ML20197E269
| ML20197E269 | |
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| Issue date: | 12/10/1997 |
| From: | NRC |
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{{#Wiki_filter:._. . --_ . _ __ . _ _ ___. . _ _ _ . _ _ _ . - . _ . _ _ _ _ - _ _ . . . _ . l r I l l INTEGRATED MATERIALS PERFGRMANCE EVALUATION PROGRAM (IMPEP) FOLLOW-UP REVIEW OF THE NEBRASKA RADIATION CONTROL PROGRAM SEPTEMBER 16-18,1997 FINAL REPORT l l l U. S. Nuclear Regulatory Commission l l l
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Nebraska Final Report Page1
1.0 INTRODUCTION
This report presents the results of the follow-up review of the Nebraska radiation control program conducted September 1618,1997. The follow up review was conducted by a review team comprised of technical staff members from the Nuclear Regulately Commission (NRC). Team members are identified in Appendix A. The follow up review was conducted in accordance with the
- Policy Statement on Adequacy and Compatibility of Agreement State Programs,' published in the Federa/ Register on September 3,1997 (62 FR 46517). and the September 12,1995, NRC Management Directive 5.6,' Integrated Materials Performance Evaluation Program (IMPEP).* The follow up review covered the State's response to, and resolution of,15 recommendations made during the July 1519,1996 IMPEP review. The follow-up review also covered the states of the program during the following pers of July 20, 1996 - September 12,1397. Preliminary results were discussed with Nebraska management on Sept 9mber 18,1997.
A draft of this report was issusd to Nebraska for factual comment on October 10,1997. The State of Nebraska responded in a letter dated October 31,1997, from Robert Leopold, Administrator, Public Health Assessment Division, Department of Regulation and Licensure, Nebraska Health and Human Services System (Attachment 1). The State's comments have been incorporated into the final report. A copy of the final report was provided to the Management Review Board (MRB). The MRB considered and concurred in the team's overall recommendation and found the Nebraska radiation control program remains adequate to protect public health and safety but needs improvement, and compatible with NRC's program. The Nebraska Department of Health and Human Services System (NHHS)is the agency within the State of Nebraska that regulates, among other public nealth issues, radiation hazards. The Director, NHHS, is appointed by and reports directly to the Govemor. Within NHHS, thw Nebraska radiation control program is administered by tne Department of Regulation and Licensure, under the Public Health Assessment (PHA) Division. The program is coordinated within Consumer Health Services (CHS) under the Consumer Safety Protection Team. The CHS team was recently reorganized in May 1997 to consolidate all radiation programs including X ray. The Department of Regulation and Licensure and the PHA Division organization charts are included as Appendix B. During the review period, the Nebraska program regulated 148 specific licenses which include three large commercial irradiators, one converted teletherapy research irradiator, manufacturers, broad academic, broad medical, radiopharmacy and radiographers. The State is also in the process of conducting a licensing review of a low-level radioactive waste disposal site. The low-level radioactive waste (LLRW) disposal regulatory program is jointly administered and managed by NHHS and the Nebraska Department of Environmental Quality (NDEQ) through a Memorandum of Understanding. In addition to its radioactive materials and low level radioactive waste disposal programs, NHHS is responsible for the control of machine produced radiation, NARM, and emergency response planning for two nuclear power plants. The follow-up review focused on the materials program as it is carried out under the Section 274h. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Nebraska. The review team's general approach for conduct of the follow up review included: (1) evaluation of the State's implementation of their *Get-Well and Stay Well Plan,' that was
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j. O Nebraska Final Report Page 2 accepted by the MRB at the January 22,1997 MRB meeting, (2) the status of the program during the period of July 20,1996 September 12,1997, (3) review of the status of applicablo Nebraska statutes and regulations, (4) review of quantitative information from the radiation control program licensing and inspection database (5) technical review of selected inspection program documentation for response to issues identified during the previous review, and (6) interviews with staff and management to answer questions or clanfy issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non common performance indicator and made a preliminary asssssment of the radiation control program's performance. 2.0 STATUS OF PREVIOUS REVIEW The previous routine IMPEP review, conducted on July 15-19,1996, resulted in a findin9f or Nebraska that the radiation control program was ' adequate to protect public health and safety but needs improvement, and compatible with NRC's program." Due to the significance and number of deficiencies found in the Nebraska program, which included a finding of unsatisfactory in one performance indicator, the review team recommended a period of probation for a duration to be established after consultation with the Nebraska radiation control program management. In consideration of the corrective actions taken, and actions planned, that were presented by the State at the January 22,1997 MRB meeting, in a "Get Well and Stay Well Plan' to address and close out all recommendations by July 1,1997, the review team revised their recommendation. The recommendation for probation was changed to a recommendation for a tollow up review of the State's radiation control program, to be conducted within one to one and ons half years from the date of the last IMPEP review, but not later than September 1997. The *.t am also recommended that the State keep NRC apprise 3 of the status of corrective actions and plans. The MRB concurred in the team's revised recommendation. In the February 12,1997 cover letter transmitting the final report of the July 1996 reviLw, the State was also requested to provide NRC with (1) a copy of the actual Corrective Action Plan (Step i and 11), and (2) a status report of resolution of the corrective actions and plans every two months. Dy letter dated May 2,1997, to Hugh L. Thompson, Jr., (Appendix C) then Acting Executive Director for Operations, and the Chairperson of the MRB, the State provided one response to the request for a status report every two months. The status report indicated that the corrective actions remained on schedule for completion by the July 1,1997 *Get Well Plan
- end date. The report summarized the status of corrective actions and included information on the development of a major database program that could accommodate tracking and status of most of the program's information related to the State's materiallicensees. Attached to the report was a more definitive Gantt Chari that presented a schedule for completion of the various tasks. The schedule covered development of work on (1) the new database tracking system for inspections including reciprocity inspections, and procedures for inspection plans, including those completed by contractors, (2) a staff qualification manual drafted by a contractor, (3) completion of a licensing action priontization procedure in January 1997 and continuing development of additional comprehensive administrative procedures, (4) annual supervisory accompaniments of inspectors, (5) use of NRC Manual Directive 8.8 for "Managero6nt of Allegations,' (6) use of the draft ' Handbook on Event Reporting in the Agreement States," and development of an i
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. 1 Nebraska Final Report Page 3 event tracking database, (7) reporting on February 28,1997 of all outstanding events identified during the 1996 IMPEP review, and the beginning of routine monthly event reporting on January 31,1997, (8) compilation of all LLRW training data for agency personnel, and (9) a revision to regulation 180 NAC 1-012.22, the State's Part 61 equivalant rule to low-level radioactive waste facilities that process or store waste, as well as disposal sites, with expected adoption by June 1997.
The State did not provide a bimonthly written status report for July 1997. During informal telephone discussions, the State continued to reiterate its expectation to complete the 'Get Well l Plan
- as scheduled. During discussion of the scheduling for the follow-up review, the team learned that several changes in management had occurred within the Department above the first line supervisor, and that procedures had not been completed. As part of the preparatory process for an IMPEP review, the team requested a written report of the current status of corrective actions and the changes in management. The State provided a status report on September 8,1997 't.ppendix C), that identified changes in management, staffing, and schedules. The September 8,1997 status report is covered in greater detailin recommendation No. 6 of this report.
Results of the follow-up review of the State's response and resolution of the 15 recommendations encompassing the IMPEP common and non-common performance indicators are presented in Section 3 and Section 4. Section 5 summarizes the review team's findings and recommendations during the follow-up review. 3.0 COMMON PERFORMANCE INDICATORS The IMPEP process uses five common performance indicators in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials inspection Program; (2) Technical Staffing and Training; (3) Technical Quality of Licensing Actions; (4) Technical Quality of inspections; and (5) Response to incidents and Allegations. 3.1 Status of Pendina issues identified under " Status of Materials insoection Proar.am' During the September 1997 follow-up review, the review team focused on four of the five factors in this indicator; inspection frequency, overdue inspections, initial inspection of new licenses, and timely dispatch of inspection findings to licensees. To evaluate these issues, the review team interviewed program management and staff, reviewed automated data, and examined the State's responses to the recommendations in the final report of the 1996 IMPEP review, which resulted in a tinding of satisfactory with recommendations for improvement. The final report contained three recommendations for this indicator. The results of the follow up review team's evaluation of the State's response to the three recommendations are presented below: Recommendation i The review team recommends that the managers responsible for the Nebraska Radioactive Materials Program establish an action plan or procedure to assure inspections are completed at the frequencies stated in the Nebraska inspection Manual
Nebraska Final Report Page 4 which is equal to the NRC's IMC 2800 and conduct reciprocity licensee inspections at the required frequencies stated in IMC 1220. Current Status in the State's May 2,1997 corrective action status report the State indicated that it had (1) updated its database system with the appropriate inspection frequencies equal to IMC 2800, (2) developed a database tracking system from which each inspector could generate a report on his or her computer showing inspections coming due, (3) developed an inspection tracking system that included reciprocity requests and that allows the inspector to generate a report indicating which licenses will be available for inspection, and (4) revised its process to assign reciprocity inspections in accordance with frequencies stated in IMC 1220, in the September 8, 1997 status report the State reported only one overdue inspection and all past due and routine inspections were scheduled into the third quarter of 1998. During the review, the team evaluated the computer tracking system and found that the new system greatly improved the oversight capabilities of the inspection process. The following list providen selected examples of reports that could be generated from the system.
- Pending Inspections frir Twelve Months through September 6,1997
- Inspections Completed from July 1996 to Current Date
- Specific Licensee Reports
- Reciprocity inspections by Priority The team evaluated the automated status reports, discussed clarifying issues with the Program Manager for Radioactive Materials, and found that the Program Manager could now identify overdue, past due and missed inspections, and take the necessary actions to address the needs of the inspection program in a timely manner Discussions with the staff determined that they were knowledgeable in the use of the computer tracking systems for inspections. The follow up review team found there were no overdue inspections, and allinspections due for inspection by the third quarter of 1998 were scheduled and assigned to ar inspector. The State had performed 11 reciprocity inspections out of a total of 25 since the 1996 IMPEP review, The team found that the State does have adequate written procedures equivalent to IMC 2800 and 1220. On September 12,1997 the State issued Radioactive Materials Procedure (RMP) No.
7,03, ' Program Management Routine Oversight," which outlines the frequencies of intelnal audits to assure inspections are being performed and includes a notation regarding supervisory accompaniments. Based on the follow up review, the team considers this recommendation to be closed. Eq.;ommendction 2 The review team recommends that the managers establish an action plan or procedure for coordinating deviations from the inspection schedule between staff and management based on ths risk of license operations, past performance and need to temporarily defer the inspections to address more urgent or critical priorities.
4 Nebraska Final Report Page 5 Current Status in the State's May 2,1997 corrective action status report, the State noted that 'the inspection scheduling and the upper managemont stay well procedures will both establish methodologies for coordinating deviaCons froris the inspection schedule and rescheduling of missed inspections? The team evaluated the automated status reports, discussed clarifying issues with the Program Manager, and found that management can now identify and manage the deviations from the inspection schedule. The team found that the State does have written procedures equivalent to IMC 2800 and 1220 which allow for extending or reducing the frequency of inspections. RMP No. 7 03 ou*jines the frequencies of internal audits to assure inspections are being performed. The Program Manager indicated that following the writttn procedures and through the automated daily, weekly, monthly and quarterly inspection status reports, he is aware of the inspection program status and can assure coordination of the deviations from the inspection schedule and escheduling of missed inspections in a timely manner. Based on the follow-up review, the team considers this recommendation to be closed. Recommendation 3 The review team recommends that the managers organize a "Get Well Plan" for rescheduling missed or deferred inspections, especially due to loss of senior staff; and establish a plan or methodology to assure initial inspections are performed within six months oilssuance of the license, beginning licensed activities, or within one year of license issuance, whichever comes first, in accordance with the Nebraska inspection Manual and NRC's IMC 2800. l Gmtent Status The State's May 2,1997 corrective action status report stated that all new licenses issued are assigned an inspection date of six months following issuance. The licenses are conditioned to require the licensee to notify the State prior to commencement of licensed operations. The team reviewed a sample computer report of New Ucenses issued since the July 1996 ! review, and compared it to the information in the State's September 8,1997 status report. The I team found that initialinspections of four of the five newly issued licenses are schedu'ed for the i third and fourth quarters of 1997, which is wi'hin six months of the issue date of the license. The1eam also found that the State had contracted out 29 inspections; the results of wh;ch had been completed and documented. The team found that on August 21,1997, the State issued RMP No. 7.04,
- Program Management - Upper Management Oversight," which addresses loss of staff, staff qualifications and unplanned or increased workloads. The team evaluated the procedure and found it edequately outlines a *Get Well Plan' for rescheduling missed or deferred inspections, especially due to loss of senior staff. The team also found that the State does have wntten procedures equivalent to IMC 2800 which address scheduling of initial inspections.
