ML20211Q887
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Issue date: | 10/10/1997 |
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) FOLLOW-UP REVIEW
[ OF THE NEBRASKA RADIATION CONTROL PROGRAM j SEPTEMBER 15-19,1997
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i-i DRAFT REPORT i
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U. S. Nuclear ReW'atory Commission i
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Nebraska Draft Report Page 1
1.0 INTRODUCTION
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} This report presents the results of the follow-up review of the Nebraska radiation control l- program conducted September 1519,1997. The follow up review was conducted by a review team comprised of technical staff members from the Nuclear Regulatory l
. Commission (NRC). Team members are identified in Appendix A. The follow up review l j was conducted in accordance with the " Policy Statement on Adequacy and Compatibility
- l of Agreement State Pregrams," published in the FederalRep/ ster on September 3,1997 ,
(62 FR 46517), and the September 12,1995, NRC Management Directive 5.6, " Integrated I i Materials Performance Evaluation Program flMPEP)." The follow up review covered the l State's response to, and resolution of,15 recommendations made during the July 15-19, i 1996 IMPEP review. The follow up review also covered the status of the program during
! the following period of July 20,1996 - Sertember 12,1997. Preliminary results were !
j discussed with Nebraska management on September 18,1997. -
t The Nebraska Department of Health and Human Services System (NHHS) is the agency within i the State of Nebraska that regulates, among other public health issues, radiation hazards; The I
i Director, NHHS, is appointed by and reports directly to the Govemor. Within NHHS, the Nebraska radiation control program is administered by the 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 four large commercial irradiators, 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 274b. (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 Stste's implementation of their "Get Well and Stay Well Plan," that was accepted by the Management Review Board (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 applicable 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) intervierns with staff and management to answer
' questions or clarify 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 assessment of the radiation control program's performance. ,
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a F Nebraska Draft Report - Page 2 l
l - [A paragraph on the fbal recommendations as approved by the MRB will be included in the final
- follow-up report) l 2.0 STATUS OF PREVIOUS REVIEW -
l l The previous routine IMPEP review, conducted on July 15-19,1996, resulted in a finding for ,
l Nebraska that the radiation control pxgram was ' adequate to protect public health and safety '
but needs improvement, and compatible with NRC's program." Due to the significance and l i tv'.nrar of deficiencies found in the Nebraska program ewhich included a finding of I
- u w sfactory in one performance indicator, the review team recommended a period of -!
! provstion for a duration to be established after consultation with the Nebraska radiation control l program management, in consideration of the corrective actions taken, and actions planned, ;
j that were presented by the State at the January 22,1997 MRB meeting, in a "Get-Well and e Stay Well Plan' to addre.s and close out all recommendations by July 1,1997, the review team j revised their recommendation. The recommendation for probation was changed to a i recommendation for a follow-up review of the State's radiation control program, to be conducted
[ witnin one to one and one-half years from the date of the last IMPEP review, but not later than September 1997 The team also recommended that the State keep NRC appraised of W l
. status c f corrective actions and plans. The MRB concurred in the team's revised l recommendation. ,
- In the February 12,1997 cover letter transmitting the final report of the July 1996 review, the i State was also requested to provide NRC with (1) a copy of the actual Corrective Action Plan
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(Step i and ll), and (2) a status r port of resolution of the corrective actions and plans every two months.
4 By letter dated May 2,1997, to Hugh L. Thompson, Jr., (Appendix C) then Acting Executive i Director for Operations, and the Chairperson of the MRB, the State provided one response to I- the request for a status report every two tr onths. The status report indicated that the corrective i actions remained on schedule for completian by the July 1,1997 'Get-Well Plan' and date. The j 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 material licensees. Attached to the report was a
- more definitive Gantt Ch3rt that presented a schedule for completion of the various tasks. The l achedule covered development of work <>n (1) the new database tracking system for inspections i including reciprocity inspections, and procedures for inspection plans, including those j_ completed by contractors, (2) a staff qualification manual drafted by a contractor, (3) completion
[ of a licensing action prioritization procsdure in January 1997 and continuing development of j additional comprehensive administrabve procedures, (4) annual supervisory accompaniments U of inspectors, (5) use of NRC Manual Directive 8.8 for
- Management of Allegations,' (6) use of I the draft " Handbook on Event Reporting in the Agreement States," and development of an
[ event tracking database, (7) reporting on February 28,1997 of all outstanding events identified
, during the 1996 lMPEP review, and the beginning of routine monthly event reporting on
! January 31,1997, (8) compilaten of all LLRW training data for agency personnel, and (9) a i revision to regulation 80 NAC 1-012.22, the State's Part 61 equivalent rule to low-level i radioactive waste facilities that process or store waste, as well as disposal sites, with expected
[ adoption by June 1997.
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Nebraska Draft Report Page 3 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
- Plan
- as scheduled. Durinq discussion of the scheduling for the follow-up review, the team -
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loamed that several changer in management had occurred within the Department above the i first line supervisor, and that r,vocedures had not been completed. As part of the preparatory l process for an IMPEP revira, the team requested a written report of the current status of 1
- corrective actions and the changes in management. LThe State provided a status report on
- September 8,1997 (Appendix C), that identified changes in management, staffing, and i schedules. The September 8,1997 status report is covered in greater detailin
. recommendation No. 6 of this report.
i i Results of the follow-up review of the State's response and resolution of W 15 recommendations encompassing the IMPEP common and non-common po'rformance indicators are presented in Section 3 and Section 4. Section 5 summarizes the review team's findings
! and recommendations during the follow-up review.
l l 3.0 COMMON PERFORMANCE INDICATORS i
( The IMPEP process uses five common performance indicators in reviewing both NRC Regional i
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, i
j 3.1 Status of Pendina lasues identified under " Status of Materiale irianantlan Procram' 1
l 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 i . licenses, and timely dispatch of inspection findings to licensees. To evaluate these issues, the L review team interviewed program management and staff, reviewed automated data, and
! examined the State's responses to the recommendations 'n the final report of the 1996 IMPEP l review, which resulted in a finding of satbfactory with recommendations for improvement. The final report contained three recommendatio.m fsr this indicator. The results of the follow-up i- review team's evaluation of the State's response to the three recommendations are presented below;
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i Recommendation 1
$ : 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 which is equal to the NRC's IMC 2800 and conduct reciprocity licensee inspections at the required frequencies stated in IMC 1220.
Current Status 1 in the State's May 2,1997 corrective action status report the State indicated that it had 3
(1) updated its database system with the appropriate inspection frequencies equal to IMC 2800, i
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! (2) developed a' database tracking system in which each inspector could generate a report on
- his or her computer showing inspections coming due, (3) developed an inspection tracking i system that included reciprocity requests and that allows the inspector to generate a report i 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, j~ 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.
f During the review, the team evaluated the computer tracking system and focod that the new system greatly improved the oversight capabilities of the inspection process. The following list j provides selected examples of reports that could be generated from the system.
Pending inspections for Twelve Months through September 6,1997 Inspections Completed from July 1996 to Current dew i j -
Specific Licensee Reports j -
Fleciprocity inspections by Priority '
i I- The team evaluated the automated status reports, discussed clarifying issues with the Program j_ 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
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follow-up review team found there were no overdue inspections, and all inspections due for inspection by the third quarter of 1998 were scheduled and assigned to en inspector. The State j 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 procedutas equivalent to IMC 2800 and j
! 1220. On September 12,1997 the State issued Radioactive Materials Procedure (RMP) No. l t
7.03, " Program Management - Routine Oversight," which outlines the frequencies of intemal '
audits to assure inspections are being performed and includes a notation regarding supervisory accompaniments.
