March 21, 2014 

Mr. Michael Snee, Chief 

Bureau of Radiation Protection 

Ohio Department of Health 

246 North High Street 

Columbus, OH 43215

Dear Mr. Snee: 

On February 18, 2014, the Management Review Board (MRB) met to consider the proposed 

final Integrated Materials Performance Evaluation Program (IMPEP) report on the Ohio 

Agreement State Program. The MRB found the Ohio program adequate to protect public health 

and safety and compatible with the U.S. Nuclear Regulatory Commission’s (NRC) program. 

Section 5.0, page 12, of the enclosed final report contains a summary of the IMPEP team’s 

findings. The review team made no recommendations in regard to program performance by the 

Ohio Agreement State Program during this review, and closed a recommendation concerning 

the development and implementation of a staff training and qualification program from the 2008 

IMPEP review. In addition, the team identified Ohio’s establishment of the Bureau Medical 

Event Review Team for reviewing medical and other possible overexposure events as a good 

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

Agreement State Program will take place in approximately 5 years, with a periodic meeting 

tentatively scheduled for June 2016. The next IMPEP review was extended by one year 

because of Ohio’s sustained high level of performance. 

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: 

Ohio Final IMPEP Report 

cc: Jennifer Opila, Colorado 

 Organization of Agreement States 

 Liaison to the MRB 

 Michael Bear, Interim Branch Chief 

 Ohio Emergency Management Agency
Mr. Michael Snee, Chief 

Bureau of Radiation Protection 

Ohio Department of Health 

246 North High Street 

Columbus, OH 43215

Dear Mr. Snee: 

On February 18, 2014, the Management Review Board (MRB) met to consider the proposed 

final Integrated Materials Performance Evaluation Program (IMPEP) report on the Ohio 

Agreement State Program. The MRB found the Ohio program adequate to protect public health 

and safety and compatible with the U.S. Nuclear Regulatory Commission’s (NRC) program. 

Section 5.0, page 12, of the enclosed final report contains a summary of the IMPEP team’s 

findings. The review team made no recommendations in regard to program performance by the 

Ohio Agreement State Program during this review, and closed a recommendation concerning 

the development and implementation of a staff training and qualification program from the 2008 

IMPEP review. In addition, the team identified Ohio’s establishment of the Bureau Medical 

Event Review Team for reviewing medical and other possible overexposure events as a good 

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

Agreement State Program will take place in approximately 5 years, with a periodic meeting 

tentatively scheduled for June, 2016. The next IMPEP review was extended by one year 

because of Ohio’s sustained high level of performance. 

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: 

Ohio Final IMPEP Report 

cc: Jennifer Opila, Colorado 

 Organization of Agreement States 

 Liaison to the MRB 

 Michael Bear, Interim Branch Chief 

 Ohio Emergency Management Agency

DISTRIBUTION: 

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ML14055A223 

OFC

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ASPB/MSSA ASPB:BC MSSA: D TechEd FSME:D EDO/DEDMRT

NAME MBeardsley via 

email w/edits 

LDimmick 

w/edits 

DWhite LDudes / 

jmm 

CPoland BHolian MWeber 

DATE 02/24/14 02/25/14 02/25/14 02/26/14 03/05/14 03/13/14 03/ 21 /14 

OFFICIAL RECORD COPY 
Letter to M. Snee from Michael F. Weber dated March 21, 2014 

SUBJECT: OHIO FY2014 FINAL IMPEP REPORT 

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RidsEdoMailCenter 

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RidsRgn4MailCenter 

LHowell, RIV 

AVegel, RIV 

RidsSecyCorrespondenceMailCenter Chairman Macfarlane 

RidsFsmeMssa Commissioner Svinicki 

JLynch, RIII/RSAO Commissioner Apostolakis 

JNick, RI Commissioner Magwood 

SPoy, FSME Commissioner Ostendorff 

SFlaherty, MN SECY 

MLight, OH 

SHelmer, OH 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE OHIO AGREEMENT STATE PROGRAM 

DECEMBER 10–13, 2013 

FINAL REPORT
EXECUTIVE SUMMARY 

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

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

period of December 10-13, 2013, by a review team composed of technical staff members from 

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

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

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

regarding program performance by the State and determined that the one recommendation from 

the 2008 IMPEP review be closed. 

The review team identified a good practice by the State regarding its creation of a board to 

review all medical events and any other events involving potential overexposures in order to 

formulate a comprehensive and informed response by all board members. 

Accordingly, the review team recommends that the Ohio Agreement State Program be found 

adequate to protect public health and safety and compatible with the NRC's program. The 

review team recommends that the next IMPEP review take place in approximately five years. 
Ohio Final IMPEP Report Page 1 

1.0 INTRODUCTION 

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

was conducted during the period of December 10-13, 2013, by a review team composed of 

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

Minnesota. 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 November 1, 2008 to December 13, 2013, were discussed 

with Ohio managers on the last day of the review. 

A draft of this report was provided to Ohio for factual comment on January 6, 2014. The State 

responded to the findings and conclusions by email dated January 14, 2014. A copy of the 

State’s response is included as an Attachment to this report. A Management Review Board 

(MRB) met on February 18, 2014, to consider the proposed final report. The MRB found the 

Ohio Agreement State Program adequate to protect public health and safety, and compatible 

with the NRC’s program. 

The Ohio Agreement State Program is administered by the Bureau of Radiation Protection (the 

Bureau) which is located within the Division of Prevention (the Division). The Division is part of 

the Department of Health (the Department). Organization charts for the Department and the 

Bureau are included as Appendix B. 

At the time of the review, the Ohio Agreement State Program regulated 608 specific licenses 

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

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

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

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to the Bureau on April 2, 2013. The Bureau 

provided its response to the questionnaire on December 10, 2013. A copy of the questionnaire 

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

(ADAMS) using the Accession Number ML13281A503. 

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

the Bureau’s response to the questionnaire, (2) review of applicable Ohio statutes and 

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

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

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

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

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

performance. 

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

during the previous review. 
Ohio Final IMPEP Report Page 2 

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, which concluded on October 31, 2008, the review team 

made one recommendation regarding the Ohio Agreement State Program’s performance. The 

status of the recommendation is as follows: 

“The review team recommends that the State document and implement a training and 

qualification program that, at a minimum, contains a statement of policy, minimum 

qualifications for staff training, and supervisory verification for ensuring this policy is 

implemented. (Section 3.1)” 

Status: The State developed and implemented a training and qualification program for 

technical staff members. Supervisors maintain a folder for each employee, which 

contains the training policy, and has records of training, supervisory accompaniments, 

and approvals for specific types of inspections and licensing actions. 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

Considerations central to the evaluation of this indicator include the Bureau’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 Bureau’s questionnaire response 

relative to this indicator, interviewed managers and staff, reviewed job descriptions and training 

records, and considered workload backlogs. 

