ML20206Q999

Proposed Final Rept, Integrated Materials Performance Evaluation Program Review of Florida Agreement State Program, 990222-26

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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF FLORIDA AGREEMENT STATE PRCGRAM j February 22 - 26,1999 l

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I PROPOSED FINAL REPORT U.S. Nuclear Regulatory Commission 1

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Florida Proposed Final Report Page1

1.0 INTRODUCTION

This report presents the results of the review of the Florida radiation control program. The review was conducted during the period February 22-26,1999 by a. review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of New York. Review team members are identified in Appendix A. The review was conducted in accordance with the " Implementation of the Integrated Materials Performance Evaluation Program and Rescission of a Final General Statemen'. of Policy," published in the Federal Reaister on October 16,1997, and the November 25,1998, revised NRC Management Directive 5.6," Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period March 4,1995 to February 21,1999, were discussed with Florida management on February 26,1999 (A paragraph on the results of the Management Review Board (MRB) meeting will be included here in the final report.}

The Florida Agreement State program is administered by the Bureau of Radiation Control (BRC) located in the Department of Health (DOH). The BRC consists of five sections managed by a Chief. Three sections within BRC have responsibilities for radioactive materials under the Agreement, which includes inspectors in six field offices and two counties under contract. The Administrators of the Field Operations Section, Environmental Radiation Labs Section and Radioactive Materials Section report to the Chief, BRC. Organization charts for the BRC and DOH are included as Appendix B. The Florida program regulates approximately 1,169 specific licenses authorizing agreement materials. The review focused on the materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended)

Agreement between the NRC and the State of Florida.

In preparation for the review, a questionnaire addressing the common and non-common performance indicators was sent to the State on November 13,1998. The State provided a response to the questionnaire on January 21,1999. A copy of the questionnaire is included in Appendix F of this report.

The review team's general approach for conduct of this review consisted of: (1) examination of Florida's response to the questionnaire; (2) review of applicable Florida statutes and regulations; (3) analysis of quantitative information from the BRC licensing and inspection i database; (4) technical review of selected licensing and inspection actions; (5) field 1 accompaniments of six Florida inspectors; and (6) interviews with staff and management to ]

answer questions or clarify issues. The review team evaluated the information that it gathered against the IMPEP criteria for each common and applicable non-common performance indicator and made a preliminary assessment of the BRC's performance.

Section 2 below discusses the State's actions in response to recommendations made following the previous review, Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-corr non performance indicators, and Section 5 summarizes the review team's findings and recommendatie :s. Recommendations made by the review team are comments that relate directly to program performance by the State. A response is requested from the State to all recommendatims in the final report.

Florida Proposed Final Report Page 2 2.0 - STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS The previous review of the Florida radiation control program concluded on March 3,1995.

The review consisted of an evaluation of 30 program indicators per the 1992 Policy Statement.

During the last review, two recommendations were made in the May 18,1995 letter to Dr. Richard Hu.1ter, Deputy State Health Officer, Department of Health and Rehabilitative Services. Both items were discussed in the NRC's February 14,1996 letter to Florida based on the State's June 28,1995 response ietter. The team's review of the current status of the open recommendations is as follows:-

1. We recommend that the pre-license inspection reports and the routine inspection reports include documentation on the method (s) used for verifying that rooms in licensee facilities are under negative pressure (when required), and the results of any measurements performed by the inspector.

Current Status: The State's pre-licensing and routine inspection reports now include the means to document methods used for verifying that rooms in licensee facilities are under negative pressure and the results of any measurements performed by the inspector. The review team noted during this review that inspectors were documenting independent measurements in the inspection reports. This recommendation is closed.

2. We recommend that a confirmatory survey be performed on the OTPO Mechanik, Inc.

facility in Melboume, Florida to determine if the former licensed facility can be released for unrestricted use.

Current Status: The OTPO Mechanik, Inc. facility requested termination of their license in November 1995 which included a closeout survey of the facility. The State performed a confirmatory survey in December 1995 at the facility. Based on the information provided by the licensee and the State's confirmatory survey, the license was terminated on January 17,1996 and the facility released for unrestricted use. This recommendation is closed.

3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.

3.1 Status of Materials insoection Proaram The team focused on four factors in reviewing the status of the materials inspection program:

inspection frequency, overdue inspections, initial inspection of new licensees, and the timely dispatch of inspection findings to licensees. The evaluation is based on the Florida questionnaire responses relative to this indicator, data gathered from reports generated from the licensee databases, examination of inspection reports, and interviews with BRC sta'f.

Evaluation of Florida's inspection priorities for the materials program indicated that the maximum period for an inspection interval is four years, and 25 of the 41 licensee categories

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Florida Proposed Final Report Page 3

- established by the State have a higher inspection frequency than similar type categories listed

' in NRC Inspection Manual Chapter (IMC) 2800. None of the State categories had a lower frequency of inspection. It was noted that the State uses discretion to increase inspection  !

frequency (decrease inspection interval) based on licensee history and performance, but did not  ;

decrease inspection frequency for good performance. l The BRC currently uses a dBase IV software application for tracking inspection frequency, but .

will be converting to a latter generation database application in the near future. Currently, most ,

staff have access to the database information, but updates to, and reports from the database l are generated by the Radioactive Materials Section. Therefore, the Radioactive Materials l l Section at the Tallahassee office generates, on a quarterly basis, the schedule for the l l inspection groups in the field offices. A monthly status report to the Field Operations Administrator in Tallahassee reflects a statistical update of inspections performed and those due for the quarter, and emphasizes any past due by field office and licensee name.

Inspectors in the six state and two county field offices perform inspections according to the I

quarterly scheduling report generated by the Tallahassee office. A policy exists for establishing I the date for the next scheduled inspection based on the date of the last inspection and the l inspection priority. BRC considers the inspection timely if it is performed by the end of the

. calendar quarter in which the due date falls (regardless of the priority interval). Since the inspection frequencies for routine inspections are more frequent or as frequent as those required by the NRC, the scheduling of inspections does not fall outside of NRC requirements.

In their res'ponse to the questionnaire, the State indicated that they had no inspections overdue r

by more than 25% of the NRC frequency. During the review, the team verified that there were  !

no inspections that were overdue by this criteria.

With respect to initial inspections, BRC assigns the inspection due date six months from the issuance of a new license. Since inspectors are given until the end of the calendar quarter to perform the inspection due in that quarter, this has resulted in several initial inspections being conducted outside of the six month period required by IMC 2800. Of the 30 initialinspections reviewed, nine were completed within six months,20 were inspected between seven and nine months, and one was within 10 months. However, the existing scheduling system maintained by BRC appears to be very efficient in tracking and scheduling initial inspections. The team considered this data and noted that the State has an established policy of performing pre- l licensing visits by licensing staff and/or inspectors. This mechanism for inspecting and l _' evaluating the initial use of radioactive material by a licensee more than adequately addresses the public health and safety concems.

With respect to reciprocity, BRC issues a general license to all out-of-State licensees that l desire to operate within Florida. Holders of out-of-State licenses are required to provide three days notification of any planned use of radioactive material at a temporary job site in Florida.

The review team noted that the inspection of Priority 1 and 2 licensees granted reciprocity during the review period fell short of the goals indicated in IMC 1220. However, inspection of teletherapy, high dose afterloaders (HDR) and irradiator source services, and Priority 3 reciprocity licensees, met the IMC 1220 goal in 1998.

The BRC identified that this inspection shortfall resulted from these licensees (i.e.,

radiographers) entering the State to conduct licensed activities for a short time, usually 1 or 2 1

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Florida Proposed Final Report Page 4 i

days. Field sites were sometimes located in remote areas of the State, making inspection of these licensees difficult. The review team noted, though, that in mid-1998, management placed emphasis on the urgency of performing reciprocity inspections, ranking them just below incident response in importance, and began tracking these inspections separately from the routine inspection to place more importance on their completion. The review team recommends that

- BRC continue their efforts to complete inspections of high priority reciprocity licensees in accordance with IMC 1220.

Timeliness of inspection correspondence issuance was evaluated during the inspection casework review. Of 53 inspection letters reviewed by the team, 31 were issued to the licensee within 30 days,20 were issued between 31 and 35 days, one at 49 days, and one at 59 days.

The 49 day report was delayed because of communications with the licensee between the inspection and the final report, and the 59 day report was considered an outlier because of a difficulty created by a mis-transfer of field notes. The review team considered the issuing of  !

Inspection correspondence timely, noting that BRC conducts approximately 500 inspections l annually, and the Tallahassee office coordinates inspection correspondence from eight field i offices that serves to ensure consistency for compliance of licensed activities across the State.

Based on the IMPEP evaluation criteria, the review team recommends that Florida's performance with respect to the indicator, Status of Materials Inspections, be found satisfactory.

3.2 Technical Quality of Inspections '

The team evaluated the inspection reports, enforcement documentation, and interviewed inspectors for 24 radioactive material inspections conducted during the review period. The casework included at least one inspector from each of the eight field offices and covered inspections of various types including: medical institutions, industrial radiography, nuclear pharmacy, irradiator, academic broad scope, medical broad scope, waste processing, transportation, mobile nuclear medicine, HDR and reciprocity. Appendix C lists the inspection casework reviewed for completeness and adequacy with case-specific comments.

Currently there are 24 radioactive material inspectors operating out of six state field offices and two county offices. All inspectors are trained to perform x-ray and radioactive materials inspections, and respond to radioactive materials incidents and incidents at nuclear power facilities.

Florida's inspection procedures are consistent with NRC procedures.'The BRC tries to conduct inspections unannounced, but a majority of the time, inspections are announced a few days before the inspection. The review team noted that, of the 24 inspections evaluated,11 were unannounced. According to the BRC annual report,32% of the inspections were unannounced during 1998.

Based on casework, the review team noted that the routine inspections covered all aspects of the licensees' radiation programs. Team inspections were performed when appropriate and for training purposes.

Florida Proposed Final Report Page 5

- The inspectors fill out a report of two or more pages. The first page is the contact form and contains licensee data, persons contacted, type of inspection, time spent for the inspection, inspector's and supervisor's signature, and other administrative information. The second and subsequent pages of the inspection report are summary sheets denodng violations of

, regulations or license conditions, documentation to support the violations, recommendations made to the licensee, unresolved or licensing issues, and exit interview discussions and comments. This report, along with the inspection field notes, is sent to the Tallahassee Radioactive Materials Section within 15 days of the inspection.

The inspection report and field notes are reviewed and signed by the field office manager.

Once received in Tallahassee, the inspection coordinator reviews the inspection findings and prepares appropriate correspondence to the licensee. The inspection coordinator contacts the inspector or office manager for clarification of the inspection findings if necessary. The Radioactive Materials Administrator reviews and concurs on all inspection correspondence.

Subsequent correspondence between the licensee and the BRC is conducted with the Tallahassee office. '

Inspection findings, including escalated enforcement actions, are routinely sent to the licensee l around thirty days with licensee responses returned in a timely manner. Boilerplate language is used to generate compliance letters and violations to ensure consistency. Responses are reviewed and replied to in a timely manner. The inspection files were generally found to be complete and in good order. The review team noted that in two cases, the inspection documentation maintained in Tallahassee did not include field notes or the inspection report. '

In one case, the inspection report was prepared by the field office but was not sent to the

- Tallahassee office along with the contact form and in the second case, no field notes were prepared by the field office. As noted in the previous section, this mis transfer affected the timely preparation of inspection correspondence to the licensee. The review team recommends that the field offices transmit field notes to the Tallahassee office to facilitate the preparation of timely correspondence to the licensee.

Field notes have been developed to cover most types of inspections that are conducted by the BRC. These field notes provide documentation for the scope of the licensees' program and cover all areas that need to be reviewed. The information contained in the field notes is comparable with NRC's inspection Procedure 87100.

The review team noted during the review of casework that the Jacksonville and Polk County offices developed their own field notes for the inspection of a waste processor and a panoramic irradiator, respectively. Other field offices are using existing field notes customized by each inspector for panoramic irradiators. BRC's inspection procedure manual does not include field notes for these types of licenses due to the small number of licensees in the State. The review team recommends that BRC incorporate the field notes for the inspection of waste processing and panoramic irradiator licensees in their inspection procedures manual.

Inspection accompaniments are most frequently performed by the field office manager. Senior inspectors also accompany less experienced inspectors, particularly for training purposes. In addition, the review team noted that the Field Operations Administrator will accompany field

. office managers. Field office managers are required to perform a minimum number of x ray and material inspections each year to maintain proficiency. The review team noted that inspectors are accompanied at least once a year.

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Florida Proposed Final Report Page 6 The Field Operations Administrator visits a field office each quarter on a rotating basis to attend a quarterly staff meeting and if necessary perform an annual office audit. Otherwise, the field office manager performs this annual field office audit.