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l_ Based on the follow-up review, the team considers this recommendation to be closed.
j Recommendation 2 L
I- The review team recommends that the managers establish an action plan or procedure
{ for coordinating deviations from the inspection schedule between staff and management l baced on the risk of license operations, past performance and need to temporarily defer l the inspections to address more urgent or critical priorities.-
Current Status
) - In the State's May 2,1997 corrective action states report, the State noted that "the inspection scheduling and the upper management stay-well procedures will both establish methodologies. ,
y for coordinating deviations from the inspection schedule and rescheduling of missed j' inspections."
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Nebraska Draft Report Page5
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i 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 2
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 outlines the frequencies of intomal audits to assure inspections are being performed.
The Program Manager indicated that following the written procedures and through the
) automated daily, weekly, monthly and quarterly inspection status reports, he is aware of the L inspection program status and can assure coordination of the deviations fror.: the inspection j schedule and rescheduling of inissed inspedions in a timely manner.
1 j . Based on the follow-up review, the team considers this recommendation to be closed.
Recommendation 3 The revLv team recommends that the managers organize a "Get Well Plan" for i 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 j months of issuance of the license, beginning licensed activities, or within one year of license issuance, whichever comes first, in accordance with the Nebraska inspection l Mansal and NRC's IMC 2800.
i-i Current Status 4
i i The State's May 2,1997 corrective action status report stated that all new licenses issued are j 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 operaticns.
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- The team reviewed a sample computer report of New Licenses issued since the July 1996 l' review, and compared it to the information in the State's September 8,1997 status report. The
[ team found that initial Inspections of four of the five newly issued licenses are scheduled for the
! third and fourth quarters of 1997, which is within six months of the issue date of the license, i The team also found that the State had contracted out 29 inspections; the results of which had been completed and documented. The team found that en August 21,1997, the State issued RMP No. 7.04, ' Program Management - Upper Management Oversight," which addresses loss -
l of staff, staff qualifications and unplanned or increased workloads. The team evaluated the procedure and found it adequately 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 i- does have written procedures equivalent to IMC 2800 which address acheduling of initial
- inspections.
L Based on the follow-up review, the team considers this recommendation to be closed.
- 3.2 Status of Pandina lasues identified under " Technical Staffino and Trainina" d
j 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 i planning, management attention and review of program problems, and development of i
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Nebraska Draft Re,wt Page6 corrective action 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 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 4 The team recommends that the quaiifications of contractor personnel be tied to the contract as identified by the program manager or as accomplished by the LLRW l program in NDEQ.
Currgnt Status in the State's May 2,1997 corrective action status repod, the State informed NRC that the inspection contract included a requirement for qualificetions 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 mode.1 contract (which implements the recommendvJon) for guidance in negotiating futuro contracts.- The model contract comprises Attachment 7.04-1, entitled " Draft inspection Con'.ract," to RMP No. 7.04, entitled " Program Management - Upper Management Oversight." The subject procedure was approved by James t-A. Wiley, Interim Director, Department of Regu'.ation and Licensure, effective August 4.1997.
The team finds the contrad clause of inspector qualifications to be an acceptable implementation of the recommendation.
Based on the follow-up review, the team considers this recommendation to be closed.
E!LXintndation 5 The team recommends that a written program for staff qualification, including retaining training records, be developed.
Current Status The State's "Get Well" correc'Jve action plan stated that the recommendation had been adopted and that a qualification manual 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, 1997 status report, the State indicated that the manual had been completed and implemented .
effective September 3,1997.
The team confirmed that the qualifications manual, RMP Ho. 6.01 was approved by James I.
Wiley, interim Director, Department of Regulation and Licensure, effective September 3,1997.
The Nebraska mar.ual addresses basic training, advanced and specialized training, and continuing educahon, all by license category _ A policy statement on training expresses the
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a Nebraska Draft Report Page 7 management position and commitment to technical staff training and qualification, and provides the general qualification procedure. Staff experience is addressed through a statement detailing the expected progress of technical staff in completing the training and qualification -
requirements.
- RMP No. 6.02, also approved effective September 3,1997, addresses training resources that may be used to complete the qualification requirements. An attachment to the RMP No. 6.02 incorporated the draft recommendations of the NRC/OAS Training Working Group. The team found that an adequate procedure for staff qualification and training has been adopted. The team recommends that the NRC review the results of the use of the new procedures at the next IMPEP review. ,
Based on the follow-up review, '.;ie team considers this recommendation to be closed.
Recommendation 6 The team recommends that the State develop comprehensive administrative l procedures, sufficient to guide the day-to-day operation of the program in the event of l another loss of senior staff. The procedures should include a formal process for l bririging to the attention of upper management the increase of significant backlogs of l
licensing, inspection, or enforcement actions, or any cther situation which increases the risk to public health and safety. Licensing procedures should include prioritization of licensing actions based upon identified factors, including health and safety significance, for new and prsviously received applications.
Current Status i
The team noted that in the cover letter transmitting the final report of the 1996 lMPEP review, Nebraska was asked to report its progress in completing the corrective actions at bimonthly intervals. The first report 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 procedures by July 1,1997, as presented in the 'Get-Well, Stay-Well* corrective action plan at the January 22,1997 MRB 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 reference 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 distabase).*
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 .'ts expectation to complete the "Get-Well Plan
- as scheduled. During discussion of the scheduling for the follow-up review, the team leamed that several changes in management had occurred within the Department above the first line supervisor, and that procedures had not been completed. As
Nebraska Draft Report Pagef.
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 i were continuing, and (3) a completely new milesione schedule Gantt Chart. The new chart information did not correlate to the information that was included in the previous May 2,1997
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chart, which made it very difficult to compare the previous status of specific issues to the
. current status of issues. The new chart indicated a current backlog of only one inspection and l t
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 l
! of the third quarter 1997, with all procedures to be completed by the end of the fourth quarter l 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 completed by the end of i the year (1997).' Additionally, the State reported in the cover letter with the chart that j ' 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 rev'mw, the i State had not developed a revised, realistic schedule as to when the rerr,aining procedures j .would likely be completed.
i Due to the team's concems regarding the discrepancies between the team's findings and the i 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 i separately with the program manager, team coordinator, and acting division administrator. As a I,
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 i . 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 lilmly require l public comment.-
I Based on the following observation, that nine' of the 27 procedures were related to fees, billing L 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 l 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 of the remaining procedures (involving the review of applications for specific licenses, the
- conduct of materials inspections, and response to events) were identified.
i The team also observed that effective procedures for the management of the licensing and i 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,
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Nebraska Draft Report Page 9 oven 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 Agreerr'ent 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 demor strated by the fact that the program received authorization for a new position and hired a new FTE staff assistant, and is in the process of refilling a position opened by a personnel transfer on September 1,1997, both despite the Department being over its authorized FTE limit and under a hiring freeze.
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.
NOTE: The State responded to Recommendation 6 above on October 1,1997 (Appendix C),
- l. within the requested two-week time frame. The revised schedule indicaMd that a!! pending i actions and procedures will be completed by December 31,1998. The State and NRC also conducted a monthly telephone conference call on October 8,1997.
The team suggested that the State place a higher priority on procedures related to those items identified as most critical, followed by those procedures identified as supporting the technical eiernents of the program.
The team recommended that the State provide copies of the procedures to NRC as they are completed for review.
The team recommended thu 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. '
Based on these findings, the team considers this recommendation to remain open, with the' above new suggestion and recommendations added.
