ML20205S181

Draft Integrated Matls Performance Evaluation Program Review of Region III Matls Program 990315-19

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Issue date:	03/19/1999
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF REGION lli MATERIALS PROGRAM MARCH 15-19,1999 i

4 DRAFT REPORT i

U.S. Nuclear Regulatory Commission Attachment 9904260128 990416 PDR ORG NOMA PDR

Region lli Draft Report Page1

1.0 INTRODUCTION

This report presents the results of the review of the Region ll1 (Rlli) nuclear materials licensing, inspection, incident response, and allegation programs, as well as the Rlll fuel cycle inspection program and Rill's Site Decommissioning Management Plan (SDMP) program. The review was conducted during the period March 15-19,1999, by a review team compri;ed of technical staff members from the Nuclear Regulatory Commission's (NRC's) Office of Nuclear Material Safety and Safeguards (NMSS); Office of State Programs (OSP); Region 1; and the State of j Georgia. Team members are identified in Appendix A. The review was conducted in accordance with the " implementation of the Integrated Materials Performance Evaluation Program and Rescission of a Final General Statement of Policy," published in the Federal Reaister on October 16,1997, and the November 25,1998, NRC Management Directive (MD) 5.6," Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period April 25,1997, to March 19,1999, were discussed with Rlll management through the Regional Administrator on March 19,1999.

[A paragraph on the results of the Management Review Board (MRB) meeting will be included l here in the final report.]

1 The Division of Nuclear Materials Safety (DNMS) administers the Rlli materials, fuel cycle, and SDMP programs. Within DNMS, responsible branches include the Materials Licensing Branch, Materials Inspection Branch 1, Materials Inspection Branch 2, Fuel Cycle Branch, Decommissioning Branch, and the Administrative Support staff. An organization chart for the Rlll DNMS program is shown in Appendix B. At the time of the review, the Regional materials program regulated 2221 specific licenses, including licensing, inspection, and enforcement for all major types of medical, industrial, and academic licensees. This figure accounts for approximately 38 percent of all materials licensees under NRC's jurisdiction.

In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the %gion on February 5,1999. Region lli provided a response to the quationnaire on March 1,1999. During the review, discussions with the Rlll staff resulted in ila; .esponses being further developed. A copy of the amended Rlll questionnaire response is included in Appendix G to this report [the amended Rill questionnaire response will be added as Appendix G to the final report, but is not included in the draft report).

The review team's general approach for conduct of this review consisted of: (1) examination of Region Ill's respse to the questionnaire; (2) analysis of quantitative licensing and irepection information frorn ;he Licensing Tracking System (LTS); (3) technical review of selected licensing, inspection, incident, and allegation actions; (4) field accompaniments of three Rill materials inspectors; and (5) interviews with staff and management to answer questions or clarify issues. The review team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the Rlll nuclear materials program's performance.

Section 2 below discusses the Region's and NMSS' actions in response to recommendations made following the previous IMPEP review in April 1997. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common performance indicators, and Section 5 summarizes the

Region 111 Draft Report Page 2 review team's findings and recommendations. Recommendations made by the review team are comments that relate directly to program performance by the Region or NRC Headquarters Offices. A response is requested from the Region to all recommendations in the final report.

. Suggestions are comments that the review team believes could enhance the Region's

! program. The Region is requested to consider suggestions, but no response is requested. On I this IMPEP review of the Rill nuclear materials program, the review team did not make any suggestions.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous iMPEP review, which concluded on April 21-25,1997, five comments and recommendations were made to Rill or NMSS, and the results were transmitted to A. Bill Beach, Regional Administrator, Region 111, on August 5,1997 in the final report. Rill had formally addressed the status of these recommendations in its response to the 1997 draft IMPEP report. The 1999 review team assessed the status of these items to determine whether l Rlli or NMSS took actions to close the recommendations. The review resulted in the closure of l four of the five recommendations. One recommendation for NMSS remains open. The team's review of the current status of these recommendations is as follows:

1. NMSS should examine the need for guidance for initialinspections of new licenses that are issued in the case of an ownership change, mailing office location change, or change in control.

l l Current Status: Following the 1997 Region lll lMPEP review, NMSS considered the need for guidance on initial inspections of new licensees that are issued in response to l licensee changes (e.g., ownership changes, mailing office location changes, or I changes of control). NMSS agrees that guidance on this issue is needed, and NMSS' Division of industrial and Medical Nuclear Safety (IMNS) is tracking the action in its detailed Division Operating Plan. The guidance is due for completion in April 1999.

This recommendation remains open, until the revised guidance is issued.

2. NMSS and Rlll management should closely monitor implementation of the laboratory quality assurance / quality control (QA/QC) program and progress on the get-well plan.

Current Status: NMSS and Rlll management have closely monitored implementation of the laboratory QA/QC program, and the laboratory get-well plan is completed. This recommendation is closed, and specific information on the review team's assessment of the Rlll laboratory is provided in Section 3.2.

3. Rill, in coordination with NMSS and its contractor (Radiation Environmental Sciences Laboratory (RESL)), should ensure that independent audits of the laboratory are conducted to ensure that an adequate QA/QC program is implemented and maintained.

Current Status: Rill, NMSS, and RESL, have ensured that independent audits of the l

l laboratory have been conducted during the review period and will be conducted in the future. Also, the review team observed that an adequate laboratory QA/QC program

Region 111 Draft Report Page 3 has been impinmented and is being adequately maintained. This recommendation is closed and specific information on this issue is provided in Section 3.2.

4. Rlll should examine all procedures or documents reiaung to the handling of allegations to ensure that they are consistent with MD 8.8 and Inspection Manual Chapter (IMC) 2800. Guidance on electronic transmittal of allegation-related material should be included in the procedures. In addition, the procedures or documents should explicitly state that information referring to an allegation should not be included in the docket file.

Current Status: Rlli revised its regional allegation procedure RP 0517A in March 1998, to provide guidance on electronic transmittal of allegation-related material. On March 10,1999, Rlli revised RP 0517A to specifically state that allegation documents or other information that could identify an issue as an allegation must not be placed in the docket file. Because Rlll revised the procedures, as directed in the 1997 IMPEP recommendation, this recommendation is closed. On the 1999 IMPEP review, the team opened two new recommendations related to the 1997 finding. The new recommendations are discussed in Section 3.5.

5. NMSS should review existing inspection procedures and manual chapters regarding performance of reactive inspections, to ensure applicability and adequacy for fuel cycle facility inspections.

Current Status: NMSS revie'wed the existing guidance and determined that additional guidance was needed for reactive inspections at fuel cycle facilities. On August 10, 1998, NMSS issued Inspection Procedure (IP) 88003, " Reactive Inspection for Events at Fuel Cycle Facilities Program." The recommendation is closed.

In summary, the review team considers all of the 1997 IMPEP review recommendations for Rlli closed, and one of the two recommendations for NMSS closed.

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

3.1 Status of Materials Inspection Proaram The team focused on four factors in reviewing this indicator: inspection frequency, overdue inspections, initial inspection of new licenses, and timely dispatch of inspection findings to licensees. The review team's evaluation is based on the Region's questionnaire responses l

! relative to this indicator, data gathered independently from the LTS, an examination of completed licensing and inspection casework, and interviews with Ritt managers and staff.

f The review team examined Rlil's inspection priorities and veafied that the inspection f

frequencies for differant types of licenses are established in the LTS. The LTS inspection l

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Region ll! Draft Report Page 4 j frequencies are managed by NMSS/IMNS, and are based on the inspection frequencies in IMC 2800. Therefore, the Region is using exactly the same standard frequencies in IMC 2800 for I core and non-core materials inspections as the rest of NRC, with two exceptions involving portable gauge and broad-scope licensees. During the review period, Rlll requested approval from IMNS on a regional initiative to defer non-core inspections of portable gauge licensees  !

during the winter months, because the Region wanted to optimize the opportunity to inspect the gauges in the field. Many portable gauges are not used during the winter for soil compaction or soil moisture measurements, because most outdoor construction work is not l conducted during the winter within Rlli's geographic area. IMNS agreed to the change, and the revitw team observed that Rlli did conduct a number of gauge inspections in the field during this review period. The Region also implemented a broad-scope inspection initiative to visit selected broad-scope materials licensees more frequently than specified in IMC 2800 to conduct limited, performance-based inspections of activities in progress at the licensee's site.

