July 14, 2011 

Shairi Turner-Davis, MD, MPH 

Deputy Secretary for Health 

Environmental Health Division 

Bureau of Radiation Control 

Department of Health 

4052 Bald Cypress Way, Bin C21 

Tallahassee, FL 32399 

Dear Dr. Turner-Davis: 

On June 7, 2011, the Management Review Board (MRB) met to consider the proposed final 

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

State Program. The MRB found the Florida Agreement State Program adequate to protect 

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

program. 

Section 5.0, page 13, of the enclosed final report contains a summary of the IMPEP review 

team’s findings. Based on the results of the current IMPEP review, the next full review of the 

Florida Agreement State Program will take place in approximately four years. 

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

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

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

Sincerely, 

 /RA/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

Florida Final IMPEP Report 

cc: William Passetti, Chief 

 Bureau of Radiation Control
July 14, 2011 

Shairi Turner-Davis, MD, MPH 

Deputy Secretary for Health 

Environmental Health Division 

Bureau of Radiation Control 

Department of Health 

4052 Bald Cypress Way, Bin C21 

Tallahassee, FL 32399 

Dear Dr. Turner-Davis: 

On June 7, 2011, the Management Review Board (MRB) met to consider the proposed final 

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

State Program. The MRB found the Florida Agreement State Program adequate to protect 

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

program. 

Section 5.0, page 13, of the enclosed final report contains a summary of the IMPEP review 

team’s findings. Based on the results of the current IMPEP review, the next full review of the 

Florida Agreement State Program will take place in approximately four years. 

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

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

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

Sincerely, 

 /RA/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: EDATS: FSME-2011-0073 

Florida Final IMPEP Report 

cc: William Passetti, Chief 

 Bureau of Radiation Control 

DISTRIBUTION: EDATS: FSME-2011-0073 

See next page 

ADAMS Accession Number: ML111661429

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME LDimmick DWhite MDelligatti TReis 

DATE 06/21/11 06/ 21 /11 06/24/11 06/24/11 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland CCarpenter MWeber 

DATE 06/27/11 6/28/11 7/14/11 

OFFICIAL RECORD COPY
Letter to Shairi Turner-Davis from Michael F. Weber dated: July 14, 2011 

SUBJECT: FLORIDA FINAL IMPEP REPORT 

DISTRIBUTION: 

Chairman Jaczko 

Commissioner Svinicki 

Commissioner Apostolakis 

Commissioner Magwood 

Commissioner Ostendorff 

SECY 

MSSA_Technical_Asst_Resource DCD (SP01) 

EDO RF 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsSecyCorrespondenceMailCenter 

MBeardsley, FSME/MSSA 

LDimmick, FSME/MSSA 

DJanda, RI/RSAO 

JLynch, RIII/RSAO 

RLorsen, RI 

KBrock, OEDO 

BJones, OGC 

JBiggins, OGC 

CPederson, RIII 

DWhite, FSME 

RLewis, FSME 

TReis, FSME 

MBeardsley, FSME 

ARogers, Texas 

Skessinger, Illinois 

AGaines, RIV 

ABoland, RIII 

SSahle, FSME/DILR 

JOlmstead, OGC 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE FLORIDA AGREEMENT STATE PROGRAM 

MARCH 28 - APRIL 1, 2011 

FINAL REPORT
EXECUTIVE SUMMARY 

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

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

period of March 28-April 1, 2011, by a review team composed of technical staff members from 

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

Based on the results of this review, Florida’s performance was found satisfactory, but needs 

improvement, for the indicator, Compatibility Requirements, and satisfactory for the six 

remaining performance indicators reviewed. The finding for the Compatibility Requirements 

indicator remains unchanged from the previous IMPEP review. Progress has been made on the 

indicator, but the State has not yet addressed a number of outstanding NRC comments 

regarding earlier regulation packages. In addition, two regulation amendments were overdue 

for adoption by the State. 

The review team did not make any recommendations regarding program performance by the 

State and determined that the recommendation from the 2007 IMPEP review, regarding 

document security markings, should be closed. Accordingly, the review team recommends, and 

the Management Review Board agreed, that the Florida Agreement State Program is adequate 

to protect public health and safety and is compatible with NRC's program. The next IMPEP 

review for Florida will take place in approximately four years.
Florida Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Florida Agreement State Program. 

The review was conducted during the period of March 28 to April 1, 2011, by a review team 

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

the State of Illinois. Team members are identified in Appendix A. The review was conducted in 

accordance with the “Implementation of the Integrated Materials Performance Evaluation 

Program and Rescission of Final General Statement of Policy,” published in the Federal 

Register on October 16, 1997, and NRC Management Directive 5.6, “Integrated Materials 

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

review, which covered the period of February 17, 2007, to April 1, 2011, were discussed with 

Florida managers on the last day of the review. 

A draft of this report was issued to Florida for factual comment on April 19, 2011. The State 

responded by letter dated May 13, 2011, from William Passetti, Chief, Bureau of Radiation 

Control. A copy of the State’s response is included as the Attachment to this report. The 

Management Review Board (MRB) met on June 7, 2011, to consider the proposed final report. 

The MRB found the Florida Agreement State Program adequate to protect public health and 

safety and compatible with NRC’s program. 

The Florida Agreement State Program is administered by the Bureau of Radiation Control (the 

Bureau), which is located within the Division of Environmental Health (the Division). The 

Division is part of the Department of Health (the Department). Organization charts for the 

Department and the Bureau are included as Appendix B. 

At the time of the review, the Florida Agreement State Program regulated 1,719 specific 

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

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

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

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Bureau on December 14, 2010. The Bureau 

provided its response to the questionnaire on March 11, 2011. A copy of the questionnaire 

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

(ADAMS) using the Accession Number ML110750665. 

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

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

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

review of selected regulatory actions, (5) field accompaniments of 15 inspectors, and 

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

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

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

performance. 

