May 23, 2007

Bonita Sorensen, M.D., M.B.A.

Deputy State Health Officer

Department of Health

4052 Bald Cypress Way, Bin A07

Tallahassee, FL 32399-1708

Dear Dr. Sorensen:

On April 30, 2007, 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

program.

Section 5.0, page 14, of the enclosed final report contains a summary of the IMPEP review

team’s findings and recommendation. We request your evaluation and response to the

recommendation within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next full review of the Florida Agreement

State Program will take place in approximately 4 years, with a periodic meeting tentatively

scheduled for February 2009.

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 and the

excellence in program administration demonstrated by your staff, as reflected in the review

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

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

 Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: Florida Final IMPEP Report

cc: Lisa Conti, Director

 Florida Division of Environmental Health

 William A. Passetti, Chief

 Florida Bureau of Radiation Control

 Barbara Hamrick, California

 Organization of Agreement States

 Liaison to the MRB
May 23, 2007

Bonita Sorensen, M.D., M.B.A.

Deputy State Health Officer

Department of Health

4052 Bald Cypress Way, Bin A07

Tallahassee, FL 32399-1708

Dear Dr. Sorensen:

On April 30, 2007, 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

program.

Section 5.0, page 14, of the enclosed final report contains a summary of the IMPEP review

team’s findings and recommendation. We request your evaluation and response to the

recommendation within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next full review of the Florida Agreement

State Program will take place in approximately 4 years, with a periodic meeting tentatively

scheduled for February 2009.

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 and the

excellence in program administration demonstrated by your staff, as reflected in the review

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

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

 Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: Florida Final IMPEP Report

cc: Lisa Conti, Director

 Florida Division of Environmental Health

 William A. Passetti, Chief

 Florida Bureau of Radiation Control

 Barbara Hamrick, California

 Organization of Agreement States

 Liaison to the MRB

DISTRIBUTION: See next page. ML071230779

OFC FSME/DMSSA FSME/DMSSA FSME/DMSSA TechEd

NAME ATMcCraw:kk ADWhite JRSchlueter CPoland

DATE 05/07/07 05/07/07 05/07/07 05/9/07

OFC FSME DEDMRT

NAME CLMiller MJVirgilio

DATE 05/11/07 05/23/07

OFFICIAL RECORD COPY
Letter to Bonita Sorensen from Martin J. Virgilio dated: May 23, 2007 

Distribution: DCD (SP01)

DMSSA RF Chairman Klein

EDO RF Commissioner McGaffigan

DSollenberger, DMSSA Commissioner Merrifield

AMcCraw, DMSSA Commissioner Jaczko

THerrera, DMSSA Commissioner Lyons

DJanda, RI/RSAO SECY

MBeardsley, RI

RGallaghar, MA

AKock, OEDO

KCyr, OGC

FCameron, OGC

TCombs, OCA (2 copies)

BMallett, RIV

JSchlueter, DMSSA

SMoore, DMSSA

DWhite, DMSSA
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF FLORIDA AGREEMENT STATE PROGRAM

February 12-16, 2007

FINAL REPORT

U.S. Nuclear Regulatory Commission

ENCLOSURE
Florida Final 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 February 12-16, 2007, by a review team comprised

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

Commonwealth of Massachusetts. 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 8, 2003, to February 16, 2007, were discussed

with Florida management on the last day of the review.

A draft of this report was issued to Florida for factual comment on March 15, 2007. The State

responded by letter on March 30, 2007, from William Passetti, Chief, Bureau of Radiation

Control (the Bureau). The Management Review Board (MRB) met on April 30, 2007, 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 Bureau, located within the Division of Environmental Health (the Division), administers the

Florida Agreement State Program. 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 approximately 1,689

specific licenses. 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 Florida.

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Bureau on November 22, 2006. The Bureau

provided its response to the questionnaire on January 26, 2007. A copy of the questionnaire

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

(ADAMS) using the Accession Number ML070600149.

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) nine field accompaniments of Florida inspectors; and

(6) interviews with staff and management to answer questions or clarify issues. 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 identifies that no recommendations were made during the previous

review. Results of the current review for the common performance indicators are presented in

Section 3.0. Section 4.0 discusses 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
Florida Final Report Page 2

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 7, 2003, no recommendations

were made by the review team.

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.

3.1 Technical Staffing and Training

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

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

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

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

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

in evaluating this indicator.

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

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

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

Section, and the Environmental Radiation Labs Section. All Sections are headed by an

Administrator. The Radioactive Materials Administrator is responsible for materials licensing

and compliance activities. The Field Operations Administrator is responsible for coordinating

the inspections activities, which are conducted primarily by the six field offices and two counties

under contract, Polk and Broward. The Environmental Radiation Labs Administrator, stationed

in Orlando, is responsible for the Bureau’s laboratory and emergency response activities.

At the time of the review, there were 62 individuals with various degrees of involvement in the

radioactive materials program, totaling 21 full time equivalents (FTE). This staffing level does

not include administrative support staff. Seventeen staff, including five managers, were

stationed in the Central Office. Thirty-six staff were inspectors or inspection managers

distributed among the six field offices and the two counties under contract. Nine staff were

involved with emergency response and laboratory services in the Orlando Office.

