November 21, 2008 

William D. Hacker, M.D. 

Commissioner 

Cabinet for Health and Family Services 

Department for Public Health 

275 East Main Street 

Frankfort, KY 40621-0001 

Dear Dr. Hacker: 

On October 28, 2008, the Management Review Board (MRB) met to consider the proposed final 

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

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

to protect public health and safety, but needs improvement, and compatible with the U.S. 

Nuclear Regulatory Commission=s (NRC) program. The MRB requested that the period of 

monitoring of the Kentucky Agreement State Program continue. Monitoring is an informal 

process that allows NRC to maintain an increased level of communication with an Agreement 

State program. As part of the Monitoring process, NRC will conduct quarterly calls with the 

appropriate representatives from the Kentucky Radiation Health Branch. 

Section 5.0, page 21 of the enclosed final report contains a summary of the IMPEP review 

team=s findings and recommendations. We request your evaluation and response to the 

recommendations within 30 days from receipt of this letter. Based on the results of the current 

IMPEP review, NRC will conduct a periodic meeting with the Kentucky Agreement State 

Program approximately 1 year from the date of review. During this meeting, NRC will assess 

the Commonwealth’s progress in addressing the review team’s recommendations. 

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

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/ 

Martin J. Virgilio 

Deputy Executive Director for Materials, Waste, 

Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

Kentucky Final IMPEP Report 

cc w/encl.: See next page 
W. Hacker - 2 -

cc w/encl.: Dewey Crawford, Manager 

 Kentucky Radiation Health Branch 

 Matthew McKinley, Supervisor 

 Kentucky Radioactive Materials Section 

 Thomas Conley, Kansas 

 Organization of Agreement States 

 Liaison to the MRB 
W. Hacker -2- 

cc w/encl.: Dewey Crawford, Manager 

 Kentucky Radiation Health Branch 

 Matthew McKinley, Supervisor 

 Kentucky Radioactive Materials Section 

 Thomas Conley, Kansas 

 Organization of Agreement States 

 Liaison to the MRB 

DISTRIBUTION: EDATS: FSME-2008-0055 

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RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Klein 

KSchneider, FSME/DMSSA Commissioner Jaczko 

KLukes, FSME/DMSSA Commissioner Lyons 

JKottan, RI/RSAO Commissioner Svinicki 

RMunoz, RIV SECY 

Michael Stephens, FL 

MOrendi, FSME/DMSSA 

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MSatorius, RIII 

APowell, OCA (2 copies) 

 

ADAMS ACCESSION NO.: ML083100878 

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

NAME ATMcCraw:knm1 ADWhite RJLewis CPoland (PTressler 

for) 

DATE 11/ 7/08 11/7/08 11/13/08 11/14/08 

OFFICE FSME DEDMRT 

NAME CLMiller MVirgilio 

DATE 11/14/08 11/20/08 

OFFICIAL RECORD COPY
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE KENTUCKY AGREEMENT STATE PROGRAM 

July 28-August 1, 2008 

FINAL REPORT
Kentucky Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Kentucky Agreement State Program. 

The review was conducted during the period of July 28 - August 1, 2008, by a review team 

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

the State of Florida. Team members are identified in Appendix A. The review was conducted in 

accordance with the “Implementation of the Integrated Materials Performance Evaluation 

Program and Rescission of Final General Statement of Policy,” published in the Federal 

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

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

review, which covered the period of July 24, 2004, to August 1, 2008, were discussed with 

Kentucky managers on the last day of the review. 

The review team issued a draft of this report to Kentucky for factual comment on August 28, 

2008. The Commonwealth responded via letter from Dr. William D. Hacker, Commissioner, 

Department for Public Health (the Department), on October 6, 2008. A copy of the 

Commonwealth’s response is included as the attachment to this report. The Management 

Review Board (MRB) met on October 28, 2008, to consider the proposed final report. The MRB 

found the Kentucky Agreement State Program adequate to protect public health and safety, but 

needs improvement, and compatible with NRC’s program. The MRB requested that the period 

of monitoring of the Kentucky Agreement State Program continue. 

The Kentucky Agreement State Program is administered by the Radiation Health Branch (the 

Branch). The Radioactive Materials Section (the Section), the Radiation Producing Machines 

Section, and the Radiation/Environmental Monitoring Section comprise the Branch. The Branch 

is part of the Division of Public Health Protection and Safety within the Department. The 

Department is part of the Cabinet for Health and Family Services (the Cabinet). Organization 

charts for the Branch and Section are included in Appendix B. 

At the time of the review, the Kentucky Agreement State Program regulated 446 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 the NRC and the Commonwealth 

of Kentucky. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Branch on March 20, 2008. The Branch 

provided its response to the questionnaire on July 11, 2008, with a revised response provided 

on August 8, 2008. A copy of the questionnaire response can be found in the NRC’s 

Agencywide Documents Access and Management System (ADAMS) using the Accession 

Number ML082240074. 

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

Kentucky’s response to the questionnaire; (2) review of applicable Kentucky statutes and 

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

review of selected regulatory actions; (5) field accompaniments of eight inspectors; and (6) 

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

against the established criteria for each common and applicable non-common performance 
Kentucky Final Report Page 2 

indicator and made a preliminary assessment of the Kentucky Agreement State Program’s 

performance. 

Section 2.0 of this report covers the Commonwealth’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 non-common performance indicators, and Section 5.0 summarizes the review team's 

findings. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, covering the period of July 22, 2000, to July 23, 2004, the 

review team made seven recommendations regarding program performance. The current 

status of the recommendations is as follows: 

1. The review team recommends that the Branch upgrade their database so that all 

relevant licensee data are incorporated and maintained to ensure that inspections can 

be scheduled and performed in accordance with the requirements of Inspection Manual 

Chapter (IMC) 2800, “Materials Inspection Program” (Section 3.2 of the 2004 IMPEP 

report). 

Current Status: The Branch identified a database limitation in which all new licenses 

were automatically assigned an initial inspection due date based on its inspection 

interval instead of 12 months after license issuance, as prescribed by IMC 2800. The 

Branch addressed this limitation by manually entering the initial inspection due date 

upon initial entry of the license into the existing database. This process allows for the 

Branch to manually alter dates, if needed, based on the actual timing of the issuance of 

the license. To ensure the accuracy of tracking inspection and licensing data, the 

Branch performs an audit of all tracking logs and the database through a monthly 

review by the Radioactive Materials Section Supervisor (the Section Supervisor) and 

subsequently, by the Branch Manager via a monthly report. This recommendation is 

closed. 

2. The review team recommends that the Branch identify those licensees who require 

financial assurance and take appropriate action to have them comply with the 

Commonwealth’s decommissioning and financial assurance requirements (Section 3.4 

of the 2004 IMPEP report). 

Current Status: The Branch has completed a review of its licenses, identified the 

licensees who require financial assurance, and took appropriate action. This 

recommendation is closed. 

3. The review team recommends that the Branch document incident and allegation 

responses in accordance with its procedures and provide training on their procedures 

to all technical staff (Section 3.5 of the 2004 IMPEP report).; 

Current Status: The Branch has a centralized binder that includes Kentucky’s policy 

and guidance, as well as NRC guidance: Nuclear Materials Events Database (NMED) 
Kentucky Final Report Page 3 

instructions: and other information pertinent to incident and allegation administration. 

The information and procedures included in the binder, along with a review of past 

incidents and allegations, are reviewed by all staff annually. The review team noted 

that, in some cases, the supervisory sign off indicating completion of annual training 

was limited. The Branch also identifies a specific Radiation Health Specialist to ensure 

all events are appropriately documented and addressed in accordance with all 

available guidance, on an annual basis. The Section Supervisor reviews this process 

monthly to verify compliance. This recommendation is closed. 

4. The review team recommends that the Branch establish, implement, and document a 

training program for Sealed Source and Device (SS&D) reviewers (Section 4.2.1 of the 

2004 IMPEP report). 

Current Status: The Branch has expended substantial effort in improving the Kentucky 

Agreement State Program, including the SS&D program. In particular, 0.5 full-time 

equivalents (FTE) were dedicated to managing the SS&D program. The primary SS&D 

reviewer, the Section Supervisor, and several additional staff have attended the NRC 

SS&D Workshop, inactivated registries, addressed amendment requests, and performed 

new device reviews. Additionally, the Commonwealth contracted a consulting company 

to provide a comprehensive 1-week SS&D training course to the Section staff. This 

recommendation is closed. 

5. The review team recommends that the registration certificate evaluation criteria and 

document format be consistent with NUREG-1556, Volume 3, “Consolidated Guidance 

About Materials Licenses – Applications for Sealed Source and Device Evaluation and 

Registration” (Section 4.2.2 of the 2004 IMPEP report). 

Current Status: The Branch utilizes NUREG-1556, Volume 3, Revision 1 for all SS&D 

evaluations. This recommendation is closed. 

