January 24, 2005

J. Nick Baird, M.D.

Director

Ohio Department of Health

246 North High Street

Columbus, OH 43266

Dear Dr. Baird:

On January 11, 2005, 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 program.

Section 5.0, page 13, of the enclosed final report presents the IMPEP team’s recommendation

for the State of Ohio. We request your evaluation and response to the recommendations within

30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next full review will be in approximately

four years. 

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

I also wish to acknowledge your continued support for the Radiation Control Program and the

excellence in program administration demonstrated by your staff, as reflected in the team’s

findings. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely,

/RA/

Martin J. Virgilio 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Robert E. Owen, Chief Carol O’Claire, State Liaison Officer

Bureau of Radiation Protection Supervisor, Radiological Branch

Ohio Department of Health Ohio Emergency Management Agency

Michael Snee, Administrator

Technical Support Program

Bureau of Radiation Protection

Ohio Department of Health

Steve Collins, IL

OAS Liaison to the MRB
January 24, 2005

J. Nick Baird, M.D.

Director

Ohio Department of Health

246 North High Street

Columbus, OH 43266

Dear Dr. Baird:

On January 11, 2005, 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 program.

Section 5.0, page 13, of the enclosed final report presents the IMPEP team’s recommendation

for the State of Ohio. We request your evaluation and response to the recommendations within

30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next full review will be in approximately

four years. 

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

I also wish to acknowledge your continued support for the Radiation Control Program and the

excellence in program administration demonstrated by your staff, as reflected in the team’s

findings. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely,

/RA/

Martin J. Virgilio 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Robert E. Owen, Chief Carol O’Claire, State Liaison Officer

Bureau of Radiation Protection Supervisor, Radiological Branch

Ohio Department of Health Ohio Emergency Management Agency

Michael Snee, Administrator

Technical Support Program bcc: Chairman Diaz

Bureau of Radiation Protection Commissioner McGaffigan

Ohio Department of Health Commissioner Merrifield

Commissioner Jaczko

Steve Collins, IL Commissioner Lyons

OAS Liaison to the MRB

 *See previous concurrence

Distribution: See next page

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DATE 01/14/05 01/21/05* 01 /21/05* 1/24 /05

ML050210313 OFFICIAL RECORD COPY
J. Nick Baird, M.D.

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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF OHIO AGREEMENT STATE PROGRAM

October 25-29, 2004

 FINAL REPORT

U.S. Nuclear Regulatory Commission
Ohio Final 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 October 25-29, 2004, by a review team comprised of

technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement

State of Maine. 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 a Final General Statement of Policy," published in the Federal

Register on October 16, 1997, and the February 26, 2004, NRC Management Directive 5.6,

"Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the

review, which covered the period of May 19, 2001 to October 29, 2004, were discussed with

Ohio management on October 29, 2004.

A draft of this report was issued to Ohio for factual comment on November 29, 2004. The State

responded by Email from Michael Snee on December 14, 2004. The Management Review

Board (MRB) met on January 11, 2005 to consider the proposed final report. The MRB found

the Ohio radiation control program adequate to protect public health and safety and compatible

with NRC's program.

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

Bureau). The Bureau is part of the Division of Prevention, within 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 program regulated 767 specific licenses, authorizing

Agreement materials, naturally occurring radioactive materials, and accelerator-produced

materials. The review focused on the 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 non-common

performance indicators was sent to the Bureau on August 26, 2004. The Bureau provided a

response to the questionnaire on September 30, 2004. A copy of the questionnaire response

may be found on the NRC’s Agencywide Document Access and Management System

(ADAMS) using the Accession Number ML042800450.

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

Ohio's response to the questionnaire; (2) review of applicable Ohio statutes and regulations; (3)

analysis of quantitative information from the Bureau’s licensing and inspection database; (4)

technical evaluation of selected licensing and inspection actions; (5) field accompaniments of

six Ohio inspectors; and (6) interviews with staff and management to answer questions or

clarify issues. The team evaluated the information that it gathered against the IMPEP

performance criteria for each common and applicable non-common performance indicator and

made a preliminary assessment of the Ohio Agreement State program’s performance.

Section 2 below discusses the State’s actions in response to recommendations made following

the previous IMPEP review and the team’s conclusions regarding close-out of the

recommendations. Results of the current review for the IMPEP common performance

indicators are presented in Section 3. Section 4 discusses results of the applicable noncommon performance indicators, and Section 5 summarizes the review team's findings and

recommendation.
Ohio Final Report Page 2

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous IMPEP review, which concluded on May 18, 2001, recommendations were

made and the results were transmitted to Dr. J. Nick Baird, Director, Ohio Department of

Health, on August 22, 2001. The review team’s evaluation of the current status of the

recommendations is as follows:

RECOMMENDATION FOR THE STATE: 

1. The review team recommends that the Bureau develop formal training and qualification

requirements for SS&D reviewers. (Section 4.2.2 of the 2001 report)

Current Status: The Bureau developed a formal training and qualification program. 

Training and qualifications are documented for each sealed source and device (SS&D)

reviewer. This recommendation is closed.

RECOMMENDATION FOR THE NRC:

1. The MRB recommends that NRC staff revise NRC guidance so that the differences

between safety analysis summary documentation for certificates for specifically licensed

verses generally licensed devices are clarified. (Section 4.2.1 of the 2001 report)

Current Status: NUREG-1556, Vol. 3, was revised in the Spring of 2004. The revision

included detailed instructions so that the differences between safety analysis summary

documentation for certificates specifically licensed and generally licensed (GL) devices

are apparent. This recommendation is closed.

3.0 COMMON PERFORMANCE INDICATORS

IMPEP identifies five common performance indicators to be used in reviewing both NRC

Regional and Agreement State 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 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 Bureau management and staff, and considered any possible workload

backlogs.