The Bureau is located in the Department offices in Columbus and is headed by the Bureau 

Chief. The Bureau is divided into three programs: the Nuclear Material Safety Program, the 

X-ray Program, and the Technical Support Program. Each program is managed by an 

administrator. The Agreement State program is implemented by the Nuclear Material Safety 

Program and a portion of the Technical Support Program. The Nuclear Material Safety Program 

functions as the licensing and inspection group for radioactive materials. The Technical Support 

Program is responsible for oversight of staff training and houses the Bureau’s radiation safety 

officer program. 

At the time of the review, there were 24 technical staff members with various degrees of 

involvement in the radioactive materials program, totaling approximately 20.3 full-time 

equivalents (FTE). No technical positions were vacant at the time of this review. Nine 
Ohio Final IMPEP Report Page 3 

technical staff members were hired during the five-year review period, including people with 

industry and medical experience. Seven employees left the program during the review period 

for other positions in Ohio government and industry, or retirement. The vacancies were 

promptly filled. Two employees are currently working remotely for the program from other 

State offices. The review team determined that staffing levels were adequate for the 

Agreement State program. 

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

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

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

Material Safety and Safeguards Program Area.” The review team suggested that the Program 

may wish to use the recently issued IMC 1248, “Formal Qualifications Programs for Federal and 

State Materials and Environmental Management Programs,” which has an expanded 

qualification journal component. 

The Bureau uses a combination of self-study and formal training, such as the NRC courses, and 

on-the-job experience to qualify staff as both inspectors and license reviewers. New staff 

members are trained in licensing and inspection by performing simple licensing and inspection 

activities and gradually working toward more technical activities. All new staff members perform 

licensing actions and inspections with a senior-level staff member providing support and 

guidance until they are approved by their supervisor to work independently. An individual is 

approved to perform independent actions after the supervisor has observed or reviewed the 

individual’s performance on several licensing actions or inspections of a given license type. 

The State uses “Ohio Train”, which is a State-wide web-based system, to electronically track 

each staff member’s training history. Monthly training sessions on current topics are widely 

attended by staff. The review team noted that Department and Bureau managers 

enthusiastically support training opportunities for staff members. 

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

that Ohio’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 Bureau’s questionnaire response relative to this indicator, data gathered from the 

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

management and staff. 

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

licenses are at the same frequency as similar license types listed in IMC 2800, “Materials 

Inspection Program”. 

The Bureau conducted 508 Priority 1, 2, and 3 inspections during the review period, none of 

which were performed overdue based on the inspection frequencies established in IMC 2800. 
Ohio Final IMPEP Report Page 4 

In addition, the Bureau performed 63 initial inspections during the review period, none of which 

were conducted overdue. The Bureau performs an initial inspection at the time of license 

delivery and requires the licensee to notify them when they receive materials at which time they 

will perform another inspection. 

The review team evaluated the Bureau’s timeliness in providing inspection findings to licensees. 

A sampling of 25 inspection reports indicated that four of the inspection findings were 

communicated to the licensees beyond the Bureau’s goal of 30 days after the inspection (from 

4 to 75 days overdue) 

During the review period, the Bureau granted 380 reciprocity permits, 122 of which were 

candidate licensees based upon the criteria in IMC 1220. The review team determined that the 

Bureau exceeded the NRC’s criteria of inspecting 20 percent of candidate licensees operating 

under reciprocity in each of the five years covered by the review period. 

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

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

be found satisfactory. 

3.3 Technical Quality of Inspections

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

notes, and interviewed inspectors for 25 radioactive materials inspections conducted during the 

review period. The casework reviewed included inspections conducted by 11 Bureau inspectors 

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

institutions-therapy (including high dose rate remote afterloader, permanent/temporary implant 

brachytherapy), medical-diagnostic, portable gauges, industrial radiography, gamma knife, 

nuclear pharmacy, and Increased Security Controls for Large Quantities of Radioactive 

Materials (Increased Controls). Appendix C lists the inspection casework files reviewed, as well 

as the results of the inspector accompaniments. 

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

aspects of 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. The 

documentation supported violations, recommendations made to licensees, unresolved safety 

issues, the effectiveness of corrective actions taken to resolve previous violations and 

discussions held with licensees during exit interviews. 

The inspection procedures utilized by the Bureau 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 Manager. Supervisory accompaniments were conducted annually for all 

inspectors. 

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

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

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

results of the inspection. The Bureau issues to the licensee, either a letter indicating a clear 
Ohio Final IMPEP Report Page 5 

inspection or a Notice of Violation (NOV), in letter format, which details the results from the 

inspection. When the Bureau 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 Program Manager. 

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

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

Geiger-Mueller (GM) meters, scintillation detectors, ion chambers, micro-R meters, and neutron 

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

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

with National Institute of Standards and Technology traceable sources. The Bureau uses a 

database to track each instrument, its current location, and next calibration date. 

Accompaniments of six Bureau inspectors were conducted by two IMPEP team members during 

the week of September 9, 2013. The inspectors were accompanied during health and safety 

inspections of source manufacturing, industrial radiography, portable gauges, nuclear 

pharmacy, medical therapy including high dose rate remote after loader/gamma knife/unsealed 

radioiodine therapy/permanent implant brachytherapy, etc., and medical diagnostic licenses. 

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 security at the licensed facilities. 

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

that Ohio’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, 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 6 new 

licenses, 3 renewals, 3 decommissioning or termination actions, and 15 amendments. Files 

reviewed included a cross-section of license types, including broadscope, medical diagnostic 

and therapy (including high dose rate remote afterloader, unsealed radioiodine therapy, 

temporary/permanent implant brachytherapy), gamma knife, industrial radiography, research 

and development, nuclear pharmacy, gauges, and manufacturers. The casework sample 
Ohio Final IMPEP Report Page 6 

represented work from 12 license reviewers. A list of the licensing casework evaluated with 

case-specific comments is provided in Appendix D. 

The review team discovered one amended license issued for a facility with a gamma knife 

included an authorized medical physicist who was added to the license without proper 

documentation to verify the training, experience, and preceptor attestation. Specifically, the 

documentation submitted did not meet the educational requirements. The review team brought 

this to the attention of the Bureau, who immediately contacted the licensee and determined this 

specific authorized medical physicist could be qualified through the same educational 

requirements he met to be on a license in 2011 for high dose rate afterloader. The Bureau then 

added the appropriate documentation to the file for the gamma knife amendment to show the 

authorized medical physicist meets the educational requirements. 