3.3 ' Staine of Pendino lean == identified under " Technical Onnrity of limasinc Ar*ians" The State was found to be satisfactory for this indicator and the review team did not identify any specific issues.
3.4 Statue of Pendino laana* Identified under " Technical Quality of trianactions During the September 1997 follow-up review, the review team focused on three of six factors in this indicator: supervisory accompaniment of inspectors, quality of insperction field notes and promptness of supervisory review, and timeliness and appropriate closure of inspections
-_ Nebraska Draft Report Page 10 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 Status '
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 stat 3d that he had accompanied two of the staffinspectors since July 1996, but had not made 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 RMo No. 6.01, entitisd
" Qualifications 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.
Based 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.
Current Status in the State's May 2,1997 corrective action status report, the Stue indicated that the new datcase system allows tracking of each aspect of the inspection from due date to
- acknowledgment of licensee's response to a notice of violation. A database report is available at any time to program management showing the time line of each open inspection. The
Nebraska Draft Report Page 11 inspection 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 lnspection cases. The team found documentation of a supervisory review in the fleid 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 awsiting 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 review 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 July 1996 review and confirmed that these inspections had been reviewed by the Program Manager and completed. The team also reviewed a sample 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 considers this recommendation to be closed.
3.5 - Status of Pendino i==n== identified under "Reananse to Ir.N;ats and Allegstions' During the September 1997 follor-up review, the review team focused on six of the seven factors in this indicator: responsiveness, investigative procedures, corrective actions, follow up, compliance and notifications, as necessary, To evaluate this indicator, the team interviewed program management and staff, evaluated sample case work and reviewed the States 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;
Nebraska Draft Report Page '12 Recommendation 10 The review team recommends revising the allegations procedures to incc:porate 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?,
Management cf Allegations.
Current Status The State's May 2, igg 7 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.
l The Program Manager indicated that they plan to incorporate key ideas from Management -
l 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 silegations. 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 tralning so that all inspectors are knowledgeable in those procedures.
Based on these finding, the team considers this recommendation to remain open, with the above new recommendation added.
Recommandation 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 moorporated into the avent reporting procedures."
The follow-up review team found that the Program Manager for Radioactive Materials is using the event reporting guidance contained in the NRC " Handbook," and was in the process of incorporating the " Handbook
- and instructions for using the Nt. clear Materials Events Database (NMED)into their own proceoures. 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 u- 1ergoing intemal review.-
m
Nebraska Draft Report Page 13 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 comprehenske procedures for tracking, follow-up and close out of events involving the use of radioactive material 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 event follow up and close out procedures."
l The follow-up review team found that the State has created a satisfactory database to track l
receipt, fonow 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 immediately begin repor*Jng current material events to NRC and send in information on the three events identifed during the review 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 reportig 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 beer: 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.'
Based on the follow-up review, the team considers this recommendation to be closed 4.0 NON-COMMON PERFORMANCE INDICATORS The team revowed two non cammon performance indicators that applied to the Nebraska program, Legislation and Regulations and Low-Level Radioactive Waste Disposal Program.
Nebraska Draft Report Page 14 4.1 Status of Pandino lasus.s Ids itined Unde- Laoislation and Raoulationg During the September 1997 follow-up review, the team focused on a regulaticn issue related to compatibility. The final report had one recommendation.
Recommendation 14 In accordrence with the State's commitment, the team recommends that Nebraska amend 180 NAC 1-012.22 to remove its applicability to waste treatment end storage y
facilities.
Current Status in response to the team's request for c!srification regarding application of the ;"Jblic dose limits in the State's equivalent regulations to 10 CFR Part 61, the State ssponded in a letter dated December 13,1996, that they did not currently have any brokers, treatment fccilities, or storage facilities to which this regulation applied. In accordance with the Division 1 compatibility requiremer t 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 MRB 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 c!.. ae 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 o'the rule, resut.ing in heightened concem by the Govemor as the promulgating official.
Based on the follow-up review, the team considers this recommendation to be closed.
4.2 Statue of Pandino leses identified Under Low-L=v=! Ra%ctive Waste Disms=!
Prooram 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 c,w suggestion.
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.
4
x; r
Nebraska Draft Report Page 15 Current Status The State's May 2,10g7 corrective action status report stated that "the LLRW program had compiled all the training it provioed to the consultant review team members. The LLRW program staff will be gathering training data for Agency personnel to be included and maintained in one train'ag documentation spreadsheet.'
The team found that the State had corapiled a training history for State staff members. A computer database had Men established and the training records for the staff had been entered. There was, howoc , no information in the database related to contractor personnel.
During discusrion with the LLRW F.rogram 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 database showing contractor personnel attendance at trahW sessions sponsored by the State. The team notes that the complete training records for individual contractor personnel remain available in the contractor personnel files.
L Based on the follow-up review, the team considers this suggestion to be closed.
5.0
SUMMARY
[ The follow-up review team found the State'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 administrative 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, The team found that the inspection backlog had been eliminated, the licensing backlog had beers reduced but not eliminated (78 actions pending),
and the State had implemented a computerized tracking system that provides much needed support to the overall materials program, and had received one additional FTE during a hiring t
freeze. HMtver, the team also four.d that a significant number of procedures (23 out of 27) identified by tha 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 overif optimistic issumptions and Agreement State program inexperience by program management and staff 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 seer during the 1996 review. The team found the currant staff is qualified, but the team observed that the program has a relatively inexperienced staff, a heavy reliance on the first-level supervisor, lack of written procedures for guidance, and totally new management above the first-level supervisor. Based on the findings, the follow-up review team is recommending to the MRB no change in the finding under the 1996 IMPEP review *that the Nebraska program is adequate to protect public health and safety but needs improvement, and compatible with NRC's program."
Nebraska Draft Report Page 16 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 is recommending that an IMPEP review be scheduled within cce year of the date of this follow-up review.
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 providod within two weeks after the completion date of the onsite follow-up review. (Section 3.2)
- 2. The team recommends that the State provide copies of the procedures to NRC as they are comp leted for review. (Section 3.2)
- 3. The team recommends that ragular 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) t
- 4. The team recommends that ir, following RMP No. 6.01 "Quali'ications 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 proceduies to manage allegations and provide staff training so that all inspectors are knowledgeable in those procedures. (Section 3.5)
Suggestion: '
- 1. The team suggested that the State place a higher prionty 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)
NRC:
The team recommends that the NRC review the results of the use of the new procedures at the next IMPEP review.
APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Patricia M. Larkins, OSP Team Leador Technical Quality of Licensing Actions Response to incidents and Allegations Jenney Johansen, Rl Status of Materials Inspection Program Technical Quality of Inspections Richard Blanton, OSP Technical Staffing and Training Legislation and Regulations Low Level Radioactive Waste W _ "
+ .
LIST Or APPENDICES Appendix A - IMPEP Review Team Members Appendix B NHHS Organizational Chart l
~ Appendix C Nebraska Status Reports, May 1997, September 1997 and October 1997 l
l
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4 f
4 L APPENDIX B l l
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, NEBRASKA HEALTH AND HUMAN SERVICES SYSTEM i i i
DEPARTMENT OF REGULATION AND LICdNSURE ,
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Acting DMsion Administrator' .