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Nebraska Final Report Page 6 Based on the follow-up review, the team considers this recommendation to be closed. 3.2 Status of Pendina isagi dentified l under ' Technical Staffino and Trainina" During the September 1997 follow-up review, the team considered all of the factors for this indicator; the radioactive materials program staffing level, staff training and qualification planning, management attention and review of program problems, and development of corrective acdon plans, when necessary. To evaluate these issues; the review team interviewed program management and staff, and considered the continuing backlog in licensing. The team also examined the State's responses to the recommendations in the final report of the 1996 IMPEP review, which resulted in a finding of satisfactory with recommendations for irnprovement. The final report contained three recommendations for this indicator. The results of the follow up review team's evaluation of the State's response to the three recommendations are presented below: Recommendation 4 The team recommends that the qualifications of contractor personnel be tied to the contract as identified by the program manager or as accomplished by the LLRW program in NDEQ. Current Status in the State's May 2,1997 corrective action status report, the State informed NRC that the inspection contract included a requirement for quelifications of the inspectors, and for the submission of an inspection plan for agency approval prior to each inspection. The team found that Nebraska had adopted a model contract (which implements the recommendation) for guidance in negotiating future contracts. The model contract comprises Attachment 7.041, entitled ' Draft inspection Contract,' to RMP No. 7.04, entitled ' Program Management Upper Management Oversight." The subject procedure was approved by James A. Wiley, Interim Director, Department of Regulation and Licensure, effective August 4,1997. The team finds the contract clause of inspector qualifications to be an acceptable implementation of the recommendation. Based on the follow-up reviaw, the team considers this recommendation to be closed. Recommendation 5 The team recommends that a written program for staff qualification, including retaining training records, be developed. Current Status The State's 'Get-Well' corrective action plan stated that tha recommendation had been adopted and that a qualification manua! was in draft and would be implemented prior to July 1,1997. The State's May 2,1997 status report did not report on this item. In the State's September 8,
Nebraska Final Report Page 7 1997 status report, ti.e State indicated that the manual had been completed and implemented l effective September 3,1997. The team confirmed that the qualifications manual, RMP No. 6.01 was approved by James A. Wiley, Interim Director, Department of Regulation and Licensure, effective September 3,1997. j The Nebraska manual addresses basic training, advanced and specialized trainir.g, and l continuing education, ail by license category. A policy statement on training expresses the j management position and commitment to technical staff training and qualification, and provides l the general quahfication procedure. Staff experience is addressed through a statement detailing the expected projress of technical staff in completing the training and qualification requirements. RMP No. 6.02, also approved effective September 3,1997, addresses train:ng resources that may be used to complete the qualification .aquirements. An attachmert to the RMP No. 6.02 incorporated the draft recommendations of tne NRC/OAS Training Working Group. The team found that an adequate procedure for staff qualification and training has been adop'ed. The team reenmmends that the NRC review the results of the use of the new procedures at the next IMPEP review. Based on the follow up review, the team considers this recommendation tr te closed. Recommendation 6 The team recommends that the State develop comprehensive administrative procedures, sufficient to guide the day to-day operation of the program in the event of another loss of senior staff. The procedures should include a formal process for bringing to the attention of upper management the increase of significant backlog:, ci licensing, inspection, or enforcemen'. actions, or any other situation which increases the risk to public health and safety. Licensing procedures should int.,,Jde prioritization of licensing actions based upon identified factors, including health and safety significance, for new and previously received applications. l Current Status The team noted that in the cover letter transmitting the final report of the 1996 IMPEP review, Nebraska was asked to report its progress in completing the corrective actions at bimonthly intervals. The first .eport was provided by the State on May 2,1997. The State's May 2,1997 corrective action status report reiterated that the State would develop and implement all l procedures by July 1,1997, as presented in the 'Get Well, Stay Well" corrective action plan at the January 22,1997 MRS meeting, and as adopted in the final report of the 1996 IMPEP review. In the status report the State indicated that:
' Comprehensive administrative procedures are in the development stage. Currently, relevant NRC and Agreement State procedures, policies, and guidance documents are being gathered for use as refererce in the preparation of program procedures. A licensing action prioritization procedure was completed in January, and all pending licensing actions are assigned a priority when logged (into a recently developed database)."
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Nebraska Final Report Page 8 i The State did not provide a written bimonthly status report for July 1997. During informal telephone discussions prior to July 31,1997, the State continued to reiterate its expectation to complete the 'Get-Well Plan' as scheduled. During discussion of the scheduling for tho follow-up review, *.he team learned that several changes in management had occurred within the Department above the first line supervisor, and that procedures had not been completed. As part of the preparatory process for an IMPEP review, the team requested a written report of the current status of corrective actions and the changes in management. The State provided a status report on September 8,1997, that identified changes in management, staffing, and schedules. The report informed NRC that a new NHHS interim director had been appointed in July 1997, and that a new coordinator for the reorganized CHS team had been appointed in May 1997. The State informed NRC that one vacancy had been created by the reassignment of the regulations and licensing reviewer to another department at the end of August 1997, and included a time line schedule for filling the vacant position. The report also included the following information: (1) an inspection schedule, (2) weekly management oversight meetings were continuing, and (3) a completely new milestone schedule Gantt Chart. The new chart information did not correlate to the information that was included in the previous May 2,1997 chart, which made it very difficult to coinpare the previous status of specific issues to the currsnt status of issues. The new cha t indicated a current backlog of only one inspection and stated that the licensing backlog has been reduced but not eliminated (78 licensing actions still pending), and that most of the pending procedures (totaling 27) would be completed by the end of the third quarter 1997, with all procedures to be completed by the end of the fourth quarter 1997, in the new chart the State reported that 18 procedures would be completed by the end of the third quarter 1997 and that the remaining 9 procedures would be completeo by the end of the year (997). Additionally, the State reported in the cover letter with the chart that
- ' comprehensive procedures should be available for use by January 1998." The team found that the State had only completed 4 of the 27 procedures, one additional procedure was in draft, and work had begun on one other procedure. At the time of the follow up review, the State had not developed a revised, realistic schedule as to when the remaining procedures would likely be completed.
Due to the team's concerns regarding the discrepancies between the team's findings and the status of 'Get Well Plan" completion, inadequate communications, and the information provided by the State in their corrective action summary report, the team discussed the findings separately with the program manager, team coordinator, and acting division administrator. As a result of the discussions, the team concluded that the discrepancies were the result of (1) continuing changes in management that resulted in totally new management above the first level supervisor, (2) a relatively inexperienced first line-supervisor and staff, and (3) the State's assumption that they could not renegotiate the "Get Well Plan
- completion date based on the State's experience with other Federal agencies where any changes would most likely require public comment.
Based on the folinwing observation, that nine of tha 27 procedures were related to fees, billing and budgeting, and general licenses (as opposed to specific licenses), the team discussed a prioritization schedule for pending procedures. The team identified 18 procedures for actions supporting the technical elements of the materials program that address the problems which underlie the recommendation, in discussions with the Program Manager, the eight most critical
s Nebraska Final Report Page 9 of the remaining procedures (involving the review of applications for specific licenses, the conduct of materials inspections, and response to events) were identified. The team also observed that effective procedures for the management of the licensing and inspection programs, centered around the computerized tracking system discussed elsewhere in this report, were in place and being used. The procedures, however, were not written down, even in draft form. The State had thus not fully met its commitment to the NRC to complete and implement the procedures by July 1,1997. The team also found that the schedule for completion of the corrective actions as committed to at the MRB meeting was not achievable. The team believes this was due to overly optimistic assumptions and management inexperience in the Agreement State program, resulting in an underestimate of the time and resources required, rather than a continuation of the lack of upper management support identified during the July 1996 review. Current management support is demonstrated by the fact that the program received authorization for a new position and hired a new staff assistant, and is in the process of refilling a position opened by a peruonnel transfer on September 1,1997, both despite the Department being over its au'.norized FTE lirrit and under a hiring freeze. The team recommended at the exit bnefing with the State that Nebraska develop a new schedule for the completion of the written procedures based on experience gained to date, to be provided within two weeks after the completion date of the onsite follow-up review. NOTE: The State responded to Recommendation 6 above on October 1,1997 (Appendix C), within the requested two-week time frame. The revised schedule indicated that all pending actions and procedures will be completed by December 31,1998. The State and NRC also conducted a monthly telephone conference call on October 8 and November 5,1997. The team suggests that the State place a higher priority on procedures related to those itens identified as most critical, followed by those procedures identified as supporting the technical elements of the program. The team recommends that the State provide copies of the procedures to NRC as they ere completed for review. The team recommends that regular communications, both verbal and written, be scheduled and maintained during the completion period. The State is requested to provide monthly status reports by telephone. The State is also requested to continue to pro,ide a corrective action status report every two months, Based on these findings, the team considers this recommendation to remain open, with the above new suggestion and recommendations added. 3.3 Status of Pendingissues identified u* der " Technical Quality of Licensina Actions' The State was found to be satisfactory for this indicator and the review team did not identify any specific issues.
Nebraska Final Report Page 10 3.4 Status of Pendina issues identified under " Technical Quaktv of insoections During the September 1997 follow-up review, the review team focused on three of six factors in this indicator; supervisory accompaniment of inspectors, quahty of inspection field riotes and promptness of supervisory review, and timeliness and appropriate closure of inspections performed by contractor inspectors. The team also reviewed the final report of the 1996 IMPEP review, which resulted in a finding of satisfactory with recommendations for improvement for this indicator. The final report contained three recommendations for improvement in this area. The results of the follow-up team's evaluation of the State's response to the three recommendations are presented below; Recommendation 7 The review team recommends that the State consider for adoption a policy of annual supervisory accompaniments of allindividuals who perform inspections for the Radioactive Materials Program. Current Statug The State's May 2,1997 corrective action status report stated 'that annual supervisory accompaniments of inspection team members will be required in the qualifications manual that is being drafted." The team discussed annual supervisory accompaniments of inspectors with the Program Manager. The Program Manager stated that he had accompanied two of the staff inspectors since July 1996, but had not rnade a formal written report of these accompaniments. The team noted in its review of the previously cited RMP No. 7.03," Program Management - Routine Oversight,' that supervisory accompaniments are noted in the procedure and as an indicator in the Upper Management Quarterly Report. During review of RMP No. 6.01, entitled
'Quahfications and Training . Qualifications Manual," issued September 3,1997, the team found that the procedure states, "The Program manager will... accompany each lead inspector at least annually.'
The team recommends that in following RMP No. 6.01 " Qualifications and Training - Qualifications Manual," that documentation of the accompaniment or other means of tracking that the accompaniment occurred should be pursued. Dased on the follow up review, the team considers this recommendation to be closed. Recommendation 8
. The review team recommends that the State develop a plan or procedure to assure that field notes, as well as, reports, and enforcement letters are promptly reviewed, signed and dated by a supervisor within the recommended 30 day time frame for issuance of inspection findings.
