September 28, 2012 

Steve Davis, M.D. 

Commissioner 

Department for Public Health 

275 E. Main Street 

Frankfort, KY 40601 

Dear Dr. Davis: 

On September 6, 2012, 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 program. 

Section 5.0, page 16 of the enclosed final report contains a summary of the IMPEP team’s 

findings and an MRB recommendation. We request your evaluation and response to the MRB’s 

recommendation regarding oversight of the inspection program within 30 days from receipt of 

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

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

meeting tentatively scheduled for June 2014. In addition, the MRB directed the period of 

monitoring continue. 

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

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

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

 Sincerely, 

/RA/ 

 Michael F. Weber 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Kentucky Final IMPEP Report 

cc w/ encl: Matthew W. McKinley, Administrator 

 Radiation Health Program 

 

 Jennifer Opila, Colorado 

 Organization of Agreement States 

 Liaison to the MRB 
Steve Davis, M.D. 

Senior Deputy State Health Officer 

Deputy Commissioner 

Department for Public Health 

275 E. Main St. 

Frankfort, KY 40601 

Dear Dr. Davis: 

On September 6, 2012, 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 Nuclear 

Regulatory Commission’s program. 

Section 5.0, page 16 of the enclosed final report contains a summary of the IMPEP team’s 

findings and an MRB recommendation. We request your evaluation and response to the MRB’s 

recommendation regarding oversight of the inspection program within 30 days from receipt of 

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

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

meeting tentatively scheduled for June 2014. In addition, the MRB directed the period of 

monitoring continue. 

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

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

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

 Sincerely, 

 /RA/ 

 Michael F. Weber 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Kentucky Final IMPEP Report 

cc w/ encl: Matthew W. McKinley, Administrator 

 Radiation Health Program 

 

 Jennifer Opila, Colorado 

 Organization of Agreement States 

 Liaison to the MRB 

DISTRIBUTION: EDATS: FSME-2012-0032 

See next page 

ADAMS Accession Number: ML12264A598 

OFC RIV MSSA MSSA MSSA MSSA:D TechEd FSME:D EDO 

NAME RBrowder via 

email w/edits 

LDimmick DWhite PHenderson BMcDermott CPoland MSatorius 

(BHolian for) 

MWeber 

DATE 09/20/12 09/24/12 09/25/12 09/25/12 09/25/12 09/25 /12 09/26 /12 09/28/12 

OFFICIAL RECORD COPY 
Letter to S. Davis from Michael F. Weber dated September 28, 2012 

SUBJECT: Kentucky 2012 FINAL IMPEP REPORT 

DISTRIBUTION: EDATS: FSME-2012-0032 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsRgn1MailCenter 

RidsRgn3MailCenter 

RidsFsmeDmssa 

RidsSecyCorrespondenceMailCenter Chairman Macfarlane 

MOrendi, RI/RSAO Commissioner Svinicki 

JNick, RI Commissioner Apostolakis 

RBrowder, RIV Commissioner Magwood 

JSepulveda, FSME Commissioner Ostendorff 

MBeardsley, FSME SECY 

RErickson, RIV 

JHarris, KS 

RLorson, RI 

DCollins, RI 

DJanda, RI 

MOrendi, RI/RSAO 

CPendergrass, KY 

MKotzalas, OEDO 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE KENTUCKY AGREEMENT STATE PROGRAM 

JUNE 11-15, 2012 

 FINAL REPORT
EXECUTIVE SUMMARY 

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

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

the period of June 11-15, 2012, by a review team composed of technical staff members from the 

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

Based on the results of this review and in accordance with the criteria in the NRC Management 

Directive 5.6, “Integrated Materials Performance Evaluation Program (IMPEP),” the review team 

recommended, and the Management Review Board (MRB) agreed, that the Kentucky 

Agreement State Program's performance be found unsatisfactory for the performance indicator 

Status of Materials Inspection Program, satisfactory, but needs improvement for the 

performance indicator Compatibility Requirements, and satisfactory for the remaining five 

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

regarding program performance by the Commonwealth; however, the MRB directed that one 

recommendation be made regarding the oversight of the inspection program. The review team 

recommended, and the MRB agreed, that the Kentucky Agreement State Program remain on 

Monitoring to provide continued assurance that the program maintains sustained performance in 

the area of timely inspections and promulgation of the required regulations. 

The review team recommended, and the MRB agreed, that the six recommendations from the 

2008 IMPEP review, regarding the inspection and licensing programs, be closed. These 

recommendations are based on the team's review of the specific changes to licensing and 

inspection checklists, observations made during the inspection accompaniments, and 

documentation in the respective licensing and inspection files. 

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

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

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

next IMPEP review take place in approximately four years and two periodic meetings be 

conducted, with the first meeting to be held in approximately 18 months. The MRB agreed that 

the next IMPEP review take place in approximately four years, but directed that just one periodic 

meeting be held in approximately two years. 
Kentucky Final IMPEP 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 June 11-15, 2012, by a review team composed of 

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

Kansas. 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 the NRC Management Directive 5.6, “Integrated Materials 

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

review, which covered the period of August 1, 2008, through June 15, 2012, were discussed 

with Kentucky managers and the acting Commissioner for the Department of Public Health on 

the last day of the review. 

A draft of this report was provided to Kentucky for factual comment on July 13, 2012. The 

Commonwealth responded by electronic mail dated August 7, 2012. A copy of the 

Commonwealth’s response is included as an Attachment to this report. The Management 

Review Board (MRB) met on September 6, 2012, 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 the NRC’s program. 

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

(Branch) which is located within the Department of Public Health (Department). The 

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

composed of three sections which includes the Radioactive Materials Section (Section), the 

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

The Radioactive Materials Section implements the elements of the Agreement State Program. 

Organization charts for the Branch and Cabinet are included as Appendix B. 

At the time of the review, the Kentucky Agreement State Program regulated 423 specific 

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

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

Act of 1954, as amended) Agreement between the NRC and the 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 14, 2012. The Branch 

provided its initial response to the questionnaire on May 30, 2012. A copy of the questionnaire 

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

(ADAMS) using the Accession Number ML12152A407. A revision to the initial response was 

submitted on August 20, 2012. A copy of the revised questionnaire response may be found in 

ADAMS using the Accession Number ML12233A222. 