The Bureau had a total of 24 turnovers in staff during the review period. The Bureau’s

turnovers can be attributed to competition with local industry for qualified staff and recent

retirements of several experienced staff members. The Bureau has been able to fill vacancies

in an expedient manner. At the time of the review, the Bureau had one vacancy, in the Miami

Field Office. The position became vacant January 26, 2007, and the Bureau is in the process of

interviewing applicants.
Florida Final Report Page 3

The Bureau Chief supports staff training opportunities, as well as staff participation in Federal

and State working groups. The Bureau has a documented training plan that is consistent with

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

NRC’s Inspection Manual Chapter (IMC) 1246. They also have been developing an in-house

training program that focuses on on-the-job training after completion of an orientation module

developed by Bureau staff. At the time of the review, the Bureau had eight staff members that

had attended the NRC Security Systems and Principles course. The Bureau was also working

to develop a training module to provide in-house training equivalent to the NRC Security

Systems and Principles course to qualify all inspectors for Increased Controls inspections. The

review team concluded that the Bureau has an adequate and well-balanced staff to carry out its

regulatory responsibilities.

The review team noted that the Bureau experienced stable funding during the review period. 

The Bureau is authorized to assess and collect fees for specific and general licenses, as well as

for the registration of radiation machines. In addition, Florida licensees are assessed an annual

licensing and inspection fee. All monies collected by the Bureau are deposited in the Radiation

Protection Trust Fund, which is held and applied solely for the expenses incurred in

implementing the radiation control program. The Bureau is currently amending its radioactive

materials license fee schedule which will maintain full funding for the radioactive materials

program.

The Advisory Council on Radiation Protection of the State of Florida (the Council), as

constituted under law, acts only in an advisory role to the Bureau. Meetings of the Council are

infrequent.

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

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

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 the Bureau’s inspection priorities for various license types are at

least as frequent as, and typically more frequent than, similar license types listed in IMC 2800. 

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 review team determined that, during the review period, the Bureau conducted

approximately 1,017 Priority 1, 2, and 3 inspections, based on the inspection frequencies

established in IMC 2800. None of these inspections were conducted overdue, nor were any

inspections overdue at the time of the review. In addition, the Bureau performed 532 initial

inspections during the review period, 18 of which were conducted overdue (greater than 12
Florida Final Report Page 4

months after license issuance). The initial inspections became overdue because, when prelicensing site visits were entered into the Bureau’s inspection software system, the system was

automatically assigning the next inspection date based on the routine inspection priority code,

not on an initial inspection interval. This resulted in the system not capturing the appropriate

initial inspection date. The Bureau self-identified this software error and has addressed the

issue by manually changing the next inspection date to the appropriate time frame following a

pre-licensing visit. Bureau staff with computer programming experience are currently evaluating

the error to determine the most effective path forward. Overall, approximately 1.1 percent of the

total Priority 1, 2, 3 and initial inspections conducted by the Bureau, during the review period,

were performed overdue (18 late inspections out of 1,549 total inspections).

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

The review team determined that, during the review period, a majority of inspection findings

were communicated to the licensees in less than 30 days. A sampling of 49 inspection reports

indicated that 2 inspection findings were communicated to the licensees beyond the Bureau’s

goal of 30 days after the inspection. These reports were issued 33 and 40 days after the date

of their respective inspections. In both cases, the inspectors failed to turn in their field notes to

the Central Office in a timely manner, thus affecting the timely issuance of the reports.

During the review period, the Bureau granted 236 reciprocity permits, 89 of which were

candidate licensees based upon the criteria in IMC 1220. 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.

The review team determined that with respect to Commission Staff Requirements Memorandum

(SRM) for COMSECY-05-0028, on Increased Controls, the Bureau planned for the initial set of

inspections of these licensees in accordance with the SRM. The review team evaluated the

Bureau’s prioritization methodology and found it acceptable. The Bureau elected to perform all

of its Increased Controls inspections by December 2006. The Bureau currently has 60

licensees subject to the Increased Controls. Fifty-three Increased Controls inspections had

been completed at the time of the review. Six Increased Controls inspections were performed

and were under Bureau review, awaiting the licensees’ responses. One new licensee’s

implementation of the Increased Controls will be inspected by June 2007 in conjunction with the

initial inspection.

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

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

was satisfactory.

3.3 Technical Quality of Inspections

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

notes, and interviewed inspectors for 20 radioactive materials inspections conducted during the

review period. The casework reviewed included inspections conducted by 15 Bureau

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

medical institutions requiring written directives, medical private practice, fixed and portable

gauges, industrial radiography, academic broad scope, irradiator, medical therapy, nuclear

pharmacy, manufacturer and distribution, waste disposal and processing, Increased Controls, 
Florida Final Report Page 5

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 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. Three

casework files reviewed contained apparent violations that were not cited by the Bureau in

correspondence sent to the licensee. The files did not contain documentation to justify not

citing the apparent violations. The Bureau agreed to modify their policy on documenting noncited violations to ensure that inspection reports and/or field notes adequately reflect all of the

inspectors’ observations and provide sufficient justification for not citing violations.

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

enforcement correspondence. Supervisory accompaniments were conducted annually for all

inspectors.

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

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

documented in the report and sent to the licensee with the appropriate form or 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, detailing 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, through the casework review, identified that

NOVs sent from the Bureau to licensees required to implement the Increased Controls

requirements were not labeled as sensitive information to be withheld from public disclosure. 

The NOVs contained specific information regarding the requirements of the Increased Controls

and how the licensee was not meeting those requirements, which is considered sensitive

information. The licensees’ response letters were appropriately marked as sensitive

information. 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.

