December 6, 2005

Sheri Johnson, Ph.D.

Administrator, Division of Public Health

Wisconsin Department of Health 

 and Family Services 

P. O. Box 2659

Madison, WI 53701-2659 

Dear Dr. Johnson:

On November 8, 2005, the Management Review Board (MRB) met to consider the proposed

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

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

health and safety and compatible with the U.S. Nuclear Regulatory Commission’s program.

Section 4.0, page 10, of the enclosed final report contains a summary of the IMPEP team’s

findings. There were no recommendations for the State of Wisconsin resulting from this IMPEP

review. Based on the results of the review, the next full review will be in approximately four

years, with a periodic meeting tentatively scheduled for August 2007.

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, 

 State and Compliance Programs

Office of the Executive Director for Operations

Enclosure: As stated

cc: Paul Schmidt, Manager

Radiation Protection Section

Cheryl Rogers, Supervisor

Radiation Protection Section

Thomas Conley, KS

Organization of Agreement States

 Liaison to the MRB
December 6, 2005

Sheri Johnson, Ph.D.

Administrator, Division of Public Health

Wisconsin Department of Health 

 and Family Services 

P. O. Box 2659

Madison, WI 53701-2659 

Dear Dr. Johnson:

On November 8, 2005, the Management Review Board (MRB) met to consider the proposed

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

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

health and safety and compatible with the U.S. Nuclear Regulatory Commission’s program.

Section 4.0, page 10, of the enclosed final report contains a summary of the IMPEP team’s

findings. There were no recommendations for the State of Wisconsin resulting from this IMPEP

review. Based on the results of the review, the next full review will be in approximately four

years, with a periodic meeting tentatively scheduled for August 2007.

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, 

 State and Compliance Programs

Office of the Executive Director for Operations

Enclosure: As stated

cc: Paul Schmidt, Manager Thomas Conley, KS

Radiation Protection Section Organization of Agreement States

 Liaison to the MRB

Cheryl Rogers, Supervisor

Radiation Protection Section

Distribution: DCD (SP01) Chairman Diaz

DIR RF JStrosnider, NMSS Commissioner McGaffigan

SMinnick, RI TCombs, OCA (2 copies) Commissioner Merrifield

JLynch, RIII KCyr, OGC Commissioner Jaczko

BParker, RI FCameron, OGC Commissioner Lyons

BTaylor, TX STreby, OGC

JZabko, STP RStruckmeyer, NMSS/IMNS

AMcCraw, STP CMiller, NMSS/IMNS SISP Review Complete

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DATE 12/01/05 12/02/05 12/02/05 12/06/05

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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF WISCONSIN AGREEMENT STATE PROGRAM

August 22-26, 2005

 Final Report

U.S. Nuclear Regulatory Commission
Wisconsin Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Wisconsin Agreement State program. The

review was conducted during the period of August 22-26, 2005, by a review team comprised of

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

Texas. Team members are identified in Appendix A. The review was conducted in accordance

with the “Implementation of the Integrated Materials Performance Evaluation Program and

Rescission of Final General Statement of Policy,” published in the Federal Register on 

October 16, 1997, and the February 26, 2004, NRC Management Directive 5.6, "Integrated

Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which

covered the period of July 3, 2003 to August 26, 2005, were discussed with Wisconsin

management on August 26, 2005.

A draft of this report was issued to Wisconsin for factual comment on September 14, 2005. 

The State responded by E-mail on September 16, 2005, from Mr. Paul Schmidt. The

Management Review Board (MRB) met on November 8, 2005 to consider the proposed final

report. The MRB found the Wisconsin radiation control program adequate to protect public

health and safety and compatible with NRC's program.

The Radiation Control Program is administered by the Radiation Protection Section (the

Section). The Section is part of the Bureau of Environmental and Occupational

Health within the Division of Public Health (the Division). Organization charts for the Division

and the Section are included as Appendix B. At the time of the review, the Wisconsin program

regulated approximately 363 specific licenses, including naturally occurring or acceleratorproduced radioactive material (NARM). 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 Wisconsin.

In preparation for the review, a questionnaire addressing the common and non-common

performance indicators was sent to the Section on June 9, 2005. The Section provided its

response to the questionnaire on July 11, 2005. A copy of the questionnaire response may be

found on the NRC’s Agencywide Documents Access and Management System (ADAMS) using

the accession number (ML051600481).

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

Wisconsin's response to the questionnaire; (2) review of applicable Wisconsin statutes and

regulations; (3) analysis of quantitative information from the Section’s licensing and inspection

databases; (4) technical evaluation of licensing and inspection actions; (5) field

accompaniments of four Wisconsin inspectors; and (6) interviews with staff and management to

answer questions or clarify issues. The review team evaluated the information that it gathered

against the IMPEP performance criteria for each common and applicable non-common indicator

and made a preliminary assessment of the radiation control program’s performance.