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- APPENDIX C l
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NEBRASKA STATUS REPORTS i
- MAY 2,1997, SEPTEMBER 8,1997, AND OCTOBER 1,1997 i
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DatAttutut or FINANCE AND SUffont May 2,1997 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 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 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 completed. The .
l progress of each task is represented by a solid bar corresponding to the percent of the task l completed. For example, the progress bars for Task ids 78 and 79 represent the 70% of the 108 i
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 each of the review team recommendations is as follows:
- 1. The program has updated its new database system v.ith the appropriate inspection frequencies equal to IMC 2800. Each inspector can generate a report on his computer showing which materials inspections are coming due. Reciprocity requests are logged into the database and inspectors can generate a report showing which licensees will be available for 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 management 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 months from the license issuance. Each new license also incl As a condition requiring the licensee to notify our Agency prior to the commencement oflicensed operations.
4 Eau ononnurWAnammAcnmEmoru FRfNTED MTN SOY DE ON R2CVQID PAMR
___J
,i .
N .-
~ Hugh L. Thompson,' Jr.
~ May 2,1997:
- Page 21
- 4. The current inspection contract includes a qualifications review requirement and the
- contractor has submitted training documentation for Agency Approval prior to allowing
' additional staff to perform inspections. Contract inspectors are also required to complete an inspection plan for Agency approval prior to each inspection.
5.'
' A staff qualification manual was drafted by a contractor. The draft ma..ual is being updated to include the NRC/OAS Training Working Group information and the NRC's 1
- policy on successful completion of training outlined in SP.96-118.
j_ 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 tracking database.
7.- - Annual supenisory accompaniments ofinspection team members will be required in the -
qualifications manual that is being drafted.
- 8. The new database system allows tracking of each aspect of the inspection, from due date
- to our acknowledgment of the licensee's response to a notice of violation. A database report is available 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 progrrm alleg < ion procedures.
- 11. The " Handbook on Event Reporting in the Agreement States"is currently being used by program staff and will be incorporated into the event procedures.
- 12. - The program created an event database to track all possible materials events. The event procedures will establish event follow up and close out procedures.
-13. - The program began routine monthly repc,rting on January 31,1997 and reparted all previous reportable events on February 28,1997.
G.
7, .
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l'
. Hugh L. Thompson, Jr.
May 2,1997
- Page 3 -
d
- 14. The proposed revision of 180 NAC 1 012.22 has been to public hearing without negative
, comment and should be adopted in June 1997, i
i 15. The LLRW program has compiled all the training it has provided to the consultant review l team members. LLRW program staff will be gathering training data for Agency
] personnel to be incinded and maintained in one training documentation spreadsheet, r
[ You will eceive further reports of our continued progress on the corrective action plan, especially our completion and implemer4tation ofcomprehensive program procedures over the s
next two months.
l : Ifyou have any other questions, please feel free to contact Brian Hearty or Cheryl Rogers at
, (402)471 2168.
i Sincerely,
- hk Deb Thomas, Director
!. HHS Regulation and Licensure 1
- DT/BPH '
4 Enclosure
-xc: Patricia M. Larkins, Health Physicist '
- 1MPEP Team Leader
} -
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Nebraska Health and Human Services System Department of Regulation and Licensure .
IMPEP ComM:tive Action Plan 1996 1997 1998 1
- D Task name- or I as 1 04 os I c2 I c3 l o4 ci l c2 l c3 l o4 at l c2 1 Materials Program Oversite I
2 % rani Management Mng ((((((((((((jjjj{jjj(([jjllll lll(({[j 42 Upper Management Briefing ll l l j.l Upper M. ,.e : Bq t l 43 W3 l Deb h& Wack Daniet.B fan Hearty 44 upper usc+aa Bnemig 2 v22 l Deb Themas.Betwi Norty 45 Uppet ManyW Bnekig 3 3t3 l DebThoreas, Burke Casert Jack Darkt.Brien Hearty
. 4s Upper Management Briereg 4 1 4/24 l Deb Thomas Burke CasarfJack Danlet. Sue Someteria.Brien Hearty 47 Upcer Mariagement Bnefing 5 i I l 0,b Thomas. Burke Casart, Jack Daniet Sue Somerona.Brien Hoerty I i 48 Upper M..,,,,e Bnefing 6 l Deb Thomes,Burte Cass 1 Jack Daniet.Sao Somerone. Brian Heerty 49 Radiation Advislovy Council y so Ramaton uvtsery counca ,, l ,,,,, g,,,Ij 51 R***ca ^*a='y canc' i 12m l Bri.n H tr .
52 Rasaten Mwesay Canc5
- 3rr l Briai Hearty ,
53 Ra& eon Aenwry Canct h l Brian Hoerty
- 54 Materials inspection y y 9M ss inspection Backlog ,
1 56 h4 W 7115 l Jim DeFrain 57 "-= c-a an9 l B,ian Hear,y
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imma=ei mi ce,iw I sa ,,73lc w no,,,,;,nn y,,,,,
~59 Netnda McDc6st Hosotal ShumaNohn Fasse5 10/23 l 4 Ta* m s- m a*e Up ereress -
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Nebraska Health and Human Services System Department of Regulation and I.icensure IMPEP Corrective Action Plan .
1996 1997 1988 1
,o yg ,,,,,, o2 l os l o4 o' l 02 1 03 I od 01 i c2 l c3 I c4 at I c2 60 Star ley Jaeger 11/7 l Brysn Eiser l
61 Lecoln Genera! HospRai 11113 l Howard Shumasi. John Fasselt l l
62 Bergan Mercy Medcal Cen'er 11/14 l .?m,DeFrain.Bry an Miner i
63 UNMC 12/6 l Bryan Miller,Jm DeFrain 64 onwes ce +I 12r6 65 Routine inspections 7
'66 Lecoin General TeletnerapY y -l ,
11/13 l Howard ShumasJohn FasseII 67 Wayne State 111 l Howard Shuman
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68 UNL XT l Jim Mrs.Brym MNordoyce Demon 69 29 Routine I.We e Stan Huber "s t
To Reciprocity Inspections 71 Edwards PoeW
! l 12/10 l Jim DeFrain.Styen Miller i
72 Maren 1116 l Bryan milW, Jim DeFrain l
73 Mewest Industnal:'M 1f16 l Bryan m1erJim DeFrain
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74 EA E v ~ = v , l Bryan MIIIer !
75 MOS InspeCICO l Jim DeFrain 76 Materials Licensing y - -
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77 Licensing Backlog g-- -
3 l
g7 , l 78 theg Actens N 711W Program M I i
79 Licenseg Actons After7/1995 Program Staff '
Task s _- _ . . . Summary Rosed Up Progress -
Project: Prorect Management Plan s R Up TM Date. 5/2/97 ;
Mdestone $ ReaedUpM4estone Q Page 2
.- ./
Nebraska Health and Human Services Cystem ~
Department of Regulation and Licensure IMPEP Corrective Action Plan 1997 1998 1 1196 ro Task Na,,,e c2 l os I o4 os l a2 I as I o4 os I c2 1 as I o4 os I or p:34sx 8o Materials Events W 8 Pgam Event Tradung Leg 1!B Brian Heary 82 Event Report Backlog 7g g 83 Event Backlog Reported to NRC gg 84 MonthrFNMED Report llll ll 85 MontNy NMED Report 1 1!31 l Brien Marty 86 MontNy NMED Report 2 2/28 l Briar Hearty 87 MontNy WED Report 3 3f28lBrlan Heesty 88 Montity WED Reput 4 4/30 l Bryan Miller 89 MontNy NMED Report 5 l Jim DeFrein 90 MontNy NMED Report 6 l Bryan Miller
~
91 Procedure Manuals FM '
92 Inspection Procedures Manual i
93 Update Field Notes E Prograrn Staff 94 ;.w W.; IMC 1220 Fremsencies Richard Barrow,Beton Hearty, Jay Noble i
95 Lww.;, IMC 2000 Frequences -Rkherd Barrow, Brian Hearty, Jay Noble 96 Inspedson Scheduing N EBrien Hearty GL Telephone Contad Procedure 97 5 Jay Noble. Brian Hearty -
1 98 2YGL FieM Notes EJay Noble,Briert Hearty 99 Staff Tramed on Lw. Procedures [
Task _. ..