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

the Branch's response to the questionnaire, (2) review of applicable Kentucky statutes and 

regulations, (3) analysis of quantitative information from the Branch's electronic spreadsheets, 

(4) technical review of selected regulatory actions, (5) field accompaniments of four inspectors, 

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

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

performance indicators and made a preliminary assessment of the Kentucky Agreement State 

Program’s performance. 

The Commonwealth's actions in response to recommendations made during the previous 

review are presented in Section 2.0. Results of the team’s review of the common performance 

indicators are presented in Section 3.0. Results of the team’s review of the applicable noncommon performance indicators are presented in Section 4.0. A summary of the review team's 

findings are presented in Section 5.0. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on August 1, 2008, the review team made 

six recommendations regarding the Kentucky Agreement State Program’s performance. The 

status of each recommendation is as follows: 

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 meeting with the licensee. 

(Section 3.3)” 

Status: The Branch revised its inspection procedures to address this recommendation 

and has trained the staff on the revised procedures. The Branch stated in its 

questionnaire response, that in order to close any violation, the licensee must submit 

both, documentation to close the violation and written commitment(s) to implement 

corrective measures to prevent reoccurrence. The Branch also indicated that all items of 

non-compliance from the previous inspection are discussed with the licensee and the 

status verified and documented in subsequent inspection reports. Based on the 

inspection reports reviewed, the review team determined that the staff follows-up on the 

licensee's corrective actions and evaluates the preventive measures put in place by the 

licensee, as evidenced by the documentation in the inspection report. The review team 

finds that the Branch has adequately addressed the issue. This recommendation is 

closed. 

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)” 

 Status: The Branch revised its inspection procedures to address this recommendation 

and has trained the staff on the revised procedures. The Branch stated that the staff 

was responsible for discussing and reviewing previous inspection findings and verifying 

corrective actions were implemented in response to those violations. In addition, the 

staff discussed that they communicated any potential or alleged violation with the 

licensee during the exit briefing. Based on the inspection reports reviewed and as 

observed through the inspection accompaniments performed, the review team 

determined that items of non-compliance identified during the current inspection were 

documented and discussed with the licensee during the exit briefing. This 

recommendation is closed. 
Kentucky Final IMPEP Report Page 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)” 

 Status: The Branch revised its inspection procedures to address this recommendation 

and trained the staff on the revised procedures and the need to use the Branch's 

equipment when conducting radiation surveys/measurements at licensee facilities. 

During the accompaniments, the review team observed the staff using the Branch's 

instruments during the performance of the inspections. This recommendation is closed. 

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)” 

 Status: The review team observed that a new database had been developed, which 

tracked and identified licensees that met the criteria for an amendment in entirety. 

Procedure Title 200, Section 206, "Entireties" provides the amendment in entirety 

selection criteria, which is five or seven years from the date the license is granted. The 

Branch typically sends ten requests per quarter to identified licensees. The number of 

requests may vary depending on the licensing action workload and other actions, such 

as adding possession limits to the licenses. During 2012, the Branch had received 

32 requests for "amendment in entirety" and had completed 17 of those requests. At the 

time of the review, the Branch had not requested any amendments in entireties, due to 

adding possession limits to the licenses. The Branch anticipated initiating the process 

again, once the possession limits were completed. The review team determined that the 

Branch had a reliable mechanism to identify licenses that met the criteria and had a 

procedure to perform the amendments in entirety. This recommendation is closed. 

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)” 

 Status: The review team confirmed that the Branch developed a new procedure to 

implement the requirements of FSME 07-026. The procedure, Title 200, Section 212, 

"Prelicensing Guidance To Ensure Radioactive Materials Used As Intended" was 

provided to the staff for review. In addition, staff meetings were conducted to discuss 

the pre-licensing requirements. The Branch implemented a checklist which contained 

the essential elements of the guidance and the review team observed the checklist was 

being used to evaluate new applicants for a radioactive material license. This 

recommendation is closed. 

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 of the SS&D manufacturer’s program. (Section 4.2.2)” 
Kentucky Final IMPEP Report Page 4 

 Status: The Branch revised the manufacturing and distribution inspection forms, to 

include verification that the licensee implements the manufacturers’ approved quality 

assurance and quality control programs. Furthermore, the license for the only affected 

M&D licensee, Ronan Engineering, was amended to list the SSDR numbers of all 

approved devices currently in production, as a license condition. Other license 

conditions were modified to require tracking of all reportable events involving those 

approved devices. The Branch has also scheduled quarterly meetings with the licensee 

to review all events reported in the Nuclear Material Events Database (NMED) involving 

its devices. The reports generated for the Ronan Engineering inspections documented 

that the quality assurance and quality control programs were verified during the 

inspection. This recommendation is closed. 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review NRC Regional and Agreement State 

radioactive materials programs. These indicators are (1) Technical Staffing and Training, 

(2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical 

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

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Branch’s staffing level and staff 

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

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

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

considered workload backlogs. 

The Branch is located in the Department, which is located in the Cabinet. The Section, which 

is within the Branch, is responsible for the materials inspection and licensing activities of the 

Agreement State program. 

During most of the review period, the Branch was composed of one manager, one supervisor 

and eight staff positions. Between December 2011 and March 2012, the Branch lost three 

staff members due to retirement or leaving the program. The Branch lost one of those staff 

positions as part of the Commonwealth's reduction in force, which brought the total available 

staff positions to seven. At the time of the review, the two remaining staff positions had not 

been filled. At the time of the review, the Branch was able to solicit interest for the two vacant 

positions and expected the two individuals to join the program. In addition, one other staff 

member is on deployment with the military and is not expected to return until sometime in 

2013. 

Therefore, at the time of the review, there were a total of four staff members, one supervisor, 

and one manager, totaling approximately 5.2 full-time equivalents (FTE). The review team 

recognized that the supervisory position continues to perform some licensing, emergency and 

incident response activities. The deployed position can not be back-filled and therefore, the 

one-FTE is not captured in the total above. The Branch has been able to fill vacant positions 

in a timely manner during the review period. While one position has been reduced during the 
Kentucky Final IMPEP Report Page 5 

review period, the review team determined that staffing levels were adequate for the size and 

scope of the Agreement State program. 

