ML20248M301
| ML20248M301 | |
| Person / Time | |
|---|---|
| Issue date: | 06/09/1998 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20248M292 | List: |
| References | |
| NUDOCS 9806150268 | |
| Download: ML20248M301 (57) | |
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF ARKANSAS AGREEMENT STATE PROGRAM March 23-27,1998 PROPOSED FINAL REPORT l
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U.S. Nuclear Regulatory Commission ATTACHMENT 1 l 9806150268 980609 PDR l
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' Arkansas Proposed Final Report Page 1
1.0 INTRODUCTION
- This report presents the results of the review of the Arkansas radiation control program. The
. review was conducted during the period March 23-27,1998 by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Oregon. 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 25,1997, revised NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period May 26,1995 to March 27,1998, were discussed with Arkansas managsment on March 27,1998.
[A paragraph on the results of the MRB meeting will be included here in the fina! report.)
The Arkansas Agreement State program is administered by the Division of Radiation Control and Emergency Management (the Division) in the Bureau of Environmental Health Services of the Arkansas Department of Health.. Organization charts for the Arkansas Department of Health and the Division of Radiation Control and Emergency Management are included as Appendix B.
At the time of the review, the Arkansas program reg'ulated 262 specific licenses, including limited and broad scope medical institutions, academic institutions, industrial radiography, fixed and portable gauge units, and nuclear pharmacy licensees.
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 Arkansas.
In preparation fnr the review, a questionnaire addressing the common and non-common l . performance indicators was sent to the State on January 9,1998. The State provided a
- response to the questionnaire on February 20,1998. A copy of the final response is included in Appendix C to this report.
The review team's general approach for conduct of this review consisted of: (1) examination of Arkansas' response to the questionnaire; (2) review of applicable Arkansas statutes and !
regulations; (3) analysis of quantitative information from the Division licensing and inspection j data base; (4) technical review of selected licensing and inspection actions; (5) field !
i accompaniments of three Arkansas inspectors; and (6) interviews with staff and management to L answer questions or clarify issues. The review team evaluated the information that d gathered
. against the IMPEP criteria for each common and applicable non-common performance indicator and made a preliminary assessment of the Division's performance. The review team also conWered a self-evaluation conducted by the program and action plans developed by the :
program based on the self-evaluation. The review team identified the self-evaluation as a good
. practice in the program.
Section 2 below discusses the State's actions in response to recommendations made following the prsvious review, Results of the current review for the IMPEP common performance
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Arkansas Proposed Final Repoit Page 2 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, recommendations, and suggestions. Recommendations made by the review team are comments that relate directly to program performance by the State. A response is requested from the State to all recommendations in the final report. Suggestions are comments that the review team believes could enhance the State's program. The State is requested to consider suggestions, but no response is requested. j 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previots routine review, which concluded on May 26,1995, five comments were made and the results transmitted to Dr. Sandra B. Nichols, Director, Arkansas Department of Health on August 7,1995. The team's review of the current status of these recommendations is as follows:
.(1) At the time of the May 1995 program review, compatibility was withheld because the State had not adopted three regulations. We recommended that the State adopt the three regulations listed below.
I (a) " Safety Requirements for Radiographic Equipment," 10 CFR Part 34 amendments, which were to be adopted by January 10,1994; (b) " Package Opening Procedures," 10 CFR Part 20 amendments, which were to be adopted by January 1,1994; and (c) " Notification of incidents," 10 CFR Parts 20, 30, 31, 34,40, and 70 amendments, which were to be adopted by October 15,1994.
Current Status: This recommendation is closed. The review team examined the Division's regulations due for adoption at the time of this review. The review team found that the State had adopted and implemented all NRC amendments required for compatibility.
(2) We recommended that the program's management and staff examine and take action to I
reduce the licensing backlog.
Current Status: This recommendation is closed. Licensing back!ogs are not a part of the IMPEP review criteria for Agreement States. The Division has conducted a self-evaluation which identified ways to expedite licensing actions and address those with potential health and safety consequences.
(3)' We recommended that the Division staff review its medical licenses to clearly determine j whether or not the 1982 procedure, which allowed exemption from the required survey of l packages received from nuclear phrmacies, has been used. Any license conditions d that exempt medical licensees from receipt surveys should be deleted to assure that
. surveys of nuclear pharmacy packages will be conducted.
Arkansas Proposed Final Report Page 3 l
Current Status: This recommendation is closed. The Division is no longer permitting this exemption for its medical licensees. The review team based its finding on reviews of selected medical license files, intpection reports, the State's 10 CFR Part 20 equivalent regulations and discussions held with the Division staff.
(4) We recommended that the State develop written escalated enforcement procedures so that program managers and staff all become familiar with the options available for l'
achieving regulatory compliance under current State policy.
Current Status: This recommendation remains open. As a result of the Division's self-evaluation effort, the sit if developed an updated escalated enforcement procedure which became effectiv, during the week of the IMPEP review. See Section 3.1.
(5) We recommended that the program consider an increase in the number of inspections conducted under reciprocity.
Current Status: This recommendation remains open. As a result of the Division's self-evaluation effort, an Action Plan was developed to revise compliance inspection procedures to improve the routine inspection of reciprocity licensees. See Section 3.1.
- COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.
3.1 Status of Materials Insoection Proaram The review team focused on four factors in reviewing this indicator: (1) inspec' ion frequency,-
(2) overdue inspections, (3) initial inspections of new licenses, and (4) timely dispatch of inspection findings to licensees. The review team's evaluation is based on Arkansas' questionnaire responses relative to this indicator, data gathered independently from the State's licensing and inspection data tracking system, the examination of completed inspection casework, and interviews with the Division Director, the Compliance Section Supervisor, and the inspection staff.
The IMPEP team's review of the Division's inspection priorities found that the inspection frequencies for various types of Arkansas licenses are established by the Licensing, Accreditation and Registration Section Supervisor and are based upon the type of license. The Division's priorities are 1 through 4 years for an inspection interval, in comparison with NRC guidance, the Division's assignment of inspection priorities was determined to be at least as frequent as NRC'S Inspection Manual Chapter (IMC) 2800. The review team did not identify any inspections, over the review period, as exceeding the IMPEP guidelines.
l The Division has provisions to extend or shorten the interval between inspections based upon the evaluation of licensee performance. This action requires the Division Director's L-_--_-_-_-_-_------_------------_-----__
Arkansas Proposed Final Report Page 4 authorization. Interviews determined that the extension for good licensee performance was used once in the review period. The Division uses a reduced inspection frequency as a tool to encourage improved licensee performance. The Division staff reported that they shorten the inspection frequency, for poor performing licensees, an average of once per quarter. The Compliance Section Supervisor reviews the inspection data and determines if a recommendation to extend or reduce the inspection frequency is warranted. The review team notes that extending inspection frequency intervals could provide some workload relief and allow staff to pursue existing projects. After evaluating the type and quantities of licensed materials used, the Division believes that its one to four year inspection interval prioritization procedure produces the best compliance with the proper mix of enforcement, inspection and licensing.
The normal interval between inspection and repod issuance was found to be 7 to 10 working days, and no report letter was identified as being more than 30 days post-inspection. Reports and letters are produced by the secretarial staff based upon a set paragraph guidance document, or may be produced by the technical staff directly.
The Division possesses a database for inspection scheduling. During the review, the IMPEP team was provided with various lists, including: licenses due for a particular period, inspections conducted, reports issued, and reciprocity licensee names and inspections. The review team noted that there were 33 new licenses issued during the review period. The Division requires that new Priority 1 licensees receive an initial inspection within 3 months of license issuance. All other priorities of new licenses are initially inspected at 6 months. During the review period four licensees were identified as being overdue for inspection. All four licensees were Priority 3 industrial gauge users, three of which were overdue by 2 months and the fourth was overdue by 1 month. These four inspections were scheduled for completion in April 1998.
During the previous review, a recommendation was made that the State develop written escalated enforcement procedures, including civil penalties, for non-compliant licensees. The Division currently uses a Management Meeting with the licensee as one of several escalated enforcement tools. Division managers believe that this technique has proven effective in focusing the licensee's attention on corrective actions. The Division has in the past used its authority to suspend or revoke licenses. The review team noted that, as a result of the Division's self-evaluation effort, the staff developed an updated escalated enforcement procedure. The updated procedure became effective during the week of the IMPEP review, and therefore, it was not reflected in compliance case files examined for the review period. The review team recommends that the Division continue to implement the updated escalated enforcement procedure in order to enhance its compliance program.
Arkansas Rules and Regulations for Control of Sources of Radiation, Section RH-750, authorizes NRC and other Agreement State licensed persons a generallicense to work for any 180 days in any 12-month period, upon provisim of 2 days notice. Inspection frequency for reciprocity licensees has been established by the Division in Procedure RAM-03.0, Procedure for Schedulino and Trackino RAM License inspection, revised January 1988. The procedure states that: (1) any licensee working in the State more than once per month will be inspected once each year; (2) every effort will be made to inspect licensees working in the State for 1 to 3 consecutive weeks; and (3) any licensee working in the State 4 or more consecutive weeks will be inspected. The review team determined that of th: Priority 1 program codes in the registered i
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Arkansas Proposed Final Report Page 5 database, the Division inspected 13% in 1995,16% in 1996 and 18% in 1997. No service licensees reported any work which should have been inspected at the 100% frev;ency. No Priority 2, 3 or 4 licensees reported work in the State. Licensees that are classift d as Priority 5 and higher (all others) by the NRC were inspected at a 10% frequency in 1995 and 1996, and at 25% in 1997. The Compliance Section Supervisor and the Division Director stated that the inspection frequencies used previously would be changed to those in IMC 1220. They also indicated that a more aggressive inspection campaign would be !aunched to obtain better compliance with both the regulations at RH-750 and the inspection priorities in IMC 1220.
Arkansas shows progress towards achieving the goals of IMC 1220, and coupled with the statements above, the review team recommends that the Division continue efforts to move its reciprocity inspection program towards the guidelines established in IMC 1220.
Based on the IMPEP evaluation criteria, the review team recommends that Arkansas' performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory.
3.2 Technical Quality of inspections The review team examined a selected sample of inspection reports, enforcement
. documentation, and inspection field notes and interviewed inspectors for 10 materials inspections conducted during the review period. The casework included five of the State's materials license inspectors, and covered inspections of various types including industrial radiography, medical institutions, academic institutions, fixed and portable gauging systems, and a nuclear pharmacy. - Appendix D lists the inspection casework files reviewed for completeness and adequacy with case-specific comments.
