ML20195G924
| ML20195G924 | |
| Person / Time | |
|---|---|
| Issue date: | 02/22/1999 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20195G922 | List: |
| References | |
| NUDOCS 9906160212 | |
| Download: ML20195G924 (85) | |
Text
[V r:.
j.
i i
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l
REVIEW OF FLORIDA AGREEMENT STATE PROGRAM February 22 - 26,1999 l 1
1 l
f
- 1 FINAL REPORT l
U.S. Nuclear Regulatory Commission i i
4 l
) l i
i i 9906160212 990525 PDR STPRG ESOFL PDR l
l l
i j
L 1
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l
REVIEW OF. FLORIDA AGREEMENT STATE PROGRAM February 22 - 26,1999 'l i
FINAL REPORT i
l i U.S. Nuclear Regulatory Commission !
l l
1
)
l l
3
Florida Final Report Page'1
1.0 INTRODUCTION
This report presents the results of the review of the Florida radiation control program. The i review was conducted during the period February 22-26,1999 by a review team comprised of t 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 Statement'of Policy," published in the Federal Register on October 16,1997, and the November 25,1998, revised NRC Management Directivo 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 i A draft of this report was issued to Florida for factual comment on March 19,1999. The State responded in a letter dated April 6,1999. The Management Review Board (MRB) met on May - !
20,1999, to consider the proposed final report. The MRB found the Florida radiation control program was adequate to protect public health and safety and compatible with NRC's program.
The Florida Agreement State program is administered by the Bureau of Radiation Control (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 include.s inspectors in'six field offices and two counties under contract. The Administrators of the Field Operations Section, Envircnmental Radiation Labs Section and Radioactive Materials Sectiorveport to the Chief, BRC. Organization charts for the BRC and DOH are included as Appenda 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 cepy of the questionnaire is included in Appendix G of the draft 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 database; (4) technical review of selected licensing and inspection actions; (5) field 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.
I i
Florida Final Report Page 2 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-common performance indicators, and Section 5 summarizes the review team's findings and recommendations. Recommendations made by the review team are comments that relate directly to program performance by the State.
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 Hunter, 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 letter. 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 Melbourne, 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 c.onfirmatory survey, the license was terminated on
- January 17,1996 and the facility released for unrestricted usa. 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.
Florida Final Report ' Page 3 3.1 ~ Status of Matenals inspecten Program The team focused on four factors in reviewing the status of the materials inspection program:
l inspection frequency, overdue inspections, initial inspection of new licensees, and the timely A dispatch of inspection findings to licensees. The evaluation is based on the Florida t
- questionnaire responses relative to this indicator, data gathered from reports generated from the
' licensee databases, examination ofinspection reports, and interviews with BRC staff.
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 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.
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
-- are generated by the Radioactive Materials Section. Therefore, the Radioactive Materials Section at the Tallahassee office generates, on a quarterly basisi the schedule for the 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 quarterly scheduling report generated by the Tallahassee office. A policy exists for establishing
- the'date for the next scheduled inspection based on the date of the last inspection and the
. inspectiun 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 t ~ required by the NRC, the scheduling of inspections does not fall outside of NRC requirements.
In their response to the questionnaire, the State indicated that they had no inspections overdue 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 initis; 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 l 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
I i-
- Florida Final Report Page 4 considered this data and noted that the State has an established policy of performing pre-licensing visits by licensing stJf and/or inspectors. This mechanism for inspecting and 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 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 goalin 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 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 J response in importance,' and began tracking these inspections separately from the routine inspection to place more importance on their completion.
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 corresoondence timely, noting that BRC conducts approximately 500 inspections annually, and the Tallahassee office coordinates inspection correspondence from eight field 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.
I
. F1 rida Final Report Page 5
. Currently there are 24 radioactive material inspectors operating out of six state field offices and two county omces. Allinspectors 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 ar's 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.- The review team found that inspection reports were thorough, complete, consistent, and of high quality, with sufficient documentation to ensure that licensee's performance with respect to health and safety was acceptable. The documentation supported violations, recommendations made to the licensee, unresolved safety issues, and discussions held with the licensee during exit interviews. Team inspections were performed when appropriate and for training purposes.
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 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 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 allinspection correspondence. Subsequent correspondence between the licensee and the BRC is conducted with the Tallahassee office.
1 Inspection findings, including escalated enforcement actions, are routinely sent to the licensee J
, 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 discussed the l field offices timely transmittal of field notes to Tallahassee to facilitate the preparation of
. correspondence to the licensee.
y Florida Final Report Page 6 Field notes have been developed to cover most types of inspections that are conducted by the BRC. These feld 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 fold notes for the inspection of a waste processor and a panoramic i f
^
irradiator, respectively. Other fold 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.
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 suppon ha 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 onvironmental dosimetry around nuclear facilities.
The laboratory also has a calibration facility that provides low and high range calibration of portable instrumentation used by local govemments 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 fielci offices. The inspections included a' private nuclear cardiology facility, two radiopharmacies, e private brachytherapy facility with an
' HDR unit, and two institution &l nuclear medicine facilities. These accompaniments are also identified in Appendix C. During the accompaniments, the Florida inspectors conducted performance based inspections and demonstrated thorough imowledge 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.
3 i
" +- .
j y
i f Florida Final Report Page 7 Based on the lMPEP 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 Staffina and Training 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 j
' li::ensing 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 l among six field offices throughout the State. The inspectors spend about 18% of their time
~
i 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 were filled during the review period. Currently, three field office positions are vacant,'and there i is no intent to fill them in the immediate future, justified by the decreased frequency of required I x-ray equipment inspections, j
' The BRC' also has contracts with Polk and Broward Florida counties to perform material and x- j 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 l receive the same training and are required to follow the same inspection and incidence response guidance as the State field offices. l 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 staff qualifications because the new positions require a bachelor degree or. equivalent; the incumbents 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 1 team concluded that the number and distribution of staff appear to be adequate to maintain the program.
, . i e ' e
L
_f'
. Florida Final Report Page 8 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 l
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 l 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 inspectors l
- are accompanied frequently, often several times in one year, on various categories of licensees. l
- 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 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.
' 3.4 Technical Quality of Licensino Actions The review team examined completed licenses and casework for 25 licensing actions, 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.
1
~
1
, Florida Final Report Page 9 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, qualifed 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 intemet 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 l followed.
l 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, the licensing section will address them with the applicant and reschedule the pre-licensing visit.
The program processed 5381 licensing actions during the review period. These consisted of f' 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 i 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 l 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 Alleoations 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 incidents reported for Florida in the " Nuclear Material Events Database" (NMED) against those
p l
- Florida Final Report .
Page 10 contained in the Florida files, and evaluated the casework and supporting documentation for 12 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 allegations, five of which were refe red 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 j
Emergency Response Group under the Environmental Radiafon Labs Section in Orlando.
When notification of an incident or an allegation is received, the Emergency Response Group 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.
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-up/ enforcement actions.
' 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 that is in NRC Management Directive 8.8, (e.g., the State has no definition specified for the term " allegation")
the State does take prompt and appropriate action in response to the concerns raised.
The' 12 incidents selected for review,'out of the 136 submitted as reportable incidents, included I 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 l responses to incidents were complete and comprehensive. Initial responses were prompt and I 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.
S p
b 1%tida Final Report' Page 11 The review team also noted that . allegations were treated and documented in the same manner L. as incidents. The team noted that, in accordance with State law, no measures exist to protect
. allegation related information except for medical records and social security numbers.
The review team recommends that BRC revise their incident and allegation procedures to i- document all existing State practices and to incorporate appropriate elements of OSP Procedure SA-300 " Handbook on Nuclear Event Reporting in the Agreer . n. States" and NRC Management Directive 8.8, " Management of Allegations," pa uw ly 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 L 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.