6. The review team recommends that the Branch review and determine the status of SS&D 

registrations issued to non-Kentucky manufacturers and take appropriate action to either 

update or inactivate the registration certificates (Section 4.2.2 of the 2004 IMPEP 

report). 

Current Status: The Branch inactivated non-Kentucky and outdated registries to the 

extent practical. This recommendation is closed. 

7. The review team recommends that the Branch implement an enforceable mechanism 

(e.g., rule or license condition) to have the manufacturers report defects, deviations or 

non-conformance of safety-related systems, structures, or components and document 

followup actions (Section 4.2.3 of the 2004 IMPEP report). 

Current Status: The Branch added a license condition to its sole manufacturer’s license 

to require reporting of defects, deviations, or non-conformances of safety-related 

systems, structures, or components and documentation of followup actions. This 

recommendation is closed. 
Kentucky Final Report Page 4 

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 program’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 Branch’s questionnaire response relative to this 

indicator, interviewed Branch management and staff, reviewed job descriptions and training 

records, and considered any possible workload backlogs. 

The Branch is located in the Department for Public Health offices in Frankfort. There are no 

field offices. The Branch Manager is responsible for the Section, the Radiation Producing 

Machines Section, and the Radiation/Environmental Monitoring Section. The Section 

Supervisor is primarily responsible for materials licensing and compliance activities. The 

Branch has 9.0 FTE dedicated to the Agreement State program. 

The performance weaknesses and the complete staff turnover that were identified during the 

previous IMPEP review period served as a basis for management’s focused attention on filling 

positions with qualified and motivated staff. During the review period, the Radiation Producing 

Machines Section Supervisor from the previous review period received a promotion as the new 

Branch Manager, which became a vacant position after the resignation of the previous Branch 

Manager. Three additional staff left the Section during the review period; however, two of those 

individuals left the Section due to promotional opportunities, one of which was within the 

Branch. One additional Section staff member was deployed with the National Guard for a 

period of time, but has since returned to his position in the Section. To address the vacancies 

within the Section during the review period, six technical staff members were hired. 

Additionally, in 2007, a consultant (approximately 0.6 FTE) was contracted to assist in preparing 

necessary regulation changes in order to maintain compatibility with NRC. At the time of the 

review, the Section was fully staffed. 

The technical staff members are classified as Radiation Health (RH) Specialists. Currently, RH 

II is the entry/junior level, and RH III is the senior level. Minimum qualifications for an RH II 

position include a bachelor’s degree, certification, or year-for-year equivalent experience in the 

physical sciences. The review team did not identify any performance issues that could be 

related to a lack of a formal degree. 

The Branch has a documented training and qualification program for licensing and inspection 

staff that is consistent with the NRC and Organization of Agreement States Training Working 

Group Recommendations for Agreement State Training Programs. Qualification is established 

through a combination of education and experience, and formal classroom, in-house, and onthe-job training. The Section considers both attendance at NRC-sponsored courses and 

alternate resources for training. 
Kentucky Final Report Page 5 

The review team observed that Branch management exhibited a strong commitment to training. 

The Section maintains a training and qualification binder with a signoff qualification record for 

each technical staff member and the Section Supervisor. Staff members must complete each 

module and receive management signoff on the qualification record prior to being authorized to 

independently perform the tasks associated with that module. In an effort to obtain qualification 

in a particular modality, staff members review licenses and conduct inspections under the 

direction and supervision of an experienced and qualified license reviewer and inspector. The 

Section heavily focuses on the completion of this on-the-job training in order for the Section 

Supervisor to certify and document that an individual is qualified as both a license reviewer and 

inspector in a particular modality. Usually, training begins with licensing activities, and then 

proceeds to inspection activities when the individual’s licensing knowledge is demonstrated as 

adequate. The review team observed that all current staff members have met the qualification 

requirements in at least one modality. The review team also discussed with the Section 

Supervisor a formalized program the Branch has in place, in which staff and managers are 

assigned to various collateral duties within the Branch on an annual basis. These collateral 

duties are essential in ensuring that various administrative functions, such as maintaining staff 

training and qualification records, within the Branch are kept up to date and organized. Through 

the annual rotation of collateral duty assignments among the staff, the staff is able to be a more 

integral part of the administrative functions of the Branch. The review team concluded that the 

Section’s staffing and training is adequate to carry out its regulatory duties. 

The Branch does not have dedicated revenue from licensee fees. Licensee fees are deposited 

in a general fund: a portion of which is appropriated back to the Branch. The last fee increase 

occurred during the last review period in 2003. 

The Commonwealth of Kentucky does not have a radiation advisory board. 

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

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

satisfactory. 

3.2 Status of Materials Inspection Program

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

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

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

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

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

Section Supervisor and staff. 

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

are generally the same as those prescribed by IMC 2800. There are some categories of 

licenses that the Branch inspects more frequently, including: private practice medical, broad 

medical, nuclear pharmacy, and portable gauge licenses. These reduced inspection intervals 

are assigned to activities the Branch has determined to be of higher risk, or for licensees who 

have demonstrated poor performance. 
Kentucky Final Report Page 6 

In its initial response to the questionnaire, the Branch indicated that there were no high priority 

(Priority 1, 2, and 3), initial, or Increased Controls licenses currently overdue by more than 25 

percent of the inspection priorities prescribed by IMC 2800. With the exception of the Increased 

Controls inspections, this information was verified during the review of the inspection casework, 

database printouts, and administrative controls put in place by the Section Supervisor. The 

review team identified 64 of the 213 Priority 1, 2, and 3 and initial inspections the Branch 

completed during the review period as performed overdue. The review team calculated the 

Branch performed approximately 30 percent of the inspections overdue. The review team found 

that during the previous IMPEP review, the number of core inspections reported was incorrect 

due to the fact that the calculation included all licenses inspected. In 2004, the Branch 

appeared to exceed the 25 percent metric of inspections performed overdue or were presently 

overdue, not the 9.6 percent calculation as noted in the report. The Branch expended 

considerable effort in completing all overdue inspections from the 2004 review period and 

managed the backlog during this review period in order to achieve no overdue Priority 1, 2, and 

3, and initial inspections at the time of this review. The Section Supervisor maintains 

supplemental database information to verify the Department’s database for accurate inspection 

information. With the Branch fully staffed and trained and the inspection schedules maintained 

by the Section Supervisor, the review team believes that the Branch is in the position to 

maintain this level of performance for future inspections. 

The review team determined that the Branch had 19 licensees subject to the Increased 

Controls, which are additional security requirements. At the time of the review, the Branch had 

conducted 12 inspections and 24 visits to these 19 licensees. The Branch did not develop and 

implement a documented and auditable prioritization methodology for ranking licensees for 

inspections of the Increased Controls, as requested in the 2006 NRC guidance for implementing 

the Increased Controls. Branch management interpreted the guidance to mean that the Branch 

had 3 years to verify that Increased Controls licensees were fully compliant, consistent with the 

requirement that all initial Increased Controls inspections should be completed within 3 years 

from the date of implementation of the controls. The review team noted that Branch inspection 

staff visited all of the Increased Controls licensees at least once since the issuance of the 

Increased Controls. During the visits, Branch inspection staff reviewed all applicable aspects of 

the Increased Controls requirements; however, due to database limitations with assigning 

multiple inspection due dates to one licensee, the inspection staff was unable to properly 

document the visits as inspections. Because the visits could not be properly documented as 

inspections in the database, the Branch had to use a less reliable mechanism to followup on 

and enforce violations that the inspectors identified during the visits. At the time of the review, 

the Branch had not officially performed initial inspections of seven Increased Controls licensees. 

On August 25, 2008, the review team was notified that the remaining seven initial Increased 

Control inspections were completed and appropriately documented. 

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

The Branch’s procedures require that inspection findings be issued to the licensee within 

30 days of the date of the inspection. Of the 30 health and safety inspection files reviewed, 

7 inspection findings were issued to the licensee beyond the 30 days ranging from several days 

to 4 months. The three inspection findings issued 2, 3, and 4 months late had significant 

violations identified, and the Section Supervisor was aware of the delays. Of the 12 initial 

Increased Control inspections conducted, 9 inspection findings were issued within 30 days; 

however, 3 inspection findings, ranging from 1.5 to 13 months, had not been issued at the time 
Kentucky Final Report Page 7 

of the on-site portion of the IMPEP review. The Section Supervisor informed the review team 

that the inspection findings were issued on August 1, 2008. 

During the review period, the Branch granted 187 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 met the criterion of inspecting at least 20 percent of candidate reciprocity 

licensees, as prescribed by IMC 1220, in each of the three years prior to 2008. For 2008, the 

Branch inspected 15 percent of the candidate reciprocity licensees as of July 1, 2008. 