During the week of March 2,1998 and on March 24,1998, a review team member accompanied all three of the State's inspectors on two inspections each of facilities licensed by the State. The inspection accompaniments are listed in Appendix D. The review team member determined that the inspectors conducted themselves in a professional manner, dealt fairly and accurately with licensee staff and management, and were well prepared for each inspection. The Division does not currently have network capability, but installation has been identified as a priority. The Division has recently acquired portable computers and intends to issue one to each inspector.
The inspectors are equipped with, and used, appropriate and calibrated survey and safety equipment. The Division requires inspection staff to perform radiation measurements and obtain wipes for evaluation of possible removable contamination as a part of each inspection. The Division staff performed inspections with guidance adapted from IMCs from the early 1990s.
The Director stated that, based on the Division's self-evaluation effort, there are plans in place for updating the guidance to that which is' most current and based upon the current Arkansas regulations. The review team explained the current efforts in consolidating guidance in the NUREG-1556 series, and the in-process inspection guidance being developed as IMCs 87110 L and oeyond. Inspectior, field notes generally are converted to a printed version. The licensee is sent a report cover letter with Notices of Violation, Recommendations, and Comments included.
The report is reviewed by the Compliance Section Supervisor. The review team recommends that the Division proceed expeditiously with its review and updating of compliance program
. guidance.
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' Arkansas Proposed Final Report Page 6 The State maintains an up-to-date well-staffed environmental radiochemistry laboratory, which analyzes samples obtained during inspections, follow-up actions, or licensing terminations. The laboratory participates in the routine EPA - Environmental Monitoring and Safety Laboratory (EMSL) cross-check program and is used routinely by inspectors taking wipe samples. Gamma l
spectrosapy QA/QC appears adequate with routine use of a NIST-traceable mixed gamma standard. The gamma spectroscopy system includes two 35% intrinsic Germanium (INGE) detectors in copper-lined caves. The laboratory does not do direct alpha spectroscopy. They do, however, have the capability to analyze drinking water samples with their low background thin window gas flow proportional counter. Utilizing the Barium Sulfate precipitation method, as specified by the EPA, samples can be analyzed at the level of 4 pCi/ liter. ,
Based on the IMPEP evaluation criteria, the review team recommends that Arkansas' performance with respect to the indicator, Technical Quality of inspections, be found satisfactory.
3.3 - Technical Staffina and Trainina issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training and staff turnover. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed program management and staff, and considered any possible workload backlogs.
The Division Director Mentified nine individuals who provide approximately 3.63 person-years of technical effort to the Division for the regulation of radioactive materials. This includes the Division Director, the Quality and Evaluation Supervisor, the Compliance Section Supervisor, the Licensing, Accreditation and Registration Section Supervisor, three compliance inspectors and two license reviewers. The staff divides its time between radioactive materials casework, administration and emergency response activities. During the review period, the Division's staff tumover, in the materials section, included the Director and three staff members. b Director left the Division to pursue Federal employment. Each of the three staff members, who left the Division, had personal reasons for leaving.
Based on the response to the IMPEP questionnaire and discussions with the Division Director, the review team noted that during the review period three technica! staff left the radioactive materials program. These vacancies were promptly filled by three candidates who are well qualified based on their education and extensive work experience in radiological science. There are currently no vacancies in the radioactive materials program. The three new staff members have bachelor's degrees and numerous specialized course-work in radiological science. Based on a review of the Division position descriptions and the resumes of the new staff, the review team noted that these individuals exceeded the minimum requirements for their positions.
During the review period, the division also filled the vacant Director's position. The new Director is a former member of the Division staff who left the program ir' 1980 and has returned after several years of private sector employment. The Director holds a Master's degree in Health Physics and is certified by the American Board of Health Physics in comprehensive health physics and nuclear power plant health physics. .
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Arkansas Proposed Final Report Page 7 The review team noted that although the licensing backlog remains high, current staffing levels are adequate and no health and safety concems attributable to staffing were identified. One possible cause for the licensing backlog is past chronic staff tumover.
The Division encourages all licensing and compliance staff to attend technical training courses.
The State utilizes a list of training courses identical to IMC 1246. Each staff member is expected
' to successfully complete the core courses identified for materials inspectors and license reviewers in IMC 1246. Waivers from specific courses may be granted, at the Director's discretion, for individuals with extensive work experience and education in a specific topic area.
There are currently three staff members in the radioactive materials program listed as being in training status Based on their previous work experience, course availability and mentoring by senior staff, it is expected that they will achieve fully qualified status as inspectors in a short time. Staff who are fully qualified can independently inspect and license all activities regulated by the Division.
The Division maintains a database which lists the training receivea by individual staff members.
A second database is used to track upcoming training and matches specific training courses with the appropriate staff.
The review team noted that the Division is conducting regular monthly in-house training for its staff. This training covers a variety of topics such as regulations, worker safety, and instrumentation. The training is conducted in the form of discussions, demonstrations, and videotape presentations. Documentation indicates that this training was initiated several years ago and is ongoing.
Based on the IMPEP evaluation criteria, the review team recommends that Arkansas' performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
3.4 Technical Quality of Licensina Actions -
- The review team examined completed licensing casework and interviewed the reviewers f'or -
nine specific licenses. 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 overall technical quality including accuracy, appropriateness of the license, its conditions, and tie-down conditions. Casework was evaluated for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authority. The files were checked
< for retention of necesssry documents and supporting data.
The licensing casework was selected to provide a representative sample of licensing actions that had been completed in the review period. The cross-section sampling included four of the State's major licenses as identified by the State in Section 16 of the questionnaire, and included the following types: academic broad scope; industrial radiography; medical institutions; nuclear pharmacy; gauge; and an industrial laboratory. Licensing actions during the review period l
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Arkansas Proposed Final Report Page 8 1 included 33 new licenses, 59 renewals,633 amendments (including 25 terminations), for a total of 725 licensing actions. In discussions with management, it was noted that there were no major l' decommissioning efforts underway with regard to agreement material in Arkansas, however, the L State was required to evaluate contamination in a terminated licensee facility. A list of licenses reviewed with case-specific comments for license reviews can be found in Appendix E.
i The licensing process was discussed with the primary license reviewer and staff. Types of licensing actions selected for review included new licenses, amendments to existing licenses, renewat licenses, and terminations. License reviews were well done, well-documented, detailed, and complete, with the exception that reviews did not specifically address annual audits of the radiation protection program or financial assurance. Reviews showed, however, that no i licenses required financial assurance, and that the scope of the license review covered the 1 essential elements expected in a comprehensive radiation protection program (actual radiation protection audits are addressed during inspections). Although license renewals often remain in .
timely renewal status for as long as 2 years, health and safety issues are adequately addressed in separate amendments to the deemed timely license or during regular compliance inspections. J Alllicensing actions receive supervisory review, and were signed by management. Deficiencies are addressed by detailed, well-written letters utilizing appropriate regulatory language. License reviewers rarely use telephone deficiencies.
The State uses detailed licensing checklists for renewals and new licenses. However, the checklists do not include radiation protection and financial assurance reviews as stated above.
The review team recommends that the Division staff revise the license reviewer guidance, including checklists, to address comprehensive radiation protection program reviews, annual program audits, and the need for financial assurance.
App!ication packages containing guidance are sent to license applicants. The applications are reviewed following standard procedures which are similar to those used by the NRC. The
' Licensing guides, as well as other applicable guidance from NRC, are available, although staff has not had time to convert references to NRC regulations to Arkansas regulations. A management Action Plan provided to the review team, however, showed that the State plans to update guidance used for license reviews. Staff typically uses Standard License Conditions (SLCs) similar to those used by NRC Licenses are issued in entirety only as new licenses or during the renewal process. Amendments are issued only with changes as noted in the amendment request (1 or 2-page amendments). License files are two-part documents organized with the license and amendments separate from all other support documents, including application, deficiency letters, review check sheet, telephone documents, memoranda, hand-delivery license report, inspection reports, and licensee response letters on the other side.
All documents are chronologically organized in the license file. There are two complete files for each license. Files are organized by license number. A new license file is created during each five-year renewal process. The timely renewal letter resides in the expired license file, which, after the renewal is issued, is stored as an archive file (timely renewal letter was not with
..,y Arkansas Proposeu Final Report Page 9 renewal license application). Compliance records are kept contiguous to licensing support documents. Reviewers are conscientious about including all pertinent documents in the license tie-down.
The Division staff routinely hand delivers new and renewal licenses. The staff considers hand delivery of licenses to be a pre-licensing visit. The visit is documented on a one-page form.
License files have all current inspection data, in addition to incident data, providing license reviewers with incident reports and inspection reports during the renewal period. Incidents are cross-referenced in licensing files. In one instance, a misadministration did not have complete supporting documentation in the license file. License reviewers have adequate supporting information and documentation readily available in the file to complete renewal license reviews.
Monthly staff training meetings include discussions of major licensing and compliance issues.
At the time of the review, the State did not have a centralized computer system for tracking licensing actions. Each license reviewer keeps a desk log of licensing actions received and reviewed A central receipt log is kept where new license numbers are issued. There is a monthly report of licensing actions generated manually. The State did not have computers for materials licensing staff until fall of 1997; only licensing staff have networked computers. No licensing statistics are kept in computers at this time but the program plans to implement a database program within one year.
l Management has high expectations of the staff and staff licensing products are very high quality, l however, production has been limited by license staff tumover. Licensing casework backlogs !
remain high and were noted during the last program review. Continued effort should be made to reduce the licensing casework backlog. _ in spite of the foregoing, no health and safety concems were identified. As a result of the program's self-evaluation, an Action Plan has been developed ;
to update guidance, to expedite licensing actions, and to address those with potential health end safety consequences. The review team suggests that management continue to reevaluate progress and implement the Action Plan.
Based on the IMPEP evaluation criteria, the review team recommends that Arkansas' performance with respect to the indicator, Technical Quality of Licensing Actions, be found !
satisfactory.
3.5 - Response to Incidents and Alleastions i In evaluating the effectiveness of the State's actions in responding to incidents, the review team l examined tM State's response to the questionnaire regarding this indicator, retviewed selected incidents reported for Arkansas in the " Nuclear Material Events Database" (NMED) against those contained in the Arkansas files, and reviewed the casework and supporting l documentation for ten material incdents. There were no medical related events during the review period that met the definition of a misadministration. A list of selected incident files !
examined along with case specific comments is contained in Appendix F. l I
The review team interviewed the Division Director, the Licensing, Accreditation, and Registration Section Supervisor, the Quality and Evaluation Section Supervisor, and the Compliance Section j Supervisor. The subject areas discussed with staff included the State's incident and allegation l
Arkansas Proposed Final Report Page 10 process, tracking system, file documentation, Freedom of Information Act, NMED, and l notification of incidents to the NRC Emergency Operations Center.
