August 13, 2008 

Mr. Dennis Burke 

Chief of Staff 

Office of the Governor 

1700 West Washington St. 

Phoenix, AZ 85007 

Dear Mr. Burke: 

On July 21, 2008, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Arizona Agreement 

State Program. The MRB found the Arizona Program adequate, but needs improvement, to 

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

(NRC’s) program. Because of the significance of the findings, the MRB determined that the 

Arizona Program should undergo a period of Heightened Oversight. Heightened Oversight is an 

increased monitoring process the NRC uses to follow the progress of improvement needed in an 

Agreement State program. It involves preparation of a program improvement plan, bimonthly 

conference calls, and submission of status reports prior to each call with the appropriate Arizona 

and NRC managers and staff members. 

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

findings and recommendations for the Arizona Agreement State Program. We request that you 

prepare and submit a program improvement plan as part of your response to the review team’s 

recommendations. I ask that you have your staff discuss the required elements of this plan with 

Mr. Robert Lewis, Director, Division of Materials Safety and State Agreements, Office of Federal 

and State Materials and Environmental Management Programs, to ensure that the “get-well” 

path and measures of success are clearly identified. The plan should be submitted within 30 

days of receipt of this letter. Upon review of your program improvement plan, NRC staff will 

schedule the first conference call. The initial conference call should be scheduled and 

conducted no later than October 1, 2008. Based on the results of the current IMPEP review, a 

followup review will be scheduled approximately one year from the date of the March 2008 

IMPEP review. The followup review will cover the State’s actions in response to the 

recommendations in the enclosed final report. 
D. Burke 2 

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

wish to acknowledge your continued support for the Agreement State Program. I look forward to 

our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA/ 

 Martin J. Virgilio 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Arizona Final IMPEP Report 

cc w/encl.: 

 

Tracy Hannah, Policy Advisor 

Arizona Office of the Governor 

Aubrey Godwin, Director 

Arizona Radiation Regulatory Agency 

Cheryl Rogers, Wisconsin 

Organization of Agreement 

States Liaison to the MRB
D. Burke 2 

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

wish to acknowledge your continued support for the Agreement State Program. I look forward to 

our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 

/RA/ 

 Martin J. Virgilio 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Arizona Final IMPEP Report 

cc w/encl.: 

Tracy Hannah, Policy Advisor 

Arizona Office of the Governor 

Aubrey Godwin, Director 

Arizona Radiation Regulatory Agency 

Cheryl Rogers, Wisconsin 

Organization of Agreement 

States Liaison to the MRB 

Distribution: See next page. 

 ADAMS ACCESSION NO.: ML082060548 (Package) 

OFFICE FSME/DMSSA FSME/DMSSA FSME/DMSSA 

NAME ATMcCraw:km ADWhite RJLewis 

DATE 7/29/08 7/29/08 7/30/08 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland (P.Tressler for) CLMiller (G.Pangburn for) MJVirgilio 

DATE 8/1/08 8/6/08 08/13/08 

OFFICIAL RECORD COPY
Letter to Dennis Burke from: Martin J. Virgilio dated: August 13, 2008

Distribution: EDATS: FSME-2008-0033 

DMSSA RF DCD (SP01) 

EDO RF 

RidsEdoMailCenter 

RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Klein 

AMcCraw, FSME/DMSSA Commissioner Jaczko 

JLynch, RIII Commissioner Lyons 

LMcLean, RI/RSAO Commissioner Svinicki 

THerrera, FSME/DMSSA SECY 

Robert Gallaghar, MA 

Sherrie Flaherty, MN 

WRautzen, FSME/DMSSA 

DSollenberger, FSME/DMSSA 

SCampbell, OEDO 

BJones, OGC 

SCollins, RI 

JGray, OGC 

APowell, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE ARIZONA AGREEMENT STATE PROGRAM 

March 10-14, 2008 

FINAL REPORT
Arizona Final Report Page 1 

1.0 INTRODUCTION 

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

review was conducted during the period of March 10-14, 2008, by a review team comprised of 

technical staff members from the U.S. Nuclear Regulatory Commission (NRC), the 

Commonwealth of Massachusetts, and the State of Minnesota. Team members are identified in 

Appendix A. The review was conducted in accordance with the “Implementation of the 

Integrated Materials Performance Evaluation Program and Rescission of Final General 

Statement of Policy,” published in the Federal Register on October 16, 1997, and 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 

February 11, 2006 to March 14, 2008, were discussed with Arizona managers on the last day of 

the review. 

A draft of this report was issued to Arizona for factual comment on April 10, 2008. The State 

responded by letter on May 14, 2008, from Dennis Burke, Chief of Staff, Office of the Governor. 

A copy of the State’s response is included as an attachment to this report. The Management 

Review Board (MRB) met on July 21, 2008, to consider the proposed final report. The MRB 

found the Arizona Agreement State Program to be adequate, but needs improvement, to protect 

public health and safety and compatible with NRC’s program. Because of the significance of the 

findings, the MRB determined that the Arizona Agreement State Program should undergo a 

period of Heightened Oversight by the NRC. 

The Arizona Agreement State Program is administered by the Arizona Radiation Regulatory 

Agency (the Agency). The Agency Director reports directly to the Governor. The day-to-day 

operations of the Arizona Agreement State Program are managed by the Radioactive Materials 

& Nonionizing Radiation Compliance Program (the Program). An organization chart for the 

Agency and Program is included as Appendix B. 

At the time of the review, the Agency regulated 375 specific licenses authorizing byproduct, 

source, and certain special nuclear materials. The review focused on the radioactive materials 

program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as 

amended) Agreement between the NRC and the State of Arizona. 

The previous IMPEP review of the Arizona Agreement State Program concluded on 

February 10, 2006. That review identified that the Agency had difficulty with recruiting and 

retaining qualified staff which resulted in the inability to perform inspections in a timely manner. 

The review team found Arizona’s performance to be unsatisfactory for the performance indicator, 

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

performance indicator, Technical Staffing and Training. As a result, the MRB directed NRC staff 

to hold a periodic meeting with the State in 2007 to determine when the next IMPEP review 

should be scheduled. 

On March 1, 2007, a periodic meeting was held with the Agency to review progress made in the 

Agreement State Program. The reviewers identified that some progress had been made to 

complete overdue high priority inspections, but that some 187 medium-risk licenses were 

overdue for inspection. The MRB directed NRC staff to perform a full IMPEP review of the 
Arizona Final Report Page 2 

Arizona Agreement State Program in 2008, due to identified concerns with staff turnover rates 

and timeliness of inspections. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Agency on November 16, 2007. The Agency 

provided its response to the questionnaire on March 5, 2008. A copy of the questionnaire 

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

(ADAMS) using the Accession Number ML073201200. 

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

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

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

review of selected regulatory actions; (5) field accompaniments of three Arizona inspectors; and 

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

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

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

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

during the previous review. Results of the current review for the common performance 

indicators are presented in Section 3.0. Section 4.0 details the results of the review of the 

applicable non-common performance indicators, and Section 5.0 summarizes the review team's 

findings and recommendations. Recommendations made by the review team are comments 

that relate directly to program performance by the State. A response is requested from the State 

to all recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on February 10, 2006, the review team 

made five recommendations in regard to program performance. The current status of each 

recommendation is as follows: 

1. The review team recommends that the Agency develop and implement a staffing plan to 

fill the current vacancy, meet growing Program needs and maintain long-term stability. 