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

during previous reviews. Results of the current review of the common performance indicators 
Florida Final IMPEP Report Page 2 

are presented in Section 3.0. Section 4.0 details the results of the review of the applicable noncommon performance indicators, and Section 5.0 summarizes the review team's findings. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on February 16, 2007, the review team 

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

The current status of the recommendation is as follows: 

The review team recommends that the State evaluate the effectiveness of their existing 

procedures and policies for marking and handling sensitive information and modify the 

existing procedures or policies, if needed, to ensure that documents containing sensitive 

information are appropriately marked in a consistent manner. (Section 3.3 of the 2007 

IMPEP Report) 

Current Status: The State implemented a procedure to ensure that all outgoing 

documents containing sensitive information are appropriately marked. Internal 

documents were already being appropriately marked prior to the IMPEP review in 2007. 

The limitation on this procedure is that, in accordance with the State’s Sunshine Law, 

only security-related information pertaining to physical security systems (e.g., alarm 

systems, room diagrams) can be withheld from the public. The review team confirmed 

that license and inspection documents were marked appropriately, in accordance with 

the limitations noted above. This recommendation is closed. 

3.0 COMMON PERFORMANCE INDICATORS 

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

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

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

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

3.1 Technical Staffing and Training

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

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

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

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

considered workload backlogs. 

The Bureau is managed by the Bureau Chief from the Central Office, located in Tallahassee. 

The Bureau consists of five Programs, three of which have responsibilities for radioactive 

materials under the Agreement: Radioactive Materials, Field Operations, and the 

Environmental Labs. All Programs are headed by an Administrator. The Radioactive 

Materials Program is responsible for materials licensing and compliance activities. The Field 

Operations Program is responsible for coordinating inspection activities, which are conducted 

primarily by the six field offices and two counties under contract, Polk and Broward. The 

Environmental Radiation Labs Program, stationed in Orlando, is responsible for the Bureau’s 

laboratory and emergency response activities. 
Florida Final IMPEP Report Page 3 

At the time of the review, there were 61 technical staff members with various degrees of 

involvement in the radioactive materials program, totaling approximately 21 full-time 

equivalents (FTE). Sixteen staff members, including managers, were stationed in the Central 

Office. Thirty-six staff members were inspectors or inspection managers distributed among 

the six field offices and the two counties under contract. Nine staff members were involved 

with emergency response and laboratory services in the Orlando office. No positions were 

vacant at the time of this review. The review team determined that staffing levels were 

adequate for the Agreement State program. 

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

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

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

Material Safety and Safeguards Program Area.” Since Florida spreads the radioactive materials 

inspection load over many inspectors (typically only 20 percent of an inspector’s workload), it is 

very difficult to schedule all of the inspectors for formal training courses. Limited availability for 

Florida staff in NRC training courses, coupled with periodic out-of-state travel restrictions, 

requires the Bureau to use internal training to meet its needs. The Bureau has developed 

several core and specific module training courses, one of which is a 3-day fundamental Applied 

Radiation Protection course for technical staff. This core training, plus on-the-job training and 

audits by inspection managers provides the basic training needs for license reviewers and 

inspectors. Staff members are assigned increasingly complex duties as they progress through 

the qualification process. The review team concluded that the Bureau’s training program is 

adequate to carry out its regulatory duties and noted that Florida management supports the 

Bureau training program. 

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

that Florida’s performance with respect to the indicator, Technical Staffing and Training, be 

found satisfactory. 

3.2 Status of Materials Inspection Program

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

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

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

on the Bureau=s questionnaire response relative to this indicator, data gathered from the 

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

management and staff. 

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

licenses are at least as frequent as, and typically more frequent than, similar license types listed 

in IMC 2800, “Materials Inspection Program.” Forty-five of the 46 license categories established 

by the Bureau were assigned inspection priority codes that prescribe a more frequent inspection 

schedule than those established in IMC 2800 for similar license types. 

The Bureau conducted approximately 2,100 high priority (Priority 1, 2, and 3) inspections during 

the review period, based on the inspection frequencies established in IMC 2800. Only one of 

these inspections was conducted overdue by more than 25 percent of the inspection frequency 

prescribed in IMC 2800. In addition, the Bureau performed approximately 400 initial inspections 
Florida Final IMPEP Report Page 4 

during the review period, three of which were conducted overdue. As required by IMC 2800, 

initial inspections should be conducted within 12 months of license issuance. The initial 

inspections were conducted late due to database entry errors. The Bureau self-identified the 

errors and provided additional training to database personnel. Overall, the review team 

calculated that the Bureau performed less than one percent of its inspections overdue during 

the review period. 

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

A sampling of 40 inspection reports indicated that none of the inspection findings were 

communicated to the licensees beyond the Bureau=s goal of 30 days after the inspection. 

During the review period, the Bureau granted 158 reciprocity permits, 46 of which were 

candidate licensees based upon the criteria in IMC 1220, “Processing of NRC Form 241 and 

Inspection of Agreements State Licensees Operating Under 10 CFR 150.20.” The review team 

determined that the Bureau met and/or exceeded the NRC=s criteria of inspecting 20 percent of 

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

period. 

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

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

be found satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, 

inspection field notes, and interviewed inspectors for 22 radioactive materials inspections 

conducted during the review period. The casework reviewed included inspections 

conducted by 18 Bureau inspectors and covered inspections of various license types, 

including: medical broad scope, medical institutions, medical private practice, portable 

gauges, industrial radiography, veterinary use, panoramic and self-shielded irradiators, 

gamma knife, nuclear pharmacy, mobile nuclear medicine, and Increased Security 

Controls for Large Quantities of Radioactive Materials (Increased Controls). Appendix C 

lists the inspection casework files reviewed, with case-specific comments, as well as the 

results of the inspector accompaniments. 

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

aspects of licensed radiation programs. The review team found that inspection reports were 

generally 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 

majority of the documentation supported violations, recommendations made to licensees, 

unresolved safety issues, and discussions held with licensees during exit interviews. 