The Region intends to complete the full scope of inspection activities with each licensee over the entire IMC 2800 inspection cycle. Regional inspectors conduct these limited inspections approximately quarterly, and the number of inspectors on each trip is fewer than the number needed for a full team review of a broad-scope licensee. The review team found that the j Region's broad-scope inspection initiative increased the frequency of inspector contact with major broad-scope licensees. Finally, the review team noted that the Region conducts follow-up inspections on licensees with escalated enforcement actions, in accordance with IMC 2800 Section 05.04. The Region schedules follow-up inspections, following escalated enforcement, j for 6 months after the violation was first identified. The review team determined that the Region is folicwing the IMC 2800 inspection frequencies, or has special regional initiatives in place that justify minor changes to the inspection frequencies.

The review team examined a partiallisting of Rllt licensees (471 licensees) from the LTS, and found that for about one-quarter of the licensees (117), the inspection frequency for the next inspection had been extended for good pertoimance. For less than one-tenth of the licensees (41), the inspection frequency had been reduced. Inspectors were actively completing the front sections of the inspection field notes, which prompt inspectors to indicate whether the next inspections should be maintained at the standard frequencies, extended, or reduced. In an interview with a Rill inspection Branch Chief, the review team learned that the supervisor questions inspectors about whether the next inspection should be extended, especially in cases where no violations were identified. The review team concluded that the Rlllis actively extending or reducing individual licensee inspection intervals, based on licensee performance, and the ratio of extensions to reductions is similar to the practices of most other regions.

In response to the questionnaire, Rlllindicated that (as of the date of the questionnaire)it had no inspections overdue by more than 25 percent of the assigned frequency in IMC 2800. Tlie manual chapter allows a 25 percent scheduling margin, or a year, whichever is shorter, around the " inspection due date" to conduct the inspection, before it becomes overdue. That is, at the time of the questionnaire, Rlll reported no overdue inspections. The review team checked the Region's answer by reviewing the March " inspection due list" from the LTS that Rlil uses to schedule inspections. The review team did not identify any overdue routine inspections, either core or non-core, at the time of the on-site IMPEP review. It appeared that a small number of inspections may have been overdue at different times during the review period, but the review team did not analyze this further because the total number was so small (and far below the MD 5.6 IMPEP criterion of less than 10 percent overdue core inspections). It is noteworthy that

5 1 I

i Region ill Draft Report Page5 l

Rlll had no overdue core or non-core routine inspections at the time of the on-site IMPEP review, whien demonstrates exemplary perfo mance by the Rill inspectors in scheduling inspections, and effective management of the inspection scheduling process.

! With respect to initial inspections, the review tesm examined an LTS listing of 154 new licenses issued by Rlll between December 1996 and August 1998 (from 5 months before the start of the review pericd to 6 months before the end), and cross-checked the new licenses with the dates of initialinspections. The review t tam performed an exhaustive check of the i docket files, for all initial inspection dates that appeared questionable, based on LTS data. l After subtracting out licensees that were inspected before this review period (four), licensees l that were not true "new" licensees as a result of c huge of ownership or address (four), )

licenses that were issued and terminated before o' eing inspected (three), and deferred inspections under the regional initiative for portable gauge inspections (two),141 new licensees remained. Of the remaining 141 licent ees, Rlliinspected 73 within 6 months, and another 55 within 7 to 12 months, for a total of 128 inspections conducted within the IMC 2800 criteria for initial inspections. Twelve new licensues remained that had not been inspected, but all were within a year of license issuance, so they had not exceeded the IMC 2800 criteria.

The review team only identified a single initial inspection that Rlli conducted late during the review period, and it was a fixed gauge licensee that was inspected in the 13th month after license issuance (i.e.,1 month late). In addition, from documentation in the docket files and interviews with Rlli personnel, the review team leamed that the Region has an effective program to contact new licensees by telephone at points approximately 3,6, and 9 months  !

after license issuance to inquire whether the licensee has obtained licensed material, and to schedule an initialinspection accordingly. The review team also noted several cases where the Region scheduled licensees for early re-inspection, following initial inspections where the licensees did not possess material (but were due for initial inspections under IMC 2800 requirements). This re-inspection practice indicates strong Rlli oversight of new licensees, and  ;

it exceeds the inspection requirements in IMC 2800. Region ill demonstrated strong l performance in scheduling and conducting initialinspections during the review period.  ;

The timeliness of inspection findings was evaluated during the inspection file review. The review team observed that inspection findings were being communicated to the licensee within 30 days after completion of the inspection. The team did note a trend regarding the number of field notes exceeding the 30-day goal, when a NRC Form 591 was issued in the field. Rlli managers told the review team that they performed a self-assessment of field note timeliness in April 1998. This self-assessment found untimely field note completion, and as a result, Rill took corrective actions by instructing inspectors to turn in field notes within 2 weeks after completion of inspections. Since the self-assessment, Rlll has begun tracking the timeliness of field notes. Since April 1998, field note timeliness was found to be adequate, and it appeared to the review team that Rill's corrective actions were successful.

In response to the questionnaire, Rlli provided statistics regarding the numbers of reciprocity inspections completed in calendar years (CY) 1997 and 1998. The review team assessed the numbers of reciprocity inspections against the inspection priorities in IMC 1220, " Processing of NRC Form 241, ' Report of Proposed Activities in Non-Agreement States," and Inspection of Agreement State Licensees Operating under 10 CFR Part 150.20," uaing data in the Region's questionnaire response. The Region noted that its reciprocity inspections in calendar years 1997 and 1998 did not meet the IMC 1220 inspection frequencies and that the Region had l

Region l11 Draft Report Page 6  !

identified this during a self-assessment. Specifically, in CY 1997, Rill performed 14 inspections of reciprocity licensees (9 of which were assist inspections for other regions), but missed the IMC 1220 requirement by a single priority 1 inspection. In CY 1998, Rlli performed i l

two reciprocity inspections, and missed the IMC 1220 requirements by three inspections of ,

different-priority rer,iprocity licensees. In interviews with the review team, Rlll management described a corrective action plan to increase the number of reciprocity inspections conducted  ;

in the future. In the DNMS reorganization, effective March 28,1999, Rlll assigned an  ;

inspector in the Decommissioning Branch to perform all reciprocity and assist inspections.

Regional management believes that clearly assigning the reciprocity inspection respons!bility to a single group, with a designated individual to perform reciprocity inspections, rather than having diffuse Division-wide responsibility for reciprocity inspections, will improve regional I l

performance in this area. The review team considered Rlll's self-identification of the issue and Rill's corrective actions, and concluded that the Region is addressing this issue appropriately.

The review team does not have any recommendations for Rlli in the area of reciprocity inspections.

In summary, Rlli surpassed or met the IMPEP standards for all four of the areas on this performance indicator: The inspection frequencies were being followed, in accordance with IMC 2800, and were being reduced or extended based on licensee performance. Rlll's inspection program had an extremely low number of overdue inspections during the review period, and none at the time of the on-site review. The Region conducted nearly allinitial inspections within the IMC 2800 requirements, and demonstrated a strong commitment to contacting new !icensees and scheduling initial inspections. Finally, most inspection findings were communicated to licensees within 30 days.

