded on April 25, 2008, the review team made four 

recommendations regarding the Tennessee Agreement State Program’s performance. The 

status of each recommendation is as follows: 

1. The review team recommends that the State evaluate the Division’s projected staffing level 

and take appropriate action to ensure the Division has adequate resources to achieve its 

primary objective of protecting the public health, safety, and security. 

 Status: The Division analyzed its staffing needs for the Central and regional office functions. 

The Program staffing level has remained stable during the review period and the Program is 

not experiencing any significant backlogs in licensing or inspection activities. Four positions 

(three technical and one clerical) were vacant at the time of this review, and according to the 

Director, will likely be eliminated in future staffing cuts. Despite the potential cuts, the review 

team determined that staffing levels were adequate. The team recommended and the MRB 

agreed; this recommendation is closed. 

2. The review team recommends that the State develop a method to clearly document that an 

inspector or license reviewer is qualified or approved to perform inspections or licensing 

actions of the different license types upon completion of specified training. 

 Status: The Program maintains training records for each inspector and license reviewer to 

document qualification/approval for the different types of licenses after completion of training 

courses and supervisory accompaniments. The Central Office maintains records for staff 

member qualifications, including documentation of training courses and on-the-job training. 

The team recommended and the MRB agreed; this recommendation is closed. 

3. The review team recommends that the State review the training policy to ensure that it 

meets current and future needs of staff and revise the policy, as appropriate, to include onthe-job training and security training. 

 Status: The Program’s current training policy includes on-the-job training and security 

training to address current and future needs of the staff. License reviewers and inspectors 

from each of the regional offices have attended the NRC security training course. The team 

recommended and the MRB agreed; this recommendation is closed. 

4. The review team recommends that the State establish a means to ensure evaluations are 

conducted with thoroughness and are consistent with American National Standards Institute 

(ANSI) standards and NUREG-155.6, Volume 3, for all Sealed Source and Device (SS&D) 

licensing actions. 

 Status: In order to ensure thoroughness and consistency with ANSI standards and existing 

guidance, the Program’s SS&D reviewers implemented a review checklist based on the 
Tennessee Final IMPEP Report Page 3 

checklist found in NUREG-1556, Volume 3, for SS&D licensing actions requiring a safety 

review. The team recommended and the MRB agreed; 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 Division’s staffing level and staff 

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

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

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

considered workload backlogs. 

The Division is composed of the Office of the Director and four Sections: Inspection and 

Enforcement, Licensing/Registration/Policy, Technical Services, and Administrative Services. 

All Sections, other than Inspection and Enforcement, are located at the Central Office in 

Nashville. Inspection and enforcement activities are conducted by four regional offices 

located in Knoxville, Memphis, Chattanooga, and Nashville. Incident response activities are 

conducted by the four regional offices and the Central Office. Inspection and enforcement 

activities are coordinated by the Inspection and Enforcement Section Manager, located at the 

Knoxville regional office. The former Division Director is currently employed as a part-time 

rehired annuitant. 

At the time of the review, the Division had 49 individuals with various degrees of involvement 

in the radioactive materials program, totaling approximately 24 full-time equivalents (FTE). 

During the review period, nine staff members left the Division and nine staff members were 

hired. Four positions (three technical and one clerical) were vacant at the time of this review, 

and according to the Director, will likely be eliminated in future staffing cuts. Despite the 

potential cuts, the review team determined that staffing levels were adequate. 

The Division has a documented training plan for technical staff that is consistent with the 

requirements in the NRC/Organization of Agreement States Training Working Group Report and 

NRC’s Inspection Manual Chapter (IMC) 1246, “Formal Qualification Programs in the Nuclear 

Material Safety and Safeguards Program Area.” The plan is currently under revision to update 

training expectations, including security training. The State relies on the NRC-sponsored 

training courses for basic training, and supplements that training with on-the-job training. Staff 

members are assigned increasingly complex duties as they progress through the qualification 

process. The review team shared the draft IMC 1248 “Qualification Programs for Federal and 

State Materials and Environmental Management Programs” with the State to help with 

employee qualifications. The review team concluded that the Division’s training program is 

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

Division training program. 
Tennessee Final IMPEP Report Page 4 

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

that Tennessee’s performance with respect to the indicator, Technical Staffing and Training, be 

found satisfactory. 

3.2 Status of Materials Inspection Program

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

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

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

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

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

management and staff. 

The review team verified that Tennessee's inspection frequencies for all types of radioactive 

material licenses are at least as frequent as license types listed in IMC 2800, “Materials 

Inspection Program.” The review team confirmed the Division is conducting Increased Controls 

inspections in conjunction with the routine health and safety inspections. 

The Division conducted approximately 479 higher priority (Priority 1, 2, and 3) inspections 

during the review period based on the inspection frequencies established in IMC 2800. At the 

time of conduct, 12 of these inspections were overdue by more than 25 percent of the 

inspection frequency prescribed in IMC 2800. 

The Division performed approximately 74 initial inspections during the review period, 4 of which 

were overdue when conducted. Two initial inspections were overdue at the time of the IMPEP 

review. As required by IMC 2800, initial inspections are to be conducted within 12 months of 

license issuance. These inspections were overdue because of a misinterpretation of the IMC 

2800 requirements for initial inspections. When the Division contacts a licensee to schedule the 

initial inspection and is told that no radioactive material has been received, the Division defers 

the initial inspection. The Division follows up with the licensee annually in the same manner 

until the licensee indicates that radioactive material has been received. In the two overdue 

cases, the Division attempted to schedule the initial inspection but the licensees indicated no 

licensed activities were being conducted so the initial inspections were deferred and not 

performed within 12 months of license issuance. The Division committed to making a swift 

modification to its inspection procedures requiring that initial inspections be performed within the 

first 12 months regardless of whether licensed activities were being conducted. The Division 

also committed to train inspection staff accordingly. The two overdue initial inspections were 

scheduled during the IMPEP review. Overall, the review team calculated that the Division 

performed 2.9 percent of its core inspections (Priority 1, 2, 3 and initial) overdue during the 

review period. 

The review team evaluated the Division’s timeliness in providing inspection findings to 

licensees. The Division has a policy of issuing inspection findings to licensees within 30 days 

from the date of the inspection. All inspection reports are submitted for a supervisory review. 