The Bureau, headed by the Bureau Chief, regulates approximately 767 specific licenses with

approximately 25 full time equivalents (FTE) assigned to implement the radioactive materials

licensing and inspection programs. The Bureau is divided into four programs: the Nuclear

Materials Safety Program; the Environmental Radiation Safety Program; the Technical Support

Program; and the X-Ray Program. Each Program is managed by an administrator. The

Nuclear Materials Safety Program consists of the Medical Section and the Industrial Section,
Ohio Final Report Page 3

both of which are managed by section supervisors. These two sections are responsible for the

routine licensing and inspecting of most materials facilities within the State. The SS&D

Evaluation Program is under the Industrial Section of the Nuclear Materials Safety Program,

and three staff members conduct the reviews. The Environmental Radiation Safety Program

consists of the Radiological Assistance Section and the Decommissioning Section, which are

also managed by section supervisors. The Decommissioning Section conducts license

terminations and partial site releases including the contaminated sites transferred from the

NRC. The Environmental Radiation Safety Program is also responsible for all low-level

radioactive waste activities. The Technical Support Program is responsible for oversight of the

training and quality assurance programs as well as for writing rules and developing procedures. 

The Agreement State program is implemented by the Nuclear Materials Safety Program, a

portion of the Decommissioning Section in the Environmental Radiation Safety Program, and

the Technical Support Program. The technical staff positions are classified as Health Physicist

I, II, or III, with Health Physicist III being the senior-level technical position. Technical staff

perform both inspection and licensing functions.

Eight staff members left the Bureau and ten staff members were hired during the review period. 

There are currently two vacant positions in the Agreement State program. One position is for a

Health Physicist II in the Industrial Section of the Nuclear Materials Safety Program and the

other position is a senior-level position in the Technical Support Program. Vacant positions are

posted quickly by the Bureau. Bureau management indicated that vacant senior-level positions

are typically filled internally. This allows the Bureau to recruit candidates outside the Bureau to

fill junior positions. The review team noted that the Bureau had stable funding during the review

period due to dedicated revenue from licensee fees.

The qualifications of the staff were determined from the questionnaire, training records, and

interviews of personnel. The staff are well qualified from an education and experience

standpoint. All staff have at least a Bachelor’s degree in the sciences, or equivalent training

and experience.

The Bureau has a documented training and qualifications program for technical staff that is

modeled after NRC’s Manual Chapter (MC) 1246, “Formal Qualification Programs in the

Nuclear Materials Safety and Safeguards Area.” The Bureau uses a combination of self-study,

formal training (such as NRC courses), and on-the-job experience to qualify both inspectors

and license reviewers. Most senior-level technical staff members have taken the NRC courses

deemed appropriate for their tasks. New staff members plan to attend appropriate required

courses when available. The review team noted that it may take several years for a new staff

member to receive all the required training due to limitations on out-of-State travel. However,

the team noted that the Bureau is making commendable efforts to provide the required training

to the staff in-house. Last year, the Bureau hosted four NRC courses: Licensing Practices and

Procedures (G-109); Inspection Procedures (G-108); Inspecting for performance (G-304); and

the Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM). In addition, the

Bureau hosted the Root Cause/Incident Investigation Workshop (G-205) following the IMPEP.

New staff are trained in licensing and inspections 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
Ohio Final Report Page 4

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

Every individual's qualification journal, contains documentation that the individual has met the

minimum qualifications and received their supervisor's approval to perform independent

inspections and/or license reviews for the license types listed on the sheet.

The Radiation Advisory Council (the Council) of the State of Ohio, as constituted under State

law, is comprised of medical and industrial stakeholders as well as a member of the public. All

members of the Council are appointed by the Governor. The Council has the responsibility to

advise and consult with the Bureau on the development of rules and the administration,

implementation and enforcement of these rules. The Council also provides advice and

guidance on the development of inspection criteria, procedures, and guidelines to be used by

the Bureau. No evidence of any conflict of interest issues was identified.

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

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

and the performance of reciprocity inspections. The review team’s evaluation is based on the

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

from the Bureau’s licensing and inspection data tracking system, the examination of completed

inspection casework, and interviews with staff.

The review team’s evaluation of the Bureau’s inspection priorities revealed that inspection

frequencies for each type of license were the same or more frequent than similar license types

listed in the NRC MC 2800, with three exceptions: Teletherapy; Source Material Possession

Only - Permanent Shutdown; and Special Nuclear Material Possession Only (Non-Fuel) -

Permanent Shutdown. These categories have an inspection priority less frequent than NRC;

however, during the review period, Priority 1, 2, and 3 licenses were inspected at intervals in

accordance with frequencies consistent with NRC MC 2800. The Bureau can only change

these priorities through rulemaking. The Bureau has included these changes with the next

scheduled rule revision, which is already in process. 

At the time of the review, there were no overdue inspections. The Bureau conducted 344

routine inspections and 43 reciprocity inspections of candidate licenses during the review

period. The Bureau exceeded the minimum 20 percent criteria prescribed in NRC MC 1220 by

inspecting 50 percent of candidate licenses. Initial inspections were scheduled and generally

conducted within six months of license issuance and all were performed within 12 months.

The Bureau currently utilizes an Oracle-based data tracking system, but will be moving to a

Microsoft.net system. The current tracking system is able to archive the inspection history of

each licensee. This feature enhances the Bureau’s management of the inspection program by

facilitating access and review of the inspection history of its licensees by inspectors. The new

system will offer a wider variety of options available to the Bureau to interact more efficiently

within the Bureau and with other programs across State government. 
Ohio Final Report Page 5

The timeliness of the issuance of inspections findings was evaluated by the team’s review of

inspection casework. In all cases, the response letters and inspection reports to the licensee

regarding the inspection results were sent within 30 days of the inspection date. Inspection

finding letters to licensees generally were dated within 2-15 calendar days after the inspection

date. The team noted that at the request of Ohio’s licensees, a complete copy of the inspection

report is sent to the licensee for their files.