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

3.2 Technical Quality of Inspections The review team examined the inspection field notes and other follow-up documentation and interviewed the responsible inspectors, when available, for 18 files documenting materials inspections conducted during the review period. These inspections were performed by 12 Rlli inspectors. The reviewed cases covered 13 license types, including limited and broad licenses of medical, academic, and industrial programs. In the file review, the team observed that Rlli inspectors used the appropriate and most recent version of the inspection field notes to document inspections, as well as reports, where appropriate. Appendix C lists the inspection casework files reviewed for completeness and adequacy with case-specific comments.

Altogether, Rlli's DNMS Division Director, Deputy Division Director, two Branch Chiefs, three members of the Licensing Assistance Staff, and 12 inspectors were interviewed.

On March 9-11,1999, a review team member performed accompaniments of three Rlli inspectors on separate inspections of three licensed programs (see Appendix C). One of the inspections was an announced, initial inspection and the other two were routine, unannounced inspections. The inspector accompaniments were performed at a medical facility, an academic broad-scope program, and a research and development facility. During the accompaniments,

Region ill Draft Report Page 7 the Rlli staff demonstrated appropriate inspection techniques and knowledge of NRC regulations and policies. The inspectors were well prepared and thorough in their reviews of the licensees' radiation safety programs, including follow-up of previous violations and incidents that had occurred during the inspection period. Inspectors observed licensee activities, interviewed licensee staff, toured facilities, took independent measurements and reviewed licensee records. Overall, the performance of the inspectors was sufficient to assess radiological health and safety at the licensed facilities and the inspectors demonstrated appropriate technical skills.

The team reviewed IMC 2800 and found that Rlli is implementing tb manual chapter appropriately. The review team performed a detailed assessment of the following topics:

extension of inspection frequency for good performance, documentation on NRC Form 591, number of inspections conducted at permanent field offices, and inspection of Year 2000 (Y2K) compliance.

In almost all cases, docket files were complete anc in order. Inspection results were well-documented, including follow-up on previous violations, with the exception of inspection location. In cases where more than one location of use was authorized on the license, field notes did not reflect where the inspection took place. This occurred because of the revision of field notes by NMSS during this review period, which no longer prompts the inspectors to list the location of the inspection. The review team recommends that NMSS revise allinspection field notes to include the location (s) that the inspection is performed.

The team determined that Rlli is performing inspections on an unannounced basis, except for initialinspections or reactive inspections where advance contact with licensee personnel is I needed. Inspectors issued NRC Form-591 in the field when appropriate. Documents reviewed were of sufficient detail to substantiate the findings of the inspection, and were completed in a timely manner with the exception of field note timeliness discussed earlier in Section 3.1.

Inspection frequency was properly determined after inspections were completed and this frequency was found to be properly updated in the Region's tracking system. Inspection results were reviewed and approved by supervisors within a few days after completion of the documentation.

The team determined that accompaniments by supervisors were performed on an annual basis, with the exception of one inspector whom the Region noted in its response to the questionnaire. A review team member accompanied this inspector, as discussed earlier in this section, and found his inspection performance to be at an appropriate level to assess health and safety issues.

The team reviewed a memorandum, dated November 17,1997, from the Director, IMNS, to the Regions, that discussed the effort of inspectors in the review of Y2K problems at licensees' facilities. Discussions with inspectors and review of docket files indicate that inspectors are reviewing Y2K issues atlicensees' sites. The review team did find that documentation of Y2K reviews could be more explicit in field notes and that inspectors should avoid using words, such as "none," that require further clarification about what was reviewed. But the review team did not link documentation to inspection performance, and the review team concluded that Rlli is appropriately reviewing Y2K issues on materials inspections.

1 Region lli Draft Report Page 8 The team also reviewed survey meter calibiation, availability, and use. Adequate and appropriate instrumentation was available for, and was used by, inspectors to perform surveys during inspections. Confirmatory and independent measurements were reported in the inspoction documents, with a description of the instrumentation used. A staff member me ntains a database with the assignment of meters and calibration due dates. On expiration of the calibration date, this individual obtains the instrument from the inspector and gives the inspector a replacement instrument that is in calibration. Also, inspectors stated that they return instruments when the calibration date is approaching the due date. The review team ,

found survey meter calibration, availability, and use to be adequate.

The review team also examined the technical quality of inspections and surveys for non-SDMP j decommissioning inspections. (See also Sections 4.3.3, " Termination Radiological Surveys,"

and 4.3.4," Inspections," within the SDMP non-common performance indicator, for additional information on how these activities were performed by Rllt staff.) The review team found that sites are inspected in accordance eith IMC 2602, " Decommissioning inspection Program for Fuel Cycle Facilities and Materials Licensees." Region 111 staff use IP 87104,

" Decommissioning Inspection Procedure for Materials Licensees," and the review team also noted that Rill staff use IP 83890, "Closecut inspection and Survey," and IP 83822, " Radiation l Protection."

Rlll's non-SDMP inspections were planned, carried out, and documented in accordance with NRC procedures. Inspection documentation was complete, and Rlll issued inspection results within 30 days. In response to the questionnaire, Region ll1 identified both routine decommissioning inspections and "in-process" inspections of licensee final surveys that had been conducted during the review period. "In-process" inspections are defined in IP 87104 as inspections of licensees' final surveys. Confirmatory surveys are defined as surveys conducted by NRC (or an NRC contractor) to verify the results of the licensees' surveys. The review team found that several of Rill's in-process inspections included confirmatory surveys, although NRC policy emphasizes "in-process" inspections more than confirmatory surveys.

The review team discussed the use of these confirmatory surveys with the Decommissioning Branch staff. IP 87104 recommends use of limited confirmatory surveys unless there is significant doubt about the licensees' final survey results. The review team found that Rill's confirmatory surveys were generally performed by NRC staff, were limited in scope consistent with the guidance in the IP, and were successful in detecting contamination not found by the )

licensees' final surveys. Appendix F identifies decommissioning cases reviewed by the team.

In summary, from reviews of files, interviews with staff, and inspection accompaniments, the 1 review team found that Rlli inspection staff were performing inspections that were of l appropriate scope and technical quality, inspection findings were well-founded and well-documented. Rillinspection staff property addressed health and safety issues, and they demonstrMed strong technical performance on this indicator. ,

The review team supplemented its case review with a review of the upgrading of the Rill laboratory used for analysis of Rlli and RIV samples. The review of the laboratory was limited to an assessment of the actions taken on the two recommendations from the 1997 IMPEP review. The first recommendation was that NMSS and Rlli management should closely monitor implementation of the laboratory QA/QC program and progress on the get-well plan.

< The second recommendation was that Rill, in coordination with NMSS and its contractor,

Region ill Draft Report Page 9 RESL, should ensure that independent audits of the laboratory are cor, ducted to ensure that an adequate QA/QC program is implemented and maintained.

Rlll had an assist visit in Augtst 1998 by RESL, which performed an independent review of the laboratory program at that time. As a result, Rlll instituted a special initiative that included actions for all of the items identified by RESL, as well as many items Rlli had self-identified.

Under this init:ative, Rlli developed a chart to ensure that every item, including the development of an adequate QA/QC program, was tracked and that corrective actions were taken. The get-well plan was completed as of December 9,1998.

RESL planned an edditional assist visit during the week of March 22,1999, to close-out previous items identified during the August 1998 visit. Also, a full audit of the program is scheduled for August 1999. An in-depth look at the laboratory was not completed during this IMPEP review, because of these planned visits by RESL, which will focus exclusively on the Rlll laboratory program.