When notification of an incident or an allegation is received, the Division Director, the Quality and Evaluation Section Supervisor, and the Compliance Section Supervisor normally meet to discuss the initial response and the need for an on-site investigation. A draft Emergency Response procedure in a checklist format is used as guidance to document the response to incidents.
The review team found that the State's actions were within the performance criteria, with the exception of incomplete documentation in two files reviewed, follow up of incidents in one file reviewed, and inconsistent notification of NRC in five files reviewed. Initial responses were prompt and well-coordinated, and 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 corrective and enforcement action. However, the review team found that there is a need for better documentation in incident files in order to close-cut incident investigations. An example of this is the Anderson Engineering case File No.1 in Appendix F.
The review team recommends that the State adequately document and closely follow the progress of investigations of incidents through close out The Division Director acknowledged the State has not consistently reported incidents to the NRC Operations Center for those that require immediate or 24-hour reporting by the State licensee. He advised that corrective actions, in the form of an Action Plan, developed as a result of the self-evaluation, are currently underway. He also indicated that the draft Emergency Response procedure has the requirement to notify the NRC incorporated into the checklist. The NMED system was discussed with the Division Director and the guidance contained in the
" Handbook on Nuclear Event Reporting in the Agreement States" was reviewed. The review team noted the Commission's position that, under the Policy Statement on Adequacy and Compatibility of Agreement State Programs, it is mandatory for Agreement States to report events to the NRC. (It should be noted that those incidents not reported to NRC under NMED occurred before the September 3,1997 publication date for this new policy.) The review team also discussed with the Division Director that monthly reports to NRC are now recommended even when no events occur. The review team noted that one reportable event occurred since September 3,1997, and the State made a prompt notification to NRC.
The review team recommends that the State continue to report events and participate in the NMED system by providing event information and close-out status to be added to the NMED system or by providing compatible information in accordance with the guidance contained in the
" Handbook on Nuclear Event Reporting in the Agreement States."
During the review period, there were no allegations referred to the Stsiie by NRC nor were there any allegations that the State handled directly. The review team examined the procedure that the Division utilizes for the handling of allegations and found that it was comprehensive. It was also noted that the Division advises allegers that they are not able to guarantee their confirientiality due to State law.
Arkansas Proposed Final Report Page 11
' Based on the IMPEP evaluation criteria, the review team recommends that Arkansas' 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. Arkansas' Agreement does not cover a uranium recovery program, so only the first three non-common performance indicators were applicable to this review.
4.1. Legislation and Proaram Elements Reauired for Compatibility 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 affects the radiation control program. The currently effective statutory authority for the Division le contained in " Arkansas Code of 1987, j Title 20, Chapter 21." The Division of Radiation Control and Emergency Management is designated as the State's radiation control agency. The review team noted that the following legisistion was passed during the review period:
e' Act 796 of 1995 changes to the fee schedule to adjust for cost of living and to add several new fee categories.
e Act 768 of 1997 Arkansas Department of Health Appropriations Bill.
The currently effective statute authorizing a Low-Level Waste Program is " Arkansas Code of 1987 Annotated, Volume 6A, Title 8, Chapter 8." No other legislation was passed, which affects the Division.
4.1.2 ~ Proaram Elements Reauired for Compatibility
. The Arkansas Regulations for Control of Radiation are found in the Rules and Regulations for Control of Sources of lonizing Radiation of the Arkansas Board of Health and apply to all ionizing radiation, whether emitted from radionuclides or devices. Arkansas requires a license for possession, and use, of all radioactive materialincluding naturally occurring materials, such as radium, and accelerator-produced radionuclides. Arkansas also requires registration of all equipment designed to produce x-rays or other ionizing radiations.
The review team examined the State's schedule for revising its regulations to maintain compatibihty. The procedure used in the State's regulations promulgation process, and detailed -
4 in their response to the IMPEP questionnaire, was discussed with the Division daff. Both the schedule and the procedure were found to be acceptable. The review team noted that ample opportunity is afforded to the public and the NRC to review and comment on proposed revisions
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Arkansas Proposed Final Report Page 12 to the Division's regulations. Comments are considered and incorporated as appropriate before the reguistions are finalized. The last revision of the State's rules and regulations became effective on January 1,1997. An Action Plan was developed based on the self-evaluation and a senior staff member was named as the project leader for the scheduled revision of the regulations which will begin in April 1998. The revision is expected to be completed in December 1998, and a revised regulation should become effective in January 1999. The current revision schedule should permit the Division to maintain regulations compatible with NRC's regulations.' The State does have the authority to issue legally binding requirements (e.g.,
license conditwns) in lieu of regulations until compatible regulations become effective.
The review team evaluated Arkansas' responses to the questionnaire and reviewed the regulations adopted by the State since the 1995 review to determine the status of the Arkansas regulations under the Commission's new adequacy and compatibility policy. The review team found that the State has adopted all regulations required for compatibility at the time of this review. There are a number of amendments to NRC's regulations which the State should adopt, j within 3 years of the effective date, in order to maintain compatibility.
The Divisbn has not yet adopted the following regulations, but intends to address them in a rulemaking or by adopting attemate generic legally binding requirements:
e
- Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment (60 FR 28323) that became effective June 30,1995.
e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995.
e " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995.
e " Compatibility with the Intemational Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996.
e
- Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective on October 20,1995.
e " Termination or Transfer of Licensed Activities: Record Keeping Requirements," 10 CFR Parts 20, 30,40,61,70 (61 FR 24669) that became effective on June 17,1996.
-o "ResoluUon of Dual Regulation of Aitborne Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997, e " Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction
- Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became i effective on February 27,1997.
1 o " Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Parts 20 and 35 amenoments (62 FR 4120) that became effective on May 29,1997.
L=__________-___-____-___-
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Arkansas Proposed Final Report Page 13
-e " Fissile Material Shipments and Exemptions," 10 CFR Part 71 amendment (62 FR 5907) that became effective on Februsty 10,1997.
t e " Licenses for industrial Radiography and Radiation Safety - Requirements for industrial l
Radiography Operations," 10 CFR Parts 30,34,71,150 amendment (62 FR 28947) that became effective on June 27,1997.
e " Radiological Criteria for License Termination," 10 CFR Parts 20, 30,40, 70 amendment
- (62 FR 39057) that became effective on August 20,1997.
It is noted that Management Directive 5.9, Handbook, Part V, paragraph (1)(c)(iii), provides that j the above regulations should be adopted by the State as expeditiously as possible, but not later
{
than 3 years after the effective date of the new Commission Policy Statement on Adequacy and '
Compatib:lity, i.e., September 3,2000.
Based on the IMPEP evaluation criteria, the review team recommends that Arkansas' performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.
4.2 Sag.edl Source and Device (SS&D) Evaluation Proaram .
At the time of the review, Arkansas had no sealed source or device manufacturers nor were any applicants anticipated in the near future. There were no sealed source or sealed source device actions received or completed by the State during the review period. The Division Director and the Licensing, Accreditation, and Registration Section Supervisor, who is responsible for SS&D eva!uations, were interviewed to determine the current status of the SS&D program. The State is considering whether or not to relinquish the authority to regulate SS&D manufacturers.
The Division has all appropriate Standard Review Plans, ANSI standards, and other documents in place tu perform SS&D evaluations.
. It was noted that the Division has not yet adopted two regulations required for compatibility.
l
' Although adoption of NRC regulations in 10 CFR 30.32(g) and 32.210 is not required until
- September 3, 2000, the review team suggests that, for the purposes of compatibility, the State adopt the NRC regulations in 10 CFR 30.32(g) and 32.210. Sections 30.32(g) and 32.210(c) would need to be in place whether or not the Division maintains an SS&D evaluation program.
' 4.2.1 - Technical Quality of the Product Evaluation Procram Category N l l
Not soplicable.
g
.i ii- - . . .. .
Arkansas Proposed Final Report Page 14 4.2.2 Technical Staffino and Trainina The criteria for the IMPEP indicator SS&D evaluation program require that a minimum of two individur.ls be fully trained to coreduct SS&D evaluations. The Division currently has only one i
. individual who attended the NRC workshop on SS&D evaluations. The Division recognizes the need for two trained individuals and indicated that they would seek technical assistance from NRC or other authorized entity if an SS&D evaluation needed to be performed. The review
. team advised the Division that another SS&D Workshop would probably be conducted in late 1998. The review team recommends that, in order to maintain an effective SS&D evaluation program, one additional individual receive training in SS&D evaluations.
3 4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds During the review, it was noted that one incident conceming a soil moisture density gauge was not well documented and was lacking in the degree of follow up (see incident # 95-28 in Appendix F for detail). Furthermore, the review team noted that in two of the three incidents i related to equipment failure, there was no root cause analysis performed and no information on l the potential for a generic design. defect was forwarded to the manufacturer or the NRC. This issue was discussed with the Quality and Evaluation Section Supervisor who agreed that potential generic design defect problems need to be evaluated and forwarded to the agency responsible for the product evaluation and registration certificate. The review team recommends that any events involving a defective device or source in a device, be evaluated for possible generic implications and such information passed on to the manufacturer and NRC.
Based on the IMPEP evaluation criteria, the review team recommends that Arkansas' performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory with recommendations for improvement.
4.3 Low-Level Rad:oactive 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 Arkansas 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 j disposal facility, they are expected to put in place a regulatory program which will meet the i criteria for an adequate and compatible LLRW disposal program. There are no plans for a l LLRW disposal facility in Arkansas. Accordingly, the review team did not review this indicator. l 1
l
Arkansas Proposed Finai Report Page 15 5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found that Arkansas' performance with respect to each of the performance indicators, with the exception of the SS&D Evaluation Program, to be satisfactory. The review team recommends that the non-common performance indicator, SS&D Evaluation Program, be found satisfactory with recommendations for improvement Accordingly, the review team recommends the Management Review Board find the Arkansas program to be adequate to protect public health and safety and compatible with NRC's program.
Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of the report, for evaluation and implementation, as appropriate, by the State.
RECOMMENDATIONS:
- 1. The review team recommends that the Division continue to implement the updated escalated enforcement procedure in order to enhance its compliance program.