The BRC has an adequate supply _of survey instruments to support the current inspection program. Appropriate, calibrated survey instrumentation such as GM meters, scintillation detectors, ion chambers, and micro-R meters were observed to be available in the Field Offices and in the Orlando Environmental Laboratory. The Environmental Laboratory provides support to the program through radiological analyses of environmental samples and samples taken by inspectors during inspection activities, and environmental dosimetry around nuclear facilities.

The laboratory also has a calibration facility that provides low and high range calibration of portable instrumentation used by local governments during emergency exercises, and portable instrumentation utilized by the BRC inspectors. Instrument repair and calibration are also available from the instrument manufacturers as needed. Instrumentation and a mobile laboratory are also available for responding to incidents as needed. The program has the capability for analyzing all types of environmental media, and evaluation of all types of radiation.

During the weeks of February 1 and 15,1999, a review team member performed six accompaniments with inspectors from each of the State's field offices. The inspections included a private nuclear cardiology facility, two radiopharmacies, a private brachytherapy facility with an HDR unit, and two institutional nuclear medicine facilities. These accompaniments are also identified in Appendix C. During the accompaniments, the Florida inspectors demonstrated appropriate inspection techniques and knowledge of the regulations.

The inspectors were well prepared and thorough in their_ reviews of the licensees' radiation safety programs. Overall, the technical performance of the inspectors was excellent, and their inspections were adequate to assess radiological health and safety at the licensed facilities.

. Based on the IMPEP evaluation criteria, the review team recommends that Florida's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

3.3 Technical Staffino and Trainina issues associated with this indicator include the radioactive material program 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 State's questionnaire responses related to this indicator, conducted interviews with BRC management and staff, and reviewed workload for backlog.

The BRC staffing level was stable over the review period. There are currently 54 people with various degrees of involvement with the Florida radioactive materials program, equivalent to about 20 FTEs to the Agreement program. This staffing level does not include clerical support staff. Of the 15 people in the Tallahassee central office,10 individuals are involved with licensing full time, with the remaining five persons in management and support contributing about 30% of their time to the materials program. The remaining 39 persons are distributed among six field offices throughout the State. The inspectors spend about 18% of their time performing materials inspections, with the balance of time dedicated to x-ray equipment inspections. During the review period, three people left the Tallahassee office and two new people were hired. For the field offices,13 positions were vacated and 10 of those positions

Florida Proposed Final Report Page 7 were filled during the review period. Currently, three field office positions are vacant, and there is no intent to fill them in the immediate future, justified by the decreased frequency of required x-ray equipment inspections.

The BRC also has contracts with Polk and Broward Florida counties to perform material and x-ray inspections. Three inspectors are employed by the two counties. The counties are paid for each inspection they perform and receive a portion of the annual fee for each licensee in the county. Although the BRC does not direct administrative control over these inspectors, they receive the same training and are required to follow the same inspection and incidence response guidance as the State field offices.

Due to the relatively low turnover rate for a program this size, the staff consists of experienced personnel, with newer personnel mostly in the inspection area. Among the materials program staff, there are three with associate degrees, with the remainder having bachelor degrees or higher, with several people with multiple degrees. A recent re-designation of the health physicist positions to environmental specialist positions re-evaluated staf' qualifications because the new positions require a bachelor degree or equivalent; the .ncumbents with associate degrees and experience were found to be bachelor degree equivalent.

Based on the lack of backlogs and the quality of the licensing actions and inspection reports, the team concluded that the number and distribution of staff appear to be adequate to maintain the program.

Training for licensing and inspection staff is similar to recommendations developed by the NRC

- Organization of Agreement State Joint Working Group. Because a majority of staff has been with the BRC for a number of years beyond the review period, training records reviewed showed extensive accumulation of both NRC and BRC training courses. New personnel receive a combination of training modalities as they become available. For instance, general health physics training is provided through home study courses, in-house training material, computer-based training, university-based training (Universities of Florida and North Carolina),

licensee and vendor-based training (i.e., cancer institutes, Syncor, Troxler), and professional meetings. BRC also uses NRC courses, depending on availability of courses and training funds.

Before performing an inspection independently, inspectors visit licensees' sites to observe inspections and become a lead inspector with an accompanying senior inspector or supervisor.

Since each field office inspection team has a manager and a senior inspector, lead !nspectors are accompanied frequently, often several times in one year, on various categories of licensees.

A good practice noted by the review team consisted of a basic health physics training module that was assembled and presented by the BRC staff. Because of the large and diversified staffing of the Florida program, BRC selected several staff members to submit topics in health I

physics for a five-day training program for BRC staff. Preparation consisted of video recording the instructor practice sessions, for self-critique and improvement on the course presentation.

Based on the IMPEP evaluation criteria, the team recommends that Florida's performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

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Florida Proposed Final Report Page 8 l 3.4 Technical Quality of Licensina Actions The review team examined completed licenses and casework for 25 licensing actions, i representing the work of eight license reviewers. The license reviewers and Radioactive Materials Administrator were interviewed to supply additional information regarding licensing decisions or file contents.

Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and of its conditions and tie-down conditions, and overall technical quality Casework was evaluated for adherence to good health

! physics practices, reference to appropriate regulations, supporting documents, peer or supervisory review, and proper signature authorities. The files were checked for retention of necessary documents and supporting data.

The licensing actions reviewed included the following types of licenses: academic, medical and research and development (both broad scope and specific), industrial radiography, radiopharmacy, commercial service, large irradiator; self-shielded irradiator; portable and fixed gauges; and HDR/ teletherapy. Licensing actions included three new licenses, twelve amendments, seven renewals, and three terminations. A list of these licenses with case-specific comments may be found in Appendix D.

All licensing actions are logged into a computer tracking system, assigned a control number, and reviewed by the Radioactive Materials Administrator who assigns each action. Monthly tracking reports are generated and reviewed. After an initial review, each licensing action, including the cover letter, is printed in draft, and then reviewed by a second, qualified reviewer or manager, and then by the Radioactive Materials Administrator. Reviews are documented (initialed) on the draft and sent to the Administrative Assistant. The Administrative Assistant confirms the proper review, prints the final for signature, and mails the license to the licensee.

Each manager and the Radioactive Materials Administrator keeps documentation of the reviews. Boilerplate licenses as well as standard conditions for each type of amendment are used to generate all licenses and amendments thus ensuring a standard license / amendment.

For all renewals, program staff verify corporate status via internet connection to the Florida Department of Corporations. Alllicense reviewers have signature authority.

- The review team found that the licensing actions were thorough, complete, consistent, and of high quality, with health and safety issues properly addressed. Tie-down conditions are backed by information contained in the file, and are inspectable. Deficiency letters clearly state regulatory positions, are used at the proper time, and identify deficiencies in the licensees' documents. Terminated licensing actions are well-documented, showing appropriate transfer and survey records. License files are complete and well organized. The program uses a

' combination of NRC and State regulatory guides. In addition, a number of additional guidance documents are used. Checklists for each category of license are used and kept with the license file. These documents are complete, well organized, available to reviewers, and appear to be followed.

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Florida Proposed Final Report Page 9 Except for new licenses that only involve a change in ownership, pre-licensing inspections are conducted for all new applicants. These inspections are conducted normally within five days after the applicant is prepared to receive material or when the licensing action is complete.

After the pre-licensing visit, the license is normally issued within a few days after the receipt of the contact form in the Tallahassee office from the inspector. If there are unresolved issues, i the licensing section will address them with the applicant and reschedule the pre-licensing visit. j i

The program processed 5381 licensing actions during the review period. These consisted of 436 terminations,482 new license applications,571 renewals, and 3,892 amendments. Based on the files reviewed, actions were completed in a timely manner and complete. The review team noted that three license renewals and one termination that have been pending for extended periods without a written response by the program. This matter was discussed with BRC management to ensure that these actions are given higher priority to ensure timely completion.

Based on the IMPEP evaluation criteria, the review team recommends that Florida's performance with respect to the indicator, Technical Quality of Licensing, be found satisfactory.

3.5 Resoonse to incidents and Alleaations '

in evaluating the effectiveness of the State's actions in responding to incidents, the review team examined the State's response to the questionnaire regarding this indicator, evaluated selected j incidents reported for Florida in the " Nuclear Material Events Database" (NMED) against those i contained in the Florida files, and evaluated the casework and supporting documentation for 12 1 material incidents. A list of incident casework examined, along with case specific comments, is )

contained in Appendix E. The team also evaluated the State's response to 10 materials j allegations, five of which were referred to the State by NRC during the review period.

The review team discussed the State's incident and allegation process, file documentation, the State's equivalent to the Freedom of Information Act, NMED, and notification of incidents to the NRC Operations Center with BRC management and staff in Tallahassee and personnel in the Emergency Response Group under the Environmental Radiation Labs Section in Orlando.

When notification of an incident or an allegation is received, the Emergency Response Group l Manager and staff at the Orlando office discuss the initial response and the need for an on site investigation. The safety significance of the incident / allegation is evaluated to determine the  :

type of response that BRC will take and to ensure that the appropriate field office is notified. l After the investigation is completed, the pertinent information is forwarded to the Radioactive  !

Materials Section at the Tallahassee office for close out approval and appropriate follow- I up/ enforcement actions. i The BRC has written guidance (SOP 1) for handling incidents and allegations. Although the State had no specific guidance for reporting to NMED or reference to the " Handbook on  !

Nuclear Event Reporting in the Agreement States" in SOP 1, the staff was familiar with and  !

followed the guidance contained in the Handbook. After a review of the incidents and discussions with staff, the review team found that all reportable materials events were appropriately reported to the NRC Operations Center. Approximately 575 other incidents that also occurred in the review period were voluntarily reported to the NMED system. SOP 1 also contains guidance on the handling of allegations. Although this guidance lacks the level of detail

Florida Proposed Final Report Page 10 that is in NRC Management Directive 8.8, (e.g., the State has no definition specified for the term " allegation") the State dces take prompt and appropriate action in response to the concerns raised.

1 The 12 incidents selected for review, out of the 136 submitted as reportable incidents, included radiation alarm events at waste facilities and steel recyclers, damaged portable gauge equipment, stolen radioactive material, loss of control of radioactive material, misadministrations, and a radiographer overexposure. The review team found that the State's responses to incidents were complete and comprehensive. Initial responses were prompt and well-coordinated. The level of effort was commensurate with the health and safety significance.

inspectors were dispatched for on-site investigations when appropriate and the State took suitable enforcement action. The review team found the documentation of the response and follow-up to incidents consistent and that incidents were followed up at the next inspection or in a timely fashion. The team did note that the documentation of incident close out was not consistent. The majority of the incident close out memoranda did not contain a management signature or date.

During the review period, there were five materials allegations referred to the State by the NRC  !

and numerous other allegations reported directly to the program. The review of the State's allegation files indicates that the State took prompt and appropriate action in response to the {

concerns raised. All of the allegations reviewed were appropriately closed, however the documentation of the closure was inconsistent in the same manner as that for incident close out. The review team also noted that allegations were treated and documented in the same manner as incidents. The team noted that, in accordance with State law, no measures exist to i protect allegation related information except for medical records and social security numbers.

The review team recommends that BRC revise SOP 1 to incorporate the requirements and process for NMED event reporting and allegation handling as provided in the Appendix to OSP Procedure SA-300 " Handbook on Nuclear Event Reporting in the Agreement States" and NRC Management Directive 8.8, " Management of Allegations," respectively, including the required documentation and management approval for closing out incidents and allegations.

Based on the IMPEP evaluation criteria, the review team recommends that Florida's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed Source and Device Evaluation Program; (3) Low Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Florida's agreement does not cover the uranium recovery program, so only the first three non-common performance indicators were applicable to this review.

Florida Proposed Final Report Page 11 4.1 Leaislation and Proaram Elements Reauired for Comoatibility 4.1.1 Leaislation l I

Along with their response to the questionnaire, the State provided the review team with the opportunity to review copies of legislation that effect the radiation control program. The currently effective statutory authority is contained in Chapter 404 of the Florida Statutes. The l statutes were revised in 1997 to designate the Florida Department of Health as the State's  !

radiation control agency. The BRC, Division of Environmental Health, DOH implements the  !

radiation control program. I 4.1.2 Proaram Elements Reauired for Comoatibility l The Florida Control of Radiation Hazard Regulations, Chapter 64E-5, Florida Administrative Code (FAC), applies to all ionizing radiation. Florida requires a license for possession and use of all radioactive materialincluding naturally occurring materials, such as radium, and accelerator-produced radionuclides. Florida also requires registration of all equipment designed to produce x-rays or other ionizing radiation.

The review team examined the State's administrative rulemaking process and found that the process takes three to six months from the development stage to the final filing with the Secretary of State, after which the rules become effective in twenty days. The regulation adoption process is provided in Chapter 1S-1 of the FAC. The public, the NRC, other agencies, and all potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments are considered and incorporated as appropriate before the regulations are finalized, approved, and filed with the Secretary of State. The State can adopt other agency regulations by reference which has been done with respect to transportation regulations adopted by the U.S. Department of Transportation, the NRC, and the U.S. Postal Service regulations that were in effect on May 15,1996. The State also has the authority to issue legally binding requirements (e.g., license conditions) in lieu of regulations until compatible regulations become effective.