4.1 Leaislation and Prooram Elements Reauired for Compatibility 4.1.1' Leaislation
= 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 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.
4.1.2 Proaram Elements Reauired for Comoatibility 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 material including 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 l Secretary of State; after which the rules become effective in twenty days. The regulation L adoption process is provided in Chapter 1S-1 of the FAC. The public, the NRC, other agencies, L and all potentially impacted licensees and registrants are offered an opportunity to comment
Jir Florida Final Report . Page 12 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:
.*- " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 ,
amendments (59 FR 36026) that became effective August 15,1994. J 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.
- " 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 that NRC and the State would require this national system to be effective at the same time.
e' " 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 'quirements. 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). I 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.
e: " Resolution of Dual Regulation of Airbome Effluents of Radioactive Materials; Clean Air
' Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.
i c I
Florida Final Report Page 13 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.
e " 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 30,34,71, 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.
e ' " Exempt Distribution of a R'adioactive 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.
e " License for Industrial Radiography and Radiation Safety Requirements for Industrial Radiogra'phic 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 during this calendar year. The State has deferred the medical regulation update until the final 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.
l
Florida Final Report Page 14
' 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 l 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 Prooram
.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 States Cne 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 fo! lows 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 foi any future reviews. All pertinent American National Standards Institute (ANSI Standards), Regulatory Guides, and workshop references 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 Staffina and Trainina -
- The Radioactive Materials Administrator conducts the SS&D reviews and is in the process of t'aining 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 have many years of experience and training in health physics. Both individuals are considered
- fully trained for licensing and inspection under the common performance indicator, Technical
, Staffing and Training. The team found that the SS&D reviewers work together closely when conducting a review and discuss issues and concems 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.
Florida Final Report - Page 15 4.2.3 Evaluation of Defects and incidents Regarding SS&Ds No incidents related to SS&Ds occurred during the review period, nor were there any defects reported.
83ased 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) Disposal 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 facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Florida. Accordingly, the review team did not review this indicator.
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found Florida's performance to be satisfactory for all of the indicators. Accordingly, the review team recommended and the MRB concurred in finding 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.
RECOMMENDATIONS:
- 1. 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. (Section 3.2) 2; The review team recommends that BRC revise their incident and allegation procedures to document all existing State practices and to incorporate appropriate elemer of OSP Procedure SA-300 " Handbook on Nuclear Event Reporting in the Agreement E 1 <s" and NRC Management Directive 8.8, " Management of Allegations," particularly the required documentation and management approval for closing out incidents and allegations.
(Section 3.5)
r l
L L Florida Final Report Page 16
- 3. . 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.
l (Section 4.1.2)
GOOD PRACTICE:
i l
- 1. - A good practice noted by the review team consisted of a basic health physics training l 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) l i
l.
l l
l i-
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 1,cident Casework Reviews Appendix F Sealed Source and Device Casework Reviews Attachment Florida's Response to Draft IMPEP Report Dated April 6,1999 l
l j
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 Steven Gavitt, New York State Health Technical Quality of Licensing Actions Thomas O'Brien, OSP Response to incidents and Allegations Richard Woodruff, Region 11 Legistriion and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program inspection Accompaniments L_
r ---
1 l-l.
t
{
l l
4 APPENDIX B STATE OF FLORIDA l
DEPARTMENT OF HEALTH l and I' BUREAU OF RADIATION CONTROL ORGANIZATION CHARTS !
4 I
I l
l l
1 i
i i
m ; ., .....- . ._.,
m m . . . ,
I se i v ' =
t i= i : q l
~ ~
,i .
... .- . i le e_. .
i lh y
g L,i 8
nR a I
3l IIlld,,!!
gS i jS j i iI
,\
h) ;] ';; a - =;
@ "g, ; q i gE >,
ni ni l -
5 -
.o g- - ,
r ; y-y- - -, .
e
- l .l
=l{ j s I 1
ell '
=j e d
sl ,
l
,1 .i : ,l a 1 ,1 3] 1
O E_
-]
1aIt I a
b i
I*i 'l
- w ln 4 -
, Il i ,! ! ,i s a n mi Ic- :)
g :J
,. d
- 1 s al}
g i;
- a. g
,ao ..
q E
= '; a S b k [
dB ;]l
[kE
.z a
, i;
~h
) "7
-Si !
5E e,.
s: . -
I 0
2 E h, 9
I a
q1. q y q ,
" f -
- n. -
. - hl s e J1 3 e. v t
e . 2 A .
n A -
s 9 2
eRt g t 1
8o 1
, e t s a 1 n e aWs g
4E me- _
eK, 4I i Gm s A E n s 5 R. Ct - Cum C Ce e nm
= E N e. .
E. Ee r
Es Eh e
- "TO A
I NteP f
me s
-m ri 1Ges 1
RO 2N R 4
Pb So - Pn So 2NOCt 2
2 2N P
S r 20 Pe SC h f.
8 t
- R a -
29e Ne OP
. 0 0M Oe OS .
Re x D t P. Os O e e
_ f no P I W E W t a- NE .- WT W m_ B, W W W M "EO We Nt w Ns 3 - N5 -
Ne Nr e S-. _ Ees EeF Eee Em
^o e 8Er a . e w - r 8 7 7 1 1 1 2 t S M 4 8 e 1 s q q q hc el,J J. hf 9' , -
. MNCefJ.c eRtom 3 o t A e o t o D 2 9 ,
2 dE t
s t , e a
dey 1
= s e t d W t
e t
- 5 i e t e
4 N t 1
t 1
0 I 4N 1
S G i eK. R. . Ce s C _
C Ce .
En d Ce e ,
N A a Nm EIS Em v Ele . Ed En .
Et Pe s O As -
PAB S PB Pr Sac Po t SS Pe r Se q YTF S y u Sn I
6Mo
- 0BWL -
T n 4 s RAM 2 A rI 1 R
2 Nip =
2 2 2Nn 2 2 No u 2 2Ne MNi e 2N :
1G-2 -
TD R NsA O
t r 0 Oso w Ro Oo OJ u Om Ra 4 OO.
RA r
FN ETF HE VT W N0 T U 2 E
P O
R Ms
. e I WJ N12 w WW Ns2 n Wv Ns IL V
NFF W
N0 M t o_
-. m S 5 9 S 0ECOE m -
D= E F e E5F r E 4 Ee Ee r_
- Em I e -
e e tO f
PDFEB EC L 8Ee 4 s
= 8 4
r 3
. s a s e w 4 S 3 r 8 4
5 5 # 4 e 4
e 4
L PUFTA AeEFT hI 3 Je 1" u :.
3 o t 3 2 A s o 0 0 -9 s e
S e e 1 e t 2 t t N eRt c s eM 1
y a 0 4 N q g ..
J_ hhn 4E 4 sEr A Ny O Gn e eK, R Cc M Cev m Ce Cd Ee e I
T A e E. Eo ; Es Ee .
NL A Nn Pn ; Ps PF OO I
SR R
E P MMo Aie y
w i,I 1C 1R.
L 4
SK 2Ns e t 2 2Ns Pe u Sv i m
2 2N Sk O t.
e r 2
Sn 2 OkNse .
NMT N O No , 0s Ob Os .
RD Roe TDO A 0R ;
eA Ro .
. Re . -
V R V A 4 I I u._ MT L l _
A HC P W W4 u E _
N13 N8e W5 8 MLTN FMf O A A t0 M
A T
2 N7e eEs s r z
e 2
S .,8
. m e 2
E57 5
w e 2
E77 3 z
. e 2
E 7 4 5
r 9
2 De Es 1 4
m
.I _
T _
NMDA -
ET R 3lA 3 q ]g 3d4 I N F 1 o J..