(Section 3.1)
- 2. The review team recommends that the Division continue efforts to move its reciprocity inspection program towards the guidelines established in IMC 1220. (Section 3.1)
- 3. The review team recommends that the Division proceed expeditiously with its review and updating of compliance program guidance. (Section 3.2)
- 4. The review team recommends that the Division staff revise the license reviewer guidance, including checklists, to address comprehensive radiation protection program reviews, annual program audits, and the need for financial assurance. (Section 3.4)
- 5. The review team recommends that the State adequately document and closely follow the I progress of investigations of incidents through close out. (Section 3.5)
- 6. The review team recommends that the State continue to report events and participate in the NMED system by providing event information and close-out status to be added to the NMED system or by providing compatible information in accordance with the guidance contained in the " Handbook on Nuclear Event Reporting in the Agreement Statas."
- (Section 3.5)
- 7. The review team recommends that, in order to maintain an effective SS&D evaluation program, one additional individual receive training in SS&D evaluations. (Section 4.2.2)
- 8. The review team recommends that any events involving a defective device or source in a device, be evaluated for possible generic implications and such information passed on to the manufacturer and NRC. (Section 4.2.3) !
I i
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__ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ______._.____m__
Arkansas Proposed Final Report Page 16 SUGGESTIONS:
- 1. The review team suggests that management continue to reevaluate progress and
' implement the Action Plan. (Section 3.4)
- 2. The review team suggests that, for the purposes of compatibility, the State adopt the NRC regulations in 10 CFR 30.32(g) and 32.210. (Section 4.2)
GOOD PRACTICE:
The review team identified the Division's Self-Evaluation Program as a good practice. The Division Director initiated a Self-Evaluation Program to assess the Division's status re:ative to the comments and recommendations made after the 1995 program review. In addition to examining the previous review findings, the Self-Evaluation Program provided an opportunity for Division staff to measure their current program against the new IMPEP indicators. Strategies were then developed to address the licensing backlog, the need to develop licensing and inspection guidance, and to revise rules and regulations.
The self-evaluation initiative led to the issuance of several Action Plans. These Action Plans identify a specific topic to be addressed (e.g., revision of rules and regulations), and are numbered for tracking purposes. A project leader and team are named, and beginning and projected completion dates are established for each Action Plan. There is a provision for amending the completion date; however, the Division Director must approve and document any changes. Upon completion of the tasks identified in the Action Plan, management will review and approve the completed work by signature.
I
LIST OF APPENDICES AND ATTACHMENTS Appendix A IMPEP Review Team Members Appendix B Arkansas Organization Charts Appendix C Arkansas' Questionnaire Response Appendix D inspection File Reviews Appendix E License File Reviews Appendix F Incident File Reviews Attachment 1 Arkansas' Response to Review Findings l
}
W_a_ - - _ _ - - __ - _ _ _ - - - - - - . _ , - - . _ _ - . - - - - - - - - - - - - - - - - - - - - . - . - - - - -- - - - - - - . - -. - - - - . . - - - - - - - - - - - - - - - . - - - - . - - _ - - - - - - - - - - - - - - - - - - - . - -.---,a - - - ------- ----- . - - -
APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Lloyd Bolling, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility David Collins, Region-ll Sts,tus of Materials inspection Program Technical Quality of Inspections Martha Dibblee, Oregon Quality of Licensing Actions Linda McLean, Region-IV Thomas O'Brien, OSP Response to incidents and Allegations Sealed Source and Device Evaluation Program
t 9
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APPENDIX B
-ARKANSAS 1 DIVISION OF RADIATION CONTROL AND EMERGENCY MANAGEMENT .
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APPENDIX C I
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE
\
1 f
Approved by OMB No. 3150-0183 Expires 4/30/98 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE i
Arkensas Department of Health Division of Radiation Control & Emergency Management Review Period: May 26,1995 to March 27,1998 A. COMMON PERFORMANCE INDICATORS
- 1. Status of Materiale Inanaction Proaram
- 1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue.
Licensee ir.spection Frequency Due issued Months Name (Years) Date Overdu o
R. Thompson Construction 3 12/97 6/9/97 2 Ark. License 864 Landex Corp.
Ark.1.icense 868 3 12/97 6/11/97 2 Johnsville Sand &
Gravel 3 12/97 6/23/97 2 Ark. License 866 Drummond Asphalt 3 1/98 7/1/97 1 Ark. License 870
- 2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire. ;
1 The four overdue inspections will be completed by March 18,1998.
- 3. Please identify individual licensees or groups of licensees the State / Region is l inspection more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.
L i
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The Arkansas inspection ' priority system is the same as that of the NRC. There are no Arkansas licensees that are inspected differently than is specified in the NRC inspection manual.
- 4. Please complete the following table for licensees granted reciprocity during the reporting period.
Number of Licensees Granted Reciprocity Number of Licensees Priority Permits Each Year inspected Each Year YR 95 - 15 YR 95 - 3 (1) YR 96 - 14 YR 96 - 2 YR 97 - 18 YR 97 - 4 (2) YR 97 - 1 YR 97 - 1 YH 95 - 41 YR 95 - 3 I) YR 96 - 22 YR 96 - 3 YR 97 - 32 YR 97 - 10
- 5. Other than reciprocity licensees, how many field inspections of radiographer were performed?
YEAR NUMBER OF INSPECTIONS 1995 4 1996 6 1997 5
- 6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed.
NOT APPLICABLE ll. Technical Quality of inspections
- 7. What, if any, changes were made to your written inspection procedures during the reporting period?
)
There were no revisions to the Compliance inspection Procedures during the review I period. However, several changes (updates) to the Field Inspection Forms were l made to incorporate new regulatory requirements or previously missing inspection criteria, as follows:
]
2 l
- a. Industrial Radioarachy (1) Alarming Ratemeters (2) Radiography Camera locking device
- b. Academic (1) Authorized Users per License (2) Individual Laboratory Quality Assurance Program
- c. Medical (Nuclear Medicine Thernov)
(1) Quality Management Program 4
- 8. Prepare a table showing the number and types of supervisory accompaniments made during the review period.
1995 Supervisory Accompaniments inspector Supervisor License Category Date Wiebeck Kelley Nuclear Medicine 2/21/95 Wiebeck Kelley Radiographer 2/22/95 Henry Kelley Industrial 4/6/95 Henry Keliey industrial 4/7/95 Webeck Kelley Nuclear Medicine 4/11/95 Henry Kelley Academic 5/31/95 Martin Kelley Pnvate Practice 9/27/95 Martin Kelley Private Practice 9/28/95 Martin Kelley Private Practice 9/29/95 Martin Kelley Nuclear Medicine 10/4/95 Martin Kelley Private Practice 11/30/95 Martin Kelley Teletherapy 11/30/35 MagsLm Kelley Nuclear Medicine 12/9/95 1 Magsam Kelley Nuclear Medicine 12/7/95 !
1 1
3 L______________________
1996 Supervisory Accompaniments inspector Supervisor License Category Date Magsam Kelley Radiographer 3/13/96 Stokes Kelley Radiographer 3/19/96 Henry Kelley in Vitro 5/16/96 Bradley Kelley Radiographer 8/12/96 Magsam Kelley Private Prachce 8/29/96 1997 Supervisory Accompaniments 1
inspector Supervisor License Category Date Bortz Kelley industrial 7/24/97 Mack Kelley Radiographer 8/8/97 Martin Kelley Nuclear Medicine 8/20/97 Martin Kelley Industrial 9/16/97 Mack Kelley Private Practice 12/3/97 Mack Kelley Private Practice 12/3/97 Stokes Kelley Radiographer 12/4/97
- 9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field, if supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.
Compliance Procedure RAM-03.0, " Procedure for Schedulina and Trackino RAM License inanections." states:
- Each inspector will be accompanied on a minimum of two (2) inspections per year by supervisory personnel, usually the RAM Section Supervisor."
A copy of the Inspection Documentation will be available during the on-site review.
Supervisory accompaniments during 1996 and 1997 did not fully comply with Procedure RAM-03.0. An Action Plan has been issued to revi6e Compliance ,
Procedures to improve supervisory accompaniment inspections. The Action Plan will l be available during the on-site review.
In preparation for the IMPEP Evaluation, the Supervisor of Quality and Evaluation performed (or will perform) management accompaniment inspections with each of the l
three Health Physicist inspectors: Steve Mack, Jim Martin, and Hamp Stokes. A copy of the Management Review Reports will be available during the on-site review.
4
v i .
- 10. Describe or provide an update en your instrumentation and methods of calibration.
Are all instruments properly calibrated at the present time?
Yes. Allinstruments available for use are properly calibrated at this time.
The Division's Radiation Detection Equipment inventory will be available during the on-site review.
The Division's instrumentation is calibrated in accordance with its established Policy
& Procedure No. ES-01.3. The calibrations are scheduled on a quanerly frequency.
The 1998 Instrument Calibration Schedule will be available during the on-site review,
. Monthly " Instrumentation Calibration Status Reports" are prepared for Division management. Copies of the Status Report will be available during the on-site review.
Ill. Technical Staffino and Trainina
- 11. Please provide a staffing plan, or complete a listirig using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program, include all vacancies and identify all senior personnel assigned to monitor l work of junior personnel. If consultants were used to carry out the program's j
- radioactive materials responsibilities, include their efforts. '
Name Posroon Area of Effort FTE%
Gary sortz Heattr. vnysost Adminstraten 5 (Transferred to Materials UoensingComphance 60 from X-Ray in January Emergency F:_; _ w 5 1998 )
Cathey stadley HosRh Physost Admenstraten 5 UcensingComphance 60 Emergency Response 5 steve Mack Heath Physost Adrrunstration 5 WoonsingComphence 60 Emergency Response 5 Jim Mart n Health Physost Admmetreten 5 UcensingCompliance 60 Emergency Response 5 Hamp stokes Heath Pnysost Admmettsten 5 l UcensinsCompliance 60 Emergency F:_;:m 5 5
Name Posit 6on Area of Effort FTE%
somard Bevdl Health Physost Mmenstration 20 supervisor Ucensing/ Compliance 10 Emergency Response 5 Rsch Kelley Health Physost Mmenstraten 45 Supervisor Ucensing/comphance 20 Emergency Response 10 David D. Snethngs, Jr. Devoon Director Mmenstraton 20 Uconsing/Comphence 10 Emergency Response 5 Jared Thompson Health Shysost Mmenstraten 40 supervisor Ucensing/Comphence 25 Emergency Response 5 ,
1
- 12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other, disciplines, if appropriate. )
Mark Henrv was hired as a Health Physicist on March 27,1995. He holds a Bachelor's Degree in Health Physics. Mr. Henry has experience in health physics computer work and environmental monitoring. Mr. Henry resigned his position on March 7,1997, to accept a position in Washington State.