The team evaluated Florida's response to the questionnaire and reviewed the status of regulations required to be adopted by the State during the review period. The review team noted that following the Agency's reorganization under the Health Department, the regulations were recodified on July 17,1997 as the Control of Radiation Hazard Regulations (CRHR),

Chapter 64E-5, FAC. Following the recodification, the CRHR regulations were updated on May 18,1998 to be compatible with NRC regulations with the adoption of NRC regulations as follows:

e " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 36026) that became effective August 15,1994.

e " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 CFR Part 20 amendment (60 FR 7900) that became effective March 13,1995.

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• " Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649 and 25983) that became effective March 1,1998. The Agreement States are to promulgate their regulations no later than March 1,1998 so l that NRC and the State would require this national system to be effective at the same I

time.

• " Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment (60 FR 28323) that became effective June 30,1995.

The team identified the following regulation changes and adoptions that are needed, and the State related that the regulations would be addressed in upcoming rulemakings or by adopting alternate legally binding requirements:

e NRC's letter to the State dated November 24,1997 identified two comments from the review of Florida's adoption of the 10 CFR Part 20 requirements. These comments related to: (1) the State's definition of " Occupational dose" [64E-5.101(93)]; and (2) the .

State's use of the term " planned exposure" instead of " planned special exposure" in the Occupational Dose Limits for Adults (64E-5.304(b)(2).

e " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32, and 35 amendments (59 FR 61767 and 65243) that became effective January 1,1995.

• " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.

e " Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective February 27,1997.

• " Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Parts 20 and 35 amendments (62 FR 4120) that became effective May 29,1997, e " Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34, /1, and 150 amendments (62 FR 28948) that became effective June 27,1997.

e " Radiological Criteria for License Termination," 10 CFR Parts 20,30,40, and 70 amendments (62 FR 39057) that became effective August 20,1997.

• " Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea," 10 CFR Part 30 amendment (62 FR 63634) that became effective January 2, 1998.

e " Deliberate Misconduct by Unlicensed Persons," 10 CFR Parts 30,40,61,70, and 150 amendments (63 FR 1890 and 13773) that became effective February 12,1998.

4 Florida Proposed Final Report Page 13 e " License for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations; Clarifying Amendments and Corrections," 10 CFR Part 34 amendment (63 FR 37059) that became effective July 9,1998.

e " Minor Corrections, Clarifying Changes, and a Minor Policy Change," 10 CFR Parts 20, 32,35,36, and 39 amendments (63 FR 393477 and 63 FR 45393) that became effective October 26,1998.

e " Transfer for Disposal and Manifest; Minor Technical Conforming Amendments,"

10 CFR Part 20 amendment (63 FR 50127) that became effective November 20,1998.

The State acknowledged in a letter dated December 23,1997 that the Part 20 equivalent regulations were oversights and that their regulations would be amended. During the review, the State related that the above regulations were being developed as a package and that the adoption process would be initiated diving this calendar year. The State has deferred the medical regulation update until the finJ1 version of 10 CFR Part 35 is published which is expected by June 1999. The team noted that except for the OSP letter concerning minor

- discrepancies on the State's adoption of the 10 CFR Part 20 equivalent regulations and the -

medical regulations due in 1998, that the State has adopted all regulations and elements needed for compatibility. The review team recommends that the State complete adoption of the revisions to Part 20 to correct discrepancies identified in NRC letter dated November 24,1997.

It is noted that Management Directive 5.9, Handbook, Part V, (1)(C)(lll) provides that

. regulations required prior to September 3,1997, should be adopted by the State as expeditiously as possible, but not later than three years after the September 3,1997 effective date of the Commission Policy Statement on Adequacy and Compatibility, i.e., September 3, 2000.

Based on the IMPEP evaluation criteria, the review team recommends that Florida's performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.

4.2 Sealed Source and Device (SS&D) Evaluation Proaram 4.2.1 Technical Quality of the Product Evaluation Proaram During the review period, three Sealed Source and Device (SS&D) certificates were issued by the State. One certificate was for non-Atomic Energy Act (AEA) material and the other two SS&D certificates were reviewed and are identified in Appendix F.

Review of the files and interviews with the staff confirms that Florida follows the recommended guidance from the NRC SS&D training workshops. The registration files contain all correspondence, photographs, engineering drawings, radiation profiles, and results of tests conducted by the applicant. In addition, the SS&D review checklist received at the NRC SS&D workshop is used to help assure all relevant materials are submitted and reviewed. The checklist is contained in the registration file. The State indicated that the guidance in NUREG-1556, V.3, issued September 1997 will be utilized for any future reviews. All pertinent American National Standards Institute (ANSI Standards), Regulatory Guides, and workshop references l

F 1

~

1 l

l Florida Proposed Final Report Page 14

[

I were confirmed to be available and are used when performing SS&D reviews. The Radioactive Materials Administrator related that non AEA reviews are performed in the same procedural manner and using the same references as used for AEA sources and devices.

4.2.2 Technical Staffino and Trainina i

The Radioactive Materials Administrator conducts the SS&D reviews and is in the process of training other staff in the review of sealed sources and devices. The Radioactive Materials '

Administrator and the BRC Chief both have attended the SS&D workshops sponsored by NRC and both individuals have had many years of experience reviewing license applications. The Radioactive Materials Administrator also has advanced degrees in physics and both managers hrs .nany years of experience and training in health physics. Both individuals are considered fu h ;ned for licensing and inspection under the common performance indicator, Technical St. .,ag and Training. The team found that the SS&D reviewers work together closely when conducting a review and discuss issues and concerns they have identified in an application.

The BRC is committed to maintaining a high degree of quality in their SS&D reviews and would, if necessary, send their reviewers for additional training or seek assistance from outside sources.

4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds No incidents related to SS&Ds occurred during the review period, nor were there any defects reported.

Based on the IMPEP evaluation criteria, the review team recommends that Florida's performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

4.3 Low-level Radioactive Waste (LLRW) Discosal Proaram in 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC 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 existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although Florida 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 fac!!!!y, 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.

l i

l l

(

1 Florida Proposed Final Report Page 15 5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found Florida's performance to be satisfactory for all of the indicators. Accordingly, the review team recommends that the MRB find the Florida Agreement State program to be adequate to protect public health and safety and compatible with NRC's program.

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for implementation and evaluation, as appropriate, by the State. Also, the " good practice" noted in the report is identified for consideration by the MRB.

RECOMMENDATIONS:

1. The review team recommends that BRC continue their efforts to complete inspections of high priority reciprocity licensees in accordance with IMC 1220. (Section 3.1)

2. The review team recommends that the field offices transmit field notes to the Tallahassee office to facilitate the preparation of timely correspondence to the licensee.

(Section 3.2)

3. The review team recommends that BRC incorporate the field notes for the inspection of waste processing and panoramic frradiator licensees in their inspection procedures manual. (Section 3.2)

4. The review team recommends that BRC revise SOP 1 to incorporate the requirements and process for NMED event reporting and allegation handling as provided in the Appendix to OSP Procedure SA-300 " Handbook on Nuclear Event Reporting in the Agreement States" and NRC Management Directive 8.8, " Management of Allegations,"

respectively, including the required documentation and management approval for closing out incidents and allegations. (Section 3.5)

5. The review team recommends that the State complete adoption of the revisions to Part 20 to cormet discrepancies identified in NRC letter dated November 24,1997.

(Section 4.1.2; GOOD PRACTICE:

1. A good practice noted by the review team consisted of a basic health physics training module that was assembled and presented by the BRC staff that included the use of video recording the instructor practice sessions, for self-critique and improvement on the course presentation. (Section 3.3)

LIST OF APPENDICES AND ATTACHMENTS 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 G Florida's Questionnaire Response Attachment Florida's Response to Draft IMPEP Report Dated April 6,1999 l

i 1

l l

)

I

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Duncan White, Region i Team Leader Technical Quality of Inspections Joseph DeCicco, NMSS Status of Materials inspection Program Technical Staffing and Training 4 Steven Gavitt, New York State Health Technical Quality of Licensing Actions Thomas O'Brien, OSP Response to Incidents and Allegations Richard Woodruff, Region II Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program inspection Accompaniments i

l L

1 APPENDIX B l

STATE OF FLORIDA DEPARTMENT OF HEALTH and BUREAU OF RADIATION CONTROL ORGANIZATION CHARTS 4

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1 APPENDIX C INSPECTION CASEWORK REVIEWS l

NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE REVIEW TEAM.-

File No.: 1 Licensee: Kooney X Ray, Inc. License No.: TX LO1074 Location: Tallahassee, FL Inspection Type: Routine, Unannounced.

License Type: Field Radiography Priority: Reciprocity inspection Date: 6/8/95 Inspectors: WC/BR J

Comments:

a) Inspection correspondence not processed in accordance with BRC procedures.

b) No supervisor signature on field notes.

c) No indication on field notes or correspondence of location were licensed activities were conducted, d) Inspection letter sent 49 days after inspection completed. ,

File No.: .2 Licensee: Theratronics international License No.: NRC 54-28315-01 Location: Gainesville, FL' Inspection Type: Routine, Announced License Type: Teletherapy Source Exchange Priority: Reciprocity Inspection Date: 10/16/97 Inspector: PP File No.: 3 Licensee: Nucletron Corporation License No.: NRC 19-28772-01 Location: Tampa, FL Inspection Type: Routine, Unannounced License Type: HDR Source Exchange Priority: Reciprocity inspection Date: 6/30/98 Inspector: DM Comments:

a) No field notes prepared by field office, b) No indication on correspondence of location were licensed activities were conducted File No.: 4 Licensee: Universal Engineering Services License No.: 1136-4 Location: Rockledge, FL Inspection Type: Special, Announced License Type: Portable Gauge Priority: 3 inspection Date: 3/10-11/98 Inspector: AG Comments a). Correspondence in file contains personal information

' File No.: 5 l Licensee: 21" Century Oncology, Inc. License No.: 0476-3

. Location: Cape Coral, FL Inspection Type: Routine, Unannounced License Type: Medical / Private Practice . Priority: 3 ,

inspection Date: 9/16/98 Inspector: LF l l

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1 Florida Proposed Final Report Page C.2 Inspection Casework Reviews ]

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File No.: 6  !

Licensee: DeSoto Memorial Hospital License No.: 13712  !

. Location: Arcadia, FL Inspection Type: Routine, Unannounced i License Type: Medical Institution Priority: 2 j Inspection Date: 4/16/97 Inspectors: KC/SH l

File No.: 7 Licensee: Bethune-Cookman College License No.: 1060-1  !

Location: Daytona Beach, FL Inspection Type: Routine, Unannounced i License Type: Academic Specific Priority: 2 l Inspection Date: 8/24/95 Inspector: LS l File No.: 8 Licensee: J&M Testing Lab License No.: 17631 l Location: Chipley, FL Inspection Type: Routine, Announced License Type: Portable Gauge Priority: 3 Inspection Date: 3/7/96 Inspector: RL File No.: 9 Licensee: American Associated Testing, Inc. License No.: 1511-1 Location: Dania, FL Inspection Type: Routine, Announced License Type: Radiography Priority: 1

. Inspection Date: 4/9/98 Inspector: MK Fiie No.: 10 Licensee: Mt. Sinal Medical Center of Greater Miami License No.: 0064 3 Location: Miami Beach, FL Inspection Type: Routine, Unannounced License Type: Broad Medical Priority: 1 Inspection Date: 3/5-7/96 Inspector: PS File No.: 11 Licensee: Baptist Hospital of Miami License No.: 0614-2 Location: Miami, FL Inspection Type: Routine, Unannounced License Type: HDR Priority: 1 Inspection Date: 8/12 and 17/98 Inspector: MB/JB File No.: 12 Licensee: Perma-Fix of Florida License No.: 25981 Location: Gainesville, FL Inspection Type: Routine, Announced License Type: Waste Processing Priority: 1 (6 months)

Inspection Date: 8/19/97 Inspector: PP Comments: .

a) Same inspector performed last five inspections at facility.

b) Inspection ficid notes specific to facility developed by Jacksonville office. Field notes did not include documentation for ALARA program, operating and emergency procedures, training program, security and transportation.

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n Florida Proposed Final Report Page C.3 Inspection Casework Reviews File No.: 13' Licensee: Florida State University . License No.: 0032-10 Location: Tallahassee, FL .

Inspection Type: Special, Announced License Type: Radioactive Waste Shipment Priority: N/A Inspection Date: 1/22/99 Inspector: CH Comment:

a) inspector issued inspection results to licensee in field, which is consistent with BRC's procedures. BRC issues inspection results in the field only to this type of license activity.