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 the Materials Inspection

Program, be found satisfactory.

3.3 Technical Quality of Inspections

The team evaluated the inspection reports, enforcement documentation, and interviewed

inspectors for 17 radioactive materials inspections conducted during the review period. The

casework included work performed by 11 of the Bureau’s materials license inspectors, and

covered a variety of license types including: academic broad; medical (broad scope, private

practice, and institutional); mobile high dose remote afterloader (HDR); mobile nuclear

medicine; teletherapy; nuclear pharmacy; industrial radiography; pool irradiator;

decommissioning services; manufacturing and distribution-broadscope; and research and

development. Appendix C lists the inspection casework reviewed for completeness and

adequacy with case-specific comments, as well as the results of the inspection

accompaniments.

Based on the casework reviewed, the review team noted that the routine inspections covered all

aspects of the licensees’ radiation programs. The review team found that inspection reports

were generally very 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 the licensee,

unresolved safety issues, and discussions held with the licensee during exit interviews. Team

inspections were frequently performed for larger and complex licensees and for training

purposes. The review team noted in the review of the documentation and in discussions with

staff, that although independent and/or confirmatory measurements are routinely conducted,

documentation of these surveys was often inconsistent and was missing from five reports

reviewed by the team. The Bureau indicated that they would review this area and modify future

reports as necessary. Since the IMPEP have commenced reviewing all inspection reports to

ensue proper documentation of inspector surveys. 

Completed inspection reports were signed by the appropriate section supervisor and the

appropriate program administrator. Supervisory accompaniments are being conducted

annually for all inspectors; however, there is currently no formal method for capturing the overall

evaluation of the inspector’s performance during their inspection. The Bureau committed to

review and modify as necessary the procedures on documenting an inspector’s performance

during accompaniments and make any changes deemed necessary. Since the IMPEP, the

Bureau has implemented a new form to document inspector performance on accompaniments. 

The inspection findings were appropriate and prompt regulatory actions were taken, as

necessary. The Bureau normally issues Compliance letters, Observations letters, or Notices of

Violations, as it deems appropriate. Violations of minor safety or environmental concerns,
Ohio Final Report Page 6

which are at or below the level of significance equivalent to NRC’s Severity Level IV violation, 

are documented in the inspection report and generally issued to the licensee as Observations. 

The licensee is required to respond to the noted Observations within 30 days. Notices of

Violations are routinely issued for licensees with repeat violations and those, which are elevated

above the Observation level. In addition, the Bureau has the ability to impose an administrative

penalty when it is deemed that the licensee has had a significant breakdown in operations that

affects overall health and safety. A “General Statement of Policy - Enforcement Actions”

procedure has been established and implemented, which explains the enforcement program. 

All inspection findings are clearly stated and documented in the report, and reviewed by the

appropriate section supervisor and the appropriate program administrator, before being sent to

the licensee with the appropriate letter detailing the results of the inspection. Escalated

enforcement actions are reviewed and sent from either the Bureau Chief or Department

Director, depending upon the situation.

The Bureau has adequate numbers and types of radiation survey instruments to support their

efforts. The review included a check of survey instruments and equipment monitoring,

including calibration frequency and repairs. Each inspector is assigned a Ludlum 3 survey

meter. A staff member in the Technical Support Program is responsible for sending survey

instruments out to the Ohio Emergency Management Agency for calibration and/or repair;

however, the neutron detectors are sent to the manufacturer for calibration and/or repair. The

Department’s Laboratory performs sampling analysis for the Bureau, as needed.

Six Bureau inspectors were accompanied during inspections by a review team member during

the weeks of October 4, 2004 and October 11, 2004. Inspection accompaniments included: 

medical institution/HDR, nuclear pharmacy, fixed industrial radiography, gauge manufacturing

and distribution, teletherapy, and a pool irradiator. These accompaniments are identified in

Appendix C. During the accompaniments, each inspector demonstrated appropriate

performance based inspection techniques and knowledge of the regulations. The inspectors

were trained, prepared, and thorough in their audits of the licensees radiation safety programs. 

Overall, each inspector utilized good health physics practices. Interviews with licensee

personnel were performed in an effective manner, and the inspections were adequate to assess

radiological health and safety 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 interviewed license reviewers, evaluated the licensing process, and examined

licensing casework for 15 specific licenses. Licensing actions were reviewed for completeness,

consistency, proper radioisotopes and quantities, qualifications of authorized users, adequate

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 files were also evaluated for timeliness, use of appropriate

deficiency letters and cover letters, reference to appropriate regulations, product certifications,

supporting documentation, consideration of enforcement history, pre-licensing visits,

supervisory review as indicated, and proper signatures. The files were checked for retention of

necessary documents and supporting data.
Ohio Final Report Page 7

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

which were completed during the review period by 12 different license reviewers. The crosssection sampling focused on the new licenses, amendments, renewals, and license

terminations issued during the review period. The sampling included the following types of

licenses: academic; pool irradiator; service provider; industrial radiography; research and

development; portable gauges; source manufacturing and distribution; nuclear pharmacy;

medical private practice; and medical institution. Licensing actions evaluated included two new

licenses, three renewals, six amendments, and four termination files. A listing of the casework

licenses evaluated with case specific comments may be found in Appendix D.

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

and of high quality with health and safety issues properly addressed. License tie-down

conditions were stated clearly, backed by information contained in the file, and inspectable. 

The licensee’s compliance history was taken into account when reviewing renewal applications

and amendments. The exemptions noted in the questionnaire response were determined to be

appropriate and well documented by license conditions. A review of termination actions found

that terminated licensing actions were well documented, showing appropriate transfer records

or appropriate disposal methods and records, confirmatory surveys, and survey records.