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 a

neutron detector, were observed to be available. The Bureau also has portable multi-channel

analyzers. Instruments are calibrated at least annually, or as needed, at the Orlando Office,

with sources that were National Institute of Standards and Technology traceable. The Bureau

uses a database to track each instrument, its current location and when it is due for calibration.
Florida Final Report Page 6

Accompaniments of nine Bureau inspectors were conducted by two IMPEP team members

during the weeks of January 22 and February 5, 2007. The inspectors were accompanied

during health and safety inspections of medical therapy, medical private practice, and portable

gauge licenses. The accompaniments are identified in Appendix C. During the

accompaniments, most of 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 may have failed to observe a potential violation of Florida’s regulation related to

radioactive material security 10 CFR 20.1802. 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, as well as the inspection as a whole, and provide

retraining for the inspector, as needed.

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

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

satisfactory.

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, proper

radioisotopes and quantities, qualifications of authorized users, adequate facilities and

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

emergency procedures, appropriateness of the license conditions, Increased Controls, and

overall technical quality. The casework was also reviewed for timeliness, use of appropriate

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

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

supervisory review as indicated, and proper signatures. The casework was checked for

retention of necessary documents and supporting data.

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, 9 renewals, 5 amendments, 2 terminations, and 1 reciprocity request. The sampling

included the following license types: medical (institution - written directive required, private

practice - no written directive, gamma knife, and high dose-rate remote afterloader), industrial

radiography, portable gauge, academic and medical broadscope, research and development

broadscope, self-shielded irradiator, waste broker, and nuclear pharmacy. A listing of the

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

The review team found that the licensing actions were thorough, complete, consistent, and of

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

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

Licenses and correspondence are generated using standardized conditions and formats. 

Licensing staff appropriately used the Bureau’s licensing guides, policies, and standard license 
Florida Final Report Page 7

conditions. Licensees’ compliance histories were taken into account when reviewing all renewal

applications and major amendments.

Each licensing action is given a technical review by a license evaluator. 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. All license

evaluators have signature authority for licensing actions. Licenses are issued for a 5-year

period under a timely renewal system.

The review team evaluated financial assurance and decommissioning activities conducted by

the Bureau. The Bureau’s procedure for financial assurance is specified in Subpart E to the

Florida Administrative Code 64E-5.217, Bonding of Persons Licensed Pursuant to Subpart IIC. 

The Bureau also has a Reclamation Fund into which 5 percent of the licensees’ annual fees are

appropriated. The review team found that terminated licensing actions were well-documented,

showing appropriate material transfer and survey records. The review team noted that

confirmatory surveys were conducted, when appropriate. The review team identified no

performance issues with the Bureau’s handling of financial assurance or decommissioning.

The Bureau had, as of December 2006, six licensing actions that have been pending for one

year or longer; however, the review team identified no health and safety significant impacts that

are attributable to the delay in issuance of these actions.

The review team determined that outgoing documents to licensees (i.e., cover letters and

licenses) containing sensitive information were not marked or identified accordingly. This issue

was previously mentioned from the inspection standpoint in Section 3.3 of this report, with a

resulting recommendation.

The review team identified that limited and broadscope medical licenses contained authorization

limits for unsealed therapeutic materials in “as necessary” amounts. This material authorization

includes iodine-131 which, if possessed in amounts greater than 10 curies, would require the

licensee to develop and implement an emergency plan for responding to releases of this

material. While it is unlikely that these licensed facilities possessed enough I-131 to require an

emergency plan, the Bureau agreed to change their licensing guidance to require either

specification of a total possession limit for these materials or insertion of a license condition on

these types of licenses restricting the possession limits of these materials below the threshold

requiring an emergency plan.

The review team examined the list of licensees that the Bureau determined to meet the criteria

for the Increased Controls, per COMSECY-05-0028. The review team determined that the

Bureau had correctly identified the licensees that require the Increased Controls based on this

criteria. The Bureau also required their licensees currently under an NRC Order for additional

security measures to implement the Increased Controls. Each licensee was issued a license

amendment, requiring the Increased Controls, in accordance with the time lines established by

the Commission in the SRM for COMSECY-05-0028.

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

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

was satisfactory.
Florida Final Report Page 8

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 seven allegations involving radioactive materials, including six 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, transportation, 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 a majority of the cases reviewed and took suitable enforcement and

followup actions.

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 followup and/or enforcement actions.

The review team identified 371 radioactive material incidents in NMED for Florida during the

review period, of which 95 required reporting. 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. In one case, the

licensee failed to notify the State of the incident in a timely manner; however, the State promptly

reported the incident to the NRC upon notification from the licensee.

Monthly reports and followup 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.

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

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

casework for one additional allegation 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.
Florida Final Report Page 9

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 recommended and the MRB agreed

that Florida’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. Florida’s Agreement does not relinquish authority for a Uranium Recovery Program;

therefore, only the first three non-common performance indicators were applicable 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. 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 State’s regulations for control of radiation 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, including naturally-occurring and acceleratorproduced 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 Florida Administrative Code. The State’s administrative

rulemaking process takes approximately 6 months from drafting to finalizing a rule. After the

Bureau drafts a proposed regulation, they must publish a notice of proposed rule development

in the Florida Administrative Weekly, which includes an offer to hold a workshop. After the

workshop, if held, the Bureau publishes another notice in the Florida Administrative Weekly of

proposed rulemaking, including an offer to conduct a public hearing. 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
Florida Final Report Page 10

with the Florida Secretary of State. A rule becomes effective 20 days after filing with the

Secretary of State. The Bureau also has an accelerated rulemaking process for regulations

required for compatibility. Under the accelerated rulemaking process, the Bureau can finalize

effective rules in 45 to 60 days.