Nebraska Final Report Page 11 Current _ Status in the State's May 2,1997 corrective action status report, the State indicated that the new database system allows tracking of each aspe;t of the inspection from due date to acknowledgment of licensee's response to a .atice of violation. A database report is available at any time to program management showing the time line of each open inspection The in.pection procedures will outline the time line requirements that are coded into the database system and outline the management oversight necessary to ensure that these goals are met. The team evaluated a sampling of inspection documentation in ten inspection cases. The team found documentation of a supervisory review in the field notes and that issuance of a letter forwarding the results of the inspections had been completed and issued on average within 30 days of the inspection, inspection milestone dates were tracked in the new automated database tracking system. A sample database report covering Pending Inspection Completions. September 16,1997, indicated that as of September 16,1997 there were 23 inspections avtalting final completion. The team found that the State does not consider the inspection closed until either an inspection letter is sent, in the case of a clear inspection, or an acknowledgment letter is sent in response to the licensee's letter documenting corrective actions in the case of enforcement letters with a notice of violation or recommendation. The team noted that the quality of inspection documentation and the timeliness in issuance of inspection results has greatly improved. Based on the follow up review, the team considers this recommendation to be closed. (See Recommendation 3, page 16 of this report, for further guidance.) Recommendation 9 The leview team recommends that the State perform an immediate review of all contractor field notes and draft enforcement letters in order to finalize and issue the findings of the remaining 22 inspections to the licensees involved. Current Status in the May 2,1997 corrective action status report, the State noted that the inspections were completed as previously indicated in correspondence to NRC. The team reviewed several of the contractor inspections performed prior to the Julv 1996 review and confirmed that these inspections had been reviewed by the Program Manager and completed. The team also reviewed a samp!d of the 29 contractor inspections performed since January 1997 and found that these were completed in a timely manner. Based on,the follow-up review, the team consHers this recommendation to be closed. 3.5 Status of Pendina issues identified under *Resoonse to incidents and Alleastions' During the September 1997 follow-up review, the review team focused on six of the seven facters in this indicator: responsiveness, investigative procedures, corrective actions, follow up,
i 1 Nebraska Final Report Page 12 compliance and notifications, as necessary. To evaluate this indicator, the team interviewed ~ program management and staff, evaluated sample case work and reviewed the State's response to the final report of the 1996 IMPEP review, which resulted in a finding of satisfactory with recommendations for improvement. The final report contained four recommendations for this indicator, The results of the follow up review team's evaluation of the State's response to the four recommendations are presented below: Ruommendation 10 , The re.iew team recommends rey; sing the allegations procedures to incorporate key areas, i.e. documentation of any communications with the alleger, documentation of the inspection findings, interviewing techniques, etc., identified in NRC Manual Directive 8.8, Management of Allegations. Current Status i The State's May 2,1997 corrective action status report stated that "the program has used the key ideas of Management Directive 8 8 in dealing with recent allegations. These ideas will be incorporated into program allegation procedures,' , The follow-up review team found that the Program Manager for Radioactive Materials is using the guidance contained in NRC Management Directive 8.8 in dealing with recent allegations. The Program Manager indicated that they plan to incorporate key ideas from Management Directive 8.8 into their own procedure, which has not yet been drafted. An evaluation of a few case files indicated that the State is using the guidance contained in Management Directive 8.8 to improve the quality of communicating, interviewing and documenting allegations. The State needs to complete development and implementation of a written procedure. The team recommends that the State continue development and implementation of procedures to manage allegations and provide staff training so that allinspectors are knowledgeable in those procedures. Based on these finding, the team considers this recommendation to remain open, with the above new recommendation added. Enommendation.11 The review team recommends that the staff use the draft ' Handbook on Event Reporting in the Agreement States (Handbook)," published March 1995, for review and reporting of material events to NRC. Current Status The State's May 2,1997 corrective action status report stated that the
- Handbook on Event Reporting in the Agreement States"is currently being used by program staff and will be incorporated into the event reporting procedures.'
Nebraska Final Report Page 13 ! The follow up review team found that the Program Manager for Radioactive Materials is using i the event repciting guidance contained in the NRC ' Handbook," and was in the process of incorporating the ' Handbook,' and instructions for using the Nuclear Materials Events Database (NMED)into their own procedures. The staff had developed RMP No. 402,
- Radioactive ,
Material Events,' which will provide guidance on monitoring and tracking of material events and willincorporate NRC's event reporting guidance. The proposed procedure was undergoing internal review. Based on the follow-up review, the team considers this recommendation to be closed. (See Recommendation 3, page 16 of this report, for further guidance). Recommendation 12 The review team recommends establishment of comprehensive procedures for tracking. follow up and close out of events involving the use of radioactive matenal covered under the Atomic Energy Act. Current Status ' The State's May 2,1997 corrective action status report stated that 'the program created an event database to track all possible material events. The event procedures will establish ever.1 follow up and close out procedures." The follow up review team found that the Gtate has created a satisfactory database to track receipt, follow up, and close out material events. The database is a subset of a primary master database developed with Microsoft Access that can accommodate tracking most of the information related to the State's material licensees. Based on the follow up review, the team considers this recommendation to be closed. Recommendation.13 The review team recommends that the State immediutely begin reporting current material events to NRC and send in information on the three events identified during the revieva as reportable, that were not previously reported to NRC. Current Status The State's May 2,1997 corrective action status report stated that the ' program began routine - monthly reporting on January 31,1997 and reported all previous reportable events on February 28,1997." The follow up review team found that on February 28,1997, the State did provide NRC information on three events that had been identified during the 1996 IMPEP review as not having been reported. The team also found that the State is continuing to provide information on the occurrence of any reportable events on a monthly basis in accordance with NRC guidance.
Nebraska Final Report Page 14 Dased on the follow-up review, the team considers thic recommendation to be closed. 4.0 NON COMMON PERFORMANCE INDICATORS The team reviewed two non common perform 3nce indicators that applied to the Nebraska program, Legislation and Regulations and Low Level Radioactive Waste Disposal Program. 4.1 Status of Pendina lasues identified Under Leaitlation and Reaulations During the September 1997 follow-up review, the team focused on a regulation issue related to compatibility. The final report had one recommendation. Recommendation 14 in accordance with the State's commitment, the team recommends that Nebraska amend 180 NAC 1-012.22 to remove its applicability to waste treatment and storage facilities. C.urrent Status in response to the team's request fur clarification regarding application of the public dose limits in the State's equivalent regulations to 10 CFR Part 61, the State responded in a letter dated December 13,1996, that tmy did not currently have any brokers, treatment facilities, or storage facilities to which this regulation applied. In accordance with the Division 1 compatibility requirement designation (now Category A ) the Department expressed its intent to amend the regulation. The State included a copy of the proposed amendment. It was determined by NRC that if the draft rule were adopted without change, it would be compatible. At the MRC meeting on January 22,1997, the State reported that the revision to the regulation was "in process.' In the May 2,1997 status report, the State reported that the proposed rule received no negative comment at public hearing. The rule was expected to be adopted in June 1997. The team found that the rule was adopted without change and became effective on September 17,1997. The team found that the delay in adoption from June to September was due to the politically sensitive nature of the rule, resulting in heightened concern by the Govemor as the promulgating official. Based on the follow-up review, the team considers this recommendation to be closed. 4.2 Etatutof Pendina issues identified Under Low Level Radioactive Waste Discosal ELQ9 Lam During the 1997 follow-up review, the team focused on the documentation of the qualifications of the technical staff and contractors. The team reviewed the final report of the 1996 IMPEP review which resulted in a finding of satisfactory for this indicator. The final report had one suggestion.
Nebraska Final Report Pago 15 Recommendation 15 The team suggested that the LLRW program assemble training documentation for individual staff and contractors and develop a consolidated training record to enable assessment of the progress of training across the entire program. Current Status The State's May 2,1397 corrective action utatus report stated that 'the LLRW program has compiled all the training it provided to the consultant review team members. The LLRW program staff will be gethering training cata for Age,cy personnel to be included and maintained in one traine; documentetion spreadsheet ' The team found that the State had compiled a training history for State staff members. A computer database had been established and the training records for the staff had been entered. There was, however, no information in the database related to contractor personnel. During discussion with the LLRW program managers, it was agreed that adding the detailed training records of the contractor personnel to the database would be of limited value since most of the contractor work is completed. The NDEQ and CHS program managers agreed to add information to the catabase showing contractor personnel attendance at training sessions sponsored by the State. The team notes that the complete training records for individual contractor personnil remain available in the contractor personnel files. Based on the follow up review, the team considers this suggestion to be closed. 5.0
SUMMARY
The follow-up review team found the S; e's performance in responding to and resolving the 15 recommendations by the planned scheduled completion date of July 1,1997, to be satisfactory with the exception of Recommendation 6 and 10. Recommendation 6 discussed the need for the State to develop comprehensive administrat% and technical procedures. This area was identified as one of the primary root causes for the significant deficiencies found in the program during the previous 1996 IMPEP review Recommendation 10 discussed the n9ed to develop procedures for responding to allegations. The team found that the inspection backlog had been eliminated, the lit ensing backlog had been reduced but not etminated (78 actions pending), and the State had imolemented a computerized tracking system that provides much needed support to the overall materials program, and had received one additional FTE during a hiring freeze. However, the team also found that a significant number of procedures (23 out of 27) identified by the State for development had not been written, completed and signed off. The staff had not developed an estimated schedule for completion of the remaining 23 procedures at the time of the review. Although the team found that the State did not adequately communicate the status of the resolution of corrective actions, the team concluded that overly optimistic assumptions and Agreement State program inexperience by program management and btaff contributed to the underestimate of the time and resources required to complete the
*Get Well Plan,' rather than a continuation of the lack of upper management support as seen during the 1996 review. The team found the current staff is quahfied, but tlue team observed that the program has a relatively inexperienced staff, a heavy reliance on the first level
i Nebraska Final Report Page 16 supervisor, lack of written procedures for guidance, and totally new management above the f rst-level supervisor. The follow up review team recommended, and the MRB concurred, that the Nebraska program remains adequate to protect public health and safety but needs improvement, and compatible with NRC's program. Due to the fact that Recommendation 6 and 10 remain open, and that Recommendation 6 was identified as especially significant during the 1996 IMPEP review, and the fact that the Nebraska radiation control program staff and management have a few years or less of Agreement State program experience, the team recommended that an IMPEP review be scheduled within one year of the date of this follow-up review. The MRB considered and concurred with the review team's recommendation. Below is a summary list of recommendations and one suggestion, as mentioned earlier in the report, for consideration by the State and NRC. Recommendations:
- 1. The team recommended at the exit briefing with the State that Nebraska develop a new schedule for the completion of the written procedures based on experience gained to date, to be provided within two weeks after the completion date of the onsite follow-up review. (Section 3.2)
- 2. The team recornmends that the State provide copies of the procedures to NRC as they are completed for review. (Section 3.2)
- 3. The team recommends that regular communications, both verbal and written, be scheduled and maintained during the completion period. The State is requested to provide monthly status reports by telephone. The State is also requested to continue to provide a corrective action status report every two months. (Section 3.2)
- 4. The team recommends that in following RMP No. 6.01
- Qualifications and Training-Qualifications Manual," that documentation of the accompaniment or other means of tracking that the accompaniment occurred should be pursued. (Section 3.4)
- 5. The team recommends that the State continue development and implementation of procedures to manage allegations and provide staff training so that allinspectors are knowledgeable in those procedures. (Section 3.5)
Suggestion:
- 1. The team suggests that the Staia place a higher priority on procedures related to those items identified as most critical, followed by those procedures identified as supporting the technical elements of the program. (Section 3.2)
I
. i I
Nebraska Final Report Page 17 i NRC. : f The team recommends that the NRC review the resuRs of the use of the new procedures at the i next IMPEP review. (Section 3.2) , a
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1 APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Respansibility Patricia M. LarKins, OSP Team Leader Technical Quality of Licensing Actions Response to incidents and Allegations Jenny Johansen, RI Status of Materials Inspection Program Technical Quality of Inspections - Richard Blanton, OSP Technical Staffing and Training Legislation and Regulations Low Level Radioactive Waste
mv= _ _ _ _ v-vm 0 e 96 APPENDIX B NEBRASKA HEALTH AND HUMAN SERVICES SYSTEM DEPARTMENT OF REGULATION AND LICENSURE AND c PUBLIC HEALTH ASSESSMENT DIVISION ORGANIZATION CHART
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'i DitattWIW10F FikANC& smD $Utt0LT May 2,1997 U.S. Nuclear Regulatory Commission Office of State Programt Mail Stop 3D23 Washington, DC 20555 Attn: 11 ugh L Thompson, Jr. Acting Executive Director for Operations
Dear Mr. Thompson:
This letter is to provide you a copy of our most current corrective action plan, and to update you on the status of corrective actions taken in response to the review team's recommendations. The enclosed chart shows the timelines and resource allocations for all the tasks of the corrective action plan. Milestones are represent.d as diamonds and show the date a major task or goal wa. met. Ecch task bar rhows the individual (s) assigned and the fm' ish date if completed. The . progress of each task is represented by a solid bar corresponding to the percent of the task completed. For example, the progress bars for Task ids 78 and 79 represent the 70% of the i )8 licensing actions pending at the time of the review and the 75% of the 158 licensing actions , received since that have been completed. The current status of the corrective action taken on et.ch of the review team recommer. cations is as follows:
- 1. The program has updated its new database system with the appropriate inspection frequene.es equal to IMC 2800. Each inspector can generate a report on his computer s showing which materials inspections are coming due. Reciprocity requests are logged it.to the database and inspectors can generate a report showing which licensees will be available lor inspection. Reciprocity inspections are being assigned to staffin accordance with the inspection frequencies ofIMC 1220. The use and maintenance of the inspection database will be addressed in the inspection scheduling procedure.