The Branch has a newly revised documented training plan for technical staff that is consistent 

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

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

the Nuclear Material Safety and Safeguards Program Area.” Staff members are assigned 

increasingly complex duties as they progress through the qualification process. 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. Qualification is established through a combination of education and experience 

through formal classroom, in-house, and on-the-job training. The Section considers both 

attendance at the NRC-sponsored training courses and alternate resources for training as a 

means to meet the education component of the training program. The review team observed 

that all current staff members have met the qualification requirements in at least one modality. 

The review team concluded that the Branch’s training program is adequate to carry out its 

regulatory duties and noted that Kentucky’s management is supportive of the training program. 

The Commonwealth does not currently have a radiation advisory board. The Branch is in 

discussions with upper Cabinet level administrators regarding the formation of a Medical 

Advisory Board (Board) composed of program administration staff members and professionals 

from the private sector. This Board would encompass both radioactive materials and radiation 

producing machines. Several current medical radiation safety officers, authorized medical 

physicists, and physician authorized users have been approached about possibly serving on 

this Board. The individuals contacted have responded favorably to the request to serve on the 

Board. Preliminary discussions have started on how to establish the Board, appoint its 

members, and develop its mission and by-laws. The Commonwealth anticipates having the 

Board established by the end of December 2012. 

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, be 

found satisfactory. 

3.2 Status of Materials Inspection Program

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

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

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

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

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

management and staff. 

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

material licenses are at least as frequent as similar types of licenses listed in IMC 2800, 

“Materials Inspection Program.” Prior to January 2012, some of Kentucky’s inspection 

frequencies were more frequent than the similar license types as listed in IMC 2800. However, 

as of January 1, 2012, Kentucky chose to inspect all licenses at the same frequency as those 
Kentucky Final IMPEP Report Page 6 

listed in IMC 2800 to make better use of available resources while still providing appropriate 

licensee oversight. 

During the review period, the Branch created a new spreadsheet for tracking inspections, 

resulting in two inspection tracking spreadsheets which were not integrated. The Branch was 

aware of the monthly and quarterly inspections that were due; however, the Branch did not realize 

the percentage of overall inspections that were conducted overdue nor did the Branch perform an 

assessment to ensure that the licensees with the highest safety significance were receiving 

priority attention. The review team calculated the Branch conducted 48 high priority (Priority 1, 2, 

and 3) inspections overdue by more than 25 percent of the inspection frequency prescribed in 

IMC 2800, during the review period. The review team found that the Branch had diverted 

resources in 2009 to support an onsite presence and perform inspections at a large, 

decommissioning/remediation activity in downtown Louisville. The Branch subsequently 

performed the backlog inspections and continued to perform the rolling backlog of inspections 

during the review period. During the period, the Branch conducted two campaigns to eliminate or 

minimize the number of overdue inspections. Although a large number of inspections were 

overdue during this period, the Branch made considerable progress in reducing the number of 

overdue inspections by the close of the review period. At the time of the review, two Priority 1, 2, 

and 3 inspections were currently overdue by more than 25 percent of the inspection frequency 

prescribed in IMC 2800. 

The review team determined that the Branch performed 34 initial inspections during the review 

period, in which 8 were conducted overdue based on the 12 month requirement in IMC 2800. 

Overall, the review team calculated that the Branch performed 41 percent of its Priority 1, 2, and 

3 and initial inspections overdue during the review period. The review team found that the 

Branch had expended considerable effort in completing overdue inspections since 2004, and 

had achieved no overdue inspections at the time of each IMPEP review. (Note: The 2008 

review team found that during the 2004 IMPEP review, the number of high priority inspections 

reported was incorrect due to a miscalculation. It should have been reported as exceeding the 

25 percent metric, not the 9.6 percent stated in the report.) 

The reasons contributing to the overdue inspections since 2004 included a total staff turnover and 

minimal staffing levels during 2004 and 2008, and management decisions to address emergent 

activities during the current review period. The fact that there were two spreadsheets also 

contributed to management not fully realizing the high percentage of overdue inspections. The 

Branch has a new spreadsheet to track and assign inspections to ensure inspections are 

completed as expected. 

The review team evaluated the timeliness of issuing 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. A sampling of 30 inspection reports indicated that 4 of the inspection 

findings were communicated to the respective licensee beyond the Branch’s goal of 30 days 

after the inspection. Those letters that were issued greater than the 30 day issuance goal, 

ranged from a few days to a few months past the goal date. Three of the four letters that were 

issued late had violations associated with the inspection reports, and the Section Supervisor 

was aware of the delays. 
Kentucky Final IMPEP Report Page 7 

During the review period, the Branch granted 211 reciprocity permits, in which 42 were 

candidate licensees 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 or exceeded the criteria of inspecting 20 percent of 

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

period and did not meet the 20 percent inspection criteria in the other two years. 

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

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

overdue during the review period and because the Branch did not perform an assessment or 

develop a plan to address the potential health and safety impacts from significantly reducing its 

regulatory presence in the field. The MRB directed that a recommendation be made for the 

Branch to perform a self-assessment to determine the effectiveness of its oversight of the 

inspection program. The results of this self-assessment would be discussed at the next periodic 

meeting. 

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, be found unsatisfactory. 

3.3 Technical Quality of Inspections

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

notes, and interviewed inspectors for 31 radioactive materials inspections conducted during the 

review period. The casework reviewed included inspections conducted by six Branch 

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

medical institutions-imaging/therapy (HDR, permanent/temporary brachytherapy), medicaldiagnostic, portable gauges, industrial radiography, gamma knife, well logging, nuclear 

pharmacy, mobile nuclear medicine, and Increased Security Controls for Large Quantities of 

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

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

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

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

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

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

Documentation supported violations, recommendations made to licensees, unresolved safety 

issues, and discussions held with licensees during exit interviews. 

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

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

and signed by the Section Supervisor or the Branch Manager. 
Kentucky Final IMPEP Report Page 8 

Supervisory accompaniments of Branch inspectors were conducted in the review period. Some 

inspectors did not have supervisory accompaniments in 2011. In addition, the documentation 

for inspector accompaniments in 2009 and 2010 could not be located. However, at least four 

inspectors were accompanied during this two-year period as determined through other methods 

of documentation including inspection reports, staff interviews and notes to file. 