The Bureau modified their policy for overnight storage of portable gauges after experiencing

multiple losses of gauges from licensee employee vehicles parked at residences. The policy

requires that gauges be returned to the licensee facility or secured at a temporary job site. If

such storage is a hardship for the licensee, vehicle storage is allowed, with certain provisions,

including notification of the Bureau.

Section supervisors assign licensing actions to license reviewers based on that individual’s

qualifications for the particular license type. Each licensing action is entered into the Bureau

database, RADMAT, an Oracle-based database. Licensing actions are also tracked in a

separate Microsoft Access database. This database has milestones so that supervisors may

easily track the status of a given licensing action. A new web-based database is being

developed which would replace the aforementioned databases and provide an interactive

licensing process. The new database is anticipated in 2006.

When a licensing action is completed by a reviewer, the entire package is given to their section

supervisor and then to the appropriate program administrator for approval. All licensing actions

are signed by the Bureau Chief, for the Department Director. License reviewers are

responsible for the handling and mailing of completed licensing actions. Licenses are issued

for a five-year term.

The Bureau utilizes the Department’s regulatory guides (NMS-LIC), which are based on NRC’s

NUREG-1556 series guides. Standard license conditions, similar to those used by NRC, are

utilized by reviewers. The review team noted consistent use of guidance documents and

standard license conditions.

The Bureau appropriately requires certain licensees to maintain financial assurance for

decommissioning. Surety instruments are maintained in a locked cabinet in the secure license

file room. The Industrial Section Supervisor has the responsibility for control of the documents. 

The review team evaluated the contents of several financial assurance folders which were

found to be in good order.
Ohio Final Report Page 8

The review team noted good communication between inspectors and license reviewers. In fact,

for some complex licensing actions, license reviewers, who are also inspectors, performed an

inspection of the license prior to renewal of the license. This inspection provided the reviewer

with a more in-depth understanding of the licensee’s program, which aided in an effective

licensing action.

The Bureau actively licenses a number of major long-term decommissioning projects. One site,

contaminated with depleted uranium, was decommissioned and released in 2003. In addition to

their own decommissioning efforts, Bureau inspectors also routinely accompany and provide

assistance to NRC inspection teams at the Battelle-West Jefferson decommissioning site, for

which the NRC retained jurisdiction after Ohio became an Agreement State.

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 and reviewed the incidents reported for Ohio in the Nuclear Material Events

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

supporting documentation, as appropriate, for 10 incidents. A list of the incident casework

reviewed is included as Appendix E. The team reviewed the Bureau’s response to the 30

allegations received during the review period involving radioactive materials including 16

allegations referred to the Bureau by NRC.

The review team discussed the Bureau’s incident and allegation procedures, file 

documentation, the Bureau’s equivalent to the Freedom of Information Act, NMED, and

notification of incidents to the NRC Operations Center with the Bureau managers and selected

staff. During the review period, each incident meeting the criteria for reporting to the NMED

system was reported to NRC and the NMED contractor for entry into NMED, as required.

Responsibility for initial response and follow-up actions to material incidents and allegations

rests with the Bureau staff. The Department provides a 24-hour emergency number for anyone

to report emergencies involving hazardous materials. The Bureau has a duty call list that is

staffed by the Bureau’s seven supervisors. When a radiological incident is reported after work

hours, they are contacted by cell phone. When the Bureau is notified of an incident during

working hours, the sections supervisors, the administrators, and/or the Bureau Chief determine

the approach to be taken regarding the incident. The review team found that the Bureau’s

responses to incidents and allegations were complete and comprehensive. The level of effort

was commensurate with the health and safety significance of the event. Inspectors were

dispatched for investigations when appropriate and the Bureau took suitable enforcement

action when indicated. 

The review team found a good correlation between the Bureau’s response to the questionnaire

and the incident information in the casework. The review team also queried the incident

information reported on the NMED system for Ohio which identified 25 reported incidents during

this review period. The ten incidents selected for evaluation included three medical events, two
Ohio Final Report Page 9

events involving lost/stolen gauges, two leaking sources, one event involving exposure to a

member of the public, and two equipment failures.

The review of incident casework and interviews with staff revealed that incidents are promptly

evaluated for the need for investigations. For those incidents not requiring investigations,

copies of reports were in the incident and inspection files. In response to incidents, the Bureau

took prompt, appropriate action. The review team found that the Bureau’s responses were

prompt and well-coordinated. The evaluation of the casework indicated that incident reports

were thorough and well-documented. All incident reports were reviewed and signed by the

appropriate level of management.

The evaluation of the 30 allegation cases indicated that the Bureau took prompt and

appropriate action in response to the allegers’ concerns. Through review of the casework and

interviews with staff, the review team determined that the Bureau provided feedback to allegers

either verbally or in writing when possible. Any alleger requesting anonymity is informed that

every effort will be made to protect his/her identity, but cannot be guaranteed. All interviewed

staff were knowledgeable of the Bureau’s allegation procedure. There were no performance

issues identified from the review of allegation files and documentation.

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 Incidents and

Allegation Activities, be found satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in evaluating 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

Along with their response to the questionnaire, the Bureau provided the review team with the

opportunity to review copies of legislation that affects the radiation control program. 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 Director has designated the Bureau Chief to administer the Agreement State

program for the Department. The review team noted that no new legislation was passed since

last review, which would affect the Agreement State program or its authority.

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 produced by machines. Ohio requires a license for the possession and use of

all radioactive material including naturally occurring materials, such as certain isotopes of
Ohio Final Report Page 10

radium, and accelerator-produced radionuclides. Ohio also requires registration of all machines

designed to produce x-rays or other ionizing radiation.