Section 2 below discusses the results of the current review for the IMPEP common

performance indicators. Section 3 discusses results of the applicable non-common

performance indicators, and Section 4 summarizes the review team's findings.
Wisconsin Final Report Page 2

2.0 COMMON PERFORMANCE INDICATORS

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

Regional and Agreement State programs. These indicators include: (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.

2.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Section’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 Section’s questionnaire response relative to this

indicator; interviewed Division management and staff; and reviewed job descriptions, training

plans, and training records. The review team also considered any possible workload backlogs

in evaluating this indicator; however, no licensing or inspection casework backlogs were

identified.

The Section, headed by the Section Chief, devotes approximately 9.5 full time equivalent (FTE)

to the radioactive materials program, of which 6.5 are allotted for licensing and inspection. The

program is fully staffed, with no vacancies or turnover since becoming an Agreement State. All

technical staff members are fully qualified to perform both licensing and inspection activities

and are classified as Nuclear Engineers, or after three years of experience, Senior Nuclear

Engineers. All but two inspectors are Senior Nuclear Engineers.

The remaining 3.0 FTE include program management, administrative support and a half-time

training coordinator who assists the program with training needs. The training coordinator

conducts in-house courses and coordinates participation in outside training courses. In-house

training was conducted on September 6, 2003, on management of allegations, and on 

October 18, 2004, on timeliness of response to radiological incidents.

The Section has a documented training plan that is consistent with the guidance in the

NRC/Organization of Agreement States Training Working Group Report and NRC’s Manual

Chapter (MC) 1246. The Section also has on-the-job training to supplement the coursework so

that individuals may broaden their work areas. Newer staff members are assigned increasingly

complex licensing duties under the direction of the Radioactive Materials Licensing and

Inspection Unit Supervisor (the Supervisor) and accompany more experienced inspectors

during increasingly complex inspections. Inspectors are assigned independent inspections

after demonstrating competence during accompaniment evaluations by the Supervisor. The

review team confirmed the qualifications of all staff through review of qualification journals,

training records, and documentation of supervisory accompaniments.

In preparation for taking over the licensing functions as an Agreement State, four staff

members received one-on-one training with an NRC Region III license reviewer. The NRC

reviewer spent approximately one week per person providing “hands-on” training for reviewing

licensing actions and writing various types of licenses.

The Section Chief indicated that upper-level management has been very supportive of staff

training opportunities as well as staff participation in working groups. Training records 
Wisconsin Final Report Page 3

demonstrate that the Section is committed to a high degree of training. All but two staff

members have gone to the five-week Health Physics course taught by Oak Ridge Institute of

Science and Education. The remaining two staff members were exempted due to extensive

experience in the field of radiation. Several staff members have been to supplementary training

courses such as Radiological Emergency Response Operations (RERO), Health Physics in

Radiation Accidents, Multi-Agency Radiation Survey and Site Investigations Manual

(MARSSIM), and Root Cause/Incident Investigation. The Supervisor and two staff members

are scheduled to attend the NRC Security course in September 2005, in Albuquerque, New

Mexico.

The review team noted that the Section had stable funding during the review period. The

Section collects 100 percent of the budget from materials fees, which goes into a dedicated

fund.

The State of Wisconsin does not have an oversight board or committee to provide direction to

the Agreement State program.

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

concurred that Wisconsin’s performance with respect to the indicator, Technical Staffing and

Training, be found satisfactory.

2.2 Status of Materials Inspection Program

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

inspections of Priority I, II, and III licensees; 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 Section’s response to the questionnaire relative to this

indicator, data gathered independently from the Section’s licensing and inspection data tracking

system, the examination of completed inspection casework, and interviews with managers and

staff.

The review team’s evaluation of the Section’s inspection priorities verified that inspection

frequencies for various types or groups of licenses are as frequent, or more frequent, than

similar license types listed in NRC MC 2800. The Section requires more frequent inspections in

some license categories. Medical broad scope programs, gamma knives, high-dose rate

remote afterloaders, nuclear pharmacies and fixed industrial radiographers are inspected on a

one-year frequency compared with the NRC two-year frequency. Mobile nuclear medicine

licenses are inspected on a two-year frequency compared with the NRC three-year frequency. 

Small source material licenses, small medical programs, teletherapy licenses, and self-shielded

irradiators are inspected on a three-year frequency compared with the NRC five-year

frequency. The Section tracks all inspection activities in a computer database. The database

can easily be queried by program management and staff to determine inspection status for any

licensed facility.

In response to the questionnaire, the Section indicated that there was only one inspection

currently overdue by more than 25 percent of the NRC frequency. That inspection was

completed prior to the on-site review. No other inspections were overdue at the time of the

IMPEP review. Initial inspections were scheduled and conducted within one year of license

issuance.
Wisconsin Final Report Page 4

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

inspection casework. Letters to licensees regarding inspection results were sent within 30 days

of the inspection date. Field inspection forms (similar to NRC 591 forms) are sometimes issued

in the field by inspectors when only minor violations are identified during an inspection.