The review team noted that the State’s rules and regulations are not subject to “sunset” laws. 

The State may adopt other agency’s regulations by reference and has the authority to issue

legally binding requirements (e.g., license conditions) in lieu of regulations until compatible

regulations become effective.

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

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

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

from the Office of Federal and State Materials and Environmental Management Programs’s

(FSME) State Regulation Status Sheet.

The review team noted that, at the time of the review, there were a number of NRC

amendments that had not been submitted to the NRC for a compatibility review, although final

effective regulations were in place. The Bureau submitted a package of final regulations,

itemized below, to the NRC for a compatibility review on February 14, 2007. A majority of the

regulations addressed in the package became effective on September 28, 2006, which was

after the Agreement State implementation date. The NRC completed its compatibility review

and transmitted the results to the Bureau by letter dated April 23, 2007. The NRC’s

compatibility review resulted in 53 comments, which will need to be addressed by the State in

upcoming rulemaking activities.

During the on-site review, the State submitted to the NRC for a compatibility review a package

of final regulations to satisfy the following NRC amendments:

• “Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiography Operations,” 10 CFR Part 30, 34, 71, and 150 amendments (62 FR 28947)

that became effective on June 27, 1997, and was due for Agreement State adoption by

June 27, 2000.

• “Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiography Operations,” 10 CFR Part 34 amendment (63 FR 37059) that became

effective on July 9, 1998, and was due for Agreement State adoption by July 9, 2001.

• “Transfer for Disposal and Manifests: Minor Technical Conforming Amendment,” 

10 CFR Part 20 amendment (63 FR 50127) that became effective on November 20,

1998, and was due for Agreement State adoption by November 20, 2001.

• “Respiratory Protection and Controls to Restrict Internal Exposure,” 10 CFR Part 20

amendment (64 FR 54543 and 64 FR 55524) that became effective on February 2,

2000, and was due for Agreement State adoption by February 2, 2003.

• “Energy Compensation Sources for Well Logging and Other Regulatory Clarifications,”

10 CFR Part 39 amendment (65 FR 20337) that became effective on May 17, 2000, and

was due for Agreement State adoption by May 17, 2003.
Florida Final Report Page 11

• “New Dosimetry Technology,” 10 CFR Part 34, 36, and 39 amendments (65 FR 63750)

that became effective on January 8, 2001, and was due for Agreement State adoption by

January 8, 2004.

• “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct

Material,” 10 CFR Part 30, 31, and 32 amendments (65 FR 79162) that became effective

on February 16, 2001, and was due for Agreement State adoption by February 16, 2004.

• “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298) that

became effective on April 5, 2002, and was due for Agreement State adoption by April 5,

2005.

• “Financial Assurance for Materials Licensees,” 10 CFR Part 30, 40, and 70 amendments

(68 FR 57327) that became effective on December 3, 2003, and was due for Agreement

State adoption by December 3, 2006.

• "Compatibility with IAEA Transportation Safety Standards and Other Transportation

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

on October 1, 2004, and is due for Agreement State adoption by October 1, 2007.

• "Security Requirements for Portable Gauges Containing Byproduct Material," 10 CFR

Part 30 amendment (70 FR 2001) that became effective on July 11, 2005, and is due for

Agreement State adoption by July 11, 2008.

At the time of the review, the following NRC amendment was overdue for adoption and had not

been addressed:

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

20249) that became effective on October 24, 2002, and was due for Agreement State

adoption by October 24, 2005.

The review team identified the following two NRC amendments that will be needed in the future:

• "Medical Use of Byproduct Materials - Recognition of Specialty Boards," 10 CFR Part 35

amendment (70 FR 16336, 71 FR 1926) that became effective on April 29, 2005, and is

due for Agreement State adoption by April 29, 2008.

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

15005) that became effective March 27, 2006, and is due for Agreement State adoption

by March 27, 2009.

The Bureau did self-identify that a number of regulations were overdue and redirected FTE to

ensure adequate resources were dedicated to rulemaking and associated activities, but not until

late in the review period. Prior to this redirection, the former Radioactive Materials Administrator

split his time between licensing, compliance activities, and rulemaking. This individual now

serves as an assistant to the Bureau Chief, and one of his primary responsibilities is oversight

of rulemaking and associated activities, including preparing and submitting rulemaking

packages to the NRC for compatibility review.
Florida Final Report Page 12

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

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

satisfactory, but needs improvement.

4.2 Sealed Source and Device (SS&D) Evaluation Program

In conducting this review, three sub-indicators were used to evaluate the Bureau’s performance

regarding the SS&D Evaluation Program. These sub-indicators include: (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 Bureau's SS&D evaluation activities, the review team examined information

provided by the Bureau in response to the IMPEP questionnaire on this indicator. A review of

all new, amended, and inactivated SS&D evaluations and supporting documents covering the

review period was conducted. The review team noted the staff’s use of guidance documents

and procedures, interviewed the two administrators involved in SS&D evaluations, and verified

the use of regulations, license conditions, and inspections to enforce commitments made in the

applications.

4.2.1 Technical Staffing and Training

Since the last review, two of the Bureau’s Administrators have conducted SS&D evaluations,

both of which are qualified SS&D reviewers with full signature authority.