Based on a sampling of 34 inspection reports, no inspection findings were communicated to the 

licensees beyond the Division’s goal of 30 days after the inspection. Each field office tracks the 

30-day metric for inspection report timeliness. Computer printouts generated by each office for 

the review period indicated that only a few inspection reports were issued beyond 30 days. 
Tennessee Final IMPEP Report Page 5 

During the review period, the Division granted 149 reciprocity permits, 84 of which were 

candidate licensees for reciprocity based upon the criteria in IMC 1220 “Processing of NRC 

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

review team determined that the Division exceeded the NRC’s criteria of inspecting 20 percent 

of candidate licensees operating under reciprocity in each of the four years covered by the 

review period. 

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

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

Program, be found satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, 

inspection field notes, and interviewed inspectors for 24 radioactive materials inspections 

conducted during the review period. The casework included inspections conducted by 20 

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

broad scope, academic broad scope, medical institutions, industrial radiography, 

veterinary use, gamma knife, nuclear pharmacy, service provider, nuclear laundry, well 

logging, research and development, and Increased Security Controls for Large Quantities 

of Radioactive Materials (Increased Controls). Appendix C lists the inspection casework 

files reviewed, with case-specific comments, as well as the results of the inspector 

accompaniments. 

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

aspects of licensed radiation programs. The review team found that inspection reports were 

thorough, complete, consistent, and of high quality, with sufficient documentation to ensure that 

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

documentation supported violations, recommendations made to licensees, unresolved safety 

issues, and discussions held with licensees during exit interviews. 

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

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

and signed by the Regional Office Manager and/or Inspection and Enforcement Manager. 

Supervisory accompaniments were conducted annually for all inspectors. 

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

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

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

results of the inspection. The Division issues to the licensee either a letter indicating a clear 

inspection or a Notice of Non-compliance (NNC), in letter format, which details the results of the 

inspection. When the Division issues an NNC, the licensee is required to provide a written 

corrective action plan, based on the violations cited, within 15 days. All findings are reviewed 

and acknowledged by the inspector. 

The review team noted that the Division has an adequate supply of survey instruments to 

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

Geiger-Mueller (GM) meters, scintillation detectors, ion chambers, micro-R meters, and neutron 
Tennessee Final IMPEP Report Page 6 

detectors, was observed to be available. The Division also has portable multi-channel 

analyzers located in offices across the State. Instruments are calibrated at least annually, or as 

needed, by K&S Associates or Ludlum with National Institute of Standards and Technology 

traceable sources. The Division uses a spreadsheet to track each instrument, its current 

location, and next calibration date. 

Accompaniments of 11 Division inspectors were conducted by 3 IMPEP team members 

during the weeks of February 20, March 12, April 2, and April 9, 2012. The inspectors were 

accompanied during health and safety inspections of industrial radiography, service 

provider, irradiator, medical therapy, medical diagnostic, and waste processor licensees. 

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

inspectors demonstrated appropriate inspection techniques, knowledge of the regulations, 

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

for the inspection, and thorough in their 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 inspections were adequate to assess radiological health and safety and 

Increased Controls at the licensed facilities. 

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

that Tennessee’s performance with respect to the indicator, Technical Quality of Inspections, be 

found satisfactory. 

3.4 Technical Quality of Licensing Actions

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

43 specific licensing actions. Licensing actions were reviewed for completeness, consistency, 

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

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

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

The casework was also reviewed for timeliness, use of appropriate deficiency letters and cover 

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

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

files were checked for retention of necessary documents and supporting data.

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

completed during the review period. Licensing actions selected for evaluation included 8 new 

licenses, 10 renewals, 4 termination actions, and 21 amendments. Files reviewed included a 

cross-section of license types, including: licenses of broad scope, medical diagnostic and 

therapy, gamma knife, industrial radiography, research and development, nuclear pharmacy, 

production of radionuclides using accelerators, veterinary use, fixed and portable gauges, 

manufacturers, self-shielded irradiators, decommissioning and decontamination services, and 

waste processors. The casework sample represented work from all four license reviewers. A 

list of the licensing casework evaluated is provided in Appendix D. 

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

and of high quality with health, safety, and security issues properly addressed. License tiedown conditions were stated clearly and were supported by information contained in the file. 
Tennessee Final IMPEP Report Page 7 

Deficiency letters clearly stated regulatory positions, were used at the proper time, and identified 

substantive deficiencies in the licensees’ documents. Terminated licensing actions were 

documented; however, two of the files reviewed were missing receipt information indicating final 

disposition of the radioactive material. License reviewers use the Division’s licensing guides 

and/or NUREG-1556 series guidance documents, policies, checklists, and standard license 

conditions to ensure consistency in licenses. 

All license reviewers have signature authority and sign their own licensing actions. 

The next higher level supervisor to the license reviewer (Program Manager, Director or 

Licensing Manager) performs a technical and supervisory review on all licensing actions before 

issuance to the licensee. Licenses are issued for a 10-year period under a timely renewal 

system. 

The license reviewers followed standard procedures, guidance documents and checklists that 

are similar to those used by the NRC. During the review period, the Division revised in full the 

Medical License Application Guide and issued five updates to existing procedures. Based on 

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

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

documents, the State’s regulations, and good health physics practices. 

The Division authorizes a number of unique licenses, identified as waste processors, who 

process radioactive wastes received from licensees throughout the country. In April 2010, the 

Division amended the licenses of the four waste processors who were authorized to dispose of 

materials with extremely low levels of contamination into Class I (Subtitle D) landfills, and 

required them to re-submit dose assessments for such disposals. The Division specified the 

minimum criteria for the assessment and established new licensing requirements for this 

activity. Evaluation of the re-submitted dose assessments were performed by the Division’s 

Health Physics Consultant using accepted industry codes, data, and modeling to confirm the 

dose assessments. 

The review team evaluated two waste processor licensing actions issued during this review 

period that required submission of emergency preparedness plans in accordance with State 

regulations. During the review period, waste processor licensing actions were reviewed by one 

license reviewer. A second reviewer on staff had done waste processor reviews in the past. 