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

found that regulations are drafted by the staff and presented to the State’s Radiation Advisory

Council (Council). The regulations are posted on the Department web site with a 45-day

comment period. At this point, the proposed rules are sent to the NRC for a compatibility 

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

regulations are revised as necessary. The revised regulations are submitted to the Radiation

Advisory Council for a recommendation for adoption. The formal rule adoption process begins

with submittal to the Public Health Council which places the review of the proposed rules on

their calendar, hold a hearing, and then submit them to the Joint Committee on Agency Rules

Review (JCARR). After JCARR completes its review of the proposed rules and takes no action

against the rule, the Public Health Council is able to take final actions to enact the rule. The

rule becomes final after it is filed with several State rule codification agencies. The minimum

amount of time for a rule to become final is ten days after such filing.

The 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 Office of State and Tribal Programs’ (STP) State Regulation Status Sheet. During the

previous IMPEP review, it was noted that the Bureau had adopted all required NRC regulations

by reference during the negotiation of the Agreement. Since then, the Bureau has replaced

many of the NRC regulations incorporated by reference with State-specific regulations. All

regulations required to be adopted are currently in effect.

For the following two amendments, the NRC reviewed the State’s proposed regulations for

these amendments and determined that if the proposed regulations are adopted without

significant changes, they would meet the NRC's compatibility and health and safety

requirements:

! “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 1629) that

became effective April 5, 2002.

! “Medical Use of Byproduct Material,” 10 CFR Parts 20, 32, and 35 amendment

(67 FR 20249) that became effective April 24, 2002. 

The team identified the following regulation changes and adoptions that will be needed in the

future, and Bureau management indicated that the regulations would be addressed in upcoming

rulemaking, incorporation by reference, or by adopting alternate legally binding requirements:

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

(68 FR 57327) that became effective December 3, 2003.

! “Compatibility with IAEA Transportation Safety Standards and Other Transportation

Safety Amendments,” 10 CFR Part 71 amendment (69 FR 3697) that became effective

October 1, 2004.
Ohio Final Report Page 11

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 (SS&D) Evaluation Program

In assessing the Ohio SS&D evaluation program, the review team examined the information

provided in response to the IMPEP questionnaire. The team evaluated SS&D registry sheets

issued during the review period and the supporting document files. The team also evaluated

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

SS&D sheets, the use of guidance documents and procedures, and interviewed the staff

currently conducting SS&D evaluations. Three sub-indicators were used to evaluate the

Bureau’s performance regarding their SS&D Evaluation Program. These sub-indicators were

(1) Technical Staffing and Training; (2) Technical Quality of the Product Evaluation Program;

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

4.2.1 Technical Staffing and Training

Presently, the SS&D Evaluation Program is under the Industrial Section of the Nuclear

Materials Safety Program, and three staff members conduct the reviews. One of the three

reviewers works in the Decommissioning Section and acts as a backup SS&D reviewer. One

previously qualified and experienced SS&D reviewer left the Bureau during the review period. 

The review team evaluated the qualifications of the individuals authorized and currently

performing SS&D evaluations. All reviewers were qualified through implementation of the newly

developed Formal Training and Qualification Journal for SS&D Reviewers. All have regulatory

experience and have attended the NRC SS&D Workshop. The review team noted that SS&D

reviewers have degrees in engineering, environmental science, or equivalent training and

experience.

4.2.2 Technical Quality of the Product Evaluation Program

The review team evaluated 12 of the 51 SS&D evaluation amendments, inactivations, and new

registrations the Bureau completed during the review period, representing the work of four

SS&D reviewers. The cases selected were representative of the Bureau’s licensees and SS&D

reviewers. A list of SS&D casework examined along with case-specific comments may be

found in Appendix F.

The team’s review of the casework and interviews with the staff confirmed that the SS&D

reviewers used “Consolidated Guidance - Application for Sealed Source and Device

Evaluation”, which is Ohio’s version of NUREG-1556, Vol. 3, and the American National

Standards Institute (ANSI)/Health Physics Society (HPS) standards. All pertinent ANSI/HPS

standards, regulatory guides, and applicable references were confirmed to be available and

were used when performing SS&D reviews. The appropriate review checklist was used to

assure relevant materials had been submitted and reviewed. The checklists were retained in all

of the registration files examined. Overall, the review team found the evaluations were of high

quality with health and safety issues promptly addressed. 

The registration files contained all correspondence, engineering drawings, radiation profiles,

and results of tests conducted by the applicant. The files were well organized in a consistent
Ohio Final Report Page 12

manner. Deficiency letters clearly stated regulatory positions and health and safety issues were

properly addressed. The Bureau handles proprietary information by creating a blue folder for

any proprietary or trade secret information. If a request to view SS&D files is received, the legal

department will conduct a review of the SS&D file to determine if material is suitable for public

review. The review team determined that product evaluations were thorough, complete,

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

products during use and in the event of likely accidents.

The review team recommends that a good practice be found in the Ohio SS&D Evaluation

Program. Whenever an SS&D casework is completed, the updated SS&D registration is

always tied to the applicant’s material license. When a sealed source and/or a device is

introduced in an applicant’s product line, a design or radioactive source strength is modified, or

an error is corrected, these actions are reflected in applicant’s license. This practice provides

an excellent reference to help license reviewers, inspectors, and investigators better

understand SS&D issues, especially when an SS&D related enforcement action is necessary.

4.2.3 Evaluation of Defects and Incidents Regarding SS&D

Three incidents or defects related to SS&D issues were reported to the Bureau during the

review period concerning devices registered by the Bureau and are noted in Appendix E, file

numbers 2, 3, and 6. There were no generic design or performance issues identified from the

review of SS&D incident files and documentation. The Bureau provided a timely and adequate

response in the investigation and resolution of the events. No allegations related to SS&Ds

were reported during 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, SS&D Evaluation Program, be found

satisfactory.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

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

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

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

becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in

place a regulatory program which will meet the criteria for an adequate and compatible LLRW

disposal program. There are no plans for a LLRW disposal facility in Ohio. Accordingly, the

review team did not review this indicator.