Jim Martin was hired as a Health Physicist on September 24,1995. He has a Bachelor's Degree in Biology, a Radiology Technologist Certificate, and a Nuclear Medicine Technologist Certificate. He has more than 18 years experience as a ,
Nuclear Medicine Technologist, and as a Nuclear Pharmacy Sales Representative.
Teri Maosam was hired as a Health Physicist on October 22,1995. She holds a Bachelor's Degree in Physical Sciences. Ms. Magsam has experience as a nuclear
, power plant health physicist and a NORM Safety Officer. Ms. Magsam resigned on December 12,1997 to accept a position with the State Office of Emergency Services in Conway,' Arkansas.
l Garv Bortz was hired as Health Physicist on March 10,1996. He holds a Bachelor's Degree in Biology. He has completed a five-week training course in Health Physics Fundamentals. He has 16 years of power plant experience as an operational health physicist, and in a corporate health physics office for a major utility. He is an active member of the National Registry of Radiation Protection Technologists.
Mandy Corter was hired as a Health Physicist on November 5,1995. She has a Bachelor of Science degree in Nuclear Medicine. She has one year experience in l laboratory chemical analysis, and two years experience as a Nuclear Medicine
! Technologist. She left the Division on September 20,1996.
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6
David D. Snellinas. Jr. was hired as the Division Director on January 27,1997. He has a Bachelor's of Science Degree in Physics and Math, and a Master's Degree in Radiological Sciences. Mr. Snellings has over thirty years experience in the radiation protection field. He is also Certified by the American Board of Health Physics.
LeAnna Mvnatt was hired as a Health Physicist on March 10,1996. She has a Bachelor of Arts degree in Political Science. Ms. Mynatt graduated frcm the St. Vincent infirmary Medical Center School of Radiological Technology and was ARRT Registered. Ms. Mynatt left the Division in January 1997 to accept a position in Virginia.
Caroline Hibbs was hired as a Health Physicist on June 15,1997. She has a degree in Radiological Technology, is certified ARRT, and has eleven years experience in the mammography field in another state.
Mark Hammond was hired as a Health Physicist on August 11,1997. He has considerable health physics knowledge and experience gained from serving as the Radiation Safety Officer at a large U.S. Army medicalinstallation, teaching health physics, and performing regulatory inspections. Mr. Hammond has also developed and implemented health physics computer applications while in the Army.
Jonathan Bibb was hired as a Health Physicist on July 13,1997. He has a Bachelor's degree in Radiological Technology and has three years experience as a Radiological Technologist.
Gwen Glinka was hired as a Health Physicist on May 19,1997. She has training in radiological special procedures from the United States Air Force School of Health, and is ARRT Registered in Radiology and Mammography.
Dave Baldwin was hired as a Health Physicist Supervisor in January 1998.
Mr. Baldwin has substantial supervisory and emergency management experience.
He has had 28 years experience as an officer in the U.S. Air Force. During his military career, approximately 18 years of that service were devoted to increasing levels of responsibilities in emergency management.
Joanna Allen was hired as a Health Physicist on January 14,1996. She has a Bachelor's degree in Occupational Safety & Health. Ms. Allen has had experience in industrial hygiene. She left the Division on March 16,1997.
Please list all professional staff who has not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualification requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.
7
l Qualification Requirements for Arkansas
- a. Materials License Reviewers Work Experience Within the Division's Materials Inspection Program or previous job experience.
On-the-job training.
FormalTraining Requirements H-109 Applied Health Physics S-301 RERO G-108 Inspection Practices & Procedures G-109 Licensing Practices & Procedures '
H-304 Diagnostic & Therapeutic Medicine H-305 Safety Aspects of Industrial Radiography H-308 Transportation of Radioactive Materials H 314 Safety Aspects of Well Logging l l
- b. Materials License Reviewers Work Experier.ce Within the Division's X-Ray Compliance Section or previous job l experience.
On-the-job training.
FormalTraining Requirements H-109 Applied Health Physics S-301 RERO -
G-108 Inspection Practices & Procedures H-304 Diagnostic & Therapeutic Medicine H-305 Safety Aspects of Industrial Radiography H-308 Transportation of Radioactive Materials H-314 Safety Aspects of Well Logging
- c. Professional Staffin Training Jim Martin Hamp Stokes Gary Bortz I i 8
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- d. Proposed Training Schedule JIM MARTIN G-108 inspection Practices & Procedures March 1998 H-305 Safety Aspects of industrial Radography May 1998 HAMP STOKES H-304 l Diagnostic & Therapeutic Medicine l August 1998 GARY BORTZ H-3,04 Diagnostic & Therapeutic Medicine March 1998 H-308 Transportation of Radioactive Materials Apnl 1998 H-305 Safety Aspects of Industrial Radiography May 1998 H-314 Safety Aspects of Well Logging November 1998
- 14. Please identify the technical staff who left the RCP/ Regional DNMS prograrn duiing this period.
Jimmy r ands October 1995 Kim Wiebeck December 1995
, Greta Dieus February 1996 Mendy Corter September 1996 LeAnna Mynett January 1997 Mark Henry March 1997 Joanna Allen March 1997 H. B. Bryant August 1997 Teri Magsam December 1997 Lisa Pentecost December 1997 Judy Tumer Febmary 1998 1
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i List the vacant positions in each program, the length of tima each position has been vacant,
! and a brief summary of efforts to fill the vacancy.
- s. Position No. 64L3-1991-Health Phvairi=+ in the Compliance Section (X-Ray).
Approval to fill the vacancy was received on January 28,1998. The vacancy was announced on February 9,1998, and will close on February 20,1998.
Interviews will be conducted in March 1538.
- b. Eggion No. 6450-0153-Hsalth Physicist in the Licensing, Accreditation, and Registration Section (Mammography). Approval to fill the vacancy was received on January 23,1998. The vacancy was announced on January 23, 1998 and closed on February 13,1998. Interviews will be conducted in March,1998,
- c. Position No. 6450-2004-Health Proaram Analvst for the Chemical Stockpile Emergency Preparedness Program (CSEPP). Approval to fill the vacancy was received on February 9,1998. The vacancy was announced on February 17,1998, and closed on February 27,1998. Interviews will be conducted in March 1998.
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- _ - - - - - - - - - - - - - - _ - - - - - - - 1
l l .
l IV. Technical Quality of Licensina Actions l
- 16. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period. Also identify any new or amerided licenses that now require emergency plans.
Major, Unusual, or Complex Licenses License Number issued During the Review Period Baptist Medical Center ARK-058-BP G-95 Bearden industrial Services ARK-818-BP-09-99 Environmen_tal Restoration Group ARK-855-NORM-06-02 H & H X-Ray Sewices, Inc. ARK-650-BP-8-00 Holt-Krock Chnic ARK-299-BP-01-97
.ones inspection Services ARK 740-BP-10-01 Little Rock Central Pharmacy ARK-873-BP-10-02 Mid-States Pipe Fabricating, inc. ARK-749-BP-10-01 Newpark Resources, Inc. ARK-833-NORM 02-99 St. Vincent infirmary Medical Center ARK 394-BP-6-01 Syncor, Inc. ARK-879-BP University of Arkansas ARK-064-INC-12-94 University of Arkansas ARK-711-INC-12-99 Westem Construction ARK-821-NORM-6-99 j No Arkansas Radioactive Material Licensee is required to have an Emergency Plan. l
- 17. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.
Industrial radiography licensees weru given a variance to comply with equipment i standards. This variance allowed the licensee sufficient time to comply with the regulations without having a serious economic impact on their business operations.
This variance expired on August 1,1997. Information Notice 97-01 will be available during the on-site review. ;
A waiver for all users of Molybdenum-99/ Technetium 99m generators was issued because of a potential disruption of the supply of these generators. The waiver allowed licensees to prepare reagent kits with the use of the generator for up to 21 days, and to use Technetium-99m eluants for up to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> with certain conditions.
This waiver was effective June 25 - July 25,1997. A copy of the waiver will be available during the on-site review.
A waiver was issued to the nuclear pharmacy licensees in the compounding of radiopharmaceuticals according to the manufacturer's insert. The waiver recognized that licensed nuclear pharmacists use professional judgement in the compounding of pharmaceuticals from kits. This waiver applied only to nuc! ear pharmacy licensees.
11
All other licensees compounding radiopharmaceuticals are required to comply fully with the regulations. This waiver was effective from July 10,1997 through September 10,1997. Subsequently, all nuclear pharmacies were granted an exemption from the regulations, panding revision of the Rules and Regulations. The exemption was effective on September 5,1997. New nuclear pharmacy licensees are given an exemption at the time that the license is issued. A copy of the waiver and the exemption will be available during the on-site review.
- 18. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
Information Notice 95-02 announcing a policy change dated June 27,1995 allowed q authorized users of nuclear medicine licenses to be available by telephone and within one hour of the licensed facility during administration of diagnostic radiopharmaceuticals. Changes in the licensing requirements were made on all renewal and new applications to reflect this change. A copy of the information Notice i will be available during the on-site review.
An intamal policy was drafted on August 13,1996, for changes in the requirements for Quality Management Plans (QMP). This policy removed the requirement for a QMP for those facilities performing diagnostic procedures using 30 millicuries or less of I-125 and 1-131. Facilities that use therapeutic amounts of these isotopes shall have a QMP that assesses the effectiveness of the program when performing diagnostic procedures. This intemal policy nas only been used as a licensing and inspection guide. its final implementation will be accomplished during the second quarter of 1998.
- 19. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.
NONAPPLICABLE l V. Responses to incidents and Allegations
- 20. Please provide a list of the reportable incidents (i.e., medical misadministration, overexposure, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-L 0178, Nuclear Material Events Database).
L I
12
+
l During the review period, approximately 157 events were reported to the Division.
l The following table summarizes the major events.
Licensee Name License Date of No. Incident / Type ofincident Report Anderson Engineering ARK-519 10/28/95 Gauge's source broke off while in use.
Anderson Engineenng ARK-519 4/8/96 Const'uction equipment damaged gauge and source popped off.
Anderson Engineenng ARK 519 7/30/06 Gauge was stolen, then recovered as a result of news releases.