This reviewer is still available to do these reviews and handles special processor amendments 

and performs import/export license reviews. The Division has started to train an additional 

reviewer to perform reviews of waste processor activities. During the 2008 IMPEP review, the 

review team discussed with Division managers the possibility of developing a guidance 

document or checklist for licensing the unique activities associated with waste processors in an 

effort to capture the expertise and experience of the Division that could be used for knowledge 

management within the Division or by other regulatory agencies. A list of standard license 

conditions for waste processors was available during the 2012 review, but no additional written 

guidance was developed. 

The Division performed pre-licensing checks of all new license applicants evaluated by the 

review team. The Division’s pre-licensing review methods incorporated the essential elements 

of NRC’s revised pre-licensing guidance to verify that the applicant will use requested 

radioactive materials as intended. When applicable, new licensees received a pre-licensing site 
Tennessee Final IMPEP Report Page 8 

visit which included an evaluation of the applicant’s radiation safety and security programs prior 

to receipt of the initial license. 

The review team examined the Division’s licensing practices regarding the Increased Controls 

and Fingerprinting orders, and the National Source Tracking System (NSTS). The review team 

noted that the State used legally binding license conditions that met the criteria for implementing 

the Increased Controls orders, including fingerprinting, as appropriate. The State also used 

legally binding license conditions that met the criteria for implementing the requirements of the 

NSTS. The review team analyzed the Division’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 Division required full implementation of the Increased Controls prior to issuance of a new 

license or license amendment that met the established criteria. 

The review team examined the Division’s procedure for the control of sensitive information. The 

Division procedure addressed the marking, control, and handling of documents that contain 

sensitive information related to the Increased Controls. The review team noted that the 

Division’s licensing and inspection files were available to all workers; however inspection files 

that contained sensitive information related to Increased Controls were further secured in locked 

file cabinets. 

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

that the State of Tennessee’s performance with respect to the indicator, Technical Quality of 

Licensing Actions, be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

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

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

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

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

casework for 16 radioactive materials incidents. A listing of the incident casework examined, 

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

Division’s response to 12 allegations involving radioactive materials, including 6 allegations 

referred to the State by the NRC during the review period. 

The incidents selected for review included the following categories: lost/stolen radioactive 

material, medical event, equipment failures, leaking sources, contamination, and radioactive 

material release. The review team determined that the Division’s response to incidents was 

complete and comprehensive. Initial responses were prompt and well-coordinated, and the 

level of effort was commensurate with the health and safety significance. The Division 

dispatched inspectors for on-site investigations in 12 of the cases reviewed and took suitable 

enforcement and follow-up actions. 

Several months prior to this IMPEP review, Division managers identified that reporting of 

incidents was not being performed as established in the Office of Federal and State Materials 

and Environmental Management Programs (FSME) Procedure SA-300 “Reporting Material 

Events.” The reporting lapse was due to changing responsibilities amongst managers, and 
Tennessee Final IMPEP Report Page 9 

although all incidents were responded to in an effective manner, the reporting to the NRC 

Headquarters Operations Center and download of information into NMED, was overlooked. 

In early 2012, the Division placed a manager in charge of incident reporting and analyzed 

incidents which had occurred since 2008 to determine if any of the incidents were reportable. 

The Division reported 2 of the incidents to the NRC Headquarters Operations Center and 

information for 38 incidents was sent to NMED. The Division also arranged for NRC’s 

contractor for the NMED database, Idaho National Laboratory, to provide training to staff in June 

2012. The training session was supplemented with SA-300 training by the NRC Region I State 

Agreements Officer. 

The review team identified three additional incidents that occurred during the review period, 

which met the criteria for reporting to the NRC Headquarters Operations Center. The Division 

appropriately responded to these incidents. The Division reported these incidents to NRC on 

April 30, 2012, after the review. At the next periodic meeting for the Tennessee Agreement 

State, the reviewers should verify that reportable radioactive material incidents are appropriately 

reported in accordance with SA-300. 

In evaluating the effectiveness of the Division’s response to allegations, the review team 

evaluated the completed casework for the 12 allegations. The review team concluded that the 

Division consistently took prompt and appropriate actions in response to concerns raised. The 

review team noted that the Division documented the investigations of concerns and retained all 

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

concerned individuals of the conclusion of their investigations. The review team determined that 

the Division adequately protected the identity of concerned individuals within the limitations of 

the State’s rules and policy related to alleger identity protection. 

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

that Tennessee=s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found 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) LowLevel Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. NRC’s 

Agreement with Tennessee does not relinquish regulatory authority for a uranium recovery 

program; therefore, only the first three non-common performance indicators applied to this 

review. 

4.1 Compatibility Requirements

4.1.1 Legislation

Tennessee became an Agreement State on September 1, 1965. The statutory authority for the 

radiation control program is found in Title 68, Chapter 202-101 through 202-709 of the 

Tennessee Code Annotated. The Division is designated as the State’s radiation control 

agency in Title 68, Chapter 203-101 through 203-105. 
Tennessee Final IMPEP Report Page 10 

The review team verified with Division staff that no legislation affecting the radiation control 

program was passed during the review period. 

4.1.2 Program Elements Required for Compatibility

Tennessee’s regulations for the control of radiation are found in the “Rules of the Department 

of Environment and Conservation,” Chapters 1200-2-4 through 1200-2-12, and apply to all 

ionizing radiation from radioactive materials and radiation-producing machines. Tennessee 

requires a license for possession and use of all radioactive material including naturally 

occurring materials (such as radium) and accelerator-produced radionuclides. 

The regulatory process provides opportunity for the public and other interested parties to 

comment on proposed rules. The review team verified that no changes have been made to 

Division procedures since the last review. Tennessee has procedures for amending four types 

of regulations: Rulemaking Hearing Rules, Proposed Rules (non-controversial filed without a 

public hearing), Emergency Rules, and Public Necessity Rules. The Division generally uses the 

Rulemaking Hearing and Proposed Rules Procedures. 

Under Rulemaking Hearing Rules Procedures, proposed rules are reviewed internally by the 

Division, the Department’s Office of the General Counsel (OGC), and by outside interested 

parties before a rulemaking hearing is established. The proposed rules are published in the 

Tennessee Administrative Register during the month prior to the public hearing. Comments are 

accepted at the hearing and during the comment period. Changes are made to the rules, as 

needed; reviewed by the OGC; signed by the Department’s Commissioner; reviewed by the 

Attorney General’s Office; filed with the Secretary of State; and become effective 90 days after 

filing. 