The Bureau’s comprehensive training program is discussed in the Common Performance

Indicator, Technical Staffing and Training. The Bureau has a documented qualification program

for SS&D reviewers as a subsection of its overall Licensing Evaluator Qualification Procedures. 

This subsection includes a review of regulations, review of application guides, review of

licensing actions with a manager or qualified individual, and facility site visit or inspection

accompaniment. 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 Administrators, who are the Bureau’s senior SS&D reviewers.

As part of its training procedure, 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 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. The Bureau has granted signature authority to two new reviewers during

the review period. Both new reviewers have several years of experience in health physics and

attended the NRC’s SS&D workshop in 2006. At the time of the on-site review, neither of the

new reviewers had worked on an SS&D review. The Bureau intends to assign the next SS&D

review to one of the new reviewers.
Florida Final Report Page 13

4.2.2 Technical Quality of the Product Evaluation Program

During the review period, the Bureau processed 11 SS&D actions, including four inactivations. 

The casework review included all amendments, supporting documentation, licenses, and

inspections associated with each of the registrations processed by the Bureau since the last

review and represented cases completed by all reviewers. A listing of the SS&D certificates

evaluated by the review team, with case-specific comments, may be found in Appendix F.

Analysis of the casework and interviews with the staff confirmed that the Bureau follows the

recommended guidance from the NRC SS&D training workshops and NUREG-1556, Volume 3,

Revision 1. Appropriate review checklists were used to assure all relevant materials had been

submitted and reviewed. The checklists were retained in the SS&D or licensing files along with

other documents that identified the assigned reviewers; however, several checklists in the files

were not signed. This issue was discussed with the Radioactive Materials Administrator. In this

discussion, the Bureau committed to verifying that the appropriate signatures were on the

checklists. In cases where a checklist was not used, the Bureau included an internal office

memorandum as a note for the file. Pertinent American National Standards Institute standards,

Regulatory Guides, and applicable references were confirmed to be available and were used

when performing SS&D reviews.

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

radiation profiles, and details of the applicant’s quality assurance and quality control program. 

The registrations clearly summarized the product evaluation to provide license reviewers with

adequate information to license the possession and use of the product. Deficiency letters

clearly stated regulatory positions and all health and safety issues were properly addressed. 

The review team found that the evaluations were of high quality with health and safety issues

properly addressed.

The review team noted that the Bureau lists the Florida radioactive materials license number

that authorizes manufacturing and distribution of the device in the SS&D registration certificate

for reference. In addition, the Bureau incorporates the SS&D registry certificate and associated

documents by license condition in the manufacturing and distribution license. Bureau

management stated that incorporating the registry certificate by license condition in the specific

license legally authorizes them to enforce the requirements of the registration certificate.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Utilizing NMED and the Bureau’s response to the questionnaire, the review team examined any

incidents or failures regarding SS&D registered products during the review period. The review

team examined all of the events that occurred in Florida that involved equipment or source

failures within the period, as well as any events that occurred nationally involving sources

registered by Florida. The review team determined that the State analyzed the events,

reviewed the issues, and followed up on the incidents. None of the events involving equipment

or source failures within the period appeared to be generic issues.

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

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

satisfactory.
Florida Final Report Page 14

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 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, Florida’s performance was found satisfactory, but needs

improvement, for the indicator, Compatibility Requirements, and satisfactory for all remaining

performance indicators reviewed. The review team made one recommendation regarding the

performance of the Florida Agreement State Program. Accordingly, the review team

recommended and the MRB agreed that the Florida Agreement State Program was adequate to

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

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

IMPEP review take place in approximately 4 years.

Below is the recommendation, as mentioned earlier in the report, for evaluation and

implementation, as appropriate, by the State.

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)
LIST OF APPENDIXES AND ATTACHMENT

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

Attachment March 30, 2007, Letter from William A. Passetti

Florida’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Dennis Sollenberger, FSME Team Leader

Technical Staffing and Training

Donna Janda, Region I Status of Materials Inspection Program

Inspector Accompaniments

Robert Gallaghar, Massachusetts Technical Quality of Inspections

Inspector Accompaniments

Michelle Beardsley, Region I Technical Quality of Licensing Actions

Aaron McCraw, FSME Technical Quality of Incident and Allegation

 Activities

Compatibility Requirements

Tomas Herrera, FSME Sealed Source and Device (SS&D) Evaluation

 Program
APPENDIX B

FLORIDA ORGANIZATION CHARTS

ADAMS ACCESSION NO.: ML070600149

PAGES 44-46
APPENDIX C

INSPECTION CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Florida State University License No.: 32-10

Inspection Type: Routine, Announced Priority: 2

Inspection Dates: 5/16-20/05 Inspectors: PP, RL, BR, TT

Comment:

Inspection field notes identified two apparent violations that were not cited in the letter

sent to the licensee, with no justification for not citing the violations documented in the

inspection file.

File No.: 2

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

Inspection Type: Routine, Announced Priority: 1

Inspection Date: 11/29/06 Inspector: JB

File No.: 3

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

Inspection Type: Increased Control, Announced Priority: 1

Inspection Date: 11/29/06 Inspector: JB

File No.: 4

Licensee: Miller School, University of Miami License No.: 1319-3

Inspection Type: Increased Control, Announced Priority: 1

Inspection Dates: 10/23-24/06 Inspector: JS

Comment:

Inspection identified six violations of the Increased Controls License Condition. Notice

of Violation letter was not labeled as sensitive information. Letter contained specific

information regarding the requirements of the Increased Controls and how the licensee

was not meeting those requirements.