2.&3. The inspection scheduling and the upper managemer.t stay-well procedures will both establish methodologies for coordinating deviations from the inspection schedule and rescheduling of missed inspections. Regarding initial inspections, all new licensees are issued an inspection date of 6 -'ionths from the license issuance. Each new license also
' includes a condition requiring the licensee to notify our Agency prior to the commencement oflicensed operaaons.
An Eeuu Orecarvurrr/A mnanvs Acim Eunorsa rammewtrusov ektouancycuDPAMR
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Hugh L Thompson, Jr. May 2,1997 Page 2
- 4. The current inspection contract includes a qualifications review requirement and the contractor has submitted tr sing documentation for Agency Approval prior to allowing additional staff to perform . spec ti ons. Contract inspectors are also required to complete an inspection plan for Agt .:y approval prior to each inspection.
- 5. A staff qualification manual was drafted by a contractor. The drcn manual is being updated to include the NRC/OAS Training Working Group information and the NRC's policy on successful completion of training outlined in SP-96118.
6.- Comprehensive administrative procedures are in the development stage. Currently, relevant NRC and Agreement State procedures, policies, and guidance documents are being gathered for use as references in the preparation of program procedures. A - licensing action prioritization procedure was completed in January, and all pending licensing actions are assigned a priority when logged into the traBking database.
- 7. Annual supervisc y accompanimems ofinspection team mcmbers will be required in the qualifications manual that is being drafted.
- 8. The new database system allows tracking of each aspect of the irm.ection, fiom due date to our acknowledgment of the licensee's response to a notice of violation. A database report is ave.ilable at any time to program management showing the timeline of each open inspection. The inspection procedures will outline the timeline requirements that are coded into the database system and outline the management oversite necessary to ensure that these goals are met.
- 9. Completed as previously indicated.
10 The program has used the key ideas of Management Directive 8.8 in dealing with recent allegations. These ideas will be incorporated into program allepion procedures. I1. The " Handbook on Event Reporting ir. the Agreement States" is currently being used by program staff and will be incorporated into the event procedures.
- 12. The program created s event database to track all possible materials events. The event procedures will estabhsh event follow up and close out procedures.
- 13. The program began routine nionthly reporting on January 31,1997 and reported all previous reportable events on Febmary 28,1997.
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' May 2,1997 Page 3 l4. The proposed revision of 180 NAC 1 012.22 has been to public hearing without negative comment and shoald be adopted in June 1997.-
- 15. The LLRW program has compiled all the training it has provided to the consultant review team members. LLRW program staff will be gathering training data for Agency personnel to be included and maintained in one training documentation spreadshee'.
You will receive further reports of our continued progress on the corrective action plan, especially our completion and implementation of comprehensive program procedures over the next two months.
. If you have any other questions, please feel free to contact Brian Heam or Cheryl Rogers at (402) 471-2168.
Sincerely. T Deb Thomas, Director HHS Regulation and Licensure DT/BPH Enclosure xc: Patricia M. Larkins, Health Physicist IMPEP Team Leader
sp49y - Nebr=ka Herith cnd Hum:n Services System Department of Regulation and Licensure . IMPEP Corrective Action Plan 1993 9 1996 1997 Of l 02 l 03 l 04 01 l O2 l 03 l 04 01 l 02 ID Task Name 02 l 03 l 04 i Materials Program Oversite 2 Program Managemeni Meeting llllllllllllllllljjj[gllllll'jlllllll
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42 Upper Management Briefing ll l l ll 43 U;pr Managen+it Brierrig i 113 ( Deb Thom;rs. Burke CasadJack Daniel, Brian Hearty 44 Upper Management Brermg 2 it22 l Deb Thosmas, Brian Hesity Upper Management Briefing 3 rhomas Burke Casad)ack Daniel, Brian Hearty 45 3/3 l Deb ~ I 46 Upper Management Brefing 4 4f24 l Deb Thomas. Burke CasarfJack Danlet Sue Somerone, Brian Hoarly I i 47 Upper Management Briers.g 5 l Deb Thomas,rurke CasacIJack Daniel, Sue Somerone, Brian Hearty I I da Upper Management Bnereg 6 l Deb Thomas, Burke CasarlJack Daniel, Sue Somerene. Brian Hearty 49 Radiation Advislory Council T I 50 Radiation Advisory CoM 916 l Brian Hearty l 51 Radiaten Advtsory Council 12/6 l Brian Hearty . 52 Radiation Nfvisory CouncM 3/7 l Briaik dearty , 53 Radiation Advisory Council 4$ l g. tan Hearty 54 Materials Inspection F ~"M 55 Inspection Backlog 56 Thele Geotech 7f16 l Jim DeFrain 57 NdhNem W 8/19 l Brian Hearty 58 imman*Nical cente 10/3 l Cheryf RogersJohn Fassell 59 Nebraska Methodist Hospital Task Summsry Rolled Up Progress N Project Prc1ect Menagement Plan p , M-,_ + n~ Up M es,_ o Page1 I l
Nebra2ka Health cnd Humcn Services System Department cf Regul: tion cnd Licensure IMPEP Corrective Action Plan . 1996 1997 19M 1
,o Tasm untre oz l os I o4 os I c2 1 o3 l o4 of I o2 I os I o4 os I ca 60 Stanley Jaeger 1117 l Bryan Miller 1
61 Unco;n General Hospital 11113 l Howard ShumaoJohn Fassell l 62 DNgan Mercy M,al Center 11114 l Jim D*Frain,Bry an Mifler i 63 UNMC 125 l Bryan Miller, jim DeFrain !. i 64 overdue inspections Completed
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l ; J 66 Uncob GeneralTehapy ggfg3 g ,;cerd ShumaoJohn Fasssit 67 Wayne State 111 l Howard Shuman e 68 UNI. hFrain, Bryan MMer, Joyce Davidson
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69 29 Routine Inspectens l M E Stan Huber Consultarrts 70 Reciprocity inspections 71 ads M M 12110 l im DeFrain Bryan Mffler i 72 8 1 11 l Bryan MilerJira DeFrain 73 Mufwest Industrial X-ray if16 l Bryan MilerJim DeFrain l 74 EA Engineenng l Brym Mmer 75 MOS Inspection ~ l Jim DeFrain Materials Licensing 76 77 Licensing Backlog 7 -- - l lM -y , t i I 78 Ucensing Actions Before 7/19/96 - Program Staff 79 Ucens% Actens After 7/19/96 Prograrn Staff ' Task .. m,ci < . . w , Summary Rolled Up Progress N Pro l*ct Project Management Plan Progress - Roued Up Task Date. 5/2/97 Milestone $ Rolled Up Milestone Q , Page 2
N;bracks Health cnd Human Services System Department of Regulation cnd Licensure IMPEP Corrective Action Plan 1997 1998 1 1196 ID Task Name 02 l 03 l 04 Q1 l 02 l 03 l 04 Q1 l 02 l 03 l 04 01 l 02 pl 345X So 81 Materials Events Pregram Event Tracking Log W 15 Bdan Hessy g 82 Event Report backlog de Hes@ 83 Event Backlog Reported to NRC
$ 2/21 84 Monthly NMED Report lllj ll 05 Montby NMED Report 1 if31 l Br'an H ' arty 86 Menthy NMED Report 2 2f28 l BrC '*."A 87 Monthh NMED Repert 3 3/28 l Br.an Hearty 88 Monthly NMED Report 4 4130 ) Bryan Mitler 89 Morithly HMED Report 5 l Jlrn DeFraln 90 Monthly NMED Report 6 l Bryan MMler f
91 Procedure Manuals P 92 Inspection Proc 'dures Manual I 93 Update Fieki Notes 5 Program StsW 94 Incorporate IMC 1220 Frequenries
-Richard Barrow,Briaa Mearty, Jay Noble 05 incorporate IMC 2800 Frequencies
-Richard Barrow, Brian i+ed. Jay Noble 96 Inspection Scheduling Procede hBrian Hearty 97 GI. Telephone Contact Precedure 5 Jay Noble,Betan Hearty 93 2YGL Field Notes l !ay Noble,Bdan 99 Staff Trained on Insrection Procedures
[ Task Summary Rolled Up Progress N ' 8"* " Progress - Ro8ed Up Task Milestone $ Rolled Up Milestone Q Page 3
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Nebraska Herith and Human Services Sys?em Department of Regulation and Licensure IMPEP Corrective Action Plan 1998 1 1996 1997 Of l 02 l 03 l 04 01 l 02 02 l 03 l 04 01 l 02 l 03 l 04 10 TOO Task Name Allegation and Event Procedures W j Review and incorporate MD 8.8 .g g 101 incorporate Reporbng H&nfuvGk gg g 102 Write Anegaten and Event F.cw;wes rian Hear *y, Support StaM . 103 104 Staff Trained on A & E Procedures 4 105 Licensing Procedures Manual FT - 106 General Licensing 107 Destributor Not.fcation Procs&Jra Jay Noble, Brian Hearty l 10s Generalvs Specife Procedure Jay Noble Br!an Hearty l 1 ( I 109 GL Bdhng Procedure ! -Jay Noble.Brfan Hearty i 110 GL Terminaten Procedure Jay Noble Brian Hemty
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111 Asseinbee GL Procedures I h Jay Noble 112 Specific tJcensing gI 113 Action Prioritization Procedure 1117 l Brian Heavty , l 114 Assemble Limnsing G4 idarice iM ian Hearty, Program StaN 115 Writo Licensing Procedurts E.h Hearty. Support StaN
- Staff Trained on Licensing F dures 116 117 Stay-Well Plan W ,
118 Upper Management Procedure EBrian Hearty , 119 Program Management Procedure EBrian Hearty f Summary, RonedUpProgress N 7,ssk Project Project Management Plan p R# Task Date: 5/2/97 Milestone $ }loned Up Maestore O Page 4
_- f ' f.. Nebraska He lth and Human Services System Departmer.t of Regulation and Licensure IMPEP Corrective Action Plan 3 1996 1997 t19s 1 ID Task Name 02 l 03 l 04 0t l O2 l 03 l 04 Of l 02 l 03 l 04 01 l 02 120 Management Trarned on Procedures 121 Qualifications Manual 122 Draft Manual 12/18Richard l1 Banow 123 incorporate NRC/OAS W.weg Group rian Hearty 124 Revew and FinaE7e Manual g rian Hearty 125 Manualimplemented LLRW Training Records
. 126 PM 127 Assemble ConsvRant LLRW TrairM 4/15 l LRW Program Staff Assembe Staff LLRW Traning Records 12s l Staff 129 Create Documentation Speadsheet LLRW Program Staff 130 131 Regulations and Guidance Regulations y ^
y 'V 132 019 Adopted I
$ 10/30 133 001.003.012. 015 Approved by RAC 1 12/6l Mtvids mJay Noble 134 007 Reviewed by RAC 1/15 E Joyce DaridsonJay Noble 135 007 Revsed i if27 -Jo 'ce Drvidson. Jay Noble 5 -
i 136 Preposed Changes Approvc4 by RAG 3/7 I 137 Proposed Changes to PRO 3/30 - 138 Pubtec Warm 9 Sri rian Hea'f 139 Pub 5c Hearing Comments locorporated ( DavMsonJay Noble Task Summary Rosed Up Progress N Project Project Managemmt Plan p 3 RM Up Td date 5/2/97 Maestone $ Rolled Up Milestone O Page5
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Nebraska Herith cnd Human Services System Department of Regulation and Licensure IMPEP Corrective Action Plan 1996 1997 1998 1 f C Task Name 02 l 03' l 04 01 l 02 l 03 l C4 Of l 02 l C1 l 04 01 l 02 I 140 Fenal Draft Approved by RAC { 141 Fenat Draft Approved by Board of Heath 142 Fenaf Draft to Atty General ; e-141 Final Draft Adopted g 141 Guidance FM 1:5 Reg Guide 19.0 Draqed
% Shent Wrt n 146 Reg Guide 19.0 Reviewed and FinaEred j oyce Davidson 147 Reg Guide 19.0 issued '
g 145 Reg Guide 7.0 Drafted M h 149 Reg Guide 7.0 Reviewed and Finalized 3 sjoyce Davidson 150 Reg Guide 7.0 issued 4 131 Create and implernent Regulation Change Log 12/30 E Brtso Henr1r)oyce Davidso"
-152 -
Task Summary Rosed Up Progress Mm""""" Progress em Rolled Up Task Mdestone $ RenedItoM5estone O Page 6
l*A busxAlhAtnlaoHtum Ssavicts SysTsu STATE OF NEBRASKA G E. Stw3Autw Netsow, Govtewon DirAarrtwt es slaves;
- Datattunut of Rtonsuow Awp t.ttt>sunt Derastutti et fewAxet Aus surront s September 8,1997 U.S. Nuclear Regulatory Commission Office of State Programs Mail Stop 3D23 .-
Washington, DC 20555 Attn: Hugh L Thompson, Jr. Acting Executive Director for Operations
Dear Mr. Thompson:
This lener is to provide you a copy of our latest corrective action plan, and to update you with a current crganizational chart for the Department. There have been three changes in the program upper managemem since the MRB meeting in January 1997. On July 1, the Radioactive Materials and 1.LRW Programs were moved under the supervision of the' Consumer Health Services Team Coordinator, M. Sue Semerena. Robert Leopold was named Acting Administrator of the Public Health Assessment Division following Burke Casari's retirement on July 8. James A. Wiley was named Interim Director of the Regulation and Licensure Department following the resignation of Deb Thomas in July. Routine oversite meetings l i between the Radioactive Materials Program Manager and the Team Coordinator and Division Administrator have been held on a weekly basis since July 9. The Department Director was briefed on his oversite responsibilities and on the sutus of the corrective action plan on August 18.