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. 

Requests for licensing deficiencies clearly stated regulatory positions, 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 Bureau’s licensing guides and NRC NUREG-1556 series guidance 

documents, policies, checklists, and standard license conditions specific to the type of licensing 

actions to ensure consistency in licenses. 

The supervisors perform a technical and supervisory review on all licensing actions before 

issuance to the licensee. The Bureau Chief signs all licenses. Licenses are issued for a five 

year period under a timely renewal system. 

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

high quality and consistent with the Bureau’s licensing procedures and/or 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 Bureau performs pre-licensing checks of all new applicants. The Bureau’s pre-licensing 

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

to verify that the applicant will use requested radioactive materials as intended. The Bureau 

hand-delivers all new licenses to the licensee’s location of material use. At that time a 

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

security programs, is performed. 

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

and Fingerprinting Orders. The review team noted that the State uses legally binding license 

conditions that meet the criteria for implementing the Increased Controls Orders, including 

fingerprinting, as appropriate. The review team analyzed the Bureau’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 Bureau requires full implementation of the Increased Controls prior 

to issuance of a new license or license amendment that meets the established criteria. 
Ohio Final IMPEP Report Page 7 

The review team examined the Bureau’s implementation of its procedure for the control of 

sensitive information. This procedure addresses the identification, marking, control, handling, 

preparation, transportation, transmission, and destruction of documents that contain sensitive 

information related to the Increased Controls. While on site, the review team evaluated the 

Bureau’s handling and storing of sensitive documents. The team noted that while files 

containing Increased Controls documents were appropriately protected, segregated from other 

files, and maintained in a manner to limit access; the actual licenses in those files were not 

marked as containing sensitive information. The team discussed this issue with Bureau 

management who committed to address this in their procedure for the handling of documents 

containing sensitive, security information and also committed to marking these documents as 

such. 

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

that Ohio’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 Bureau’s actions in responding to incidents and 

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

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

Database (NMED) against those contained in the Bureau’s files, and evaluated the casework for 

27 radioactive materials incidents. A list of the incident casework examined, with case-specific 

comments, may be found in Appendix E. The review team also evaluated the Bureau’s 

response to 13 allegations involving radioactive materials, including 4 allegations referred to the 

State by the NRC during the review period. 

The review team examined the Bureau’s implementation of its incident and allegation 

processes, including written procedures for handling allegations and incident response, file 

documentation, and reporting of incidents. When notification of an incident or an allegation is 

received, a program supervisor determines the appropriate level of initial response. If the 

incident involves a medical event or other potential exposure event, the Bureau Medical Event 

Review Team (BMERT) is assembled. The BMERT is chaired by the Radiation Protection 

Bureau Chief and is composed of administrators from the Nuclear Materials Safety, Technical 

Support, and X-Ray Sections, the Supervisor overseeing the incident, the Office of General 

Counsel, and other personnel as requested. Participation by both radioactive material and x-ray 

program representatives allows the Bureau a comprehensive view of radiation use in the State. 

The process has resulted in the identification of crosscutting issues amongst the represented 

sections who regulate the same licensees, but different activities such as linear accelerators 

and brachytherapy. The BMERT also tracks escalated enforcement and allegation cases. The 

review team identified, and the MRB agreed, this as a good practice by the State. 

The review team identified approximately 208 radioactive material incidents listed in Ohio’s 

RADMAT database for the review period, 59 of which required reporting. Twenty 

non-reportable incidents were also reviewed for reportability and found to be correctly 

categorized as non-reportable by the Bureau. The review team selected 27 reportable 

radioactive material incidents for evaluation. These incidents included the several types of 

events: lost radioactive material, overexposure, medical event, equipment failure, damaged 
Ohio Final IMPEP Report Page 8 

equipment, leaking source, and contamination. The Bureau’s responses to the incidents were 

found to be complete and comprehensive. Initial responses were prompt and well-coordinated, 

and the level of effort was commensurate with the potential health and safety significance of the 

event. Inspectors were dispatched for onsite investigations when appropriate. Ohio places a 

high priority on on-site responses as evidenced by an on-site response in 22 of the 27 incidents 

evaluated during this review. Enforcement and other regulatory actions were taken as 

appropriate. The actions taken in response to incidents were documented in Ohio’s RADMAT 

database. 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,” the State notified the NRC Headquarters Operations Center and 

entered the information into NMED in a prompt manner. 

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

evaluated the completed casework for 13 allegations, including 4 that NRC referred to the State 

during the review period. The review team concluded that the Bureau took prompt and 

appropriate actions in response to concerns raised. The review team noted that the Bureau 

documented the investigations of concerns and retained all necessary documentation to 

appropriately close the allegations. The Bureau notified the concerned individuals of the 

conclusion of its investigations. The review team determined that the Bureau adequately 

protected the identity of concerned individuals. 

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

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

Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

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

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

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

4.1 Compatibility Requirements

4.1.1 Legislation

Ohio became the 31st Agreement State in 1999. Legislative authority to create an agency and 

enter into an Agreement with the NRC is granted in Ohio Revised Code, Section 3748.03. The 

Department is designated as the State’s radiation control agency. The Department Director 

has designated the Bureau Chief to administer the Agreement State program for the 

Department. The review team noted that three new pieces of legislation in the Ohio Revised 

Code were passed since the last review affecting the Agreement State program or its authority. 

These included Chapter 3748 regarding overall legislation for the program, Chapter 3747 

regarding low level radioactive waste act, and Chapter 119 regarding due process for license 

termination; however, none of these changes affected the radioactive materials program. 

 
Ohio Final IMPEP Report Page 9 

4.1.2 Program Elements Required for Compatibility 

The Ohio Regulations for Control of Radiation are found in various chapters of Section 3701 of 

the Ohio Administrative Code. These rules apply to all ionizing radiation, whether emitted 

from radionuclides or machine sources. Ohio requires a license for possession and use of all 

radioactive material. These rules are subject to review every five years to decide whether to 

continue the rule as it exists or modify it. 