Sununary Rosed W W N Project: Prc,ed Management Plan Rosed Up Task Date: 5/2/97 Milestone $ RolledUpnHestone h Page 3
- ~ ' - ' - ~
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.- .2 Nebraska Health and Human Services System Department of Regulation and Licensure
~
IMPEP Corrective Action Plan 1996 1997 1998 1 ID Task Name C2 l 03 l 04 01 l 02 l 03 l 04 01 l 02 l 03 l 04 01 l 02
~ 100 A!!egation and Event Procedures @ !
i 101 Revew and incorporate MD 8.8 EEBrien Heerty [
102 3.-gw e;e Reporting Handbook 103 Wnte Asegaten and Event Procedures Hearty, Support Staff .
l 104 Staff Traced on A & E Procedures g 105 Licensing Procedures Manual p9 1
106 General Licensing g 107 Drstreutor Not6 cation N h Joy Notde,Br!sn Heerty i
108 Generalvs Specfic Procedum (Jay Notde, Baton Hearty
- I t GL Baing Procedum 109
$ Jay Notde, Brian HeartY I i
110 GL Termnsten Procedum (Jay Mobee. Brian Hearty 111 Assemtde GL Procedures Jay Notd3 Specific Ucensing 112 113 Action Priorituation Procedu" 1rtr I art a a <rev .
114 Assemble Ucensing Guidance
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1on Hearty, Program Staff 115 WreeUcensegFie iea IPlan Hearty,Suos, ort Staff 11s Staff Trcined on Ucensing F.M ea p
117 Stay-Well Plan W ,
118 Upper Management Procedure , EBrian Hearty j 119 Program Management Procedum , EBrian Hearty Tssk _ . - . Summary Rosed Up Progmss N ,
MP'd #8"W - Roned Up Task Date: 5/2/97 % - ._
Mkstone $ RosedUpMaestone O Page 4
Nebraska Health and Human Services System s Department of Regulation and Licensure i IMPEP Corrective Action Plan ,
1996 1997 9998 '$ ~
ID Task Name 02 l 03 l 04 Of l 02 l 03 l 04 Q1 l 02 l Q3 l W Of l C2 aus 4'
^
120 Ma wgement Tramed on F. 1 l
121 QualiGcations Manual 122 Dran Marmal 12/18 R l l ichard ow Bari 123 Lwg ie NRC/OAS Worting Group l rien Hearty 124 Renew and Fealize Manual rian Hearty 125 Manual L% .+ Jed 12s LLRW Training Records PM 127 Assemble Consutant LLRWTreW 4115 l Program Staff 128 Assemble Staff LLRW Trammg Records Program Staff 129 Create Cuc ,e-4. en Speadsheet LLRW Program StaM 130 131 Regulations and Guidance Regulations y ^
132 019 Adopted I
$ 10f30 133 W1,003.012. 015 Approved by RAC 1 12/6lL,J..m7., Jay Noth 1
134 007 Reviewed by RAC itt5 Eg
- Dar4dson, Jay Nobie 135 136 007 Revised Proposed Changes Approved by RAC 1 h ,
'ce DPvidson, Jay Noble
. r 3t7 I
~137 Proposed Changes to PRO 3,,30 l 138 Putk Hearmg Sff Hearty e
139 Put$c Hearing Comments Lwy.a l Noble Task .
..w; Summary Romed up Progress -
M..wg.ma Plan '
Td ,
M_ + Ro.ed u.M- o Page 5
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Nebraska Health and Human Semces System Department of Regulation and Licensure IMPEP Corrective Action Plan 1996 1997 1998 1 ID 7ask Name 02 l Q3 l 04 Q1 l Q2 l Q3 l 04 Q1 l Q2 l Q3 l
.J4 Q1 l Q2 140 Fatal Draft Approved by RAC :
141 Final Drat Approved by Board of Heath 142 FsnalDraft to Atty Generat ,
- 4 l j Fenal Draft Adopted I 143 g
144 Guidance q 145 Reg Guide 19 0 Drafted .
g,,
146 Reg Gisde 19.0 Revewed and Fr.akred ,
147 Reg Guide 19.01ssued g 145 Reg Guide 7.0 Dr. fted -
( h 149 Reg Guide 7.0 Revewed and Finalized j 150 Reg Guide 7.0 issued 151 Create and implement Reg / stern Change 1.og 9g g g .
152 -
l Task _.
Summary Rosed Up Progress -
gY ""# Prgess HIIMIElllEIMIWWIIIM Rosed Up Task 1 Milestone $ Rolled Up Milestorie O Page 6
Ntausu HIA1.TH MD UtMM Sr.WICf,$ SYSTD4 4 STATE OF NEBRASKA
-s==:. -. a . a -
s September 8,1997 U.S. Nuclear Regulatory Commission Office of State Programs Mail Stop 3D23 . .
Washington, DC 20555 Atm: Hugh L. Thompson, Jr.
Acting Executive Director for Operations
Dear Mr. Thompson:
This letter is to provide you a copy of our latest corrective action plan, and to update you with a current organizational chart for the Department. There have been three changes in the program upper management since the MRB meeting in January 1997. On July 1, the Radioactive Materials and LLRW Programs were moved under the supervision of the' Consumer Health servlees 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 knd Licensure Department following the resignation of Deb Thomas in July. Routine oversite meetings between the Radioactive Materials Program Manager and tl.e Team Coordinator and Division i Administrator have been held on a weekly basis since July 9. The Department Director was briefed on his oversite responsibilities and on the status of the corrective action plan on August 18.
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 completed.
The progress 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 Program License Reviewers.
The current corrective action plan was developed to ensure that program performance 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.
atm om.mnanwn,ucrx-tmoru
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!* Hugh L.nompson,Jr.
- September 8.1997 ,
Page 2 All radioactive materials inspections due in the next twelve months haVe been scheduled and inspectors assigned. The inspections are scheduled to minimize the number of past due l
- k:;d,ons, be in accordance with Inspector training, and ensure supervisory accompaniments. i De only currently overdue inspection is a radiography licenses that had not performed sealed l source radiography since 1994, and was subsequently authorised for storage only. De licensee l 1
l . had provided infonnation on the transfer of their sources, and requested termination of the '
- license only to abandon that request after the inspection overdue date. An inspection is
- scheduled prior to renewing the license for use. Because a majority of our inspections art '
conducted unannounced, we request that you do not provide the attached corrective action plan i .
as public informat lon. ,
! I De status of proposed rulemaking has been updated to include compatibility items that will be required to be adopted within the time frame of the plan.
Radioactive Materials Program pocedures are being drafted and implemented in accordance l' with the recommendations of the IMPEP Team. Comprehensive procedures should be available *
~
for use by January 1998.
We look forward to nkeeting with your review team during the week of September 15 19.
i If you have any other questions, please feel free to contact Brian Hearty or Cheryl Rogers at '
(402) 471-2168.
\,
Y
,. Robert 1. pol . Adnknistrator .
i Public He Assessment Division w
- RIJBPH Enclosure FAX Copy; Patricia M. Larkins, Health Physicist i IMPEP Team Leader 1
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- State of Nebraska !