4.4 Uranium Recovery Program

Although Ohio has Uranium Recovery authority, 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, they are expected to put in place a regulatory program which will

meet 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.
Ohio Final Report Page 13

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found Ohio’s performance to be

satisfactory for all performance indicators reviewed. 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 NRC’s program. Based on

the results of the current IMPEP review, the review team recommended and the MRB agreed

that the next full review should take place in approximately four years. The review team made

no recommendations regarding the performance of the Ohio Agreement State Program.

GOOD PRACTICE:

The review team found that whenever SS&D casework is completed, the updated SS&D

registration is tied to the applicant’s material license. When a sealed source and/or a

device is introduced in an applicant’s product line, a design or radioactive material

strength is modified, or an error is corrected, all these actions are reflected in applicant’s

license. This practice provides an excellent reference in helping license reviewers,

inspectors, and investigators better understand SS&D issues, especially when an SS&D

related enforcement action is necessary. (Section 4.2.2)
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

Attachment December 14, 2004 Email from Michael Snee

Ohio’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Linda McLean, Region IV Team Leader

Technical Quality of Incident and Allegation

Aaron McCraw, STP Technical Staffing and Training

Compatibility Requirements

Shawn Seeley, State of Maine Status of Materials Inspection Program

Technical Quality of Inspections

Inspector Accompaniments

James Lynch, Region III Technical Quality of Licensing Actions

Inspector Accompaniments

Xiaosong Yin, NMSS Sealed Source and Device Evaluation Program
APPENDIX B

OHIO ORGANIZATION CHARTS

ADAMS: ML042800450

PAGES 26-30
Ohio Final Report Page C.1

Inspection Casework Reviews

APPENDIX C

INSPECTION CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Knox Community Hospital License No.: 02120430001

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 4/16/02 Inspectors: AC, JA

Comment:

Independent surveys were not recorded.

File No.: 2

Licensee: Advanced Cardiovascular Specialists License No.: 02201230000

Inspection Type: Initial Priority: 3

Inspection Date: 10/7/04 Inspector: AC

File No.: 3

Licensee: Cardinal Health License No.: 02500580000

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 9/30/04 Inspector: LS

Comments:

a) Independent surveys were not recorded.

b) Survey instrument was not recorded.

File No.: 4

Licensee: Mercy Hospital–Fairfield License No.: 02120310032

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 11/13/03 Inspector: JA

Comment: 

Independent surveys were not recorded.

File No.: 5

Licensee: Premier Physicians Center - Mobile License No.: 02220180000

Inspection Type: Routine, Unannounced Priority: 2 and 3

Inspection Date: 9/30/04 Inspector: CC

Comments:

a) Independent surveys were not recorded.

b) Survey instrument was not recorded.

File No.: 6
Ohio Final Report Page C.2

Inspection Casework Reviews

Licensee: Cardinal Health License No.: 02500180000

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 7/2/04 Inspectors: CC, MC

Comment:

Survey instrument was not recorded.

File No.: 7

Licensee: Cooperheat – MQS, Inc. License No.: 03320990000

 Inspection Type: Routine, Unannounced Priority: 1

Inspection Dates: 6/22-24/04 Inspectors: KB, MR

File No.: 8

Licensee: Mount Carmel Health System License No.: 02120250034

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/12/04 Inspector: AC

Comment: 

Independent surveys were not performed.

File No.: 9

Licensee: Cancer Treatment Partner License No.: 02300780008

Inspection Type: Routine, Unannounced Priority: 3/NRC 5

Inspection Date: 10/6/04 Inspector: DC

File No.: 10

Licensee: ABB, Inc License No.: 03211250000

Inspection Type: Routine, Unannounced Priority: 1/NRC 2

Inspection Date: 10/15/04 Inspector: KV

Comment:

Survey instrument was not recorded.

File No.: 11

Licensee: Sterigenics License No.: 03521250000

Inspection Type: Routine, Unannounced Priority: 1/NRC 2

Inspection Date: 10/13/04 Inspector: KB

File No.: 12

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

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/7/04 Inspector: SD

File No.: 13

Licensee: University of Cincinnati License No.: 02110310010

Inspection Type: Routine, Unannounced Priority: 1/NRC 2

Inspection Dates: 5/22-24/04 Inspectors: AC, LS, CC
Ohio Final Report Page C.3

Inspection Casework Reviews

File No.: 14

Licensee: The Ohio State University License No.: 02110250037

Inspection Type: Routine, Unannounced Priority: 1/NRC 2

Inspection Dates: 2/18-20/04 Inspectors: DC, LS, CC

File No.: 15

Licensee: Solutient Technologies, LLC License No.: 03219770000

Inspection Type: Routine, Announced Priority: 2/NRC 3

Inspection Date: 10/30/03 Inspector: CM

Comment:

Survey instrument was not recorded.

File No.: 16

Licensee: Proctor & Gamble License No.: 03610090000

Inspection Type: Routine, Announced Priority: 2/NRC 3

Inspection Date: 7/30//03 Inspectors: SD, WH

File No.: 17

Licensee: Cardinal Health 419, LLC License No.: 03211180000

Inspection Type: Routine, Unannounced Priority: 1/NRC 2

Inspection Date: 10/20/04 Inspectors: KB, MR

Comment:

Survey instrument was not recorded.
Ohio Final Report Page C.4

Inspection Casework Reviews

INSPECTOR ACCOMPANIMENTS

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

Accompaniment No.: 1

Licensee: Sterigenics License No: 03521250000

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/13/04 Inspector: KB

Accompaniment No.: 2

Licensee: Mount Carmel East Hospital License No: 02120250034

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/12/04 Inspector: AC

Comment:

No independent measurements were taken.