Overall, the review team found that Rlli, NMSS, and RESL, Fave ensured that independent audits of the laboratory have been conducted and will be conducted in the future. The review team observed that an adequate laboratory QA/QC program has been implemented and is being adequately maintained. Also, the review team found that NMSS and Rill management closely monitored implementation of the laboratory QA/QC program and the get-well plan.

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

3.3 Technical Staffina and Trainina Issues central to the evaluation of this indicator include the DNMS materials program staffing level and staff tumover, as well as the technical qualifications and training histories of the staff.

To evaluate these issues, the review team examined the Region's questionnaire response relative to this indicator, interviewed DNMS management, interviewed the training coordinator in Rlli's Division of Resource Management and Administration (DRMA), considered any possible workload backlogs, and reviewed the DNMS staffing plan for the reorganization that became effective on March 28,1999.

The DNMS organizational structure had not changed since the time of the 1997 IMPEP review, although at the time of the 1999 on-site review, the Division was about to undergo a reorganization, effective March 28,1999. Technical and licensing support staff in the Rill materials program were organized during the review period into five branches within DNMS:

Materials Licensing Branch; Materials inspection Branch 1; Materials inspection Branch 2; Fuel Cycle Branch; and the Decommissioning Branch. Licensing assistance staff were assigned directly to the Materials Licensing Branch. On March 28,1999, DNMS was to reorganize into a four-branch structure, with the two inspection branches combined into a single branch and some materials inspection activities (e.g., reciprocity inspections) assigned to the Decommissioning Branch.

a Region til Draft Report Page 10 At the time of the on-site review, DNMS had 12 materials inspectors and 9 license reviewers.

Two of the 9 license reviewers are in part-time positions, and another has both licensing and inspection responsibilities. In addition, DNMS had nine technical staff in the Decommissioning Branch who cover decommissioning inspections, non-SDMP decommissioning licensing actions and project management, the regionallaboratory, reactor decommissioning, and dry cask storage issues. Technical staffing and qualifications of the fuel cycle inspectors are discussed in Section 4.2. The review team concluded that the Region has a good mix in staffing for materials licensing and inspection activities, as well as decommissioning activities.

In addition, it appeared to the review team that adequate administrative support is available.

Rill's DNMS staffing situation remained extremely stable during the review period. In its response to the IMPEP questionnairo, the Region reported that no new professional personnel have been hired since the last review. The Region also indicated that, since the last review, four DNMS technical staff members transferred to positions outside of DNMS within the Region, and one transferred to NMSS. These staffing losses come at a time of decreasing resource allocations for the DNMS program, especially once Ohio becomes an Agreement  !

State, so some level of attrition is beneficial. At the time of the on-site review, DNMS reported  !

four vacancies or upcoming vacancies, including a new lead inspector position in the i reorganized inspection branch; the Division Secretary position, which becomes a team leader f 4

position at the time of the reorganization; a fuel cycle inspector position that will be vacated when the incumbent moves to a reactor resident inspector position soon; and an administrative support staff position that will open when the incumbent transfers to a position in another Rill division soon. At the time of the on-site review, the Region was interviewing for, or had issued, a solicitation of interest or a job nnnouncement for several of the open positions. Additional discussion of resource utilization appears in Section 4.1 of this report.

The region reported in its response to the questionnaire that all Rlll materials inspectors have completed the training requirements in IMC 1246, Section ll, " Training Requirements for Materials Radiation Specialist inspector," except for one inspector scheduled to attend the next

" Inspecting for Performance" (G-304) course and two inspectors who need to complete the i I

" Health Physics Technology"(H-201) course. The review team noted that all three inspectors have been with the Rlli materials program for a number of years. The two inspectors who need to complete the H-201 course were previously grandfathered, and did not need to complete the course under the previous IMC 1246 provisions, but DNMS management has elected not to exempt any inspectors from tha course, and the remaining two inspectors will complete the training. The review team checked the Region's master training roster, and the inspector still requiring the G-304 " Inspecting for Performance" course is scheduled to take it in June 1999. The review team also checked the training files for two materials inspectors who were qualified, through oral boards, at the start of this review period, and found the qualification documentation to be in order. The review team concluded that all materials inspectors were well qualified to perform their inspection duties.

The Region also replied, in its response to the questionnaire, that all Rlli license reviewers have completed all of the training requirements in IMC 1246,Section I, " Training Requirements for Materials License Reviewers," except for three reviewers who have not completed the H-201 course," Health Physics Technology." These three ticense reviewers had previously been waived from the course. The review team explicitly checked the training records kept by DRMA's training coordinator against the IMC 1246 requirements for license reviewers, to verify

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Region ll1 Draft Report Page 11 the Region's questionnaire response. With the single exception of a fourth license reviewer the team identified who needs to complete the H-201 course, the Region's analysis of staff qualifications is accurate. Except for two reviewers with substantial licensing experience who had the G-109, " Licensing Practices and Procedures" course naived, and the four individuals who had not completed the H-201 course (all of whom could legitimately be grandfathered from the course), all Rill license reviewers have completed all core training, and many have completed a number of specialty-training courses as well (such as " Internal Dosimetry and Whole Body Counting,"" Air Sampling for Radioactive Material," and " Root Cause/ Incident Investigation Team" training). In addition, the Region noted in the response to the questionnaire that Rlli requires each license reviewer to be granted signature authority before independently signing a licensing action for a particular category of licensee. The Region reported that all reviewers have signature authority for niedical, gauges, and i academic /research/ development licensees, and many also have signature authority for 1 broad-scope licenses, radiography, and teletherapy licenses. The review team concluded that all materials license reviewers were well qualified to perform their licensing duties.

In the area of decommissioning training, the Region reported in the questionnaire response )

that all decommissioning inspection staff have met the qualification requirements of IMC 1246. {

The review team checked the requirements in IMC 1246,Section IX, " Training Requirements for Decommissioning Inspections," against the Region's lists of completed training for the six staff in the Decommissioning Branch who conduct materials decommissioning inspections or materials decommissioning program management activities. The review team found that all six had either; taken the required courses, been exempted from the required courses as a result  ;

of prior education and experience, or were, in just one materials case, projected to take the training in FY 1999. Regional managers and training staff did note that the limited availability of the

• Environmental Transport (including groundwater transport)" course, which is not offered intemally by NRC, and the " Finance for Nonfinancial Professionals" course, continues to be a problem for the Region. Region lli is sending its decommissioning inspectors to a commercially available course for " Environmental Transport," and the financial course is available through videotape. The review team, after noting that a number of Rlli decommissioning inspectors have not completed both of these courses, checked with NMSS' Division of Waste Management (DWM) on the training policy. The program office's reply was ,

l that the two courses are currently optional; they no longer are required for decommissioning inspection qualification. This same issue was raised during the Region i IMPEP last year by RI decommissioning managers, and DWM addressed the problem by making the courses optional for decommissioning inspector qualification. In addition, the Rlli review team learned through interviews that the significant drop in the Region's training budget during this review period has strained the Region's ability to send materials staff to outside (NRC Form 368) training, or to authorize much Priority 2 (supplemental) or Priority 3 training. Overall, the review team concluded that the Rlll materials decommissioning inspectors and project managers were well qualified to perform their decommissioning duties.

l l The review team spot-checked completed training lists, sample agendas from Regional inspector training, the Region's training priority list, and supervisors' training documents. The !

review team also interviewed the DNMS Director, the Deputy Director, a Branch Chief, and the DRMA training coordinator regarding staff training, and attended a DNMS Division Meeting where technicalissues were discussed. The review team determined that Ritt has a well-organized system for planning, approving, conducting, and tracking training, that includes

l Region ill Draft Report Page 12 DNMS Deputy Division Director participation on a regional Training Council. Regional managers were generally cognizant of the qualification status and training plans for their staff, and Rlll management displayed a strong commitment to training. Technical staff attended specialty training courses and refresher training, and appeared to maintain technical currency for their assigned positions. All technical staff appeared to the review team to have the basic technical skills to perform theirjobs adequately, and some Rlli staff have advanced training or certification (e.g., one Decommissioning Branch staff member became a Certified Health Physicist during the review period). The review team determined that Rill adequately implements the training requirements of IMC 1246, and manages an appropriate regional training program for the materials program.