(Section 3.1 of the 2006 IMPEP report) 

Current Status: In response to the previous IMPEP review, the Agency submitted a 

simplified staffing and budget plan covering fiscal years 2007 to 2011, which addressed 

projected staffing changes, potential salary increases, and Agency budget. The plan 

was updated for fiscal year 2008. The program staffing is discussed in more detail in 

Section 3.1. This recommendation is closed. 

2. The review team recommends that the Agency take appropriate measures to conduct 

core inspections (including initial inspections) in accordance with the inspection priority 

schedule in IMC 2800, and conduct reciprocity inspections in accordance with IMC 1220. 

(Section 3.2 of the 2006 IMPEP report) 

Current Status: The review team determined that 58 of the 86 Priority 1, 2, and 3 and 

initial inspections (core inspections) selected as a representative sample of inspections 
Arizona Final Report Page 3 

conducted by the Agency during the review period were performed overdue. The review 

team also identified 15 core inspections that were overdue at the time of the review. 

Additionally, reciprocity inspections were conducted less frequently than required by 

Inspection Manual Chapter (IMC) 1220, “Processing of NRC Form 241 and Inspection of 

Agreement State Licensees Operating under 10 CFR 150.20.” This recommendation 

remains open. 

3. The review team recommends that the Agency review all Arizona licenses to ascertain if 

they require financial assurance, and take appropriate action on each affected license to 

ensure that all licenses meet the State’s financial assurance requirements. (Section 3.4 

of the 2006 IMPEP report) 

Current Status: The Agency reviewed all of the Arizona licenses and implemented the 

appropriate license conditions, when applicable, to ensure that all licenses meet the 

State’s financial assurance requirements. This recommendation is closed. 

4. The review team recommends that the Agency develop a process that allows for the 

adoption of NRC regulations within the three-year timeframe. (Section 4.1.2 of the 2006 

IMPEP review) 

Current Status: The Agency developed a process after the 2006 review to ensure that 

rulemaking packages are initiated promptly after notification from NRC of a compatibilityrequired regulation so that adequate time is allowed for rule promulgation. Arizona 

regulations are currently up to date. This recommendation is closed. 

5. The review team recommends that the Agency develop and implement a process to 

ensure that, during routine inspections, the QA/QC requirements in the SS&D registry 

sheets are being implemented by the manufacturer. (Section 4.2.2 of the 2006 IMPEP 

review) 

Current Status: The Agency developed a process that ensures that the quality 

assurance/quality control (QA/QC) requirements in the sealed source and device (SS&D) 

registration certificates are being implemented by the manufacturer. Agency inspectors 

use a checklist to review the licensee’s QA/QC procedures when performing an 

inspection of the licensee’s facility. This recommendation is closed. 

3.0 COMMON PERFORMANCE INDICATORS 

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

and Agreement State radioactive materials programs. These indicators are: (1) Technical 

Staffing and Training, (2) Status of Materials Inspection Program, (3) Technical Quality of 

Inspections, (4) Technical Quality of Licensing Actions, and (5) Technical Quality of Incident and 

Allegation Activities. 
Arizona Final Report Page 4 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include staffing levels and turnover, in addition to 

the staff’s technical qualifications and training histories. To evaluate these issues, the review 

team examined the Agency’s questionnaire response relative to this indicator; interviewed 

managers and staff; and reviewed job descriptions, training plans, and training records. The 

review team also considered any possible workload backlogs stemming from turnover and 

vacancies or inadequate staffing levels. 

The Agency is comprised of several regulatory programs, one of which is the Radioactive 

Materials and Nonionizing Radiation Program (the Program). The Program is responsible for 

radioactive materials licensing, inspection, and some emergency response activities. At the time 

of the review, the Program was staffed by a Program Manager and four technical staff members. 

The technical staff members perform licensing and inspection activities and assist the 

Emergency Response Program on incident response. New staff members were hired in August 

2006 and May 2007 to fill vacancies and are currently being trained. The Program was fully 

staffed at the time of the review. 

Technical staff members are required to have a Bachelor’s degree in a science or equivalent 

Health Physics experience. As was noted during the 2006 IMPEP review, the Agency has been 

able to recruit staff; however, several personnel have left for higher paying jobs after 

qualification. This remains an issue for the Agency, as salaries are low compared to nearby 

industry and academic pay scales. A pay raise is not anticipated in fiscal year 2009. 

The review team noted that one of the senior staff members, who performs most of the on-thejob training for newer staff members, is planning to retire at the end of 2008. This issue was 

discussed with Agency managers, who acknowledged the issue and indicated that they were 

researching future staffing solutions. During the previous IMPEP review, a recommendation was 

made that the Agency develop and implement a staffing plan to meet Program needs and 

maintain long-term stability. In response to the recommendation, the Agency submitted a 

staffing and budget plan. That plan, recently revised, calls for the conversion of two technical 

positions from “covered” to “uncovered.” An uncovered position provides the Director a 15 

percent latitude in salary negotiation. Currently, the Director, the Program Manager, and two of 

the four technical positions in the Program are uncovered. The Director indicated that this 

process may help, to a small degree, to retain staff members, but will not alleviate the turnover 

issue because of the low Agency salary structure. 

The Agency has a documented training plan equivalent to the guidance in NRC’s IMC 1246, 

“Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area.” 

The Program Manager and the staff members were not aware of the Agency’s training plan; 

therefore, the prescribed qualification journals were not being used for the two staff members 

currently in training. The review team recommends that the State develop and use qualification 

journals to track and monitor training for technical staff. 

Two Agency staff members attended the NRC’s Security Systems and Principles Course and 

were qualified to perform Increased Controls inspections. During this review, team members 

provided Agency managers and staff with detailed information regarding the upcoming 

fingerprinting requirements. 
Arizona Final Report Page 5 

Agency managers stated that NRC’s recent policy change to cover Agreement State training 

costs will allow the State to send staff members to training courses which would not have been 

otherwise possible. As a result, staff members were recently enrolled in upcoming Inspection 

Procedures, Irradiator Technology and Security training courses. 

As detailed in Section 3.4, the review team identified that many licensing products generated by 

the Agency were of poor quality. The root cause of the deficiencies was determined to be a lack 

of training received by the staff member who performs a majority of the licensing actions. This 

individual has not attended the nuclear medicine or the brachytherapy training courses. The 

review team recommends that the State ensure that license reviewers be provided appropriate 

training to ensure familiarity with medical license modalities. 

NRC Region IV representatives offered the Agency an invitation for license reviewers to receive 

on-the-job licensing training in Arlington, Texas. The Agency Director indicated that current 

budget restrictions may prohibit out-of-state travel. 

The Arizona Agreement State Program is funded entirely by general fund allocations. Fees 

collected from licensees go directly into the general fund. The Agency is authorized to assess 

and collect fees for specific and general radioactive materials licenses, radiation machine 

registrations, and medical technologist certifications. The fees collected by the Agency amount 

to approximately 70 percent of the general fund allocations received. The last fee change was 

in 1993 and was based upon 1987 costs. 

Over the past several years, budgeting for the Agency has been subject to various cuts and 

restrictions. In early 2008, for a short period of time, travel restrictions were instituted that 

prohibited the use of State vehicles by inspectors. To perform an inspection, an inspector would 

have to use a personal vehicle with no cost reimbursement. During this time, inspectors were 

unwilling to perform inspections outside of the Phoenix area because of the personal costs. This 

restriction was lifted after a few days, but with continuing budget crises looming, the Agency 

Director said that similar restrictions may be implemented in the future. 