Anheuser Busch Co. NRC 5/20/97 Improper disposal of Amencium source License holder causing a major search in NUCOR Scrap.
Bhate Engineering Alabama 4/22/g7 Recovery of two stolen gaeg?s and the Birmingham, Alabama License investigation of resultant dose to members in Memphis of the public.
TN (REC-114)
CARTI (North) ARK-809 10/12/95 Metastron contamination in patient's home.
Cartesville Industnal Service N/A 11/18/97 Reported depleted uranium find in Georgia (FBIinvolvement).
Coastal Midwest N/A 12/21.97 Transportation response (non-event / driver abandonment).
Grubbs Engineering ARK-456 2/6/98 Lost and found gauge.
H & H X-Ray ARK-650 5/21/97 Abandoned radiography device confiscated j by ADH. i Jefferson Regional Medical ARK-623 9/17/96 Federal Express misplaced Rx, which was Center eventually located in a secure area.
NUCOR ARK-722 3/23/97 Melt down over Ronan device.
NUCOR ARK-786 9/14/97 Berthold gauge problem.
NUCOR Steel Mill N/A 5/1/96 Apparent source housing from Holland found l in scrap.
Porocel ARK-637 7/14/97 Misplaced gauge was eventually located in a secure area at facility.
Robert Construction ARK-850 2/14/97 Federal Express delivery problem.
Syncor-Memphis @ TN 1/15/98 Lost /Not Lost Rx Ammo Box Methodist Hospital of License &
Jonesboro ARK-504 Union Pacific Railroad N/A 4/15/96 Anonymous call to NRC re: railcar with labeled RAM inside.
- 21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely noti 5 cation made to NRC7 For Regions, was an appropriate and timely PN generated?
13
U In answer to question 21, please see the answer to questiot',22 below.
- 22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic desip jeficiency? Please provide details for each case.
On September 15,1997, an incident involving a Berthold model LB300MLT mold level gauge containing 36 mci of Cobalt-60 resulted from the failure to maintain standard operating integnty. The bottom @n became displaced from the extemal housing and allowed the source to be unshielded. This incident occurred at NUCOR Steel Company, Armoral, Arkansas (Arkansas Radioactive Material License Number ARK-786-BP-5-97).
NRC Region IV staff, Operations Center Staff, and NMSS staff were notified of the defect. Doug Broaddus of NNMS with the NRC conducted an on-site investigation on September 18,1997, at the Nucor facility, accompanied by Division personnel. The incident Package will be available during the on-site review.
- 23. In the period covered by this review, were there any cases involving poss,sie wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.
NONE
- 24. Identify any changes to your procedures for handling allegations that occurred during the period of this review.
NONE For Agreement States, please identify any allegations referred to your program by the NRC t;.si have not been closed.
NONE VI. General
- 25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.
The NRC Review of the A,rkansas Agreement State Program conducted in May 1995 identified five concems. The concems and subsequent corrective actions are as follows:
l a. Exemption of requirement to perform radiation surveys of radiopharmaceutical packages received from local nuclear pharmacies.
Elatus: The Rules and Regulations were revised effective January 1,1997, to 14
i-delete the provision exempting the requirement to perform surveys. The applicable Rules and Regulations are now compatible with 10 CFR 35.
Action No additional action is required. This concem is closed.
l l b. Status and Compatibility of the Rules and Regulations Statua: The Rules and Regulations were revised effective January 1,1997 to incorporate many of the concems identified during the May 1995 review.
However, a thorough Self-Evaluation of the Rules and Regulations has been performed in conjunction with IMPEP, which has indicated that additional revi61ons are now required. Additional review has indicated that, " Definition of Land Disposal and Weste Site QA Program: Part 61," has not been included in the current revision of the Rules and Regulations. Arkansas has no waste disposal sites and is restricted from licensing a land disposal site by state law
]
(Act 562 of 1987 requires above-ground disposal facilities). Therefore, the NRC requirements do not apply and should not be required as regulations. A copy of the Self-Evaluation will be available during the on-site review.
Action An Action Plan to revise the Rules and Regulations has been issued.
The revision process will begin on April 1,1998. The Action Plan will be available during the on-site review.
An Action Plan to revise the Division's Procedures and Licensing Guides has been issued. The revision process will begin April 1,1998. The Action Plan will be available during the on-site review,
- c. Licensing procedures and practices regarding radiation surveys of radiopharmaceutical packages received from local nuclear pharmacies:
Status. The licensirig procedures and practices have been revised to delete any reference to exempting radiation surveys. Radioactive Material License applications (both new and renewal) require that radiation surveys of all packages be routinely performed.
Astier No additional action is required. This concem is closed.
. d. Procedures for escalated enforcement actions:
Status Written procedures for implementing escalated enforcement actions have not been completed.
Action: The procedure for escalated enforcement action will be completed j by March 16,1998. A working group was formed in December 1997 to develop i recommendations for development and implementation of civil penalties for radiation control, andincreasing the maximum total civil penalty amount.
I Recommendations for revis!ng legislation regarding civil penalties will be 15 l
l E____ _
provided to Department Senior Management by March 1,1998. The working group will provide Division management recommendations for implementing civil penalties by April 1,1998.
- e. Increase the number of reciprocity inspections'.
Status The number of reciprocity license inspections has increased from five (13.9%) in 1996, to 15 (29.4%) in 1997.
Action An Action Plan has been developed to revise appropriate inspection procedures to require that reciprocity inspections be performed on a routine basis. The procedures will be revised by May 31,1998. The Division Performance Indicator System will be expanded to track reciprocity inspections. The Action Plan will be available during the on-site review.
- f. Backlog of license renewal application actions:
Status: The backlog of overdue license renewals continues to be a problem. In mid-February 1998, there are 100 significant licensing actions pending. This includes 83 by-product licenses, 9 new applications, one radium license renewal, and 7 accelerator license renewals. The backlog of by-product license renewals has increased from 65 in 1995 to 83 in 1998. These totals do not reflect the number of license amendment requests processed on a monthly basis. Since June 1997, an average of 22 license amendments has been issued per month.
Action Several remedies to resolve the backlog issue have been attempted during the review period. However, none have been successful. A thorough Self Evaluation has concluded that significant changes to the licensing process must I be made before a reduction in the backlog can be achieved. A
- process engineering" l evaluation will be conducted to identify / examine possible program changes. An !
Action Plan has been issusd to improve administrative licensing practices to !
help reduce the backlog. The estimated completion date for the Action Plan is May 31,1998. A copy of the Action Plan will be available during the on-site review.
\
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, . - _ _ _ - _ _ _ _ _ _ _ _ _ . _ _ _ - - _ _ _ - - _ _ _ _ _ _ - _ _ = - _ _ _ _ _-_
- 26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties that occurred during this review period.
- s. Strenaths The following stren2ths are noted:
Licensing actions are of continuing high technical quality.
Health Physics inspectors have demonstrated ability to perform thorough compliance inspections.
Demonstrated strong Department management support for Division budgetary and programmatic actions.
Ability to hire experienced, qualified technical personnel at above entry-level salary.
Ability to manage response activities and incident investigations considering the limited number of experienced staff personnel.
. Technical staff is competent and is willing to work; individuals have shown a desire to do a good job.
- b. Weaknesses The following weaknesses are noted:
. Division Operating Procedures are outdated and personnel are not familiar with procedural requirements.
. Revision of Rules and Regulations is too cumbersome and lengthy; the revision process is virtually continuous.
- Existing culture is resistant to change; also resistant to questioning attitude (why?) and approach to identify and solve problems. i
. Division administrative processes and practices are not current. l
. Limited training opportunities for professional staff because of reduced funding for trairing; individual promotion / advancement is dependent upon attending trainir,g courses.
. Existing resources challenged by a wide variety of responsibilities in addition to the regulatory programs, including radiological emergency response (both ANO i and source-oriented), non-radiological emergency response (CSEPP, hazardous materials, natural disasters, etc.), NORM, and radon.
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I l 17 1
v B. NON-COMMON PERFORMANCE INDICATORS
- 1. Legislation and Proaram Elements Reauired for Compatibility
- 27. Please list all currently effective legislation that affects the radiation control program (RCP).-
Radiation Control: Statutes are Arkansas Code 20, Chapter 21 (reference Arkansas Code 1987 Annotated, Volume 20A. Title 20, Chapter 21).
Legislation:
Act 19 of 1983. Revised original enabling Legislative Act 8 of 1961 (also has civil penadies).
Act 504 of 1987. Enabled fees.
Act 796 of 1995. Changed fees.
Mammography Legislation:
Act 292 of 1989. Mammography accreditation.
Act 508 of 1995. MSAQ compliance.
Nuclear Planning & Response Legislation:
Act 101 of 1981. Amended original enabling legislative Act 67 of 1980 (placed program 100% within the Arkansas Department of Health). j Act 536 if 1983. Established Ccunty Grant Program.
Act 544 of 1983. Established Nuclear Planning & Response Program Advisory Committee.
Low LevelWaste:
Statutes:
Arkansas Code 8, Chapter 8,201 et. Seq. (reference Arkansas Code 1987 Annotated, Volume 6A, Title 8, chapter 8).
Legislation:
Act 9 of 1983. Arks;isas a member of the Central Interstate Compact.
Act 929 of 1985. Established member and attemate.
Act 562 of 1987. Defined LLW and required above-ground disposal facility.
Act 847 of 1991.
- Nebraska Amendments."
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18
Appropriation Legislation:
Act 768 of 1997. Arkansas Department of Health's Appropriations Bill.
- 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
Arkansas Radiation Control regulations are not subject to a " sunset" or equivalent law.
- 29. Please complete the enclosed table to ed on NRC chronology of amendments.
Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that.the State has adopted through legally binding requirements other than regulations.
Please see Attachment No.1 to this document, " Table Answering Question 29."
if you have not adopted all amendments within three years from the date of NRC ,
rule promulgation, briefly describe your State's procedures for amending regulations j in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.
The Division will begin its major 1998 Rules and Regulations revision process in April 1998.
After receiving approval from the Division Director, the Bureau Director, and an Agency attomey, the DRAFT Revision will be presented to the Arkansas Board of Health in July 1998. During the formal board meeting, a request to proceed to a public hearing will be made.
Allinterested parties, the Arkansas Govemor's Office, and the members of the Legislative Council will be notitied of changes to the Arkansas Regulations. Notice will be given regarding a Public Hearing on the Revisions. The Public Hearing will be held in late August or early September 1998.
Comments will be reviewed and analyzed. Revised Regulations will be presented to the Legislative Council Committee in late September or early October 1998.