Based on the criteria in Management Directive 5.6, the review team considered a finding of 

unsatisfactory because of the high percentage of inspections that the Branch performed 

overdue during the review period. The review team determined that the overdue inspections 

were a legacy issue and that the Branch expended considerable effort during the review period 

to eliminate the backlog. The review team concluded that the Branch’s considerable efforts to 

eliminate the inspection backlog, the efforts to complete the Increased Controls inspections, and 

the performance of reciprocity inspections was justification for a finding of satisfactory, but 

needs improvement. 

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

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

Program, was satisfactory, but needs improvement. 

3.3 Technical Quality of Inspections

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

notes and interviewed the responsible inspectors for 41 radioactive materials inspections 

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

inspections conducted by all eight current inspectors and covered a wide variety of inspection 

types. These included academic broadscope, medical broadscope, medical institutions, nuclear 

cardiology, nuclear pharmacy, gamma knife, brachytherapy, self-shielded blood irradiators, 

industrial radiography, service provider, positron emission tomography, well logging, portable 

gauges, fixed gauges, manufacturers, and reciprocity licensees. Appendix C lists the inspection 

casework files reviewed and includes case-specific comments. 

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

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

reports were generally thorough, complete, and consistent, with sufficient documentation to 

support that the licensees’ performances with respect to health, safety, and security were 

acceptable. In general, inspection report documentation supported violations and 

recommendations made to licensees. The review team found that routine inspections 

adequately covered each licensee's radiation protection program; included a written summary of 

the scope of the licensed activities; and categorized violations into severity levels, which can 

later be used for escalated enforcement, if necessary. The documentation adequately 

supported the cited violations. 
Kentucky Final Report Page 8 

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

2800. The Branch requires licensees to respond to any violation within 30 days of issuance of a 

Notice of Violation. All responses are reviewed for adequacy by the inspector. In several of the 

casework files reviewed, the inspection field notes did not document the closure of previous 

violations. The review team recommends that the Commonwealth revise its inspection 

procedures to require documentation of the closure of any previous violation, verification of 

corrective actions, and evaluation of preventive measures implemented by the licensee both in 

the inspection documentation and during the exit with the licensee. 

The review team determined that documents involving Increased Controls inspections were 

protected, segregated from the electronic file storage system, and maintained in a locked file 

cabinet with limited access. Files were kept in visually distinct folders, identifying the 19 

licensees subject to the Increased Controls. The review team determined that documents were 

sufficiently marked as sensitive information to be withheld from public disclosure. 

As part of the preparation of the initial site visit to a licensee’s facility, the inspector would 

suggest that the licensee invite the respective local law enforcement agency’s representative to 

attend the initial on-site visit. The review team observed this practice during the inspector 

accompaniments and determined it was very productive in communicating the intent and 

clarifying the requirements of the Increased Controls between the licensee and local law 

enforcement agency. This practice would be particularly beneficial to new licensees that meet 

the criteria for implementing the Increased Controls. The review team recommended, and the 

MRB agreed, that the Branch’s practice of requesting that the licensees extend an invitation to 

the local law enforcement agency during initial on-site visits/inspections for Increased Controls 

is a good practice. 

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 response events. Each inspector is assigned a 

calibrated dual function (Geiger-Mueller and micro-R) survey meter that is carried with them at 

all times to facilitate a rapid response in emergency situations. The meters are calibrated by the 

manufacturer or a properly licensed facility. The Branch includes the Radiation/Environmental 

Monitoring Section, which maintains a well-equipped and adequately staffed analytical 

laboratory. The laboratory has broad analytical capability including liquid scintillation counters, 

gas proportional counters, intrinsic germanium detectors, multichannel analyzers, alpha 

spectroscopy, and radiochemistry. The laboratory is capable of analyzing a broad range of 

environmental media. 

The Branch performs staff accompaniments annually. Due to the hiring of new staff in Calendar 

Years 2005 and 2006, annual accompaniments did not occur during the training period for the 

new inspectors. The Section Supervisor conducted formal, announced accompaniments of all 

radioactive materials inspectors in Calendar Years 2007 and 2008. The Section Supervisor 

indicated that the inspector accompaniments will continue on a routine basis. 

The review team accompanied all of the Branch’s radioactive materials inspectors during the 

weeks of May 12, 2008 and June 9, 2008, at a hospital, a nuclear pharmacy, an industrial 

radiography jobsite, facilities with portable and fixed gauges, and a facility using a self-shielded 

irradiator. Appendix C lists the inspector accompaniments and includes observations. During 
Kentucky Final Report Page 9 

the accompaniments, the review team noted that the inspectors demonstrated appropriate 

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

safety, and security at the licensed facilities. 

The inspectors held entrance and exit meetings with the appropriate level of licensee 

management. During the accompaniments, the review team noted that the inspectors did not 

discuss previous inspection findings and the licensees’ corrective actions with the licensees 

during the entrance or exit meetings. The review team also observed that inspectors do not 

communicate any potential violations to the licensees at the exit meetings. Discussions with the 

Section Supervisor and staff revealed that it is standard practice not to communicate to the 

licensee whether the inspection findings during an inspection are actual violations or potential 

violations during the exit meeting. The Section does not contact the licensee before the 

issuance of the final Notice of Violation. The review team recommends that the Commonwealth 

discuss previous inspection findings, corrective actions, and any violations with the licensee 

during inspections. 

Although each inspector is provided an appropriate, calibrated radiological survey instrument, 

the review team noted that, on several accompaniments, the inspectors used the licensees’ 

radiological survey instruments to perform independent confirmatory surveys. The review team 

recommends that the Commonwealth use its own calibrated radiological survey equipment to 

perform independent confirmatory surveys during inspections. 

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

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

satisfactory, but needs improvement. 

3.4 Technical Quality of Licensing Actions

The review team interviewed license reviewers, evaluated the licensing process, and examined 

the licensing casework for 16 specific licenses, which included 32 licensing actions. Licensing 

actions were reviewed for completeness, consistency, proper possession authorizations, 

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, prelicensing 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 1 new 

license, 4 renewals, 25 amendments, and 2 license terminations. Files reviewed included a 

cross-section of license types, including: medical diagnostic and therapy, brachytherapy, 

gamma knife, industrial radiography, nuclear pharmacies, manufacturing and distribution, and 

academic and industrial broadscope. The casework sample represented work from each of the 
Kentucky Final Report Page 10 

license reviewers. A listing of the licensing casework reviewed, with case-specific comments, 

can be found in Appendix D. 

Licensing actions are assigned to one of the Branch’s radioactive materials license reviewers. 

Once the reviewer completes the action, the action undergoes a peer review, a management 

review by the Section Supervisor, and then the license is signed by the Branch Manager. The 

license reviewers and Section Supervisor do not have signatory authority for licensing actions. 

Licensing checklists are used for each type of program and are included in the license file. The 

status of licensing actions is tracked using a log book. The Branch generates licenses and 

correspondence with standardized conditions and formats using program codes listed in a 

Department database. The use of the current database to generate licensing actions permits 

errors to enter the license documents when unique licensing types, sealed sources models, or 

license conditions are needed. The Branch utilizes appropriate licensing guides, standard 

licensing conditions, and issues a complete license for each licensing action. Overall, the 

review team found that the licensing actions were of adequate quality and generally consistent 

with the Branch’s procedures, the Commonwealth’s regulations, and good health physics 

practices. 

The Branch issues licenses for a 1-year period based on the collection of an annual fee. The 

Commonwealth’s regulations and the Branch’s licensing guidance documents require a 

comprehensive technical renewal to be performed every 5-7 years; however, the review team 

found that the Department’s database did not contain the data to identify that renewals were 

performed and does not have the capability to identify and track licenses that are required to 

have a comprehensive technical renewal. The review team recommends that the 

Commonwealth develop and implement a reliable mechanism to identify when a license is in 

need of a comprehensive renewal, identify these licenses, and develop and implement a plan to 

perform these renewals. 

The review team evaluated the Branch’s application of the Commonwealth’s financial assurance 

requirements. The review team’s evaluation revealed that the license reviewers use checklists 

to appropriately identify licensees required to maintain financial assurance and have taken 

appropriate steps to ensure compliance with the financial assurance requirements. 

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

and Fingerprinting requirements. 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 Branch’s methodology 

for identifying those licenses and found the rationale was thorough and accurate. 

The Branch performs pre-licensing checks of all new applicants to verify their identity and need 

for radioactive materials. The Branch performs pre-license visits on all new applicants that meet 

the criteria for Increased Controls. In the evaluation of the pre-licensing checks, the review 

team found copies of corporation registrations from a variety of States and verifications that 

certain applicants are known to possess NRC or Agreement State licenses in the license files. 

At the time of the review, the Branch was unaware of the pre-license guidance requirements 

specified in the Office of Federal and State Materials and Environmental Management 

Programs (FSME) letter issued March 20, 2007, FSME 07-026. Although the Branch did not 

formally implement the pre-licensing guidance requirements, the essential objectives of this 
Kentucky Final Report Page 11 

program element were addressed. The Section Supervisor indicated that the Branch will 

implement the remaining requirements of FSME 07-026, as soon as possible. The review team 

recommends that the Commonwealth integrate the pre-licensing requirements of FSME 07-026 

into their licensing program and reevaluate new licenses issued since September 2007 for 

implementation of these requirements. 