The inspection procedures utilized by the Bureau are generally consistent with the inspection 

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

reviewed and signed by the Regional Manager. Completed inspection actions are then sent 

electronically to the Inspection Coordinator in the Central Office for issuance of inspection or 

enforcement correspondence. Supervisory accompaniments were conducted annually for all 

inspectors. 
Florida Final IMPEP Report Page 5 

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

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

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

results of the inspection. The Bureau issues to the licensee, either a letter indicating a clear 

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

inspection. When the Bureau issues an NOV, the licensee is required to provide a written 

corrective action plan, based on the violations cited, within 30 days. All findings are reviewed by 

the Inspection Coordinator. 

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

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

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

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

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

at the Orlando Office, with National Institute of Standards and Technology traceable sources. 

The Bureau uses a database to track each instrument, its current location, and next calibration 

date. 

Accompaniments of 15 Bureau inspectors were conducted by three IMPEP team members 

during the week of March 7, 2011. The inspectors were accompanied during health and 

safety inspections of source manufacturing, radiography, nuclear pharmacy, irradiator, 

medical therapy, and medical private practice licenses. The accompaniments are identified 

in Appendix C. During the accompaniments, the inspectors demonstrated appropriate 

inspection techniques, knowledge of the regulations, and conducted performance based 

inspections. The inspectors were trained, well-prepared for the inspection, and thorough in 

their audits of the licensees’ radiation safety programs. The inspectors conducted 

interviews with appropriate personnel, observed licensed operations, conducted 

confirmatory measurements, and utilized good health physics practices. The inspections 

were adequate to assess radiological health and safety and Increased Controls at the 

licensed facilities. The review team identified one instance where an inspector would benefit 

from additional medical brachytherapy training. The review team determined this instance 

was an isolated event and was not indicative of a programmatic weakness. The Bureau 

committed to evaluate the review team=s observation and provide appropriate training for the 

inspector, as needed. 

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

that Florida=s performance with respect to the indicator, Technical Quality of Inspections, be 

found satisfactory. 

3.4 Technical Quality of Licensing Actions

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

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

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

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

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

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

letters, reference to appropriate regulations, supporting documentation, consideration of 
Florida Final IMPEP Report Page 6 

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 

5 new licenses, 4 renewals, 3 decommissioning or termination actions, and 10 amendments. 

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

diagnostic and therapy (including gamma knife and high dose rate remote afterloader), 

brachytherapy, industrial radiography, research and development, nuclear pharmacy, gauges, 

manufacturers, panoramic and self-shielded irradiators. The casework sample represented 

work from 10 license reviewers. A listing of the licensing casework evaluated is provided in 

Appendix D. 

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

and of high quality with health, safety, and security issues properly addressed. License tiedown conditions were stated clearly and were supported by information contained in the file. 

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

substantive deficiencies in the licensees’ documents. Terminated licensing actions were well 

documented, showing appropriate transfer and survey records. All licensing actions are entirely 

paperless and are maintained in the Bureau’s electronic laserfiche system. License reviewers 

use the Bureau’s licensing guides, policies, checklists, and standard license conditions specific 

to the type of licensing actions to ensure consistency in licenses. 

All license evaluators have signature authority for licensing actions. The Radioactive Materials 

Administrator or a Radioactive Materials Licensing Manager performs a technical and 

supervisory review on all licensing actions before issuance to the licensee. Licenses are issued 

for a 5-year period under a timely renewal system. 

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

high quality and consistent with the NUREG-1556 guidance documents, the State’s regulations, 

and good health physics practices. The review team attributed the consistent use of templates 

and quality assurance reviews to the overall quality noted in the casework reviews. 

The Bureau performs pre-licensing checks of all new applicants. Current licensees who 

undergo a change of ownership are considered new applicants and are issued a new license 

concurrent with the termination of the current license. The Bureau’s pre-licensing review 

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

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

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

and security programs prior to receipt of the initial license. 

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

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

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

fingerprinting, as appropriate. The review team analyzed the Bureau’s methodology for 

identifying those licenses and found the rationale was thorough and accurate. The review team 

confirmed that license reviewers evaluated new license applications and license amendments 

using the same criteria. The Bureau requires full implementation of the Increased Controls prior 

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

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

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

be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Bureau=s actions in responding to incidents and 

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

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

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

11 radioactive materials incidents. A listing of the incident casework examined, with casespecific comments, may be found in Appendix E. The review team also evaluated the Bureau=s 

response to 10 allegations involving radioactive materials, including 8 allegations referred to the 

State by the NRC during the review period. 

Incident responses that are prompt, thorough, and commensurate with health and safety can 

instill public confidence in a radiation control program. The incidents selected for review 

included the following categories: medical, lost/stolen material, and equipment failure. The 

review team determined that the Bureau=s response to incidents was complete and 

comprehensive. The review team noted that allegations were also considered, and treated as, 

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

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

on-site investigations in all of the cases reviewed and took suitable enforcement and follow-up 

actions. If the incident met the reportability thresholds, as established in the Office of Federal 

and State Materials and Environmental Management Programs (FSME) Procedure SA-300 

“Reporting Material Events,” the State notified the NRC Headquarters Operations Center and 

entered the information into NMED, in a prompt manner. 

When notification of an incident or an allegation is received, the Incident Response Coordinator 

and staff at the Environmental Radiation Labs Section in Orlando determine the appropriate 

level of initial response and contact the appropriate field office. After the investigation is 

completed, the pertinent information is forwarded to the Radioactive Materials Section in the 

Central Office for closeout approval and appropriate follow-up and/or enforcement actions. 

The review team identified 227 radioactive material incidents in NMED for Florida during the 

review period, of which 118 required reporting. Seven non-reportable incidents in NMED for 

Florida were reviewed for reportability and found to be correctly categorized as non-reportable 

by the Bureau. The review team evaluated the Bureau’s timeliness of reporting incidents and 

found that all incidents are reported in the required time frame, following the Bureau’s receipt of 

notification from the licensees. 