. Health and Human Services Regulation and Licensure Department I l Public Health Assessment Dhision Radioactive Materials Program i 301 Centenniel Mkil South i
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- P.O. Box 95007 Lincoln.Nebrasi:a 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.: (301) 415-3502 1
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 l Comments: Original sent by mall to Hugh Thompson. l Call me if you have any other questions prior to your visit.
i Date: 09/08/97 Sent by: BPH <
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4
HHS REGULATION AND LtCENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DMSION RADIOACTIVE MATERIALS PROGRAM i im 19,s 1m g 3r1 loir 3 loir 4 otr1 lm2 lotr3 Task won,. car i loir 2 1or3 loer 4 lOtr 2 so 1 Status of Materials inspection Program
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM im 1*** m' -
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.- .- .d HHS REGULATION AND UCENSURE DEPARTMENT PUBUC HEALTH ASSESSMENT DMSION i
RADIOACTIVE MATERIALS PROGRAM -
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o HHS REGULATION AND LICENSURE DEPARTMENT PUBlic HEALTH ASSESSMENTDIVISION -
RADICACTWE MATERIALS PROGRAM m7 i ,se sus O Task Magee Otr 1 lOtt 2 lOtr 3 lOtr 4 Otr 1 lOtr 2 lCer3 lOtr4 Otr 1 lO1:2 lOrr 3 70 Diagnosse and Tb4.~ , Nucleer Medorie '
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Page 4 of 9
HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DMSION RADIOACTIVE MATERIALS PROGRAM i,,7 toes it,s Tm m otr 1 lotr 2 lotr 3 jotr4 ott1 jotr2 lOr3 l"Jer 4 or1 1 car 2 lorr 3 to *
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DMSION RADIOACTIVE MATERIALS PROGRAM i mr toss =
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM itse 1999 1wr Orr 1 lOr3 [Otr 4 , Car 1 Otr2 {Otr3 fD Task knie Or1 lOtr 2 ]Ott3 l Olr 4 { Ott 2
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLic HEALTH ASSESSMENT DMSION ' ~
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Public Health Assessment Division .
. i Acting Division Administrator Robert Leopold *
- N Admboetreeve Pa4Gc Huet!tTodukst -
AssistansTeam AssessmentTese i
CONSUMER SAFETYPftC7ECDORTEAM PUBLICHEALTH SURWEILLANCETFlet CONS 124ER HEAT.m E*FMONMENTAUGLE EratorurenhL Decem a I
. Dide Servime SERVICES SERVICES
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'NtausxA HEA!.m AND Huurn Stavicts SYSm{
STATE OF NEBRASVA Darantwint of sinvicts e Darantunut or Reeviation ako LKansvat E. Baulawin Netson, oovianon Derasturut or Fiwawc awo surroat October 1,1997 O
g U.S. Nuclear Regulatory Commission cb 00 ice of State Programs
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-o u Mall Stop 3D23 Washington, DC 20555
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.a Attn: Richard L Bangart, Director Office ofState 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 resource allocations for the tasks of the conective 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 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 to you. The one overdue inspection, Task ID 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.
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 Gantt chart, Task 1D 23, after a review of pending inspections. One reciprocity inspection was also scheduled, i
Materials lacensine Procram:
The materials licensing section of the Gantt Chart has been redesigned to provide a clearer picture of the program status. The total number of pending actions is provided in Task ID 86.
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 the percentage of the actions in that category that have received an initial review and had r.
deficiency letter sent, ste:a ommemumwmAcutmom rapitta mTru sovemow nsevnsorapta
3 Richard L. Bangart, Director October I,1997 -
Page 2 Reananne to incidents and Alleontinna:
Task ids 97 and 98 have been added. Brian Hearty has been working with Brian Smith of NRC l
' in regards to this event and Charles Hackney has requested that a follow-up report be provided to NRC.
l t#eialmelan and Resulmelona:
l De proposed regulations that were previously provided to your office were signed by the i
Governor and became effective September 17,1997. As indicated in your exit meeting, Nebraska is compatible with NRC regulations.
' Regulatory Guide 7.1, equivalent to NRC RG 8.39, has been approved and sent to medical use licensees. Regulatory Guide 19.0 for irradiator licensees has been drafted. Work on Regulatory Guide 7.0 for medical licensees is progressing and should be completed by a meeting with our largest medical licensing consultant on October 22. This meeting will facilitate future medical licensing and decrease the number of deficiency letters currently required.
Materlats Program Procedures:
Radioactive Materials 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.
De 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 stafThave 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.
O* YMrLR..O y , Robert Leopold, Administrator y, Public Health Assessment Division RllBPi 4
Enclosure FAX Copy: Patricia M. Larkins, Health Physicist IMPEP Team Leader
- a; HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION '
6 RADIOACTIVE MATERIALS PROGRAM N 1997 190s 1988 l
D Task 90eme Otr 3 lOtr 4 Otr 1 lOtr 2 lOtr 3 lOtr 4 Otr 1 lOtr2 lOtr 3 lOtr 4 Oy1 lQir2 lOtr 3 lOtr 4 4 1 2
Status of Maserilais Artspectiotr Prograrra Overttue inspections
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3 01-2241. Mexm Tecteologes. Inc-gr9 l hm DeFrein
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l Bryan IEEler. Jim DeFrain s 01-50-01. Urwverssty of Nebraska Metcal Cereer L --
i j l l Jhn DeFrain, Bryan Meer.Desar hjBrien Hoorty 9 09-0441. Uruversity of Nebraska at Keemey hDeF 10 99-37-01. Norton intemshonal. Inc. l h Jim DeFrein 1
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HMS REGULATION AND UCENSURE DEPARTMENT PUBUC HEALTH ASSESSMENT DMSION .
RADIOACTNE MATERIALS PROGRAM DE 1997 1998 1998 m TaskMemo Otr3 lOtr4 Otr 1 lOtr 2 lOtr 3 l Otr 4 Otr 1 lOtr 2 lOtr3 lOtr4 Otr 1 lOtr2 lOtr 3 lOtr 4 l l Jim DeFrair.Iryan W5or f 4 >
l 25 07 05-01. Fath ReW Hooth Sennees - Lutheren (: ,,
26 0741-01.Ourlady of Lourdes Hosptal l l l g,,
27 14eci.nory tan -s Memann Hesoad i ,,,,
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l 28 1443-02. Mary Lanrung Mem3 riel Hoepital DeF 29 OS 09-01. St. Francis Memonal Health Center ,,,,
30 0843-01. Grand Island Radiology Assoostes g ,,,,
31 01-0642. Profeseenet Sennee Induetnes. Inc. g 32 01-0643. Profeseenal Serwoe Industnes. Inc.
l 33 02-01-08. Urwwersity of Nebraska l l gry y MIIIer 34 02-37-01 Syncor Intemabonal Corporation I e i l Cru r14K geroJMonHoerty 35 01-76 01. EndoTects. let l l 3ry RIlmerb 36 16-01-01. 'm'Cor,munity College - Mapord !
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37 01-77-01. Anderson Emeswahng and Wred*ig Co. j l8ym MIIer 3e 01-4501. Douglas County Heath Deportrrient
} i i lgy m asiler 39 01-75-01. Omaha Housing Authorty l lgry an ROIN 4
40 01-8601. Great Plains Teseng Laboratones.1*x:. T--- I i
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41 02-1841. HWS Consulhng Group. Inc. ] i i
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HHS REGULATION AND UCENSURE DEPARTMENT PUBUC HEALTH ASSESSMENT DMSION RADIOACTWE MATERIALS PROGRAM es iser sees ****
so Task eserves air 3 joer4 ,
otr i loer2 loers loire mi loer2 lotr3 loir 4 mi lm2 loirs im4 47 37-03-01. Bedan Dddnoon l M as 044141. secnon ockinson vacutemer Systems j'an.