File No.: 5

Licensee: Diagnostic Physics Consulting, Inc. License No.: 1440-1

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 11/2/04 Inspector: MT
Florida Final Report Page C.2

Inspection Casework Reviews

File No.: 6

Licensee: Variety Children’s Hospital, Inc. License No.: 0993-1

Inspection Type: Special, Announced Priority: 2

Inspection Date: 6/8/05 Inspector: FN

Comment:

Inspection conducted following report of the loss of licensed material. Inspection file

documents the source was lost on 10/5/04 and reported to State on 6/6/05. Notice of

Violation did not contain a citation for failure to notify, nor a reason for not issuing a

violation.

File No.: 7

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

Inspection Type: Increased Control, Announced Priority: 1

Inspection Date: 12/29/06 Inspector: LB

File No.: 8

Licensee: Mallinckrodt Medical, Inc. License No.: 1937-4

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 2/5/04 Inspector: JG

File No.: 9

Licensee: Florida Cardiac Consultants, Inc. License No.: 3497-1

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 2/5/07 Inspector: MB

Comment:

Apparent violation was not cited, nor did the file reflect the justification for not citing the

violation.

File No.: 10

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

Inspection Type: Reciprocity, Announced Priority: N/A

Inspection Dates: 3/30 - 4/1/05 Inspector: LB

File No.: 11

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

Inspection Type: Routine, Increased Control, Announced Priority: 1

Inspection Dates: 11/6-9, 11/15, 11/21, 11/27/06 Inspectors: LB, MY

Comment:

Notice of Violation letter dated 12/11/06 contained sensitive information. Letter was not

labeled or marked as such.

File No.: 12

Licensee: Mt. Sinai Medical Center of Miami License No.: 64-14

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 5/18/05 Inspectors: FN, LS
Florida Final Report Page C.3

Inspection Casework Reviews

File No.: 13

Licensee: Cardinal Health 414, Inc. License No.: 3453-6

Inspection Type: Routine, Unannounced Priority: 1

Inspection Dates: 11/4/04, 11/8/04 Inspector: PP

File No.: 14

Licensee: Amglo Kemlite Laboratories, Inc. License No.: 3010-1

Inspection Type: Reciprocity Priority: 1

Inspection Date: 10/12/06 Inspector: TF

File No.: 15

Licensee: Perma-Fix of Florida, Inc. License No.: 2598-1

Inspection Type: Routine, Announced Priority: 0.5

Inspection Date: 2/7/07 Inspector: PP

File No.: 16

Licensee: Lockheed Martin Corporation License No.: 3137-1

Inspection Type: Routine, Announced Priority: 1

Inspection Date: 8/6/06 Inspector: PP

File No.: 17

Licensee: Digirad Imaging Solutions, Inc. License No.: 3176-8

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 12/15/06 Inspector: RK

File No.: 18

Licensee: Halifax Hospital Medical Center License No.: 0194-3

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 1/24/07 Inspector: MY

File No.: 19

Licensee: Iridium Holdings, Inc. License No.: 2936-1

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 1/23/07 Inspector: RD

File No.: 20

Licensee: Southport Cardiology Associates, P.A. License No.: 3158-1

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 1/22/07 Inspector: KT

INSPECTOR ACCOMPANIMENTS

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

Accompaniment No.: 1

Licensee: Southport Cardiology Associates, P.A. License No.: 3158-1

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 1/22/07 Inspector: KT
Florida Final Report Page C.4

Inspection Casework Reviews

Accompaniment No.: 2

Licensee: Iridium Holdings, Inc. License No.: 2936-1

Inspection Type: Routine, Announced Priority: 1

Inspection Date: 1/23/07 Inspector: RD

Accompaniment No.: 3

Licensee: Halifax Hospital Medical Center License No.: 194-3

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 1/24/07 Inspector: MY

Accompaniment No.: 4

Licensee: Florida Medical Clinic License No.: 2534-3

Inspection Type: Initial, Announced Priority: 2

Inspection Date: 1/25/07 Inspector: SR

Accompaniment No.: 5

Licensee: Florida Cardiac Consultants, Inc. License No.: 3497-1

Inspection Type: Routine, Announced Priority: 3

Inspection Date: 2/5/07 Inspector: MB

Comments:

a) Radiation Safety Officer was not contacted during inspection.

b) Inspector failed to observe a potential security violation (refer to Section 3.3).

Accompaniment No.: 6

Licensee: Charlotte Cardiovascular Institute, Inc. License No.: 3854-1

Inspection Type: Initial, Announced Priority: 2

Inspection Date: 2/6/07 Inspector: GH

Accompaniment No.: 7

Licensee: Langan Engineering & Environmental Services, Inc. License No.: 1414-1

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 2/7/07 Inspector: JS

Accompaniment No.: 8

Licensee: Dadeland Nuclear Imaging, d/b/a B&R Diagnostics, Inc. License No.: 3159-1

Inspection Type: Routine, Announced Priority: 2

Inspection Date: 2/8/07 Inspector: EK

Accompaniment No.: 9

Licensee: Lanzo Construction Co. License No.: 3496-1

Inspection Type: Routine, Announced Priority: 3

Inspection Date: 2/9/07 Inspector: DS
APPENDIX D

LICENSE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: TYCO Healthcare License No.: 3007-1

Type of Action: Renewal Amendment No.: 13

Date Issued: 9/15/05 License Reviewer: WK

Comment:

Outgoing license and letter not marked as sensitive information.