TEO R 3 2
t e . n o Dt 2
t o
t e
S 8 m ANI POM . eRt 4E r e _
s eWC .
e 4Me r e
4W 1
e 1 Cm ERE S Gme Chi DMU R N A Ns s g R E
L
_ Es Ps Ea s Pn m_
Ee Pn sK-.
9B WO I Aa .
tC ._ Se c SeF u Sss n .
E Y T . 2 u 4 2 A NMn No 1R 2 Ma 0v 2N d0y s 2Ne .
M. R 0 O R H.
T FP E 0c 4
W u E eC p
4 W
W
- t s We W L u
S ._ -
O Ws Ne Nt M5 .
g a _ _ _
Nea Eete n F
SW Ee7 u E 2 _
8Er s ,
8 F n 8 8 3 r 3 a a . 3 3 3 s 3 5 _
3 3 q 3iJ 4
3 2 e. _
e .3 t s e A s o e
e t
- s o e
g t r
u 2
1 1Jo. t .
8 Rt o 1 m
. g 8 4E .
eK = d Ne sNe n AN r 4M S Ge c R Cts Ce C Ce s
MT N
0 9
MMe An Na A L tCLM E ,e 2
Ee Pn SA .
2Ns Em Pe Se 2
2Na Et Pn Se c .
. 4 Ed Pu SS n 2 0u Ne Om y. 2Nn t
TA e Rt s 2 OV NR Ns t 0, s Rae R Oe s AE O e m mL i R O ,s Mtt I
LP m p
W _
W o M2 O Wt e E 8 Se Nte u_ 9 Ns c 95 Ns re Ee Eed E72 i Ee 0Es 5 a e ,4 s . m e s 4 7 u se ro v e S
3 5
L s e ed - _
9 3 ]1 1 - _
3 t
P 3
2Rt e
4 E r os e .
td3 s
eK.,
1 s Dt e
o d N t 2
t s
eM y o
t e o s t o
dgr e
c e
da 1 l.
s o s t o
m.
0 Ge Ce r Cs Cs Cm Mss a Rs 9
T 6M.
2 4
mO wI 1 E
L .e C.
1 tf I. _ 2N e Ed n Pe 2 Se b 2N e 4
Eem Pe S,
m xS m.
2 2
Ee PM Nes r
i e
2 2Ns m s.
SeS m
N te eo OJ O s eO Os O o W
W J
- Oa O
We Oe ReJ -
Oen O
WP e
b A
I We Ws u l E e N5 a W t Ne e Me f t W
N4 S ,s z.. Ee E 77 E3 Era n .
I M Ns .
, w 3 s r 3 3 r 7
m 3Ee 1 2 n 3 1 3 e 3 1
7 3 1 s 1 e 1 3
~
O S. c .. : .:,. - T FM i : i.: i.: t
?
11 5 11 sl l
a,} ; ali ; ami ,
4 g 1 7 ,
. . .a .I.g ' 1 6 3
lgI -
!':g :
I i e s i.-
11 g
t 4
it i-
- t. ap a l a1
~
d,al ,
. i f .i t .i d! .l a J
1:" 1:l l l gs k a d, aIcl a~5 l11, E 5 gg g si 81 lH 6 ;1 np s .i<i l I l a1 ;"
nl8 o o . .
r r gi g* "1 i P * '
l,lD!. - & ll e f] g .
1 . .a - .. v
.11 e ni.l 1 ge # 81
.1 2 .1 1 rm r- rq g s :' 1.: 5 s.: u i.: ;j
.h 11 ;
u, s =l i ps WL 1
- 4 , ng .:
.g j .g j 3
- r. j i ;
rm m : e ,;
{ . = i. .,i 2 -- n-- r-,
! l . , r 1g l.
l r ilf.
=I 3 =lp s
i: s j ? i-=] I
- i.
il ? ll
- i.= y
.gs 2
J , -
.t .
g -
diap J ap a, p t.
=
1 a e u -
. b . E
. .N '
I
'l
.' - p- 1 2
- m.
3 0 0 0 a 0 0 9 0 1 r.
2R1 8
4 E y Gs
- 0 0
4 N1 Ce o
i 0
0 R 1 4
C r
0 0
4 N C
1 -
c.
Ae ~ EL a r Ese E N
A G Pt Sn a a.
P S
Pi Sd n. 1 1 6MeM 2
Nb Oe u
u m
I 2 2 Oi RR Ni d L:
2 2 EW N
O.
RC r
o w 2 2 NMO RL l
i r,
I RD u I
V4 I
N4 a V
I V
N33 n I V
N4 M N 68 r E35 //
7E0 e 7 7 z 7 E 75 - 7 E 48 n 7 -
3 2 3 5 3 5 3 6
- l 8
g 1
T A 11 N'D;,..
E VN TI.F NCE OUCEOi.
I T ,'
P P
1 8I 4 H o r 0
1 w Cle Ed w Pa 4
SF u :
2Nr e n Ote m RP I
V N00 u 7
E 32 an 3 5 NL O O I
SRT I 3 ,
1 . , q .
, _ ' g 5' HV N 10O f
2 2
0 1 2,
. 9 0
0 4
0 0
1 4
0 0
u 4
0 0
1 4
0 0 _
n.
1 1 1 6 0 0 0 HC s 7 m 0 a E 8Mn f 04y o 0 Kn ; 0 Ks e 0 Ks 0Kn t n
MTN FET L
AO I WS L Me Dph i.r c
I Tc C Ra En t Rt Eo s
Re n En Ra Er y c A
lA GI Aet SM 7 Lo CJ LC LoJ C y :
LB Ca
=
I AR 30NS 5 S y 1 1 C t . 1 1 :
O T 4 H. D OE 1 Ac 1Ry 1Re g u 1Rn z 1Ric NAA 5 Rk Oe Nan z. Oud Ono ,.
i I T ',
Od 0o ETR DA i 9 T I r m I I MN F AM I i VM MM NJ I i NrB NM _
TE R N5 D 0 . E S 2 E O S 73 -
E 5 RM O ANU 7 E9 6 n E 7 A0 6
8 u 7 9
6 0 r S 18 2
a T
4 6
r 7 S
5 2
7 n POA 3 6
2 3 2 3 2 7 3 r 3 2 3 5 3 5 ERE DIV R NU S E
<=
2 1
0 1
8I .
4 N r -
Clo c Eo e PC r -
Sr e i 4
2Nt Oa '.
RW I
V N 06 1 E9 7 0 3
r 3
. ' , o ,
.'
- d 9 9 0 3
2R1 0
- . 0 8 W n t 0
1 r 0 eNr e 1 '
48 E -
4 4 Ge r. Co .. s Clg r.
As Nu - En c Pe En Ao Sh PM S '
0Mve m1 2
2 2 Npe m 2
2 Ny S
r
- Na i q
Ot . On RaL r OP R
I S.
R c, V J 3 IV I
V1 3 . N9 n N5 w N 3 vm E 79 E 40 .
7E1 3 3
7 3
7 3
m 7 3
6 0
e
L': ym n a i s l ;4 i
=lg!
aln ol i- . ! .
j IWl J
se s i n,
-l .-l f U pt =ga
=5! 5l ai d l!!,?
9 s
RE 5 l1' 4 l* 0l h i
.s u . . _
IIle 4
i *l:
l :l g
1 :i; .p s q$ I i U h n p u R ;
k E! E R E W k i I
1 l
l r, - i
-1 m 1 ; Ip !
j "l j !
"1l
- n. i g.
=n
- t -
1 I
et 1
,_ - .m , ..
I ,8 I l0 lI, ;
lsj k
e l
3 < !