The budget for fiscal year 2009, starting July 1, 2008, has been approved with one new position 

slated for the Program. The Agency Director indicated, however, that due to State budget deficit 

projections, serious budget cuts are anticipated. 

The Radiation Hearing Board of the State of Arizona, as constituted under law, avoids conflicts 

of interest, as required under Arizona Revised Statutes in Section 38-511. The Board conducts 

hearings and reviews orders of the Director or the Agency. 

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

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

satisfactory, but needs improvement. 

3.2 Status of Materials Inspection Program

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

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

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 
Arizona Final Report Page 6 

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

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

Program Manager and staff. 

The review team determined that the Agency’s inspection priorities are determined by a license 

category assigned to each license. The review team identified a significant number of medical 

licensees authorized for uses requiring a written directive that were incorrectly categorized and 

assigned a longer inspection frequency than prescribed by IMC 2800, “Materials Inspection 

Program.” As a result, the review team found it difficult to identify the correct inspection 

frequency for all medical licenses without reviewing 100 percent of the Agency’s license files. 

Due to the miscategorization of medical licenses, the review team elected to evaluate a sample 

of Priority 1, 2, and 3 inspections; initial inspections; and reciprocity inspection files. The review 

team determined that other (non-medical) inspection frequencies were at least as frequent as 

the frequencies prescribed by IMC 2800. 

The review team evaluated inspection files for 70 Priority 1, 2, and 3 inspections and 16 initial 

inspections conducted by the Agency during the review period. The review team determined 

that 77 percent of these inspections were conducted overdue per the criteria in IMC 2800. In 

addition, 14 inspections of Priority 1, 2, and 3 licenses and 1 new license were overdue for 

inspection at the time of the review. This represents a significant decline in the timeliness of 

inspections since the 2006 IMPEP review, when the Agency was found to have 31 percent of its 

Priority 1, 2, and 3 and initial inspections performed overdue. The review team noted that the 

Agency increased its effort to conduct more inspections in the third and fourth quarters of 2007 

in an attempt to reduce the backlog. 

During the review period, the Agency received reciprocity requests from 63 licensees, of which 

27 were candidate for inspection. The review team determined that the Agency conducted 15 

percent of the candidate reciprocity inspections during the review period, which represented a 

small decline in performance since the 2006 review, when the Agency performed 17 percent of 

the candidate reciprocity inspections during that review period. The Agency did not meet the 20 

percent criterion prescribed by IMC 1220. 

The review team discussed the significant number of overdue inspections and inspections 

completed overdue, as well as performance of reciprocity inspections, with the Program 

Manager and the Agency Director. The review team identified two root causes for the inspection 

program performance weaknesses. 

The review team determined that one of the root causes for the inspection delays is the lack of 

fully qualified inspectors. Another root cause is that many licenses issued by the Agency were 

incorrectly prioritized. Because the concerns identified during the 2006 IMPEP review have not 

been resolved, the review team recommends that the recommendation regarding timeliness of 

inspections made during that review remains open. 

Arizona law requires, in part, that when an agency conducts an inspection, they must provide a 

copy of the inspection report to the licensee within 30 working days after the inspection. The 

review team evaluated the Program’s timeliness of issuance of inspection reports. In most 

cases, the preliminary findings of inspection reports were sent to the licensees within 30 

calendar days, and generally within 2-5 calendar days of the inspection date. 
Arizona Final Report Page 7 

The review team determined that the Agency adequately planned for the initial set of Increased 

Controls inspections of affected licensees. The review team evaluated the Agency’s 

prioritization methodology and found it acceptable. The Agency identified 14 licensees that are 

subject to the Increased Controls and performed all of the first-year inspections in a timely 

manner. 

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

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

was unsatisfactory. 

3.3 Technical Quality of Inspections

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

notes, and interviewed inspectors for 30 radioactive materials inspections conducted during the 

review period. The casework examined included a cross-section of inspections conducted by 

the four current Agency inspectors and covered a wide variety of inspection types, including: 

broadscope medical, broadscope academic, industrial radiography, self-shielded irradiators, 

medical, nuclear pharmacy, Increased Controls, and reciprocity. Appendix C lists the inspection 

casework files reviewed, with case-specific comments, as well as the results of the inspector 

accompaniments. 

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

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

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

ensure that licensees’ performances with respect to health and safety were acceptable. 

Inspection report documentation supported violations and summarized discussions held with 

licensees during exit interviews. 

Inspection findings were clearly stated and documented. If potential violations are identified 

during an inspection, the Agency issues a “preliminary findings of inspection” report. The 

Agency identifies proposed violations and any items of concern to the licensee in this report. 

The licensee is required to respond to the preliminary findings within 30 days. If the violations 

are accepted by the licensee, a notice of violation is then issued which can include sanctions 

such as civil penalties if health and safety is affected. The Agency Director signs all preliminary 

and final inspection actions. 

The review team evaluated 11 Increased Controls inspection reports. The inspections included 

all aspects of the licensees’ security programs, and some inspections identified significant 

violations and program concerns. The review team found that, although the preliminary findings 

were issued, several inspection files did not have responses from the licensees. Agency 

managers believe that the responses from the licensees were misplaced in the Agency files. 

Inspection staff members were not able to confirm that appropriate corrective actions were taken 

by the licensees. During the review, the Agency contacted the affected licensees and requested 

copies of the responses. The review team recommends that the State conduct followup 

inspections of licensees with unresolved violations or issues with regard to the Increased 

Controls requirements to ensure that appropriate corrective actions were implemented. 
Arizona Final Report Page 8 

The review team found that inspection and licensing documents involving Increased Controls 

issues were not appropriately labeled as sensitive information to be withheld from public 

disclosure. The review team recommends that the State review its Increased Controls files to 

ensure that all sensitive security-related documents are labeled accordingly. 

The review team noted that supervisor accompaniments of the four-member inspection staff had 

not been consistently performed over the review period, and that only two accompaniments had 

had been conducted in 2007. The review team recommends that an Agency manager 

accompany each inspector, at least annually, to ensure quality and consistency in the inspection 

program. 

The review team verified that the Agency maintains an adequate supply of appropriately 

calibrated survey instrumentation to support its inspection program, as well as to respond to 

radioactive materials incidents and emergency conditions. The instruments are sent either to 

the manufacturer or to an approved laboratory for calibration. The Agency maintains an inhouse laboratory and a mobile laboratory capable of performing a full battery of radiological 

analyses. 

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

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

satisfactory, but needs improvement. 

3.4 Technical Quality of Licensing Actions

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

20 specific licenses. Licensing actions were reviewed for completeness, consistency, 

possession authorizations, qualifications of authorized users, adequacy of facilities and 

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

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

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

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

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

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

completed during the review period. Licensing actions selected for evaluation included 3 new 

licenses, 4 renewals, 11 amendments (including 1 administrative change initiated by the 

Agency), and 2 license terminations. Files reviewed included a cross-section of license types, 

including: medical diagnostic and therapy (including high dose-rate remote afterloaders), 

industrial radiography, and nuclear pharmacies. A listing of the licensing casework reviewed, 

with case-specific comments, may be found in Appendix D. 