Accompaniment No.: 3

Licensee: Regional Nuclear Pharmaceuticals License No: 02500250001

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/14/04 Inspector: JA

Accompaniment No.: 4

Licensee: ABB Industrial, Inc. License No: 03211250000

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/15/04 Inspector: KV

Accompaniment No.: 5

Licensee: Cancer Treatment Center Partners License No.: 02300780008

Inspection Type: Routine Priority: 3

Inspection Date: 10/6/04 Inspector: DC

Accompaniment No.: 6

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

Inspection Type: Routine Priority: 1

Inspection Date: 10/7/04 Inspector: SD
APPENDIX D

LICENSE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM

File No.: 1

Licensee: Knox Community Hospital License No.: 02120430001

Type of Action: Renewal Amendment No.: 3

Date Issued: 10/8/03 License Reviewer: AC

File No.: 2

Licensee: Cardinal Health License No.: 02500180000

Type of Action: Renewal Amendment No.: 6

Date Issued: 2/10/04 License Reviewer: DC

File No.: 3

Licensee: ABB, Inc. License No.: 03211250000

Type of Action: Amendment Amendment No.: 4

Date Issued: 3/12/02 License Reviewer: KB

Comment:

License Condition 9 is unclear. The license was later modified (Amendment 7) to rectify

this issue.

File No.: 4

Licensee: Crystal Clear Imaging, Ltd. License No.: 02200120002

Type of Action: Amendment Amendment No.: 2

Date Issued: 3/28/03 License Reviewer: JA

File No.: 5

Licensee: Baker Inspection Group, LLC License No.: 03320770014

Type of Action: New Amendment No.: 0

Date Issued: 8/5/04 License Reviewer: MR

File No.: 6

Licensee: GE Reuter-Stokes, Inc. License No.: 03214780011

Type of Action: Amendment Amendment No.: 4

Date Issued: 2/2/04 License Reviewer: KV

File No.: 7

Licensee: Aultman Hospital License No.: 02120770003

Type of Action: Amendment Amendment No.: 16

Date Issued: 2/2/04 License Reviewer: LS

Comment:

 The maximum allowed possession limit is incorrect.
Ohio Final Report Page D.2

Licensing Casework Reviews

File No.: 8

Licensee: NUCON International, Inc. License No.: 03225250036

Type of Action: Renewal Amendment No.: 3

Date Issued: 5/5/03 License Reviewer: SD

File No.: 9

Licensee: Denison University License No.: 01129460000

Type of Action: Termination Amendment No.: 1

Date Issued: 9/26/02 License Reviewer: JD

File No.: 10

Licensee: Wyle Laboratories License No.: 03510460000

Type of Action: Termination Amendment No.: 4

Date Issued: 3/29/02 License Reviewer: JD

File No.: 11

Licensee: Dayton Testing Laboratory, Inc. License No.: 31210580010

Type of Action: Termination Amendment No.: 2

Date Issued: 7/21/03 License Reviewer: SD

File No.: 12

Licensee: Mallinckrodt, Inc. License No.: 02500310002

Type of Action: Amendment Amendment No.: 8

Date Issued: 10/23/04 License Reviewer: CC

File No.: 13

Licensee: Multi-Dimensional Imaging, Inc. License No.: 03214180000

Type of Action: Termination Amendment No.: 1

Date Issued: 3/22/04 License Reviewer: SD

File No.: 14

Licensee: Isomedix Operations, Inc. License No.: 03521250028

Type of Action: Amendment Amendment No.: 3

Date Issued: 10/6/04 License Reviewer: KB

File No.: 15

Licensee: Best Lighting Products, Inc. License No.: 03214460000

Type of Action: New Amendment No.: 0

Date Issued: 8/26/04 License Reviewer: WH
APPENDIX E

INCIDENT CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

File No.: 1

Licensee: BBC&M Engineering License No.: 31210-25-0006

Date of Incident: 9/14/04 NMED Number: 04063

Investigation Date: 9/14/04 Type of Incident: Stolen Device

Type of Investigation: Phone, Written report

File No.: 2

Licensee: ABB, Inc. SS&D No.: OH-0109-D-121-B

Date of Incident: 5/14/04 NMED Number: N/A

Investigation Date: N/A Type of Incident: Equipment Failure

Type of Investigation: Phone, Written report

File No.: 3

Licensee: Ohmart/Vega Corp. SS&D No.: OH-0321-231-0036

Date of Incident: 7/22/03 NMED Number: 030631

Investigation Date: N/A Type of Incident: Leaking Source

Type of Investigation: Phone, Written report

File No.: 4

Licensee: The Cleveland Clinic License No.: 02110-18-0013

Date of Incident: 2/18/04 NMED Number: 040178

Investigation Date: 3/12/04 Type of Incident: Medical Event

Type of Investigation: Inspection

File No.: 5

Licensee: University of Cincinnati (University Hospital) License No.: 02110-31-0010