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

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

documented in the reports. Inspection findings were sent to the licensees by a letter 

summarizing the results of the inspection. The Branch issues either a letter indicating a clear 

inspection or a Notice of Violation (NOV). When the Branch issues an NOV, the licensee is 

required to provide a written corrective action plan, based on the violations cited, within 30 days. 

All findings are reviewed by the Section Supervisor or the Branch Manager. 

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

support their inspection program. Appropriate, calibrated survey instrumentation was observed 

to be available. Instruments are calibrated at least annually, or as needed. 

The review team accompanied four of the Branch's radioactive materials inspectors during the 

weeks of April 23 and June 7, 2012. The inspectors were accompanied during health and 

safety inspections of nuclear medicine, radiography, medical therapy, including a security 

inspection at a gamma stereotactic radiosurgery facility. The accompaniments are identified in 

Appendix C. 

During the accompaniments, the inspectors demonstrated appropriate inspection techniques, 

knowledge of the regulations, and conducted performance based inspections. The inspectors 

were trained, well-prepared for the inspection, and thorough in their audits of the licensees’ 

radiation safety programs. The inspectors conducted interviews with appropriate personnel, 

observed licensed operations, conducted confirmatory measurements, and utilized good health 

physics practices. The inspections were adequate to assess radiological health and safety and 

Increased Controls at the licensed facilities. 

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

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

found satisfactory. 

3.4 Technical Quality of Licensing Actions

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

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

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

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

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

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

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

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

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

completed during the review period. Licensing actions selected for evaluation included 
Kentucky Final IMPEP Report Page 9 

3 new licenses, 1 renewal in entirety, 1 decommissioning or termination action, and 

22 amendments (including one transfer of control). Files reviewed represented a cross-section 

of license types, including: broadscope, medical diagnostic and therapy (including, high dose 

rate remote afterloader and unsealed radioiodine therapy), mobile nuclear medicine, industrial 

radiography, well logging, waste disposal service, research and development, nuclear 

pharmacy, gauges and manufacturers. The casework sample represented work from ten 

license reviewers. A listing of the licensing casework evaluated is provided in Appendix D. 

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

and of high quality with health, safety, and security issues properly addressed. License 

tie-down conditions were stated clearly and were supported by information contained in the file. 

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

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

were well documented, showing appropriate transfer and survey records. License reviewers 

use the Branch's licensing guides and/or NUREG-1556 series guidance documents, policies, 

checklists, and standard license conditions specific to the type of licensing actions to ensure 

consistency in licenses. 

All licensing actions undergo a peer and management review by the Section Supervisor. The 

Branch Manager subsequently signs the license. The license reviewers and Section Supervisor 

do not have signatory authority for licensing actions. Licenses are issued for a one-year period 

based on the collection of an annual fee. The Commonwealth’s regulations require, and the 

Branch’s licensing guidance documents note, that an amendment in entirety must be performed 

every five to seven years. However, due to staff turnover and license backlog issues, requests 

for amendment in entirety have been temporarily suspended. 

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

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

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

attributed the consistent use of templates and quality assurance reviews to the overall quality 

noted in the casework reviews. 

The review team evaluated 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 initial licenses that required financial assurance. The review team also 

noted that the Branch places a license condition on all licenses, which restricts the licensee to 

possess radioactive material in amounts less than the amount required for financial assurance 

or the licensee is required to provide financial assurance. The review team identified two cases 

in which the Branch did not address financial assurance requirements properly. One involved a 

licensing action to increase the maximum possession of radioactive material above limits that 

would require the licensee to obtain financial assurance for decommissioning; however, this was 

not addressed as part of the licensing action. The second case was noted during a review of 

one cyclotron license, which also indicated that financial assurance was not addressed as a 

component of the licensing action. The review team discussed these observations with the 

Branch. The Branch immediately took the appropriate steps to ensure compliance with the 

financial assurance requirements which included implementing the use of a financial assurance 

spreadsheet calculator and updating the checklists to include a review of financial assurance as 

part of the license amendment process. In addition, the Branch initiated an entire review of 
Kentucky Final IMPEP Report Page 10 

licenses to verify financial assurance was properly addressed. On September 10, 2012, the 

review team was notified that the Branch had completed its review and identified one other 

license that required financial assurance and it was being addressed. 

The Branch performs pre-licensing checks of all new applicants. The Branch's pre-licensing 

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

verify that the applicant will use requested radioactive materials as intended. All new licensees 

receive a pre-licensing site visit which includes an evaluation of the applicant’s radiation safety 

and security programs prior to receipt of the initial license. 

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

Fingerprinting Orders. The review team noted that the Commonwealth uses legally binding 

license conditions that meet the criteria for implementing the Increased Controls Orders, 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 review team confirmed 

that license reviewers evaluated new license applications and license amendments using the 

same criteria. The Branch requires full implementation of the Increased Controls prior to issuance 

of a new license or license amendment that meets the established criteria. 

The review team examined the Branch’s practice for the control of sensitive information. The 

review team noted that the Branch controls access to all of its licensing and inspection files. 

Files that contained sensitive information are conspicuously marked and were further secured in 

locked file cabinets. 

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, 

be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Branch's actions in responding to radioactive material 

incidents, 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 nine radioactive materials incidents. A 

listing of the incident casework examined, with case-specific comments, may be found in 

Appendix E. 

The review team examined the Branch's allegation and incident processes and procedures, 

including Section 412, "Responding to Allegations/Complaints" and Section 413, "Responding to 

Incidents." These written procedures described the criteria for responding to incident and 

allegations, file documentation, notification of incidents to the NRC Headquarters Operations 

Center, and the use of NMED software. When notification of an incident or an allegation is 

received, the Section Supervisor determines the appropriate level of initial response. The 

review team determined that the basis for performing an onsite investigation was commensurate 

with the potential health and safety impacts of the incident. The review team observed that 

procedure Section 413 did not contain any response criteria for a medical event. However, the 

review team determined that the Branch responded to medical events as expected. The Branch 

agreed to incorporate the medical response criteria that it utilizes into written procedures. 
Kentucky Final IMPEP Report Page 11 

The review team selected nine incidents for review, including the following categories: lost 

radioactive material, potential overexposure, medical event, and damaged portable gauge 

equipment. The review team determined that the Branch's response to incidents reflected the 

response criteria in its written procedures and guidance from the Section Supervisor. Initial 

responses were prompt and well-coordinated, and the level of effort was commensurate with the 

health and safety significance. If the incident met the reportability thresholds, as established in 

the Office of Federal and State Materials and Environmental Management Programs (FSME) 

Procedure SA-300 “Reporting Material Events,” then the Commonwealth notified the NRC 

Headquarters Operations Center and entered the information into NMED in a prompt manner. 