I st - -
- y : -
uE -
k h } !
y ~ u ic l a e S 2 - I Q
~
b g# ,,
,1 IP
! ay i la h llla an a r r-- r- .t y r g o ;
.g I E , ,
a f U y ri U ;<
-j Q
n, e xE r, x . an. 9 5
C E
?
h g] 4-l d 2 g 3 k si s 5 ' sa s ml ' l O
9
APPENDIX C INSPECTION CASEWORK REVIEWS 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 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 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
I
~
Florida Final Report Page C.2 i inspection Casework Reviews File No.: 6 Licensee: DeSoto Memorial Hospital License No.: 1371-2 Location: Arcadia, FL Inspection Type: Routine, Unannounced License Type: Medicalinstitution Priority: 2 4 Inspection Date: 4/16/97 Inspectors: KC/SH File No.: 7 Licensee: Bethune-Cookman College License No.: 1060-1
' Location: Daytona Beach, FL Inspection Type: Routine, Unannounced License Type: Academic Specific Priority: 2 Inspection Date: 8/24/95 Inspector: LS File No.: 8 Licensee: J&M Testing Lab License No.: 1763-1 )
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 l Inspection Date: 4/9/98 Inspector: MK {
i File No.: _10 ;
Licensee: Mt. Sinal Medical Center of Greater Miami License No.: 0064-3 j Location: Miami Beach, FL Inspection Type: Routine, Unannounced l License Type: Broad Medical Priority: 1 l Inspection Date: 3/5-7/96 Inspector: PS File No.: 11 Licensee: Baptist Hospital of Miami License No.: 0614-2 l
. 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.: 2598-1 Location: Gainesville, FL Inspection Type: Routine, Announced i License Type: Waste Processing Priority: 1 (6 months)
Inspection Date: 8/19/97 Inspector: PP l Comments: I a) Same inspector performed last five inspections at facility. l b) Inspection field notes specific to facility developed by Jacksonville office. Field notes did j not include documentation for ALARA program, operating and emergency procedures, l training program, security and transportation.
1
- r. j u-1 4
Florida Final Report - Page C.3 inspection Casework Reviews i
File No.: 13
- Licensee: Florida State University License No.: 0032-10 Location: Tallahassee, FL Inspection Type: Special, Announced J 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 1 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: .
i a) Acknowledgment letter did not address licensee's denial of some violations, File No.: 15 I Licensee: Winter Haven Hospital - License No.: 2845-1 )
Location: Lake Wales, FL Inspection Type: Initial, Announced {
License Type: MedicalInstitution Priority: 2 i inspection Date: 6/4/98 Inspector: TM File No.: 16 Licensee: Delray Nuclear Center License No.: 2464-1 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 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
- -1 Florida Final Report - Page C.4
= Inspection Casework Reviews-File No.: .19
. Licensee: Everglades Regional Medical Center - Ucense No.: 0844-1 Location: Paholee, FL. .. Inspection Type: Special, Announced Licensee Type: Medical Institution - . Priority: 2
. Inspection Date: 7/1 and 10/98' Inspector: MUMB
- File No.: 20 Licensee: Mallinckrodt Medical- License No.: 1937-2.
Location: Ft. Lauderdale, FL _ Inspection Type: Special, Announced i License Type: Nuclear pharmacyL 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: .
a) Inspection field notes specific to facility developed by Polk County office. These field notes could be utilized by BRC staff.-
File No.: 22
- Licensee: University of Southern Florida .
License No.: 0806-1 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:
La) 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: Melboume, FL' Inspection Type: Routine, Unannounced License Type: Nuclear pharmacy Priority: 1 Inspection Date: 8/25/97. Inspectors: JB/JB i
.L 1
(
i
[:.' u I
I' 'i Florida Final Report Page C.5 Inspection Casework Reviews 1
INSPECTOR ACCOMPANIMENTS l The following inspection accompaniments were made as part of the on-site IMPEP review:
Accompaniment No.: 1 Licensee: Louis Alberto Fernandez, MD, PA License No.: 2274-1 Location: Hialeah, FL Inspection Type: Routine, Unannounced License Type: Medical / Private Practice Priority: 4 Inspection Date: 2/1/99 Inspector: MB Accompaniment No.: 2 j Licensee: Syncor International 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 1 Accompaniment No.: 4 l Licensee: Morton Plant Health License No.: 0021-1 Location: Clearwater, FL Type Inspection: Routine, Unannounced i License Type: Medical Institution Priority: 2 l 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: Routine, 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
l
i 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 Ucense Type: Instrument Calibration and Analytical Senrices 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 1
File No.: 3 Licensee: Cargill Fertilizer, Inc. License No.: 2970-1 Location: Ft. Meade, FL Amendment No.: N/A l License Type: Broad Industrial /R&D Type of Action: New 1 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 4 File No.: 6 Licensee: Nuclear Medicine of Central Florida License No.: 2357-3 !
Location: Brandon, FL Amendment No.: 13 l License Type: Medical / Private Practice Type of Action: Amendment !
Date issued: 9/14/98 Reviewer: RL 1
File No.: 7 l 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
Florida Final Report Page D.2 License Casework Reviews
. File No.: 8 Ucensee: 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 Ucensee: Greenhorne & ODMara, Inc License No.: 2143-1 Location: West Palm Beach, FL Amendment Nos.:5&6 Ucense 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: Portable 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 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 Amendment No.: 4 License Type: Specific (Other) Type of Action: Renewal 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 Reviewor: CH File No.: 16 Licensee: Gamma Diagnostics Ucense No.: 2125-7 Location: Sarasota, FL .
Amendment No.: 10
. License Type: Medical / Private Practice Type of Action: Termination Date issued: 1/25/99 Reviewer: CH
m-Florida Final Report Page D.3 License Casework Reviews -
File No.: 117 . . .
e ~ 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 e . Location: Daytona Beach, FL Amendment Nos.: 1,2,&3
' License Type: Radiopharmacy 1 .
Type of Actions: Amendment Dates lasued: 3/21/96; 6/25/97; and 4/15/98 - Reviewer: JS & LS -
File No.: 2122 1
- Licensee: St. VincentUs Med. Ctr. License No.: 0014-1 Location: Jacksonville, FL ' .. Amendment Nos.: 94 & 95 License Type: Medical Institution 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 lasued: 12/10/98 Reviewer: JS ,
File No.: 24 i Licensee: National Diagnostics License No.: 2634-1 i Location: Orange Park, FL Amendment No.: 6 License Type: Medical / Private Practice Type of Action: Amendment Date lasued: 8/25/97 Reviewer: JS p
i File No.: 251 Licensee: Hospital Corp. of Lake Worth - License No.: 0829-2 {
Location: Lake Wodh, FL - . Amendment No.: 10 !
' License Type: MedicalInstitution Type of Action: Termination !
Date lasued: 8/24/97 ' Reviewer: PF 1 I
o 1
ls
7 APPENDIX E INCIDENT CASEWORK REVIEWS 1
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 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 l-131. The bags were impounded and were held for decay and disposal by the State.
File No.: 3 Licensee: Longview Inspection incident ID No.: 95-096 Location: Orlando, FL License No.: 2239-1 Date of incident: 7/12/95 Type of incident: Overexposure 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 apparently 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 l 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 i left on a reception desk. The maximum dose received by an individual was 67 mrem. The State inspected the licensee and issued yiolations.
l 1
l i.
J I
=
s H Florida Final Report Page E.2 incident Casework Reviews O 9 .. File No.: 5 - .
. License: Lee Moffit Cancer Research Center incident ID No.: 96-072 Location: Tampa, FL .
Licensee No.: 1739-1 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.
'.Licensee:
File No.: 6 - Power Corporation Florida '
incident ID No.: 97-034 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.
k" ! 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- i repair.