File No.: 14 I Licensee: West Coast Radiology License No.: 1768-1 Location: Clearwater, FL Inspection Type: Follow up, Unannounced License Type: Medical / Private Practice Priority: 3 Inspection Date: 9/17/98 Inspector: RD

' Comment:

a) Acknowledgment letter did not address licensee's denial of some violations.

File No.: 15 Licensee: Winter Haven Hospital License No.: 2845-1 Location: Lake Wales, FL Inspection Type: Initial, Announced License Type: MedicalInstitution Priority: 2 Inspection Date: 6/4/98 Inspector: TM File No.: 16 Licensee: Delray Nuclear Center License No.: 24641 Location: Delray Beach, FL Inspection. Type: Routine, Unannounced License Type: Medical / Private Practice Priority: 2 Inspection Date: 11/21 and 23/98 Inspector: LB Comment:

a) Therapy field notes not used by inspector to document inspection results.

File No.: 17 Licensee: Bethesda Memorial Hospital License No.: 0658 2 Location: Boynton Beach, FL Inspection Type: Routine, Announced License Type: HDR Priority: 1 I Inspection Date: 9/17/97 Inspector: GS File No.: 18 Licensee: Central Florida Diagnostic ' License No.: 2216-1

. Location: Brandon, FL Inspection Type: Routine, Unannounced License Type: Mobile Nuclear Medicine Priority: 2 Inspection Date: 12/9/97 Inspectors: JL

9 Florida Proposed Final Report Page C.4 Inspection Casework Reviews File Nc.: 19 Licensee: Everglades Regional Medical Center License No.: 0844-1 Location: Paholee, FL Inspection Type: Special, Announced Licensee Type: MedicalInstitution Priority: 2 Inspection Date: 7/1 and 10/98 Inspector: ML/MB File No.: 20 Licensee: Mallinckrodt Medical License No.: 1937-2 Location: Ft. Lauderdale, FL Inspection Type: Special, Announced License Type: Nuclear pharmacy Priority: 1 Inspection Date: 12/14/95 Inspector: HR File No.: 21 Licensee: Food Technology Services License No.: 22441 Location: Mulberry, FL . Inspection Type: Routine, Unannounced License Type: Panoramic Irradiator Priority: 1 Inspection Date: 10/14/96 Inspector: TM Comment: l a) Inspection field notes specific to facility developed by Polk County office. These field I notes could be utilized by BRC staff. }

l File No.: 22 -

1 Licensee: University of Southern Florida License No.: 0806-1 i Location: Tampa, FL . Inspection Type: Routine, Announced License Type: Academic Broad Scope Priority: 2 Inspection Date: 10/13-16/98 Inspectors: DM/RK/AW/CB/RE/HM Comments:

a) Inspection report not in Tallahassee office docket file.

b) Inspection letter sent 59 days after inspection completed File No.: 23 Licensee: Ardaman and Associates License No.: 0972-5 Location: Hialeah, FL Inspection Type: Routine, Announced License Type: Portable Gauge Priority: 3 Inspection Date: 10/7/97 Inspectors: PS File No.: 24 Licensee: Medi-Physics License No.: 2133-2 Location: Melbourne, FL Inspection Type: Routine, Unannounced License Type: Nuclear pharmacy Priority: 1 inspection Date: 8/25/97 Inspectors: JB/JB

s.

Florida Proposed Final Report Page C.5 Inspection Casework Reviews INSPECTOR ACCOMPANIMENTS The following inspection accompanimentu were made as part of the on-site IMPEP review:

- Accompaniment No.: 1 Licensee: Louis Alberto Femandez, MD, PA License No.: 2274-1 Location: Hialeah', FL Inspection Type: Routine, Unannounced License Type: M,edical/ Private Practice Priority: 4 Inspection Date: 2/1/99 Inspector: MB Accompaniment No.: 2 Licensee: Syncor Intemational Corporation License No.: 1264-9 Location: Jupiter, FL Inspection Type: Routine, Unannounced License Type: Nuclear Pharmacy Priority: 2 Inspection Date: 2/1/99 Inspector: GS Accompaniment No.: 3 Licensee: 21st Century Oncology, Inc. License No.: 1797-2 Location: Port Charlotte, FL Type Inspection: Routine, Unannounced

- License Type: Brachytherapy /HDR Priority: 1 Inspection Date: February 3,1999 Inspector: LF Accompaniment No.: 4 Licensee: Morton Plant Health License No.: 0021-1 Location: Clearwater, FL Type inspection: Routine, Unannounced License Type: Medical Institution Priority: 2 Inspection Date: February 4,1999 Inspector: RK Accompaniment No.: 5 Licensee: Coastal Pharmacy Services, Inc. License No.: 2497-1 Location: Daytona Beach, FL Type Inspection: Routi,e, Unannounced License Type: Nuclear Pharmacy Priority: 1 '

Inspection Date: 2/17/99 Inspector: AG Accompaniment No.: 6 Licensee: Santa Rosa Medical Center, Inc. License No.: 2703-1 Location: Melton, FL . .

Type Inspection: Routine, Unannounced License Type: MedicalInstitution Priority: 2 Inspection Date: 2/18/99 Inspector: BR I

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APPENDIX D LICENSE CASEWORK REVIEWS NOTE: ALL LICENSES LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE REVIEW TEAM.

File No.: 1 Licensee: Southeastern Atomic License No.: 0186-1 Location: Gainesville, FL Amendment No.: 17 License Type: Instrument Calibration and Analytical Services Type of Action: Renewal Date Issued: 8/21/98 Reviewer: CH File No.: 2 Licensee: Perma-Fix of Florida License No.: 2598-1 Location: Gainesville, FL Amendment No.: 12 License Type: Waste Treatment Type of Action: Amendment Date issued: 1/13/99 Reviewer: PV File No.: 3 Licensee: Cargill Fertilizer, Inc. License No.: 2970-1 Location: Ft. Meade, FL Amendment No.: N/A License Type: Broad Industrial /R&D Type of Action: New Date issued: 11/25/98 Reviewer: WC File No.: 4 Licensee: Adventist Health License No.: 2897-1 Location: Orlando, FL Amendment No.: N/A License Type: Broad Medical Type of Action: New Date issued: 4/22/98 Reviewer: PV File No.: 5 Licensee: Curtis McKnight Testing License No.: 0164-6 Location: Tampa, FL Amendment No.: 21 License Type: Industrial Radiography Type of Action: Renewal Date issued: 1/25/99 Reviewer: LS File No.: 6 Licensee: Nuclear Medicine of Central Florida License No.: 2357-3 Location: Brandon, FL Amendment No.: 13 License Type: Medtal/ Private Practice Type of Action: Amendment Date issued: 9/14/98 Reviewer: RL File No.: 7 Licensee: Holmes Regional Medical Center License No.: 0545-3 Location: Melbourne, FL Amendment No.: 7 License Type: HDR Type of Action: Renewal Date issued: 2/4/98 Reviewer: LS

M Ficrida Proposed Final Report Page D.2 License Casework Reviews File No.: 8 Licensee: Florida A&M License No.: 0846-1 Location: Tallahassee, FL- Amendment No.: 31 License Type: Academic Specific Type of Action: Amendment Date issued: 4/13/98 Reviewer: LS File No.: 9-10 Licensee: Greenhorne & 00Mara, Inc License No.: 2143-1

' Location: West Palm Beach, FL Amendment Nos.:5&6 License Type: Portable Gauge Type of Action: Amendment Date issued: 5/27/98 & 7/7/98 Reviewer: LS File No.: 11 Licensee: Greenhorne & ODMara, Inc License No.: 2143-1 Location: West Palm Beach, FL Amendment No.: 4 License Type: Porteble Gauge Type of Action: Renewal Date Issued: 3/11/96 Reviewer: DG File No.: 12 Licensee: US AGRI-Chemicals License No.: 0114-1 Location: Fort Meade, FL Amendment No.: 38 License Type: Fixed Gauge Type of Action: Renewal Date issued: 12/31/95 Reviewer: JS a File No.: 13 Licensee: Baptist Hospital License No.: 2623-1 Location: Gulf Breeze, FL Amendment No.: N/A License Type: MedicalInstitution Type of Action: New Date issued: 10/5/95 Reviewer: DG File No.: 14 Licensee: PdMA Corp. License No.: 2400-1 Location: Tampa, FL Amendm6nt No.: 4 "

License Type: Specific (Other) Type of Action: Renewal l Date issued: 10/20/98 Reviewer: RL File No.: 15 Licensee: Florida Institute of Technology License No.: 0651-3 Location: Melbourne, FL Amendment No.: 15 License Type: Academic Specific Type of Action: Renewal Date issued: 2/26/96 Reviewer: CH File No.: 16 Licensee: Gamma Diagnostics License No.: 2125-7 Location: Sarasota, FL Amendment No.: 10 License Type: Medical / Private Practice Type of Action: Termination Date lasued: 1/25/99 Reviewer: CH I

Florida Proposed Final Report Page D.3 License Casework Reviews File No.: .17 Licensee: Nuclear Pharmacies, Inc. License No.: 2447-1 Location: Pensacola, FL Amendment No.: 02 License Type: Radiopharmacy Type of Action: Termination Date issued: 3/24/95 Reviewer: PV File No.: 18-20 Licensee: Costal Pharmacy Services License No.: 2497-1 Location: Daytona Beach, FL Amendment Nos.: 1,2,&3 License Type: Radiopharmacy . Type of Actions: Amendment Dates issued: 3/21/96; 6/25/97; and 4/15/98 Reviewer: JS & LS File No.: 21-22

' Licensee: St. VincentDs Med. Ctr. License No.: 0014-1 Location: Jacksonville, FL Amendment Nos.: 94 & 95 License Type: MedicalInstitution .

Type of Actions: Amendment Date issued: 1/4/99 & 11/30/98 Reviewer: LS & RL File No.: 23

. Licensee: 21st Century Oncology, Inc. License No.: 0476-2 Location: Ft. Meyers, FL Amendment No.: 18 License Type: Teletherapy /HDR Type of Action: Amendment Date issued: 12/10/98 Reviewer: JS File No.: 24 Licensee: National Diagnostics License No.: 2634-1

' Location: Orange Park, FL Amendment No.: 6 License Type: Medical / Private Practice Type of Action: Amendment Date issued: 8/25/97 Reviewer: JS File No.: 25 Licensee: Hospital Corp. of Lake Worth License No.: 0829-2 Location: Lake Worth, FL Amendment No.: 10 License Type: MedicalInstitution Type of Action: Termination Date issued: 8/24/97 Reviewer: PF l

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APPENDIX E INCIDENT CASEWORK REVIEWS NOTE: ALL INCIDENTS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE REVIEW TEAM.

File No.: 1 Licensee: Southern Earth Sciences -

Incident ID No.: 96-002 Location: Tallahassee, FL License No.: 1957-1 Date of incident: 12/4/95 Type of incident: Stolen Portable Gauge Investigation Date: 1/19/96 - Investigation Type: On-site Summary of Incident and Final Disposition: A nuclear moisture density gauge was stolen from a truck parked at home. On-site investigation resulted in numerous violations including an administrative fine being issued.

File No.: 2 I Licensee: Non-licensee incident ID No.: 95-102 Location: Miami, FL License No.: N/A Date of incident: 4/10/95 Type of incident: Loss of Control )

Investigation Dates: 4/10/95 investigation Type: On-site Summary of incident and Final Disposition: A radiation alarm activated at a waste handling facility. An investigator isolated two bags of trash that contained materials contaminated with I-131. The bags were impounded and were held for decay and disposal by the State. j File No.: 3 j Licensee: Longview inspection Incident ID No.: 95-096 l Location: Orlando, FL License No.: 2239-1 ,

Date of incident: 7/12/95 Type of incident: Overexposure l Investigation Date: 7/26/95 Investigation Type: On-site Summary of Incident and Final Disposition: A radiography camera source disconnect resulted in an 8.8 rem overexposure to the radiographer. The dose was due not only to mitigative '

actions of the radiographer on site (the exposure was performed in South Carolina), but also apparentiy due to his and managements decision to return the source back to the licensee headquarters office in Florida by covering it with lead pieces and sandbags in the back of a pickup truck. The State was notified on July 25,1995 and responded the next day. Numerous violations and civil penalties were issued.

File No.: 4 Licensee: Adventist Health Systems incident ID No.: 79-010 Location: Altamonte Springs, FL License No.: 0069-1 Date of incident: 1/23/97 Type of incident: Loss of Control Investigation Date: 1/23/97 investigation Type: On-site Summary of Incident and Final Disposition: After a brachytherapy treatment, one Cs-137 was noted as missing. The seed was found 1.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> later in the physicians medical bag which was left on a reception desk. The maximum dose received by an individual was 67 mrem. The State inspected the licensee and issued violations.

f Florida Proposed Final Report Page E.2 Incident Casework Reviews File No.: 5 License: Lee Moffit Cancer Research Center Incident ID No.: 96-072 Location: Tampa, FL Licensee No.: 1739-1 I Date of incident: 5/2/96 Type of Incident: Misadministration Investigation Date: 5/7/96 Investigation Type: On-site Summary of incident and Final Disposition: A brachytherapy treatment to the esophagus resulted in one of the 6 strands not in the proper treatment position. An on-site investigation was performed and violations were issued.