Monthly reports and follow-up information are provided to the NRC’s contractor responsible for 

maintaining NMED by extracting information from the State’s incident database. If a reportable 

event is discovered due to an allegation, the Bureau reports the information to the NRC for 

inclusion in NMED only after the allegation has been substantiated, fully investigated, and 

closed. Even then, the Bureau is careful to exclude any language in the information reported 

that reveals that the incident was associated with an allegation. 
Florida Final IMPEP Report Page 8 

In evaluating the effectiveness of Florida's actions responding to allegations, the review team 

evaluated the casework for the eight allegations referred to the State by the NRC, as well as the 

casework for two additional allegations reported directly to the State. The Bureau evaluates 

each allegation and determines the proper level of response. The casework review indicated 

that the Bureau took prompt and appropriate action in response to all concerns raised. All of the 

allegations reviewed were appropriately closed, and appropriate parties were notified of the 

actions taken. The review team identified no performance issues from the review of the 

allegation casework. 

The review team noted that Florida law requires that public documents be made available upon 

request. The Bureau makes every effort to protect an alleger’s identity, but cannot guarantee 

full protection. During initial contact, an alleger is advised that their anonymity cannot be 

guaranteed. Throughout the investigation of an allegation, the Bureau does not voluntarily offer 

the name of an alleger in response to inquiries, but protection is limited following closure of the 

allegation. 

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

that Florida=s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

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

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) LowLevel Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. NRC’s 

Agreement with Florida does not relinquish regulatory authority for a uranium recovery program; 

therefore, only the first three non-common performance indicators applied to this review. 

4.1 Compatibility Requirements

4.1.1 Legislation

Florida became an Agreement State on July 1, 1964. The current effective statutory authority is 

contained in the Florida Radiation Protection Act in Title XXIX, Chapter 404, of the Florida 

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

implements the radiation control program. 

Florida's rulemaking process was changed in 2010. Criteria were established that determines 

whether a proposed rule has to be submitted for legislative approval. In January 2011, 

Executive Order 11-01 halted all rules in process requiring all rules to receive review and 

approval from the Governor's Office under the newly established Office of Fiscal Accountability 

and Regulatory Reform (OFARR). OFARR will now review and approve all rulemaking efforts. 

The Governor's Office has also requested that each agency submit an annual regulatory plan 

that identifies each rule it expects to promulgate in the next 12 months be submitted to OFARR 

no later that July 1, 2011. With OFARR review, it is anticipated that it may take up to 12 

months to complete a rule to the point where legislative ratification may or may not be required. 
Florida Final IMPEP Report Page 9 

While not all rules require legislative ratification, those that do will not become effective until 

ratified by the Florida Legislature. 

4.1.2 Program Elements Required for Compatibility 

The Florida regulations governing radiation protection requirements are located in 

Chapter 64E-5 of the Florida Administrative Code (FAC) and apply to all ionizing radiation. 

Florida requires a license for possession and use of all radioactive material. Florida also 

requires registration of all equipment designed to produce x-rays or other ionizing radiation. 

The Bureau’s rulemaking process is governed by the Administrative Procedure Act in Title X, 

Chapter 120, of the Florida Statutes. The administrative process for regulation adoption is 

provided in Chapter 1S-1 of the FAC. With the changes described above now in effect, the 

State’s administrative rulemaking process takes approximately 12 months from drafting to 

finalizing a rule. OFARR reviews and approves all rulemaking efforts. After the Bureau drafts a 

proposed regulation, they must publish a notice in the Florida Administrative Weekly (FAW) 

offering to hold public workshops about the proposed regulations. After the workshops (if held), 

the Bureau publishes a notice in the FAW of proposed rulemaking and offers the opportunity for 

a public hearing on the proposed rules. Concurrently, the Bureau must prepare and send an 

initial rule review file to the Joint Administrative Procedures Committee, which is a legislative 

committee that oversees rulemaking by all State agencies. If there are no objections or 

changes needed, the Bureau prepares the final regulation and files it with the Florida Secretary 

of State. The final rule must be filed within 90 days of the notice of the proposed rule. While not 

all rules require legislative ratification, those that do will not become effective until ratified by the 

Florida Legislature.

The review team evaluated Florida’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. 

During the review period, Florida submitted seven final regulation amendments, one proposed 

regulation amendment and one legally binding license condition to the NRC for a compatibility 

review. Five of the amendments were overdue for State adoption at the time of submission. 

The NRC’s compatibility review resulted in 38 comments, which will need to be addressed by 

the State in upcoming rulemaking activities. The following five amendments were submitted 

overdue during this review period: 

• “Medical Use of Byproduct Material,” 10 CFR Parts 20, 32, and 35 amendment (67 FR 

20249), that was due for Agreement State adoption on October 24, 2005. 

• “Medical Use of Byproduct Material – Recognition of Specialty Boards,” 10 CFR Part 35 

amendment (70 FR 16336, 71 FR 1926) that was due for Agreement State adoption on 

April 29, 2008. 

• “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40, and 70 amendment (71 FR 

15005) that was due for Agreement State adoption on March 27, 2009. 
Florida Final IMPEP Report Page 10 

• “National Source Tracking System – Serialization Requirements,” 10 CFR Part 32 with 

reference to Part 20 Appendix E amendment (71 FR 65685) that was due for Agreement 

State adoption on February 6, 2007. 

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

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

adoption on January 3, 2011. 

According to the Bureau’s Environmental Health Program Consultant, who is responsible for 

oversight of rulemaking and associated activities, the Bureau is reviewing the NRC comments 

on the final regulation amendments submitted during this review period and plans to address 

the comments in upcoming rulemaking. 

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

legally binding requirements no later than 3 years after the effective date of NRC’s regulations. 