The review team examined the procedures used in the Department’s regulatory process and 

found that regulations are drafted by staff and presented to the Radioactive Materials 

Committee of the Radiation Advisory Council (the Council). The regulations are posted on the 

Department’s web site and electronically sent to interested stakeholders for a 30- to 45-day 

comment period. Concurrently, the proposed rules are sent to the NRC for a compatibility 

review. Any comments received from the NRC, stakeholders, or the public are evaluated, and 

the regulations are revised, as necessary. The revised regulations are submitted to the Council 

for a recommendation for adoption. The formal rule adoption process begins with submittal to 

the Ohio Public Health Advisory Board, which places the review of the proposed rules on its 

calendar, holds a public hearing, and then submits the proposed rules to the Joint Committee on 

Agency Rules Review (JCARR). The JCARR is composed of State legislators and senators. 

After JCARR completes its review of the proposed rules and if it takes no action against the 

rule, the Director of Health signs the rule into enactment after it receives final approval by the 

Common Sense Initiative-Small Business Initiative of the Governor’s Office. The legislation 

process takes approximately one year from submittal to finalization. 

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

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

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

from the State Regulation Status sheet that FSME maintains. The team found that Ohio 

submitted eight proposed regulation amendments for the NRC review during the review period. 

None were submitted overdue. Ohio is current on all rulemaking. These amendments are as 

follows: 

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

32, 33, 35, 50, 61, 62, 72, 110, 150, 170, and 171 (72 FR 55864, 73 FR 42671) due for 

adoption November 30, 2010. 

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

Parts 19 and 20, (72 FR 68043) due for adoption February 15, 2011. 

• Medical Use of Byproduct Material—Authorized User Clarification, Part 35 

(74 FR 33901) due for adoption September 28, 2012. 

• “Decommissioning Planning”, Parts 20, 30, 40, 70, (76 FR 35512) due for adoption 

December 17, 2015. 

• “Licenses, Certifications, and Approvals for Materials Licensees”, Parts 30, 36, 39, 40, 

70, and 150, (76 FR 56951) due for adoption November 14, 2014. 
Ohio Final IMPEP Report Page 10 

• “Change of Compatibility of 10 CFR 31.5 and 31.6”, (77 FR 3640), due for adoption 

January 25, 2015. 

Advance Notification to Native American tribes of Transportation of Certain Types of 

Nuclear Waste (77 FR 34194) due for adoption August 10, 2015. 

• Physical Protection of Byproduct Material, 10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 

39, 51, 71 and 73 (78 FR 16922, due for adoption March 19, 2016 

A complete list of regulation amendments can be found on the NRC website at the following 

address: http://nrc-stp.ornl.gov/rss_regamendents.html. 

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

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

satisfactory. 

4.2 Sealed Source and Device Evaluation Program

In reviewing this indicator, the review team uses three subelements to evaluate the Bureau’s 

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

subelements are (1) Technical Staffing and Training, (2) Technical Quality of the Product 

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

In assessing the State SS&D evaluation activities, the review team examined the information 

provided in response to the IMPEP questionnaire and evaluated the SS&D registry sheets and 

supporting documents processed during the review period. The team also evaluated SS&D 

staff training records, certain reported incidents involving products authorized in Ohio SS&D 

registrations, the use of guidance documents and procedures, and interviewed the staff 

currently conducting SS&D evaluations. 

4.2.1. Technical Staffing and Training

The Bureau had three qualified SS&D reviewers with full signature authority during the review 

period. The Bureau had two SS&D reviewers-in-training and one qualified SS&D reviewer 

leave the Bureau during the review period. 

The Bureau currently has two qualified reviewers. Both individuals have completed the NRC 

SS&D Workshop. The Bureau plans to designate two new reviewers-in-training to be trained 

in-house with oversight from the senior SS&D reviewers. The Bureau intends to send the new 

reviewers-in-training to the NRC SS&D Workshop in 2014. 

4.2.2 Technical Quality of the Product Evaluation Program

The review team evaluated all of the 35 SS&D actions that the Bureau processed during the 

review period. The actions reviewed were for 2 new, 29 amended, and 4 inactivated SS&D 

registrations. The casework reviewed represented the efforts of all three SS&D reviewers. The 

casework review included all supporting documentation, licenses, and inspections associated 
Ohio Final IMPEP Report Page 11 

with the distributors of the SS&Ds. A list of SS&D casework examined, with case-specific 

comments, can be found in Appendix F. 

Analysis of the casework and interviews with the managers and staff confirmed that the 

Bureau’s policy is to follow the recommended guidance from the NRC’s SS&D Workshop and 

the Bureau’s SS&D Evaluation and Registration procedure, NMS-LIC-03, which is equivalent to 

NRC’s NUREG-1556, Volume 3, Revision 1, “Consolidated Guidance About Materials 

Licenses - Applications for Sealed Source and Device Evaluation and Registration”. 

Appropriate review checklists were used to ensure that all relevant materials were submitted 

and evaluated. The checklists were retained in the SS&D files along with other documents that 

identified the responsible reviewers. The review team confirmed that pertinent American 

National Standards Institute standards, NRC Regulatory Guides, and applicable references 

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

The registration files contained all correspondence, engineering drawings, photographs, 

radiation profiles, and details of the licensees’ quality assurance and quality control programs. 

However, the review team found that in 10 of the 35 case files reviewed, the drawings provided 

by the licensee were missing dimension labels. This issue was discussed with the Bureau, who 

indicated that they would review those registrations. The review team determined that overall 

the 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. The review team determined that the evaluations were of 

high quality with health and safety issues properly addressed. The Bureau enforces the 

requirements of SS&D registrations through license conditions in the specific licenses issued to 

the distributors of SS&D products. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Based upon the Bureau’s response to the questionnaire, interviews with the Bureau’s managers 

and staff, and the review team’s searches of NMED, the review team determined that there 

were incidents or defects that the Bureau reported during the review period that involved SS&D 

products registered in Ohio. The review team determined that the Bureau analyzed the events, 

reviewed the issues, and followed up on the incidents in accordance with procedures 

established by the Bureau in NMS-LIC-03 which includes generic fault considerations when 

evaluating SS&D incidents. The review team concluded that the Bureau is routinely evaluating 

the root causes of defects and incidents involving SS&D evaluations and is taking appropriate 

actions. 

The review team noted that the Bureau routinely monitors incidents reported to the NRC and to 

NMED and identified incidents or defects associated with SS&D products registered in Ohio for 

further investigation and review. The review team concluded that the Bureau evaluates the root 

causes of defects and incidents involving SS&D evaluations and takes appropriate actions. 

The review team did not identify any allegations received by the Bureau related to defects or 

failures of SS&D products registered in Ohio during the review period. 
Ohio Final IMPEP Report Page 12 

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

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

Program, be found satisfactory. 