File No.: 6 Licensee: Florida Power Corporation Incident ID No.: 97-034 I Location: Crystal River, FL License No.: 1157-1 Date of incident: 4/1/97 Type of incident: Overexposure Public Dose Limit Investigation Date: 4/5/97 investigation Type: On-site Summary of incident and Final Disposition: The nuclear gauge was not placed in the safe /off position as called for in lockout procedures. As a result, several maintenance workers received

. exposures up to 408 mrem. The State inspected the licensee and issued several violations.

4

. File No.: 7 Licensee: White Construction Incident ID No.: 98-046 Location: Chiefland, FL License No.: 2882-1 Date of Incident: 4/21/98 Type of incident: Damaged Gauge

. Investigation Date: 4/21/98 investigation Type: On-site Summary of incident and Final Disposition: A moisture / density gauge stored in a truck on the roadway shoulder was damaged when the gauge was struck by a tire that was ejected from a passing truck. The State surveyed and swiped the area and sent the gauge to Troxler for repair.

File No.: 8 Licensee: Syncor International Corporation incident ID No.: 98-047 Location: Jupiter, FL License No.: 1264-9 Date of incident: 4/22/98 Type of incident: Loss of control of radioactive material Investigation Date: 4/22/98 investigation Type: On-site Summary of incident and Final Disposition: The exhaust pipe of a glove box for iodine use was not re-connected to a fume hood after a routine maintenance procedure. The problem was noted after a two iodine procedures had been performed. The licensee performed area surveys and bloassays. No contamination or internalization occurred.

File No.: 9 Licensee: Resource Recycling incident ID No.: 98-113 Location: St. Petersburg, FL License No.: N/A Date of incident: 10/14/98 Type of Incident: Loss of Control of Radioactive Material Investigation Date: 10/15/98 Investigation Type: On-site Summary of Incident and Final Disposition: A Cs-137 and Am 241 source caused a radiation monitor to alarm at a metal recycling facility. The sources were isolated, wipe tested, and ,

removed by the State. No contamination was detected. The State reviewed their data bank of l missing gauges and none was missing that contained the sources.

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1 Florida Proposed Final Report Page E.3 incident Casework Reviews File No.: 10 Licensee: South Miami Hospital incident ID No.: 98-116 Location: Miami, FL - License No.: 0034-1 Date of incident: 10/13/98 Type of incident: Misadministration investigation Date: 10/22/98 investigation Type: On-site Summary of incident and Final Disposition: The first (1026 rads) of 3 irradiations to the left eye of a patient was delivered to the medial aspect rather than the lateral aspect. The State conducted an investigation of the incident and issued several violations.

File No.: 11 Licensee: OST Environmental Incident ID No.:99-003 Location: Gainesville, FL . License No.:2874-1 Date of incident: 11/10/98 Type of incident: Fire Resulting in Inoperable Equipment investigation Date: 11/12/98 investigation Type: Telephone

- Summary of incident and Final Disposition: A fire destroyed three beta gauges (GL devices) each containing 30 mci of Kr-85. The State determined that no site visit was necessary.  !

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APPENDIX F SEALED SOURCE AND DEVICE CASEWORK REVIEWS NOTE: ALL SEALED SOURCE AND DEVICE CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM File No.: 1 Registry No.: FL-1001-D 101-S SS&D Type: Coal Slurry Analyzer Manufacturer: Amdel Limited Corporation Model No.: OLA-100 Date issued: 1/26/06 File No.: 2 Registry No.: FL-1001-D-102 S SS&D Type: Coal Slurry Analyzer Manufacturer: Amdel Limited Corporation Model No.: CSA Series Date issued: 10/28/96 AM213 Density Probe AM222 Aeration Probe AM263 Ash Probe l

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APPENDIX G l

STATE OF FLORIDA QUESTIONNAIRE RESPONSE l

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Approved by OMB' No. 3150-0183 Expires 5/31/2001 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l

QUESTIONNAIRE j State: FLORIDA Reporting Period: March 4,1995 to February 21,1999 A. COMMON PERFORMANCE INDICATORS i

1. Status of Materials inspection Program

1. Please prepare a table identifying the licenses with inspections that are overdue l by more than 25% of the scheduled frequency set out in NRC Inspection Manual ]'

Chapter 2800. The list should include Initial inspections that are overdue.

insp. Frequency Licensee Name (Years) Due Date Months O/D None. j

2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.

N/A

3. Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.

' Estimated burden per response to comply with this voluntary collection request: 45 hours5.208333e-4 days <br />0.0125 hours <br />7.440476e-5 weeks <br />1.71225e-5 months <br />.

Forward comments regarding burden estimate to the information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, i DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

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We inspect no licensees less frequently than NRC. Below are those licenses that we inspect more frequently than NRC. I NRC Remarks NRC Florida Florida See NRC NRC CategoryTitle Priority License insp.Freq. comments Program Category (years) below (years) 7 1A 1 A NA Yellow Cake Uranium NA Production / Possession 7 1B 1 A NA Green Cake Uranium NA Producten/ Possession 5 1C 3 B 11200 Source Material- Other Less than 150 Kilograms 5 2C 4 B l 22120 SNM Plutonium - Sealed Neutron Source Less than 200 Grams 5 2C 4 B 22150 SNM Plutonium - Sealed Sources Less than Critical Mass 5 2C or 4 or 3 B 22140 SNM Plutonium - Sealed 3L(1)

Sourcesin Devices

' 5 2C or ~ 4 or 3 B 22151 SNM U 235 and/or U 233 l Sealed Sources Less than 3L(l)

Critical Mass 3 3A 1 C 03214 Manufacturing and Distribution Other Prepared 3 3B 1 C 02511 Medical Product Distribution-32.72 Radiopharma-ceuticals Therapy 3 38 1 C l

02513 Medical Product Distribution -

l sources, 32.74 Sources and Devices calibration and reference sources 5 3E 3 D trradi9 tors Self Shielded Less includes blood l 03510 Than 370 TBq(10,000 curies) Irradiators 3 3F(l) 2 D

03511 Irradiators- Other Less than 370 Panoramic; TBq(10,000 curies) includes converted tele -

therapy units 3 3F(ll) 1 D 03520 Irradiators Self Shielded Greater than 370 TBq(10,000 curies)

Generally 5 3G 1 C 03240 General License Distribution-ficensed l 32.51 gauges,other l

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NRC NRC Category Title NRC Remarks NRC Florida Florida See Program Priority License insp.Freq. comments (years) Category (years) below

? Calibration or reference sources ?  ? 30 4 D and totalpossession is less than 1 millicurie.

03220 Leak Test Services Only 7 3P 3 D 03221 Instrument Calibration Services 5 3P 3 D Only - Self-Shielded 03231 Waste Disposal- Burial 1 4A 0.5 0 03233 Waste Disposal Service 1 4A 0.5 E Incineration 03232 Waste Disposal Service 2 48 0.5 E Prepackaged Only 03234 Waste Disposal Service 1 48 0.5 E Processing and/or Repackaging

? Commercial treatment of  ?  ? 4C 0.5 E radioactive materials for release

.to unrestricted areas 02120 Medical Institution - Quality Hospitals, 3 5B 2 G Management Program (QMP) clinics required 02121 Medical Institution -no QMP 5 58 2 G required 02201 Medical Private Practice - no 5 SC 3 G QMP required 02210 Eye Applicators Strontium-90 Hospitals or 3 50 2 G physicians' offices

? Radiopharmaceutical Therapy  ?  ? 50 3 G Use only or Bone Mineral Analyzer Use only 22160 Pacemaker Byproduct, and/or 7 SE 2 D l SNM - MedicalInstitution l 22161 Pacemaker Byproduct, and/or 7 SE 2 D l SNM -Individual i 03710 Civil Defense 5 6 3 O A. Production license facilities have a greater potential for health and safety issues.

The increased inspection frequency of this type of license is warranted.

B. There are few SNM licenses and an increased inspection frequency helps assure radioactive material accountability and addresses potential health and safety issues timely.

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C. Manufacturing of distribution licenses have a greater potential for health and safety issues. The increased inspection frequency of this type of license is warranted.

D. There are few of this type of license. An increased inspection frequency helps assure radioactive material accountability and addresses potential health and safety issues timely.

E. Commercial radioactive waste disposal facilities have a greater potential for health and safety issues. The increased inspection frequency of this type of license is warranted.

F. These types of licenses historically have higher numbers of violations and radioactive materials accountability problems. The increased inspection frequency of this type of licenses is warranted.

G. The increased inspection frequency for medical use licenses is more appropriate.

4. Please complete the following table for licensees granted reciprocity during the reporting period.

Number of Licensees Number of Granted Reciprocity Licensees inspected Priority Permits Each Year Each Year Service Licensees 1995 7 1995 0 performing teletherapy and 1996 5 1996 1 Irradiator source installations 1997 7 1997' 4 or changes 1998 8 1998 8 1 1995 8 1995 2 1996 6 1996 0 i 1997 10 1997 2 l 1998 7 1998 2 l 2 1995 3 1995 1 1996 0 1996 0 1997 2 1997 0 1998 2 1998 0 3 1995 47 1995 0 1996 26 1996 0 1997 33 1997 3 1998 33 1998 14 4 1995 0 1995 0 1996 0 1996 0 1997 0 1997 0 1998 0 1998 0 All Other 1995 1 1995 1 1996 1 1996 0 1997 1 1997 1 1998 0 1998 0

5. Other than reciprocity licensees, how many field inspections of radiographers were performed?

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6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of l Inspections actually performed, and the reasons for any differences between the goals and the l actual number of inspections performed. i N/A l

11. Technical Quality of Inspections

7. What, if any, changes were made to your written inspection procedures during the reporting period?

We made no significant changes to our written inspection procedures. We did made slight revisions to our inspection guides to make them easier to use and to coincide with the numbering changes that occurred when our rules were moved to Chapter 64E-5, Florida Administrative Code. l

8. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Inspector Supervisor License Cat. Date See Attachment 1.

9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

We base supervisory accompaniments on training, auditing and inspection needs as well as the availability of time. As supervisors train their staff, they accompany them on a variety of license inspections. The senior inspector (environmental specialist Ill)in each area office assists the supervisor with training and accompaniments. Following the training, supervisors audit the staff and then allow them to conduct independent inspections. Once trained, supervisors often accompany staff to assist with the inspection and provide coaching and mentoring.

10. Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?

Vendors perform some calibrations or portions of calibrations. Staff from our calibration laboratory perform all other calibrations using procedures specific to the type of instrument. All instruments in use are calibrated property. l 6

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Ill. Technical Staffing and Trainina

11. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compilance, emergency response, LLW, U-mills, other. if these regulatory responsibilities are divided between offices, I the table should be consolidated to include all personnel contributing to the radioactive materials

) program, include all vacancies and identify all senior personnel assigned to monitor work of

( junior personnel, if consultants were used to carry out the program's radioactive materials i responsibilities, include their efforts. The table heading should be:

Name Position Area of Effort FTE%

William A. Passetti Chief Administration / Tallahassee 30 Cynthia L. Becker Administrator inspections & Training / Tallahassee 27 Richard Parham Manager inspections & Training / Tallahassee 27 Hazim Mohammed Environmental Specialist 11 Inspections & Training / Tallahassee 27 Robert Latham Environmental Specialist lli inspections & Training / Tallahassee 27 Jose Quadix Manager Field inspections / Miami 18 Jose Mendez Environmental Specialist il Field Inspections / Miami 18 Mark Bromley Environmental Specialist lli Field inspections / Miami 18 Jozsef Binder Environmental Specialist 11 Field Inspections / Miami 18 Paul Stickna Environmental Specialist 11 Field Inspections / Miami 18 Mike Leiba Manager Field inspections / Lantana 18 Linda Andreis Environmental Specialist ll Field Inspections / Lantana 18 Mark Bouwens Environmental Specialist 11 Field Inspections / Lantana 18 Vacant Environmental Specialist il Field inspections / Lantana 18 Glenn Smith Environmental Specialist lli Field Inspections / Lantana 18 Dan Borek Manager Field Inspections /Ft. Myers 18 Vacant Environmental Specialist 11 Field Inspections /Ft. Myers 18 Lloyd Fontaine Environmental Specialist til Field Inspections /Ft. Myers 18 Steve Hammann Environmental Specialist 11 Field Inspections /Ft. Myers 18 Ray Dielman Manager Field inspections / Tampa 18 Robert Knecht Environmental Specialist til Field Inspectionsnampa 18 Adam Weaver Environmental Specialist 11 Field Inspections / Tampa 18 Dennis Mitchell Environmental Specialist 11 Field Inspections /Tampo 18 Vacant Environmental Specialist 11 Field inspections / Tampa 18 Arthur Glenn Manager Field Inspections /Orlanco 18 Joseph Motley Environmental Specialist 11 Field Inspections /Orlando 18 Jerry Bai Environmental Specialist 11 Field Inspections /Orlando 18 Vacant Environmental Specialist 11 Field Inspections /Orlando 18 Lilian Sterrett Environmental Specialist 11 Field Inspections /Orlando 18 Leo Bakersmith Environmental Specialist 11 Field inspections /Orlando 18 Angel Gonzalez Environmental Specialist 111 Field inspections /Orlando 18 Paul Pavlick Manager Field Inspections / Jacksonville 18 Bill Roberts Environmental Specialist til Field inspections /Pensacola 18 Mark Comwell Environmental Specialist 11 Field lospections/ Jacksonville 18 7