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

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

Actions, was satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

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

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

this indicator, evaluated selected incidents reported for Kentucky in NMED against those 

contained in the Branch’s files, and evaluated the casework for 12 of the 32 radioactive 

materials incidents listed in the Branch’s incident database. A listing of the casework examined 

can be found in Appendix E. The review team also evaluated the Branch’s response to six 

allegations involving radioactive materials reported directly to the Branch during the review 

period and one allegation that NRC referred to the Branch during the review period. 

When notified of an incident or an allegation, the Section Supervisor and staff discuss the event 

and determine the level of initial response based on the health and safety risk associated with 

the incident or allegation. The Branch maintains a database for tracking the status of all 

incidents and allegations. The actions taken in response to an incident are documented and 

filed. If the incident meets the reporting thresholds established in the NRC’s FSME Procedure 

SA-300 “Reporting Material Events,” the Branch notifies NRC. If an investigation is complex 

and extends over a period of time, NMED is appropriately updated, using the NMED software. 

The review team verified the staff’s understanding of NMED through a demonstration of a data 

search and generation of specific reports. During the review period, the review team identified 

20 incidents in NMED for Kentucky, of which 12 required reporting to NRC. The review team 

evaluated the Branch’s timeliness in reporting incidents to NRC’s Headquarters Operations 

Center, and determined that, following notification from the licensee, the Branch reported 

incidents within the required time frame. 

The incidents selected for review included medical events; lost, stolen, or abandoned 

radioactive material; overexposures; damaged equipment; equipment failures; and 

transportation incidents. 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 review team noted that at the conclusion of investigations, inspectors documented the 

investigations. 

The review team discussed the reporting of incidents involving certain naturally occurring and 

accelerator-produced material (NARM) with the Section Supervisor. A review of the Branch’s 

tracking database verified that no incidents involving NARM have occurred since the 

November 30, 2007 waiver termination date for expansion of the definition of “byproduct 
Kentucky Final Report Page 12 

material,” as established by the Energy Policy Act of 2005. The Section Supervisor was aware 

of the requirement to report NARM events to NRC and include the events in NMED. 

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

evaluated the casework for seven allegations, one of which NRC referred to Kentucky. The 

review team concluded that the Branch consistently took prompt and appropriate action in 

response to concerns raised. The review team noted that the Branch thoroughly documented 

the investigations and retained all necessary documentation to appropriately close the 

allegations; however, in four of the casework reviews, the allegation files contained no 

documentation that the allegers had been notified of the disposition of the allegations at the 

conclusion of the Branch’s investigations. The Branch is currently revising its allegation 

procedure and will include specific guidance in the procedure to require documentation of 

contact with allegers at the conclusion of an investigation of an allegation. 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 Kentucky’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. Kentucky’s 

Agreement does not relinquish authority for a uranium recovery program; therefore, only the first 

three non-common performance indicators were applicable to this review. 

4.1 Compatibility Requirements

4.1.1 Legislation

Kentucky became the first Agreement State in 1962. The effective statutory authority for the 

Branch is contained in Kentucky’s Revised Statutes (KRS) Title XVIII, Chapter 211, which 

names the Cabinet as the radiation control agency of the Commonwealth. The Branch is 

designated as the Commonwealth’s radiation control agency. Chapter 211 also authorizes the 

Cabinet to regulate the registration and licensing for the possession or use of any sources or 

ionizing or machine produced radiation, handling and disposal of radioactive waste, and 

establishing and assessing fees. The review team noted that no legislation affecting the Branch 

was passed during the review period. 

4.1.2 Program Elements Required for Compatibility

The Kentucky Regulations for Control of Radiation, found in 902 Kentucky Administrative 

Regulations (KAR) Chapter 100, “Regulations for Radioactive Materials,” apply to all ionizing 

radiation, whether emitted from radionuclides or machine sources. Kentucky requires a license 

for possession and use of all radioactive material, including NARM. 
Kentucky Final Report Page 13 

The review team examined the Commonwealth’s administrative rulemaking process and found 

that the process takes approximately 12 months after the Branch submits the drafted 

amendment for Cabinet review until it is submitted to NRC for a final compatibility review. The 

public and other interested parties are provided an opportunity to comment on proposed rules. 

The Commonwealth can adopt other agency’s regulations by reference and has the authority to 

issue legally binding requirements (e.g., license conditions) in lieu of regulations until compatible 

regulations become effective. The regulations are not subject to sunset provisions. 

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

reviewed the status of regulations required to be adopted by the Commonwealth 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 NRC’s regulations. 

The following 16 amendments are overdue, some significantly longer than 3 years from the 

effective date. The current status for each amendment is included: 

• “Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and 

61 amendment (60 FR 15649 and 60 FR 25983), that was due for Agreement State 

implementation on March 1, 1998. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

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

amendment (60 FR 38235), that was due for Agreement State implementation on 

November 24, 1998. 

Status: The Commonwealth adopted a final rule that addressed NRC’s comments 

transmitted on June 1, 2000, on the proposed rule, but did not submit the package for 

NRC review as a final rule. The Commonwealth plans to include the final rule with the 

package of 12 amendments that was being prepared for public comment within the 

Commonwealth’s regulation process as soon as the package is ready to be sent for 

NRC review of the final rules. 

• “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20 and 

35 amendment (60 FR 48623), that was due for Agreement State implementation on 

October 20, 1998. 

Status: The Commonwealth’s adoption of the overdue amendments, “Medical Use of 

Byproduct Material” and “Medical Use of Byproduct Material – Recognition of Specialty 

Boards,” will supersede this amendment. 
Kentucky Final Report Page 14 

• “10 CFR Part 71: Compatibility with the International Atomic Energy Agency,” 10 CFR 

Part 71 amendment (60 FR 50248 and 61 FR 28724), that was due for Agreement State 

implementation on April 1, 1999. 

Status: The Commonwealth’s adoption of the overdue amendment, “Compatibility with 

IAEA Transportation Safety Standards and Other Transportation Safety Amendments,” 

will supersede this amendment. 

• “Minor Corrections, Clarifying Changes, and a Minor Policy Change,” 10 CFR Parts 20, 

35, and 36 amendment (63 FR 39777 and 63 FR 45393), that was due for Agreement 

State implementation on October 26, 2001. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

• “Transfer for Disposal and Manifests: Minor Technical Conforming Amendment,” 

10 CFR Part 20 amendment (63 FR 50127), that was due for Agreement State 

implementation on November 20, 2001. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

• “Respiratory Protection and Controls to Restrict Internal Exposure,” 10 CFR Part 20 

amendment (64 FR 54543 and 64 FR 55524), that was due for Agreement State 

implementation on February 2, 2003. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

• “Energy Compensation Sources for Well Logging and Other Regulatory Clarifications,” 

10 CFR Part 39 amendment (65 FR 20337), that was due for Agreement State 

implementation on May 17, 2003. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

• “New Dosimetry Technology,” 10 CFR Parts 34, 36, and 39 amendment (65 FR 63749), 

that was due for Agreement State implementation on January 8, 2004. 

Status: This is one of 12 amendments was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 
Kentucky Final Report Page 15 

• “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct 

Material,” 10 CFR Parts 30, 31, and 32 amendment (65 FR 79162), that was due for 

Agreement State implementation on February 16, 2004. 

Status: While on site, the review team examined a revised license condition that the 

Section Supervisor drafted that addressed the three comments submitted by NRC on 

March 16, 2004, on the Commonwealth’s proposed license condition. The Section 

Supervisor committed to incorporating the revised license condition on its sole 

manufacturer’s license and submitting the revised license condition to NRC for final 

review. 

• “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298), that was 

due for Agreement State implementation on April 5, 2005. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

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

20250), that was due for Agreement State implementation on October 24, 2005. 

Status: The Commonwealth adopted a final rule that addressed the comments 

submitted by the NRC on October 28, 2004, on the proposed rule. The Commonwealth 

plans to include the final rule with the package of 12 amendments that was being 

prepared for public comment within the Commonwealth’s regulation process, as soon as 

the package is ready to be sent for NRC review of the final rules. 

 

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

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

 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

• “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 implementation on October 1, 2007. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 
Kentucky Final Report Page 16 

• “Medical Use of Byproduct Materials - Recognition of Specialty Boards - Part 35,” 

10 CFR Part 35 amendment (70 FR 16336 and 71 FR 1926), that was due for 

Agreement State implementation on April 29, 2008. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

• “Security Requirements for Portable Gauges Containing Byproduct Material,” 10 CFR 

Part 30 amendment (70 FR 2001), that was due for Agreement State implementation on 

October 1, 2007. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

The review team identified the following NRC amendments that the Commonwealth will need to 

address in the future. The Section Supervisor related that the amendments would be 

addressed in upcoming rulemakings or in the adoption of alternate legally binding requirements: 

● “National Source Tracking System,” 10 CFR Part 20 amendment (71 FR 65865), that is 

due for Agreement State adoption by January 31, 2009. 