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

3.4 Technical Quality of Licensino Actions The review team examined completed licensing casework for 15 specific license files, '

evaluated the licensing process and procedures, and interviewed the Branch Chief and nine of the staff's !icense reviewers. The total number of licensing actions reviewed included four new licenses, three renewals, five amendments, and three terminations. Licensing documents were evaluated for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis forlicensing actions. Licenses were reviewed for accuracy, appropriateness of the license conditions, and tie-down conditions, and overall technical quality. Each case was evaluated for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation  ;

reports, product certifications and/or other supporting documents, consideration of j enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authority. The files were checked for retention of necessary documents and supporting data. Deficiencies were addressed by letters and/or documented telephone i inquiries that used appropriate regulatory language. A list of the licenses evaluated during the l review, with case-specific comments, can be found in Appendix D.

The licensing casework was selected to provide a representative sample of licensing actions that were completed during the review period. The cross-section sampled by the review team j included the following types: medical institution broad; academic type A broad; medical private practice; mobile nuclear medicine; irradiator; hot cell operations; industrial radiography; portable and fixed gauges; measuring systems; and byproduct material storage only. The appropriate licensing checklists and NRC Policy & Guidance Directives were being used. l Finalized volumes of NUREG-1556," Consolidated Guidance About Materials Licensees," were j also being used by Rlli as they pertain to specific types of licenses. Region Ill has a signature l authorization and qualification policy for licensing in place and has implemented the policy. l Signature authorization is approved by the Branch Chief as each reviewer becomes qualified l to work on certain types of licenses. The Region completed 2705 licensing actions during this l review period, which included 195 new licenses,74 renewals,2426 amendments, and  ;

10 terminations. j I

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Region 111 Draft Report Page 13 The few deficiencies that were identified by the review team in licensing cases were minor, isolated, or administrative in nature, and most were corrected during the on-site visit. The review team did identify two cases involving two separate licenses, that had incorrect program codes assigned to the licenses. In one case, a license was assigned a progum code for a manufacturing and distribution license, but the license was actually for a portable gauge. in the second case, the licensee was assigned a program code for research and development, but the program code should have been for a " Measuring Systems - Other" type license. Each case was discussed with the responsible license reviewer, and the appropriate steps were taken to correct the program codes at the time of the review. The review team did not find this program code issue to be a systemic problem for the Region, so the review team has no recommendation on this issue. See Appendix D for further detail.

The review team also examined the technical quality of non-SDMP decommissioning licensing actions. The areas reviewed included license termination documentation in the docket files, an in-progress decommissioning plan review by Rill staff, and, to a limited degree, financial assurance for decommissioning.

The review team found that Rlli's docket files contain license closecut documentation, such as NRC Form 314, a license amendment terminating the license, and final and confirmatory 1 surveys, where necessary. However, IMC 2605, " Decommissioning Procedures for Fuel Cycle and Materials Licensees," states that all personnel implementing the decommissioning program shall use the guidance in NUREG/BR-0241, the NMSS Decommissioning Handbook.  ;

f Appendix F of the Handbook contains a " Materials License Termination / Retirement Form," a checklist of items that license reviewers are to consider and address before terminating a license. The review team found that this checklist was not being used by license reviewers.

The review team also examined Rlll's application of the decommissioning timeliness rule provisions. One of the first steps in the license termination process is a notification by a licensee of its intent to cease operations, under the provisions of the decommissioning timeliness rule,10 CFR 30.36(d). The Decornmissioning Handbook, Appendix E, has a checklist of actions to be completed by NRC staff on receipt of such notification. For example, j the reviewer is prompted by the checklist to determine the type of decommissioning (from one I of four decommissioning types of varying complexity), which then defines a number of other parameters, such as whether a decommissioning plan is needed from the licensee, and whether an environmental review is required by NRC staff. The review team found that the Appendix E checklist is also not being used by decommissioning and licensing staff. With regard to the review team's findings that Rill is not using two checklists from the Decommissioning Handbook, the review team recommends that Rlll implement the tools l 1

l prescribed in the Decommissioning Handbook for ensuring that decommissioning and license l termination reviews are complete and fully documented.

l The review team examined one decommissioning review that was being processed by Rlli's l Decommissioning Branch staff, for McDermott Technology, an active licensee with research facilities in Alliance, Ohio. The licensee has several on-site burials that require re-evaluation in accordance with Information Notice 96-47, "Recordkeeping, Decommissioning Notification for Disposals of Radioactive Waste by Land Burial Authorized under Former 10 CFR 20.304, 20.302, and 20.2002," August 16,1996. The licensee has submitted a remediation plan for I t

these on-site burials. Regional staff has been working closely with the licensee on the 1

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Region lli Draft Report Page 14 l documentation that is required for NRC review. The review team found Rill's decommissioning l reviewers to be focusing on appropriate risk-significant issues regarding the remediation plan, and Rlll staff were reviewing McDermott Technology's remediation plan in a technically sound manner. ,

The review team also conducted a limited review of financial assurance for decommissioning.

The review team found that Rlli conducted its annual evaluation of the financial assurance instrument security program in December 1998, and completed the evaluation report in January 1999. Rlil's evaluation report identified several minor, administrative errors that Rlllis  ;

I correcting. As part of this IMPEP review, the team also discussed Rlll financial assurance review capabilities with Headquarters staff. The review team found that the Region is addressing financial assurance for decommissioning in an appropriate manner. The review team was told that Rlli routinely coordinates its financial assurance reviews with NMSS to ensure that they are performed correctly.

Overall, the review team found that the Region's system for processing licensing actions remains formal, structured, clear, and appears to be operating in an efficient manner. j Region 111 licensing staff were performing license reviews that were generally thorough, complete, consistent, and of appropriate technical quality. Region lll licensing staff properly addressed health and safety issues, and they demonstrated strong technical performance on this indicator.

Based on the IMPEP evaluation criteria, the review team recommends that the Region's  !

performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

1 3.5 Response to incidents and Alleaations i

in evaluating the effectiveness of the Region's actions in responding to incidents and l allegations, the review team examined the Region's response to the questionnaire relative to  !

this indicator and reviewed 10 files containing incident reports, as well as 10 allegation files. In  !

addition, tne review team conducted interviews with DNMS Branch Chiefs, the Regional State l' Agreement Officer, the Regional Office Allegation Coordinator and allegation staff, and several materials inspectors. l The review team cross-checked the incidents listed in the Nuclear Material Events Database (NMED) against those contained in Rlli's license files and supporting documentation. The 10 incidents selected for review included the following incident types: three misadministrations; ,

three lost or stolen radioactive material; one equipment failure; one overexposure, one loss of j control of radioactive material; and one receipt of a contaminated package. A list of the j incidents reviewed in depth, with comments, is included in Appendix E. l The .ncident investigations were reviewed for health and safety significance, technical quality of the Region's response, coordination, level of response effort, regional follow-up and corrective actions, and compliance issues. The review team found that the Region's response ,

to incidents was very prompt, appropriately coordinated, well-documented, and of good l technical quality, with health and safety issues properly addressed. Licensees' noncompliance l

Region ll1 Draft Report Page 15 issues were adequately and clearly identified and, as appropriate, enforcement actions were initiated to assure prompt compliance. All 13 incident case files reviewed were found in the NMED system. All of the review team's questions about specific incident files were resolved during discussions with the Rlli staff.