At the time of this review, the following two amendments were overdue: 

• “Exemptions from Licensing, General Licenses, and Distribution of Byproduct Material; 

Licensing and Reporting Requirements,” 10 CFR Parts 30, 31, 32, and 150 amendment 

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

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

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

adoption by November 30, 2010. 

The Bureau is currently drafting proposed regulations for these two amendments and plans to 

submit them to NRC for review by June 2011. The review team noted that the State had made 

significant process in the promulgation of regulations since the last IMPEP review, but still faced 

challenges in negotiating the arduous State regulatory process. 

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

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

satisfactory, but needs improvement. 

4.2 Sealed Source and Device Evaluation Program

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

performance regarding the Sealed Source and Device (SS&D) 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 Florida SS&D evaluation activities, the review team examined the information 

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

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

staff training records; certain reported incidents involving products authorized in Florida SS&D 

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

currently conducting SS&D evaluations. 
Florida Final IMPEP Report Page 11 

4.2.1. Technical Staffing and Training

SS&D evaluation responsibilities are distributed between two reviewers, with one additional 

reviewer in training. Another individual who evaluated most of the SS&D registries in the 

current reporting period is no longer with the Bureau. 

The Bureau has a documented qualification program for SS&D reviewers as a subsection of its 

overall Licensing Evaluator Qualification Procedures. The Bureau is in the process of 

developing a structured in-house training program, but due to the infrequent SS&D application 

or amendment requests, the Bureau is focusing its resources on developing structured training 

programs for more frequent regulatory actions. In the interim, the Bureau will use on-the-job 

training for new reviewers with oversight from the two qualified senior SS&D reviewers. 

The Bureau currently has three qualified reviewers, although one individual has not performed 

any SS&D evaluations. All three individuals have completed the NRC SS&D Workshop. The 

new reviewer in training will be trained in-house with oversight from the senior SS&D reviewers. 

As part of its training, the Bureau grants reviewers signature authority immediately, so that they 

may begin their training. The Bureau believes that this method makes the reviewers more 

conscientious when working on SS&D actions. As part of their on-the-job training, the Bureau 

will use a double concurrence approach, where the two active senior reviewers will both perform 

technical and concurrence reviews for any new application or amendment request. The Bureau 

plans to use the double concurrence process for the new reviewers for the foreseeable future. 

4.2.2 Technical Quality of the Product Evaluation Program

During the review period, the Bureau processed six SS&D actions. Five of the actions were 

amendments, with one new application. There were no inactivations of SS&D registrations or 

emerging technology evaluations processed during the review period. The review team 

evaluated all six actions processed during the review period. The casework selected for review 

was representative of two qualified reviewers (one of whom is no longer with the Bureau) and 

one reviewer in-training. A listing of the SS&D certificates evaluated by the review team, with 

case-specific comments, may be found in Appendix F. 

The review team identified that one of the SS&D registries issued was not signed by two 

qualified individuals. The concurrence reviewer for the new SS&D had not completed the inhouse SS&D training program and is not considered a qualified reviewer. The Bureau has an 

internal policy that two qualified individuals review the SS&D application and a third individual 

in-training may also review the SS&D application. Several unusual circumstances played a role 

in the review of this SS&D application. The initial review and initial letter requesting additional 

information from the applicant was completed by a qualified reviewer. He left State employment 

after the initial review and prior to issuance of the SS&D certificate. The second qualified 

reviewer, who peer reviewed the work of the initial reviewer, took over the project. He 

completed his review of the device and issued the registry. The concurrence signature for the 

SS&D registry was signed by the individual in-training. Therefore, the SS&D registration was 

not signed by two qualified reviewers. 

Florida Statute Title X, Chapter 120, Section 120.60, requires an agency to approve or deny an 

application for a license within 90 days after receipt of a completed application. If the 
Florida Final IMPEP Report Page 12 

application is not approved or denied within the 90-day timeframe, within 15 days after 

conclusion of a public hearing held on the application, or within 45 days after a recommended 

order is submitted to the agency, the application is considered approved unless the 

recommended order directs that the agency deny the license. Due to the untimely departure of 

the original qualified reviewer and the 90-day statutory requirement, the Bureau’s time to 

complete the review and issue the SS&D registration was limited. The second qualified 

individual completed the review; however, the other qualified individual on staff was unable to 

review the submittal in a timely fashion. The reviewer in-training was available and performed 

the concurrence review. The Bureau submitted a Technical Assistance Request (TAR) to the 

NRC for this SS&D on June 28, 2010. The TAR requested NRC’s assistance in interpretation of 

the regulations regarding the definition of a generally licensed device and distribution of these 

devices to general licensees. NRC’s response was dated February 10, 2011. Due to Florida 

statutory time limitations on issuance of registrations and licenses, the Bureau was required to 

issue the registry prior to receiving NRC’s response, and was thus not able to consider the TAR 

response prior to issuance of the SS&D. 

The Bureau performed evaluations based on sound conservative assumptions to ensure public 

health and safety was adequately protected. Good health physics practices were implemented 

throughout this review. Since the original review was performed by a qualified individual and 

the second qualified individual peer reviewed the first reviewer’s work and completed the SS&D 

registry, although the actual concurrence reviewer had not completed the training, the team 

determined that two qualified individuals actually reviewed the SS&D submittal and therefore 

determined that the Bureau met the intent of the requirement of having two qualified individuals 

perform the review. All other SS&D registrations completed during the review period were 

signed by two qualified reviewers. 