Date of Incident: 5/10/04 NMED Number: 04032

Investigation Dates: 5/10-11/04 Type of Incident: Medical Event

Type of Investigation: Inspection

File No.: 6

Licensee: Scott Process Systems, Inc License No.: 03320-77-0000

Date of Incident: 1/8/03 NMED Number: 030154

Investigation Date: N/A Type of Incident: Equipment Failure

Type of Investigation: Phone, Written report

File No.: 7

Licensee: Battelle Memorial Institute License No.: 03610-25-00001

Date of Incident: 0/1/04 NMED Number: 040767

Investigation Date: N/A Type of Incident: Leaking Source

Type of Investigation: Phone, Written report
Ohio Proposed Final Report Page E.2

Incident Casework Reviews

File No.: 8

Licensee: Premcor Refining Group License No.: 3120-10-20001

Date of Incident: 8/18/04 NMED Number: 040597

Investigation Date: 8/19/04 Type of Incident: Overexposure

Type of Investigation: Investigation, Inspection

File No.: 9

Licensee: Southwest General/Ireland Cancer Center License No.: 02120-18-0001

Date of Incident: 12/22/03 NMED Number: 040003

Investigation Date: 12/29/03 Type of Incident: Medical Event

Type of Investigation: Investigation, Inspection

File No.: 10

Licensee: Solar Testing Laboratories, Inc. License No.: 31210-18-0065

Date of Incident: 4/18/03 NMED Number: 030334

Investigation Date: N/A Type of Incident: Stolen Device

Type of Investigation: Phone, Written report
APPENDIX F

SEALED SOURCE AND DEVICE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENTS IS INCLUDED FOR COMPLETENESS

ONLY; MOST COMMENTS, SUCH AS INCONSISTENT S&SD REGISTRY ISSUANCE DATE

ISSUE, HAVE BEEN DISCUSSED WITH THE BUREAU AND APPROPRIATE ACTIONS ARE

EXPECTED.

File No.: 1

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

Manufacturer: ABB Inc. Model No.: TG-4

Date Issued: 1/2/04 Type of Action: Amendment

SS&D Reviewers: KV, SD

Comments:

a) Format: Amended in Its Entirety was under Issuance Date instead of under the Title.

b) Inconsistent issuance date and review date, issued on 1/27/04, second reviewer signed

on 2/9/04.

File No.: 2

Registry No.: OH-0522-S-900-S SS&D Type: (T) Other 

Manufacturer: Ohmart/VEGA Model Nos.: LAB-23601(s), 111(s),

Date Issued: 1/2/04 355(s), 244(s), 238(s), 454(s)

Type of Action: Inactivation

SS&D Reviewers: KV, SD

Comment:

Inconsistent issuance date and review date, first reviewer signed 1/23/04, second

reviewer signed on 1/2/04.

File No.: 3

Registry No.: OH-1211-D-101-G SS&D Type: (W) Self Luminous Light Source

Manufacturer: Best Lighting Model No.: SLXTU NCHYY

Date Issued: 7/13/04 Type of Action: New

SS&D Reviewers: KV, SD

Comment:

Inconsistent issuance date and review date, issued on 1/23/04, second reviewer signed

on 1/26/04.

File No.: 4

Registry No.: OH-1075-D-102-S SS&D Type: (B) Medical Radiography

Manufacturer: Hitachi Medical Systems Model Nos.: Sceptre and ART Series

Date Issued: 1/21/03 Type of Action: New

SS&D Reviewers: KV, GC

Comments:

a) Inconsistent isotope authorization. On the first page isotope stated as Cs-137, however, 

attachment 1 provided labeling information for GE/GA-68.

b) Inconsistent radiation profile. In the text the maximum radiation level was for Cs-137,

however, in attachment 2, the maximum radiation level was for Ge/Ga-68.
Ohio Final Report Page F.2

Sealed Source and Device Casework Reviews

File No.: 5

Registry No.: OH-0522-D-114-B SS&D Type: (D) Gamma Gauge

Manufacturer: Ohmart/VEGA Model Nos.: MTDS Series

Date Issued: 8/6/04 Type of Action: New

SS&D Reviewers: KV, KB

Comment:

Inconsistent issuance date and review date, issued on 8/6/04, second reviewer signed

on 8/9/04.

File No.: 6

Registry No.: OH-1090-D-104-B SS&D Type: (E) Beta Gauge

Manufacturer: Automation & Control Model No.: FAM-1

Date Issued: 8/26/04 Type of Action: Amendment

SS&D Reviewers: KV, KB

File No.: 7

Registry No.: OH-1189-D-101-B SS&D Type: (D) Gamma Gauge/(E) Beta Gauge

Manufacturer: SENTEK Corp. Model No.: TX-1

Date Issued: 5/30/04 Type of Action: New

SS&D Reviewers: KV, SD

Comment:

In attachment 3, “the actual size and color” was used. However, the color has been

changed when the original was copied for the registration.

File No.: 8

Registry No.: OH-0522-S-108-S SS&D Type: (D) Gamma Gauge

Manufacturer: Ohmart/VEGA Model No.: A-58755

Date Issued: 7/31/01 Type of Action: Correction

SS&D Reviewers: KV, GC

File No.: 9

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

Manufacturer: Ohmart/VEGA Model Nos.: SH-x & SH-Fx Series

Date Issued: 7/31/01 Type of Action: Amendment

SS&D Reviewers: KV, GC

Comment:

a) Inconsistent issuance date and review date, issued on 7/31/01, second reviewer signed

on 8/3/01.

b) Format: Amended in Its Entirety was under Issuance Date instead of under the Title.

File No.: 10

Registry No.: OH-1177-D-101-G SS&D Type: (E) Beta Gauge

Manufacturer: UPA technology Model No.: Micro-Derm

Date Issued: 3/9/04 Type of Action: Amendment

SS&D Reviewers: KV, SD

Comment:

When the registration was amended for the maximum activity, however, the maximum

radiation level was not amended accordingly.
Ohio Final Report Page F.3

Sealed Source and Device Casework Reviews

File No.: 11

Registry No.: OH-0522-D-110-B SS&D Type: (D) Gamma Gauge

Manufacturer: Ohmart/VEGA Model No.: SHGL

Date Issued: 4/19/04 Type of Action: Amendment

SS&D Reviewers: KV, SD

File No.: 12

Registry No.: OH-0104-D-104-S SS&D Type: (B) Medical Radiography

Manufacturer Phillips Medical Systems Model No.: MOSAIC

Date Issued: 4/8/04 Type of Action: Amendment

SS&D Reviewers: KV, SD
ATTACHMENT

December 14, 2004 Email from Michael Snee

Ohio’s Response to Draft IMPEP Report

ADAMS: ML050030045