The review team identified 28 radioactive material incidents in NMED for Kentucky during the 

review period of which 22 were reported in accordance with SA-300. Six non-reportable 

incidents in NMED for Kentucky were reviewed for reportability and found to be correctly 

categorized as non-reportable by the Branch. For the radioactive material incidents evaluated, 

the Branch dispatched inspectors for on-site investigations in three of the nine cases reviewed. 

The review team determined that the Branch's responses to incidents were thorough and 

complete. While the actions taken in response to incidents were documented and completed in 

NMED, the review team identified that the Branch did not always perform follow-up reviews of 

the incident during the subsequent inspection. A follow-up review would verify that the 

corrective actions were adequate and or the incident was sufficiently closed. In some instances, 

the cases reviewed indicated that the inspector was not aware that an incident had occurred 

during the inspection review period. The Branch immediately modified its checklist to ensure 

that a copy of the incident tracking sheet was included in the license folder, so that it would be 

readily apparent to the inspector, and to ensure that appropriate follow-up would be performed 

during a subsequent inspection. 

The Branch did not receive any allegations during the review period. Therefore, the review 

team was unable to review the implementation of this aspect of the program. The Branch 

indicated that by procedure, the Commonwealth will notify concerned individuals of the 

conclusion of its investigation and that the Branch protects the identity of concerned individuals 

within its regulations. 

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, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

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

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program (SS&D), 

(3) Low-Level Radioactive Waste (LLRW) Disposal Program, and (4) Uranium Recovery 

Program. The Agreement State program has been performing routine inspections at the former 

LLRW facility, Maxey Flats. The facility was closed in 1977 and an interim cap was put into 

place in 2003. Therefore, the review team did not review this indicator, although the status of 

the facility is briefly discussed in the report. In addition, the NRC’s Agreement with Kentucky 

does not relinquish regulatory authority for a uranium recovery program. Therefore, only the 

first two non-common performance indicators applied to this review. 
Kentucky Final IMPEP Report Page 12 

4.1 Compatibility Requirements

4.1.1 Legislation

Kentucky became an Agreement State on March 26, 1962. The current effective statutory 

authority is contained in the Kentucky Revised Statutes 13B.170, 194A.050, 211.090, 211.842 

to 852, 211.859, 211.990(4), and 211.861 to 869. The Branch is designated as the 

Commonwealth’s radiation control agency. The review team noted that no legislation affecting 

the radiation control program was passed during the review period. 

4.1.2 Program Elements Required for Compatibility 

The Kentucky regulations for “Control of Radiation” are located in 902 Kentucky Administrative 

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

radiation. Kentucky requires a license for the receipt, possession, use, ownership, or transfer of 

all radioactive material, including byproduct, source, certain quantities of special nuclear material, 

accelerator-produced radionuclides, and naturally-occurring materials, such as radium. 

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

that the process takes approximately 19 months from the development stage to the final 

approval. The public, the NRC, other agencies, and potentially impacted licensees and 

registrants are offered an opportunity to comment during the process. Comments are 

considered and incorporated, as appropriate, before the regulations are finalized. 

The review team noted that the Commonwealth’s rules and regulations are not subject to sunset 

laws. The Commonwealth has the authority to issue legally binding requirements (e.g., license 

conditions) in lieu of regulations until compatible regulations become effective. 

The review team evaluated Kentucky’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. 

During the review period, Kentucky submitted 14 final regulation amendments and 1 legally 

binding license condition to the NRC for a compatibility review. Fourteen of the amendments 

were overdue for Agreement State adoption at the time of submission. 

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

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

regulations. The review team observed that the Commonwealth had made considerable 

progress in the promulgation of regulations since the last IMPEP review. At that time, the 

Commonwealth had 16 amendments, which ranged from one to ten years overdue. At the time 

of this review, the following five amendments were overdue. The Branch is currently drafting 

proposed regulations for these five amendments and plans to submit them to NRC for review. 

 
Kentucky Final IMPEP Report Page 13 

• “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 adoption by February 16, 2004. 

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

32 and 35 amendment (72 FR 45147, 54207), that was due for Agreement State 

adoption by October 29, 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 was due for Agreement State adoption by December 17, 2010. 

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

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

adoption by November 30, 2010. 

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

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

adoption by February 15, 2011. 

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

address in the future. 

• “Medical Use of Byproduct Material – Authorized User Clarification,” 10 CFR Part 35 

amendment (74 FR 33901), due for Agreement State adoption by September 28, 2012. 

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

35512), due for Agreement State adoption by December 17, 2015. 

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

39, 40, 70, and 150 amendments (76 FR 56951), due for Agreement State adoption by 

November 14, 2014. 

• “Change of Compatibility of 10 CFR 31.5 and 31.6 in the Withdrawal of Proposed Rule 

and Closure of Petition For Rulemaking: Organization of Agreement States and Florida 

Department of Health, Bureau of Radiation Control,” 10 CFR Part 31 amendment (77 FR 

3640), due for Agreement State adoption by January 25, 2015. 

• “Advance Notification to Native American Tribes of Transportation of Certain Types of 

Nuclear Waste,” 10 CFR Part 71 amendment (77 FR 34194), due for Agreement State 

adoption by August 10, 2015. 

• “Technical Corrections,” 10 CFR Parts 30, 34, 40, and 71 amendments (77 FR 39899), 

due for Agreement State adoption by August 6, 2015. 

• “Requirements for Distribution of Byproduct Material,” 10 CFR Parts 30, 31, 32, 40, and 

70 amendments (77 FR 43666), due for Agreement State adoption by October 23, 2015. 
Kentucky Final IMPEP Report Page 14 

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, be found 

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 Sealed Source and Device (SS&D) Evaluation Program: Technical 

Staffing and Training, Technical Quality of the Product Evaluation Program, and 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 issued one amendment to an existing registration during the review period. 