The review team noted that licensing actions, especially those regarding medical licenses, were 

inconsistent and of poor quality, with health, safety, and security items erratically addressed. 

The review team identified a broad range of concerns with approximately 75 percent of the 

licenses reviewed. Several licenses for high dose-rate remote afterloaders omitted key health 

and safety components, including material receipt, source security, storage, viewing systems 

and patient monitoring, and annual staff training. Multiple licenses, particularly those with high 

dose-rate remote afterloaders and medical therapy, had been incorrectly categorized; therefore, 
Arizona Final Report Page 9 

negatively affecting the inspection frequency schedule as discussed in Section 3.2. The review 

team recommends that the State ensure its licenses are properly categorized and assigned the 

correct inspection frequency. 

Verification of training and experience requirements for medical authorized users and radiation 

safety officers was inconsistent with current State regulations; therefore, medical material users 

have been authorized without providing proper documentation of training and experience. This 

finding potentially has transboundary implications because users would be authorized by other 

Agreement States and the NRC if they are currently authorized on an Arizona license. Other 

regulatory programs will not require an applicant to repeat the authorization process if that 

individual is currently authorized on a license. The review team provided instruction to the 

principal license reviewer in the medical authorization process used by the NRC and other 

Agreement States. The review team recommends that the State ensure proper documentation 

of training and experience for authorized users, authorized medical physicists, authorized 

nuclear pharmacists and radiation safety officers. 

Interviews with the license reviewers indicated that the Agency does not utilize written 

procedures for license reviews or perform peer reviews. Most licensing actions evaluated by the 

review team indicated that material submitted by the licensee was taken at face value, and there 

were few requests for additional information. Licenses are issued for a 5-year term and can 

continue under timely renewal until the Agency issues a renewed license. The review team 

assessed two open licensing actions. Both were on track to meet the Agency’s mandated 120-

day goal for processing licensing actions. 

After a license reviewer completes a licensing action, the Program Manager performs a 

supervisory review. The Director performs a final review prior to signing out the license. The 

review team determined that these supervisory reviews were not effective, as evidenced by the 

license quality issues identified by the review team. The review team recommends that the 

State implement a detailed and documented license review system to ensure accuracy and 

consistency for all licensing actions. 

The review team evaluated the Agency’s efforts in response to the 2006 IMPEP review 

recommendation regarding decommissioning financial assurance. The review team noted that 

the remaining six licensees required to comply with Arizona’s financial assurance requirements 

have been issued license conditions to ensure compliance with the State’s regulations. The 

Agency currently applies a process to identify new licenses requiring financial assurance that is 

compatible with the State’s regulations. 

The review team identified that, of the two terminated licensing actions reviewed, one was well 

documented, showing appropriate material transfer and survey records. The other did not 

include verification of transfer of material to another State. The review team noted that 

confirmatory surveys were reportedly conducted when appropriate; however, they were 

frequently undocumented. License reviewers indicated to the review team that, in the future, 

they would put more emphasis on documenting termination actions. 

Pre-licensing checklists to ensure radioactive material will be used as intended are sporadically 

used on new and renewal licenses and not used on amendments. Only two of the licensing 

actions evaluated by the review team included pre-licensing documentation. Program managers 
Arizona Final Report Page 10 

were reminded of the guidance provided to the Agreement States in the Office of Federal and 

State Materials and Environmental Management Programs (FSME) All Agreement States Letter 

FSME-06-114, “Implementation of Pre-Licensing Guidance,” dated December 21, 2006, and the 

recent NRC/Agreement State pre-licensing pilot project. When pre-licensing checklists were 

used, and indicated that a pre-licensing visit should be performed, the review team confirmed 

that the Agency completed the visits, as required. The review team recommends that the State 

implement the pre-licensing checklist and guidance for all licensing actions to provide assurance 

that radioactive material will be used as specified on the license. 

The review team examined the Agency’s licensing practices in regard to the Increased Controls. 

The review team noted that the Agency added legally-binding license conditions to the licenses 

that met the criteria for implementing the Increased Controls. The review team analyzed the 

Agency’s methodology for identifying those licenses and found the rationale was thorough and 

accurate. The review team identified several licenses not currently under Increased Controls 

restrictions that authorized amounts of material exceeding quantities of concern. In these cases, 

the licensees may not actually possess quantities of concern. Agency managers indicated that 

corrections would be made to the licenses to clarify that quantities of concern are not authorized. 

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

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

was unsatisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

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

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

this indicator, evaluated all of the incidents reported for Arizona in the Nuclear Material Events 

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

11 radioactive material incidents. A listing of the incident casework examined, with case-specific 

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

response to one allegation involving radioactive materials that NRC referred to the State during 

the review period. 

The incidents selected for review included medical events, lost radioactive material, damaged 

equipment, and stolen equipment. When notification of an incident is received, the Agency 

Director, Program Manager, and staff determine the appropriate level of initial response. The 

review team determined that the Agency’s response to incidents was complete and 

comprehensive. Initial responses were prompt and well coordinated, and the level of effort was 

commensurate with the health and safety significance. The Agency dispatched inspectors for 

on-site investigations in appropriate situations and took suitable enforcement and followup 

actions when necessary. 

The review team identified eight reportable radioactive materials incidents in NMED for Arizona 

during the review period. The review team identified three additional incidents that required 

reporting to the NRC that were not captured in NMED. The Agency believes that the incidents 

were reported to NRC and submitted to NMED; however, the review team did not find records of 

the notifications. Agency managers committed to submitting information regarding the three 

incidents for inclusion in NMED. 
Arizona Final Report Page 11 

Agency staff members had not been regularly entering incident information in NMED due to 

miscommunication within the Agency. NRC’s contractor responsible for maintaining NMED 

requested additional information for five incidents; however, Arizona has not responded to the 

requests. The Agency has put a process in place where the Agency Director will forward 

incident information requests to the Program staff for resolution. Program staff members also 

contacted the NRC’s contractor to make sure that they are included in any requests for 

additional information that is needed for incident closure. 

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

the casework for the only allegation received during the review period. The review team’s 

evaluation revealed that the Agency took prompt and appropriate action in response to the 

concerns raised. The allegation was appropriately closed, and affected individuals were notified 

of the actions taken. The Agency makes every effort to protect an alleger’s identity. 

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

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

Allegation Activities, was satisfactory.

4.0 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. Arizona’s Agreement does not cover a uranium recovery program, so only the first 

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

4.1 Compatibility Requirements

4.1.1 Legislation

Arizona became an Agreement State on May 15, 1967. The statutory authority for the Arizona 

program is found in the State’s Radiation Control Program, Title 30, Chapter 4 of the Arizona 

Revised Statutes, “Control of Ionizing Radiation.” The Agency is designated as the State’s 

radiation control agency and implements the radiation control program. 

Other statutes that affect the Agency are contained in Title 30, Chapter 5, “Interstate 

Cooperation in Atomic Energy Matters,” and Title 41, Chapter 6, “State Government.” These 

statutes describe the State’s administrative procedures for rulemaking, adjudicative 

proceedings, licensing timeframe, and hearing procedures. The review team noted that no 

legislation affecting the radiation control program was passed during the review period. 