The review team compared the inspection reports and licensee incident reports for this review period with lists of documents shown on the corresponding NMED records. From this comparison, the review team identified that two inspection reports and three licensee reports related to incidents were not identified on the NMED records. The review team learned that all five reports had moved through NRC's Document Control Desk, and all five reports have been assigned accession numbers in NRC's Nuclear Documents System (NUDOCS). Rlll has processed the reports correctly and they should have been available for NRC's NMED contractor to capture as reference documents on the corresponding NMED records. To improve the accuracy and thoroughness of the NMED records, the review team recommends that NMSS evaluate the causes for omission of reference documents from NMED reports, and take appropriate follow-up action in response to any findings.

This R!ll IMPEP review was the first time that an IMPEP review of regional response to incidents and allegations was conducted at the same time as NRC's Agency Allegation Advisor (AAA) annual audit of the regional allegation program. The two reviews were scheduled concurrently, this year, to minimize the impact on regional operations and to reduce overlap between the separate reviews.

Before the on-site review, the review team coordinated with AAA staff to avoid duplication of AAA's efforts to audit regionalimplementation of MD 8.8," Management of Allegations." The IMPEP review team focused on technical effort commensurate with the potential health and safety 7,ignificance of the allegations, corrective action, and notifications to the appropriate internal and external organizations. To a lesser extent, the team reviewed procedural aspects of matarials allegation handling. The AAA audit covered a detailed review of the processing of both materials and reactor allegations and regional compliance with MD 8.8 requirements, including whether the technical effort was commensurate with the potential health and safety significance of the allegations. The IMPEP review team and the AAA audit team shared information and compared results throughout the on-site review. The IMPEP review team also reviewed an April 17,1998, memorandum documenting results of the 1997 Rlli allegation program audit.

Ritt staff who are responsible for coordinating allegations are assigned to the Regional Administrator's Office. The Office Allegation Coordinator has responsibility for tracking all Rill allegations, and coordinating the allegation review boards. Agency guidance for processing allegations is contained in MD 8.8, with supplementary information in IMC 2800. Regional guidance for processing allegations is contained in RP 0517A, " Management of Allegations,"

dated March 5,1998, and revised on March 10,1999.

Discussions with the Regional Office Allegation Coordinator and allegation staff indicate that they follow the guidance in MD 8.8 and RP 0517A. The IMPEP team reviewed allegation )

I procedure RP 0517A and found that guidance on electronic transmittal of allegation-related information is included in the procedures. On March 10,1999, the Region revised RP 0517A to l i

specifically state that allegation documents or other information that could identify an issue as I

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a Region ll1 Draft Report Page 16 an allegation must not be placed in the docket file. This regional procedure will soon be revised in its entirety to inccrporate the changes in a recent revision to MD 8.8, dated February 4,1999.

During the review period,77 materials allegations were opened in Rlll [ power reactor and gaseous diffusion plant (GDP) allegations are excluded here; fuel cycle facility allegations are discussed in Section 4.2]. Of those,64 cases were closed and 13 remain open. The review team examined the allegations reported by Rlliin the Allegations Management System (AMS) against those contained in the Rlil allegation files and supporting documentation. Ten allegation files involving a variety of health physics issues were selected for in-depth review.

Three of the 10 cases were also reviewed in the AAA audit to compare findings. The AAA audit covered a total of 21 reactor and materials allegation files. Of those 21 cases,11 of the AAA audit cases involved materials allegations. During the week on-site, two IMPEP team members and the AAA audit team also observed an Allegation Review Board relating to materials allegations.

The review team found that allegations wera responded to promptly, actions taken were appropriate, and internal and external coordination was conducted with appropriate parties on a timely basis. R!!I's DNMS routinely refers cases involving potential wrongdoing to the Office of Investigations for resolution. In addition, the review team noted that allegations involving Agreement States were appropriately managed. I The review team found that Rlli addressed potential health and safety issues when following up on allegations and the review team concluded that Ritl's technical response to materials allegations was being performed in an appropriate manner.

During the assessment of the inspection files, the review team found that three docket files contained allegation information. Two of the files contained allegation information dated in 1988-1992 and 1994, respectively. Docket files containing allegation information were also identified during the 1997 Rlli IMPEP review. Investigating further, the review team learned from Rlll managers that the Licensing Assistance staff has been removing allegation information from the docket files as they pull the records to file more recent documents (such as licensing and inspection documents). However, the two files identified by the review team contained inspection documents dated after the 1997 IMPEP review, and the allegation information that was highlighted by bold cover sheets had not been removed from the docket file. The review team spoke to the Licensing Assistance staff and inspection staff about their responsibilities with regard to removing allegation material from the docket files. The staff told the review team that they remove allegation information from the docket files if they see it in the files, but the staff did not have the understanding that it was their responsibility to actively search the docket file for allegation information, and pull the allegation information if found. In a third case, the review team found inspection field notes dated after the 1997 IMPEP review, that had been in the docket file. These field notes had redacted sections, but they still contained a reference to concerns raised by an individual. Both the Office Allegation Coordinator and a DNMS Branch Chief had reviewed the document. The review team consulted with the AAA and concluded that the references to " concerns raised,"" concerned individual," and the date that the concerns were raised were not appropriate for publicly

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Region Ill Draft Report Page 17 available inspection field notes. In response to the allegation material found in the files, the review team recommends that Rlli develop and implement a process to remove allegation material from the docket files.

The review team examined the Regional Procedure 0517, " Management of Allegations." This procedure was revised on March 10,1999, to specifically state that allegation documents or other information that would identify an issue as an allegation must not be included in the docket file. Most Rlll personnel were aware of this policy, but the review team found that some i staff had different understandings of the exact wording that could and could not be placed in a docket file. The review team recommends that Rlll train the DNMS staff on what allegation .

language, if any, is acceptable to place into the docket file. l Based on the IMPEP evaluation criteria, the review team recommends that the Region's performance with respect to this indicator, Response to incidents and Allegations, be found satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS i

in addition to the common performance indicators addressed in the preceding Section 3.0, IMPEP identifies four non-common performance indicators to be used in reviewing Regional programs: (1) Performance Against Operating Plan Goals; (2) Regional Fuel Cycle Inspection Program; (3) SDMP Program; and (4) Uranium Recovery Program. Region Ill's nuclear j materials program does not regulate uranium recovery licensees, so the uranium recovery non-common performance indicator was not evaluated during this IMPEP review. Only the first three Regional non-common performance indicators were applicable to this review.

4.1 Performance Aaainst Ooeratina Plan Goals During this review period, the format and function of the Regional Operating Plan shifted dramatically. The Regional Operating Plan evolved during this review period from a document that previously set broad regional priorities, objectives, goals, and planned accomplishments, with associated resource data, into a document that tracks progress and resource expenditures against highly detailed performance measures (outcome and output measures) and defined metrics. The Operating Plan now contains metrics for quantity, quality, timeliness, efficiency, and effectiveness, that Rlll uses to appraise regional performance.