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Ed Pockelwald Environmental Specialist 11 Field Inspections / Jacksonville 18 Talat Chohan Environmental Speciahst 11 Field Inspections / Jacksonville 18 )

Martin Korman Health Physicist Field Inspections /Broward County 18 l Vijay Raghaven Health Physicist Field Inspections /Broward County 18 i Tom McNally Health Physicist Field inspections / Polk County 18 Michael Stephens Administrator Licensing / Tallahassee 100 l Paul Vause Manager Licensing / Tallahassee 100 Joy Stephenson Environmental Specialist 11 Licensing / Tallahassee 100 Larry Shingler Environmental Specialist 11 Licensing /Tellahassee 100 Waiter Cofer Environmental Specialist lli Licensing / Tallahassee 100 ;

Peter Fadale Environmental Specialist 111 Licensing / Tallahassee 100 l Debbie Gilley Manager Licensingfl'allahassee 100 Richard Le Environmental Specialist ll Licensing / Tallahassee 100 Charles Hamilton Environmental Specialist il Licensing / Tallahassee 100 Elizabeth Mitchell Environmental Specialist il Licensing / Tallahassee 100 Lillian Weitzel Chemist ll Sample Analysis /Orlando 100 David Higgins Environmental Specialist il LLRW/Orlando 100 Charles Adams Environmental Specialist 11 Emergency Response /Orlando 50 TOTAL 2000 20 FTE i i

12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

DATE NAME HlRED EDUCATION ADDITIONAL EXPERIENCE Mark Cornwell 5/5/95 A.S., Radiation Protection Radiation Control Technician, Senior Health Physicist Technician Dennis Mitchell 5/5/95 S.S., Radiation Protection Sr. Health Physicist Technician, Radiation Protection Instructor Hazim Mohammed 6/30/95 S.S., Mechanical Health Physicist Engineering; M.E.E.,

Environmental Engineering Sciences Linda Andreis 7/3/95 B.S., Radiological Sciences Radiologic Technologist Jerry Bai 8/8/95 B.S., Electrical Engineering, Radiologic Technologist Radiological Sciences Glenn Sn.ith 1/29/96 B.S., Health Physics Health Physicist, Environmental Technician Steve Hammann 12/27/9 B.A., Natural Science, Technical Assistant, Dosimetry 6 Mathematics Laboratory Talal Chohan 1/24/97 B.S., Health Physics; M.S., Medical Physicist Medical Health Physics Jozsef Binder 3/3/97 B.S., Chemical Engineering; Assistant RSO B.S., Health Physics Mark Bouwens 8/9/97 B.S., Physics Health Physicist, U.S.NRC 8

i Adam Weaver 4/27/98 B.A., Biology; M.S., Health Physicist Consultant, Radiation Sciences Radiation Control Manager, Certified Health Physicist Richard Le 5/11/98 B.S., Biology; B.S., Bio. Senior Health Physicist chemistry; B.S., Chemistry ,

13. Please list all professional staff who have not yet met the qualification requirements of license j reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement l States, please describe your qualifications requirements for materials license reviewers and 1 inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements. .

1 All inspection and licensing staff have met the qualification requirements necessary to review and inspect most radioactive material license categories. For the few licenses that are unique, the senior licensing staff and inspectors receive additional specific training. We base licensing and inspection staff qualification requirements on a combination of in-house training and the education and experience that the individual brings to the job. Records of in-house training, NRC sponsored training and workshops as well as other privately sponsored training are available for review on each employee. . Supervisors from each program and field office are responsible for insuring staff have the necessary skills to conduct radioactive materials license reviews and inspections. Staff receive knowledge and skills through supervisory j accompaniments, senior inspector accompaniments, supervised on-the-job-training, peer and i supervisory reviews, and in-house training courses. We audit staff to insure competency.

14. Please identify the technical staff who left the RCP/ Regional DNMS program during this period.

NAMES OFFICE HIRED TERMINATED Carless George Tampa 10/1/88 4/27/95 .

Bums Clarence Orlando 8 /15/94 7/13/95  !

Caldwell Leonard Miaml 6 /22/92 7/21/95 )'

Boykin Vonya Licensing 8/13/93 10/18/95 Blessing George Pensacola 11/5/82 12/14/95 Bessemer Bonnie Tampa 5 /31/88 3/21/96 Springer Rhonda Lantana 2/1/93 5/31/96 Velasquez Humberto Miaml 3/2/90 6/18/96 Portwine Wayne Orlando 5 /13/94 6/24/96 Howard Michael Tampa 12/2 /94 8/13/96 ,

Douthat James Ft. Myers 2/15/80 9/19/96 l McCarthy Roxanne Orlando 11/25/85 2/6/97 '

Thompson Willie Miami 01/17/97 2/20/97  !

Gavathas Evangelos Tallahassee 04/04/94 4/17/97 1 l Comer Kenneth Ft. Myers 04/28/95 4/24/97 .

Jerrett Lyle Tallahassee 03/17/93 8/29/97 Accurso Gail Miami 01/22/90 10/17/97 Lattimer Charles Tampa 10/01/88 12/31/97 Lacy Joni Tampa 12/02/96 4/25/98 9

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15. List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

Date -

Position Office Vacant Recruitment Efforts / Status Env. Specialist il Inspection /Orlando 6/14/98 No Plans to Fill Env. Specialist 11 Inspection / Lantana 7/29/98 No Plans to Fill Env. Specialist ll Inspection /Ft. Myers 4/29/98 No Plans to Fill Env. Specialist il inspection / Tampa 6/14/98 Selection made, awaiting approval IV. Technical Quality of Licensing Actions

16. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.

No licensee currently is required to have an emergency plan as required in Section 64E-5.219, Florida Administrative Code.

Majorlicenses category 3A Commercial manufacture or distribution 3B Radiopharmacy 3F(3) Large Irradiator (megacuries) i 3M(1,2,3) Broad scopes academic, medical, industrial  ;

I 4C Commercial waste disposal unrestricted release to the environment 48 Commercial waste processing and DIS SA Medical HDR or Gamma Knife Note: status date of 1/1/1901 means license status was assigned before January 1994.

Status Status: License Lic. Cat. Licensee Name date Actival Number Terminated 11/8/94 T 2139-1 5A Central Florida Radiation 1/1/1901 T 2241-1 SA Atlanta Oncology Associates, P.C.

1/1/1901 A 2137-1 SA Orlando Cancer Center, Inc.

12/7/94 T 2128-1 SA Central Florida Radiation 1/1/1901 A 1215-2 SA Martin Memorial Medical l 1/1/1901 A 2165-1 SA Marion Community Hospital,  !

1/1/1901 A 0416 2 SA Tallahassee Memorial. Reg. Med. Center 1/1/1901 A 0339-1 5A St. Mary's Hospital 3

1/1/1901 T 0681-1 SA Sun Coast Hospital i 1/1/1901 A 0014-6 5A St. Vincent's Medical Center l 1/1/1901 A 0064-12 SA Mt. Sinal Medical Center Of  !

9/22/98 T 2223-1 5A Nor1h Miami Beach Cancer 10 l

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Status Status: License Lic. Cat. Licensee Name date Actival Number Terminated 1/1/1901 T 1658 2 SA S. F1 Radiation Oncology Center 1/1/1901 A 0063 2 SA Mercy Hospital, Inc.

1/1/1901 T 0073-4 5A Cedars Medical Center 1/1/1901 A 1275-3 SA Naples Community Hospital, Inc.

1/1/1901 T 0008 5 5A Memorial Radiotherapy Center 1/1/1901 A 0155-4 5A Southem Baptist Hospital Of FI, 1/1/1901 A 1857-2 SA Radiation Therapy Center Of 1/1/1901 A 0145-4 5A University Medical Center 1/1/1901 A 1797-2 SA 21st Century Oncology, Inc.

1/1/1901 A 0131-3 SA St. Joseph's Hospital

]

1/1/1901 4/18/95 T

T 0011-3 2127-1 5A SA Broward General Medical Center Central Florida Radiation h 1/1/1901 1/1/1901 A

A 0476-2 SA 21st Century Oncology, Inc.

2155-1 SA Norman H. Anderson, M.D., P.A.

3/5/97 A 2756-1 SA Key West Oncology Associates, 10/26/94 A 2517-1 SA Winter Park Healthcare Grp.,

R 5/21/98 T 0069-14 SA Fl Hospital /Mem. Cancer Care Cntr.

p_ 2/10/95 A 2541-1 5A Makar, Wasfi A., M.D., P.A.

2/17/95 A 2542-1 SA Lake Cancer Care Center, Inc.

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4/23/98 T 0069-15 5A Adventist Health Sys/ Sunbelt, 4/7/95 A 2559-1 5A Florida Oncology Center, Inc.

1/15/96 T 2560-1 SA Broward Radiation Therapy 5/3/95 A 2570-1 5A Aoa Gulf Coast Partners, Ltd 10/5/95 A 2619-1 SA Watson Clinic 2/27/96 A 2660-1 5A Oncology Services Corp. Of 3/20/96 A 2667-1 SA 21st Century Oncology, Inc.

4/15/92 A 0021-6 SA Morton Plant Hospital 5/8/96 A 2674-1 SA 21st Century Oncology, Inc.

9/22/93 A 0550-2 SA Boca Raton Community 4/9/97 A 2768-1 SA Fi instit. Of Radiation &

9/25/97 A 2818-1 SA 21st Century Oncology, Inc.

11/7/97 A 2832-1 SA Intracoastal Health 12/1/97 A 2842-1 SA Radiation Onco. Assoc. Of Palm 12/4/97 A 2844-1 SA Equimed, Inc.

1/2/98 A 2857-1 SA S.E. Regional Cancer 2/4/98 A 2870-1 SA Tenet Healthsystem Hospitals, 4/27/98 A 2902-1 SA 21st Century Oncology, Inc.

5/19/98 A 2906-1 SA Center For Radiation 6/30/98 A 2915-1 5A Leesburg Community Cancer 7/21/98 A 2927-1 5A Port St. Lucie Ventures, Inc.

8/18/98 A 2936-1 SA Iridium Holdings, Inc.

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Status Status: License Lic. Cat. Licensee Name date . Actival Number Terminated 12/24/97 T 2653-2 SA Columbia /Jfk Healthcare 8/21/92 T 2299-1 SA Intercommunity Cancer Center, P.A.

10/28/94 T 0338-1 5A Winter Haven Hospital 1/29/98 T 1065-4 5A Porter, Alan H., M.D.

5/12/95 A 1065-1 SA Porter, Alan H., M.D.

1/1/1901 A 2219-1 SA Sarasota County Public 1/29/98 T 1146-3 5A Sarasota Oncology Center-2/23/98 T 0069-9 5A Florida Hosptial- Altamonte 1/1/1901 A 2231-1 5A Treasure Coast Radiation 1/1/1901 A 0194-3 5A Halifax Medical Center 6/20/95 T 2268-1 SA Central Florida Radiation 3/12/92 A 2272-1 SA Cancer Care Centers 1/1/1G01 A 0031-1 SA University Of Florida 12/24/96 T 2280-1 5A Palm Sch. Radiotherapy Assoc.,

1/14/94 A 1275-5 5A Naples Community Hospital, Inc.

8/29/94 T 0060-4 5A Bay Medical Center i 5/13/96 T 2424-1 5A Orlando Radiation Care, Inc.

9/10/92 A 1087-5 5A West Fi Reg. Med. Center, Inc.

3/11/98 T 0817-2 5A Tenet Healthsystem Hospitals, 3/28/96 T 0627-2 5A Jfk Medical Center 1/6/93 A 0294-2 SA St. Anthony's Hospital,Inc.