Reciprocity was granted to 20 licensees in 2004 and to 25 licensees thus far in 2005. The

Section reciprocity inspection goals are: 100 percent of source exchange service providers, 50

percent of Priority I and II licensees, 30 percent of Priority III licensees, and 10 percent of

Priority V licensees. The team verified that the Section had met their reciprocity goals, which

are more aggressive than NRC MC 1220 reciprocity inspection requirements.

The team also reviewed the Section's work on general licensees. The Section has completed a

large effort to verify the general license database transferred to them from the NRC, since

becoming an Agreement State. The program currently has approximately 150 registered

general licensees. Each year, the Section requires a self-inspection and fee from registrants. 

They have been successful in obtaining 100 percent response, after some staff persistence. Of

the registered general licensees, the Section has identified approximately 50 higher risk general

licensees, of which they perform on-site inspections. They accomplish this task by having each

inspector perform a small number of general license inspections each year, in addition to their

normal inspection workload.

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

concurred, that Wisconsin’s performance with respect to the indicator, Status of Materials

Inspection Program, be found satisfactory.

2.3 Technical Quality of Inspections

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

members for 20 radioactive materials inspections conducted during the review period. The

casework included work performed by all of the Section’s materials license inspectors, and

covered a variety of license types including: academic; medical; nuclear pharmacy; industrial

radiography; mobile nuclear medicine; service provider; manufacturing and distribution; 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 inspections covered all

aspects of the licensees’ radiation programs. The review team determined 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 performed for larger and complex licensees and for training purposes.

Supervisory accompaniments were conducted annually for all inspectors in 2004 and are on

track to be completed in 2005. Accompaniments are documented on a review checklist which

is placed in the inspector’s qualification and training file.
Wisconsin Final Report Page 5

The team identified that inspection findings were appropriate, and prompt regulatory actions

were taken, as necessary. All inspection findings were clearly stated and documented in the

reports, and reviewed by the Supervisor. The Section has the ability to require enforcement

conferences and impose civil penalties or orders when it is deemed that a licensee has had a

significant breakdown in operations affecting health and safety. The Section’s enforcement

program is detailed in Radioactive Materials Program Procedure 3.05 “Enforcement, Escalated

Enforcement, and Administrative Actions.” Enforcement actions to date appear to have been

appropriate and effective.

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

radiation control program efforts. Instruments are calibrated by the manufacturer or the

University of Wisconsin Radiation Calibration Laboratory. The laboratory is accredited by the 

National Voluntary Laboratory Accreditation Program (NVLAP) and uses sources directly

traceable to National Institute of Standards and Technology (NIST) primary standards. 

Appropriate, calibrated survey instruments such as Geiger-Mueller (GM) meters, scintillation

detectors, ion chambers, micro-R-meters, and neutron meters were observed. Portable multichannel analyzers are used in response to incidents and recycling facility alarms. The Section

maintains calibrated equipment to analyze environmental samples and samples of unknown

radioactive materials for isotopic identification and quantification.

The team performed an on-site review of the Section's waste storage facility located within the

campus of the University of Wisconsin, Madison. The Section collects radioactive material that

has been abandoned within the State and holds it in storage until they can dispose of it at an

authorized low-level radioactive waste disposal facility. The storage area was found to be

secure, appropriately posted, well maintained and inventoried.

Four Section inspectors were accompanied during inspections by review team members in July

2005. Inspection accompaniments included: an industrial radiographer; a mobile nuclear

medicine service; an academic research program and a hospital medical license, as 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. 

Each inspector utilized good health physics practices during the inspections. 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

concurred, that Wisconsin’s performance with respect to the indicator, Technical Quality of

Inspections, be found satisfactory.

2.4 Technical Quality of Licensing Actions

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

licensing casework for 21 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 the license conditions, and overall

technical quality. The casework files were also reviewed for timeliness, use of appropriate

deficiency letters and cover letters, reference to appropriate regulations, product certifications, 
Wisconsin Final Report Page 6

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.

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

which were completed during the review period. The sampling included the following types:

medical and academic broad scope, manufacturing and distribution, medical institution - limited,

private practice, mobile nuclear medicine, nuclear pharmacy, permanent radiography,

radiography - temporary jobsite, portable gauge, fixed gauge, veterinarian, special nuclear

material (pacemaker), and self-shielded irradiator. Types of licensing actions selected for

evaluation included two new licenses, four renewals, nine amendments to existing licenses, 

four license terminations, and several licenses that were converted from NRC to Wisconsin. A

listing of the casework licenses evaluated with case specific comments can 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 inspectible.

Deficiency letters clearly state regulatory positions, are used at the proper time, and identify

substantive deficiencies in the licensees' documents. Terminated licensing actions are well

documented, showing appropriate transfer and survey records.