File No.: 2

Licensee: EI DuPont License No.: 3868-1

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

Date Issued: 11/14/06 License Reviewer: TT

File No.: 3

Licensee: Southern Baptist Hospital of Florida License No.: 155-4

Type of Action: Renewal Amendment No.: 35

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

File No.: 4

Licensee: Food Technology Svcs. License No.: 2244-1

Type of Action: Amendment Amendment No.: 41

Date Issued: 11/1/06 License Reviewer: LS

Comment:

Outgoing license and letter not marked as sensitive information.

File No.: 5

Licensee: Professional Engineering & Inspection Co. License No.: 2940-1

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

Date Issued: Pending License Reviewer: JK

Comment:

Change in control issue - referred to legal counsel.

File No.: 6

Licensee: Perma-Fix of Florida License No.: 2598-1

Type of Action: Renewal Amendment No.: 29

Date Issued: 7/29/05 License Reviewer: JS
Florida Final Report Page D.2

License Casework Reviews

File No.: 7

Licensee: Adventist Health License No.: 2897-1

Type of Action: Amendment Amendment No.: 39

Date Issued: 11/17/06 License Reviewer: TT

Comments:

a) Therapeutic materials licensed in “as necessary” amounts.

b) Outgoing license and letter not marked as sensitive information.

File No.: 8

Licensee: Renegade Testing & Inspection License No.: 3891-1

Type of Action: New Amendment No.: 0

Date Issued: 12/29/06 License Reviewer: JS

Comment:

Outgoing license and letter not marked as sensitive information.

File No.: 9

Licensee: Youngquist Bros., Inc. License No.: 3348-1

Type of Action: Renewal Amendment No.: 5

Date Issued: 11/6/06 License Reviewer: LT

File No.: 10

Licensee: University of Florida License No.: 356-1

Type of Action: Renewal Amendment No.: 87

Date Issued: 3/24/05 License Reviewer: JS

Comment:

Outgoing license and letter not marked as sensitive information.

File No.: 11

Licensee: Technical Products Group, Inc. License No.: 3447-1

Type of Action: New Amendment No.: 0

Date Issued: 2/14/03 License Reviewer: PV

File No.: 12

Licensee: Mallinckrodt, Inc. License No.: 1937-4

Type of Action: Renewal Amendment No.: 18

Date Issued: 4/13/05 License Reviewer: JS

File No.: 13

Licensee: Mt. Sinai Medical Centers License No.: 64-14

Type of Action: Termination Amendment No.: 8

Date Issued: 2/9/06 License Reviewer: JS
Florida Final Report Page D.3

License Casework Reviews

File No.: 14

Licensee: Memorial Health Systems License No.: 3154-1

Type of Action: Termination Amendment No.: 3

Date Issued: 7/20/04 License Reviewer: JS

File No.: 15

Licensee: Florida State University License No.: 32-10

Type of Action: Renewal Amendment No.: 64

Date Issued: 1/11/06 License Reviewer: TT

Comments:

a) Outgoing license and letter not marked as sensitive information.

b) License Conditions 25 and 26 reference superceded NRC Regulatory Guides.

File No.: 16

Licensee: JANX Integrity Group License No.: NRC 21-16560-01

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

Date Issued: 1/23/07 License Reviewer: JS

File No.: 17

Licensee: HDR Construction Control Group License No.: 2763-1

Type of Action: Renewal Amendment No.: 11

Date Issued: 9/22/06 License Reviewer: LT

File No.: 18

Licensee: South Broward Hospital District License No.: 2573-1

Type of Action: Renewal Amendment No.: 6

Date Issued: 10/6/05 License Reviewer: JS

Comment:

Outgoing license and letter not marked as sensitive information.

File No.: 19

Licensee: Cardinal Health 414, Inc. License No.: 3010-1

Type of Action: Amendment Amendment No.: 14

Date Issued: 8/9/06 License Reviewer: LT

File No.: 20

Licensee: Perma-Fix License No.: 2598-1

Type of Action: Amendment Amendment No.: 31

Date Issued: 3/15/06 License Reviewer: JS
APPENDIX E

INCIDENT CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Florida Medical Center License No.: FL-2816-1

Date of Incident: 10/14/03 Incident Log No.: FL03-192; NMED 030847

Investigation Date: 10/21/03 Type of Incident: Lost/Stolen RAM

Type of Investigation: Site

File No.: 2

Licensee: Certified Testing Laborartories License No.: FL-2332-1

Date of Incident: 6/30/04 Incident Log No.: FL04-094; NMED 040492

Investigation Date: 6/30/04 Type of Incident: Equipment Failure

Type of Investigation: Site

File No.: 3

Licensee: Diagnostic Products Corp. License No.: CA-2493-19

Date of Incident: 12/17/04 Incident Log No.: FL05-009; NMED 050041

Investigation Date: N/A Type of Incident: Transportation

Type of Investigation: N/A

File No.: 4

Licensee: University of Florida Shands Hospital License No.: FL-0013-3

Date of Incident: 5/25/05 Incident Log No.: FL05-086; NMED 050392

Investigation Date: 6/1/05 Type of Incident: Medical

Type of Investigation: Licensee Report

Comment:

Event not closed in Nuclear Material Events Database (NMED) although State is no

longer investigating this incident.