4.3 Low Level Radioactive Waste Program (LLRW)

Although Ohio has LLRW disposal authority, the NRC has not required States to have a program 

for licensing a LLRW disposal facility until such time as the State has been designated as a host 

State for a LLRW disposal facility. When an Agreement State has been notified or becomes 

aware of the need to regulate a LLRW disposal facility, it is expected to put a regulatory program 

in place that meets the criteria for an adequate and compatible LLRW disposal program. There 

are no plans for a LLRW disposal facility in Ohio. Accordingly, the review team did not review 

this indicator. 

4.4 Uranium Recovery Program

Although Ohio has authority to regulate uranium recovery activities, the NRC has not required 

States to have a program for licensing a uranium recovery facility until such time as the State 

has such a facility. When an Agreement State has been notified or becomes aware of the need 

to regulate a uranium recovery facility, it is expected to put a regulatory program in place that 

meets the criteria for an adequate and compatible uranium recovery program. There are no 

plans for a uranium recovery facility in Ohio. Accordingly, the review team did not review this 

indicator. 

5.0 SUMMARY 

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

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

determined that the recommendation from the 2008 IMPEP review be closed. One good 

practice was identified during the review, as detailed in Section 3.5. 

Accordingly, the review team recommended, and the MRB agreed, that the Ohio Agreement 

State Program be found adequate to protect public health and safety and compatible with the 

NRC's program. Based on the results of the current IMPEP review, the review team 

recommended, and the MRB agreed, that the next full IMPEP review take place in 

approximately five years. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Ohio 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

Michelle Beardsley, FSME Team Leader 

 Status of Materials Inspection Program 

 Compatibility Requirements 

James Lynch, Region III Technical Staffing and Training 

 Technical Quality of Incidents and Allegations 

 Inspection Accompaniments 

Sherrie Flaherty, Minnesota Technical Quality of Licensing Actions 

Joseph Nick, Region I Technical Quality of Inspections 

 Inspection Accompaniments 

Stephen Poy, FSME Sealed Source and Device Evaluation Program 
APPENDIX B 

OHIO ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML13281A813 
 

 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Scott Process Systems, Inc. License No.: 03320770000 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 1/14/13 Inspectors: PB/SK 

File No.: 2 

Licensee: Medical Physics Consultants License No.: 03225990000 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 1/16/13 Inspector: CL 

File No.: 3 

Licensee: Janx Integrity Group License No.: 03320990002 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 12/31/12 Inspectors: SK/PB 

File No.: 4 

Licensee: Kanawha Scales & Systems License No.: 03214130000 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 12/26/12 Inspector: SD 

File No.: 5 

Licensee: Case Western Reserve University License No.: 01100180011 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 12/11/12 Inspector: SD 

File No.: 6 

Licensee: Navitus Engineering, Inc. License No.: 31210800002 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 10/24/12 Inspector: PB 

File No.: 7 

Licensee: Northrup Grumman Systems License No.: 032140310003 

Inspection Type: Initial, Announced Priority: 5 

Inspection Date: 10/3/13 Inspector: PB 

File No.: 8 

Licensee: Desert NDT License No.: 03320990009 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 9/12/13 Inspector: SK 

 
Ohio Final IMPEP Report C. 2 

Inspection Casework Reviews 

File No.: 9 

Licensee: Halliburton Energy Services License No.: 31210990018 

Inspection Type: Initial, Unannounced Priority: 5 

Inspection Date: 6/25/13 Inspector: CS 

File No.: 10 

Licensee: VEGA Americas Corporation License No.: 03214310002 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 5/3/12 Inspector: SD 

File No.: 11 

Licensee: Morrow County Hospital License No.: 02121600000 

Inspection Type: Initial, Unannounced Priority: 5 

Inspection Date: 1/31/13 Inspectors: CG/RB 

File No.: 12 

Licensee: The Cleveland Clinic Foundation License No.: 02110180013 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 10/8/13 Inspector: AC 

File No.: 13 

Licensee: Ohio State University License No.: 02110250037 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 12/4/12 Inspectors: AC/SD/CG/RB 

File No.: 14 

Licensee: Jewish Hospital LLC License No.: 02120310029 

Inspection Type: Initial, Announced Priority: 3 

Inspection Date: 1/3/13 Inspector: DC 

 

File No.: 15 

Licensee: Chetan Patel MD LLC License No.: 02201440002 

Inspection Type: Initial, Unannounced Priority: 5 

Inspection Date: 11/4/09 Inspector: SD 

File No.: 16 

Licensee: Fisher-Titus Medial Center License No.: 02120400001 

Inspection Type: Special, Announced Priority: 3 

Inspection Date: 8/27/10 Inspector: AC 

File No.: 17 

Licensee: Christ Hospital License No.: 02120310008 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 6/14/11 Inspectors: SD/KA 

 
Ohio Final IMPEP Report C. 3 

Inspection Casework Reviews 

File No.: 18 

Licensee: University Hospitals of Cleveland License No.: 02110180077 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 4/17/12 Inspectors: AC/CG/SD 

File No.: 19 

Licensee: Unicon Physics, Inc. License No.: 03220310040 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 1/21/10 Inspector: PB 

File No.: 20 

Licensee: Sen Tek Corporation License No.: 03214250002 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 12/26/12 Inspector: CL 

File No.: 21 

Licensee: Progress Services, Inc. License No.: 03320530004 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 9/10/13 Inspector: SK 

File No.: 22 

Licensee: Team Industrial Services License No.: 03320990000 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 10/9/13 Inspector: SK 

File No.: 23 

Licensee: Coca Cola Refreshments License No.: 00006GL0279 

Inspection Type: Initial, Announced Priority: N/A 

Inspection Date: 8/21/13 Inspector: PB 

File No.: 24 

Licensee: Johns Manville License No.: 00006GL0047 

Inspection Type: Initial, Announced Priority: N/A 

Inspection Date: 5/29/13 Inspector: PB 

File No.: 25 

Licensee: Worthington Steel License No.: 00006GL0218 

Inspection Type: Initial, Announced Priority: N/A 

Inspection Date: 4/24/13 Inspector: PB 

 
Ohio Final IMPEP Report C. 4 

Inspection Casework Reviews 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Flower Hospital License No.: 02120490004 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/9/13 Inspector: AC 

Accompaniment No.: 2 

Licensee: Cardinal Health (Nuclear Pharmacy Services) License No.: 02500490001 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 9/10/13 Inspector: CG 

Accompaniment No.: 3 

Licensee: Mercy St. Charles Hospital License No.: 02120490017 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 9/11/13 Inspector: RB 

Accompaniment No.: 4 

Licensee: URS Corporation License No.: 31210180083 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 9/9/13 Inspector: CS 