 Status: While on site, the review team provided the Section Supervisor a copy of an 

example license condition for the amendment. The Section Supervisor committed to 

addressing the amendment via license condition and submitting it to the NRC for review 

in the near future. 

● “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. 

Status: This is one of 12 amendments that was sent to the Commonwealth’s Legislative 

Research Commission for publication as a final rule and was being prepared for public 

comment. 

● “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. 
Kentucky Final Report Page 17 

● “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. 

The review team recognized the amount of progress since the last review to address the 

number of overdue regulations. With the submittal of the previously mentioned rulemaking 

package and several additional amendments to NRC for final review, the Commonwealth will be 

up to date with regulation development. The Branch implemented a plan to help ensure that the 

Commonwealth continues to adopt and maintain compatibility with the NRC by addressing 

upcoming regulation changes and adoptions. 

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

that Kentucky’s performance with respect to the indicator, Compatibility Requirements, was 

satisfactory, but needs improvement. 

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 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 Branch’s response to the IMPEP questionnaire for this indicator. The review 

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

period. The Branch conducted 1 new SS&D evaluation, issued 2 amendments to existing 

registrations, and inactivated 14 registrations since the last review. 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 six reviewers who are qualified to perform safety evaluations of SS&D 

applications. All have degrees in a physical science or engineering and have attended the 

NRC’s SS&D Workshop or the Branch’s week-long training discussed in Section 2.0. The 

review team evaluated the independent training program materials and found it to be 

comparable in content and quality to NRC’s 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 a device or source and had access to applicable reference documents. 

4.2.2 Technical Quality of the Product Evaluation Program

The review team evaluated 2 of the 3 SS&D actions and 2 of the 14 SS&D registration 

inactivations issued during the review period. One of the actions was a significant amendment 

and the other was a new registration. The casework reviewed represented the efforts of two of 

the Branch’s six SS&D reviewers. These were the only two reviewers who performed 
Kentucky Final Report Page 18 

evaluations during the review period. A list of SS&D casework examined, with case-specific 

comments, 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. 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 follows a documented internal process when performing an SS&D review that 

includes a round-table discussion with the manufacturer and physically inspecting the prototype 

device. 

The Commonwealth currently has one device manufacturer who has active registrations. 

Registrations clearly summarized the product 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. Overall, 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. 

The review team found that the Branch does not have a legal means (e.g., regulations, license 

conditions, etc.) to enforce any commitments a manufacturer makes in its application and does 

not list the SS&D commitments in the manufacturer’s radioactive materials possession license. 

Subsequent to the review, the Branch added a license condition to the manufacturer’s license 

that ties the active SS&D registries to the license, providing a legal means to enforce any 

commitments made in the applications. 

The review team also found that while the Branch performs a review of the submitted quality 

assurance and quality control program used with the SS&D registry, the Branch does not have a 

mechanism to verify whether the approved quality assurance and quality control program is 

implemented by the manufacturer. The review team recommends that the Commonwealth 

develop and implement a mechanism to verify the implementation of the approved quality 

assurance and quality control program. 

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 

Commonwealth were reported during the review period. Incident procedures are in place 

should an SS&D-related incident occur. The Branch Manager and Section Supervisor were 

aware of the need to look at such incidents as potentially generic issues with possible wideranging effects. 

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

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

Program, was satisfactory. 
Kentucky Final Report Page 19 

4.3 Low-Level Radioactive Waste Disposal Program

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

performance regarding the low-level radioactive waste (LLRW) disposal program. These 

subelements were: (1) Technical Staffing and Training, (2) Status of Low-Level Radioactive 

Waste Disposal Inspection, (3) Technical Quality of Inspections, (4) Technical Quality of 

Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities. 

The LLRW program consists of oversight at one facility, the Maxey Flats site, which is located in 

eastern Kentucky near Hillsboro in Fleming County. The site operated as a commercial LLRW 

disposal facility authorized by the Commonwealth from May 1963 through December 1977. The 

site was listed on the National Priority list in 1986, and a Record of Decision was issued in 

September 1991 by the Environmental Protection Agency (EPA) under its Comprehensive 

Environmental Response, Compensation, and Liability Act (CERCLA) authority to stabilize the 

site and treat contaminated leachate (mainly tritium) from tanks and trenches. 

The license for the site authorizes maintenance activities related to the closed LLRW disposal 

site. The license is issued to the Energy and Environment Cabinet (EEC), who is responsible 

for carrying out regulatory requirements. Since the facility is closed and has no on-site activity 

or operations, the activities at the site are limited to a radiological environmental monitoring 

program consisting of soil, surface water, and ground water monitoring. 

4.3.1 Technical Staffing and Training

The Branch staff, whose qualifications satisfy the RH Specialist III level of training discussed in 

Section 3.1, serves as license reviewers and inspectors. The laboratory technical staff in the 

Radiation/Environmental Monitoring Section involved with the Maxey Flats radiological 

environmental monitoring program consists of five individuals, who have been trained in 

radiochemistry, environmental sampling, and analysis and data evaluation. The review team 

discussed the qualifications of the laboratory technical staff with the Section Supervisor and 

determined that their qualifications are commensurate with expertise needed to regulate and 

monitor the closed LLRW disposal site. The review team found that the Branch=s radioactive 

materials qualification and training requirements are adequate for technical staff to perform 

LLRW licensing actions and inspections. 

4.3.2 Status of Low-Level Radioactive Waste Disposal Inspection

The Branch's inspection frequency for the site is every 2 years. NRC has not established an 

inspection frequency for closed LLRW sites. The Branch conducted an inspection of the site on 

June 18, 2008. The previous inspection was conducted in January 2004. No formal inspection 

was conducted in 2006 due to staffing issues and prioritization of overdue inspections identified 

during the last review. Despite the lack of a formal radioactive materials inspection in 2006, the 

Branch Manager stated that other oversight activities are routinely conducted at the site through 

radiological environmental monitoring program. The laboratory technical staff conducts monthly 

and quarterly site visits. In addition, the licensee conducts quarterly inspections at the site and 

provides detailed reports to EPA and the Branch. The Section Supervisor committed to 

continue the 2-year inspection frequency for the site based on discussions with the review team. 
Kentucky Final Report Page 20 

Regarding the timeliness of the Branch inspection reports, the review team noted that for the 

inspection conducted in June 18, 2008, the inspection results and report had not been issued at 

the time of this review. The Section Supervisor indicated that the delay was due to higher 

priority activities and that the inspection format has changed from an inspection checklist to a 

formal narrative report. 

4.3.3 Technical Quality of Inspections

The inspection of the NRECP license is handled in the same manner as the other radioactive 

materials licensees. No inspection casework from the review period was available for review, 

as noted in Section 4.3.2. 

The review team visited the Radiation/Environmental Monitoring Section laboratory and found 

the facility was well equipped to support the radiological environmental monitoring program at 

Maxey Flats. The laboratory staff makes use of written approved procedures, instrument control 

charts, participates in an interlaboratory quality control program, and conducts independent 

review and assessment of data. The laboratory has a wide array of analytical equipment, as 

described in Section 3.3. Both the licensee and laboratory staff collect soil and water samples 

at prescribed frequencies. Split sampling is conducted on all compliance point sampling 

locations. Action levels for reporting unusual sample analysis results are based on historical 

knowledge. If a sample result is returned as elevated or high, the State Environmental 

Contractor is notified. Following the notification to the contractor, the Radiation/Environmental 

Monitoring Section Supervisor reports the result to the Branch Manager, who in turn, sends the 

report to the Section Supervisor all within a 5-day period. 

In addition, laboratory analysis activities include wipe analysis and analysis of samples from 

items found in the public domain. Sample results are provided in a timely manner.

Periodic site visits are made by the laboratory technical staff on at least a monthly basis and 

also during major rainfall for environmental sampling and monitoring purposes, radiological 

environmental monitoring program data are maintained at the laboratory. The Branch maintains 

an adequate number and type of calibrated radiation survey instruments to support the 

materials program, as discussed in Section 3.3. Survey instruments are also available at the 

laboratory. 

4.3.4 Technical Quality of Licensing Actions

EEC=s license authorizes the possession of the wastes previously disposed of at the site, 

management and maintenance of the site, and possession and treatment of radioactive solids 

and liquids generated as a result of management and maintenance activities at the site. The 

license covers the on-site radiation control program, occupational exposure of individuals, and 

control of radioactive materials as it affects occupational exposures. The Section Supervisor is 

the reviewer for all license amendment actions. 