The administrative staff receives all licensing actions and enters all pertinent information into

the Section’s database (RAMPROD). The status of all actions is tracked by RAMPROD. The

Supervisor assigns each action to one of six reviewers based on workload and experience. For

reviewers with less experience in a given area, the Supervisor provides additional oversight

and/or assigns another experienced reviewer as a mentor. All completed actions are reviewed

and signed by the Supervisor. Deficiency letters are reviewed and signed by the reviewers. 

When the reviewer completes a licensing action, a second technical review is performed by

another reviewer or the Supervisor. The administrative staff conducts an administrative review

and final processing before mailing out to the licensee. 

While the Section does not yet use templates to generate correspondence and licenses, there

are standard formats and license conditions for each license type. The Section utilizes

licensing guides based on NRC licensing guides (NUREG-1556 series), as appropriate and

maintains other licensing guidance (i.e., Technical Assistance Requests, regulatory guides) that

are the same or similar to those used by the NRC.

After Wisconsin became an Agreement State, the Section began converting licenses

transferred from NRC Region III to Wisconsin licenses. The conversions were performed over

many months to distribute the workload. Licenses were converted “as is” from the NRC

licenses, using existing expiration dates, unless the expiration period was greater than five

years. In those cases, the expiration date was five years from the date of conversion. For

licenses at or near expiration, a renewal was performed following the Section’s renewal

procedures. All licenses have been converted. New and renewed licenses are issued for a

five-year term. After the five-year term, licensees are required to submit a complete renewal

application to maintain current information in the file. 
Wisconsin Final Report Page 7

The Section appropriately requires certain licensees to maintain financial assurance for

decommissioning. Applicable financial assurance documents are maintained in a locked

cabinet. The Section has converted 16 of 17 financial surety instruments from NRC to

Wisconsin as the beneficiary. The Section continues to work with NRC Region III to complete

the one outstanding instrument which is partially converted.

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

concurred, that Wisconsin’s performance with respect to the indicator, Technical Quality of

Licensing Actions, be found satisfactory.

2.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Section’s actions in responding to incidents, the review

team examined the Section’s response to the questionnaire relative to this indicator, evaluated

selected incidents reported for Wisconsin in the Nuclear Material Events Database (NMED)

against those contained in the Section files, evaluated the casework and supporting

documentation for radioactive materials incidents and accompanied staff on an incident

investigation. A list of the incident casework examined, with case-specific comments, is

included in Appendix E. The team also reviewed the Section’s response to allegations involving

radioactive materials including allegations referred to the State by NRC during the review

period. Incident and allegation policies, file documentation, the Branch’s incident and allegation

tracking system, NMED, and notification of incidents to the NRC Operations Center were

discussed with the Section Chief and staff.

When notified of an incident, the State Radiological Coordinator (SRC) determines the

approach to be taken regarding the incident. Individuals designated as SRCs are the Section

Chief, Supervisor and trained Senior Nuclear Engineers. The SRC can be contacted by beeper

if necessary, when a notification of an incident is received. The SRC assumes the lead role

and assigns appropriate staff to assist with the initial response and follow-up actions.

The Section responded to 20 radioactive material incidents as reported to NMED during the

review period. Monthly reports and follow-up information are submitted electronically using the

NMED software. One designated staff member manages the submissions to NMED. A sample

of 11 incidents was selected for review. The incidents included: unauthorized removal of a

gauge, damage to equipment, release of radioactive material, contamination, loss and recovery

of radioactive material, three equipment malfunctions, a medical event and two abnormal

occurrences.

During the June 10, 2004, orientation meeting held between Wisconsin and the NRC, the

Section Chief stated that additional efforts would be directed to future incident response to

assure an appropriate level of response is coordinated. The review team noted that following

the meeting, incident response training was conducted, close coordination with the NRC was

maintained, and the Section’s response to incidents was commensurate with the health and

safety significance of the event. Inspectors were dispatched for investigations when

appropriate and the enforcement action was taken when indicated. Incident reports were

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

appropriate level of management.
Wisconsin Final Report Page 8

The Section responded to two incidents resulting from a MICK® Applicator malfunction. Staff

researched the issue through NMED. They discussed the issue with the relevant hospitals, the

device manufacturer, Agreement States and the NRC. They concluded that the malfunction

was a generic issue and issued an Information Notice (IN) on June 9, 2005. The IN informs

Wisconsin medical licensees of the incidents and alerts them to problems associated with the

applicator. The information was shared with the NRC, and shortly thereafter, on June 23, 2005,

the NRC issued IN 2005-17: Manual Brachytherapy Source Jamming, using Wisconsin’s IN as

an attachment. The review team recommended and the MRB agreed that Wisconsin's process

of actively reviewing and analyzing incidents to establish and evaluate root causes, to recognize

generic issues, and to notify affected licensees of their findings be identified as a good practice.