Under Proposed Rules Procedures, rules considered non-controversial may be filed without a 

public hearing. Proposed rules are reviewed internally by the Division, the OGC, and by outside 

interested parties. The proposed rules are published in the Tennessee Administrative Register. 

A petition requesting a public hearing may be filed within 60 days from the first day of the month 

subsequent to the filing of the proposed rule. In the absence of a petition, the rule becomes 

effective after a waiting period of 150 days. 

After a rule becomes effective, representatives of the Division and OGC are scheduled to 

appear before the Government Operations Committee of the legislature for the Committee’s 

hearing and approval of the rules. Rules adopted during the year are subject to sunset on June 

30 of the following calendar year, unless approved by the legislature. 

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

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

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

from the State Regulation Status sheet that FSME maintains. 

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

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

regulations. During the 2008 IMPEP review, Tennessee was found satisfactory, but needs 

improvement, for the compatibility indicator because of the number of overdue regulations. 
Tennessee Final IMPEP Report Page 11 

Since the 2008 IMPEP review, the Division submitted final amendments to the NRC in 2008, 

2010, and 2012. Division management dedicated staff to its regulation process. At the time of 

the onsite IMPEP review, Tennessee had no overdue amendments. During the review period, 

Tennessee submitted 16 final regulation amendments, and 2 legally binding license conditions 

to the NRC for compatibility review. Twelve of the 16 final amendments were overdue when 

they were submitted. NRC’s compatibility review of the 16 final amendments resulted in no 

comments. 

The 12 of 16 amendments submitted overdue during the review period include: 

• “Decommissioning Recordkeeping and License Termination: Documentation Additions 

[Restricted areas and spill sites],” 10 CFR Parts 30 and 40 amendment (58 FR 39628) 

that was due for Agreement State adoption by October 25, 1996. 

• “Clarification of Decommissioning Funding Requirements,” 10 CFR Parts 30, 40, and 70 

amendment (60 FR 38235) that was due for Agreement State adoption by November 24, 

1998. 

• “Termination or Transfer of Licensed Activities: Recordkeeping Requirements,” 10 CFR 

Parts 20, 30, 40, 61, and 70 amendment (61 FR 24669) that was due for Agreement 

State adoption by June 17, 1999. 

• “Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, and 70 

amendment (62 FR 39057) that was due for Agreement State adoption by August 20, 

2000. 

• “Medical Use of Byproduct Material,” 10 CFR Parts 20, 32, and 35 amendment (67 FR 

20249) that was due for Agreement State adoption by October 24, 2005. 

• “Financial Assurance for Materials Licensees,” 10 CFR Parts 30, 40, and 70 amendment 

(68 FR 57327) that was due for Agreement State adoption by December 3, 2006. 

• “Compatibility With IAEA Transportation Safety Standards and Other Transportation 

Safety Amendments,” 10 CFR Part 71 amendment (69 FR 3697) that was due for 

Agreement State adoption by October 1, 2007. 

• “Medical Use of Byproduct Material—Recognition of Specialty Boards,” 10 CFR Part 35 

amendment (70 FR 16336: 71 FR 1926) that was due for Agreement State adoption by 

April 29, 2008. 

• “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40, and 70 amendment (71 FR 

15005) that was due for Agreement State adoption by March 27, 2009. 

• “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 was due for Agreement State adoption by December 17, 2010. 
Tennessee Final IMPEP Report Page 12 

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

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

adoption by November 30, 2010. 

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

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

adoption by February 15, 2011. 

The Division will need to address the following amendments during the next IMPEP review 

period: 

• “Decommissioning Planning,” 10 CFR Parts 20, 30, 40, and 70 amendment (76 FR 

35512) that is due for Agreement State implementation by December 17, 2015. 

• “Licenses, Certifications, and Approvals for Materials Licensees,” 10 CFR Parts 30, 36, 

39, 40, 70, and 150 amendment (76 FR 56951) that is due for Agreement State 

implementation by November 14, 2014. 

• “Changes of Compatibility of 10 CFR 31.5 and 31.6,” 10 CFR Part 31 amendment (77 

FR 3640) that is due for Agreement State Implementation by January 25, 2015. 

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

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

found satisfactory. 

4.2 Sealed Source and Device Evaluation Program

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

performance regarding the SS&D Evaluation Program. These subelements are (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 Division’s SS&D evaluation activities, the review team examined information 

provided in response to the IMPEP questionnaire for this indicator. The review team conducted 

a review of all new and amended SS&D registrations and supporting documents processed 

during the review period. The review team noted the staff’s use of guidance documents and 

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

regulations and license conditions. The review team also evaluated SS&D staff training records 

and certain reported incidents involving products authorized in Tennessee SS&D registrations. 

4.2.1. Technical Staffing and Training

The Division has a documented qualification program for SS&D reviewers as a subsection of its 

overall Licensing Evaluator Qualification Procedures. The Division utilizes a structured in-house 

training program due to the infrequent SS&D application for a new registration or amendment 

request. Currently, the SS&D Evaluation Program is fully staffed and the Division does not plan 

in the near future to add any more reviewers. The SS&D reviewers, who have extensive health 

physics experience perform device evaluations as secondary duties. 
Tennessee Final IMPEP Report Page 13 

The Division currently has four qualified reviewers, and one other is working on becoming a fully 

qualified reviewer. All five individuals have completed the NRC SS&D Workshop. According to 

the Division’s response to the questionnaire, the Division expends approximately 0.13 FTE on 

SS&D evaluations. The review team concluded that the current SS&D staffing level is adequate 

for the needs of the Division. 

4.2.2 Technical Quality of the Product Evaluation Program

During the review period, the Division processed 16 SS&D actions. Fourteen of the actions 

were amendments and two were new applications. There were no inactivations of SS&D 

registrations or emerging technology evaluations processed during the review period. The 

review team evaluated all 16 actions processed during the review period. The casework 

selected for review was representative of five qualified reviewers. A listing of the SS&D 

certificates evaluated by the review team, with case-specific comments, may be found in 

Appendix F. 

The Division performed evaluations based on sound conservative assumptions to ensure public 

health and safety was adequately protected. Good health physics practices were implemented 

throughout the evaluations. 