File No.: 5

Licensee: Variety Children’s Hospital License No.: FL-993-1

Date of Incident: 6/5/05 Incident Log No.: FL05-088; NMED 050391

Investigation Date: 6/8/05 Type of Incident: Lost/Stolen RAM

Type of Investigation: Site

Comments:

a) Documentation of closure not contained in State’s file although no investigation ensues. 

Event is closed in NMED.

b) NMED record is not complete, pending a request for additional information from the

NMED contractor. State responded via e-mail, but NMED record has not been updated.
Florida Final Report Page E.2

Incident Casework Reviews

File No.: 6

Licensee: Atlantic Geotechnical Services, Inc. License No.: FL-2725-1

Date of Incident: 10/29/05 Incident Log No.: FL05-154; NMED 050725

Investigation Date: 11/1/05 Type of Incident: Lost/Stolen RAM

Type of Investigation: Site

Comment:

Device was recovered; however, closure memorandum in file indicated that device was

not recovered.

File No.: 7

Licensee: Unison Industries, Inc. License No.: FL-1594-2

Date of Incident: 1/30/06 Incident Log No.: FL06-018; NMED 060091

Investigation Date: 1/30/06 Type of Incident: Release of RAM

Type of Investigation: Site

File No.: 8

Licensee: 21st Century Oncology License No.: FL-2667-1

Date of Incident: 4/3/06 Incident Log No.: FL06-062; NMED 060317

Investigation Date: 6/22/06 Type of Incident: Medical

Type of Investigation: Site

File No.: 9

Licensee: Florida Hospital Ormond Beach License No.: FL-2897-1

Date of Incident: 7/21/06 Incident Log No.: FL06-098; NMED 060469

Investigation Date: 8/2/06 Type of Incident: Medical

Type of Investigation: Site

File No.: 10

Licensee: BTL Engineering License No.: FL-1315-1

Date of Incident: 12/4/06 Incident Log No.: FL06-152; NMED 060740

Investigation Date: 12/4/06 Type of Incident: Transportation

Type of Investigation: Licensee Report

File No.: 11

Licensee: HDR Construction Control Corp. License No.: FL-2763-1

Date of Incident: 1/1/07 Incident Log No.: FL07-001; NMED 070008

Investigation Date: 1/2/07 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

ONLY.

File No.: 1

Registry No.: FL-1146-S-102-S SS&D Type: (V) General Medical Use

Applicant Name: IsoAid, LLC Type of Action: New Registration

Date Issued: 4/23/04 SS&D Reviewers: PV, MS

Comment:

In the device description, the dimensions of the silver rod inside the titanium tube were

inverted. The Bureau issued a corrected page during the IMPEP review.

File No.: 2

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: 1/28/04 SS&D Reviewers: PV, MS

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: 4/30/04 SS&D Reviewers: PV, MS

File No.: 4

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: 3/2/06 SS&D Reviewers: PV, MS

File No.: 5

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: 3/4/06 SS&D Reviewers: PV, MS

File No.: 6

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

Static Eliminators

Applicant Name: Litton Systems Inc. Type of Action: Amendment

Date Issued: 12/5/03 SS&D Reviewers: PV, MS

File No.: 7

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

Static Eliminators

Applicant Name: Litton Systems Inc. Type of Action: Amendment

Date Issued: 11/24/04 SS&D Reviewers: PV, MS
Florida Final Report Page F.2

Sealed Source and Device Casework Reviews

File No.: 8

Registry No.: FL-8136-D-801-G SS&D Type: (D) Gamma Gauges

Applicant Name: Barry-Wehmiller Electronics Type of Action: Inactivation

Date Issued: 7/31/03 SS&D Reviewers: PV, MS

Comment:

The licensee did not request an inactivation; however, their manufacturing and

distribution license was terminated in 1995. The State inactivated the certificate in July

2003; however, since the licensee was no longer active, the State was not able to

determine how many devices were distributed nor confirm that the device had not been

modified.

File No.: 9

Registry No.: FL-8137-D-803-B SS&D Type: (D) Gamma Gauges

Applicant Name: Stock Equipment Co. Type of Action: Inactivation

Date Issued: 7/31/03 SS&D Reviewers: PV, MS

Comment:

The licensee did not request an inactivation; however, their manufacturing and

distribution license was inactivated in 1973. The State inactivated the certificate in July

2003; however, since the licensee was no longer active, the State was not able to

determine how many devices were distributed nor confirm that the device had not been

modified.

File No.: 10

Registry No.: FL-8137-S-804-S SS&D Type: (D) Gamma Gauges

Applicant Name: Stock Equipment Co. Type of Action: Inactivation

Date Issued: 7/31/03 SS&D Reviewers: PV, MS

Comment:

The licensee did not request an inactivation; however, their manufacturing and

distribution license was inactivated in 1973. The State inactivated the certificate in July

2003; however, since the licensee was no longer active, the State was not able to

determine how many devices were distributed nor confirm that the device had not been

modified.

File No.: 11

Registry No.: FL-8137-D-805-S SS&D Type: (D) Gamma Gauges

Applicant Name: Stock Equipment Co. Type of Action: Inactivation

Date Issued: 7/31/03 SS&D Reviewers: PV, MS

Comment:

The licensee did not request an inactivation; however, their manufacturing and

distribution license was inactivated in 1973. The State inactivated the certificate in July

2003; however, since the licensee was no longer active, the State was not able to

determine how many devices were distributed nor confirm that the device had not been

modified.
ATTACHMENT

March 30, 2007, Letter from William A. Passetti

Florida’s Response to Draft IMPEP Report

ADAMS: ML071060096