A review team member accompanied staff members on an incident investigation that occurred

during the review week. The incident investigation involved response to tritium exit signs that

ended up at a non-licensed facility. Staff were prepared and assessed the radiological hazard

quickly. Wipe tests were performed and sent for analysis. The radiological hazard and proper

disposal of the material was explained to members of that facilities staff, which are nonradiation workers.

The SRC also evaluates each allegation and determines the proper level of response. The

review of casework files indicated that prompt and appropriate action was taken in response to

the concerns raised. Allegers requesting anonymity are informed that every effort will be made

to protect his/her identity, but cannot be guaranteed. Each of the allegations reviewed were

appropriately closed, and the allegers were informed of the results either verbally or in writing. 

Staff were knowledgeable of the allegation procedure. There were no performance issues

identified from the review of the allegation casework documentation.

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

concurred, that Wisconsin’s performance with respect to the indicator, Technical Quality of

Incident and Allegation Activities, be found satisfactory.

3.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in reviewing 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. Only the first non-common performance indicator was applicable to this review.

3.1 Compatibility Requirements

3.1.1 Legislation

Wisconsin became an Agreement State on August 11, 2003. Along with their response to the

questionnaire, the Section provided the review team with the opportunity to review copies of

legislation that affect the radiation control program. Legislative authority to create an agency

and enter into an Agreement with the NRC is granted in Wisconsin Revised Statue, Section

254.34. The Division is designated as the State's radiation control agency.
Wisconsin Final Report Page 9

3.1.2 Program Elements Required for Compatibility

The Wisconsin regulations governing radiation protection requirements are found in various

subchapters of the Department of Health and Family Services Section 157 of the Wisconsin

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

radionuclides or produced by machines. Wisconsin requires a license for the possession and

use of all radioactive material including naturally occurring materials, and accelerator-produced

radionuclides. Wisconsin also requires registration of all machines designed to produce x-rays

or other ionizing radiation.

The review team examined the State's rulemaking process and found that the process takes

approximately one year after preparation of a draft rule. The Section Chief is responsible for

the radiation protection rule promulgation process. Every step in the process is tracked on the

State of Wisconsin Administrative Rules web site. The first step in the process begins with a

“Statement of Scope of Proposed Rules,” which is the Agency’s public notice that it intends to

begin the development of a permanent rule, submitted to the Office of Legal Counsel. Draft

rule language is developed with input from staff. Wisconsin has used an ad hoc Advisory

Group to comment on the draft language. The group is comprised of a cross section of the

regulated community who will be effected by the new regulations and has been helpful in

identifying controversial issues before the rule process gets underway. Depending on the

scope of the draft language, the group is given a minimum of 90 days to comment. Comments

from the group are incorporated in the draft rule, or a justification for not changing the rule is

provided.

The proposed draft rules are sent to the Legislative Counsel Rules Clearinghouse, and posted

on the Division web site. The public comment period is a minimum of 30 days and at least one

public hearing is held. At the same time, the proposed rule is submitted to the NRC for

compatibility review. Following the hearing, the Division may modify the rule based on the

Clearinghouse and public comments.

The final proposed rule is sent to the Senate and Assembly for legislative review, then to the

Secretary of State for rule publication in the Wisconsin Administrative National Register. 

Normally, the rule will take effect 30 days later.

The review team evaluated Wisconsin’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’ State Regulation Status Sheet.

At the time of their Agreement, the program had in place, State-specific regulations that are

compatible with the NRC. The Section has the authority to issue legally binding requirements

(e.g., license conditions) in lieu of regulations until compatible regulations become effective.

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

legally binding requirements no later than three years after they are effective. All regulations

required to be adopted, including amendments, are currently in effect.

Wisconsin Administrative Code, Chapter HFS 157 became effective on August 1, 2002. The

NRC transmitted 33 comments of the final regulations, in a letter dated November 27, 2002. 

Wisconsin responded in a letter dated December 12, 2002, stating that all comments would be 
Wisconsin Final Report Page 10

addressed in the next revision to HFS 157. In a letter dated December 20, 2003, the NRC

transmitted acceptance of Wisconsin's plan to make the necessary changes in the next revision

to HFS 157, and that the State met compatibility requirements. 

The review team verified that all 33 of the NRC comments on proposed Wisconsin Regulations

have been incorporated into their rules and are currently in the rule promulgation process. The

team also noted that the comments were not significant enough to change compatibility

requirements, in agreement with the aforementioned correspondence from the NRC.

The review team also identified the following regulation adoptions that will be needed in the

future, and Section management indicated that the regulations are currently proposed and

going through the rule promulgation process: 

! “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

on October 1, 2004.

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

30, amendment, 70 FR 2001, that became effective on July 11, 2005.

! “Medical Use of Byproduct Material - Recognition of Speciality Boards,” 10 CFR 30,

amendment, 70 FR 16336, that became effective on April 29, 2005.