In assessing the Bureau’s SS&D evaluation activities, the review team examined information 

contained in the questionnaire response and interviewed program staff and managers. The 

review team confirmed that the Bureau follows the recommended guidance from the NRC 

SS&D Workshop, NUREG-1556 Series Guidance, applicable and pertinent American National 

Standards Institute (ANSI) standards, Military Standards, International Standards Organizations 

ISO-9001, and Florida regulations, statutes, policies and procedures. The review team verified 

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

Deficiency letters clearly stated regulatory positions and all health and safety issues were 

addressed. The review team determined that product evaluations were complete and 

adequately addressed the integrity of the products during use and in the event of accidents. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

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

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

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

nationally involving sources/devices registered by the Bureau. The review team determined that 

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

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

registered in Florida were related to manufacturing or design of the product. 
Florida Final IMPEP Report Page 13 

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

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

Program, be found satisfactory. 

4.3 Low-level Radioactive Waste 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 low level radioactive 

waste (LLRW) as a separate category. Although the Florida 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 which 

will meet the criteria for an adequate and compatible LLRW disposal program. There are no 

plans for a LLRW disposal facility in Florida. Accordingly, the review team did not review this 

indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, Florida’s performance was found satisfactory, but 

needs improvement, for the indicator, Compatibility Requirements, and satisfactory for the 

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

recommendations regarding program performance by the State and determined that the 

recommendation from the 2007 IMPEP review should be closed. Accordingly, the review team 

recommends, and the MRB agreed, that the Florida Agreement State Program is adequate to 

protect public health and safety and is compatible with NRC's program. Based on the results of 

the current IMPEP review, the review team recommends, and the MRB agreed, that the next full 

IMPEP review take place in approximately four years. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Florida Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source and Device Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Jim Lynch, Region III Team Leader 

 Technical Staffing and Training 

 Inspector Accompaniments 

Donna Janda, Region I Technical Quality of Licensing Actions 

 Compatibility Requirements 

 Inspector Accompaniments 

Solomon Sahle, FSME Status of Materials Inspection Program 

Anthony Gaines, Region IV Technical Quality of Inspections 

 Technical Quality of Incident & Allegation Activities 

 Inspector Accompaniments 

Sandi Kessinger, Illinois Sealed Source and Device Evaluation Program 

 Technical Quality of Licensing Actions 
APPENDIX B 

FLORIDA ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML111661860
 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: University of Florida License No.: 0031-3 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 11/28/07 Inspectors: BT, TT 

File No.: 2 

Licensee: Cardiology Diagnostics Imaging, Inc. License No.: 3119-2 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 4/29/08 Inspector: FN 

File No.: 3 

Licensee: Southwest Volusia Healthcare Corporation License No.: 2467-1 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 10/7-8/08 Inspector: DD 

File No.: 4 

Licensee: Cardiology Consultants, P.A. License No.: 3516-2 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Dates: 2/2-5/09 Inspectors: DD, JB 

File No.: 5 

Licensee: V.P. Jeyabarath, M.D., P.A. License No.: 4062-1 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 1/23/09 Inspector: AO 

File No.: 6 

Licensee: Orlando Heart and Vascular Center, LLC License No.: 3939-1 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 6/4/09 Inspector: HS 

File No.: 7 

Licensee: Palmetto Open MRI, Inc. License No.: 3650-1 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 5/6/09 Inspector: JS 

File No.: 8 

Licensee: Yovaish Engineering Sciences, Inc. License No.: 2649-1 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 2/25/10 Inspector: LB 
Florida Final IMPEP Report Page C.2

Inspection Casework Reviews 

File No.: 9 

Licensee: Nodarse and Associates, Inc. License No.: 2429-5 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Dates: 8/11-12/10 Inspectors: TM, CB 

File No.: 10 

Licensee: Veterinary Internis License No.: 3190-1 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 2/15/11 Inspector: HS 

File No.: 11 

Licensee: Food Technology Services, Inc. License No.: 2244-1 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/9/11 Inspector: TM 

File No.: 12 

Licensee: Bayfront Medical Center, Inc. License No.: 0023-2 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 5/28/10 Inspector: SR 

File No.: 13 

Licensee: Halifax License No.: 0194-5 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 11/15/10 Inspector: DD 

File No.: 14 

Licensee: Cardinal Health 414, LLC License No.: 3453-1 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 11/19/09 Inspector: GH 

File No.: 15 

Licensee: Formweld Fitting, Inc. License No.: 3472-1 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/11/11 Inspector: BR 

File No.: 16 

Licensee: Tampa Radiation Oncology, P.C. License No.: 4152-1 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 2/9/11 Inspector: SR 

File No.: 17 

Licensee: Triad Isotopes, Inc. License No.: 3920-12 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 10/19/10 Inspector: LG 
Florida Final IMPEP Report Page C.3

Inspection Casework Reviews 

File No.: 18 

Licensee: Cardiovascular Diagnostic Image, Inc. License No.: 3119-2 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 6/3/09 Inspectors: JG, EK, WL 

File No.: 19 

Licensee: Space Science Services, Inc. License No.: 0140-2 

Inspection Type: Routine, Announced Priority: 1 

Inspection Dates: 11/19-27/07 Inspector: LB 

Comment: Corrective actions for a repeat violation did not appear to be adequate. The 

licensee just stated that they had corrected the problem, which was similar to their response for 

the original violation. 

File No.: 20 

Licensee: Law and Associates, Inc. License No.: 2466-1 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Dates: 4/23-25/08 Inspectors: DD, HS 

File No.: 21 

Licensee: RCOA Imaging Services, Inc. License No.: 3110-4 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/22/11 Inspector: DB 

File No.: 22 

Licensee: Marlin Engineering, Inc. License No.: 2886-1 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Dates: 7/11-16/07 Inspector: JS 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Port Saint Lucie Surgery Center, LTD License No.: 3957-1 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 3/7/11 Inspector: NP 

Accompaniment No.: 2 

Licensee: Innovative American Technology, Inc. License No.: 4209-1 

Inspection Type: Initial, Announced Priority: 1 

Inspection Date: 3/8/11 Inspector: LG 

Accompaniment No.: 3 

Licensee: Denis R. Weinberg, M.D. and Associates Corporation License No.: 3213-1 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 3/9/11 Inspector: WL 
Florida Final IMPEP Report Page C.4