- 1 The enclosed Gantt chart shows the time lines and resource allocations for the tasks of the corrective action plan. Milestones are represented as diamonds and show the date a major task or goal was met. Each task bar shows the individual (s) assigned and the finish date if cornpleted.
The pregress of each task is represented by a solid bar corresponding to the percent of the task completed. For example, the progress bar for Task ID 78 indicates that 50% of the 78 currently pending licensing actions that have received an initial review by Prog am License Reviewers. The current corrective action plan was developed to ensure that program performunce will be maintained at, or improved to, a satisfactory level on all IMPEP indicators by October 1998. The time frame of the corrective action plan extends to the end of the current NRC fiscal year to take into account the training courses required by Technical Staff members as outlined in our Qualifications Manual. A time line for filling the Health Physicist I position vacated by Joyce Davidson on September 1,1997 is included in the plan. simommmnumwmaaatewm
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~~ ~ a,,, p u , ,[ t4.F. U. 3 t*f t v A c** s s e.n Liw nom i n a ww . , 4 m e.r o P . Hugh L, Thompson, Jr. September 8,1997 Page 2 All radioSetive materials inspections due in the next twelve months haVe been scheduled and inspectors assigned. The inspections are scheduled to minimim the number of past due
- inspectiore, be in accordance with inspector training, and ensure supervisory accompaniments.
The only currently overdue inspection is a radiography licensee that had not performed :ealed source radiography since 1994, and was subsequently authorind for storege only. The licensee had provided information an the transfer of their sources, and requested' termination of the license only to abandon that request after the inspection overdue date. A'n inspection is scheduled prior to renewing the license for use Because a majority of our inspections are conducted unannounced, we request that you do not provide the attached corrective action plan ; u public information. The status of proposed rulemaking has been updated to include compatibilir'y items that will be required to be adopted within the time frame of the plan. Radioactive Materials Program procedures are being drafted and implemented in accordance with the recommenostions of the IMPEP Team. Comprehensive procedures should be available for use by January 1998. We look forward to meeting with your review team during the week of September 15 19. If you have any other questions, please feel free to contact Briza Hearty or Cheryl Rogers at (402) 471 2168.
'. .t v, m '0 Robert Qopoft . Adnknistrator Public HeMtfi Assessment Division .
RUBDH Enclosure FAX Copy: Patric!a M. Larkins, Health Physicist IMPEP Team Lenir l
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State of Nebraska Health and Human Services Regulation and Licensure Department N- Public Health Assessment Division Radioactive Materials Program 301 Centennial Mall South l g* *"" P.O. Box 95007 Lincoln,Nobraska 68509-5007 Phone: 402-471-2168 FAX No.:- 402-471-0169 DELIVER TO: Pat Larkins, Health Physicist Location: NRC Office of State Programs FAX No.: - 0 01)415 3502 _
Subject:
Copy of Corrective Action Plan and Organizational Charts SENT BY: - Brian P. Hearty, Manager Location: Radioactive Materlats Program . Total Number of Pages (including cover page): 14
- Comments: Original sent by mail to Hugh Thompson. 1, Call me 4f you have any other questions prior to your visit.
Date: 09/08/97 Sent by: BPH i i J l-4 4 4
ey y gy liHS REGULATION AND LICENSURE DEPARTMENT q PUBLIC HEALTH ASSESSMENT DIVISION )? RADIOACTIVE MATERIALS PROGRAM e 1998 1999 1997 Im2 Ima Im4 mi Im2 Im3 $ ca i Iw2 las Im4 .m i so Ta.k we, _ j l. t j 1 Statt,.s of Materials inspection Pmgrans ! i *R
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM
* {
, o 1997 1998 1999 -
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HHS REGULATION AND LICENSURE DEPARTMENT
. PUBLIC HEALTH ASSESSMENT DMSION N, RADIOACTIVE MATERIALS PROGRAM 19 1991 1998 1999 **
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM ( 7 m7 1a,e toes r. g %w m1 [o's 2 ler3 [Cs4
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Page 4 of 9
HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM 1997 1998 l 1999 to rew we,no ont 10 2 Im3 134 otr 1 Im2 Im3 Im4 art l=2 im3 ,
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HHS REGUI.ATION AND LICENSURE DEPARTMENT PUZLtc HEALTH ASSESSMENT DIVISION 'd l RADIOACTIVE MATERIALS PROGRAM 1999
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEAL.TH ASSESSMENT DIVISION RADIOACTIVE MATERIAL S PROGRAM 1997 1990 1999 Oer 1 lOtr 2 ]Or3 lCtr 4 Ora lOr2 lOr3 {0D4 ,Otr 1 lOtt 2 {Gr3 ID Ten hme in W h 105.* : 1 E Jay Noble j j l } ; f l RMP No.1.06. Leoe'ine F5e inadhra en s
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- Approved by DMalon Admifilstrator: Summary Revised: Mon 9f3197 rom WTak M l Roned Up Milestone O s F/ @ Rolled Up Prosess -
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October 1,1997 R
- . ll U.S. Nuclear Regulatory Commission Ofnce of State Programs E3 Mail Sr.,p 3D23 g7 a
Washington, DC 20355 " a [ Attn: Richard L. Bangan, Directo-Office of State Programs
Dear Mr. Bangan:
As you requested in our meeting on September 18,1997, this letter is to provide you a copy of our latest corrective action plan, and to update you with a current status of our program. The enclosed Gantt chan shows the time lines and r. source allocations for the tasks of the , corrective action plan. Milestones are represented as diamonds and show the date e major task or goal was met. Each task bar shows the individual (s) assigned ai.d the finish date if completed. The progress of each task is represented by a solid bar corresponding to the percent of the task completed unless otherwise identified in this report. Status of Materials insocction Procram: , Eight inspections have been performed since the September 8,1997 progress report was provided I to you. The one overdue inspection, Task 1D 3, was completed September 9 and currently there are no overdue inspections. One past due inspection was completed September 25 and three , routine inspections were also performed. Three reciprocity inspections were performed in September. j ; l Two routine inspections were rescheduled into October, Task ids 16 and 19, to provide the flexibility to perform the needed reciprocity inspections. One routine inspection was added to the I( Gantt chan, Task 1D 23, after a review of pending inspections. One reciprocity inspection was also scheduled, l i i Materials Licensing Procram: The materials licensing section of the Gantt Cha:t has been redesigned to provide a clearer picture of the program status. The tota' lumber of pending actions is provided in Task ID 86. i The actions are then broken into three categories. Task ids 87-89 correspond to the actions received prior to the initial IMPEP review in July 1996, the actions that have been received since that date but are overdue, and the actions that are not overdue. The progress bars correspond to .I the percentage of the a;tions in that category that have received an initial review and had a deficiency letter sent. ntu ormnemumawmsamzwww swrtowftu sovsaow ascycunrann
/
Richard L Bangart, Director N.t' October 1,1997 Page 2 Resnonne to incidents and Allegations: Task ids 97 and 98 have been added. Brian Hearty has been working with Brian Smith of NRC
' in regards to this event and Charles Hackney has tequested tt..t a follow-up report be provided to NRC.
Legislation and Regulations: The proposed regulations that were previously provided to your office were signed by the Governor and became efTective September 17,1997. As indicated in your exit meeting, Nebraska is compatible with NRC regulatior.s. - Regulatory Guide 7.1, equivalent to NRC RG 8.39, has been approved and sent to medical use licensees. Rego'atory Guide 19.0 for irradiator licensees has been drafted. Work on Regulatory Guide 7.0 for medi:al licensees is progressing and should be completed by a meeting with our l largest tr:edical licensing consultant on October 22. This meeting will facilitate future medical licensing and decrease the number of deficiency letters currently required. Materials Procram Procedures:
. Radioactive Materi:;'s Program Procedure No. 4.02, Radioactive Material Events, has been issued and a copy is enclosed for your review Attachments I and 3 are not included since you have access to them already.