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

concurred, that Wisconsin’s performance with respect to the indicator, Compatibility

Requirements, be found satisfactory.

4.0 SUMMARY

As noted in Sections 2 and 3 above, the review team found Wisconsin’s performance to be

satisfactory for all performance indicators reviewed. The review team made no

recommendations regarding the performance of the Wisconsin Agreement State program and

identified one potential good practice. Accordingly, the review team recommended and the

MRB concurred, that the Wisconsin 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 concurred, that the next full

review should take place in approximately four years.

GOOD PRACTICE:

The review team recommended and the MRB agreed that Wisconsin's process of actively

reviewing and analyzing incidents to establish and evaluate root causes, to recognize generic

issues, and to notify affected licensees of their findings be identified as a good practice. 

(Section 2.5)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Wisconsin Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Attachment September 16, 2005 E-mail from Paul Schmidt

Wisconsin’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Sheri Minnick, RI Team Leader

Technical Staffing and Training

Inspector Accompaniments

James Lynch, RIII Status of Materials Inspection Program

Technical Quality of Inspections

Inspector Accompaniments

Bryan Parker, RI Technical Quality of Licensing Actions

Barbara Taylor, TX Technical Quality of Incident and

 Allegation Activities 

Compatibility Requirements
APPENDIX B

WISCONSIN ORGANIZATION CHARTS

Governor to Division Org. Chart: ML052150236

Division of Public Health: ML052150250

Division of Public Health Bureau Environmental 

 & Occupational Health Radiation Protection Section: ML052150257
APPENDIX C

INSPECTION CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Metal Tek International License No.: 133-1181-01

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 5/12/05 Inspectors: MM, RS

File No.: 2

Licensee: NDT Specialists, Inc. License No.: 079-1199-01

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/7/04 Inspectors: MW, RS

File No.: 3

Licensee: Froedtert Memorial Lutheran Hospital. License No.: 079-1104-01

Inspection Type: Routine, Announced Priority: 1

Inspection Dates: 5/10-12/05 Inspectors: JH, LD, PC

Comment:

The inspection did not address a contaminated medical waste incident reported by the

licensee in September 2004.

File No.: 4

Licensee: Seaman Nuclear Corporation License No.: 079-1257-01

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 9/30/04 Inspectors: MM, PC, CR

File No.: 5

Licensee: Marquette University License No.: 079-1161-01

Inspection Type: Follow-up, Announced Priority: 3

Inspection Date: 7/18/05 Inspector: LD

File No.: 6

Licensee: Covance Clinical Research Unit, Inc. License No.: 025-1075-01

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 2/8/05 Inspectors: MS, PC

File No.: 7

Licensee: Cardinal Health-Wauwatosa License No.: 079-1311-01

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 5/6/04 Inspectors: MS, CR

File No.: 8

Licensee: Mercy Hospital License No.: 105-1176-01

Inspection Type: Routine, Unannounced Priority: 1

Inspection Dates: 3/8-15/05 Inspectors: MS, PC, PS
Wisconsin Final Report Page C.2

Inspection Casework Reviews

File No.: 9

Licensee: Team Cooperheat-MQS, Inc. License No.: 079-2005-01

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 10/26/04 Inspector: JH

File No.: 10

Licensee: Shared Medical Technology License No.: 005-1271-01

Inspection Type: Routine, Announced Priority: 2

Inspection Date: 7/13/05 Inspector: RS

File No.: 11

Licensee: Medi-Physics, Inc. License No.: 079-1168-01

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 11/23/04 Inspectors: LD, MS

File No.: 12

Licensee: Sacred Heart Hospital License No.: 035-1253-01

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 8/5/04 Inspector: MW

Comment:

Inspection letter issued late (35 days).

File No.: 13

Licensee: WOS Testing License No.: 035-1358-01

Inspection Type: Routine, Announced Priority: 1

Inspection Date: 11/25/03 Inspector: JH

File No.: 14

Licensee: Columbia-St. Mary’s Hospital License No.: 079-1064-01

Inspection Type: Initial, Announced Priority: 1

Inspection Date: 3/22/04 Inspectors: PC, MS

File No.: 15

Licensee: Waukesha Memorial Hospital License No.: 133-1339-01

Inspection Type: Routine, Announced Priority: 1

Inspection Date: 12/15/04 Inspectors: LD, MM

File No.: 16

Licensee: Lafayette Testing License No.: 079-1147-01

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 12/12/03 Inspectors: MW, MM

File No.: 17

Licensee: MNC License No.: 079-1194-01

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 2/15/05 Inspector: RS
Wisconsin Final Report Page C.3

Inspection Casework Reviews

File No.: 18

Licensee: Elmbrook Memorial Hospital License No.: 079-1092-01

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 7/19/05 Inspector: PC

File No.: 19

Licensee: JANX License No.: 21-16560-01 (NRC)