Inspection Casework Reviews 

Accompaniment No.: 4 

Licensee: Cardinal Health 414, LLC License No.: 3469-2 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/10/11 Inspector: MK 

Accompaniment No.: 5 

Licensee: Bethesda Memorial Hospital License No.: 0658-2 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/11/11 Inspector: RB 

Accompaniment No.: 6 

Licensee: Certified Testing Laboratories, Inc. License No.: 2332-1 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 3/7/11 Inspector: HS 

Accompaniment No.: 7 

Licensee: IBA Molecular North America, Inc. License No.: 3287-1 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/8/11 Inspector: RC 

Accompaniment No.: 8 

Licensee: Southwest Volusia Healthcare Corporation License No.: 2467-2 

Inspection Type: Initial, Announced Priority: 2 

Inspection Date: 3/9/11 Inspector: DD 

Accompaniment No.: 9 

Licensee: GE Inspection Services, Inc. License No.: 2861-1 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 3/10/11 Inspector: MC 

Accompaniment No.: 10 

Licensee: Formweld Fitting, Inc. License No.: 3472-1 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 3/11/11 Inspector: BR 

Accompaniment No.: 11 

Licensee: Specialists in Urology, P.A. License No.: 4149-1 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/7/11 Inspector: MB 

Comment: The inspector would benefit from additional brachytherapy training. 

Accompaniment No.: 12 

Licensee: National Inspection and Consultants, Inc. License No.: 2850-1 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 3/8/11 Inspector: LF 
Florida Final IMPEP Report Page C.5

Inspection Casework Reviews 

Accompaniment No.: 13 

Licensee: Food Technology Services, Inc. License No.: 2244-1 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/9/11 Inspector: TM 

Accompaniment No.: 14 

Licensee: Petnet Solutions, Inc. License No.: 3887-4 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/10/11 Inspector: DM 

Accompaniment No.: 15 

Licensee: IsoAid, LLC License No.: 3196-1 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 3/11/11 Inspector: AO 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Cardinal Health 414, LLC License No.: 3453-8 

Type of Action: Renewal Amendment No.: 19 

Date Issued: 5/1/08 License Reviewer: LT 

File No.: 2 

Licensee: Tyco Healthcare Group, LP License No: 3007-1 

Type of Action: Renewal Amendment No.: 24 

Date Issued: 8/4/10 License Reviewer: TT 

File No.: 3 

Licensee: University of Central Florida License No.: 4187-1 

Type of Action: New Amendment No.: 0 

Date Issued: 1/21/10 License Reviewer: TT 

File No.: 4 

Licensee: Adventist Health Systems/Sunbelt, Inc. License No.: 2897-1 

Type of Action: Amendment Amendment No.: 54 

Date Issued: 9/20/10 License Reviewer: MG 

File No.: 5 

Licensee: Morton Plant Gamma Knife, LLC License No.: 3667-1 

Type of Action: Termination Amendment No.: 14 

Date Issued: 4/29/10 License Reviewer: JS 

File No.: 6 

Licensee: St. Anthony’s Hospital, Inc. License No.: 0294-3 

Type of Action: New Amendment No.: 0 

Date Issued: 2/11/10 License Reviewer: LT 

File No.: 7 

Licensee: Triad Isotopes, Inc. License No.: 3920-3 

Type of Action: Amendment Amendment No.: 3 

Date Issued: 6/16/08 License Reviewer: BT 

File No.: 8 

Licensee: Team Industrial Services, Inc. License No.: 3721-1 

Type of Action: Renewal Amendment No.: 7 

Date Issued: 11/19/10 License Reviewer: DW 
Florida Final IMPEP Report Page D.2 

License Casework Reviews 

File No.: 9 

Licensee: Baptist Medical Center of Nassau, Inc. License No.: 2523-1 

Type of Action: Amendment Amendment No.: 24 

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

File No.: 10 

Licensee: Anazao Health Corporation License No.: 2975-1 

Type of Action: Amendment Amendment No.: 34 

Date Issued: 12/27/10 License Reviewer: EL 

Comment: The file contained no documentation regarding safety procedures related to 

licensee’s request to add P-32 use to the license for research and development activities. 

File No.: 11 

Licensee: Tenet St. Mary’s Inc. License No.: 3279-1 

Type of Action: Amendment Amendment No.: 18 

Date Issued: 6/22/10 License Reviewer: MG 

File No.: 12 

Licensee: Clinical P.E.T. of Ocala, LLC License No.: 3355-1 

Type of Action: Amendment Amendment No.: 9 

Date Issued: 5/8/09 License Reviewer: KF 

File No.: 13 

Licensee: Rad Onc Group, LLC License No.: 3989-1 

Type of Action: New Amendment No.: 0 

Date Issued: 10/24/07 License Reviewer: JS 

File No.: 14 

Licensee: Lee Memorial Health System License No.: 2695-2 

Type of Action: Termination Amendment No.: 11 

Date Issued: 4/1/09 License Reviewer: JS 

File No.: 15 

Licensee: Alliance Surgical Center, LLC License No.: 4213-1 

Type of Action: New Amendment No.: 0 

Date Issued: 8/26/10 License Reviewer: JS 

File No.: 16 

Licensee: Martin Memorial Medical Center, Inc. License No.: 1215-3 

Type of Action: Amendment Amendment No.: 33 

Date Issued: 6/5/09 License Reviewer: KF 

File No.: 17 

Licensee: Food Technology Services, Inc. License No.: 2244-1 

Type of Action: Amendment Amendment No.: 48 

Date Issued: 7/21/10 License Reviewer: LT 
Florida Final IMPEP Report Page D.3 

License Casework Reviews 

File No.: 18 

Licensee: University of Miami License No.: 1319-1 

Type of Action: Amendment Amendment No.: 54 

Date Issued: 10/22/10 License Reviewer: EL 

File No.: 19 

Licensee: Space Science Services, Inc. License No.: 0140-2 

Type of Action: Amendment Amendment No.: 21 

Date Issued: 1/21/09 License Reviewer: LT 

File No.: 20 

Licensee: Lifescan Institutes of America, LLC License No.: 3418-1 

Type of Action: Termination (Revocation) Amendment No.: 2 

Date Issued: 6/13/07 License Reviewer: CH 

Comment: File contained no documentation of final disposition of radioactive material and no 

documentation of close out surveys. 