. File No.: 8 Licensee: Syncor Intemational Corporation ' Incident ID No.: 98-047 Location: Jupiter, FL License No.: 1264-9 l Date of incident: 4/22/98 .
Type of incident: Loss of control of radioactive material
. Investigation Date: 4/22/98 Investigation Type: On-site i i
- 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 j and bloassays. No contamination or internalization occurred.
i i
l
I l
l f .'
l l
Florida Final Report Page E.3 Incident Casework Reviews 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 missing gauges and none was missing that contained the sources.
~ 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. I l
l I
s 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: 1/26/96 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
RID DEP T Job Bush Roben G. Brooks, M.D.
Governor Secretary April 6,1999 Mr. Paul H. Lohaus, Director Office of State Programs U.S. Nucleat 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 l 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 inspectors fill out a report of two or more pages. The first page is the contact form and contains licenses data, persons contacted, type of inspection, time spent for the inspection, inspectors 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 licenses, 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 l Materials Administrator reviews and concurs on allinspection correspondence. Subsequent l
correspondence between the licensee and the BRC is conducted with the Tallahassee office. l l
In addition, I have the following comments about the team's five recommendations on Page 15.
l I
2020 Capital Circle SE
- Tallahassee, FL 32399-0700 I
3
- 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, to reinforce this requirement, we
' vill 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.
l hope I have addressed all of your concems._ Thank you again for the ooportunity to meet and discuss the program with you. If you have further questions, please contact Bill Passetti at (850) 487-1004.
Sincerely, fLa Sharon Heber, M.P.H., Director Division of Environmental Health SH/ rat
f a
f* "%,t l UNITED STATES f', j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2056t@001 o
- May 25, 1999 Sharon Heber, M.P.H., Director .
Division of Environmental Health j
/
Florida Department of Health 2020 Capital Circle, SE, Bin #A08 Tallahassee, FL 32399 1709 1 l
Dear Ms. Heber:
I On May 20,1999, the Management Review Board (MRB) met to consider the proposed final l Integrated Materials Performance Evaluation Program (IMPEP) report on the Florida Agreement State Program. The MRB found the Florida program adequate to assure public health and safety and compatible with NRC's program. i Section 5.0, page 15, of the enclosed final report presents the IMPEP team's ,
recommendations. We received your April 6,1999 letter which described your actions taken in response to the recommendations in the draft report. We request no additionalinformation.
Based on the results of the current IMPEP review, the next full review will be in approximately 4 !
years.
I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your support of the Radiation Control Program. I look forward to our agenc'es continuing to work cooperatively in the future.
4 Sincerely, r
Frank J. M lia, .
Deputy Executive Director for Regulatory Programs '
Enclosure:
As stated cc: William A. Passetti, Chief Bureau of Radiation Control l
L
^l .
.l.
)
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF FLORIDA AGREEMENT STATE PROGRAM February 22 - 26,1999 l
FINAL REPORT l
i i
I 1
i U.S. Nuclear Regulatory Commission i
i
T 1
^^
\. t' I .
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF FLORIDA AGREEMENT STATE PROGRAM February 22 - 26,1999 :-
FINAL REPORT l' l I
l 1
U.S. Nuclear Regulatory Commission l
i l
l' I
i I
L-
l t
Florida Final Report Page1 1.0 < lNTRODUCTION 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. Geview 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 Statement 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 draft of this report was issued to Florida for factual comment on March 19,1999. The State responded in a letter dated April 6,1999. The Management Review Board (MRB) met on May 20,1999, to consider the proposed final report. The MRB found the Florida radiation control program was adequate to protect public health and safety and compatible with NRC's program.
The Florida Agreement State program is administered by the Bureau of Radiation Control (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.
l In preparation for the review, a questionnaire addressing the common and non-common I 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 G of the draft 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 database; (4) ;
- technical review of selected licensing and inspection actions; (5) field accompaniments of six Florida inspectors; and (6) interviews with ste# 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.
Florida Final Report' Page 2 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 l
indicators are presented in Section 3. Section 4 discusses results of the applicable non-common performance indicators, and Section 5 summarizes the review team's findings and recommendations. Recommendations made by the review team are comments that relate directly to program performance by the State.
2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS
.The previous review of the Florida radiation cmtrol 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 Hunter, Deputy State Health Officer, Department of Health and Rehabilitative Services. Both items were discussed in the NRC's Fetuary 14,1996 letter to Florida based on the State's June 28,1995 response letter. The team % 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. i l ..
Florida Final Report Page 3 3.1- Status of Materials inspection Proeiem 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 staff.
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 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.
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 are generated by the Radioactive Materials Section. Therefore, the Radioactive Materials Section at the Tallahassee office generates, on a quarterly basis, the schedule for the inspection groups in the field offices. A monthly status report to the Field Operations Administrator in r 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 quarterly scheduling report generated by the Tallahassee office. A policy exists for establishing the date for the next scheduled inspection based on the date of the last inspection and the 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 hispection 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 response to the questionnaire, the State indicated that they had no inspections overdue 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 cix 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 i
I
.v
._.j..
I Florida Final Report Page 4 -
considered this data and noted that the State has an established policy of performing pre-licensing visits by licensing staff and/or inspectors. This mechanism for inspecting and
- 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 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 goalin 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 days. Field sites were sometimec 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.'
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 annually, and the Tallahassee office coordinates inspection correspondence from eight field 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 Insoections ,
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.
w f
r 6 Fiorida Final Report Page 5 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 I
. during 1998.
Based on casework, thS review team noted that the routine inspections covered all aspects of the licensees' radiation programs. The review team found that inspection reports were
. thorough, complete, consistent, and of high quality, with sufficient documentation to ensure that licensee's performance with respect to health and safety was acceptable. The documentation
, supported violations, recommendations made to the licensee, unresolved safety issues, and discussions held with the licensee during exit interviews. Team inspections were performed !
when appropriate and for training purposes. j i
- 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, i inspector's and supervisor's signature, and other administrative information. The second and l 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 Tallahassee Radioactive Materials Section within 15 days of the inspection.
I The inspection report and field notes are reviewed and signed by the field office manager. Once received in Tallahassee, the inspection coordinator reviews the inspe:: tion 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 ;
around thirty days with licensee responses retumed in a timely manner. Boilerplate language is !
used to generate compliance letters and violations to ensure consistency. Responses are i 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 ' i 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 discussed the field offices timely transmittal of field notes to Tallahassee to facilitate the preparation of correspondence to the licensee'.
- Florida Final Report Page 6 i Field notes have been developed to cover most types of inspections that are conducted by the BRC. These fold notes provide documentation for the scope of the licensees' program and cover all areas that need to be reviewed. The information contained in the fold notes is l 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 fold notes for the inspection of a waste processor and a panoramic irradiator, respectively. Other field offices are using existing feld 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 j 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.
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. i 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 accompanirr ints are also identified in Appendix C. During the accompaniments, the Florida inspectors e inducted performance based inspections and demonstrated thorough 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.
p 1
~ Florida Final Report Page 7 Based o'n the IMPEP evaluation criteria, the review team recommends that Florida's performance'with respect to the indicator, Technical Quality of Inspections, be found satisfactory.,
3.31 Technical Staffina and Trainino issues associated with th's. i indicator include the radioactive material program staffing level and staff tumover 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 1 licensing full time, with the remaining five persons in management and support contributing s : 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 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 slso has contracts with Polk'and Broward Florida counties to perform material and x- I 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.
1 Due to the relatively low tumover 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 staff qualifications because the new i
. positions require a bachelor degree or equivalent; the incumbents 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 l
. program.
l l
m 7
v Florida Final Report Page 8
. 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 l 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 inspectors 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 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.