A retum will be made to the Board of Health for final rule adoption in October 1998.
Review will be made of appropriate certifications in November 1998.
The printing of the approved and certified Rules and Regulations will begin in December 1998. The certified Regulation Review will be mailed to the Arkansas registrants and licensees in early 1999.
19
5 ll, Saaled Source and Device Proerem
- 31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period.
The State of Arkansas has not evaluated or registered any sealed sources or devices during the review period.
- 32. What guides, standards and procedures are used to evaluate registry applications? NOT APPLICABLE
- 33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program.
NONAPPLICABLE Ill. Low-Level Waste Proaram
- 34. Please include information on the following questions in Section A, as they apply to the Low-levelWaste Program:
Status of Materials Inspection Program - A.I.1-3, A.I.6 Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.Ill.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 NOT APPLICABLE IV. Uranium Mill Pronram
- 35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:
Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Quality of Inspections - A.II.7-10 Technical Staffing and Training - A.lll.11-15
. Technical Quality of Licensing Actions - A.lV.16-18 Responses to incidents and Allegations - A.V.20-23 NONAPPLICABLE i
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APPENDIX D INSPECTION FILE REVIEWS NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.
1 File No. 1 Licensee: Little Rock Central Pharmacy License No.: ARK-873-BP-10-02 Location: Little Rock, AR inspection Type: Initial, Announced License Type: Nuclear Pharmacy Priority: 1 Inspection Date: February 12,1998 Inspector: JM File No.: 2 Licensee: Arkansas Heart Hospital License No.: ARK-858-BP-02-02 Location: Little Rock, AR inspection Type: Unannounced, Routine License Type: Nuclear Medicine Priority: 2 Inspection Date: November 21,1997 Inspector: JM File No.: 3 Licensee: St. Vincent infirmary Medical Center License No.: ARK-394-BP-06-01 Location: Little Rock, AR inspection Type: Routine Announced License Type: Medical Institution (QMP Required) Priority: 1 Inspection Date: October 15-16,1997 Inspector: MH File No.: 4 Licensee: Georgia Pacific Corporation License No.: ARK-321-BP-03-97 Location: Crossett, AR inspection Type: Routine, Short Notice Announced License Type: Fixed Gauges Priority: 3 Inspection Date: February 11 & 25,1998 Inspector: JM File No.: 5 Licensee: Tigue Construction Co. License No.: ARK-713-BP-11-96 Location: Heber Springs, AR inspection Type: Follow-up, Special Termination License Type: Portable Gauge Priority: 3 Inspection Date: December 4,1997 Inspector: GB File No.: 6 Licensee: Arkansas State University License No.: ARK-307-INC-2-96 Location: State University, AR inspection Type: Routine License Type: Academic-Research & Development Priority: 2 Inspection Date: October 9,1996 Inspector MH File No.: 7 Licensee: Doctor's Hospital License No.: ARK-472-BP-05-96 Location: Little Rock, AR inspection Type: Routine, Announced License Type: MedicalInstitution Priority: 2 inspection Date: March 6,1998 Inspector: SM i
- Arkansas Proposed Final Repstt Page D.2 Inspection File Reviews -
File No.: '8
- Licensee: Jack Wood Construction Company, Inc. License No.: ARK-769-BP-05-96 l Location: Russellville, AR inspection Type: Routine, Announced t
~ License Type: Portable Gauges Priority: 3 inspection Date: March 5,1998 Inspector: SM File No.: 9 l Licensee: International Testing & Inspection Sycs, Inc. License No.: ARK-773-BP-08-97 Location: Little Rock, AR inspection Type: Routine, Announced l License Type: Industrial Radiography Priority: 1 Inspection Date: March 4,1998 Inspector: HS l
- ' File No.
- 10 Licensee: Construction Testing Services, Inc. License No.: ARK-750-BP-11-99
. Location:~Arkadelphia, AR inspection Type: Routine, Announced
- License Type: Portable Gauges Priority: 3 Inspection Date: March 24,1998 Inspector: HS l
INSPECTOR ACCOMPANIMENTS
'In addition Mr David J Collins Region ll a review team member made the following inspection
, . . , , , j accompaniments as part of the on-site IMPEP review: '
, Accompaniment No.: 1
- Licensee: Jefferson Regional Medical Center License No.: ARK-623-BP-RA-10-96 Location: Pine Bluff, AR- .
Inspection Type: Routine, Announced License Type: Medical Institution (QMP Required) Priority: .1
- Inspection Date: March 2,1998 Inspector: JM l
Accompaniment No.: 2
- Licensee: St. Joseph Regional Medical Center License No.: ARK-346-BP-RA-5-97
~ Location: Hot Springs, AR inspection Type: Routine, Announced License Type: Medical Institution (QMP Required) Priority: 1
! - Inspection Date: March 3,1998 Inspector: JM i
[ Accompaniment No.: 3 l Licensee:IntemationalTesting License No.: ARK-773-BP-8-97 l Location: Little Rock, AR .
Inspection Type: Routine, Announced -
L License Type: Industrial Radiography' Priority: 1
!. Inspection Date: March 4,1998 inspector: HS Accompaniment No.: 4 Licensee: Wood Construction Co. License No.: ARK-769-BP-5-96
- Location: Russellville, AR inspection Type: Routine, Announced
- License Type: Portable Gauge Priority: 3 Inspection Date: March 5,1998 Inspector SM
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Arkansas Proposed Final Report Page D.3 Inspection File Reviews Accompaniment No.: 5 Licensee: Columbia Doctor's Hospital License No.: ARK-473-BP-5-96 Location: Little Rock, AR inspection Type: Routine, Announced License Type: MedicalInstitution Priority: 2 Inspection Date: March 6,1998 Inspector. SM File No.: 6 Licensee: Construction Materials Testing License No.: ARK-750-BP-11-99 Location: Arkadelphia, aR Inspection Type: Routine, Announced License Type: Portable Gauge Priority: 2 Inspection Date: March 24,1998 Inspector: HS I
APPENDIX E ,
- i LICENSE FILE REVIEWS NOTE
- ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.
File No.: 1 Licensee: Arkansas Tech. University License No.: ARK-106-INC-09-08 Location: Russellville, AR Amendment No.: 22 License Type: Academic Type of Action: Renewal Date issued: 12/5/95 License Reviewer: SM Comments:
a) Typo in LC 14.A (RH1206 should be RH 1212).
! b) Amendment No. 21 authorized annualinventory, guidelines require semiannual inventory.
c) Did not use Arkansas standard license condition for transportation.
d) Leak test procedure did not include LLD calculation. 1 e) Review did not include financial surety or requirement for annual radistion program 1 review.
f) No specific request for decay in storage as authorized in license.
File No.: 2 Licensee: Univ. of Arkansas - SRCC IM:nc: Nn ARK 411-BP-RA Location: Fayetteville, AR Amendmant No.: 10 License Type: Academic-Broad Type of Action: Renewal, Amendmant Date issued: 11/30/95,2/5/98 License Reviewer: JT Comment:
a) Review did not include financial surety or requirement for annual radiation program review.
File No.: 3 Licensee: Mid States Pipe Fabricating, Inc License No.: ARK-749-BP-10-01 Location: El Dorado, AR Amendment No.: 10 License Type: Radiography Type of Action: New, Amendment j Date issued: 3/13/98 License Reviewer: CB, RK Comment:
a) Review did not include financial surety or requirement for annual radiation program i
review.
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v l,
i Arkansas Proposed Final Report Page E.2 l License File Reviews L
File No.: 4 Licensee: H&H X-ray Services License No.: ARK-650-BP-00 Location: West Monroe, LA LA Amendment No.: Entirety License Type: Radiography Type of Action: Amendment Date issued: 4/5/96 License Reviewer: CB, JT Comment:
a) Review did not include financial surety or requirement for annual radiation program l
review.
File No.: 5 Licensee: Arkansas Heart Hospital License No. ARK-858-BP-02-02 Location: Little Rock, AR License Type: MedicalInstitution Type of Action: New Date issued: 3/7/97 License Reviewer: JT Comments:
a) Review did not include financial assurance or annual program reviews.
b) Did not use standard Arkansas license condition for transportation, File No.: 6 Licensee: Little Rock Central Pharmacy License No.: ARK-873-10-02 Location: Little Rock, AR License Type: Radiopharmacy Type of Action: New ;
Date issued: 11/16/97 License Reviewer: JT j i
Comments:
a) Review did not include financial assurance or annual program reviews.
b) No peer review sign off, c) Did not use Arkansas standard condition for transportation in license.
d) No verification of NIST-traceability requirement for bioassay standard.
e) Did not use bioassay requirements of 10 CFR Part 20 Appendix B (reference was to old Part 20, not ALis and DACs in new Part 20).
File No.: 7 Licensee: Cleburne Memorial Hosp dba Baptist Med Center License No.: ARK-713-BP-11-96 Location: Heber Springs, AR Amendment No.: 12 License Type: Medical institution Type of Action: Termination Date issued: 12/17/97 License Reviewer: JT Comments:
! a) . Close-out survey performed by Division.
l b) Wipe survey results not in file, but available and kept in analytical lab data.
i
l Arkansas Proposed Final Report Page E.3 License File Reviews File No.: 8 Licensee: AEB Consultants dba Nuclear Assay & Env. Sycs. License No.: ARK-763-IV-10-95 Location: Pine Bluff, AR Amendment No.: 9 License Type: Industrial Type of Action: Termination Date issued: 7/3/97 License Reviewer: JT File No.: 9 l
Licensee: Georgia Pacific Corp. License No.: ARK-321-BP-03-97 Location: Crossett, AR Amendment No.: 54 License Type: Gauge Type of Action: Amendment Date issued: 4/17/97 License Reviewer: JT i
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O APPENDIX F i
INCIDENT FILE REVIEWS NOTE: ALL INCIDENT FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM 10 BE ACCEPTABLE.
l File No.: 1
( Licensee: Anderson Engineering incident Log #: 95-28 i Site of incident: Batesville, AR Licensee #: 519-BP-10-95
[- Date of incident: 10/18/95 Type of incident: Equipment Failure
' investigation Date: 10/18/95 Type of Investigation: On-site Summary:
l A source separated from the guide rod of a soil density gauge (assumed to be a Troxler gauge l
with a Cs-137 source) due to apparent failure of the weld. The source was recovered from a depth of 6-8 inches of soil and placed in a shielded centainer. A survey of the soilindicated
)
there was no contamination present. A soil sample was taken for lab analysis at the Division. J Comments:
a) There was no identification of the type of gauge or source activity /nuclide in the incident
< file.
l b) The environmentallab log did not indicate receipt or analysis of the soil sample, c) The root cause of the defect and possibility of generic implications was not evaluated.
d) No information was passed on to the manufacturer.