The procedure scheduling has been changed to reflect discussions with the review team regarding the priority of the pending procedures. The licensing and inspection program procedures that will be used daily by the technical staff have been given the highest priority, if you have any other questions, please feel free to contact me, Sue Semerena, or Brian Hearty at (402)471 2168. Sincerely, N *b- YAOu'4. M h) , Public i Robert HealthLeopold, Administrator Assessment Division RUBPH Enc!osure FAX Copy: ' Patricia M. Larkins, Health Physicist IMPEP Team Leader
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,3 l' HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DtVtSION RADIOACTIVE MATERIALS PROGRAM D6 1997 toes tsee 10 Mh otr 3 j otr 4 otr 1 lotr 2 lotr 3 lotr 4 Otr 1 jotr2 lotr 3 j otr 4 otr 1 loir 2 l Otr 3 iotr 4 L 1 Status of Maserials inspecffon Prografn j : i 2 Overdue inspections
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l _ _.%1 -.L -' -- - 23 01-04-01. Immanuel Medical Center f ! l BrtrikM .Eryan RENor f ! l -( Page 1 of 9 e -r F). f _ a {e nc- s /1 M i~ P, - T.. d I.a r # r, ., , , t. rw Ae , ^,/ Coy kfst
HHS REGULATIOf[AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DMSION RADIOAChc. MATERIALS PROGRAM M 1M7 I 1995 1999 ID Task Name ur3 lOtr 4 Ott 1 lOtr 2 lOtr 3 lOtr 4 lOtr 1 lOtr 2 lOtr 3 lOtr4 Otr 1 ] Otr 2 lOtr 3 lOtr 4 24 02-06-03. Larnz*t General Hospital i
! ; l l Jim DeFrair.Eryan Meer 25 07-05 01, Faith Regenal Hea8th Seryces - Lutheran (-
j._ , _ i. , 1, - , f j 9 g,
,' .+..
en RAINor .,-_ { _ g . --- 26 07-01-01, Our Lady of Lourdes Hospital ' i l , j l Bryan Mit se l 1 __.} 3
-+ - -
27 14-03-01. Mary Lanrnng Memonal Hospstal I i
! l oeFroio rs 1443-02, uary Lanneg Memons' Ho ortal
_{ _. _ { .- g .. --. - - -- - - - -
! ; i
__j. ..
! l Jim DeFrmio
__4____ - 29 08-09-01, St. Franos Memonal Heafth Center i ' i en m, lier l 30 08-03-01, Grand Island Radiology Assocates I
.d - _ h _ _ - -- . > --I -- - - ~ ~
l . l Bryan k Iter 9 _. 4 _ - 01-08-02, Professonal Sennee Industnes. M 31 i l l {j DeFroin.Brien Hearty _ , .,. __ , .a__ --. 32 ** %3. kvofessonal Sennce Industnes. Inc. '
! l rsin r
l 33 ' .1.Urwersq of Nebraska 4 _ 4 __ _ __1.. __ _ { _ .rl _. Jim Dei -- --~~
; l
; l l l Brf er RAIRor 1 , _ L 4 .. .
. _ _ . - - {--- --
34 02-37-01 Syncor Intematonal Corporaten l ! qt Rogers.Brien Hoerty 4 q _. _ . _ _ . .lClu .
. .- q . --._. - ~ g - - - - -
35 01-76-01, EndoTech. Inc. I l i l Bry es RIIIIsc, Brian Hearty 36 1M1-01. Southeast Communstw CoNege - Msiford g -- g I Jirr keF HIro 37 01-77-01, Anderson Excavating and Meding Co. __ 1 ;
.t. .p . _ . _t i _ _ - -
l j, l { l gym aseter
; __j .. _ _ _ . . _ _ -
3e at-45-01, Douglas County Heath Department l ;
,i l l8yan M Ror
; 1 2 . . _ _ _
_____p ---- - - --. --- - - - - 39 01-75-01, Omaha Housmg Author 4 l , i lgr;y en imeter
. ; , 3 40 01-66-01, Great Plains Testmg Laboratones. Inc.
..j - - -- --..-- --
l l l lEryon RIIIIst
, 2. . , . . _. _ _ , - --._.. - - ---- -
41 02-18-01, HWS Coneutmg Group. inc- i i } } ltEearts SNumenE-ion Hoorty 42 01-65 02, P E.T. Net Pharmswubcal Sennces. LLC
}
l
; 4 ;_ 1 I
p _ , _ . _ _ ll been Hoerty
. .__e._-.. - -- y- - - ---
43 01-48-01, Urdversh of Nebrsska at Ominna t
! hlaNn F Hoerty t- ; p
_. lppehn_Fassett. y _ 9- __ t 44 01-48-02 Uruversh of Nebraska at Omaha - Bology ,
- l , l j Brian Hoorty i ; .; -
t. l 45 08-11-01. Filter Specraksts. Inc. _j. _a___ _.j_-+ 1- - c l Jin DeFrain. Mow b , j j 46 21-014., %geonal West Medical Ce er . j , lJm DeFrein,New Hire ! , l l { Page 2 of 9 f t
*b bo.
HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM so m7 twee isee ID TaskName "Jtr3 lOtt 4 Otr 1 lOtr 2 lOtr 3 lOtr 4 Otr 1 lOtr 2 lOtr 3 lOtr 4 Otr 1 lOtr 2 lOtr 3 { Qar 4 - 47 3743-01, Bedon Ddsroon l 1 j j DeFrein
} } g _ . __ } - _ . - _ ._
.q - f as 0441-01. Becton Ddmon vacutamer Systems a 1
; l i l Jim DeFrain es 074241.Sherwood - Does & Geck
^ _..,______p-i
$0 01-52 01 Radiology Nuclear Medone a' _._ J. _
._-_ . b' __4 l_Jhn -- DeFreen ----+
I , i l l Jim DeFrein,New Hire 51 02-2042. State of Netreska - Departme W of Health
._: 4 . _ .._
__.1- - jl 4 t~ -t i l lesw Her-t d.Drien Hoerty 1 __p-52 01-5941, Great Ploes Nudear Serums. Inc l l
; l l Bryan MIBer 53
_.} --_4._- ' 02-1042. Ha ns Latxwetones ! l " ( ;. _ . 4 _. . l ar M Miser 54 SS Reciprocity: ~ r Avesisese REC 0156. EA Ergneermg Soence & Technology. In
] - ..
l 3 trio l BryanIndler se REC 0116. TN Technologes. Inc. _9 _ _ . , _ . _ i 9t11 l3hryan INIIIsr _ _ 4 . ... . _ i- . _ . . . _ 1- t +- ' --- 57 REC 0131, Edwards Pipeime Terwj. Inc. ; l J' im DeFemin
,t l grq7 l 9 - 3 J se REC 0188. X-Ray Inspechon, Inc. ! I l l Bryan GNWor
_ p , _ _ .[ _{ _ _ .. - - - - - ---4 .(
= roca,* ise mne ,Nr rr.e*, ; ;
4 _ 4_ . _. 60 StaffHg vacant gestoriale Health Pnysicist I ._. . _ .,
~ 61 Receive Authorizahon to Fill Posdion !
{ gr3 _[.___i_._- yyggsy! 1
$2 Post intemany and ExtemaWy
_ f t { _ .. p _.{_...__~ -- - j i t-i try3 j Hoe,ty __ . . _ _ _ _ 4 ._j _ - w_.- -. - - 63 Screen Applicahons . Moorty
.1
_ 3 __
. p. . _ _ . -- --
~~--
84 Interwew Carudates l f Hoorty.See Somerone
- _- ~ . _--.- - - -_ - --
65 New HPi Hved i i { _
- 4. bt ._ - $ -
66 Basic Training y} . - i 1
, .I _
p._ .. _ j _-. . ~ - - - ---- - 67 Introdudory Health Physacs ; ' ,
' : t l Trudy HW ;
i 1 j _ .. _ _ _ _ __- _ .+ d - --- - - -- 6e inspecbon Procedures ' j lNN 4 - _. - _ _ . _ ,
$g IiCer1 sing Predices and Procedures ,
, l h hMa FM "
Page 3 of 9 i _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ , I
u HHS REGl>LATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADl0 ACTIVE MATERIALS PROGRAM 36 1997 1888 1"
,o yg y,,,,, as lm4 mt lotr 2 loir s l ott 4 ote t im2 lotr3 l** otr $ 10'r 2 lm3 Lea 3 70 Licenseg Practas and Procedures j i j ; H l j
! 1 ; , _ 4 ., . ' _ ____.{l _ -lp - - oward --- - - h + - - - 22atr, Transportaten of Radcactive N f { l { l Bryan MIHer.How &#re l 3 4 .. ___..-.4.- - . - - ----+-- --- 72 Spectattred Training j l j l 1 l s .. _. ) l
-.7..-.-.
j 73 Diagnoste and Therapeutc Nuclear Medcme l j f BryanIS#er i ; .i ; J. . _ . . . . n - , - - 4 .1- W - 74 Diagnoste and Therapeute Nuclear Medicme ! [ t l [ Mew HIro l
; } _ , _ ,
_ . . _ . .._L._ . . . - - - - --. - L-~ 75 Teletherapy and Brachytherapy l !
! _ . . [4 Bryan RuperJIrlen Hoerty 4 4 __ 9_
- - __ q ,- p -- - - - -.--- -
76 Teletherapy and Brachythe*apy i ! . Ne w FMrs j,_ l
} , 1 .- _ _ _ . . _ _ _ . _ _. - . .
._p---.-- .
77 Safety Aspects of troustnal Radography l l . l g,yan WN5er, John Feeees _ ! , .1 . .q _ . - - _ __- _ {_ 73 Sakty Aspects ofIndustnal Revdr l l Brien Hearty [_ . - - . -.. .--- - --- --. - - - -- - - - - - 79 Safety Aspeds of Wet Loggeg ! . l Jirn DeFrein, Bryan NIInor i ._. .- ...--j -.-}. j } _ , - 80 trradiator Tecimalogy ! e 'l Brian esty,lirn DeFrain,(Dete to be C." ....--a L .j _ __4.___ ._ -
-p_- .--
81 Adva-iced TrattWng ' i j 1 ;_ __. _ _ . _ . ._. -- - - - - . - - - 82 Health Physes Tod-navvy i l Cheryl Rogers L
, 3 _. _ ._ _ _ _ . -.
.__.9.- f- - - - - - - - - - - -
a3 Ermronrnental Mondonng for Radcactw#y i j
! }
4 l 4_ j _. 3 _._. l. 4'JD Edwards . . . - _-- -- L- --- -- 84 inspedmg for Feac- - Matenals j i hhurnenJDate to b C_.-M
.g. .'l Cheryl Rogers, s _ ~ -- --_ 4 - . _ . -
85 htaterials lJcensing Progrern {. . l g. - a _ _ _ _ } - 85 Total Nurnber of Pending Ucensing Actions (74) , j l , I
. { 3, 2 . } __ _ f . .__ . . . - . - - ----
87 Actons Recevved Pnor to 7/96 (29) z7 I M,pe,q,,p _._. 4 _p--- . - - - - ~ ~ - - 88 Actorts Recerved After 7/96 that are Overdue (40) . _ Licon ,pM ) { ._ g . __q . . ._-____- _ _ j . . . _ ._ _ 90 Response to incidents and AHegation s j l J. l . _. t. ._ _ . _ _ . 91 Radioactive WIsterials AIIegations I
, l L- _
92 Anegaton identifer NE-97-001 Speoal Inspedon l Brian Hearty ! l Page 4 of 9
. ;. .:o HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM BS 1997 1999 1999 E TM h Otr 3 lOtr 4 Otr 1 lOtr 2 l Ott 3 lOtr 4 Otr 1 lOtr 2 l O*.13 lOtr 4 Ot 1 lOtr 2 lOtr 3 lOtr 4 93 Radioacttwo heaterta's Events j
! , l j
_ 1 o .._ a _ - 94 NE970001008 24 hr Report Reweved l l g gg4 95 NE970001006 24 hr Report Evaluated _, ,. 4 _ __ y _ . _ ._ __--- - i w4 Derrain,Betan Hearty 96 NE970001008 Reported to NRC [ _ y._. . _ _- - . - -- - - - l
, ; [ ___ 915 l J,ern. D#ra6n.