3.4 TechnicalQuality of Licensina Actions The review team examined completed licenses and casework for 25 licensing actions, 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 opersting and j 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 i physics practices, reference to appropriate regulations, supporting documents, peer or i supervisory review, and proper signature authorities. The files were checked for retention of necessary documents and supporting data, i l
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.
i l
m, .
fri Florida Final Report . Page g 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, qualifed 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 licerses 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's 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.
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, the licensing section will address them with the applicant and reschedule the pre-licensing visit.
The program processed 5381 licensing actions during the review period. These consisted of
, 436 terminations,482 new license applications,571 renewals, and 3,8g2 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 leview team recommends that Florida's performance with respect to the indicator, Technical Quality of Licensing, be found satisfactory.
3.5 . Resnonse to incidents and Allegations in evaluating the effectiveness o' f the State's actions in responding to incidents, the review team examined the State's response to the questionnaire regarding this indicator, evaluated selected incidents reported for Florida in the " Nuclear Material Events Database" (NMED) against those
i
-s
)
Florida Final Report Page 10 contained in the Florida files, and evaluated the casework and supporting documentation for 12 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 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 j NRC Operations Center with BRC management and staff in Tallahassee and personnel in the j Emergency Response Group under the Environmental Radiation Labs Section in Orlando. ,i When notification of an incident or an allegation is received, the Emergency Response Group 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 re6ponse that BRC will take anc to ensure that the appropriate field office is notified.
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-up/ enforcement actions.
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 that is in NRC Management Directive 8.8, (e.g., the State has no definition specified for the term " allegation")
the State does take prompt and appropriate action in response to the concerns raised.
- 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 j
- 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. i l
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 concems 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.
4 i
t-
'i Florida Final Report' Page 11 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 protect allegation related information except for medical records and social security numbers.
. The review team recommends that BRC revise their incident and allegation procedures to
' document all existing State practices and to incorporate appropriate eternents of OSP Procedure SA-300 " Handbook on Nuclear Event Reporting in the Agreement States" and NRC Management Directive 8.8, " Management of Allegations," particularly the required :
, documentation and management approval for closing out incidents and allegations.
, i 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 l
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. -
1 4.1- Leaislation and Proaram Elements Reauired for Comoatibility 4.1.1 Legislation 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 j
- 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.
41.2 . Proci.m Elements Reauired for Como.iiLility 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 l
' of all radioactive material including naturally occurring materials, such as radium, and accelerator-produced radionuclides. Florida also requires registration of all equipment designed ,
to produce x-rays or oth6r 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 l
1 l
l
l 15 0 Florida Final Report Page 12 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 l,
regulations adopted by the U.S. Department of Transportation, the NRC, ar,d 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 i regulations become effective. i i
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:
o " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 36026) that became effective August 15,1994.
- " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 CFR Part 20 amendment (60 FR 7900) that became effective March 13,1995.
- " 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 that NRC and the State would require this national system to be effective at the same time. j i
e " Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment l (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).
-* "Preraration, Transfer for Commercial Distribution, and Use of Byproduct Material for l
. 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 Airbome Effluents of Radioactive Materials; Clean Air j ' Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997. !
i I
t
f-
]
Florida Final Report Page 13 I 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. I e 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 q Radiography Operations," 10 CFR Parts 30, 34,71, and 150 amendments (62 FR j 28948) that became effective June 27,1997.
- " Radiological Criteria for License Termination," 10 CFR Parts 20, 30,40, and 70 I amendments (62 FR 39057) that became effective August 20,1997.
-e " 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.
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 Par 120 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 during this calendar year, The State has deferred the medical regulation update until the final version of 10 CFR Part 35 is published which is expected by' June 1999. The team noted that except for the OSP letter conceming minor discrepancies on the State's adoption of the 10 CFR Part 20 equivalent regulations and the i medical regulations due in 1998, that the State has adopted all regulations and elements l
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.
I i
f
m L "
' Florida Final Report Page 14
- It is noted that Management Directive 5.9, Handbook, Part V, (1)(C)(lli) 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 critelia, 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 i Sealed Source and Device (SS&D) Evaluation Prooram f 4.2.1 L . Technical Quality of the Product Evaluation Prooram A-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 applicantc 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- i 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 were confirmed to be available and are used when performing SS&D reviewsi The Radioactive i 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 Staffina and Trainina ;
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 have many years of experience and training in health physics. Both individuals are considered ,
fully trained for licensing and inspection under the common performance indicator, Technical ,
Staffing 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.
i
\
l i
- Florida Final Report Page 15 4.2.3 Evaluation of Defects and incidents Regardina 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) Disoonal 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 facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Florida. Accordingly, the review team did not review this indicator.
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found Florida's performance to be satisfactory for all of the indicators. Accordingly, the review team recommended and the MRB concurred in finding 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.
RECOMMENDATIONS:
- 1. 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. (Section 3.2)
- 2. The review team recommends that BRC revise their incident and allegation procedures to document all existing State practices and to incorporate appropriate elements of OSP Procedure SA-300 " Handbook on Nuclear Event Reporting in the Agreement States" and NRC Management Directive 8.8, " Management of Allegations," particularly the required documentation and management approval for closing out incidents and allegations.
(Section 3.5) i i
1 1.
l Florida Final Report - Page 16 l 3. The review team recommends that the State complete adoption of the revisions to l Part 20 to correct 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) i
(; }
LIST OF APPENDICES AND ATTACHMENTS l
Appendix A IMPEP Review Team Members Appendix B Florida Organization Charts -
Appendix C Inspection Casework Reviews Appendix D License Casework Reviews Appendix E . Incident Casework Reviews Appendix F Sealed Source and Device Casework Reviews Attachment Florida's Response to Draft IMPEP Report.
Dated April 6,1999 i
l l
4 i
l i
l l
l 4
- i l
(
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 l Steven Gavitt, New York State Health Technical Quality of Licensing Actions Thomas O'Brien, OSP Response to incidents and Allegations )
Richard Woodruff, Region 11 Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program inspection Accompaniments I
I APPENDIX B STATE OF FLORIDA
)
DEPARTMENT OF HEALTH and BUREAU OF RADIATION CONTROL ORGANIZATION CHARTS l
l l
I
(
e e
c -. .4 . .., ,_ ._.,
., .. m ., . - - -
.s I
Eg0 $ i_00 ll0 f l2 [ . E: (, f nIlL :ll W ) g xll s nl
,I J! ,o-H l . l1=1 ls.9
- p. r ..
l a 1 l, ,
ili m
1 J
r- ;g r-
.]
E 63 M
N s-E 1' '.
g
"!h.
i ll5ln:i 11,I g
g nE 4 0 I I!
=
l!! )
l}0=;) jl -
dp =I, e la ,
s l : piI j mi .i u. -
[ L a.
S
~
,l ( '7
{ .' '
f
! l I
=j <; =lf, g.)
}. 1 $
g a
=l{
.I E- H
- =g n
- =g. i- l .g ]Il -
9 E_ .'
k n i e t , ,
Il .
n
)
a yl ap g{.: IlJl i8I[*
d r "jj{ "jl s m
,ge1 1 1 2 al '
I i 1 l a, a et
!< u l 1a j i nlgE" .3 I e ;
L
$ k b; N
ll0lk U}
3
- \', $;
M p "
a le gE 1
Q
- 2 E
1 l 3
- . . . re rm rm rm rm 8 : i: 9 ; in s I u : t il "1 ; .ll i:l i il " .l " 1.1!
4 I.
ll ; ~l- i *dt l ; .je:
I
~
i j
. 1 .t .I "l1 1 .l1 . 1:
4
. r 2m r, r 2m 2 2 i:
I: ( l.5 1 I.: I.: q I.5 0 f . y: l i . m: i
"!