4.1.2 Program Elements Required for Compatibility

The Agency’s regulations for control of radiation are found in the Arizona Administrative Code 

under Title 12, Chapter 1, “Radiation Regulatory Agency,” Articles 1 through 17, and apply to all 

radioactive materials and devices designed to produce radiation. 
Arizona Final Report Page 12 

The Arizona Statutes require the Agency to review all regulations every 5 years. For each 

regulation, the Agency must describe the effectiveness of the regulation and provide the 

statutory authority under which the regulation is issued. The Agency must also demonstrate that 

the regulation is consistent with other Agency regulations, and that the regulation is clear and 

understandable. In addition, in developing regulations, the Agency is to consider the economic 

impact on small businesses and consumers. 

The review team examined the State’s administrative rulemaking process and found that it takes 

approximately 1 to 3 years to promulgate a final rule. After preparation of a regulation package, 

the Agency publishes the proposed rules in the State Register, and sends the rules to NRC and 

the Radiation Hearing Board. The Agency must obtain approval from the Governor’s Regulatory 

Review Council prior to publication of a final rule. The State’s process allows opportunity for 

members of the public and other stakeholders to comment on proposed rules. The State has 

the authority to issue legally binding requirements (e.g., license conditions) until equivalent State 

rules become effective. 

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

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

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

from the State Regulation Status Sheet that FSME maintains. The review team noted that the 

State is up to date on all amendments currently required for compatibility with NRC’s program. 

Since the previous review, the State submitted four packages for compatibility reviews. With 

these submissions, Arizona is up-to-date on regulation development. The review team reminded 

Agency managers that NRC-identified comments on three earlier submitted regulation packages 

that have yet to be answered. Also, final versions of three regulations need to be submitted to 

the NRC for evaluation. 

The review team noted that the Agency expended a good deal of effort in regulation 

development since the 2006 review. The Agency Director assigned responsibility and oversight 

for rulemaking actions and regulations to the recently hired Program Manager. 

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

the future. The Agency Director related that the regulations would be addressed in upcoming 

rulemaking or in the adoption of alternate legally binding requirements: 

● “Order Imposing Fingerprinting Requirements and Criminal History Records Check 

Requirements for Unescorted Access to Certain Radioactive Material,” NRC Order EA07-305 (72 FR 70901), that is due for Agreement State adoption by June 5, 2008. 

● “Medical Use of Byproduct Material - Recognition of Specialty Boards,” 10 CFR Part 35 

amendment (70 FR 16336 and 71 FR 1926), that is due for Agreement State adoption by 

April 29, 2008. 

● “National Source Tracking System,” 10 CFR Part 20 amendment (71 FR 65685), that is 

due for Agreement State adoption by January 31, 2009. 
Arizona Final Report Page 13 

● “Minor Amendments,” 10 CFR Part 20, 30, 32, 35, 40 and 70 amendments (71 FR 

15005), that are due for Agreement State adoption by March 27, 2009. 

● “Medical Use of Byproduct Material – Minor Corrections and Clarifications,” 10 CFR Part 

32 and 35 amendments (72 FR 45147 and 72 FR 54207), that are due for Agreement 

State adoption by October 29, 2010. 

● “Requirements for Expanded Definition of Byproduct Material,” 10 CFR Part 20, 30, 31, 

32, 33, 35, 61, and 150 amendments (72 FR 55864), that are due for Agreement State 

adoption by November 30, 2010. 

● “Exemptions from Licensing, General Licenses, and Distribution of Byproduct Material: 

Licensing and Reporting Requirements,” 10 CFR Part 30, 31, 32 and 150 amendments 

(72 FR 58473), that are due for Agreement State adoption by December 17, 2010. 

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

10 CFR Part 19 and 20 amendments (72 FR 68043), that are due for Agreement State 

adoption by February 15, 2011. 

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

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

satisfactory.

4.2 Sealed Source and Device Evaluation Program

In conducting this review, three subelements were used to evaluate the Agency’s performance 

regarding the Sealed Source and Device Evaluation Program. These subelements were: (1) 

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

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

In assessing the Agency's SS&D evaluation activities, the review team examined information 

contained in the Agency’s response to the IMPEP questionnaire for this indicator. The review 

team evaluated all of the amended SS&D evaluations and supporting documents covering the 

review period. The Agency conducted no new SS&D evaluations since the last review. The 

review team noted the staff's use of guidance documents and procedures, interviewed the staff 

involved in SS&D evaluations, and verified the use of regulations and inspections to enforce 

commitments made in the applications. 

4.2.1 Technical Staffing and Training

A health physicist from the Program and a health physicist from the Radiation Measurement 

Program, another group within the Agency, are the reviewers who conduct safety evaluations of 

SS&D applications. The Program staff member has a science degree, and the other staff 

member has a degree in engineering. The Program staff member is a new SS&D reviewer and 

has not attended the NRC workshop for SS&D reviewers. During the on-site review, the review 

team suggested to the Program Manager that the Program staff member, who is new to SS&D 

evaluations, should attend the NRC workshop for SS&D reviewers scheduled for the week of 
Arizona Final Report Page 14 

September 15, 2008. The review team informed the Program Manager and staff that NRC will 

pay for Agreement State representatives to travel to and attend the workshop. 

The review team interviewed the staff and found that the reviewer from the Radiation 

Measurement Program was familiar with the SS&D evaluation process and had access to the 

applicable reference documents. The review team was confident that this reviewer was 

sufficiently familiar with the SS&D process to train and assist the Program staff member. 

Agency procedures require both reviewers to conduct the safety evaluation and that the Agency 

Director signs the registration certificate. The review team determined that the reviewer from the 

Radiation Measurement Program met the technical training required for SS&D reviews, as 

described under the State’s training guidance. The Program staff member still needs to 

complete the workshop for SS&D reviewers and receive additional on-the-job training. 

Due to the small number of Arizona licensees that require registration certificates, the review 

team determined that even though only one staff member was qualified to perform SS&D 

evaluations at the time of the review, the staffing level was adequate. During the review, the 

review team offered to the Agency Director the possibility of Arizona returning the SS&D 

program to NRC, particularly due to the fact that there is little activity and the cost of maintaining 

trained SS&D reviewers may not be economical for the Agency. The Agency Director declined 

the offer. 

4.2.2 Technical Quality of the Product Evaluation Program

The review team evaluated all four SS&D evaluation amendments, representing the work of the 

two SS&D reviewers. The Agency currently manages two active SS&D manufacturer/ 

distributors. The Agency performed a full SS&D review of the four sheets. A list of SS&D 

casework examined, with case-specific comments, can be found in Appendix F. 

Analysis of the casework and interviews with staff confirmed that the Agency generally follows 

the recommended guidance from NRC’s SS&D training workshops and that found in NUREG1556, Volume 3, “Consolidated Guidance About Materials Licenses – Applications for Sealed 

Source and Device Evaluation and Registration.” The review team confirmed that all applicable 

and pertinent American National Standards Institute standards, NUREG-1556 Series, NRC 

Regulatory Guides, and applicable references were available and used appropriately in 

performing the SS&D reviews. 

The four amendments involved the addition of two manufacturing locations outside of the U.S. 

and an additional distribution location. The Agency’s files did not contain the licensee’s initial 

incoming request to amend the registration certificates. Agency staff contacted the licensee and 

obtained a copy of the original requests for the amendments. The review team discussed the 

missing information with Program staff and explained that the information should be included the 

Agency’s files in order to be able to reference the decision behind the Agency’s amendment to 

the registration certificate. The review team also noted that, with the addition of two 

manufacturers outside of the U.S., the staff did not confirm that the distributor in Arizona would 

be able to provide copies of the quality assurance programs and quality control checks. The staff 

committed to making sure that the required information would be made available at the 

licensee’s facility in Arizona. 
Arizona Final Report Page 15 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

No incidents related to SS&D defects were noted by the State of Arizona during the review 

period. The review team conducted a search of the NMED system to determine whether other 

incidents might have taken place that were not registered by the Agency staff. No incidents 

were identified that could have been related to malfunctioning devices or products considered 

during the review. 