File No.: 21 

Licensee: Florida Blood Services, Inc. License No.: 4055-1 

Type of Action: New Amendment No.: 0 

Date Issued: 7/14/08 License Reviewer: JS 

File No.: 22 

Licensee: Intersil Communications, Inc. License No.: 3044-1 

Type of Action: Renewal Amendment No.: 6 

Date Issued: 11/30/07 License Reviewer: JK 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: University of Florida Shands Hospital License No.: 0031-1 

Date of Incident: 7/11/07 NMED No.: 070439 

Investigation Date: 7/13/07 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 2 

Licensee: Tierra, Inc. License No.: 2307-2 

Date of Incident: 12/7/07 NMED No.: 070756 

Investigation Date: 12/7/07 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 3 

Licensee: Cardinal Health 414, LLC License No.: 3453-2 

Date of Incident: 3/19/08 NMED No.: 080417 

Investigation Date: 4/15/08 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 4 

Licensee: Saint Vincent Medical Center, Inc. License No.: 0014-6 

Date of Incident: 9/10/08 NMED No.: 080694 

Investigation Date: 10/17/08 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 5 

Licensee: IsoAid, LLC License No.: 3196-1 

Date of Incident: 12/31/08 NMED No.: 100399 

Investigation Date: 7/27/10 Type of Incident: Overexposure 

 Type of Investigation: Site 

Comment: This incident was discovered during an inspection in 2010. 

File No.: 6 

Licensee: Renegade Testing and Inspection, Inc. License No.: 3891-1 

Date of Incident: 5/12/09 NMED No.: 090624 

Investigation Date: 5/12/09 Type of Incident: Damaged Equipment 

 Type of Investigation: Site 
Florida Final IMPEP Report Page E.2 

Incident Casework Reviews 

File No.: 7 

Licensee: Condotte America, Inc. License No.: 3622-1 

Date of Incident: 12/15/09 NMED No.: 090881 

Investigation Date: 12/15/09 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 8 

Licensee: Florida Bureau of Radiation Control License No.: 0001-3 

Date of Incident: 3/6/10 NMED No.: 100176 

Investigation Date: 4/6/10 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 9 

Licensee: 21st Century Oncology License No.: 1797-2 

Date of Incident: 3/31/10 NMED No.: 100249 

Investigation Date: 4/1/10 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 10 

Licensee: Target Engineering Group, Inc. License No.: 3366-1 

Date of Incident: 6/7/10 NMED No.: 100296 

Investigation Date: 06/7/10 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 11 

Licensee: Anderson Columbia Co., Inc. License No.: 2708-1 

Date of Incident: 12/14/10 NMED No.: 100603 

Investigation Date: 12/14/10 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 
APPENDIX F 

SEALED SOURCE AND DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Registry No.: FL-1146-S-101-S SS&D Type: (AA) Manual Brachytherapy 

Applicant Name: IsoAid, LLC Type of Action: Amendment 

Date Issued: 9/7/07 SS&D Reviewers: TT, PV 

Comments: 

a) Exposure rate measurements were not calculated for the maximum source quantity. 

b) Surface exposure rates were not listed. 

c) Tolerances were not listed for physical dimensions of the source. 

File No.: 2 

Registry No.: FL-1146-S-102-S SS&D Type: (AA) Manual Brachytherapy 

Applicant Name: IsoAid, LLC Type of Action: Amendment 

Date Issued: 9/7/07 SS&D Reviewers: TT, PV 

Comments: 

a) Exposure rate measurements were not calculated for the maximum source quantity. 

b) Surface exposure rates were not listed. 

c) Tolerances were not listed for physical dimensions of the source. 

File No.: 3 

Registry No.: FL-1116-D-101-S SS&D Type: (O) Ion Generators, Static Eliminators 

Applicant Name: Lockheed Martin Corporation Type of Action: Amendment 

Date Issued: 10/2/07 SS&D Reviewers: TT, PV 

File No.: 4 

Registry No.: FL-1172-D-101-S SS&D Type: (O) Ion Generators, Static Eliminators 

Applicant Name: Northrop Grumman Type of Action: Amendment 

Date Issued: 12/30/07 SS&D Reviewers: TT, PV 

File No.: 5 

Registry No.: FL-1172-D-101-S SS&D Type: (O) Ion Generators, Static Eliminators 

Applicant Name: Northrop Grumman Type of Action: Amendment 

Date Issued: 12/10/08 SS&D Reviewers: TT, PV 

Comment: The approved quality assurance manual did not reference the current manufacturer 

for this device. 

 
Florida Final IMPEP Report Page F.2 

Sealed Source and Device Casework Reviews 

File No.: 6 

Registry No.: FL-1334-D-101-G SS&D Type: (T) Other (Power Generation) 

Applicant Name: City Labs, Inc. Type of Action: New Application 

Date Issued: 10/28/10 SS&D Reviewers: PV, CH 

Comments: 

a) The SS&D registry does not contain signatures of two qualified individuals. The 

concurrence review was performed by a reviewer in-training. 

b) The SS&D registry does not clarify that the source is not approved for use in any other 

device. 

c) The diagram on page 9 and parts of the diagram on page 10 are illegible in the Bureau’s 

files; as well as on the NRC SS&D database. 
ATTACHMENT 

May 13, 2011 letter from Bill Passetti 

Florida’s Response to the Draft Report 

ADAMS Accession No.: ML11143A062