In assessing the Division’s SS&D evaluation activities, the review team examined information 

contained in the questionnaire response and interviewed program staff and managers. The 

review team confirmed that the Division follows the recommended guidance from the NRC 

SS&D Workshop, NUREG-1556 guidance, applicable and pertinent ANSI standards and military 

standards, ISO-9001 and Tennessee regulations, statutes, policies and procedures. The review 

team verified these documents were available and used appropriately in performing SS&D 

evaluations. 

Deficiency letters clearly stated regulatory positions and all health and safety issues were 

addressed. The review team determined that product evaluations were complete and 

adequately addressed the integrity of the products during use and in the event of accidents. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Utilizing NMED, the review team determined that there were no incidents involving SS&D 

registered products during the review period. The review team determined that there were no 

events that occurred in Tennessee, or nationally, involving sealed sources/devices registered by 

the Division. 

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

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

Evaluation Program, be found satisfactory. 

4.3 Low-level Radioactive Waste Disposal Program

In 1981, the 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 
Tennessee Final IMPEP Report Page 14 

Waste (LLRW) as a separate category. Although the Tennessee 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, they are expected to put in place a regulatory program which 

will meet the criteria for an adequate and compatible LLRW disposal program. There are no 

plans for a LLRW disposal facility in Tennessee. Accordingly, the review team did not review 

this indicator. 

5.0 SUMMARY 

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

performance indicators reviewed. The review team determined that the four recommendations 

from the 2008 IMPEP review should be closed (Section 2.0). Accordingly, the review team 

recommended, and the MRB agreed, that the Tennessee Agreement State Program be found 

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 take place in approximately four years. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Tennessee Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source and Device Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Jim Lynch, Region III Team Leader 

 Technical Staffing and Training 

 Technical Quality of Incident and Allegation 

 Activities 

 Inspector Accompaniments 

Lisa Dimmick, FSME Team Leader in Training 

 Status of Materials Inspection Program 

 Compatibility Requirements 

Donna Janda, Region I Technical Quality of Inspections 

 Technical Quality of Incident and Allegation 

 Activities 

 Inspector Accompaniments 

Betsy Ullrich, Region I Technical Quality of Licensing Actions 

 Inspector Accompaniments 

Steve Mack, Arkansas Technical Quality of Licensing Actions 

Steve Poy, FSME Sealed Source and Device Evaluation Program 

 Technical Quality of Incident and Allegation 

 Activities 
APPENDIX B 

TENNESSEE ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML121010523 
 

 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: University of Tennessee Knoxville License No.: R-47005 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 12/1-4/09 Inspectors: AH, SH, BF 

File No.: 2 

Licensee: Horizon Medical Center License No.: R-22001 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/1/11 Inspector: GK 

File No.: 3 

Licensee: Cardinal Health License No.: R-79174 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/31/11 Inspector: AG 

File No.: 4 

Licensee: Music City Nuclear Pharmacy License No.: R-19245 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/1/09 Inspectors: GK, RH 

File No.: 5 

Licensee: Mountain States Health Alliance License No.: R-90005 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/26/11 Inspectors: SD, NM 

File No.: 6 

Licensee: Erlanger Health System Radiation Oncology License No.: R-33090 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 12/5/08 Inspector: SS 

File No.: 7 

Licensee: Le Bonheur Children’s Medical Center License No.: R-79172 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/23/11 Inspector: JP 

File No.: 8 

Licensee: Tennessee Equine Hospital License No.: R-94039 

Inspection Type: Initial, Announced Priority: 3 

Inspection Date: 2/25/10 Inspector: TB 
Tennessee Final IMPEP Report Page C.2

Inspection Casework Reviews 

File No.: 9 

Licensee: Vanderbilt University License No.: R-19021 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 5/10-12/11 Inspectors: GK, RH, PR, DB, JB 

File No.: 10 

Licensee: Vanderbilt University Medical Center License No.: R-19021 

Inspection Type: Special, Unannounced Priority: 2 

Inspection Date: 5/26/11 Inspector: GK 

File No.: 11 

Licensee: Fort Sanders Regional Gamma Knife Center License No.: R-47188 

Inspection Type: Initial, Special, Announced Priority: 2 

Inspection Date: 12/9/10 Inspector: RM 

File No.: 12 

Licensee: Fort Sanders Regional Gamma Knife Center License No.: R-47188 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/9/11 Inspector: RM 

File No.: 13 

Licensee: Duratek Services, Inc. License No.: R-73008 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 7/20-23/10 Inspectors: RM, JT 

File No.: 14 

Licensee: Studsvik Processing Facility, LLC License No.: R-86011 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 10/9-10/08 Inspectors: AH, JT, NM, BW 

File No.: 15 

Licensee: Cardinal Health 414, Inc. License No.: R-57025 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 1/31/11 Inspector: THG 

File No.: 16 

Licensee: UniTech Services Group, Inc. License No.: R-01086 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 9/2/09 Inspector: JM 

File No.: 17 

Licensee: NDC Infrared Engineering, Inc. License No.: CA-1451-19 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 2/15/12 Inspector: DS 
Tennessee Final IMPEP Report Page C.3

Inspection Casework Reviews 

File No.: 18 

Licensee: Hopewell Designs License No.: GA-1434-1 

Inspection Type: Special, Announced Priority: 5 

Inspection Date: 11/14/11 Inspector: SH 

File No.: 19 

Licensee: Norris Well Services, Inc. License No.: KY-201-251-40 

Inspection Type: Special, Announced Priority: 3 

Inspection Date: 3/18/10 Inspectors: SB, RM 

File No.: 20 

Licensee: Acuren Inspections, Inc. License No.: R-01006 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 4/11-12/11 Inspector: SH 

File No.: 21 

Licensee: Bionomics License No.: R-73021 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 7/21-25/11 Inspectors: NM, JT 

File No.: 22 

Licensee: Ivey Cooper License No.: R-33145 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 2/24/11 Inspector: SB 

File No.: 23 

Licensee: Microbac – Tri Cities Division License No.: R-90051 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 12/8/09 Inspector: JM 

File No.: 24 

Licensee: Team Industrial Services, Inc. License No.: R-79304 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 3/16/12 Inspector: GS 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: SE International License No.: R-51002 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 3/13/12 Inspector: RH 
Tennessee Final IMPEP Report Page C.4

Inspection Casework Reviews 

Accompaniment No.: 2 

Licensee: Lincoln Medical Center License No.: R-52002 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/14/12 Inspector: JB 

Comment: Inspector did not perform an effective exit meeting with licensee management. 