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- l ,a - n l HHS REGULATION AND LICENSURE DEPARTMENT l
PUBLIC HEALTH ASSESSMENT DIVISION .
RADIOACTIVE MATERIALS PROGRAM B6 1997 1998 1999 ID Task Name Otr 3 lOtr 4 Otr 1 lOtr 2 lOtr 3 l Otr 4 Otr1 l Otr 2 lOtr 3 lQtr 4 Otr 1 lQtr 2 lOtr 3 lOtr 4 70 W h aM h l
4 l l l p ,,,,,y Q 1
T-w1.'u.of Ra$oachve Matenal 224R1r, l NM l j 72 Specialized Training 73 Diagnostic and Therapeubc Nuclear Mediane f
p_._ _4 l l Bryan IAMier n
74 Carpestc and Therapeube Nuclear Me@ane l-New FEre 75 Teletherapy and GM 1 bwy I
[ Bryan DuBorJ leerty I 76 Teletherapy and &.eyJewy ; V 1 l NewHire 77 Safety Aspeds ofIndustrW RWM y l Bryan John Fasee8 7s Safety Aspects of Industnal Radography lBrbHok 79 safety Aspects of weit togging l Jim DeFrain, Bryan asser l
30 trradiatorTechnology i ! t i i
l Brien HoertyJisn DeFreiri,(Dete to tse C ^ ... Ms, 81 Advanced Train.ng ;
l f
.2 Hea i w Tw+, i L- w -
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83 EnWonmental Mondonng for Rat-cocbdy #
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34 ;..M,v for Performarw. alaterials Cheryl Re,Houverd tolm 1
85 Maferisks llCer3SirNJ Prograrrr , ,
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86 Total Number of Pending Uconsing Actions (74)
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37 Acteor's Recewed Pnor to 7/96 (29) 27 8 Ucense Reviousers l 33 Acbons Recewed After 7/96 that are Overdue (40)
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HHS REGULATION AND LICENSURE DEPARTMENT PUBijC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM
[s 19er 19es im ID Task Name Otr 3 lOtr 4 Otr 1 lOtr 2 lOtr 3 lOtr 4 Otr 1 lOtr 2 lOtr 3 l Otr 4 Otr 1 lOtr 2 lOtr 3 lOtr 4 93 Radioective Metertmis Events 94 NE970001006 24 hr Report Received 1 ! I i l 4 ,4 l
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95 NE970001008 24 hr Report Evaluated W DeF 6 % *
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122 LegisteNon arniRegada60rts l 123 Reguistion Changes to 001,003,004,007,009,012, art ]
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125 Proposed Changes Draned g .
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. m Approved by RAc ~ -- ~i 3,7 ; r 127
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Proposed Changes Revewed by PRO g, 29 Notice of R*rn&ng Heeg I
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131 PostW Aretyses and Revissons y 132 Final Rule 133 Agency Revew and Approval j ;
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_- -. . .. . .. _ . . ..-c HHS REGULATIGN AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION ,
RADIOACTIVE MATERIALS PROGRAM B6 1997 1998 1999 i 10 Task Name Otr3 lOtr 4 Otr 1 l Otr 2 lOtr3 lOtr 4 Otr 1 lOtr2 lOtr 3 lOtr 4 l Otr 1 lOtr 2 lOtr3 lOtr 4 137 Reguletkm Changes to 004,005,010, and 012 l
138 Pre 4tulo 139 Proposed Changes Drafted E Staff 140 Approved by RAC L l g
141 Proposed Changes Reviewed by PRO 143 Nctice of Rulemalung Hearing
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145 Post-hearing Analysis and Revessons
{ 3,,,g 146 Final Rule 147 Agency Review and Approval 148 Attomey General Review and Approval !
149 "Ms Revew and Approval 150 Proposed Changes Adopted h
151 Regulatory Guidance i 152 Regulatory Guide 19.0
_ - L g 153 Proposed Guidance Drafted W22 %h N W f
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154 Approved by Program Manager l l
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158 Regulatory Guide 7.1 i l
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Page 6 of 9
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i HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSE LSMENT DIVISION .
RADIOACTIVE MATERIALS PROGRAM 36 1997 1998 1999 ID Task Name Otr 3 lOtr 4 Otr 1 lOtr 2 lOtr 3 lOtr 4 Otr 1 [Qtr 2 lOtr 3 lOtr 4 Otr 1 l Otr 2 { Qtr 3 [Otr 4 160 Approved ty Program Manager i j 9/29 (Brier Hearty~
161 Materials Program Procedures 162 General Ucensing l
163 RMP No.1.01, Certain Measuring, Gauging, and Con l Joy . Brian Hearty 164 RMP No.1.02, Depleted Uranium
_ , _ . _ _ __ _ _ _ _ 4 l Jay b 165 j RMP No.1.03, in Vitro Testing l Joy $,6oble 166 RMP No.1.04, Redprocal Recognibon of an Out4-S l Joy Moble 167 RMP No.1.05, BMng l Noble 168 RMP No.1.06, Ucense File inadwation lJoyNob'e 169 Specific Ucensing 170 RMP No. 2.01. Request for Applicaten l Joy Noble 171 RMP No. 2.02, Review of an Apphcation or Amendme Brian F,eerty, Program Staff 172 RMP No. 2.03, Renewal of Ucenses
___[_ . . - ._
l Brian > oerty j 173 RMP No. 2.04, Billing j l Joy Noble 174 RMP No. 2.05, Ucense Termmaton l l Brien y-175 RMP No. 2.06, Priortizaten of Ucensmg Adens ;
l'Brien Hearty 178 Inspections 1
177 RMP No. 3.01. Scfieduling ofInspectons ' . _ _ _ ..
___ .! j __L t l Brien Hearty l
( 178 RMP No. 3.02. Inspecten n w .'uvii l' Brian Hoerty l
i 179 RMP No. 3 03. Pe b.w Based Inspedion 6 i 1
l Eirten Hoerty l
____L.__
180 RMP No. 3 04, Documenta* ion of Inspecton Results Brien t Staff 181 RMP No. 3.05, Enforcement
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_._ _ v a f 182 Allegations and tncidents
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HHS REGULATION AND LICENSURE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM B6 1997 itse 1999 10 Task Name Otr 3 lOtr 4 Q!r 1 lOtr 2 lOtr 3 lOtr 4 Otr 1 lOtr 2 lQtr 3 lOtr 4 Otr 1 1Otr2 IQtr 3 u Otr4 183 RMP No. 4.01, Management of Allegations I m'%
184 RMP No. 4.02, Radeactive Metertal Events W26 . Brian Hearty 185 Legislation, Regulation and Guidance Development 186 RMP No. 5.01, Traciong a,d Scheduhng E Br.n ae <v.s e s - r.a=
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187 RMP No. 5.02, Revision and implementaten ;
E Brien ,R.A.LD.
188 Qualifications and Training
,189 RMP No. 6.01, Quahfiestkms Manual 9t3 l Brian Hearty. Sue !WBob LeopokLJim W 190 RMP No. 6.02. Training Resources Avaastulity trd Ec y3 g h 191 Program L :,-_.-..;
192 RMP No. 7.01, Budgeting l Brien Hearty 193 RMP No. 7.02, Fee Cakartaten l Heer1y 194 RMP No. 7.03, Routine Program Oversight i 7/31 Brian Hearty 195 RMP No. 7.04 Upper Management Oversaght l Brian Heery, Sue Senwmne, Bob LeopokLJirn Mey Page 8 of 9
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HHS REGULATION AND LICEN URE DEPARTMENT PUBLIC HEALTH ASSESSMENT DIVISION RADIOACTIVE MATERIALS PROGRAM h
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Task Progress muuuuuuuuuuuuus RADIOACTNE MATERIALS PROGRAM CORRECTNE ACTION PLAN Milestone $ .