The review team examined four licensing actions related to the EEC license issued during the 

review period, as indicated in Appendix D. Applicable guidance documents related to licensing 

actions were available and used, as needed. The review team found that the licensing actions 

were thorough, complete, consistent, and of high quality, with health, safety, and security issues 

properly addressed. 
Kentucky Final Report Page 21 

4.3.5 Technical Quality of Incident and Allegation Activities

The review team found that the Branch has procedures in place for handling incidents and 

allegations. During the review period, the Branch received no reports of incidents or allegations 

pertaining to the LLRW disposal program. 

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

that Kentucky’s performance with respect to the indicator, Low-Level Radioactive Waste 

Disposal Program, was satisfactory. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0, Kentucky’s performance was found satisfactory, but needs 

improvement, for the performance indicators, Status of Materials Inspection Program, Technical 

Quality of Inspections, and Compatibility Requirements. Kentucky’s performance was found 

satisfactory for all other performance indicators reviewed. The review team made six 

recommendations regarding program performance and identified one good practice. 

Accordingly, the review team recommended, and the MRB agreed, that the Kentucky 

Agreement State Program was adequate to protect public health and safety, but needs 

improvement, and compatible with NRC's program. The review team also recommended, and 

the MRB agreed, that the period of monitoring will continue, including quarterly conference calls 

and a periodic meeting in approximately 1 year to assess the Branch’s progress in addressing 

the review team’s recommendations. 

Below are the recommendations, as mentioned earlier in the report, for evaluation and 

implementation, as appropriate, by the Commonwealth. 

1. The review team recommends that the Commonwealth revise its inspection procedures 

to require documentation of the closure of any previous violation, verification of 

corrective actions, and evaluation of preventive measures implemented by the licensee 

both in the inspection documentation and during the exit with the licensee (Section 3.3). 

2. The review team recommends that the Commonwealth discuss previous inspection 

findings, corrective actions, and any potential violations with the licensee during 

inspections (Section 3.3). 

3. The review team recommends that the Commonwealth use its own calibrated 

radiological survey equipment to perform independent confirmatory surveys during 

inspections (Section 3.3). 

4. The review team recommends that the Commonwealth develop and implement a reliable 

mechanism to identify when a license is in need of a comprehensive renewal, identify 

these licenses, and develop and implement a plan to perform these renewals (Section 

3.4). 

5. The review team recommends that the Commonwealth integrate the pre-licensing 

requirements of FSME 07-026 into their licensing program and reevaluate new licenses 

issued since September 2007 for implementation of these requirements (Section 3.4). 
Kentucky Final Report Page 22 

6. The review team recommends that the Commonwealth develop and implement a 

mechanism to verify the implementation of the approved quality assurance and quality 

control program (Section 4.2.2). 

Below is a good practice, as mentioned earlier in the report: 

The review team recommends that the Branch’s practice of requesting that the licensees 

extend an invitation to the local law enforcement agency during initial on-site 

visits/inspections for Increased Controls be identified as a good practice. (Section 3.3) 
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B Kentucky 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 October 6, 2008, Letter from William D. Hacker 

 Kentucky’s Response to Draft IMPEP Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Kathleen Schneider, FSME Team Leader 

 Status of Materials Inspection Program 

Kim Lukes, FSME Technical Staffing and Training 

 Compatibility Requirements 

James Kottan, Region I Technical Quality of Incident and Allegation 

 Activities 

Michael Stephens, FL Technical Quality of Licensing Actions 

 Sealed Source and Device Evaluation Program 

Ricardo Munoz, RIV Technical Quality of Inspections 

Low-Level Radioactive Waste Disposal Program 

 Inspector Accompaniments 
APPENDIX B 

KENTUCKY ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML082410026 
APPENDIX C 

 INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Schlumberger Technology License No.: 201-665-40 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 6/14/07 Inspector: AB 

Comment: 

Inspection findings were dispatched to the licensee 13.5 months after the date of the 

inspection. 

File No.: 2 

Licensee: Jewish Hospital of Shelbyville License No.: 202-198-25 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 6/4/05, 5/15/08 Inspector: BP 

Comments: 

a) The inspection report for the 2005 violation did not document the date of violation or the 

length of time the violation occurred. 

b) Inspector notes for the 2008 inspection did not document the closeout of the previous 

inspection’s violations. 

c) Documentation in the file stated that there is no “Return to Compliance” letter. 

File No.: 3 

Licensee: Springview Hospital License No.: 202-311-24 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/13/08 Inspector: RH 

Comment: 

The inspection report did not document that the corrective actions for the violations from 

the 2004 inspection were verified. 

File No.: 4 

Licensee: Mays Suddereth & Etheredge License No.: 201-207-51 

Inspection Type: Routine, Unannounced Priority: 4 

Inspection Date: 5/14/08 Inspector: NG 

Comment: 

Previous inspection identified repeat violations. The inspection report did not document 

how the corrective action for these violations was verified during the 2008 inspection. 
Kentucky Final Report Page C.2 

Inspection Casework Reviews

File No.: 5 

Licensee: Radiopharmacy of Paducah, Inc. License No.: 202-211-32 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 6/10/08 Inspectors: MMG, AB 

File No.: 6 

Licensee: University of Kentucky License No.: 212-024-31 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 6/3/08 Inspector: CP 

File No.: 7 

Licensee: Flaget Memorial Hospital License No.: 202-193-25 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/13/08 Inspector: RH 

File No.: 8 

Licensee: American Red Cross Blood Services License No.: 202-216-96 

Inspection Type: Special, Announced Priority: 3 

Inspection Date: 5/12/08 Inspectors: AB, SB 

Comment: 

Inspection findings were dispatched to the licensee 80 days after the date of the 

inspection. 

File No.: 9 

Licensee: University of Kentucky License No.: 212-266-96 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 6/3/08 Inspector: CP 

Comment: 

Sensitive information was incorrectly filed. 

File No.: 10 

Licensee: Kentucky Blood Center License No.: 202-243-96 

Inspection Type: Special, Announced Priority: 3 

Inspection Date: 5/24/08 Inspector: CP 

Comment: 

Inspection findings were dispatched to the licensee 68 days after the date of the 

inspection. 

File No.: 11 

Licensee: Acuren Inspection License No.: 201-666-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 5/20/08 Inspector: CP 
Kentucky Final Report Page C.3 

Inspection Casework Reviews

File No.: 12 

Licensee: Logan Aluminum License No.: 201-419-57 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 4/30/08 Inspector: CP 

File No.: 13 

Licensee: Huntington Testing & Technology License No.: 201-551-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 3/25/08 Inspector: CP 

File No.: 14 

Licensee: Stupp Bridge License No.: 201-674-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 5/1/08 Inspector: CP 

File No.: 15 

Licensee: Integrity Testing License No.: 201-692-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 6/11/08 Inspector: CP 

File No.: 16 

Licensee: Integrity Testing & Inspection License No.: 201-692-05 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 2/19/08 Inspector: CP 

File No.: 17 

Licensee: EI DuPont DeNemours & Company License No.: 201-028-57 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 6/12/08 Inspector: MG 

File No.: 18 

Licensee: American Red Cross Blood Services License No.: 202-216-96 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 5/12/08 Inspectors: AB, SB 

File No.: 19 

Licensee: St. Luke Hospital West License No.: 202-003-25 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 1/26/08 Inspector: BP 

File No.: 20 

Licensee: Lake Cumberland Regional Hospital License No.: 202-123-26 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 10/10/07 Inspector: RH 
Kentucky Final Report Page C.4 

Inspection Casework Reviews

File No.: 21 

Licensee: Norton Suburban Hospital License No.: 202-099-26 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 1/25-26/07 Inspector: RH 

Comment: 

Ten violations noted during the inspection. The notice of violation/inspection findings 

correspondence was issued approximately 5 months after the inspection. 

File No.: 22 

Licensee: Owensboro Medical Health System License No.: 202-161-26 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/19/08 Inspector: BP 

File No.: 23 

Licensee: Cardiac & Vascular Imaging License No.: 202-317-29 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 12/13/07 Inspector: BP 

Comment: 

The Section has not yet issued a “Return to Compliance” letter in response to licensee’s 

February 15, 2008 correspondence. 

File No.: 24 

Licensee: StanTec Consulting License No.: 201-142-51 

Inspection Type: Routine, Unannounced Priority: 4 

Inspection Date: 9/19/07 Inspector: CP 

File No.: 25 

Licensee: West Kentucky Well Surveys License No.: 201-056-41 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/27/07 Inspector: CP 

File No.: 26 

Licensee: Lourdes Medical Pavilion, LLC License No.: 202-302-24 

Inspection Type: Routine, Unannounced Priority: 4 

Inspection Date: 11/8/08 Inspector: RH 

File No.: 27 

Licensee: Hayes Testing Laboratory License No.: 211-168-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 6/9/08 Inspectors: CP, SB 

File No.: 28 

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

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 6/9/08 Inspectors: CP, SB 
Kentucky Final Report Page C.5 

Inspection Casework Reviews

File No.: 29 

Licensee: Kentucky State University License No.: 202-029-22 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 9/11/07 Inspector: MG 

Comments: 

a) Status of previous non-compliance items not addressed in the inspection report. 

b) Licensee’s response to notice of violation findings was not in the file. 