Accompaniment No.: 5 

Licensee: Progress Services, Inc. License No.: 03320530004 

Inspection Type: Routine, Announced, Special Priority: 1 

Inspection Date: 9/10/13 Inspector: SK 

Accompaniment No.: 6 

Licensee: Fluke Biomedical License No.: 03211180000 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 9/11/13 Inspector: PB
 

APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: TSS Technologies, Inc License No.: 03362009000 

Type of Action: New Amendment No.: 0 

Date Issued: 2/3/11 License Reviewer: LB 

File No.: 2 

Licensee: Desert NDT, LLC License No: 03320990009 

Type of Action: New Amendment No.: 0 

Date Issued: 9/26/13 License Reviewer: SK 

File No.: 3 

Licensee: Cardinal Health License No.: 02500310032 

Type of Action: New Amendment No.: 0 

Date Issued: 12/9/11 License Reviewer: CG 

File No.: 4 

Licensee: OSU Mobile License No.: 02220250000 

Type of Action: New Amendment No.: 0 

Date Issued: 4/16/11 License Reviewer: CG 

File No.: 5 

Licensee: UH AHUSA Medical Center License No.: 02120180103 

Type of Action: New Amendment No.: 0 

Date Issued: 9/29/10 License Reviewer: SD 

File No.: 6 

Licensee: St, Elizabeth Boardman Health Center License No.: 02120510001: 

Type of Action: Amendment Amendment No.: 12 

Date Issued: 8/20/13 License Reviewer: AC 

File No.: 7 

Licensee: Gamma Med License No.: 02500510004 

Type of Action: Renewal Amendment No.: 9 

Date Issued: 9/2/11 License Reviewer: SD 

File No.: 8 

Licensee: Tri State Urologic Services License No.: 02200310050 

Type of Action: New Amendment No.: 0 

Date Issued: 10/11/13 License Reviewer: DC 

 
Ohio Final IMPEP Report D. 2 

License Casework Reviews 

File No.: 9 

Licensee: Fairview Hospital License No.: 02120180101 

Type of Action: Renewal Amendment No.: 15 

Date Issued: 9/27/13 License Reviewer: DC 

File No.: 10 

Licensee: Oncology/Hematology Care, Inc. License No.: 02230310001 

Type of Action: Amendment Amendment No.: 15 

Date Issued: 9/18/13 License Reviewer: RB 

File No.: 11 

Licensee: Cleveland State University License No.: 01110130017 

Type of Action: Amendment Amendment No.: 9 

Date Issued: 4/30/12 License Reviewer: SD 

File No.: 12 

Licensee: Ohio University License No.: 01100050003 

Type of Action: Amendment Amendment No.: 22 

Date Issued: 9/26/12 License Reviewer: SD 

File No.: 13 

Licensee: University Hospitals of Cleveland License No.: 02110180077 

Type of Action: Amendment Amendment No.: 24 

Date Issued: 2/12/10 License Reviewer: AC 

File No.: 14 

Licensee: Team Industrial Services License No.: 03320990000 

Type of Action: Amendment Amendment No.: 18 

Date Issued: 6/2/11 License Reviewer: PB 

File No.: 15 

Licensee: Hi-Tech Testing Services License No.: 03320770023 

Type of Action: Amendment Amendment No.: 1 

Date Issued: 12/10/12 License Reviewer: SK 

File No.: 16 

Licensee: MISTRAS Group License No.: 03320460000 

Type of Action: Renewal Amendment No.: 18 

Date Issued: 9/26/13 License Reviewer: PB 

File No.: 17 

Licensee: Triad Isotopes License No.: 02500250072 

Type of Action: Termination Amendment No.: 39 

Date Issued: 12/17/12 License Reviewer: KA 

 
Ohio Final IMPEP Report D. 3 

License Casework Reviews 

File No.: 18 

Licensee: Elite Inspection License No.: 03320990005 

Type of Action: Termination Amendment No.: 6 

Date Issued: 11/18/09 License Reviewer: KVA 

File No.: 19 

Licensee: Deaconess Hospital License No.: 02120310012 

Type of Action: Termination Amendment No.: 17 

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

File No.: 20 

Licensee: Viewray Incorporated License No.: 03214180005 

Type of Action: Amendment Amendment No.: 6 

Date Issued: 8/19/11 License Reviewer: CS 

File No.: 21 

Licensee: Phillips Medical Systems License No.: 03214180003 

Type of Action: Amendment Amendment No.: 41 

Date Issued: 6/8/12 License Reviewer: SD 

File No.: 22 

Licensee: Akron Gamma Medical License No.: 02120780000 

Type of Action: Amendment Amendment No.: 32 

Date Issued: 5/14/12 License Reviewer: AC 

File No.: 23 

Licensee: Jewish Hospital, LLC License No.: 02120310029 

Type of Action: Amendment Amendment No.: 23 

Date Issued: 10/15/12 License Reviewer: DC 

File No.: 24 

Licensee: Jewish Hospital, LLC License No.: 02120310029 

Type of Action: Amendment Amendment No.: 25 

Date Issued: 2/8/13 License Reviewer: DC 

Comment: 

AMP added to the license without proper documentation of educational requirement. 

File No.: 25 

Licensee: Nationwide Children’s Hospital License No.: 02110250012 

Type of Action: Amendment - Variance Amendment No.: 18 

Date Issued: 5/28/13 License Reviewer: AC 

 
Ohio Final IMPEP Report D. 4 

License Casework Reviews 

File No.: 26 

Licensee: Advanced Medical Systems, Inc License No.: 03900180000 

Type of Action: Amendment Amendment No.: 12 

Date Issued: 3/20/13 License Reviewer: JC 

File No.: 27 

Licensee: Mercy Hospital – Mt. Airy License No.: 02120310000 

Type of Action: Amendment Amendment No.: 14 

Date Issued: 11/25/13 License Reviewer: RB 

 
 

APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Community Regional Medical Center License No.: 02120480002 

Date of Incident: 12/10/08 NMED No.: 080891 

Investigation Date: 12/22/08 Type of Incident: Contamination 

 Type of Investigation: Site 

File No.: 2 

Licensee: University Hospitals of Cleveland License No.: 02110180077 

Date of Incident: 12/15/08 NMED No.: 090443 

Investigation Date: 3/19/09 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

Comment: 

The licensee did not report the incident. It was discovered during an inspection by the 

Bureau. 