1/20/93 A 0545-3 5A Holmes Regional Medical 2/5/93 A 0745 3 SA Sacred Heart Hospital Of 3/9/93 A 0658-2 5A Bethesda Memorial Hospital 6/30/93 A 0549-3 5A University Community Hospital, 8/6/93 A 2301-2 SA Healthsouth Doctor's 8/12/93 A 2397-1 SA Cedars Medical Center j 8/30/93 A 1319-3 5A Um/ Jackson Medical Center 1/1/1901 T 0189-2 5A Lakeland Regional Medical Center 6/5/92 A 0614-2 5A Baptist Hospital Of Miami, Inc.

8/19/95 T 1354-1 4C Quadrex Environmental Company ,

8/19/95 A 2598-1 4B Forma-Fix Of Florida, Inc. I 1/1/1901 T 0240-1 3M(3) Eg & G Florida, Inc.

4/24/95 A 2564-1 3M(3) Imc-Agrico Gp Co./Ime-Agrico Mp, 11/25/98 A 2970-1 3M(3) Cargill Fertilizer, Inc.

l 4/19/94 A 1091-5 3M(3) Florida Power & Light Company  !

1/1/1901 A 1319-1 3M(2) Um/ Jackson Memorial Medical 1 1/1/1901 A 0064-3 3M(2) Mt. Sinal Hosp. Of Gitr. Miami, i 1/1/1901 A 0031-3 3M(2) University Of Florida 4/23/98 A 2897-1 3M(2) Adventist Health 8/13/97 A 1812-3 3M(2) Mayo Clinic Jacksonville 12

Status Status:. License Lic. Cat. Licensee Name date Active / Number Terminated 1/1/1901 A 0076-13 3M(1) Um/ Jackson Memorial Medical 1/1/1901 A 0356-1 3M(1) University Of Florida 1/1/1901 A 0064-13 3M(1) Mt. Sinal Med. Cntr Of Greater 1/1/1901 A 0806-1 3M(1) University Of South Florida 1/1/1901 A 0032-D 3M(1) Florida State University 1/1/1901 A 1521-1 3F(3) Shenuood Medical Company 1/1/1901 A 2244-1 3F(3) Food Technology Services.

1/1/1901 A 1355-1 3B Syncor intomational Corp. I 3/29/96 T 2524-1 3B Pyramid Diagnostic Services, 1/1/1901 A 1937-1 38 Mallinckrodt, Inc.

3/31/92 A 1264-9 3B Syncor Intemational Corp.

1/1/1901 A 1264-2 3B Syncor Intemational Corp.

9/2/94 A 2497-1 3B Coastal Pharmacy Services, 1/1/1901 A 1937-3 38 Mallinckrodt Medical, Inc.

1/1/1901 A 1264-8 3B Syncor Intemational Corp.

4/7/94 A 1264-11 3B Syncor Intemational 3/27/95 T 2447-1 3B Nuclear Pharmacies, Inc.

3/29/96 T 2330-1 3B Nuclear Technologies, Inc.

1/1/1901 A 1264-1 3B Syncor intemational Corp.

1/1/1901 T- 1384-1 3B American Diagnostics 1/1/1901 A 0709-1 3B Mt. Sinal Medical Center 9/22/94 A- 2504-1 3B Central Pharmacy Services, i 8/29/95 T 2094-1 3B Mallinckrodt Medical, Inc. l 1/1/1901 A 2133-1 3B Medi-Physics, Inc.

1/1/1901 A 1264-3 38 Syncor intomational Corp.

10/13/92 A 1264-10 3B Syncor Intemational 10/7/92 A 2133-2 38 Medi-Physics, Inc.

12/15/98 A 2975-1 3B Genesis Pharmacy Services. l 1/1/1901 A 1462-1 3B Syncor intemational Corp.

2/9/94 A 1937-4 3B Mallinckrodt Medical, Inc.

5/9/96 A 2677-1 3B Central Pharmacy Services, 1/1/1901 A 1937-2 3B Mallinckrodt Medical, Inc.

1/1/1901 A 1243-1 3B Syncor Intemational Corp.

11/19/96 A 2728-2 3B P.E.T. Net Pharmaceutical 9/13/96 A 2711-1 3B Nuc-Phar, Inc.

8/2/96 A 2700-1 3B Central Source Pharmacy 9/29/98 A 2957-1 3B Cox Nuclear Pharmacies, Inc.

1/1/1901 A 2134-1 3B Medi-Physics, Inc.

9/1/95 A 2603-1 38 Cox Nuclear Pharmacy - Panama 9/12/95 A 2608-1 3B Captech Group, Inc.

7/19/95 T 2591-1 3B Cti Services, Inc.

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Status Status: License Lic. Cat. Licensee Name date Active / Number Terminated 11/19/96 T 2091-1 3A Ctl Services, Inc.

8/29/95 A 2601-1 3A Technical Products Group, 9/6/95 A 2605-1 3A Bio-Nucleonics, Inc. (Ssdr) 10/3/95 A 2617-1 3A Amdel Limited Corporation (Ssdr) 2/28/94 A 0231-15 3A Martin Marietta Technologies.

1/1/1901 A 1594-2 3A Unison Industries, L.P.

11/19/96 A 2728-1 3A P.E.T. Net Pharmaceutical 1/1/1901 T 2251-1 3A Aeg Corporation 8/21/92 T 2300-1 3A Graseby lonics 1/1/1901 A 2189-1 3A Litton Systems, Inc.

1/1/1901 T 1370-1 3A Merrick Corporation, The 1/1/1901 T 1326-1 3A Opto Mechanik, Inc.

9/8/95 T 1026-2 3A Brunswick Corp.

17. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

A. Exemption issued to authorize the medical use of F-18 labeled FDG to be administered prior to FDA issuing an IND/NDA. FDA has since issued an NDA.

B. Patient Release Criteria Exemption: Eye plaque 1-125 seeds made into an eye plaque that is stitched to the patient's eye. This is a temporary implant. To reduce medical expenses, the patient is released to a hotel across from the hospital with instructions.

The patient time with the seeds implanted is 3-10 days. See file 1813-3 for specifics.

C. Quality Management Program: Exception required due to FDA approved double blind restenosis studies in femoral arteries called the P.A.R.I.S. study involving Ir-192 HDR vascular procedures D. Quality Management Program: Exce;; tion required due to FDA APPROVED double blind studies on the effectiveness of using 1-192 wire in treating restenosis of the cardiovascular system with a U.S. Surgical Corporation device.

E. Quality Management Program: Exception required due to FDA approved double blind studies on the effectiveness of using a Sr-90 source train in a "Novoste Beta Catheterization" System for brachytherapy procedures in treating vascular restenosis.

F. One microcurie C-14 urea capsule exemption. NRC new class of exemptions

" Radioactive Drugs" allowed.

G. Exemption from section 64E-5,402(6)(g), Florida Administrative Code, regarding ANSI N432-1980 test criteria for guide tubes used with industrial radiographic exposure devices. Licensee (originally RML #1219-1, EG&G Florida, Inc.; now RML #2953-1, Wyle Laboratories, Inc.) uses custom rigid guide tubes made from materials similar to those used by Amersham Corp., and designed and fabricated similar to Amersham's Engineering Test Plan for rigid guide tubes. Tube is used only in limited instances where use of a flexible guide tube is less efficient and results in higher doses to radiographic personnel. Licensee's personnel follow approved procedures to ensure safe operations.

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H. Exemption from section 64E-5.402(5), Florida Administrative Code, regarding radiographic equipment performance requirements for use of an industrial tomography device employing a cobalt 60 source for industrial radiography. Exemption originally granted to RML #1219-1, EG&G Florida, Inc.; now RML #2953-1, Wyle Laboratories, Inc.

Device underwent a safety evaluation and was approved for use as an industrial gauging device (see NR-0628-D-130-S), but actual use is industrial radiography. Device was designed originally for use as a calibrator then converted into a prototype tomography system. Device appears to comply with ANSI N432 requirements except for endurance test, which requires 20,000 cycles, while device was tested at only 10,000 cycles. However, the requirement was designed to test radiographic exposure devices subject to greater wear and impact than the unit in question; the source does not move outside the device, and use of the device is confined to an approved permanent radiographic installation equipped with a visible and audible alarm system. In addition, the unit has functioned without incident for more than 12 years I. Exemptions from section 64E 5.402(5), Florida Administrative Code, regarding radiographic equipment performance requirements granted to licensees in possession of devices loaded with Iridium 192 or cobalt 60 sources having activities high enough for effective use beyond the 1/1/96 Implementation date for the new requirements. All exemptions were of limited duration (< 1 year), providing time for liconsees to use the Ir-192 sources until their activities decreased below effective use levels, and to allow time

' to find replacement equipment meeting the new requirements. At this time, all devices have been replaced and this exemption no longer exists.

18. What, if any, c'hanges were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

We made no changes to our written licensing procedures.

19. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.

N/A V. Responses to incidents and Allegations

20. Please provide a list of the reportable incidents (i.e., medical misadministration, overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-0178, Nuclear Material Events Database). The list should be in the following format:

Licensee Name License # Date of incident / Report Type of incident This information has been provided previously in the monthly updates that are sent to INEEL.

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21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC 1 licensees who might be affected notified? For States, was timely notification made to NRC? For 1 Regions, was an appropriate and timely PN generated?

l Incident FL95-115, August 22,1995, involved a leaking Ni 63 special form check source. The item was retumed to the manufacturer Hewlett Packard for evaluation. The written report was processed the same day and a copy was sent to NRC. J Incident FL96-141, November 6,1998, involved a leaking Mo 99fTc 99m generator discovered on receipt. NCR, Federal Express, State of Tennessee, and manufacturer DuPont in Maine j were all notified the same date by phone.  !

22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible l generic design deficiency? Please provide details for each case.

The items in FL95-115 and FL96-141 (item #21, above) were retumed to the source manufacturers for evaluation.

23. In the period covered by this review, were there any cases involving possible wrongdoing that l were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

1 incident FL95-089 involved a calibration "E-vial" Co 57 250 Ci source that had been stolen and a depleted vial substituted for it.

24. Identify any changes to your procedures for handling allegations that occurred during the period of this review.

A new section titled " Allegations" was added to the Bureau's Standard Operating Procedure #1, Page 5. See Attachment 2.

a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.

None.

VI. General

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

a. We have modified our inspection reports to require clearly documented methods used to verify negative pressure and to record results of measurements made to demonstrate 16

negative pressure,

b. Department staff performed a closeout survey of Opto Mechanik, Inc., License 1326-1, j on December 15,1995.

26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

a. Our inspection program has a number of strengths: 1

1. A comprehensive training program using in house expertise

2. An extensive peer review system that promotes quality and consistency

3. An experienced inspection staff with long-term experience both in the state program and in health physics

4. A professional, courteous and helpful staff willing to assist other programs and other 1 inspection offices.

b. Our licensing program has a number of strengths:

1. Management reviews every licensing and inspection action for technical and procedural accuracy before being sent to the licensee. This ensures that actions are in accordance with established procedures and policies and helps identify areas where additional training is needed.

2. To ensure statewide uniformity in the inspection findings, every inspection finding and corrective action is generated by a headquarters staff member and receives management review for technical procedural accuracy before being sent to the licensee. This also identifies areas where additionalinspection training is needed.

3. Department staff visit new licensees before issuing a license to ensure facility, staff, and equipment are in place to receive radioactive materials.

4. Staff are encouraged to attend up to two professional meetings a year paid by the bureau for continuing education. These include meetings to the Health Physics Society and Association of Physicists in Medicine.

5. The program has retained staff with a diverse background for an extended time; this provides knowledgeable and trained personnel.

6. The licensing program has received the Davis Productivity Award for the last 4 years for innovations that result in performing more work with no increased resources.

c. The incident response program has the following strengths:

1. Area inspection staff, located throughout the state, respond quickly to incidents.

2. The program provides initial and following up training for responders to assure a high level of skills. The program updates standard operating procedures used by responders quarterly.

3. There is strong management involvement in incident response. Each report is coordinated through both the incident response and the licensing programs with close communication with the responder.

4. Both the laboratory in Orlando and the mobile laboratory provide expedient identification of incident radioactive materials. The radioactive materials storage area 17

Ee at the laboratory in Orlando helps the bureau decide what to do with incident ,

l radioactive material. )

5. The mobile laboratory and sample preparation vehicle enable a quick sustained response to a major incident anywhere in the state.

l The bureau has developed procedures that help address the many alarms that occurred in l

waste dumps. Most of these alarms are caused by medical waste that decays quickly or over a few months. Inspection offices that responded to these types of alarms now have 55 gallon drums with liners and secured lids to store for decay and discarding this radioactive material instead of sending it to the radioactive materials storage area at the laboratory in Orlando. At the two locations where most of these alarms are generated, the operators of the waste dumps now have procedures that allow the owners to dump and sort through any loads that set off the radiation monitors so that our staff only need to respond when a significant source is located.