File No.: 30 

Licensee: Bluegrass Regional Imaging License No.: 202-367-24 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 7/12/08 Inspector: AB 

File No.: 31 

Licensee: PetNet Solutions, Inc. License No.: 202-281-32 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 3/13/08 Inspector: BP 

File No.: 32 

Licensee: St. Elizabeth Medical Center License No.: 202-152-26 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 1/26/06 Inspector: BP 

Comment: 

Inspection findings were dispatched to the licensee approximately 2 months after the 

date of the inspection. 

File No.: 33 

Licensee: Cardinal Health Services License No.: 202-204-32 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 3/18/08, 7/9/08 Inspectors: BP, AB 

File No.: 34 

Licensee: Bluegrass Cardiology License No.: 202-256-26 

Inspection Type: Routine, Unannounced Priority: 4 

Inspection Date: 12/19/05 Inspector: RH 

File No. 35 

Licensee: Ronan Engineering Company License No. 201-260-95 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 6/28/07 Inspector: MG 

File No. 36 

Licensee: Grand Eagle Mining License No. 201-660-56 

Inspection Type: Routine, Announced Priority: 4 

Inspection Date: 11/15/07 Inspector: CP 
Kentucky Final Report Page C.6 

Inspection Casework Reviews

File No.: 37 

Licensee: TEI Analytical Services License No.: NRC 37-28004-01 

Inspection Type: Reciprocity, Unannounced Priority: 1 

Inspection Date: 5/9/07 Inspector: CP 

Comment: 

The special inspection requirements were not covered during the safety inspection. 

File No.: 38 

Licensee: Jan-X Integrity Group License No.: NRC 21-16560-01 

Inspection Type: Reciprocity, Unannounced Priority: 1 

Inspection Dates: 8/22/07, 2/18/08 Inspectors: CP, MG 

Comment: 

The special inspection requirements were not covered during the safety inspection. 

File No.: 39 

Licensee: Tracerco License No.: NRC 07-28386-01 

Inspection Type: Reciprocity, Unannounced Priority: 4 

Inspection Date: 6/12/08 Inspector: MG 

File No.: 40 

Licensee: Appalachian Well Surveys, Inc. License No.: OH 03111300001 

Inspection Type: Reciprocity, Unannounced Priority: 1 

Inspection Date: 3/17/08 Inspector: MG 

File No.: 41 

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

Inspection Type: Reciprocity, Unannounced Priority: 4 

Inspection Date: 3/17/08 Inspector: BP 

 INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: American Red Cross/River Valley Region License No.: 202-216-96 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 5/12/08 Inspectors: AB, SB 

 

Comment: 

During the exit briefing with the licensee, the inspector did not discuss any inspection 

findings or potential violations. 
Kentucky Final Report Page C.7 

Inspection Casework Reviews

Accompaniment No.: 2 

Licensee: American Red Cross/River Valley Region License No.: 212-216-96 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 5/12/08 Inspectors: AB, SB 

Comment: 

The inspectors needed to pursue additional queries into the requirements of continuous 

monitoring and communication among component systems were not addressed during 

the initial site visit. 

Accompaniment No.: 3 

Licensee: Flaget Memorial Hospital License No.: 202-193-25 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/13/08 Inspector: RH 

Comment: 

Although inspectors carry their own survey instruments, during the inspection, the 

inspector used the licensee’s radiological survey equipment to perform independent 

confirmatory surveys. 

Accompaniment No.: 4 

Licensee: Mayes Sedderth & Ethridge License No.: 201-207-51 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/14/08 Inspector: NG 

Comments: 

a) The inspector did not perform independent confirmatory surveys. 

b) During the exit briefing with the licensee, the inspector did not discuss any inspection 

findings or potential violations. 

Accompaniment No.: 5 

Licensee: Jewish Hospital of Shelbyville License No.: 202-198-25 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/15/08 Inspector: BP 

Comment: 

Although inspectors carry their own survey instruments, during the inspection, the 

inspector used the licensee’s radiological survey equipment to perform independent 

confirmatory surveys. 

Accompaniment No.: 6 

Licensee: Hays Testing Laboratory, Inc License No.: 211-168-05 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 6/9/08 Inspector: CP 
Kentucky Final Report Page C.8 

Inspection Casework Reviews

Accompaniment No.: 7 

Licensee: Hays Testing Laboratory, Inc. License No.: 201-168-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 6/9/08 Inspector: CP 

Comments: 

a) The inspector needed to pursue additional queries into the requirements of continuous 

monitoring and communication among component systems that were not addressed 

during the initial site visit. 

b) The inspector did not identify violations related to line-cut detection at the facility and on 

the licensee’s transport vehicles. 

Accompaniment No.: 8 

Licensee: Radiopharmacy of Paducah, Inc License No.: 202-221-32 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 6/10/08 Inspectors: MMG, AB 

Comment: 

During the exit briefing with the licensee, the inspector did not discuss any inspection 

findings or potential violations. 

Accompaniment No.: 9 

Licensee: Integrity Testing & Inspection License No.: 201-692-05 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 6/11/08 Inspector: CP 

Accompaniment No.: 10 

Licensee: Integrity Testing & Inspection License No.: 211-692-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 6/11/08 Inspector: CP 

Comments: 

a) The inspector needed to pursue additional queries into the requirements of continuous 

monitoring and communication among component systems that were not addressed 

during the initial site visit. 

b) The inspector did not identify violations related to line-cut detection at the facility and on 

the licensee’s transport vehicles. 

Accompaniment No.: 11 

Licensee: Tracerco License No.: NRC 07-28386-01 

Inspection Type: Reciprocity, Unannounced Priority: 3 

Inspection Date: 6/12/08 Inspector: MG 

Comment: 

The inspector did not observe the licensee set up or conduct of licensed activities. 
Kentucky Final Report Page C.9 

Inspection Casework Reviews

Accompaniment No.: 12 

Licensee: DuPont License No.: 201-028-33 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/12/08 Inspector: MG 

Comments: 

a) The inspector did not review issues related to receipt and disposal of licensed material to 

the manufacturer. 

b) The inspector had not prepared by reviewing the entire license file. Previous violations 

were not reviewed or verified during the inspection. 

c) During the exit briefing with the licensee, the inspector did not discuss any inspection 

findings or potential violations. 

Accompaniment No.: 13 

Licensee: Western Kentucky Energy, D.B. Wilson Plant License No.: 201-277-56 

Inspection Type: Incident Investigation Type of Incident: Equipment Failure 

Inspection Date: 6/11/08 Inspector: CP 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: E.I. Dupont De Nemous & Company License No.: 201-028-57 

Type of Action: Amendments Amendment Nos.: 77, 79, 80 

Dates Issued: 7/21/05, 7/24/06, 12/15/06 License Reviewers: SB, CP, AB 

File No.: 2 

Licensee: Bluegrass Cardiology License No.: 202-256-24 

Type of Action: Amendment Amendment No.: 15 

Date Issued: 1/8/08 License Reviewers: MMG, RH 

File No.: 3 

Licensee: Kentucky State University License No.: 203-037-83 

Type of Action: Amendments Amendment Nos.: 30, 33 

Dates Issued: 1/10/06, 6/4/07 License Reviewer: AB 

Comment: 

License expired on May 31, 2008 for non-payment of annual fees and licensee still 

possesses radioactive materials. 

File No.: 4 

Licensee: PetNet Solutions Inc. License No.: 202-281-32 

Type of Action: Renewal, Amendment Amendment Nos.: 13, 14 

Dates Issued: 2/5/08, 5/16/08 License Reviewers: AB, MMG 

Comment: 

License tie-down condition does not list all of the licensee’s renewal application 

commitments. 

File No.: 5 

Licensee: Cardinal Health Nuclear Pharmacy Services License No.: 202-204-32 

Type of Action: Renewal Amendment No.: 53 

Date Issued: 2/18/08 License Reviewer: AB 

Comments: 

a) License tie-down condition does not list all of the licensee’s renewal application 

commitments. 

b) Item 9 on the license lists correspondence containing licensee’s commitments (dated 

1991), and this correspondence is not in the license file. 

File No.: 6 

Licensee: Consol of KY, Inc. License No.: 201-507-51 

Type of Action: Termination Amendment No.: 18 

Date Issued: 6/2/08 License Reviewer: MG 
Kentucky Final Report Page D.2 

Licensing Casework Reviews

File No.: 7 

Licensee: Ronan Engineering Company License No.: 201-260-95 

Type of Action: Amendments Amendment Nos.: 42, 60, 61 

Dates Issued: 8/17/06, 8/21/06, 6/16/08 License Reviewer: MG 

Comments: 

a) The license’s was last comprehensive renewal was issued February 1, 2002. Based on 

the program’s protocol, this license should have been renewed within 5 years. 

b) The license does not have any of the sealed source registry certificate licensee 

commitments identified either by license or tie-down condition. 