Inspection Type: Reciprocity, Unannounced Priority: 1

Inspection Date: 8/8/05 Inspector: MM

File No.: 20

Licensee: Nucletron License No.: MD-27-035-01 (Maryland)

Inspection Type: Reciprocity, Unannounced Priority: 3

Inspection Date: 5/5/05 Inspector: RS

INSPECTOR ACCOMPANIMENTS

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

Accompaniment No.: 1

Licensee: Twin Ports Testing, Inc. License No.: 31-1317-02

Inspection Type: Routine Priority: 1

Inspection Date: 7/12/05 Inspector: JH

Accompaniment No.: 2

Licensee: Shared Medical Technology License No.: 5-1271-01

Inspection Type: Routine Priority: 3

Inspection Date: 7/13/05 Inspector: RS

Accompaniment No.: 3

Licensee: Marquette University License No: 079-1161-01

Inspection Type: Follow-up, Announced Priority: 3

Inspection Date: 7/18/05 Inspector: LD

Accompaniment No.: 4

Licensee: Elmbrook Memorial Hospital License No: 079-1092-01

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 7/19/05 Inspector: PC

Comment:

The inspector missed an opportunity to observe handling of licensed material.
APPENDIX D

LICENSE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Heart Hospital of Milwaukee License No.: 076-1376-01

Type of Action: Termination Amendment No.: 02

Date Issued: 1/10/05 License Reviewer: MS

File No.: 2

Licensee: Cardinal Health License No.: 025-1123-01

Type of Action: Renewal Amendment No.: 04

Date Issued: 1/15/05 License Reviewer: MS

File No.: 3

Licensee: Longview Inspection License No.: 133-2008-01

Type of Action: Conversion Amendment No.: 00

Date Issued: 7/15/04 License Reviewer: MS, MW

File No.: 4

Licensee: Red Feather, LLC License No.: 125-1387-01

Type of Action: New Amendment No.: 00

Date Issued: 5/24/05 License Reviewer: MS

File No.: 5

Licensee: Wisconsin Veterinary Referral Center License No.: 133-1357-01

Type of Action: Conversion Amendment No.: 00

Date Issued: 10/1/04 License Reviewer: MW

File No.: 6

Licensee: Iroquois Foundry License No.: 045-1130-01

Type of Action: Termination Amendment No.: 01

Date Issued: 3/11/05 License Reviewer: MW

File No.: 7

Licensee: Seaman Nuclear Corporation License No.: 079-1257-01

Type of Action: Amendment Amendment No.: 01

Date Issued: 4/20/05 License Reviewer: MW, MS

File No.: 8

Licensee: Aurora Baycare Medical Center License No.: 009-1017-01

Type of Action: Amendment Amendment No.: 05

Date Issued: 3/23/05 License Reviewer: MW

Comment:

An authorized use of gadolinium-153 was inadvertently omitted for one authorized user.
Wisconsin Final Report Page D.2

License Casework Reviews

File No.: 9

Licensee: Bellin Memorial Hospital License No.: 009-1033-01

Type of Action: Renewal Amendment No.: 02

Date Issued: 3/23/05 License Reviewer: RS

File No.: 10

Licensee: Advanced Healthcare, S.C. License No.: 079-1001-01

Type of Action: Amendment Amendment No.: 02

Date Issued: 6/27/05 License Reviewer: RS

File No.: 11

Licensee: Northern Shared Medical Services License No.: 025-1209-01

Type of Action: Amendment Amendment No.: 05

Date Issued: 2/11/05 License Reviewer: RS

File No.: 12

Licensee: St. Joseph Hospital License No.: 079-1288-02

Type of Action: Termination Amendment No.: 01

Date Issued: 3/12/04 License Reviewer: PC

File No.: 13

Licensee: Appleton Medical Center License No.: 087-1014-01

Type of Actions: Renewal, Amendment Amendment Nos.: 04, 05

Dates Issued: 11/30/04, 3/30/05 License Reviewer: PC

File No.: 14

Licensee: MD Imaging License No.: 079-1190-01

Type of Action: Amendment Amendment No.: 03

Date Issued: 10/8/04 License Reviewer: PC

File No.: 15

Licensee: Shared Medical License No.: 005-1271-01

Type of Action: Conversion Amendment No.: 00

Date Issued: 6/15/04 License Reviewer: LD

Comment:

Two locations of use were properly requested, but inadvertently omitted from this action.