- a a$ 0 "I j a " *
[f hl$gy.n .n .n .c .u .n .i .n z
- sm x= -- + r I: < i: I.: < l.: n 2 ti s I.:t h
I i Il: "Ir 14 "1v 1 "h
il! !"l11 l! )-nll1 1
!a T w
=m -
=R d ll- "l:a s n . w 3
r~ y rm r-- ' rm rm I: q ll* l1ej , 1 =Iljo j 8 : '.i l.: 9 :i
]_
3 .i 4 ,N] 3 i.:l !
,1 1 ,e I:l d y y
.l1 .n al ;
r! 3 .! J 2
.- . , r, c , r-i: i I.:
~
E5 1 8.- -
1.: E i.: j "1 "I
- ll f "in .o .lu
. "o .o .n
, r- r- r- ,- r-lI $ lI i l:
b lI h lI ,
l$ (
I "jt 1 EI ) l
.1 "ll l *[1 "] O "lI f I? l h l1 l ol ! .l ; ei : =D .i i ol !
qe , i 1 n 1 [
0 0 = s 8
. n0R1 -
0 0 1
- e o 1
.E n - 4 N : d 5 _
.Gemmo Ce Ess x Cse En m MW - Pe Pt _
SD Sr I
=Me r
r 2 2 Os Nis 1 2
2Nm O
m _
N F.
OD ReJ n Oe R
9 9
R I
V 05 r I V
N2 I
V N2 9
1 T
N2
- 8. E 81 r
u 8 4
E 30 1
3 w
g 8 4
Es?
7 3
w 9 t
i n
o A M NESR D Z, T
9v$
MNFU0 .!
I 0 1G. 0 0 y C O1
. 5 0 0 s. G g 0 A; 0 1 ECE 2 1 NNT FEG FTA EFP 1T 0NA Tsc Si I
1 e m N
I N
I M
T n.GnE.R1 mne s MP a t
8 4 N n Cn Eu PD Sy g
e 0
4 5ie g Cp Es Po SJ e
w 3
1 Sw S
2 I S O =MrNn d l 2
2 Nhs Oa 2Nd 2 e A s.
F
=
P OaR K R
Rm I
V T i m Orm Re V G =
I N4 L F _
As5 E M6 9 N2 _
T R E 30 E35 8
S7 7
v a '
P 3D0 5
9 4
r 3 5
8 1
g 3 5
7 m
4 3 4
4 g '
4 4
0 1
" 1 -
0 0 '.
5 5 e N
o N
O t
O 0
T S
- 2
^
0I L Nv Tn Sa t
I SR r 2WE 2Mn 9 '
Eo HMTN x . 0 J_
5 0 H
C,
- He CL L
g LTDO 2 2
9 4R1 7 4 1 '
c.
8 AH C L , S 6 8Nn 1
t Y
R 0 T
.S t 0
5 e n 3
5 ET N A I S Ct i Mtos Nisr T HLAO S T I t n ' 8 4
E 8 4
7 5
g FET I
M LA L De 2: I M Meu I
p Ea I l a
OH A M N 03NnAM '. E 5 DrP Tc -
TLD I
NIO 2A n 3Ss NA A 5Ota H 2I E .
. C 0
Te SB g Me Eo 3 '
VD NA VH 1:
I N7 0
D A
I M
E 75 g
HJ C3 9
w_ 4 4
0 7 U 4 4
0 9
E4 0 J AN U POA ER E ER 8
4 6
2 n
R .H3
.C6 2 r 8 4
1 8
1 n 5 5 N
g i._
DIV R NU Tg S
E B 0 2
0I 2ME ,
M H
C .
8 4
E 8 4
g r:_,_ _
I J jJ
?h .J l _
V R1 0
9 0
0 ' s o 01 :
9 0
0 1
.s.
.s R
U n.
.Gr E t 0
4 N 1 e 4 N
- 8 4 Ne S As e Ch =
Ce -
Cin .a.
Ee m - En Eg T Nm =
Po Pne - Pig ,_-
N Ae SH = SD SH n 3
.MH 2 2 2
~
I A. u 1, 2 Hy 2Nw 2 Nd - -_
Oa u t i P NW i Oo Ov .
RM n Ra RJ g R O . RL -
E W
I VT I
V N53
- M1 A I V
N2T D
N23 g O E 8 ; DT4 g E 4 9 s. o 4 0 4 0 ,
P .E1 g 8 6 g 3 6 8 6 h.
9 1 0 0 1 0
0 1 4 3 4 2- 1 2 4 2 7 m 0C 0 Kr w 0C Uel S
Tr e r Re y Eo
- m. De m .
q ]: q S
L Lmc ar _
- 4 3E 0, ,_ 9 0
0 m 9 0 o. ,-
1A R. iI 1R 1Ry 2 1 8 1 -
8 1 f O S.
No m 2 Or a E r 7H d r. 4 N 4 N ,
I I G N 1 I
NM L Ge ' Cn z Cse Cs .- -
M _
E Ah r Eo Ee u Em E 0 Dt S 7 c Nt Tm s Aa e m S 9 7
m 2
2
! AsE 1 r Ca r PN S k Pa Sd
.MNryr i
5I 2 2 N D. u s s s 7 m 8 8 r. 2 Ncu 2N A.
m.
I 8 I 1 .
4 2 e 3 4 1 a O L Oh 0C .e Oe RJ r RM i RC -
4 W .
9 r T VI V .
' C N? p Ns3 M2 9 E6 Es Es6
.D0
. 3 0
& 8E6 4
L4 2
n 8 4
n a
r 8 4 2 L
3 W l. ;L i.8 )i I:l le Il.: l 2 n l c I-
.p a al nI a !
..]
g h o i J 5 j I al l al s al =! ; t i
5d 3 ilraEl Em 3J 1
-llp$ r 5
a
- r. - . .. <g r , . . .; r. ,
g: i j :: .E .j
!I gl*I gl{)') gll gl] E gl*}?
~
i 2 fl ll I5lf n "gl i "lt i =lP =l4 *lF 111nl -
u al s al .1 =l l =1 2 c N O !
g,- )
~
)
"j .; ;
. "l L i s- a r j n_. .. ]
"j
$ i<
i ll i d 2 1
[ ! 0 "l!
.i .i i "l1
- r. .., rm S
i s j l af b =l ; i 5 ! g n-h 8 h k a .
ltl .< - ry i= n sel;0 !l !
xlli e -l- id a! b nl ll.
3 1g a<
E- W 31b '.;
l s g,.
g g L r rm ' r v -
ll8 g1 5 lEj :?
e6 c
gs
=p 81 i
1 g* #
=llu [n 8 P I$g H o 5 L1 a s M -
E M rn U M S k E: , rm l} l I ij
- 1 4 s o n e E E $k e.
0 e
E \
1
^
'l [*- 1 E' ' il ' 9 g. .
- }
1 el .i .53 .II iI .5j ;! l gl la i
gl i gm e .! . .g i ,gls ! ,i :
i l.'ldil!
IIsti e-ll 8
4 f
E Es 's l
l eN a IBl j n' :u r- y r y e-m ;j '
A 'l N q k N o q l * "
f kE~ h5 m il i;:
j?
"*la r *ilil Il
- a la
, s s st. ;s el-I c
1
"=5w as a ,1l c e
APPENDIX C INSPECTION CASEWORK REVIEWS
- 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;lnc. 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
. Comments:
a) . Inspection correspondence not processed in accordance with BRC procedures, b) No supervisor signatwo on field notes.
c) . No indication on fiele notes or correspondence of location were licensed activities were conducted.
d) Inspection letter serit 49 days after inspection completed.