File No.: 8 

Licensee: Murray State University License No.: 203-018-83 

Type of Action: Amendment Amendment No.: 59 

Date Issued: 3/3/08 License Reviewer: MK 

File No.: 9 

Licensee: Dart Polymer License No.: 201-586-56 

Type of Action: Amendment Amendment Nos.: 0-7 

Date Issued: 8-29-96-Annual Fee Expiration Date License Reviewers: Various 

Comment: 

The license was issued in 1996 and has never been renewed in its entirety. 

File No.: 10 

Licensee: The Medical Center at Bowling Green. License No.: 202-124-26 

Type of Action: Amendments Amendment Nos.: 90, 91, 92, 

Dates Issued: 5/1/07, 4/9/08, 5/28/08 License Reviewer: BP 

Comments: 

a) The license does not identify the sealed source model numbers authorized for large 

activity sources. 

b) Incorrect documentation on the license documents. Both amendments were identified 

as “Amended in its Entirety,” which is essentially a “renewal;” however, neither 

amendment was the 5- or 7-year resubmittal. 
Kentucky Final Report Page D.3 

Licensing Casework Reviews

File No.: 11 

Licensee: University of Kentucky License No.: 202-024-31 

Type of Action: Amendments Amendment Nos.: 56, 57 

Dates Issued: 12/13/07, 6/6/08 License Reviewer: AB 

Comments: 

a) The license does not identify the sealed source model numbers authorized for large 

activity sources. 

b) Deficiency in the facility diagram was not addressed in a deficiency letter, but additional 

information was gathered and documented during the pre-licensing visit which 

addressed the deficiency in the submitted material reviewed. A shield plan survey 

diagram dated May 23, 2008, is in the license file. 

File No.: 12 

Licensee: Cardiovascular Specialists License No.: 202-162-24 

Types of Action: Renewal, Amendments Amendment Nos.: 47, 49, 50, 51 

Dates Issued: 2/16/06, 9/29/06, 7/5/07, 3/10/08 License Reviewer: AB 

File No.: 13 

Licensee: JANX License No.: 201-700-05 

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

Dates Issued: 12/12/06, 6/11/08 License Reviewers: CP, SB 

Comment: 

The licensee’s response to the deficiency letter contained sensitive information and was 

not appropriately marked. 

File No.: 14 

Licensee: Associated Veterinary License No.: 201-696-33 

Type of Action: Termination Amendment No.: 2 

Date Issued: 6/20/08 License Reviewer: MG 

File No.: 15 

Licensee: Derby City Engineering and Inspection License No.: 201-523-05 

Type of Action: Amendments Amendment Nos.: 42, 44, 46, 47 

Dates Issued: 12/3/04, 3/21/06, 4/26/07, 8/8/07 License Reviewers: SB, RH, RH, MG 

Comment: 

License does not limit the maximum number of sources. The licensee is authorized to 

possess an unlimited number of devices. 

File No.: 16 

Licensee: Harlan Appalachian Regional Healthcare License No.: 202-018-24 

Type of Action: Renewal Amendment No.: 51 

Date Issued: 6/16/08 License Reviewer: RH 
Kentucky Final Report Page D.4 

Licensing Casework Reviews

File No.: 17 

Licensee: EEC-Maxey Flats Project License No.: 206-002-03 

Type of Action: Amendments, Renewal Amendment Nos.: Various 

Dates Issued: 3/1/05, 10/21/05, 11/23/05, 6/16/08 License Reviewer: MM 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Equitable Production Co. License No.: 201-027-56 

Date of Incident: 2/1/05 NMED Log No.: 050103 

Investigation Date: 2/18/05 Type of Incident: Abandoned Source 

 Type of Investigation: Telephone 

File No.: 2 

Licensee: Asher, Inc. License No.: 201-565-51 

Date of Incident: 5/13/05 NMED Log No.: 050332 

Investigation Date: 5/14/05 Type of Incident: Lost Gauge 

 Type of Investigation: Site Visit 

File No.: 3 

Licensee: Cardinal Health License No.: 202-204-32 

Date of Incident: 6/7/05 NMED Log No.: 060195 

Investigation Date: 6/21/05 Type of Incident: Overexposure 

 Type of Investigation: Telephone 

File No.: 4 

Licensee: Cardinal Health License No.: 202-204-32 

Date of Incident: 10/31/05 NMED Log No.: Not Reportable 

Investigation Date: 10/31/05 Type of Incident: Transportation Accident 

 Type of Investigation: Telephone/Data Review 

File No.: 5 

Licensee: National Standard Co. License No.: 401-637-00 

Date of Incident: 12/14/05 NMED Log No.: Not Reportable 

Investigation Dates: 12/14-20/05 Type of Incident: Lost Material 

 Type of Investigation: Telephone 

File No.: 6 

Licensee: University of Kentucky License No.: 202-049-22 

Date of Incident: 4/4/06 NMED Log No.: 060372 

Investigation Date: 6/12/06 Type of Incident: Equipment Failure 

 Type of Investigation: Telephone/Site Visit 

File No.: 7 

Licensee: Pikeville Medical Center License No.: 202-053-26 

Date of Incident: 9/22/06 NMED Log No.: 060603 

Investigation Date: 9/22/06 Type of Incident: Medical Event 

 Type of Investigation: Telephone 
Kentucky Final Report Page E.2 

Incident Casework Reviews

File No.: 8 

Licensee: Fuller, Mossbarger, Scott 

 and May Engineering, Inc. License No.: 201-142-51 

Date of Incident: 7/12/07 NMED Log No.: 070435 

Investigation Dates: 7/12/07, 9/19/07 Type of Incident: Stolen Gauge 

 Type of Investigation: Telephone/Site Visit 

File No.: 9 

Licensee: Rogers Group, Inc. License No.: 201-412-51 

Date of Incident: 5/22/07 NMED Log No.: 070319 

Investigation Dates: 5/22/07, 10/4/07 Type of Incident: Lost Gauge 

 Type of Investigation: Telephone/Site Visit 

File No.: 10 

Licensee: Weatherford International, Inc. License No.: 201-094-40 

Date of Incident: 7/27/07 NMED Log No.: 070510 

Investigation Date: 7/27/07 Type of Incident: Overexposure 

 Type of Investigation: Telephone 

File No.: 11 

Licensee: Owensboro Medical Health System License No.: 202-161-26 

Date of Incident: 1/11/07 NMED Log No.: 080041 

Investigation Date: 1/11/08 Type of Incident: Medical Event 

 Type of Investigation: Telephone/Site Visit 

File No.: 12 

Licensee: International Specialty Products, Inc. License No.: GL-401-693-10 

Date of Incident: 7/27/08 NMED Log No.: Not Reportable 

Investigation Date: 7/27/08 Type of Incident: Damaged Gauge 

 Type of Investigation: Telephone 
APPENDIX F 

SEALED SOURCE & DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: KY-576-D-101-B SS&D Type: (D) Gamma Gauge 

Applicant Name: Ronan Engineering Company Type of Action: Amendment 

Date Issued: 8/21/06 Reviewers: MG, MK 

Comments: 

a) The registry sheet was marked as an amendment rather than as an “Amendment in its 

Entirety,” as specified in NUREG 1556, Volume 3, Revision 1. 

b) The principal use code was listed as “Gamma Gauge” instead of “(D) Gamma Gauge.” 

File No.: 2 

Registry No.: KY-576-D-115-S SS&D Type: (D) Gamma Gauge 

Applicant Name: Ronan Engineering Company Type of Action: Amendment 

Date Issued: 9/25/07 Reviewers: MG, MK 

Comments: 

a) The registry sheet was marked as an amendment rather than as an “Amendment in its 

Entirety,” as specified in NUREG 1556, Volume 3, Revision 1. 

b) The principal use code was listed as “Gamma Gauge” instead of “(D) Gamma Gauge.” 

File No.: 3 

Registry No.: KY-8195-S-801 SS&D Type: (G) Portable Gauge 

Applicant Name: New England Nuclear Type of Action: Inactivation 

Date Issued: 2/25/08 Reviewers: MG, MK 

File No.: 4 

Registry No.: KY-512-D-809-S SS&D Type: (D) Gamma Gauge 

Applicant Name: Ohmart\Vega Corporation Type of Action: Inactivation 

Date Issued: 12/28/07 Reviewers: MG, MK 
ATTACHMENT 

October 6, 2008, Letter from William D. Hacker 

Kentucky’s Response to Draft IMPEP Report 

ADAMS Accession Number: ML082830013