File No.: 3 

Licensee: Urology Center License No.: 02200310002 

Date of Incident: 5/11/09 NMED No.: 090497 

Investigation Date: 6/12/09 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 4 

Licensee: Acuren Inspection, Inc. License No.: 03320990006 

Date of Incident: 6/26/09 NMED No.: 090572 

Investigation Date: 6/26/09 Type of Incident: Equipment Failure 

 Type of Investigation: Telephone 

File No.: 5 

Licensee: PetroChem Inspection Services License No.: 03320990001 

Date of Incident: 6/9/09 NMED No.: 090612 

Investigation Date: 7/1/09 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

File No.: 6 

Licensee: Meridian Automotive Systems, Inc. License No.: N/A 

Date of Incident: 8/25/09 NMED No.: 090694 

Investigation Date: 8/26/09 Type of Incident: Lost RAM 

 Type of Investigation: Site 

File No.: 7 

Licensee: Scott Process Systems, Inc. License No.: 03320770000 

Date of Incident: 10/6/09 NMED No.: 090852 

Investigation Date: 11/18/09 Type of Incident: Damaged Equipment 

 Type of Investigation: Telephone 
Ohio Final IMPEP Report E. 2 

Incident Casework Reviews 

File No.: 8 

Licensee: The Jewish Hospital License No.: 02120310029 

Date of Incident: 1/21/10 NMED No.: 100049 

Investigation Date: 2/4/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 9 

Licensee: The Jewish Hospital License No.: 02120310029 

Date of Incident: 12/28/09 NMED No.: 100053 

Investigation Date: 2/4/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 10 

Licensee: JANX Integrity Group License No.: 03320990002 

Date of Incident: 4/9/10 NMED No.: 100178 

Investigation Date: 4/19/10 Type of Incident: Overexposure 

 Type of Investigation: Site 

File No.: 11 

Licensee: Ohio State University Medical Center License No.: 02110250037 

Date of Incident: 4/16/10 NMED No.: 100209 

Investigation Date: 4/21/10 Type of Incident: Overexposure 

 Type of Investigation: Site 

File No.: 12 

Licensee: Tiffin Mercy Hospital License No.: 02120750001 

Date of Incident: 12/10/08 NMED No.: 100480 

Investigation Date: 5/4/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

Comment: 

The licensee did not report the incident. It was discovered during an audit conducted 

by the Bureau. 

File No.: 13 

Licensee: Cleveland Clinic Foundation License No.: 02110180013 

Date of Incident: 9/27/10 NMED No.: 100483 

Investigation Date: 9/28/10 Type of Incident: Medical Event 

 Type of Investigation: Telephone 

File No.: 14 

Licensee: Clinton Memorial Hospital License No.: 02120140000 

Date of Incident: 5/20/09 NMED No.: 100501 

Investigation Date: 9/10/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

Comment: 

The licensee did not report the incident. It was discovered during an inspection by the 

Bureau. 
Ohio Final IMPEP Report E. 3 

Incident Casework Reviews 

File No.: 15 

Licensee: Riverside Methodist Hospital License No.: 02120250070 

Date of Incident: 4/6/10 NMED No.: 100510 

Investigation Date: 7/28/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

Comment: 

The licensee did not report the incident. It was discovered during an inspection by the 

Bureau. 

File No.: 16 

Licensee: Cleveland Clinic Foundation License No.: 02110180013 

Date of Incident: 10/26/10 NMED No.: 100543 

Investigation Date: 11/3/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 17 

Licensee: Private Individual License No.: N/A 

Date of Incident: 10/31/11 NMED No.: 110599 

Investigation Date: 11/1/11 Type of Incident: Lost RAM 

 Type of Investigation: Site 

File No.: 18 

Licensee: University of Toledo License No.: 0211049006 

Date of Incident: 12/19/11 NMED No.: 120050 

Investigation Date: 1/12/12 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 19 

Licensee: Trinity Medical Center License No.: 02120420003 

Date of Incident: 8/24/12 NMED No.: 120498 

Investigation Date: 9/25/12 Type of Incident: Leaking Source 

 Type of Investigation: Site 

File No.: 20 

Licensee: Acuren Inspection, Inc. License No.: 03320990006 

Date of Incident: 7/24/12 NMED No.: 120522 

Investigation Date: 9/5/12 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

File No.: 21 

Licensee: Southern Ohio Medical Center License No.: 02300740000 

Date of Incident: 11/21/12 NMED No.: 120696 

Investigation Date: 12/6/12 Type of Incident: Equipment Failure 

 Type of Investigation: Telephone 

 
Ohio Final IMPEP Report E. 4 

Incident Casework Reviews 

File No.: 22 

Licensee: University of Toledo License No.: 02110490006 

Date of Incident: 11/27/12 NMED No.: 130001 

Investigation Date: 12/19/12 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 23 

Licensee: Akron General Medical Center License No.: 02120780000 

Date of Incident: 3/19/13 NMED No.: 130142 

Investigation Date: 3/29/13 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 24 

Licensee: Private Individual License No.: N/A 

Date of Incident: 4/19/13 NMED No.: 130216 

Investigation Date: 4/21/13 Type of Incident: Lost RAM 

 Type of Investigation: Site 

File No.: 25 

Licensee: Cleveland Clinic Foundation License No.: 02110180013 

Date of Incident: 5/9/13 NMED No.: 130438 

Investigation Date: 10/8/13 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 26 

Licensee: Wittenberg University License No.: 01120120000 

Date of Incident: 1/9/13 NMED No.: 130460 

Investigation Date: 1/23/13 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 27 

Licensee: Mount Carmel Health System License No.: 02120250034 

Date of Incident: 10/25/13 NMED No.: 130530 

Investigation Date: 11/14/13 Type of Incident: Medical Event 

 Type of Investigation: Site 
APPENDIX F 

SEALED SOURCE AND DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Registry No.: OH-0522-D-120-B SS&D Type: (D) Gamma Gauge 

Applicant Name: Ohmart/VEGA Type of Action: Amendment 

Date issued: 11/3/08 Reviewers: KVA, KB 

File No.: 2 

Registry No.: OH-0298-S-102-S SS&D Type: (H) General Neutron Source/ 

 (W) Well Logging 

Applicant Name: Frontier Technology Corporation Type of Action: Amendment 

Date issued: 4/3/09 Reviewers: KB, SD 

File No. 3 

Registry No.: OH-0522-D-120-B SS&D Type: (D) Gamma Gauge 

Applicant Name: Ohmart/VEGA Type of Action: Amendment 

Date issued: 5/8/09 Reviewers: KVA, SD 

File No.: 4 

Registry No.: OH-8211-D-801-G SS&D Type: (W) Self Luminous Light Source 

Applicant Name: Best Lighting Products, Inc. Type of Action: Inactivation 

Date issued: 8/5/09 Reviewers: KVA, SD 

File No.: 5 

Registry No.: OH-0522-D-120-B SS&D Type: (D) Gamma Gauge 

Applicant Name: Ohmart/VEGA Type of Action: Amendment 

Date issued: 8/20/09 Reviewers: KVA, SD 

Comment: 

Drawing/diagram not included in the registration certificate. 