There were no inactivations or new evaluations performed 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 had three reviewers who were qualified to perform safety evaluations of SS&D 

applications during the review period. However, one SS&D reviewer retired in March 2012, but 

a new reviewer is in the process of becoming qualified. All reviewers have degrees in a 

physical science or engineering and have attended the NRC’s SS&D Workshop or the Branch’s 

contracted training course that was conducted in July 2007. 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 Commonwealth currently has one device manufacturer who has eleven active SS&D 

registrations. Registrations clearly summarize the product evaluations and 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 evaluation was thorough, 

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

the product during use and under accident conditions. 

The review team evaluated the one amendment action issued during the review period. The 

casework reviewed represented the efforts of two of the SS&D reviewers. An amendment was 

also submitted for a second registry; however, the Branch indicated that it was not approved 

due to health and safety concerns not being adequately addressed by the manufacturer. Since 

this second action was not completed, it was not included in the casework evaluated. A listing 

of the one SS&D casework examined may be found in Appendix F. 
Kentucky Final IMPEP Report Page 15 

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 communication via e-mail with a licensee and the use of the evaluation checklist as 

recommended in NUREG 1556 Vol. 3, Rev. 1. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Utilizing NMED, the review team examined 26 incidents involving SS&D registered products 

during the review period. The review team examined all events that occurred in Kentucky that 

involved equipment or source failures within the period, as well as any events that occurred 

nationally involving devices registered by the Commonwealth. The review team determined that 

the Branch analyzed the events, reviewed the issues, and followed up on the incidents. None of 

the events involving sources/devices manufactured or distributed by a licensee with a SS&D 

registered in Kentucky were related to manufacturing or design of the product. 

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, be found satisfactory. 

4.3 Low-Level Radioactive Waste Disposal Program

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

on approximately 800 acres 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 facility used trenches as the disposal method. The 

trenches were located in a fenced portion of the site. Once the license was terminated, the site 

was transferred to the Commonwealth of Kentucky. 

A temporary cover was placed over approximately 30 acres of the trenched area for 

stabilization. Maintenance activities for surface water controls and environmental monitoring 

was initiated. However, water continued to collect in the trenches and leach radioactive material 

into the surrounding environment. The site was listed on the National Priorities List in 1986, and 

a Record of Decision (ROD) was issued in September 1991, by the Environmental Protection 

Agency (EPA) under its Comprehensive Environmental Response, Compensation, and Liability 

Act authority. The ROD selected a remedy of natural stabilization, which also included installing 

and monitoring a landfill cap made of a synthetic liner, replacing the landfill cap after 20 years, 

and installing a final landfill cap after 35 to 100 years. The final cap would allow for the natural 

stabilization of wastes in the trenches. Construction of the interim cap was completed in 2003, 

and the site entered the "interim maintenance period" of operation. The plan to replace the cap 

after 20 years would allow the trenches to stabilize and allow further decay of the shorter halflife radionuclides. Although natural stabilization was estimated to require 35 to 100 years, the 

EPA is evaluating whether to proceed to the Final Closure Period, which would require a final 

cap. If the Commonwealth and EPA agree to proceed to the final closure, then there would be 
Kentucky Final IMPEP Report Page 16 

an increase in support activities by the Branch. Once the Final Closure Period is complete, then 

the site would enter the Custodial Maintenance Period, in perpetuity. 

The review team did not review this indicator and therefore, the performance indicator is not 

incorporated into the overall assessment of the Kentucky Agreement State program. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, Kentucky's performance was found satisfactory for five 

of the seven performance indicators reviewed, satisfactory, but needs improvement for the 

performance indicator Compatibility Requirements, and unsatisfactory for the performance 

indicator Status of Materials Inspection Program. The review team did not make any 

recommendations regarding program performance by the Commonwealth and determined that 

the six recommendations from the 2008 IMPEP review should be closed. The MRB directed 

that a recommendation be made under Section 3.2, Status of Materials Inspection Program, and 

as indicated below. Accordingly, the review team recommended, and the MRB agreed that the 

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

needs improvement and compatible with NRC's program. Based on the results of the current 

IMPEP review, the review team recommended that the next full IMPEP review take place in 

approximately four years and two periodic meetings be conducted with the first meeting to be 

held in approximately 18 months. The MRB agreed that the next full IMPEP review take place 

in four years, but directed that just one periodic meeting be held in two years. The review team 

also recommended, and the MRB agreed, that the period of monitoring will continue in order to 

assess the status of the inspection program during the quarterly conference calls. 

Below is the recommendation, as mentioned earlier in the report, for evaluation and 

implementation, as appropriate, by the Commonwealth. 

1. The MRB recommends that the Branch perform a self-assessment to determine the 

effectiveness of its oversight of the inspection program and that the results of this selfassessment be reviewed as part of the periodic meeting. 
LIST OF APPENDICES 

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 and Device Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Rachel S. Browder, Region IV Team Leader 

 Technical Quality of Incidents and Allegations 

Monica L. Orendi, Region I Technical Staffing and Training 

 Status of Materials Inspection Program 

 Compatibility Requirements 

Joseph L. Nick, Region I Technical Quality of Inspections 

Lymari Sepulveda, FSME Sealed Source and Device Evaluation Program 

James Harris, State of Kansas Technical Quality of Licensing Actions 

Randy Erickson, Region IV Inspection Accompaniments 

Michelle Beardsley, FSME Inspection Accompaniments 
APPENDIX B 

KENTUCKY ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML12194A751 
 

 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Central Baptist Hospital License No.: 202-004-26 

Inspection Type: Routine Unannounced Priority: 2 

Inspection Date: 8/18/11 Inspector: AS 

File No.: 2 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 11/16/11 Inspector: MMG 

File No.: 3 

Licensee: Alliance Imaging License No.: 202-227-29 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/16/10 Inspector: MMG 

Comment: Inspection findings were dispatched to the licensee 90 days after the date of 

the inspection. 

File No.: 4 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 12/20/11 and 1/26/12 Inspector: MV 

 File No.: 5 

Licensee: Hardin Memorial Hospital License No.: 202-148-26 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 6/28/11 Inspector: MMG 

Comment: Inspection findings were dispatched to the licensee 172 days after the date 

of the inspection. 

File No.: 6 

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

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 8/19/11 Inspector: AS 

Comment: Previous inspection identified noncompliance and current inspection did not 

mention close out of the noncompliance issue. 