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

that Arizona’s performance with respect to the indicator, SS&D Evaluation Program, was 

satisfactory. 

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

In 1981, the NRC amended its Policy Statement “Criteria for Guidance of States and NRC in 

Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through 

Agreement” to allow a State to seek an amendment for the regulation of LLRW as a separate 

category. Those States with Agreements prior to 1981 were determined to have continued 

LLRW disposal authority without the need of an amendment. Although the Arizona Agreement 

State Program 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 that will meet the criteria for an adequate and compatible LLRW disposal 

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

team did not review this indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0, Arizona’s performance was found satisfactory for the 

performance indicators: Technical Quality of Incident and Allegation Activities, Compatibility 

Requirements, and Sealed Source and Device Evaluation Program. Arizona’s performance was 

found satisfactory, but needs improvement, for the indicators: Technical Staffing and Training 

and Technical Quality of Inspections. Arizona’s performance was found unsatisfactory for the 

indicators: Status of Materials Inspection Program and Technical Quality of Licensing Actions. 

The review team made ten recommendations regarding Agency performance. Accordingly, the 

review team recommended, and the MRB agreed, that the Arizona Agreement State Program 

was adequate, but needs improvement, to protect public health and safety and compatible with 

NRC's program. The review team recommended, and the MRB agreed, that NRC institute a 

period of Heightened Oversight for Arizona to assess the progress of the State, including 

bimonthly conference calls and a followup IMPEP review in 1 year. 

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for 

evaluation and implementation by the State, including one open recommendation from the 2006 

IMPEP report: 

1. The review team recommends that the State develop and use qualification journals to 

track and monitor training for technical staff. (Section 3.1) 
Arizona Final Report Page 16 

2. The review team recommends that the State ensure that license reviewers be provided 

appropriate training to ensure familiarity with medical license modalities. (Section 3.1) 

3. The review team recommends that the State take appropriate measures to conduct core 

inspections (including initial inspections) in accordance with the inspection priority 

schedule in IMC 2800, and conduct reciprocity inspections in accordance with IMC 1220. 

(Section 3.2) (Open item from 2006 review) 

4. The review team recommends that the State conduct followup inspections of licensees 

with unresolved violations or issues with regard to the Increased Controls requirements 

to ensure that appropriate corrective actions were implemented. (Section 3.3) 

5. The review team recommends that the State review its Increased Controls files to ensure 

that all sensitive security-related documents are labeled accordingly. (Section 3.3) 

6. The review team recommends that an Agency manager accompany each inspector, at 

least annually, to ensure quality and consistency in the inspection program. (Section 

3.3) 

7. The review team recommends that the State ensure its licenses are properly categorized 

and assigned the correct inspection frequency. (Section 3.4) 

8. The review team recommends that the State ensure proper documentation of training 

and experience for authorized users, authorized medical physicists, authorized nuclear 

pharmacists and radiation safety officers. (Section 3.4) 

9. The review team recommends that the State implement a detailed and documented 

license review system to ensure accuracy and consistency for all licensing actions. 

(Section 3.4) 

10. The review team recommends that the State implement the pre-licensing checklist and 

guidance for all licensing actions to provide assurance that radioactive material will be 

used as specified on the license. (Section 3.4) 
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B Arizona Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source & Device Casework Reviews 

Attachment May 14, 2008, Letter from Dennis Burke 

 Arizona’s Response to Draft IMPEP Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

James Lynch, Region III Team Leader 

 Technical Staffing and Training 

 Inspector Accompaniments 

Robert Gallaghar, Massachusetts Status of Materials Inspection Program 

Linda McLean, Region IV Technical Quality of Inspections 

 Compatibility Requirements 

Sherrie Flaherty, Minnesota Technical Quality of Licensing Actions 

Tomas Herrera, FSME Technical Quality of Incident and Allegation 

 Activities 

 Sealed Source and Device Evaluation Program 
APPENDIX B 

ARIZONA ORGANIZATION CHART 

ADAMS ACCESSION NO.: ML080850827 
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: CHS Arizona, dba St. Joseph 

 Hospital & Medical Center License No.: 7-024 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 12/12-13/07 Inspectors: JS, BG, PK 

Comments: 

a) Report mailed late on February 15, 2008. 

b) Inspection conducted overdue; last inspection was March 15, 2006. 

File No.: 2 

Licensee: Phoenix Memorial Hospital License No.: 7-077 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/23/06 Inspector: PK 

Comment: 

Inspection conducted overdue; last inspection was October 2, 2002. 

File No.: 3 

Licensee: Arizona Oncology Services License No.: 7-161 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 2/7/08 Inspector: JS 

File No.: 4 

Licensee: Sierra Vista Regional Health Center License No.: 2-012 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/9/07 Inspector: JS 

Comment: 

Inspection conducted overdue; last inspection was November 13, 2002. 

File No.: 5 

Licensee: Cardinal Health License No.: 7-123 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 1/9-10/08 Inspectors: JS, BG, HS 
Arizona Final Report Page C.2 

Inspection Casework Reviews

File No.: 6 

Licensee: Biotech Pharmacy of Arizona License No.: 8-036 

Inspection Type: Initial, Unannounced Priority: 2 

Inspection Dates: 8/22-23/06 Inspector: JS 

Comment: 

Initial inspection conducted overdue; license issued on January 14, 2005. 

File No.: 7 

Licensee: Western Technologies, Inc. License No.: 7-049 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 11/16/06 Inspectors: JS, BG 

File No.: 8 

Licensee: Team Industrial Services, Inc. License No.: 7-493 

Inspection Type: Field, Routine, Unannounced Priority: 1 

Inspection Date: 7/10/07 Inspectors: JS, HS 

File No.: 9 

Licensee: Medi-Physics, Inc., dba GE Healthcare License No.: 7-346 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 1/11-12/05 Inspectors: PK, JL, JS 

Comment: 

Inspection conducted overdue; last inspection was May 21, 2003. 

File No.: 10 

Licensee: Payson Hospital Corporation License No.: 4-016 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/11/07 Inspector: JN 

Comment: 

Inspection conducted overdue. 

File No.: 11 

Licensee: P.E.T. Net Pharmaceuticals, Inc. License No.: 7-363 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 9/16/06 Inspector: JS 

Comment: 

Inspection conducted overdue; last inspection was January 23, 2003. 
Arizona Final Report Page C.3 

Inspection Casework Reviews

File No.: 12 

Licensee: Mayo Clinic Arizona License No.: 7-448 

Inspection Type: Special, Announced Priority: 1 

Inspection Dates: 7/17-19/07, 8/15/07 Inspectors: JS, HS, PK, BG 

Comments: 

a) Sensitive information contained in file was not marked appropriately. 

b) No followup inspection was conducted. 

File No.: 13 

Licensee: University of Arizona License No.: 10-044 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 7/17-20/06 Inspectors: JS, WW, JL, DK, PK 

Comment: 

Inspection conducted overdue; last inspection was April 5-8, 2004. 