- e) The Division did not notify the NRC of the event or provide information for the NMED database.
j i
File No.: 2 Licensee: Bhatt Engineering incident Log #: 97-20 i Site ofincident: West Memphis, AR Licensee #: REC-114 Date of Incident: 4/16/97 Type of Incident: Stolen Gauges investigation Date: 4/18/97 Type of Investigation: On-site l
Summary:
I '
Two Humboldt soil moisture density gauges (10 mci Cs-137/40 mci Am-241:Be), stolen on 2/24/97, were found by a member of the general public. The source rod was exposed on one gauge and resulted in doses to several members of the general public. Dose reconstruction l studies indicated that the individuals involved received less than 100 mrem.
I l Comment:
a) The Division did not notify the NRC of the event and has not provided information for the NMED database.
L___--_----_---------_______________________________________-.______.____________._-----_------_----__ -_--__J
Arkansas Proposed Final Report Page F.2 Incident File Review File No.: 3 Licensee: Central Arkansas Radiation Therapy institute incident Log #: 95-27 Site of incident: Newark, AR Licensee #: 809-BP-12-98 Date of incident: 10/12/95 Type ofincident: Contaminatica investigation Date: 10/13/95 Type of Investigation: Phone / letter Summary:
A patient receiving an injection of 4 mci of Sr-89 contaminated a vehicle and areas in his home as a result of bladder control problems. The concemed family called Central Arkansas Radiation Therapy Institute (CARTI) who in turn contacted the Division. The Division advised CARTl on the proper corrective actions to take and requested that CARTl provide a detailed report on the incident.
File No.: 4 Licensee: NUCOR Steel Company incident Log #: None assigned Site of Incident: Hickman, AR Licensee #: 786-BP-05-97 Date of incident: 9/14/97 Type of incident: Equipment Failure investigation Date: 9/15/97 Type of Investigation: Letter /Onsite Summary:
An incident involving a Berthold Mold L evel gauge containing 36 mci of Co-60 occurred when the bottom plate of the gauge came off and allowed the source holder to drop out into a casing well. Three employees took actions to recover and store the source in a safe configuration. The maximum whole body dose received was estimated to be 51 mrem. NRC Region IV was notified and Headquarters dispatched a staff member to evaluate the gauge. A Confirmatory Action Letter was subsequently issued to Berthold Systems. The Division issued several violations to NUCOR as a result of their follow-up inspection of the incident.
File No.: 5 Licensee: Anderson Engineering incident Log #: 96-54 Site ofincident: Ft. Smith, AR Licensee #: 519-BP-8-00 Date of incident: 7/29/96 Type of incident: Stolen Gauge Investigation Date: 8/12/97 Type of Investigation: Telephone & On-site Summary:
An unlocked Troxler Soil Density gauge containing Cs-137 (8 mci) / Am-241:Be (40 mci) was stolen from a construction site. Region IV was notified and the gauge was found on a public road approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> later. Surveys indicated there was no contamination and that the source was in the shielded position. The Division issued several violations as a result of their on-site inspection.
4' - Arkansas Proposed Final Report Page F.3 incu$ent File Review File No.: 6 Licensee: H_& H X-ray Services incident Log #: None Assigned
. Site ofincident: Crossett, AR Licensee #: 650-BP-8-00 l Date ofinc6 dent: 5/14/97 Type of incident: Loss of Control of RAM i investigation Date: 5/14/97 Type of Investigation: On-site 1
Summary:
l The Divisior. inspectors discovered a radiography site at which a SPEC 2T (Ir-192) camera with the key inserted was left unattended. The inspectors surveyed the area and determined that the source was in the shielded position. When no radiography personnel showed up after 15 minutes, the inspectors left a business card and confiscated the camera. The Division
' subsequently issued a letter to the licensee suspending their license until corrective actions, including training, were taken.
File No.: 7 L Licensee: NUCOR incident Log #: 97-14 l Site ofincident: Blytheville, AR Licensee #: 722-BP-2-98 l Date of incident: 3/23/97 Type of incident: Damaged Source i
investigation Date: 3/24/97 Type of Investigation: On-site Summary:
L ' A source holder containing a Cs-137 (5 Ci) source used for level measurements was partially
- i. damaged by an overflow of molten metal. The Division responded and provided assistance in i the removal of the source holder from the mold. It was determined that the source had not been damaged. All personnel exposures were less than 10 mrem. The Division issued one violation.
L Comment:
a) The Division did not notify NRC of the event and has not provided information for the
- NMED database.
File No.: 8 Licensee: Anderson Engineering incident Log #: 96-85 Site of incident: Fort Smith, AR Licensee #: 519-BP-8-00 Date ofincident: 4/8/96 Type of incident: Equipment Failure investigation Date: 4/15/96 Type of Investigation: On-site at Licensee
' Summary:
A Troxler soil density gauge, in use at a construction site, was pushed over on its side as a result of dirt being pushed by a grader's blade. The source (Cs-137/Am-241:Be) was exposed
.and the operator quickly retracted the probe. During the retraction, the source separated from the rod. The operator secured the area and notified the RSO. The RSO recovered the source and placed it in shielded portion of the gauge. The gauge and source were transferred to the licensee's lab. The Division performed their investigation at the licensee's lab.
Comment:
- a) The Division did not notify the NRC of the event and did not provide information for the NMED database.
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f Arkansas Proposed Final Report Page F.4 incident File Review t l l File No.: 9 Licensee: Harris Hospital incident Log #: 96-01 f
Site ofincident: Newport. AR Licensee #: 450-BP-10 1 Date ofincident: Unknown Type of incident: Misadministration Investigation Date: Unknown Type of Investigation: None j Summary:
i A bone scan using 20.4 mCl of Tc-99m was performed on the wrong patient. The incident did not meet the definition of misadministration, and the Division did not request further information.
' Comment: ,
a) No dates or details of the incident, or corrective actions were provided by the licensee. l File No.: 10 Licensee: NUCOR : Incident Log #: 97-04 I Site of incident: Blytheville, AR Licensee #: 722-BP-2-98 Date of incident: 1/8/97 Type of incident: Unidentified RAM Investigation Date: 1/14/97 Type of Investigation: On-site Summary: l 1
A gondola containing scrap metal from a barge caused a radiation detector to alarm. The Division was notified and determined that a five inch diameter container reading 200 mR/hr on contact caused the detector to alarm. The Division retrieved the radioactive item and shipped (via DOT-E 10656 exemption) it to Hake Associates of Tennessee for identification and .,
disposal. The Division notified the Regional ONice and a PN was issued on January 8,1997. l The Division believed the nuclide was Ra-226 and, therefore, the event was not entered into
- NMED.
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i A Arkansas Department of Health
( / 48 4815 West Markham Street + ljttle Rock. Arkansas 72205-3867 + Telephone (501) 661 2000 Sandra B. Nichols, M.D., Director + Mike Huckabee, Governor i
May 26,1998 $
E Mr. Richard L. Bangart, Director E8 C 7 Office of State Programs @,
United States Nuclear Regulatory Commission Washington, D.C. 20555-0001 w
Dear Mr. Bangart:
Thank you for your letter of May 1,1998 in which you reported the results of the Integrated Materi d Performance Evaluation Program (IMPEP) review of the Arkansas i Agreement State program conducted on March 23-27,1998. j I am pleased thit the IMPEP team found the program adequate to protect the public health and safety and compatible with the Nuclear Regulatory Commission's (NRC) program. I understand this finding of adequacy and compatibility will be recommended to the NRC Management Review Board (MRB) on June 16,1998. Mr. David D.
Snellings, Jr., will represent the Arkansas program at the MRB meeting. I am also pleased that the IMPEP team recognized the Division of Radiation Control and Emergency Management's (DRCEM) Self- Evaluation Program as a good practice.
The management of the DRCEM has reviewed the draft repon and agrees with the findings and recommendations provided by the IMPEP team. The draft report contains eight recommendations and two suggestions for program improvement. The Department concurs with these recommendations and suggestions and we will implement these improvements through the DRCEM Self Evaluation Program / Corrective Action Plan process.
1 l
ATTACHMENT 1 l i
Keeping Your Hometown Healthy l o gji5'uqk M
~
9 9
The Department strongly supports the IMPEP process for pro';; ram reviews, particularly the review team concept and the inclusion of other Agreement State personnel as team members. The IMPEP review of the Arkansas program was performed effectively and efficiently. I commend the members of the team for the professional manner in which they conducted the review.
\
If you have questions, please contact David D. Snellings, Jr. or me.
e Sincerely,
[ i Sanh .Nichols,M.D. C Director
1 o Aaenda for Manaaement Review Board Meetina Tuesday. June 16.1998 .10:30 - 12:30 o.m.. OWFN.16-B-4
- 1. Convention. MRB Chair convenes meeting (R. Bangart)
- 2. New Business - Consideration of Arkansas IMPEP Report A. Introduction of Arkansas IMPEP Team Members (L. Bolling)
B. Introduction of Arkansas representatives and other State representatives participating through teleconference.
C. Findings regarding Arkansas Program (IMPEP Team)
Status of Materials Inspection Program Technical Quality of Inspections Technical Staffing and Training Technical Quality of Licensing Actions Response to incidents and Allegations Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program D. Questions. (MRB Members)
E. Comments from State of Arkansas F. MRB Consultation / Comments on issuance of Report (R. Bangart)
Recommendation for next IMPEP review
- 4. Status of Upcoming Reviews
- 5. Planned IMPEP Procedural improvements Concise Final IMPEP Ptports New Timeliness Goal
- 6. Adjournment (R. Bangart)
Attendees: Richard Bangart, MRB Acting Chair, OSP Karen Cyr, MRB Member, OGC Malcom Knapp, MRB Member, NMSS Thomas Martin, MRB Member, AEOD Richard Ratliff, OAS State Liaison to MRB David Snellings, Jr., AR Lloyd Bolling, IMPEP Team Leader, OSP Tom O'Brien, IMPEP Team Member, OSP Martha Dibblee, IMPEP Team Mernber, Oregon Linda McLean, IMPEP Team Member, RIV Dave Co!!!ns, IMPEP Team Member, Rll L Paul Lohaus, OSP l
ATTACHMENT 2