File No.: 16

Licensee: Bay Area Medical Center License No.: 075-1030-01

Type of Action: Conversion Amendment No.: 00

Date Issued: 3/23/04 License Reviewer: LD

File No.: 17

Licensee: Prevea Clinic, Inc. License No.: 009-1174-01

Type of Action: New Amendment No.: 00

Date Issued: 7/15/05 License Reviewer: LD
Wisconsin Final Report Page D.3

License Casework Reviews

File No.: 18

Licensee: Waukesha Foundry Co. License No.: 133-1337-01

Type of Action: Conversion Amendment No.: 00

Date Issued: 11/1/04 License Reviewer: JH

File No.: 19

Licensee: Milwaukee Cardiac Nuclear Imaging License No.: 079-1378-01

Type of Action: Termination Amendment No.: 01

Date Issued: 3/9/05 License Reviewer: JH

Comment:

This termination was completed without written confirmation from the licensee that

radioactive material was no longer possessed.

File No.: 20

Licensee: Univ. of Wisconsin - Madison License No.: 025-1323-04

Type of Action: Renewal Amendment No.: 01

Date Issued: 7/1/05 License Reviewer: JH

Comment:

This action contained multiple typographical errors.

File No.: 21

Licensee: Univ. of Wisconsin - Madison License No.: 025-1323-01

Type of Actions: Amendments Amendment Nos.: 05, 06, 07

Dates Issued: 11/29/04, 6/2/05, 6/21/05 License Reviewer: JH
APPENDIX E

INCIDENT CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Wisconsin Public Services Corp. License No.: General Licensee

Date of Incident: 9/25/03 NMED No.: 030825

Investigation Date: 10/14/03 Type of Incident: Unauthorized Removal of Gauge

Type of Investigation: Inspection

File No.: 2

Licensee: Mead & Hunt Inc. License No.: 025-1167-01

Date of Incident: 7/29/04 NMED No.: 040604

Investigation Date: 7/30/04 Type of Incident: Damaged Gauge

Type of Investigation: Inspection

File No.: 3

Licensee: Cardinal Health 414, Inc. License No.: 025-1123-01

Date of Incident: 8/9/04 NMED No.: 040578

Investigation Date: 8/10/04 Type of Incident: Release of Radioactive Material

Type of Investigation: Inspection

File No.: 4

Licensee: University of Wisconsin License No.: 025-1323-01

Date of Incident: 8/30/04 NMED No.: 040643

Investigation Date: 9/3/04 Type of Incident: Loss/Recovery of Radioactive Material

Type of Investigation: Inspection

File No.: 5

Licensee: Aurora Baycare Medical Center License No.: 009-1017-01

Date of Incident: 8/31/04 NMED No.: 040635

Investigation Date: 9/2/04 Type of Incident: Equipment Malfunction

Type of Investigation: Inspection

File No.: 6

Licensee: Memorial Hospital of Burlington License No.: 101-1173-01

Date of Incident: 9/1/04 NMED No.: 050410

Investigation Date: 3/9/05 Type of Incident: Loss of RAM

Type of Investigation: Inspection

Comment:

This incident was discovered during a routine inspection.
Wisconsin Final Report Page E.2

Incident Casework Reviews

File No.: 7

Licensee: Mercy Hospital License No.: 105-1176-01

Date of Incident: 7/13/04 NMED No.: 050353

Investigation Date: 3/15/05 Type of Incident: Other (Abnormal Occurrence)

Type of Investigation: Inspection

Comment:

This incident was discovered during a routine inspection.

File No.: 8

Licensee: University of Wisconsin License No.: 025-1323-01

Date of Incident: 4/5/05 NMED No.: 050235

Investigation Dates: 4/11-5/3/05 Type of Incident: Medical Event (Abnormal Occurrence)

Type of Investigation: Inspection

Comment:

Enforcement action, including a civil penalty, was issued. This event has not been

closed by the State. The Section has retained a medical consultant to review the

medical consequences to the patient.

File No.: 9

Licensee: Aurora Baycare Medical Center License No.: 009-1017-01

Date of Incident: 4/19/05 NMED No.: 050289

Investigation Date: 4/25/05 Type of Incident: Equipment Malfunction, Leaking Source

Type of Investigation: Inspection

Comment:

Information Notice concerning MICK® Applicators was developed and distributed to

Wisconsin licensees. This event has not been closed by the State. The manufacturer is

currently investigating the cause of the device malfunction.

File No.: 10

Licensee: Gunderson Lutheran Medical Center License No.: 063-1121-01

Date of Incident: 5/18/05 NMED No.: 050351

Investigation Date: 5/19/05 Type of Incident: Equipment Malfunction, Leaking Source

Type of Investigation: Inspection

Comment:

Information Notice concerning MICK® Applicators was developed and distributed to

Wisconsin licensees. This event has not been closed by the State. The manufacturer is

currently investigating the cause of the device malfunction.

File No.: 11

Licensee: Aspirus - Wausau Hospital License No.: 073-1342-01

Date of Incident: 7/6/05 NMED No.: 050451

Investigation Date: 7/11/05 Type of Incident: Medical Event

Type of Investigation: Inspection
ATTACHMENT

September 16, 2005, E-mail from Mr. Paul Schmidt

Wisconsin’s Response to Draft IMPEP Report 

ADAMS: ML053040055