 
Kentucky Final IMPEP Report Page C.2 

Inspection Casework Reviews 

File No.: 7 

Licensee: Manalapan Mining Company License No.: 201-307-51 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/17/12 Inspector: CK 

File No.: 8 

Licensee: TPM, Inc. License No.: 201-654-51 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 4/19/12 Inspector: CK 

File No.: 9 

Licensee: Jewish Hospital License No.: 202-294-25 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/24/12 Inspector: MV 

File No.: 10 

Licensee: University of Kentucky License No.: 202-049-22 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/29/11 Inspector: AS 

Comment: No documentation of a medical event that occurred in April 2009. 

File No.: 11 

Licensee: Hinkle Contracting Corp. License No.: 201-472-51 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 9/22/11 Inspector: MG 

File No.: 12 

Licensee: Murray Calloway County Hospital License No.: 202-120-26 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 11/16/11 Inspector: MMG 

Comment: No documentation of a medical event that occurred in December 2008. 

File No.: 13 

Licensee: Our Lady of Bellefonte Hospital License No.: 202-144-26 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 11/30/10 Inspector: MMG 

File No.: 14 

Licensee: LE Gregg Associates License No.: 201-098-52 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 4/19/12 Inspector: CP 

 
Kentucky Final IMPEP Report Page C.3 

Inspection Casework Reviews 

File No.: 15 

Licensee: Huntingdon Testing & Technology, Inc. License No.: 201-551-05 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 12/29/11 Inspector: RJ 

Comment: No documentation of an event that occurred in September 2011. 

File No.: 16 

Licensee: Mistras Services License No.: 201-736-05 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 11/18/11 Inspector: RJ 

Comment: No documentation of an event that occurred in November 2011. 

File No.: 17 

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

Inspection Type: Special, Announced Priority: 3 

Inspection Date: 11/29/11 Inspector: MGG 

File No.: 18 

Licensee: Mistras Group, Inc. License No.: 201-699-05 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 3/15/12 Inspector: MG 

File No.: 19 

Licensee: Professional Services Industries License No.: 209-137-05 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 8/18/10 Inspector: MG 

File No.: 20 

Licensee: Varian Medical Systems License No.: 209-119-90 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/30/11 Inspector: MG 

File No.: 21 

Licensee: Elekta License No.: 209-087-90 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/10/11 Inspector: AS 

File No.: 22 

Licensee: America Tower Scanning License No.: 209-372-60 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 9/22/10 Inspector: MG 

 
Kentucky Final IMPEP Report Page C.4 

Inspection Casework Reviews 

File No.: 23 

Licensee: Nucletron License No.: 209-016-60 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 6/3/10 Inspector: MG 

Comment: No supervisory review signature on the inspection record. 

File No.: 24 

Licensee: Albany International License No.: 209-028-51 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 2/11/09 Inspector: MG 

File No.: 25 

Licensee: Industrial Dynamics License No.: 209-204-60 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 3/11/09 Inspector: CP 

File No.: 26 

Licensee: World Testing License No.: 209-061-05 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 2/26/09 Inspector: MG 

File No.: 27 

Licensee: Southern Well Services License No.: 201-170-40 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 11/21/11 Inspector: CK 

File No.: 28 

Licensee: Ace Clinique License No.: 202-376-24 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 10/22/09 Inspector: MGG 

File No.: 29 

Licensee: Danville Cardiovascular Consultants License No.: 202-257-24 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 9/2/11 Inspector: AS 

Comment: Two violations noted during the inspection. Inspection findings were 

dispatched to the licensee approximately 60 days after the date of the inspection. 

 
Kentucky Final IMPEP Report Page C.5 

Inspection Casework Reviews 

File No.: 30 

Licensee: 21st Century Radiation Oncology License No.: 202-352-27 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 9/28/11 Inspector: AS 

Comment: Seven violations noted during the inspection. Inspection findings were 

dispatched to the licensee approximately 45 days after the date of the inspection. 

File No.: 31 

Licensee: Enterprise Mining Company License No.: 201-280-51 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 4/30/10 Inspector: CK 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Saints Mary and Elizabeth Hospital License No.: 202-096-26 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/23/12 Inspector: MMG 

Accompaniment No.: 2 

Licensee: Jewish Hospital License No.: 202-294-25 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/24/12 Inspector: MV 

Accompaniment No.: 3 

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

Inspection Type: Routine/Special, Unannounced Priority: 2 

Inspection Date: 4/25/12 Inspector: AS 

Accompaniment No.: 4 

Licensee: Technical Welding Insp., Inc. License No.: 201-324-05 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 6/6/12 Inspector: CK 

.
 

APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

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

Type of Action: Amendment Amendment No.: 65 

Date Issued: 5/14/10 License Reviewer: MG 

File No.: 2 

Licensee: Medical Mall Imaging Center License No.: 202-416-29 

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

Date Issued: 10/26/11 License Reviewer: MV 

File No.: 3 

Licensee: Bizzack Construction, LLC License No.: 201-765-51 

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

Date Issued: 5/30/12 License Reviewer: CK 

File No.: 4 

Licensee: GEM Engineering License No.: 201-642-51 

Type of Action: Amendment Amendment No.: 21 

Date Issued: 3/5/09 License Reviewer: CP 

File No.: 5 

Licensee: GEM Engineering License No.: 201-642-51 

Type of Action: Amendment Amendment No.: 24 

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

File No.: 6 

Licensee: GEM Engineering License No.: 201-642-51 

Type of Action: Amendment Amendment No.: 25 

Date Issued: 4/3/12 License Reviewer: MG 

File No.: 7 

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

Type of Action: Amendment Amendment No.: 86 

Date Issued: 4/16/12 License Reviewer: AS 

File No.: 8 

Licensee: Cardinal Health Louisville License No.: 202-206-32 

Type of Action: Amendment Amendment No.: 51 

Date Issued: 4/22/09 License Reviewer: BP 

 
Kentucky Final IMPEP Report Page D.2 

Licensing Casework Reviews 

File No.: 9 

Licensee: Cardinal Health Louisville License No.: 202-206-32 

Type of Action: Amendment Amendment No.: 57 

Date Issued: 8/30/10 License Reviewer: AS 

File No.: 10 

Licensee: Cardinal Health Louisville License No.: 202-206-32 

Type of Action: Amendment Amendment No.: 61 

Date Issued: 1/17/12 License Reviewer: CP 

File No.: 11 

Licensee: Superior Well Service License No.: 201-714-40 

Type of Action: Amendment Amendment No.: 12 

Date Issued: 11/17/11 License Reviewer: RJ 

File No.: 12 

Licensee: AMEC Environment & Infrastructure License No.: 201-257-51 

Type of Action: Transfer Control Amendment No.: 65 

Date Issued: 3/29/12 License Reviewer: CP 

File No.: 13 

Licensee: Morehead State University License No.: 203-022-83 

Type of Action: Amendment Amendment No.: 60 

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

File No.: 14 

Licensee: Morehead State University License No.: 203-022-83 

Type of Action: Amendment Amendment No.: 58 

Date Issued: 8/27/08 License Reviewer: SB 

File No.: 15 

Licensee: Morehead State University License No.: 203-022-83 

Type of Action: Amendment Amendment No.: 63 

Date Issued: 4/3/12 License Reviewer: MG 

File No.: 16 

Licensee: Trieco, LLC License No.: 201-717-90 

Type of Action: Amendment Amendment No.: 3 

Date Issued: 7/9/10 License Reviewer: CK 

File No.: 17 

Licensee: Pharmacology Toxicology Research Lab License No.: 201-332-04 

Type of Action: Termination Amendment No.: 30 

Date Issued: 2/1/12 License Reviewer: CP 

 
Kentucky Final IMPEP Report Page D.3 

Licensing Casework Reviews 

File No.: 18 

Licensee: Northern Shared Medical License No.: 202-368-29 

Type of Action: Amendment Amendment No.: 7 

Date Issued: 3/16/12 License Reviewer: MV 

File No.: 19 

Licensee: Radiopharmacy of Paducha License No.: 202-221-32 

Type of Action: Amendment Amendment No.: 37 

Date Issued: 1/4/12 License Reviewer: RP 

File No.: 20 

Licensee: Oncology Hematology Care License No.: 202-336-27 

Type of Action: Amendment Amendment No.: 12 

Date Issued: 12/11/08 License Reviewer: AS 

File No.: 21 

Licensee: Oncology Hematology Care License No.: 202-336-27 

Type of Action: Amendment Amendment No.: 13 

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

File No.: 22 

Licensee: University Louisville License No.: 202-029-22 

Type of Action: Amendment Amendment No.: 89 

Date Issued: 10/26/11 License Reviewer: MV 

File No.: 23 

Licensee: Bourbon Community Hospital License No.: 202-186-24 

Type of Action: Entirety Renewal Amendment No.: 34 

Date Issued: 8/14/08 License Reviewer: MMG 

File No.: 24 

Licensee: K.D. Analytical Consultants License No.: 201-763-60 

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

Date Issued: 5/30/12 License Reviewer: CK 

File No.: 25 

Licensee: Stupp Bridge Co. License No.: 201-674-5 

Type of Action: Amendment Amendment No.: 19 

Date Issued: 3/17/09 License Reviewer: SB 

File No.: 26 

Licensee: Chemical Solutions License No.: 201-735-4 

Type of Action: Amendment Amendment No.: 1 

Date Issued: 4/6/12 License Reviewer: CK 

 
Kentucky Final IMPEP Report Page D.4 

Licensing Casework Reviews 

File No.: 27 

Licensee: Applied Technical Services License No.: 201-754-5 

Type of Action: Amendment Amendment No.: 1 

Date Issued: 9/22/11 License Reviewer: CK 
 

APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Mistras Group Inc. License No.: 201-699-05 

Date of Incident: 3/31/12 NMED No.: 120280 

Inspection Date: 5/8/12 Type of Incident: Possible Overexposure 

 Type of Investigation: N/A 

Comment: An inspection was conducted on May 8, 2012; however, there was no 

follow-up documented regarding the possible overexposure. 

File No.: 2 

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

Date of Incident: 11/16/11 NMED No.:110625 

Investigation Date: 11/23/11 Type of Incident: Medical event 

 Type of Investigation: Site 

File No.: 3 

Licensee: Mistras Services License No.: 201-736-05 

Date of Incident: 11/13/11 NMED No.:110600 

Inspection Date: 11/18/11 Type of Incident: Radiography, source disconnect 

 Type of Investigation: N/A 

Comment: The inspection conducted on November 18, 2011, was a security inspection 

only; no follow-up was documented regarding the source disconnect. 

File No.: 4 

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

Date of Incident: 9/11/11 NMED No.:110598 

Investigation Date: N/A Type of Incident: Radiography, breached boundary 

 Type of Investigation: N/A 

File No.: 5 

Licensee: L.E. Gregg Associates License No.: 201-098-52 

Date of Incident: 8/25/11 NMED No.:110444 

Investigation Date: 8/27/11 Type of Incident: PG 

 Type of Investigation: Site 

 
Kentucky Final IMPEP Report Page E.2 

Incident Casework Reviews 

File No.: 6 

Licensee: Our Lady of Bellefonte Hospital License No.: 202-144-26 

Date of Incident: 7/15/11 NMED No.:110426 

Investigation Date: N/A Type of Incident: Medical event 

 Type of Investigation: N/A 

File No.: 7 

Licensee: Jewish Hospital License No.: 202-115-22 

Date of Incident: 12/15/09 NMED No.:110037 

Investigation Date: N/A Type of Incident: Lost source 

 Type of Investigation: N/A 

File No.: 8 

Licensee: Hinkle Contracting Corp. License No.: 201-472-51 

Date of Incident: 5/25/10 NMED No.:110288 

Investigation Date: 5/25/10 Type of Incident: Damaged PG 

 Type of Investigation: Site 

File No.: 9 

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

Date of Incident: 2/23/10 NMED No.:100079 

Investigation Date: N/A Type of Incident: Medical event 

 Type of Investigation: N/A 
 

APPENDIX F 

SEALED SOURCE AND DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

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: 10/08/08 Reviewers: MG, MK 
 

 

ATTACHMENT 

August 7, 2012 email from Matthew McKinley 

Kentucky’s Response to the Draft Report 

ADAMS Accession No.: ML12220A281