Approved by Division Administrator: Summary Revised: Wed 10/1/97 Rolled Up Task Rolled Up Milestone Q O Rolled Up Progress -
't Page 9 of 9 I
~ . . - _ . . _ _ _ _ .
__ _ . _ _ _ ..._ _. _...____..-._..__...___-...-_.__-.-__..m..__. _ _ _ ___..___
e Radioactiv3 Meterleto Program Procedur:s Nebr*ske Health and Human Services Regutetton and Uconsurs Department
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j l STATE OF NEBRASKA !
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i 9
Radioactive Materials Procedure No. 4.02 Allegations and incidents - Radioactive Material Events i
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RMP No. 4.02 issued: September 26,1997 Revision No. 0 4
Page 1 of 6
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.R.dio.cQv. M.t.ri.6s Progr m Proc.dur.s N.bre.k. H ish .ad Hum.n s.rvic R ui. tion .nd uc.a.u,. o rim.nt 1.0 PURPOSE 1.1 Applicability 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 1.2.1 NRC, Office of State Programs, " Handbook on Nuclear Material Event Reporting in the Agreement States", Published as Draft for Comment March 1995 1.2.2 NRC, Idaho National Er.gineering 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 j
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
\
RMP No. 4.02 lesu.d: S.pt.mber 26,1997 R. vision No, O P.g. 2 of 6 -
. _ . . ~
Nobreake Howe and Hwnen servloes and C 1.4.2 Radioactive Materials License Files 1.5 Definitions Abnormal Occurrence An ut scheduled 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 of 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.
Routine Event An event involving radioactive 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 includes events that are required to bc reported within 30 days such as 180 NAC 1-005.13A.
NMED The Nuclear Materials Events Database that was
, developed and is maintained by INEL for the NRC, and is used to provide information on reportable radioactive materials events for both NRC and Agreement State -
licensees.
Significant Event An event involving radioactive material that does, will, or may impact public health and safety risk. Events in this category should be reported to the Agency within 24 ;
hours such as 180 NAC 1-004.52A and B,003.25A and B, and 007.13A1.
Special Inspection An inspection that is in response to an incident or allegation that is performed outside of the normal inspection frequency.
2.0 RESPONSIBILITIES
-2.1- Technical Staff Member Technical Staff shall use this procedure when receiving a report of, logging, RMP No. 4,02 lesued: September 28,1997
' Revision No. 0 Page 3 of 6
3
. R.do.ctjv. M.t.rl.ls Progenm Proc.dur.a
- w.br..k. w ith .no Hum.n s.rvie R. oui. tion .nd uc.n.ur. o .,tm.nt e
investigating, 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 special inspection, the Agency and i4RC reporting requirements, and the event close-out requirements.
3.0 PROCEDURES 3.1 Event Logging 3.1.1 Radioactive Materials Program Event Log 1
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 shall also be tracked and documentec' in accordance with RMP No. 4.01. Immediatelv after the initial information has been logged, the Technical Staff member shall inform the Radioactive Materials Program Manager of the event and -
begin assessing the risk to public health and safety. Nu) y b d'~"
3.2 Event investigation p dqu=M y* n*& ~ C .u, ,r4 3.2.1 Emergency Response W, 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 terminated a specialinspection shall be performed.
3.2.2 Special Inspection A special inspection shall be performed as soon as nossible within 30 day.s if the event may have resulted a significant exposure to an individual or the public, be a generic device defect, or have been RMP No. 4.02 is.u.d: Sept.mb.e 26,1997 R. vision No. O Page 4 of 6
i R.dno.ctive M.t.rt.ls Progr.rn Proc.dur:s
, u.br..k. w wh .no Hum.n s.rvie.s n.nui.oon and ue.n.ur. o rtm.ni caused by a violation of_ a regulation or license condition. A special inspection should also be performed when the information available is not complete enough to make a determination of the above situations.
The specialinspection shall be performed by a qualified Lead Inspector and documented in accordance with RMP No. 3.04, 3.3 Event Reporting 3.3.1 Reports to NRC Events shall be reported in accordance with Attachment 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. Attachment 4.02-2 piovides the 180 NAC 1 regulatory citations which require Agency notification that are equivalent to the NRC citations listed in Table 2, Reportable Events, page 16 of the Handbook.
3.3.2 NMED Database The NMED database system shall be used to generate Event Detal/s reports for documentation of the event and transmittal to NRC, if required. Attachment 4.02-3, NRC, Idaho National Engineering Laboratory, "Nticlear Materials Events Database User Guide",
Published as Draft 09/05/96 is available for reference when using the ;
NMED database. (WCTT, !)rn ri w b u To '% \n tw a, cc2 p a. Fono m w cl o n o <~ r =WR a n wri e.rA 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:
RMP No. 4.02 lesued: S.pt.mber 26.1997 R. vision No. 0
. P.ge 6 of 6
htet. M.t.rt.ls Progr.m Proc.dur.s m.br k. w wh .nd Hum.n s.rvie R.eui.iw .ad ue.n.or. o rtm.nt 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 material, the existence of similar circumstances in the State shall 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 specialinspection have been reviewed and the corrective action accepted.
3.4.3 Events shall be closed upon approval of the Radioactive Materials Program Manager.
4.0 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 C of the Event Log and Event Details report shall be maintained
.le 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 4
RMP No. 4.02 is.u.d: S.pt.mb.t 26,1997 R.vi. ion No. O P g. 6 of 6
7 D* *:*
Red 60ective Meterials Program Procedur:s a
Nobreake Health end Human services Regulation and Ucensure Department Attachment 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 This attachment contains a copy of the handbook to be used when reporting events the NRC.
The followina naaes are attached: # Paaes Cover Page 1 Abstract 1 Table of Contents 2 Preface 2 Section i 4 Section ll 19 Appendix 18 RMP No 4.02 issued: September 26.1997 Revision No. 0
Radioactive Materials Program Proceduros w.bron. H hh and Human Services Regulation and ucensure DE;...at Attachment 4.02 2 180 NAC 1 Regulatory Citations Requiring Agency Notification This attachment contains the citations equivalent to Table 2 in Attachment 4.02-1.
The followina naaes are attached: # Pages
. Regulatory Citations 1 RMP No 4.02 issued: September 26.1997 Revision No. 0
m '
q REPORTABLE EVENTS Typical items covered under reporting requirements include the following:
180 NAC 1-003.25 Reporting of events involving:
Prevention of immediate protective action, Unplanned contamination restricting access > 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, Safety equipment failed or disabled, Unplanned medical treatment of contaminated person, Fire, explosion affecting integrity of material or container.
180 NAC 1-004.51 Reports of theft or loss of licensed material.
180 NAC 1-004.52 Immediate and 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 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 irradiators.
,. * , . , Radioactive Motorials Program Procedures Nobreake Health end Human Services Regulation end ucensurs Department l
Attachment 4.02-3
,1NEL " 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 followina naaes are attached: # Paaes Cover Page 1
- Table of Contents 1 Purpose 1 instructions 13 Appendix A Event Descriptions 8 Appendix B Data Dictionary 7 Ap)endix C Data Table Relationship 1 i
RMP No 4.02 issued: September 26,1907 Revision No. O