Accompaniment No.: 3 

Licensee: Dyersburg Regional Medical Center License No.: R-23002 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/15/12 Inspector: AG 

Accompaniment No.: 4 

Licensee: Team Industrial Services, Inc. License No.: R-74005 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 3/16/12 Inspector: GS 

Accompaniment No.: 5 

Licensee: AFCO NDE License No.: R-01092 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 2/23/12 Inspector: JM 

Accompaniment No.: 6 

Licensee: Canberra Industries, Inc. License No.: R-01013 

Inspection Type: Initial, Special, Unannounced Priority: 2 

Inspection Date: 2/22/12 Inspector: RM 

Accompaniment No.: 7 

Licensee: Chattanooga Imaging License No.: R-06017 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/10/12 Inspector: SS 

Accompaniment No.: 8 

Licensee: Eagle Testing License No.: R-33155 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 4/11/12 Inspector: CB 

Accompaniment No.: 9 

Licensee: IMPACT Services License No.: R-73024 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 4/2-6/12 Inspectors: SD, SH, DS 

.
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Saint Thomas Hospital License No.: R-19001 

Type of Action: Renewal Amendment No.: 155 

Date Issued: 12/2/08 License Reviewer: GB 

File No.: 2 

Licensee: Advanced Specialty Pharmacy License No.: R-47202 

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

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

File No.: 3 

Licensee: Applied Technical Services License No.: R-51004 

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

Date Issued: 3/20/09 License Reviewer: RP 

File No.: 4 

Licensee: Alstom Power License No.: R-33001 

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

Date Issued: 12/12/08 License Reviewer: RP 

Comment: Termination amendments are not issued, letter only. 

File No.: 5 

Licensee: MedActinium License No.: R-01098 

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

Date Issued: 4/20/10 License Reviewer: CA 

Comment: The licensee indicated that radioactive material had been shipped off-site for 

disposal; however, no receipt information was available in the file. 

File No.: 6 

Licensee: Baptist Riverside License No.: R-47014 

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

Date Issued: 3/24/09 License Reviewer: GB 

Comment: The licensee indicated that radioactive material (sources) had been shipped off-site 

for disposal; however, no receipt information was available in the file. 
Tennessee Final IMPEP Report Page D.2 

License Casework Reviews 

File No.: 7 

Licensee: Tennessee Equine Hospital License No.: R-94039 

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

Date Issued: 6/2/09 License Reviewer: RP 

File No.: 8 

Licensee: Mistras Group License No.: R-19001 

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

Date Issued: 4/16/10 License Reviewer: RP 

File No.: 9 

Licensee: Fort Sanders Regional Gamma Knife Center License No.: R-47188 

Type of Action: Renewal Amendment No.: 15 

Date Issued: 10/29/10 License Reviewer: RP 

File No.: 10 

Licensee: Professional Service Industries, Inc. License No.: R-79242 

Type of Action: Renewal Amendment No.: 12 

Date Issued: 2/22/10 License Reviewer: SK 

File No.: 11 

Licensee: Maury Regional Hospital License No.: R-60018 

Type of Action: Amendment Amendment No.: 20 

Date Issued: 9/26/11 License Reviewer: CA 

File No.: 12 

Licensee: Maury Regional Hospital License No.: R-60018 

Type of Action: Amendment Amendment No.: 21 

Date Issued: 10/11/11 License Reviewer: GB 

File No.: 13 

Licensee: Erlanger Health System License No.: R-33099 

Type of Action: Amendment Amendment No.: 52 

Date Issued: 6/9/11 License Reviewer: SK 

File No.: 14 

Licensee: Stern Cardiovascular Foundation License No.: R-79263 

Type of Action: Renewal Amendment No.: 18 

Date Issued: 3/8/12 License Reviewer: GB 

File No.: 15 

Licensee: Professional Engineers, Inc. License No.: R-47170 

Type of Action: Renewal Amendment No.: 6 

Date Issued: 10/23/09 License Reviewer: GB 
Tennessee Final IMPEP Report Page D.3 

License Casework Reviews 

File No.: 16 

Licensee: Centennial Heart, LLC License No.: R-19234 

Type of Action: Amendment Amendment No.: 13 

Date Issued: 1/14/09 License Reviewer: GB 

File No.: 17 

Licensee: World Testing, Inc. License No.: R-95009 

Type of Action: Amendment Amendment No.: 46 

Date Issued: 3/7/12 License Reviewer: GB 

File No.: 18 

Licensee: St. Jude Children’s Research Hospital License No.: R-79056 

Type of Action: Amendment Amendment No.: 121 

Date Issued: 2/10/09 License Reviewer: SK 

File No.: 19 

Licensee: Cognate BioServices, Inc. License No.: R-79275 

Type of Action: Amendment Amendment No.: 6 

Date Issued: 2/25/11 License Reviewer: SK 

File No.: 20 

Licensee: IMPACT Services, Inc. License No.: R-73024 

Type of Action: Amendment Amendment No.: 42 

Date Issued: 5/20/11 License Reviewer: CA 

File No.: 21 

Licensee: IMPACT Services, Inc. License No.: R-73024 

Type of Action: Amendment Amendment No.: 41 

Date Issued: 3/4/11 License Reviewer: CA 

File No.: 22 

Licensee: IMPACT Services, Inc. License No.: R-73024 

Type of Action: Amendment Amendment No.: 40 

Date Issued: 3/4/11 License Reviewer: CA 

File No.: 23 

Licensee: Duratek Services, Inc. License No.: R-73016 

Type of Action: Amendment Amendment No.: 96 

Date Issued: 10/11/11 License Reviewer: CA 

File No.: 24 

Licensee: Duratek Services, Inc. License No.: R-73016 

Type of Action: Amendment Amendment No.: 88 

Date Issued: 5/15/08 License Reviewer: CA 
Tennessee Final IMPEP Report Page D.4 

License Casework Reviews 

File No.: 25 

Licensee: Philotechnics, Ltd. License No.: R-01084 

Type of Action: Amendment Amendment No.: 23 

Date Issued: 2/17/12 License Reviewer: CA 

File No.: 26 

Licensee: Diversified Scientific Services, Inc. License No.: R-73014 

Type of Action: Amendment Amendment No.: 96 

Date Issued: 8/14/09 License Reviewer: CA 

Comment: The emergency preparedness plan required by regulation was referenced by the 

licensee in the amendment but the plan was not in the current license file. The plan was found 

in a folder labeled “superseded” with other documents that were replaced during a renewal that 

preceded this review period. 