Brian Hoorty___ _.. - - - - 97 30 day Wntten Repart Recerved j i l l
,_ __, _u_ _ . - --
98 NE970001008 FoRow-up Report to NRC ; 4 9
- 1. _ _ .,_ ._ ,l Estan +. k- - - -- - - - - -
99 Nuclear Nintertals Events N Reporting i i
- i. . y . .. { ._
_.._y _. 100 % awo a po t {lIIiillIIIIfIIIIIIIIi 122 Legislation andRegulations ! \ j_ 4 l y . _ _. _. . [ _. - _ . - - - - 123 Regula6on Changes to 001,003,004,007,009,012, an j ; j 4_ p ._ __ .1. ___.._ L .._ . . - -- - - - - .-- ---- 124 Pre-Rule l i l f _ o o q __ l - - - -- '2s Pn>poseo Changes oraned 126 Approved by RAC j 35 Mglrogra,npian l yy l 3
. J .. 4 t.. .._.,_.....__p---- -
------ ~~--
127 Proposed Changes Revewed by PRO j
! 3/21 i f 1 ; . . . . b __
123 Proposed Rule I ! l
} [ ~ _ . , _ k. j. - --- -- - - - --
12g No6ce of Rulernsking Heanng l
., N28 h syce Devidson'
{
} _ , _ _ _ _ ______ .- - - - - . - - -
130 Pubhc Heanng 5/1 - Hearty 131 Post-heanng Anatysis and Revisaons
, 54 Prograrn StsN l
{ , , __ . a __. . . _ _ . .. - __,. - - .
. _ - j - .. --
132 Final Rule j i i _ _. } _ _ . _ _.-- - - _ _. - - - . - - - - - - - - + - - - --- 133 Agency Revew and Approval gfgg 134 Attorney General Revew and Approval ; 7121 f l u - 135 Govemor's Review and Approval 1 -
~
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r i
-{ p-
[ _ g{ _ j_ _ ._ i f 136 Proposed Changes Adopted
- F' - t -- -
lgfty $ { ; j ' l Page 5 of 9
HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PPOGRAM B6 1997 1998 1999 ID Task Name Otr 3 lOtr 4 Otr 1 lC52 lOtr 3 lOtr 4 Otr 1 l Ott 2 lOr3 lOtr 4 Otr 1 l Otr 2 [Otr 3 [Orr 4 137 Regulation Changes to 004,005,010, and 012 g ; j j !
-_s. .-
133 Pre-Rule
- j L .{ __ . ; .L-_.-- --- -_ - ..---- - - - - -
139 Proposed Changes Dram i ,-Nogram Sts# 4
.; .t. , .-
9.._ _ . . - ---_6 ----. --- 140 Approved by RAC ! * { ! I 141 Proposed Changes Reviewed by PRO
, q_ _ . ._ J - __ _ -. -- --- - - - -
l l ! !
, ._ 3 , .t. __
1 _ . _ _. _ _ - - - - . - - - --- . ~ ~ ----- - - - 142 Proposed Rule ! ! l 143 Nohce of Rulemaking Heanng { ._-.. . . .
. . . - - ..l -- -~--- -
[ }
.g . ... a %. . ,, _ , _ _ _ _ . __ . - - -- - .---
144 PtN : Heanng --- -- - - l 145
. . _ _ , 1 ._ '_. _ _ . -_ _. -.1-----
1 p - - - -- Post-hearmg Analyses and Revisens ' ___ _ _ Program-.__A StsN 146 Final Rule .. ._ f. _ _ . _ . _.t.___-.. . . . . ._._ .- 147 Agency Review and Approvst
, j 143 Attomey General Reva and Awal !
__j ._ _. . - _ . . __ _ l -- -- - - - ---- -- 14g GoverrWs Review and Approval I i
._ j . . _ . . I _. _ _ _ . b gh . - - - ----< ---
150 Proposed Changes Adopted _ _p __ . t _ _ ; ._ 151 Regulatory Guidance
, ! { t
_4_ .L __ _ 4 -
.1 - -- --- - --- ----
152 Regulatory Guide 19.0 I j _1 2 153 Proposed Man WaN p----.. ._-p_---. - -- 9/22 & 15hmi
+ r e
M, _ , _ _ __ __ 154 Approved by Program Wnager , 1 j t l Brian Heatty i l
.._ _ .1 - '
t-- t- - Reg
- tory Gum 7 0
- - - -' - ~ - ~ --- ~~~
155 ! t I ,i _ l j 156 Proposed Mae &aW i _ , J__ .--- _ - - - - ce herej Wme ,57 App, d bv P ---, . 158 Regulatory Guide 7.1 i 1
, _ ,% t . __ t _ _ t- ;
l
, , 1 1
t l t j f l 15g Proposed Gudance Drafted ; 7 ,g . -- i a 9/26 pherrt Wren, Susan Farnsworth. Sue Gemerena l Page 6 of 9
HHS REGULATION AND UCENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM w mr iges isso in Tash Mame m3 loti d mi Im2 123 Imd *' Im2 lm3 Im4 ' otr i lotr 2 lm3 lotr 4 160 Approved ty Program Manager ! l l 9r29 l Brian Hearty i 161 Materials Program Procedures _} ;
.. } . ,
_ _ _1 _ _ ---
! l , ;
} - . - _ .. ..__ - -.
+-
162 General Ucensirig i
~ -163 RMP No.101, Cedawi Messunng, Gauging, and Con '
l
; ; ! l 164 RMP No 1.02. Depleted Urarnum
; J 4_ ;. _ g. _ . , _ . _ - _ .__ _ , l Jay Notde. Brian Heartyf ---
j ', j l Jay 4 . 165 RMP No 103 in vitro Testeg ! ' __ .q . -
! l l Joy Notdo l.
g ! t
~ q --._-_ f 166 RMP No 104. Reoprocal Recogneon of an Outef-S 6
; } l l Jay Notdo 167 RMP No 105. Balhng
.f . q. h 1
. -j -. -. - p-.----- - - - - - ~ -
j ;
- lJoyNotdo
;. 1 _ . .
.. l.____.
l Jay g -- 168 RMP No.106. Ucense Flie triadrration j l Notre 169 Specific Ucensing l _ {. . ._ _ . - .._. . -, - - - } -
- l. _ ,
7 70 RMP No 2 01. Request for Apphcstm ' t . lJayNotdo
. {_.
i ; 1 1' . ._ 171 RMP No 2 02. Review of an Apphcaten or Amendme j ..___.-___3.__
, ! Brian > earty. Program Staff j.
4 _ _ _ __ _. . . _ . . - _ _ . . i_ _-- 172 RMP No_2 03. Renewal of Licenses ! j l i grian F eerty 4 , 4 { 4.. q _ _._. .-- _ . - - 173 RMP No. 2 04 B+!hng l I l l
; _[
t
;. ..__.p_
l l Jay Notde !
, f g__-__ 1 -
--4 - - - - - - - -
174 RMP No 2 05 Ucense Temunation l } t i l Brien Hoerty 175 RMP No. 2 06. Poortzaten of Ucensmg Adions i
; 1 i
6 (' _._ _. _. __ _ . ; - -- g i l ; l " Brian Heart . _y__. 176 Inspect *ons [. 3 3 [ [ _ ._ _. l t . .__ - _ - _ _ .. ---- j . t 4
. _ . . . _ _ __ _ l . - _-_ . _ - - _ _ - -
177 RMP No. 3 01. Scheduhng of LM*6 l f l Brian Hearty . 3 ; {' i .._ ,, ._ . _ .
.q. ._..__ -.---1-.-
173 RMP No. 3 02, inspection Prepara' son ; l j 179 RMP No. 3 03. Performance Based Inspedon 4 .. j . _ . . . E.Briaa __p-___ n. rtr - - - - - _ . _ - i ' j
._ E Ekrten Hoerty 180 RMP No 3 94. Documentation of Inspecton Results
_ e _._ ._ _ . _ _ _
, ,i Brian M, Staff a __ _ .g .._.
g _ 181 RMP No. 3 05. Enforcement ' - 1142 Allegations and incidents i
.! E Bri a n r'r . _ Ip __ .i.
! l !
l } f Page 7 of 9
.~ ,. .,
HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM p6 1997 1988 I'"
,o reesumme m3 Imd 21 lotr 2 lms Im4 otr i lm2 loir 3 Im4 otr i lon 2 lotr3 lotr4 133 RMP No 4 01, Manageme d of Wees i '
} ( ; l BNHowtr 184 RMP No. 4 02, Radrosdne Metena! Events
; } W26 l Brian Hearty $
t 185 Legistation, Rg_" _' -.and Guldence C-4 4.4 j ! l _3 ;' __ . . t _. _ .j l 9 .. __ . - RMP No. 5 02, Revision and tmplementahon
- - I -
187 f .__ . l g gegen 4,ortyNA.I.D.
.- - _s. . . . , -- .
1ss ouaimcations and Trawns j l _.$....-. .__ l .~ 189 RMP No. 6.01. Quahncatens Manua! j l W3 l Beton Hearty, Sue t .. , Bob Leopold jim Whey _ _ ,. __ a ..t. g --- - - & 190 RMP No. 6 02. Training Resources AvailabMy and Et g3g b % 4 , - ~ 9 191 Prograrn .~ .. . 4 g
, l l
._. q ._ _ _.
._.--...l.--..-_--
192 RMP No. 7.01, Budgeting . l ilBetonHoerty 193 _ . _ ._ . 1 - .~ -. - --l - - -- 1 - - ~~ RMP No. 7.02. Fee Calculation __ ._( l r -. -- - l-- hy V -- 194 RMP No. 7.03. Routine Program Overss@t
! ! 7131 E BrtdHoorty. . - - - .
195 RMP No. 7 04, Upper Management OversWW
. - ~ - -
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HHS REGULATION AND LICENSURE DEPARTMENT l PUBLIC HEALTH ASSESSMENT DtViSION RADIOACTIVE MATERIAlt PROGRAM i i Task M Prr.gress - RADIOACTIVE MATERIALS PROGRAM CORRECTIVE ACTION PLAN Milestone $ Approved by Division Administratw. Summary Revised: Wed 10/1/97 RW Upd M Rolled Up Milestone <C)
\_ -
RoHed Up Progress -
'# '- Page 9of 9
Radioactivs Materials Progr:m Procedur:s l Nebraska Heshh and Hum n Servlees Regulation and Ucensure Department a STATE OF NEBRASKA HEALTH AND HUMAN SERVICES REGULATION AND LICENSURE DEPARTMENT Radioactive Materials Procedure No. 4.02 Allegations and incidents - Radioactive Material Events l
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Approved by: L N/M , N. Date: h RMP No. 4.02 lasued: September 26,1997 Revision No. O Page 1 of 6
' i !j ama e m p,.y p, . t m m ,,,,n ,,,,,, m :__ w.' -- - -
*11c0 ' PURPOSE - e i
1,1 ' Applicability ; :
'.i This procedure outlines the tracking, investigation, reporting,.and- ..
documentation of radioactive material events. It incorporates the U.S. ; Nuclear Regulatory. Commission's
- Handbook on Nuclear Material Event Reporting in the Agreement States" and provides instructions on using the:
Nuclear Materials Events Database.
-1.2 References ,
1 1.2.1 - NRC, Office _ of State Programs, " Handbook on Nuclear Material. ; Event Reporting in the Agreement States", Published as Draft-for Comment March 1995 , p 1. 2. 2 . NRC, Idaho National Engineering Laboratory, " Nuclear Materials Events Database User Guide", Published as Draft 09/05/96-1.2.3 RMP No. 4.01, Allegations and incidents - Management of Allegations 1.2.4 -ERP No.1'.03 - Emergency Response Non Specific Locations 1.3- Computer Based Letters, Forms, and Reports 1.3.1 Microsoft Access 2.0 R:\RAMDATA\ EVENT.MDB Report: Event Log Report
-Report: Pending Radioactive Materials Events Form: - Event Log 1.3.2 :Microsoft Access 2.0 R:\NMED_ LOC \ LOC _ PROG.MDB Report: Event Details 1.3.3- Microsoft Access 2.0 R:\NMED_NRC\NRC_ PROG.MDB 1.4 Hardcopy Files -
- 1.4.1 Event Documentation Files--
. MAP No. 4.02 leoised: S.pt.mber 26.-1997 ~
Revies.n No. 0 -
- P.ge 2 of 5 -
- .- - - ~.
.[ R.dio.ctive M.t.rt.ls Progr.m Proc.dur.s w br..k. w nh .nd wom.n s.rvie.. R.nui tion end ue.a.or. o .rtm.nt
.- 1.4.2 Radioactive Materials License Files 1.5 Definitions Abnormal Occurrence An unscheduled incident or event which the NRC has determined to be significant from the standpoint of public health and safety. NRC has established specific criteria to evaluate the significance o'i an event as a potential AO.