File No.: 6 

Registry No.: OH-0522-S-109-S SS&D Type: (D) Gamma Gauge 

Applicant Name: Ohmart/VEGA Type of Action: Amendment 

Date issued: 8/24/09 Reviewers: KB, SD 

File No.: 7 

Registry No.: OH-0522-D-102-B SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 9/01/09 Reviewers: KVA, SD 

 
Ohio Final IMPEP Report F. 2 

Sealed Source and Device Casework Reviews 

File No.: 8 

Registry No.: OH-8208-S-801-S SS&D Type: (AD) Photo Emitting Teletherapy 

Applicant Name: Advanced Medical Systems Type of Action: Inactivation 

Date issued: 9/22/09 Reviewers: KVA,SD 

File No.: 9 

Registry No.: OH-8208-D-802-S SS&D Type: (AD) Photo Emitting Teletherapy 

Applicant Name: Advanced Medical Systems Type of Action: Inactivation 

Date issued: 11/13/09 Reviewers: KVA, KB 

File No.: 10 

Registry No.: OH-8208-D-803-S SS&D Type: (AD) Photo Emitting Teletherapy 

Applicant Name: Advanced Medical Systems Type of Action: Inactivation 

Date issued: 11/13/09 Reviewers: KVA, KB 

File No.: 11 

Registry No.: OH-1090-D-103-B SS&D Type: (E) Beta Gauge 

Applicant Name: Automation and Control Tech. Type of Action: Amendment 

Date issued: 2/16/10 Reviewers: KVA, SD 

File No.: 12 

Registry No.: OH-0522-D-120-B SS&D Type: (D) Gamma Gauge 

Applicant Name: Ohmart/VEGA Corp Type of Action: Amendment 

Date issued: 10/14/10 Reviewers: KVA, SD 

File No.: 13 

Registry No.: OH-0522-D-112-S SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 11/01/10 Reviewers: KVA, SD 

File No.: 14 

Registry No.: OH-1033-D-101-B SS&D Type: (D)Gamma Gauge, (E)Beta Gauge 

Applicant Name: IRM Group, Inc. Type of Action: Amendment 

Date issued: 11/05/10 Reviewers: SD, KVA 

File No.: 15 

Registry No.: OH-0522-D-120-B SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 1/7/11 Reviewers: KVA, SD 

File No.: 16 

Registry No.: OH-0522-D-116-S SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 2/4/11 Reviewers: KVA, SD 
Ohio Final IMPEP Report F. 3 

Sealed Source and Device Casework Reviews 

File No.: 17 

Registry No.: OH-1090-D-103-B SS&D Type: (E) Beta Gauge 

Applicant Name: Automation and Control Tech. Type of Action: Amendment 

Date issued: 11/1/11 Reviewers: SD, KVA 

File No.: 18 

Registry No.: OH-0522-D-120-B SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Type of Action: Amendment 

Date issued: 7/5/12 Reviewers: SD,KVA 

File No.: 19 

Registry No.: OH-0109-S-125-S SS&D Type: (R) Gas Source 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 7/17/12 Reviewers: SD, KVA 

File No.: 20 

Registry No.: OH-0109-S-126-S SS&D Type: (T) Other 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 7/17/12 Reviewers: SD, KVA 

File No.: 21 

Registry No.: OH-1346-D-101-S SS&D Type: (AD) Teletherapy (AE) Gamma Device 

Applicant Name: ViewRay, Inc. Type of Action: New 

Date issued: 8/17/12 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

File No.: 22 

Registry No.: OH-0522-D-102-B S&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 10/29/12 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

File No.: 23 

Registry No.: OH-0522-D-111-S SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 11/20/12 Reviewers: SD, KVA 

 
Ohio Final IMPEP Report F. 4 

Sealed Source and Device Casework Reviews 

File No.: 24 

Registry No.: OH-0109-D-121-B SS&D Type: (D)Gamma Gauge, (E)Beta Gauge 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 11/30/2012 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

File No.: 25 

Registry No.: OH-0109-D-122-B SS&D Type: (D)Gamma Gauge, (E)Beta Gauge 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 12/3/12 Reviewers: SD, KVA 

File No.: 26 

Registry No.: OH-0109-D-123-B SS&D Type: (D)Gamma Gauge, (E)Beta Gauge 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 12/3/12 Reviewers: SD, KVA 

File No.: 27 

Registry No.: OH-0109-D-124-B SS&D Type: (D)Gamma Gauge, (E)Beta Gauge 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 12/3/12 Reviewers: SD, KVA 

File No.: 8 

Registry No.: OH-0109-S-127-S SS&D Type: (T) Other Beta Gauge 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 12/3/12 Reviewers: SD, KVA 

File No.: 29 

Registry No.: OH-0109-S-128-S SS&D Type: (T) Other Beta Gauge 

Applicant Name: ABB, Inc. Type of Action: Amendment 

Date issued: 12/3/12 Reviewers: SD, KVA 

File No.: 30 

Registry No.: OH-1219-D-104-S SS&D Type: (Y) Calibrator 

Applicant Name: Thermo Eberline LLC Type of Action: New 

Date issued: 12/14/12 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

 
Ohio Final IMPEP Report F. 5 

Sealed Source and Device Casework Reviews 

File No.: 31 

Registry No.: OH-1219-D-102-S SS&D Type: (Y) Calibrator 

Applicant Name: Thermo Eberline LLC Type of Action: Amendment 

Date issued: 12/14/12 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

File No.: 32 

Registry No.: OH-0522-D-111-S SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 3/5/13 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

File No.: 33 

Registry No.: OH-0522-D-112-S SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 3/7/13 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

File No.: 34 

Registry No.: OH-0522-D-102-B SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 3/26/13 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 

File No.: 35 

Registry No.: OH-0522-D-111-S SS&D Type: (D) Gamma Gauge 

Applicant Name: VEGA Americas Corporation Type of Action: Amendment 

Date issued: 5/29/13 Reviewers: SD, KVA 

Comment: 

Missing dimension labels on the attached diagrams/drawings. 
ATTACHMENT 

January 14, 2014 Email from Michael Snee 

Ohio’s Response to the Draft Report 

ADAMS Accession No.: ML14027A002