Like the rest of the Agency, Rlli updates its operating plan quarterly, so the details in the Regional Operating Plan present a current, comprehensive picture of the Region's performance. Because of the new level of detail and amount of data tracked in the Regional Operating Plan, and the increased number of managers and staff reviewing regional performance against the Operating Plan metrics, an IMPEP review cannot and should not match the scrutiny of regional performance against the Regional Operating Plan that is occurring under simultaneous, parallel Agency processes. Therefore, the review team performed a less-detailed assessment of Rlil's performance on thR non-common indicator than in past Rlll IMPEP reviews. Essentially, the Region's performance against Operating Plan goals is being reviewed more frequently,in far greater detail, by more NRC staff now, so

4 l

l Region ill Draft Report Page 18 the IMPEP review team reduced effort on assessing this non-common indicator on this review. I Because the Regional Operating Plan changed, a natural consequence is that the role of this I non-common performance indicator must also change on this and future IMPEP reviews.

For these reasons, the following discussion just covers broad highlights of regional performance against the Operating Plan.

Materials Licensina. During the first 6 months of the review period, Rlll made dramatic progress in reducing the number of pending,"old" pending, and backlogged licensing cases.

l The Region began the review period with 304 pending licensing cases, of which 93 were considered "old"(new applications, amendments, and terminations greater than 90 days pending, and renewals greater than 180 days pending). Over the first 6 months of this review period, Rlli cut the number of pending actions by one-third, and cut the number of "old" pending cases from 93 to 25. The Region made similar cuts in backicgged cases, from 55 at the start of the review period to 7 at the end of fiscal year (FY) 1997. This was a remarkable achievement for Rlll's licensing staff, and it demonstrates clear commitment by Rlli staff and management to eliminating the old, often complex cases and improving licensing timeliness.

At the beginning of FY 1998, the licensing casework statistics leveled off for pending cases and backlogged cases, while the number of pending "old" cases continued to drop. By February 1999, the latest month for which licensing casework statistics were available, NMSS reported that the Region had brought the nurrber of pending cases down to 198 actions, with l only 18 pending "old* cases, and only 7 backlogged licensing cases. For comparison l purposes, Rill averaged about 110 licensing action completions per month during the review period, so the number of 198 pending cases, in the most recently available data, represents less than 2 months of pending licensing actions for the Region. The licensing casework data for the review period is summarized in the following table:

Rlli Licensing Casework Statistics Pending "Old" Pending Backlogged March 1997 304 93 55 FY 1997 Year End 192 25 7 FY 1998 Year End 200 20 6 FY 1999 (as of 2/99) 198 18 7 From this licensing data, the review team concluded that Rill licensing staff made substantial reductions in the pending casework at the start of the review period, then maintained a nearly constant pending licensing casework load of about 1.8 months of licensing work throughout j the rest of the review period. This compares reasonably with the other regions, in terms of months of licensing work pending. The regions ranged from about 1.5 months to 2.6 months of pending work at the end of FY 1998. In terms of gross number of pending actions, Ritt had the highest of all four regions in FY 1998 and as of February 1999, but Rill also had the highest number of licensing action completions by far (1324 completions in FY 1998, vs. 960 completions in Region I). The review team also concluded that the number of backlogged l

y Region 111 Draft Report Page 19 licensing actions dropped sharply at the start of the review period, then remained relatively constant throughout the rest of the review period. The Region showed substantial progress in reducing the number of "old" pending cases and backlogged cases, dropping the numbers to 19 percent and 13 percent, respectively, of the levels at the stuit of the review period.

Overall, the review team concluded that Rlli performed at an appropriate rate on its licensing actions during the review period. Rlll demonstrated rapid licensing progress for the first 6 months of the review period, then steady progress in completing licensing actions for the rest of the review period. The Region considerably reduced the number of "old" pending and backlogged licensing cases, while performing a very high volume of licensing actions throughout the review period. These accomplishments demonstrate effective management of the Rill licensing program, as well as hard work by Rill's materials licensing staff.

Materials inspections. See Section 3.1. Regional performance on materials inspections is compared, in Section 3.1, to timenness goals, rather than total numbers of inspections performed.

Resource Utilization. The review team examined the Rlli budget figures and expenditure data for FY 1998 and FY 1999 ( rough January 2,1999) that were provided by NMSS' Program Management, Policy Deve ment, and Analysis Staff (PMDA)in advance of the RlliIMPEP review. The resource utilu ;on table provided by PMDA is shown later in this Section. The review team discussed ti esource expenditure data with the DNMS Director and Deputy Director, and compared the, PMDA resource data with the Region's own, internally generated resource data. The FY 1998 PMDA data were similar to, but not the same as, the Rlli-generated resource data. The review team tried to resolve the differences between the two sets of data, but was not able to do so. This is noteworthy, since the two sets of resource expenditure information were generated from the same raw data, namely the Rill staff's Regulatory Information Tracking System (RITS)-hours reports. The FY 1999 PMDA data matched the Region's data much more closely, which may indicate that the problem has been resolved this fiscal year. The review team has observed small discrepancies on other Regional IMPEP reviews in the past, and the review team discussed this issue with the DNMS management. The DNMS Division Director emphasized that the Agency needs a method of j tying RITS hours directly to the Operating Plan line items. The review team agrees with Rlli on I this issue, and the review team leader committed to address the RITS-hours reporting issue with PMDA. This problem with the FY 1998 data appears to potentially be an Agency-wide issue, and for the purposes of tne Rlli IMPEP review, resource analysis practices are beyond j

the traditional scope of the IMPEP process. Therefore, the team has no recommendation on this issue, although the review team leader agreed to look into it. For the review team's analysis, PMDA's data are discussed here, because they were taken from regional input provided in response to the FY 2000 President's budget update (December 1998).

In FY 1998, Rlli expended 34.9 full time equivalents (FTE) (direct staff effort) versus 37.7 FTE budgeted for NMSS program activities (93 percent). [ Rill's own resource data show 38.4 FTE direct staff expenditures against 38.7 FTE budgeted for NMSS programs, total, resulting in a higher resource expenditure rate of 99 percent.] For the first quarter of FY 1999, Ritt expended 7.8 FTE versus 9.8 FTE budgeted for the first quarter, for an 80 percent expenditure rate. [For comparison, the Ritt data showed 8.04 FTE expended for the same quarter, which '

results in an expenditure rate slightly closer to the budgeted levels.] In FY 1999, the Region is

Region 111 Draft Report Page 20 budgeted 36.2 FTE for materials programs for the whole year. Data for FY 1998 and FY 1999 (first quarter) reveal that Rill's expenditures are generally close to the levels budgeted for the different materials activities. For instance, in FY 1998, Rlli had a slight overexpenditure on event evaluation, incident response, and allegations activities, whereas Rlli slightly underexpended on fuel cycle and decommissioning activities, according to the data. Region ill materials licensing and materials inspection expenditures nearly matched the budgeted levels in FY 1998. During the first quarter of FY 1999, Rlli expenditures for decommissioning and j materials rulemaking are higher than budgeted levels, whereas allegation activities and fuel J cycle activities appear to be underexpended. Overall, it appeared to the review team that the Region is following the general priorities in the Regional Operating Plan, as indicated by resource expenditures. The review team also concluded that in the first quarter of this fiscal year, it is probably too early to draw conclusions from the FY 1999 expenditure data. In general, the review team observed that Rlli has been successful at keeping expenditures close to budgeted levels, which demonstrates strong resource management.

REGION lli RESOURCE UTILIZATION FY 1998 FY 1999 Program Actmty Annual Expended'  % Annual Budget Expended  %

Budget Budget oct-Dec 2 oct-Dec3 Matenals Licensing 7.4 7.3 99 6.7 1.8 1.8 100 Materials Inspection 11.4 11.4 100 10.7 2.9 2.3 79 Materials Rulemaking 2.8 1.5 54 1.1 0.3 0.5 167 Evt Eval / Incident Response Allegations 39 51 131 48 1.3 0.8 62 l Fuel Cycle 60 49 82 58 1.6 1.1 69 Low-Level Waste 00 00 0 0.0 00 00 Decommissioning 50 40 80 36 1.0 1.3 130 Uranium Recovery 0.0 00 0 00 0.0 00 0 spent Fuel 04 0.4 100 0.4 0.1 Agreement states 08 03 38 3.1 0.8 00 TOTAL 37.7 34.9 93 36.2 9.8 7.8 80

' FY 1998 expenditures from regional input provided in response to the FY 2000 President's tiudget update 12/98.