Reportable Event An event involving licensed radioactive material that is required by regulation to be reported to the Agency by the licensee. Attachment 4.02-1, Table 2, lists the NRC regulatory citations which require reports, and Attachment 4.02 2, lists the equivalent 180 NAC 1 citations. Routino Event An event involving radion:tive material that does, will, or may lead to, or may be part of a pattern that could pose a health and safety risk. This category of events inciudes events that are required to be. reported within 30 days such as 180 NAC 1-00'3.13A. NMED The Nuclear Materials 'ivents Database that was developed and is maintained by INEL for the NRC, and is used to provide information on reportable radicactive materials events for both NRC and Agreement State licensees. Significant Event An event involving tadioactive material that does, will, or may impact public 'nealth and safety risk. Events in this category should be reported to the Agency within 24 hours such as 180 NAC 1004.52A and B,003.25A and B, and OC7.13A1. Special Inspection An inspection that is in response.to an incident or allegation that it; performed outside of the normal inspection frequency. 2.0 RESPONSIBILITIES l l 2.1 Technical Staff Member i L Technical Staff shall use this procedure when receiving a report of, logging, l l RMP No. 4.02 issued: September 23.1997 l Revision No, O Page 3 of 6
?
Red.wth,. M.t.,4 1. Progr.m Pr.o.dwee m.a. w m .a4 wom.a s.,*.. R **m .ad ue.a... e== a
, inves'.igating, reporting, and documenting a radioactive material event.
2.2 Radioactive Materials Program Manager The Program Manager shall work with the Technical Staff member to determine if the risk to public health may require an emergency response or specialinspection, the Agency and NRC reporting requirements, and the event close out requirements. 3.0 PROCEDURES T 3.1 Event Logging 3.1.1 Radioactive Materials Program Event Log The Event Log is a database for tracking and documenting possible radioactive material events. The log shall be used by the Technical Staff member that becomes aware of an event either by a required notification from a licensee, on inspection, or by an allegation. The Technical Staff member shallimmediatelv enter all known information on the event into the appropriate fields of the Event Log form, if the event is discovered on inspection, the Inspector may call back to the office for assistance in logging the event and initiating any required reports. Written or verbal allegations sheli also be tracked and documented in accordance with RMP No. 4.01, immediatelv af ter the initialinformation has been logged, the Technical Staff member shall inform the Radioactive Materials Program Manager of the event and l begin assessing the risk to public health and safety. l 3.2 Event Investigation l 3.2.1 Emergency Response l If the event is on going and harm to public health and safety is imminent, the Emergency Response Team shall be activated in ! accordance with ERP No.1.03. Once the emergency response is I terminated a specialinspection shall be performed. 3.2.2 Special Inspectic,n ! A specialinspection shall be performed as soon as nossible within 30 l day.s if the event may have resulted a significant exposure to an l individual or the public, be a generic device defect, or have been l i RMP No. 4.02 - L leau.d: S.ptembee 26,1997 R.wleion No. O P.ge 4 of 6
~ . - - - .- ,. - . - - .-..-_ - . ..- .~. - .
Radioactive Meteriale Program Procedures
, n.breake Health and Human Services Regulation and Ucensure Department J
U ' caused by a violation of a regulation or license condition. A special . i inspection should also oe performed when the information available is
.I not complete enough to make a determination of the above situations.
.i The special inspection shall be performed by a qualified Lead Inspector
! and documented in accordance with RMP No. 3.04.
ia 3.3 i! vent Reporting i [.l.3.1 Reports to NRC Events shall be reported in accordance with Attachment 4.021, NRC, N Office of State Programs, " Handbook on Nuclear Material Event Reporting in the Agreement States", Published as Draft for Comment March 1995. Attachment 4.02 2 provides the 180 NAC 1 regulatory citations which require Agency notification that are equivalent to the NRC citations listed in Table 2, Repc,rtable Events, page 16 of the Handbook. 3.3.2 NMED Database . The NMED database system shal; be used to generate Event Details reports for documentation of the event and transmittal to NRC, if required. Attachment 4.02 3, NRC, Idaho Nr.tional Engineering Laboratory, " Nuclear Materials Events Database User Guide", Published as Draft 09/05/96 is available for reference when using the NMED database. 3.3.3 ' Electronic Reporting to NRC NMED is capable of generating transfer file reports in an electronic format that can be sent to the NRC on disk or over the internet for easier input into the national database. Attachment 4.02-3 provides instructions on creating the transfer file. 3.3.4 Confirmation of Final NMED Report After an NMED update is received from the NRC and NRC_ PROG.MDB is revised,- each recently reported event should be reviewed to ensure the event details were properly transferred. 3.4 Event Close-Out An event may be considered closed when: R4 No. 4.02 lesued: September 26,1997 Revision No. O Page 6 of 6 --_____________-u - _m - .__ _ _- - _ _ _ +'% m +- 7
n ev. u..,a n .,a e, .. w.w 6. w..iin ., wom.n s., vie.. R.eus.ii.n .a4 tie.n.u . o .,tm.ni 3.4.1 There is no further risk to public health from this event if this is a generic device defect or common use of rnaterial, the existence of similar circumstances in the State shbil be determined and the likelihood of a repeat event estimated prior to closure.-
'3.4.2 All required written reports and. if applicable, replies to a Notice of Noncompliance generated from a special inspection have been reviewed and the corrective action accepted.
3.4.3 Events shall be closed upon approval ref the Radioactive Materials Program Manager. 400 RECORDS
- 4.1 Hardcopy 4.1.1 Event Log reports and NMED Event Details reports shall be maintained in chronological order in the Event Documentation Files. Coples of the event reporting fax cover sheet provided to the NRC shall be maintained with the appropriate reports.
4.1.2 Copies of the Event Log and Event Details report shall be maintained with the inspection results in the appropriate licensee file. 4.1.3 Specialinspection reports should be maintained with the inspection results in the appropriate licensee file. 4.2 Computer Based 4.2.1 The Event Log and NMED databases shall be maintained for access by program Technical Staff. 5.0 ATTACHMENTS TO RMP No. 4.02 4.02 1 NRC, Office of State Programs, " Handbook on Nuclear Material Event Reporting in the Agreement States", Published as Draft for Comment March 1995 4.02 2 180 NAC 1 Regulatory Citations Requiring Agency Notification 4.02 3 INEL " Nuclear Materials Events Database Users Guide"; Draft 09/05/96 RMP No. 4.02 1 u.d: 5.ptemb., 26.1997 R.vlsion No. O P.g. 6 of 6 w
Qf bdio.ctiv. M.t.d.ls Pr.gr.m Procedures ; w.6,. 6. w wh .no wom.n s.~ie.. n.,ui.ii.n ns u n.or. o.nmm.ni Attachment 4,021 NRC, Office of State Programs,_" Handbook on Nuclear Material Event Reporting in the Agreement States", Published as Draft for Cominent March 1995 This attachment contains a copy of the handbook to be used when reporting events the NRC. 4 The followino naaes are attached; # Paaes
- Cover Pege 1
= Abstract 1 Table of Contents 2 Preface 2 Section 1 4 Section ll 19 Appendix 18 2
RMP No 4.02 issu.d: S.pt.mb.e 26,1997 R. vision No. O
. . - -. ~ , . _
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' Radioactive Meteriale Program Procedures Nobreehe Hoekh end Homen Services Regulation end Ucensure Depectment
.* - _ n Ie Attachment 4.02-2
. 180 NAC 1 Regulatory Citations Requiring Agency Notification This attachment contains the citations equivalent te Table 2 in Attachment 4,021.
The followina unaes are attached: # Paoes Regulatory Citations 1 l- , RMP No 4.02 l' losued: September 26,1997
- l. Revit'on No. 0 l
!9 4 Y,' REPORTABLE EVENTS Typicalitems covered under reporting requirements include the following: 180 NAC 1-003.25 'Aeporting of events involving: Prevention of immediate protective action, Unplanned contamination restricting access > 24 hours, Safety equipment failed or disabled, Unplanned medical treatment of contaminated person, Fire, explosion affecting integrity of material or container. 180 NAC 1-004.51 Rep :rts of theft or loss of licensed material. 180 NAC 1-004.52 Immediate and 24 hour notification criteria for materials events. 180 NAC 1-004.53 Radiation exposures, releases or concentrations of radioactive material that exceed the limits. 180 NAC 1-005.13 Radiation safety reporting requirements for radiographic operations. 180 NAC 1-007,17 Notifications, records, and reports of misadministrations. 180 NAC 1-014.24 Notification of incidents and lost sources, abandonment procedures for irretrievable sources. 180 NAC 1-019.29 Notification of incidents involving irradiator.s.
f f , R so.ctive Meteel.ls Prce,.m Proc.dures m.6,.a. H nh and wom n s., vie.s n.ovi.o.n no ue.a.u,. o .,t-t -
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i Attachment 4.02 3
. INEL Nuclear Materials Events Database User Guide", Draft 09/05/96 This attachment contains a copy of the instructions for use of the NMED database.
The followino naaes are attached: #..Paacs Cover Page 1 Table of Contents 1
-Purpose 1 Instructions 13 Appendix A Event Descriptions 8 Appendix B Data Dictionary. 7 Appendix C Data T6ble Relationship- 1 RMP No 4.02 lesued: Septemb.t 26,1997
- Revision No. 0
r_ p Public Health Assessment Division Acting Division Administrator . Robert Leopold - M-AdMirdubsthe PuedeHeethTedudtsi
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STATE OF NEBRASKA DatAstmawi of stavices e Datasiugwt or Recutation Amo Lictusuas E. AsnAwiw Natsow, ooviaros y Dstattuswt et T4NAwCE AND SUtroef October 31,1997
~
U.S. Nuclear Regulatory Commission Of.lce of State Programs
- Mail Stop 3D23 Washington, DC 20555 Attn: Richard L. Bangart, Director Office ofState Programs
Dear Mr.Bangart:
This letter is in regards to the draft report received by our office on October 15,1997 which deta!!s the findings and recommendations of the IMPEP team which conducted a follow-up review of our radiation control program during the period of September 16-18,1997. The draft report was reviewed for factual correctness by the appropriate program managers and the proposed minor revisions are outlined below.
- 1. The cover letter, draft report cover page, and first paragraph of the report indicate that the follow-up review was conducted September 15 19,1997 and that recommendations were discussed on September 19,1997. However, the review team was at our office beginning September 16 and concluded its review with an exit briefing on September 18,1997, it is
- proposed that the dates be revised.
l l 2. Page 1, Jtem 1.0, Paragraph 2. Line 10, indicates that Nebraska has four large commercial I irradiator licensees. The materials program licenses three large commercial irradiators ) and one converted teletherapy research irradiator. It it proposed that the reference to four commercialirradiators be revised.
- 3. Page 2, Item 2.0, Paragraph 3. Line 19, references regulation 80 NAC 1-012.22. It is proposed that the reference be revised to indicate the proper citation,180 NAC 1-012.22.
L l- 4. The handwritten comments in RMP No. 4.02, thouj;h very useful fe' program staff, should be removed from the final repon ifit is to represent what was submitted by our j progra;n. L l HHS Regulation and Licensure Pubhc Hestth Assessment Division P.o. Box 95007 l- , Lincoln.NI 68509 5007 hEeuaommmn'AmmumsAcmwzmora emwisowitssovomonasevaantarsa ! _ a , ; , , , _, , , _ ATTACHMENT 1 we e a c - <a
@i
- ]% Richard L. Bangan, Director
.; October 31,1997 Page 2 If you have any other questions prior to luuing the fmal report, please fxl free to contact Brian .
Heany at (402) 471 2168 or the LLRW Program at (402) 471-3380 as appropriate. We look forward to our next monthly telephone conference on November 5,1997. Sincerely, , [ Robert o d, A tinistrator Public de Assessment Division HHS Regulation and Licensure e 4 e 1
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