File No.: 27 

Licensee: ATG Catalytics, Inc. License No.: R-73020 

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

Date Issued: 7/17/08 License Reviewer: CA 

File No.: 28 

Licensee: East Tennessee Materials and Energy Corporation License No.: R-01088 

Type of Action: Renewal Amendment No.: 49 

Date Issued: 9/18/09 License Reviewer: CA 

File No.: 29 

Licensee: East Tennessee Materials and Energy Corporation License No.: R-01088 

Type of Action: Amendment Amendment No.: 53 

Date Issued: 11/30/10 License Reviewer: CA 

Comment: Unlabeled computer disc with potentially sensitive information in current license file. 

File No.: 30 

Licensee: University of Memphis License No.: R-79315 

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

Date Issued: 4/1/11 License Reviewer: SK 

File No.: 31 

Licensee: University of Tennessee - Knoxville License No.: R-47005 

Type of Action: Renewal Amendment No.: 80 

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

File No.: 32 

Licensee: Ameriphysics License No.: R-47205 

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

Date Issued: 3/4/09 License Reviewer: RP 
Tennessee Final IMPEP Report Page D.5 

License Casework Reviews 

File No.: 33 

Licensee: Manufacturing Sciences Corporation License No.: S-01046 

Type of Action: Renewal Amendment No.: 89 

Date Issued: 2/1/11 License Reviewer: CA 

File No.: 34 

Licensee: Cardinal Health, LLC License No.: R-47211 

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

Date Issued: 7/26/11 License Reviewer: SK 

File No.: 35 

Licensee: Aerojet Ordnance Tennessee License No.: S-90009 

Type of Action: Amendment Amendment No.: 155 

Date Issued: 12/15/11 License Reviewer: RP 

File No.: 36 

Licensee: Aerojet Ordnance Tennessee License No.: S-90009 

Type of Action: Renewal Amendment No.: 154 

Date Issued: 10/28/11 License Reviewer: RP 

File No.: 37 

Licensee: Midtown Animal, LLC License No.: R-79311 

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

Date Issued: 6/11/09 License Reviewer: SK 

File No.: 38 

Licensee: MediPhysics, Inc. License No.: R-79249 

Type of Action: Amendment Amendment No.: 39 

Date Issued: 11/12/10 License Reviewer: RP 

File No.: 39 

Licensee: Teledyne Brown Engineering, Inc. License No.: R-47173 

Type of Action: Amendment Amendment No.: 12 

Date Issued: 8/19/10 License Reviewer: RP 

File No.: 40 

Licensee: Erlanger Medical Center License No.: R-33008 

Type of Action: Amendment Amendment No.: 98 

Date Issued: 8/2/11 License Reviewer: GB 

File No.: 41 

Licensee: Mid Continent Laboratories, Inc. License No.: R-79219 

Type of Action: Renewal Amendment No.: 18 

Date Issued: 9/24/09 License Reviewer: GB 
Tennessee Final IMPEP Report Page D.6 

License Casework Reviews 

File No.: 42 

Licensee: Nucor Steel Memphis, Inc. License No.: R-79303 

Type of Action: Amendment Amendment No.: 1 

Date Issued: 2/24/09 License Reviewer: GB 

File No.: 43 

Licensee: American Red Cross Blood Services License No.: R-19180 

Type of Action: Amendment Amendment No.: 16 

Date Issued: 1/29/10 License Reviewer: CA 
 

APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Studsvik License No.: R-79273 

Date of Incident: 1/23/09 NMED No.: 120258 

Investigation Date: 1/23/09 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

Comment: Incident not reported to the NRC Headquarters Operations Center. [Note: reported 

to NRC HOC on 4/30/12] 

File No.: 2 

Licensee: Impact Services, Inc. License No.: R-73024 

Date of Incident: 5/11/09 NMED No.: N/A 

Investigation Date: 5/11/09 Type of Incident: RAM Release 

 Type of Investigation: Site 

Comment: Incident not reported to NMED. [Note: reported to NMED on 5/1/12] 

File No.: 3 

Licensee: Saint Thomas Hospital License No.: R-19190 

Date of Incident: 8/10/09 NMED No.: 120151 

Investigation Date: 9/1/09 Type of Incident: Contamination 

 Type of Investigation: Telephone 

Comment: Incident reported late to NMED, in 2012. 

File No.: 4 

Licensee: Bionomics, Inc. License No.: R-73021 

Date of Incident: 12/9/09 NMED No.: 090878 

Investigation Date: 12/15/09 Type of Incident: Contamination 

 Type of Investigation: Site 

File No.: 5 

Licensee: Cookeville Regional Medical Center License No.: R-71026 

Date of Incident: 12/15/09 NMED No.: 090885 

Investigation Date: 12/15/09 Type of Incident: Medical Event 

 Type of Investigation: Telephone 
Tennessee Final IMPEP Report Page E.2 

Incident Casework Reviews 

File No.: 6 

Licensee: Eastman Chemical Company License No.: R-82007 

Date of Incident: 1/19/10 NMED No.: 120152 

Investigation Date: 1/19/10 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

Comment: Incident reported late to NMED, in 2012. 

File No.: 7 

Licensee: Professional Service Industries License No.: R-19014 

Date of Incident: 3/5/10 NMED No.: 120164 

Investigation Date: 3/17/10 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

Comment: Incident reported late to NMED, in 2012. 

File No.: 8 

Licensee: AFCO NDE License No.: R-01092 

Date of Incident: 3/15/10 NMED No.: 120163 

Investigation Date: 3/19/10 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

Comment: Incident reported late to NMED, in 2012. 

File No.: 9 

Licensee: Construction Materials Laboratory License No.: R-47079 

Date of Incident: 5/4/10 NMED No.: 120169 

Investigation Date: 5/5/10 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

Comment: Incident reported late to NMED, in 2012. 