' File No.: 2 Licensee: Theratronics intemational 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 I a)- Correspondence in file contains personal information File No.: 5 Licensee: 21" Century Oncology, lnc. 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 i
Florida Final Report Page C.2 Inspection Casework Reviews -
File No.: 6 Licensee: DeSoto Memorial Hospital License No.: 1371-2 Location: Arcadia, FL Inspection Type: Routine, Unannounced
. License Type: MedicalInstitution Priority: 2 inspection Date: 4/16/97 - Inspectors: KC/SH File No.: 7 Licensee: Bethune-Cookman College License No.: 1060-1 Location: Daytona Beach, FL Inspection Type: Routine, Unannounced License Type: Academic Specific Priority: '2 Inspection Date: 8/24/95 Inspector: LS File No.: 8 Licensee: J&M Testing Lab License No.: 1763-1 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 File 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. l b) Inspection field 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.
F' Florida 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 nrocedures. BRC issues inspection results in the field only to this type of license .
)
activity.-
. File No.: 14.
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: I a). . Acknowledgment letter did not address licensee's denial of some violations. l 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 1
- File No.: 16 Licensee: Delray Nuclear Center: , .
License No.: 2464-1 l 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 :
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 i inspection Date: 12/9/97 ' Inspectors: JL 4
L.
s y e.
Florida Final Report Page C.4
- Inspection Casework Reviews u,
File No.: .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: MidMB File No.: 20 d 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:
a) . Inspection field notes specific to facility developed by Polk County office. These field notes could be utilized by BRC staff.
J File No.: 22' ;
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 j File No.: 23 .
- Licensee: Ardaman and Associates - License No.: 0972-5 :
Location: Hialeah, FL Inspection Type: Routine, Announced i 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: 8/25/97L Inspectors: JB/JB j b i j.
r
{ Florida Final Report Page C.5 Inspection Casework Reviews INSPECTOR ACCOMPANIMENTS The following' inspection accompaniments 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: Medical / Private Practice - .
Priority: 4 inspection Date: 2/1/99 Inspector: MB
- i. Accompaniment No.: 2 , _
Licensee: Syncor International Corporation License No.: 1264-9 L
, Location: Jupiter, FL ' _
_ inspection Type: Routine, Unannounced I 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 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: Routine, Unannounced
~ License Type: Nuclear Pharmacy . Priority: 1 Inspection Date: 2/17/99 Inspector: AG J Accompaniment No.: 6 Licensee: Santa Rosa Medical Center, Inc. License No.: 2703-1 Location: Melton, FL Type inspection: Routine, Unannounced ;
- License Type: Medical Institution . Priority: 2 Inspection Date: 2/18/99 - Inspector: BR l
i a
>\-
1
)
La- '!
e y -
~
APPENDIX D LICENSE CASEWORK REVIEWS
- NOTE: ALL LICENSES LISTED WITHOUT COMMENT ARE INCLUDED FO'l COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE REVIEW TEAM.-
- File No.: 1 .
Licensee: Southeastern Atomic License No.: 01861 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 a 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 lasued: 11/25/98 Reviewer: WC :
File No.: 4 Licensee: Adventist Health - License No.: 2897-1 Location: Orlando, FL Amendment No.: N/A - I 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: Medical / Private Practice Type of Action: Amendment Date lasued: 9/14/98 Reviewer: RL
. File No.: 7 ..
Licensee: Holmes Regional Medical Center License No.: 0545-3 l Location: Melboume, FL Amendment No.: 7 i License Type: HDR Type of Action: Renewal Date issued: 2/4/98 Reviewer: LS !
l 1
I
r.
Florida 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 & ODMara, Inc License No.: 21431 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: Portable Gauge Type of Action: Renewal Date issued: 3/11/96 Reviewer: DG 1 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 File No. 13 Licensee: Baptist Hospital License No.: 2623-1 Location: Gulf Breeze, FL Amendment No.: N/A License Type: Medical Institution Type of Action: New Date issued: 10/5/95 Reviewer: DG File No.: 14 Licensee: PdMA Corp. License No.: 2400-1 i Location: Tampa, FL Amendment No.: 4 '
License Type: Specific (Other) Type of Action: Renewal l Date Issued: 10/20/98 Reviewer: RL I 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 issued: 1/25/99 Reviewer: CH e
w
! { Florida 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 Data lesued: 3/24/95 Reviewer: PV File No.: 18-20 Licensee: Costal Pharmacy Services 4
- License No.: 2497-1 Location: Daytona Beach, FL ' - Amendment Nos.: 1,2,&3 License Type: Radiopharmacy _ .
Type of Actions: Amendment x ' 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 i 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 l Licensee: 21 st Century Oncology, Inc. License No.: 0476-2
. Location: Ft. Meyers, FL Amendment No.: 18 License Type: Teletherapy /HDR Type of Action: Amendment L Date lasued: 12/10/98 Reviewer: JS
< File No.: 24 i Licensee: National Diagnostics License No.: 2634-1 L = Location: Orange Park, FL: Amendment No.: 6 l
License Type: Medical / Private Practice Type of Action: Amendment
[- "Date lasued: 8/25/97 Reviewer: JS L File No.: 25 l- . Licensee: Hospital Corp. of Lake Worth License No.: 0829-2 l- , Location: Lake Worth, FL Amendment No.: 10 License Type: MedicalInstitution Type of Action: Termination Date lasued: 8/24/97 Reviewer: PF i-l
rp
'f
' 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: Southem 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 InvestigationType: 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
. 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 ,
1 Summary of incident and Final Disposition: A radiation alarm activated at a waste handling i
- facility. An investigator isolated two bags.of trash that contained materials contaminated with j l-131.- The bags were impounded and were held for decay and disposal by the State.
File No.: 3 Licensee: Longview Inspection ~ lncident ID No.: 95-096
, Location: Criando, FL _ License No.: 2239-1
- Date of incident
- 7/12/95 . Type of Incident: Overexposure 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
/- Lactions of the radiographer on site (the exposure was performed in South Carolina), but also apparently due to his and managements decision to retum 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 mrom.' The State inspected the licensee and issued violations.
W N. ,
Florida Final Report Page E.2 incident Casework Reviews. l 1
- File No.: 5 ,
License: Lee Moffit Cancer Research Center Incident ID No.: 96-072 Location: Tampa, FL Licensee No.: 1739-1
- Date'of incident: 5/2/96 Type of incident: Misadministration 1 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-Licenses: Florida Power Corporation incident ID No.: 97-034 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 mrom. The State inspected the licensee and issued several violations.
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. !
l File No.: 8' l Licensee: Syncor intomational Corporation incident ID No.: 98-047 l 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 investigationType: On-site ;
i
' 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 bioassays. No contamination or internalization occurred.
4 ,
I i: l y.
's.
' Florida Final Report Page E.3 incident Casework Reviews 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 missing gauges and none was missing that contained the sources.
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.i 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 Invest.gation 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.
I w _-
I
- APPENDIX F SEALED SOURCE AND DEVICE CASEWORK REVIEWS l
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: 1/26/96 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 1
i l
1
DP T O Jeb Bush' Roben G. Brooks, M.D.
_ Governor Secretary s
April 6,1999 Mr. Paul H. Lohaus, Director Office of State Programs U.S. Nuclear Regul story Commission Washington, D.C. 20555-0001 I
I
Dear Mr. Lohaus:
This is in response to your March ig letter about the recent on-site evaluation of our Agreement i 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 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, inspectors and supervisors signature, and other administrative ,
information. The second and subsequent pages of the inspection report are summary sheets I 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 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 allinspection correspondence. Subsequent correspondence between the licenses 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 Caphal Circle SE e Tallahassee, FL 32399-0700 L
- 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 pcsition 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 m'splaced. However, to 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. Wo.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 concems. 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, Sharon Heber, M.P.H., Director Division of Environmental Health SH/ rat-1 E