File No.: 14 

Licensee: Phoenix National Laboratory, Inc. License No.: 7-415 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 10/26/06 Inspectors: BG, DK 

Comments: 

a) Sensitive information contained in file was not marked appropriately. 

a) Licensee’s response to notice of violation was missing from file. 

File No.: 15 

Licensee: Western Technologies, Inc. License No.: 7-049 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 11/16/07 Inspectors: JS, BG 

Comment: 

 Sensitive information contained in file was not marked appropriately. 

File No.: 16 

Licensee: Arizona State University License No.: 7-489 

Inspection Type: Special, Announced Priority: 1 

Inspection Dates: 6/12-13/06 Inspectors: PK, JL, JS 

Comments: 

a) Sensitive information contained in file was not marked appropriately. 

b) No followup inspection was conducted. 
Arizona Final Report Page C.4 

Inspection Casework Reviews

File No.: 17 

Licensee: St. Joseph’s Medical Center License No.: 7-424 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 11/30/06 Inspectors: DK, BG, PK 

Comment: 

 Sensitive information contained in file was not marked appropriately. 

File No.: 18 

Licensee: American Red Cross License No.: 10-143 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 10/19/06 Inspectors: BG, DK 

File No.: 19 

Licensee: Varian Medical Systems License No.: 45-30957-01 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 10/23/06 Inspectors: JS, PK 

File No.: 20 

Licensee: Alpha-Omega Services, Inc. License No.: CA-3925-19 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 12/19/07 Inspector: BG 

File No.: 21 

Licensee: United Blood services License No.: 7-299 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 9/7/06 Inspectors: PK, BG, DK 

Comments: 

a) Sensitive information contained in file was not marked appropriately. 

b) No followup inspection was conducted. 

File No.: 22 

Licensee: Banner Good Samaritan Medical Center License No.: 7-478 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 9/13/06 Inspectors: BG, DK 

Comments: 

a) Sensitive information contained in file was not marked appropriately. 

b) No followup inspection was conducted. 

c) Licensee’s response to notice of violation was missing from file. 

File No.: 23 

Licensee: Southwest Veterinary Oncology License No.: 10-132 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 12/14/06 Inspectors: BG, PK 
Arizona Final Report Page C.5 

Inspection Casework Reviews

File No.: 24 

Licensee: Team industrial Services, Inc. License No.: 7-493 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 11/15/06 Inspectors: BG, PK 

Comments: 

a) Sensitive information contained in file was not marked appropriately. 

b) No followup inspection was conducted. 

File No.: 25 

Licensee: University of Arizona License Nos.: 10-024, 10-044 

Inspection Type: Special, Announced Priority: 1 

Inspection Dates: 7/17-20/06 Inspector: WW 

File No.: 26 

Licensee: St. Joseph’s Medical Center License No.: 7-424 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 11/30/06 Inspectors: DK, BG, PK 

File No.: 27 

Licensee: Qual-Tek Associates License No.: 11-27610-01 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 6/27/07 Inspector: BG 

File No.: 28 

Licensee: Quality Assurance Services, Inc. License No.: 6073-37 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 5/22/97 Inspectors: BG, PK 

File No.: 29 

Licensee: G.E. Healthcare License No.: 133-1197-01 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 6/4/07 Inspectors: BG, PK 

File No.: 30 

Licensee: Beckman Coulter License No.: 0441-30 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 6/28/07 Inspector: WW 
Arizona Final Report Page C.6 

Inspection Casework Reviews

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: City of Chandler License No.: 7-295 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/19/08 Inspector: HS 

Accompaniment No.: 2 

Licensee: AMEC Earth and Environmental, Inc. License No.: 7-369 

Inspection Type: Routine/Special, Unannounced Priority: 1 

Inspection Date: 2/20/08 Inspector: JS 

Accompaniment No.: 3 

Licensee: Cardiovascular Associates of Mesa License No.: 7-487 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/21/08 Inspector: BG 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: CONAM Inspection & Engineering 

 Services, Inc. License No.: 16021 

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

Date Issued: 12/26/07 License Reviewer: PK 

Comments: 

a) Licensee requested authorization for source retrieval in the application. It was not 

authorized on the license, and there was no documentation regarding denial. 

b) Sensitive information contained in file was not marked appropriately. 

File No.: 2 

Licensee: Cancer Treatment Services Arizona License No.: 16017 

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

Date Issued: 9/25/07 License Reviewer: PK 

Comments: 

a) The authorized use condition referenced “storage as indicated in Amendment 2;” 

however, this was a new license and no such document existed. 

b) The application did not address such items as: material receipt procedures, annual 

training, facility diagram, and security and storage of the HDR. 

c) There was no documentation regarding type of HDR requested. 

d) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

File No.: 3 

Licensee: Kingman Regional Medical Center License No.: 8-004 

Type of Action: Amendment Amendment No.: 43 

Date Issued: 4/11/07 License Reviewer: PK 

File No.: 4 

Licensee: Sun Radiology License No.: 7-514 

Type of Action: Renewal Amendment No.: 7 

Date Issued: 2/20/08 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) Licensee requested an additional authorized user/RSO. File contained no 

correspondence with licensee regarding denial. 

c) Condition 17 authorized mobile medical services; however, the licensee does not 

perform mobile services. 
Arizona Final Report Page D.2 

License Casework Reviews

File No.: 5 

Licensee: Accredited Cardiology of Arizona License No.: 7-442 

Type of Action: Renewal Amendment No.: 9 

Date Issued: 11/19/07 License Reviewer: PK 

Comment: 

File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

File No.: 6 

Licensee: Chandler Regional Hospital License No.: 7-241 

Type of Action: Renewal Amendment No.: 49 

Date Issued: 11/27/07 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) License did not have appropriate security license condition imposed. 

c) License conditions 12 and 16 referenced a nonexistent subitem N. 

d) Application did not address HDR procedures. 

File No.: 7 

Licensee: Associates in Radiation Oncology License No.: 7-153 

Type of Action: Amendment Amendment No.: 37 

Date Issued: 12/3/07 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) License did not have appropriate security license condition imposed. 

c) Condition 10 did not address location of use for the HDR. 

d) Training requirements for new authorized users were not evaluated properly. 

File No.: 8 

Licensee: Molecular Imaging Center License No.: 15-090 

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

Date Issued: 1/25/08 License Reviewer: PK 

Comment: 

No documentation requesting verification that sources have been disposed of properly. 
Arizona Final Report Page D.3 

License Casework Reviews

File No.: 9 

Licensee: Ironwood Cancer & Research Center, PC License No.: 7-571 

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

Date Issued: 10/11/06 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) License was assigned an incorrect program code. 

File No.: 10 

Licensee: Arizona Oncology Services License No.: 7-161 

Type of Action: Amendment Amendment No.: 61 

Date Issued: 9/10/07 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) License was assigned an incorrect program code. 

File No.: 11 

Licensee: Arizona Oncology Services License No.: 7-161 

Type of Action: Amendment Amendment No.: 57 

Date Issued: 11/22/06 License Reviewer: DK 

File No.: 12 

Licensee: Yavapi Regional Medical Center License No.: 13-006 

Type of Action: Amendment Amendment No.: 42 

Date Issued: Pending License Reviewer: BG 

File No.: 13 

Licensee: Banner Mesa Medical Center License No.: 7-127 

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

Date Issued: 1/25/08 License Reviewer: PK 

Comment: 

Confirmatory surveys were not documented in file. 
Arizona Final Report Page D.4 

License Casework Reviews

File No.: 14 

Licensee: Phoenix National Laboratories, Inc. License No.: 7-415 

Type of Action: Amendment Amendment No.: 66 

Date Issued: 3/6/08 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) Sensitive information contained in file was not marked appropriately. 

c) Licensee possesses more material than license allows, as identified in the inspection file. 