File No.: 10 

Licensee: Saint Thomas Hospital License No.: R-19190 

Date of Incident: 5/22/10 NMED No.: 120174 

Investigation Date: 5/22/10 Type of Incident: Contamination 

 Type of Investigation: Site 

Comment: Incident reported late to NMED, in 2012. 

File No.: 11 

Licensee: Federal Express License No.: Non-licensee 

Date of Incident: 11/23/10 NMED No.: 110101 

Investigation Date: 11/23/10 Type of Incident: Lost/Stolen RAM 

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

Incident Casework Reviews 

File No.: 12 

Licensee: Eberline Services License No.: R-01063 

Date of Incident: 1/12/11 NMED No.: N/A 

Investigation Date: 1/13/11 Type of Incident: RAM Release 

 Type of Investigation: Site 

File No.: 13 

Licensee: K & S Associates, Inc. License No.: R-19075 

Date of Incident: 1/18/11 NMED No.: 120279 

Investigation Date: 1/24/11 Type of Incident: Leaking Source 

 Type of Investigation: Site 

Comment: Incident not reported to the NRC Headquarters Operations Center or to NMED. 

[Note: reported to NRC HOC on 4/30/12 and subsequently to NMED] 

File No.: 14 

Licensee: World Testing License No.: R-95009 

Date of Incident: 3/3/11 NMED No.: 120171 

Investigation Date: 3/4/11 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

Comment: Incident was not reported to the NRC Headquarters Operations Center and was 

reported late to NMED, in 2012. [Note: reported to NRC HOC on 4/30/12] 

File No.: 15 

Licensee: University of Tennessee-Knoxville License No.: R-47005 

Date of Incident: 3/22/11 NMED No.: 120298 

Investigation Date: 3/23/11 Type of Incident: Contamination 

 Type of Investigation: Telephone 

Comment: Incident was not reported to NMED. [Note: reported to NMED on 5/1/12] 

File No.: 16 

Licensee: St. Jude Children’s Research Hospital License No.: R-79037 

Date of Incident: 5/17/11 NMED No.: N/A 

Investigation Date: 5/18/11 Type of Incident: Equipment Failure 

 Type of Investigation: Telephone 
 

APPENDIX F 

SEALED SOURCE AND DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Registry No.: TN-1031-D-119-B SS&D Type: Gamma Density Gauge 

Applicant Name: Berthold Technologies Type of Action: New 

Date Issued: 7/30/08 SS&D Reviewers: CA, JG 

Comment: The registration indicates that it is possible to lock the shutter of the device in the 

open position. The ability to lock the shutter in the open position should be better clarified within 

the certificate, including the safety aspects of this practice. 

File No.: 2 

Registry No.: TN-0799-D-102-B SS&D Type: Density Gauge 

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

Date Issued: 9/15/08 SS&D Reviewers: RP, CA 

Comment: Isotope labels on the device radiation profiles were transposed. 

File No.: 3 

Registry No.: TN-1031-S-110-S SS&D Type: Gamma Source 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 1/26/09 SS&D Reviewers: RP, CA 

File No.: 4 

Registry No.: TN-1031-D-104-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 3/11/09 SS&D Reviewers: CA, JG 

File No.: 5 

Registry No.: TN-1031-D-101-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 5/6/09 SS&D Reviewers: CA, JG 

File No.: 6 

Registry No.: TN-1031-D-109-S SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 12/2/09 SS&D Reviewers: RP, CA 

File No.: 7 

Registry No.: TN-1031-D-101-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 10/14/10 SS&D Reviewers: GB, RP 
Tennessee Final IMPEP Report Page F.2 

Sealed Source and Device Casework Reviews 

File No.: 8 

Registry No.: TN-1031-D-119-B SS&D Type: Gamma Density Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 11/15/10 SS&D Reviewers: CA, JG 

File No.: 9 

Registry No.: TN-1031-D-104-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 3/1/11 SS&D Reviewers: CA, JG 

File No.: 10 

Registry No.: TN-1031-D-113-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 5/9/11 SS&D Reviewers: RP, CA 

File No.: 11 

Registry No.: TN-1031-D-114-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 5/9/11 SS&D Reviewers: RP, CA 

File No.: 12 

Registry No.: TN-0237-S-103-S SS&D Type: Medical Reference Source 

Applicant Name: Siemens Medical Solutions Type of Action: Amendment 

Date Issued: 8/12/11 SS&D Reviewers: SK, RP 

Comments: 

a) The principle use code for this device should have been “(X) Medical Reference Source” 

rather than “Instrument Calibration and Transmission Determinations.” 

b) The radiation profile, using non-standard isodose lines, was for a 1.5 mCi Ge-68 source, 

much less than the maximum activity of 10 mCi. 

c) The expected useful life of the source was not obtained or otherwise indicated on the 

registration certificate. 

d) These corrections were suggested during the previous IMPEP review. 

File No.: 13 

Registry No.: TN-1031-S-120-S SS&D Type: Gamma Source 

Applicant Name: Berthold Technologies Type of Action: New 

Date Issued: 9/1/11 SS&D Reviewers: RP, CA 
Tennessee Final IMPEP Report Page F.3 

Sealed Source and Device Casework Reviews 

File No.: 14 

Registry No.: TN-1031-D-101-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 10/3/11 SS&D Reviewers: RP, CA 

Comments: 

a) The registration indicates that it is possible to lock the shutter of the device in the open 

position. The ability to lock the shutter in the open position should be better clarified 

within the certificate, including the safety aspects of this practice. 

b) Information on the length of the expected working life of the device and supporting 

testing information was not requested in the review process. 

File No.: 15 

Registry No.: TN-1031-D-104-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 10/3/11 SS&D Reviewers: RP, CA 

Comment: Information on the length of the expected working life of the device and supporting 

testing information was not requested in the review process. 

File No.: 16 

Registry No.: TN-1031-D-119-B SS&D Type: Gamma Density Gauge 

Applicant Name: Berthold Technologies Type of Action: Amendment 

Date Issued: 10/3/11 SS&D Reviewers: RP, CA 
 

ATTACHMENT(S) 

June 18, 2012 Letter from Shari Meghreblian, Ph.D 

Tennessee’s Response to the Draft Report 

ADAMS Accession No.: ML12171A287