B. NON COMMON PERFORMANCE INDICATORS

1. Lecislation and Procram Elements Required for Compatibility

27. Please list all currently effective legislation that affects the radiation control program (RCP).

Chapter 404, Florida Statutes

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

Florida has eliminated the " Sunset" laws.

29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

10 CFR RULE DATE DATE OR CURRENT EXPECTED DUE ADOPTED STATUS ADOPTION Any amendment due prior to NA NA NONE PENDING 1991. Identify each regulation (refer to the Chronologyof Amendments) 18

4 I

10 CFR RULE DATE DATE OR CURRENT EXPECTED DUE ADOPTED STATUS ADOPTION Decommissioning; Parts 30, 7/27/91 NA Funding mechan- 64E-5.217 40,70 ism for decommis- equivalent in sioning. Current place since mechanism in 7/17/85 regulations. See 64E-5.217, Florida Adminis-l trative Code Emergency Planning; Parts 4/7/93 5/12/93 DONE 30,40,70 l Standards for Protection 1/1/94 1/1/94 DONE Against Radiation; Part 20 Safety Requirements for 1/10/94 1/1/94 DONE '

l Radiographic Equipment '

Part 34 i Notification of incidents; Parts 10/15/94 1/1/94 DONE l

20,30,31,34,39,40,70 l Quality Management Program 1/27/95 8/25/91 DONE and Misadministrations; Part 35 Licensing and Radiation 7/1/96 8/14/96 DONE Safety Requirements for Irradiators; Part 36 l Definition of Land 7/22/96 NA No Part 61 LLRW NA l Disposal and Waste Site QA Commercial burial Program; Part 61 facility '

Decommissioning 10/25/96 1/1/94 DONE Recordkeeping:

l Documentation Additions; Parts 30,40,70 Self-Guarantee as an 1/28/97 NA Current funding NA

, Additional Financial mechanism in l Mechanism; Parts 30,40,70 regulations. See

, 64E-5.217, 1

F!orida Adminis-trative Code Uranium Mill Tailings: 7/1/97 NA No Uranium Mill NA Conforming to EPA Tailing Activities i Standats; Part 40 Tirneliness in 8/15/97 5/18/98 DONE Decommissioning Parts 30, 40,70 l

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e 10 CFR RULE DATE DATE OR CURRENT EXPECTED DUE ADOPTED STATUS ADOPTION Preparation, Transfer for 1/1/98 No action to be Pending Commercial Distribution, and taken until NRC NRC Part 35 Use of Byproduct Material for completes current proposed Medical Use: Parts 30,32,35 massive revi- revisions sions proposed to 10 CFR Part 35.

This materialis handled by other legally binding requirements.

Frequency of Medical 3/13/98 5/18/98 DONE Examinations for Use of Respiratory Protection Equipment Low-Level Waste Shipment 3/1/98 5/18/98 DONE Manifest Information and Reporting Performance Requirements 6/30/98 5/18/98 DONE for Radiography Equipment Radiation Protection 8/14/98 5/18/98 DONE Requirements: Amended Definitions and Criteria j Clarification of 11/24/98 NA Current funding 64E-5.217 Decommissioning Funding mechanism in equivalent in Requirements regulations. See place since 64E-5.217, 7/17/85 Florida Admin!s-trative Code 10 CFR Part 71: Compatibility 4/1/99 with the Intemational Atomic Energy Agency Medical Administration of 10/20/98 Proposal being End 1999 Radiation and Radioactive submitted (patient Materials. '

to individual)

Termination or Transfer of 6/16/99 NA Only H&S NA Licensed Activities: compatibility is to l Recordkeeping provide for trans-l Requirements.

fer of decommis-sioned licenses to new licensees.

Florida Law pro-hibits this transfer.

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J 10 CFR RULE DATE DATE OR CURRENT EXPECTED l DUE ADOPTED STATUS ADOPTION Resolution of Dual Regulation 1/9/00 Proposal being End 1999 of Airbome Effluents of submitted Radioactive Materials; Clean Air Act Fissile Material Shipments 2/10/00 and Exemptions Recognition of Agreement 2/27/00 Proposal being End 1999 State Licenses in Areas submitted Under Exclusive Federal Jurisdiction Within an Agreement State Criteria for the Release of 5/29/00 No action to be Pending Individuals Administered taken until NRC NRC Part 35 Radioactive Material completes current proposed massive revi- revisions slons proposed to 10 CFR Part 35 Licenses for industrial 6/27/00 Radiography and Radiation Safety Requirements for Industrial Radiography Operations: Final Rule Radiological Criteria for 8/20/00 License Termination Radioactive drug: Capsules 1/2/2002 Proposal being End 1999 containing carbon-14 urea for submitted "in vivo" diagnostic use for humans

30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normallength of time anticipated to complete each step.

After the program drafts the proposed regulations, the bureau publishes a notice in the Florida Administrative Weekly offering to hold a workshop about the proposed regulations. After the workshop (if held), the bureau publishes a notice in the Florida Administrative Weekly of proposed rulemaking and offering the opportunity for a public hearing on the proposed rules.

After the date of the proposed hearing, the department prepares the final regulation and files it with the Florida Secretary of State. A 21-day notice must be given for the workshop and another 21-day notice must be given for the proposed rulemaking. The final rule must be filed within 90 days of the notice of proposed rulemaking.

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11. Sealed Source and Device Program

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices I issued during the review period. The table heading should be: 1 SS&D Manufacturer, Type of Registry Distributor or Device Date Number Custom User or Source issued FL-10010d-101-S Amdel Limited Corporation Device Fixed Gauge 1/26/96 Radioactive Materials License l Number 2717-1 i FL-100100-102-S Amdel Limited Corporation Device Fixed Gauge 10/28/96 Radioactive Materials License Number 2717-1 FLO714-S-101-S Blonucleonics, Inc. Sealed Source 9/6/95 ,

Radioactive Materials License (Co 57 Flood Source  :

Number 2605-1 NARM) l 4

32. What guides, standards and procedures are used to evaluate registry applications?

a. U. S. department of Health and Human Services Publication FDA 81-8025 June 1981, Guides for Naturally Occurring and Accelerator-Produced Radioactive Materials (NARM)

b. U. S. Nuclear Regulatory Commission Regulatory Guide 10.10 March 1987, Guide for the Preparation of Applications for Radiation Safety Evaluations and Registration of Devices Containing By-product Material

c. U. S. Nuclear Regulatory Commission Regulatory Guide 10.11 June 1987, Guide for the Preparation of Applications for Radiation Safety Evaluatius of Sealed Sources Containing By-product Material

d. American National Standards institute Standard N538, Classification of industrial lonizing Radiation Gauging Devices October 1979 j American National Standards Institute Standard N540, Classification of Radioactive Self-e.

Luminous Light Sources January 1976

f. American National Standards Institute Standard N432, Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography January 1980,

g. American National Standards Institute Standard N542, Sealed Radioactive Sources Classification July 1978

h. Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations NUREG -1550 October 1996

1. Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration (NUREG-1556, Vol. 3) July 98

33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:

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Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 "

Responses to incidents and Allegations - A.V.20-23 Technical Staffing and Training - A.lll.11-15:

Michael Stephens and Bill Passetti have attended SSDR courses and workshops. See answers to questions 11-15 for specifics. In addition, the departrnent has 1997 SSDR workshop training materials as reference materials.

Technical Quality of Licensing Actions - A.IV.16-18:

A.IV.16. See answer to question 31 (2605-1 and 2617-1)

A.IV.17. See answer to question 17 (No Exceptions Provided in SSDR reviews)

A.IV.18. See answer to question 18 (No changes)

Responses to incidents and Allegations - A.V.20-23:

No incidents or allegations identified have been identified with either of the products distributed through the SSDR or Florida Radioactive Materials Licenses identified in the answer to question 31 above.

Ill. Low-level Waste Program

34. Please include information on the following questions in Section A, as they apply to the Low-level Waste Program:

Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Quality of Inspections - A.II.7-10 Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 N/A IV. Uranium Mill Program

35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:

Status of Materials inspection Program - A.I.1-3, A.l.6 Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.lll.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 i

Florida has no licenses that produce uranium mill tailings.

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PLORIDA DEARTMEbfr OP Jeb Bush Governor HEALT Robert G. Brooks, M.D. (

Secretary s

April 6,1999 1 4

Mr. Paul H. Lohaus, Director Office of State Programs U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Mr. Lohaus:

This is in response to your March 19 letter about the recent on-site evaluation of our Agreement State Program that regulates the use of radioactive materialin Florida.

I recommend some technical changes to the draft team evaluation report, as listed below.

Page 4, Section 3.2, Second Paragraph Change the paragraph to read: Currently there are 24 radioactive materials inspectors operating out of six state field offices and two county offices. Allinspectors are trained to perform x-ray and radioactive materials inspections, response to radioactive materials incidents and response to incidents at the nuclear power facilities.

Pages 4-5, Section 3.2, Fifth and Sixth Paragraphs Change the paragraphs to read: The inspectc,s fill out a report of two or more pages. The first page is the contact form and contains licensee data, persons contacted, type of inspection, time

' spent for the inspection, inspector's and supervisor's signature, and other administrative information. The second and subsequent pages of the inspection report are summary sheets denoting violations of regulations or license conditions, documentation to support the violations, recommendations made to the licensee, unresolved or licensing issues, and exit interview discussions and comments. This report, along with the inspection field notes, is sent to the Tattahassee Radioactive Materials Section within 15 days of the inspection.

The inspection report and field notes are reviewed and signed by the field office manager. Once received in Tallahassee, the inspection coordinator reviews the inspection findings and prepares appropriate correspondence to the licensee. The inspection coordinator contacts the inspector or office manager for clarification of the inspection findings if necessary. The Radioactive Materials Administrator reviews and concurs on allinspection correspondence. Subsequent correspondence between the licensee and the BRC is conducted with the Tallahassee office.

In addition, I have the following comments about the team's five recommendations on Page 15.

2020 Capital Circle SE = Tallahassee, FL 32399-0700 AM &&? ' f

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1. We have continually increased our efforts on reciprocity inspections over the last several years, in 1998 we inspected 24 of the 50 licensees that entered the state. We will continue our efforts to complete inspections of high priority reciprocity licensees to satisfy the percentages specified in IMC 1220. We have designated an individual to assist in meeting these requirements and have changed their position description accordingly.

2. Field offices have always sent field notes to the Tallahassee office with the inspection reports within 15 days of the inspection. We performed 2,002 specific license inspections during the time period that your team audited. Of the two inspections found to be without field notes, one was already in the process of being rectified and the other appears that the field notes were misplaced. However, tu reinforce this requirement, we will remind field office managers during the next quarterly staff meeting.

3. We have one waste processor licensee and two large panoramic megacurie irradiator licensees, one of which sterilizes medical products and the other sterilizes food. The field offices that inspect these licensees have developed unique field notes for these inspections. We will remind the field offices to use the approved field notes based on the regulations as well as the unique field notes for these licensees. The unique field notes will be reviewed and approved and incorporated into our procedures.

4. We will revise SOP 1 to incorporate those parts of SA-300 and NRC Management Directive 8.8 that are appropriate to our programs and statutes. We will document close out of incidents and allegations with management approval.

5. We plan to start the rule promulgation process of the required revisions to Part 20 soon.

I hope I have addressed all of your concerns. Thank you again for the opportunity to meet and discuss the program with you. If you have further questions, please contact Bill Passetti at (850) 487-1004.  :

Sincerely, hw Sharon Heber, M.P.H., Director Division of Environmental Health l

SH/ rat

O Aaenda for Manaaement Review Board Meetina Thursday. May 20.199910:00 a.m. - 12:00 p.m.. TWFN. 2-B-5

1. Convention. MRB Chair convenes meeting

2. New Business - Consideration of Florida IMPEP Report A. Introduction of Florida IMPEP Team Members (D. White)

B. Introduction of Florida representatives and other State representatives participating through teleconference.

C. Findings regarding Florida Program (IMPEP Team)

Status of Materials inspection Program Technical Quality of Inspections Technical Staffing and Training Technical Quality of Licensing Actions Response to incidents and Allegations Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program D. Questions (MRB Members)

E. Comments from State of Florida F. MRB Consultation / Comments on issuance of Report Recommendation for next IMPEP review

3. Status of Upcoming Reviews

4. Adjournment A_ttendees: Frank Miraglia, MRB Member, DEDR Paul Lohaus, MRB Member, OSP Karen Cyr, MRB Member, OGC Carl Paperiello, MRB Member, NMSS Edgar D. Bailey, California, OAS Liaison to MRB William Passetti, Florida Duncan White, IMPEP Team Leader, RI Richard Woodruff, IMPEP Team Member, Ril Steven Gavitt, IMPEP Team Member, NY Joseph DeCicco, Team Member, NMSS Thomas O'Brien, IMPEP Team Member, OSP Kathleen Schneider, OSP Lance Rakovan, OSP Brenda Usilton, OSP ATTACHMENT 2