File No.: 15 

Licensee: United Blood Services of Arizona License No.: 7-299 

Type of Action: Amendment Amendment No.: 19 

Date Issued: 2/20/07 License Reviewer: DK 

Comment: 

Sensitive information contained in file was not marked appropriately. 

File No.: 16 

Licensee: West Valley Hospital License No.: 7-528 

Type of Action: Amendment Amendment No.: 12 

Date Issued: 3/26/07 License Reviewer: BG 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) Training requirements for new authorized user were not properly evaluated. 

File No.: 17 

Licensee: Valley Radiologists License No.: 7-519 

Type of Action: Amendment Amendment No.: 8 

Date Issued: 1/31/08 License Reviewer: BG 

Comment: 

File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 
Arizona Final Report Page D.5 

License Casework Reviews

File No.: 18 

Licensee: Scottsdale Heart Hospital License No.: 7-497 

Type of Action: Amendment Amendment No.: 3 

Date Issued: 7/2/07 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) Training requirements for new authorized user were not properly evaluated. 

File No.: 19 

Licensee: Sierra Vista Regional Health Center License No.: 2-012 

Type of Action: Amendment Amendment No.: 37 

Date Issued: Pending License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) Training requirements for a new authorized user were not properly evaluated and the 

license reviewer was unaware of the needed evaluation process. 

File No.: 20 

Licensee: Tucson Heart Hospital License No.: 10-138 

Type of Action: Renewal Amendment No.: 10 

Date Issued: 8/3/07 License Reviewer: PK 

Comments: 

a) File did not include pre-licensing checklist to provide assurance that radioactive material 

will be used properly. 

b) License included authorization for phosphorus-32 from previous license, although the 

licensee did not request authorization. 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Western Technologies, Inc. License No.: 7-080 

Date of Incident: 3/8/06 NMED No.: N/A 

Investigation Date: 3/10/06 Type of Incident: Damaged Equipment 

 Type of Investigation: Telephone 

Comment: 

Incident was not recorded in NMED. 

File No.: 2 

Licensee: Madhi Sadek, P.E. License No.: 7-534 

Date of Incident: 3/16/06 NMED No.: N/A 

Investigation Date: 3/20/06 Type of Incident: Vehicle Accident 

 Type of Investigation: Site 

Comment: 

Incident was not recorded in NMED. 

File No.: 3 

Licensee: Flagstaff Medical Staff License No.: 3-003 

Date of Incident: 8/17/06 NMED No.: 060537 

Investigation Date: 8/17/06 Type of Incident: Loss of Control 

 Type of Investigation: Telephone 

File No.: 4 

Licensee: MRM Construction Services License No.: 7-512 

Date of Incident: 1/29/07 NMED No.: 070071 

Investigation Date: 1/29/07 Type of Incident: Stolen Gauge 

 Type of Investigation: Site 

Comment: 

Additional information was requested to complete the incident file in NMED, however, the 

State had not responded to the request. 
Arizona Final Report Page E.2 

Incident Casework Reviews

File No.: 5 

Licensee: Construction Inspection and Testing License No.: 7-098 

Date of Incident: 2/22/07 NMED No.: N/A 

Investigation Date: 2/23/07 Type of Incident: Stolen Gauge 

 Type of Investigation: Telephone 

Comments: 

a) Incident was not recorded in NMED. 

b) Incident was not reported to NRC Headquarters Operations Center in a timely manner. 

File No.: 6 

Licensee: Geotechnical and Environmental 

 Consultants License No.: 7-402 

Date of Incident: 3/14/07 NMED No.: 070150 

Investigation Date: 3/15/07 Type of Incident: Damaged Equipment 

 Type of Investigation: Site 

Comment: 

Additional information was requested to complete the incident file in NMED, however, the 

State had not responded to the request. 

File No.: 7 

Licensee: ATL, Inc. License No.: 7-116 

Date of Incident: 6/29/07 NMED No.: 070402 

Investigation Date: 7/3/07 Type of Incident: Stolen Gauge 

 Type of Investigation: Site 

Comment: 

Additional information was requested to complete the incident file in NMED, however, the 

State had not responded to the request. 

File No.: 8 

Licensee: Terracon Consultants, Inc. License No.: 10-130 

Date of Incident: 7/17/07 NMED No.: 070443 

Investigation Dates: 7/20/07 and 7/24/07 Type of Incident: Lost Gauge 

 Type of Investigation: Site 

Comment: 

Additional information was requested to complete the incident file in NMED, however, the 

State had not responded to the request. 
Arizona Final Report Page E.3 

Incident Casework Reviews

File No.: 9 

Licensee: Walter Boswell Memorial Hospital License No.: 7-138 

Date of Incident: 8/14/07 NMED No.: 070534 

Investigation Date: 8/17/07 Type of Incident: Lost Sources 

 Type of Investigation: Site 

Comment: 

Additional information was requested to complete the incident file in NMED, however, the 

State had not responded to the request. 

File No.: 10 

Licensee: Arizona Oncology Services License No.: 7-161 

Date of Incident: 12/3/07 NMED No.: 070748 

Investigation Date: 12/3/07 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 11 

Licensee: Acura Engineering License No.: 7-550 

Date of Incident: 1/23/07 NMED No.: 080052 

Investigation Date: 1/25/07 Type of Incident: Stolen Gauge 

Type of Investigation: Site
APPENDIX F 

SEALED SOURCE & DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: AZ-0501-D-105-B SS&D Type: (D) Gamma Gauge and 

 (E) Beta Gauge 

Applicant Name: Honeywell-International Type of Action: Amendment 

Date Issued: 10/24/07 Reviewers: PK, RK, AG 

Comment: 

Quality Assurance Program in the U.S. was not confirmed for international 

manufacturers. 

File No.: 2 

Registry No.: AZ-0501-D-106-B SS&D Type: (E) Beta Gauge 

Applicant Name: Honeywell-International Type of Action: Amendment 

Date Issued: 10/25/07 Reviewers: PK, RK, AG 

Comment: 

Quality Assurance Program in the U.S. was not confirmed for international 

manufacturers. 

File No.: 3 

Registry No.: AZ-0501-D-107-B SS&D Type: (E) Beta Gauge 

Applicant Name: Honeywell-International Type of Action: Amendment 

Date Issued: 10/25/07 Reviewers: PK, RK, AG 

Comment: 

Quality Assurance Program in the U.S. was not confirmed for international 

manufacturers. 

File No.: 4 

Registry No.: AZ-0501-D-108-B SS&D Type: (D) Gamma Gauge and 

 (E) Beta Gauge 

Applicant Name: Honeywell-International Type of Action: Amendment 

Date Issued: 10/31/07 Reviewers: PK, RK, AG 

Comment: 

Quality Assurance Program in the U.S. was not confirmed for international 

manufacturers.
ATTACHMENT 

May 14, 2008, Letter from Dennis Burke 

Arizona’s Response to Draft IMPEP Report 

ADAMS: ML081410324