'FY 1999 budget and expended resources are from September F,1998. through January 2,1999 (i e., fourteen weeks.)

The review team did examine one significant Rlll resource issue in-depth during the IMPEP review. Just before the on-site IMPEP review, as part of routine budget activities, NMSS performed a resource analysis on regionallabor rates in FY 1996 - FY 1998 for materials inspections. The results appeared startling for Rlll. They appeared to show that all regions had an average labor rate of 0.015 to 0.019 FTE/ inspection over the 3 years. However, Rill's i labor rate appeared to increase from 0.015 FTE/ inspection in FY 1996, to 0.020, to 0.022, respectively,in succeeding years. More detailed analysis showed that although Rill's inspection preparation / documentation and travel times were consistent with the other regions, Rill's actual inspection hours appeared far higher than the other three regions (16.3 hrs / inspection in FY 1998, compared with the other three regions, which had 7.2-7.9 hrs / inspection). The review team looked closely at this issue, and discussed it with the DNMS

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Region ill Draft Report Page 21 Branch Chief who compiles Rill's resource statistics, as well as the Fuel Cycle Branch Chief.

They explained, and the review team agrees, that the inspection hours probably include fuel cycle inspection hours and GDP resident inspection hours, along with the materials inspection expenditures, for Rill. The same problem does not appear to affect the data 'or the other three regions. When the review team subtracted the fuel cycle inspection hours and the GDP resident hours from the resource expenditures, the Rlli on-site inspection hours drop significantly to 8.9 hours1.041667e-4 days <br />0.0025 hours <br />1.488095e-5 weeks <br />3.4245e-6 months <br /> / inspection and come closer to the rates of the other three regions.

The Rill supervisors explained that an apparent cause of the problem is the manner in which RITS captures and aggregates staff hours against certain program activities. During the on-site review, Rlli contacted Region ll's fuel cycle staff to address the issue and discuss l possible solutions. The review team concluded that the materials inspection hours shown in the original resource data from NMSS do not indicate actual hours spent on materials inspections (alone). However, the issue serves as another example where the Agency's resource data tracking system does not closely match the materials program activities, and this difference had the potential to lead program managers to erroneous conclusions about regional efforts.

The Region is budgeted for materials rulemaking in FY 1998 and FY 1999, and these I resources are intended to support NMSS rulemaking and guidance-development program initiatives. The Region continues to be a strong contributor to such initiatives. Rlli provided the review team with information showing that Rlli staff and management participated as team members, team leaders, or reviewers of at least 13 guidance-developmen activities. In some cases, such as the NUREG-1556 radiopharmacy an.1 bankruptcy / change of ownership guidance teams, the Region both participated on the writing teams, and also had a supervisor participate on the review teams for the same guides. In addition to the NUREG-1556 activities, Rlli staff or managers participated on NMSS teams involving the Part 35 Risk Assessment, Radiography Cable Break Investigation, Medical Inspection Temporary Instruction, Veterans' Affairs Master Materials License, License Renewal Review and Streamlining, Standard Review l Plan for Decommissioning and License Termination, and a prototype inspection of the U.S.

Department of Energy by NRC's External Regulation Task Force in the area of regional support for NMSS program initiatives, the review team determined that Rill is providing appropriate support for NMSS program activities.

Based on the review team's analysis of the resource expenditures and the Region's productive use of the resources, the review team recommends that the Region's performance with respect to this non-common indicator Performance Against Operating Plan Goals, be found satisfactory.

4.2 Reaional Fuel Cycle Inspection Prooram 4.2.1 Introduction The Ritt fuel cycle inspection program includes the ABB Combustion Engineering fuel fabrication facility in Hematite, Missouri; the Allied Signal uranium conversion facility in Metropolis, Illinois; and two GDPs in Paducah, Kentucky, and Portsmouth, Ohio. The regional fuel cycle inspection program is currently staffed at fu!! ievels. This includes two resident inspectors at each GDP and two region-based inspectors.

Region lll Draft Report Page 22 4.2.2 Status of Fuel Cycle Prooram inspections at fuel facilities (including the two GDPs) are coordinated between NMSS and the regions through an integreted Fuel Cycle Master inspection Plan (MIP). Inspections are ,

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scheduled based on considerations of risk and licensee performance. Rlll uses the general guidance provided in IMC 2600, " Fuel Facility Operational Safety and Safeguards inspection Program" for the Allied Signal and Combustion Engineering facilities, and IMC 2630, " Gaseous Diffusion Plant Operational Safety and Safeguards Inspection Program," for the GDPs, to schedule and plan inspections at the four facilities within the Region's program. At the beginning of each fiscal year, the Region transmits its plan to NMSS for scheduling purposes.

Once this baseline schedule has been approved, all changes are resubmitted throughout the year. The review team evaluated this process and reviewed the Region's effectiveness in adequately implementing both the baseline schedule and all modifications. In general, the review team observed that during the review period, Rlli scheduled inspections according to the requirements in IMC 2600 and IMC 2630. Additionally, any modifications to the initial schedules were based on changes in the performance of the particular licensee. The review team also observed that changes were properly reviewed and approved by regional management and transmitted to NMSS for inclusion in the MIP.

Rlli fuel cycle inspection reports were generally issued in a timely manner when measured against the IMPEP performance indicator of 30 days for routine inspection reports. Instances of late inspection reports were a result of the Region placing a higher priority on ensuring the quality of the reports over timeliness. The review team noted that at the time of the IMPEP review, Rill's average time to issue a fuel facility inspection report was approximately 21 days.

The review team also noted that Rllt has a program in place to summarize performance strengths and weaknesses for each of the fuel cycle facilities. Rlli keeps the " Plant issues Matrix"(PIM) current for each facility, and the PIM is used by both regional and Headquarters inspectors in the planning phase of the inspection process, to focus on areas of weak licensee performance. ,

Currently, Rlli and other regions are using the Inspection Follow-up System (IFS) to track the results of fuel cycle inspections. The IFS system is not Y2k compliant, and NRC plans to replace IFS soon with a new program that currently does not address fuel cycle inspections.

NMSS is working with the Office of the Chief information Officer to extend the capabilities of the Inspection Reporting and Analysis Module (IRAM) of the Office of Nuclear Reactor Regulation's Reactor Program System (RPS) to track the results of fuel cycle inspections, as a replacement for IFS. Work on this effort is scheduled to be completed by August 1999. In parallel with this effort, Rill's Fuel Cycle Branch has begun evaluating options to track the open items from inspection reports to facilitate an effective transition from IFS to the new tracking system.

4.2.3 Technical Quality of Inspections The review team observed that Rlil's fuel cycle inspection findings were well-founded and well-documented throughout the assessment period. The review team evaluated a cross-section of

Region 111 Draft Report Page 23 reports against the requirements in IMC 610, " Inspection Reports," and found that the Rlli inspection reports meet the manual chapter requirements. In general, the reports received proper peer and management review.

Rlli's fuel cycle inspection program, in general, and the specific reports examined as part of tne IMPEP review, appear to focus on the higher-risk functional areas. As mentioned above, Rlll has a program in place to track past issues at each facility. These issues include past inspection findings, events, and routine activities at each site. Rlli maintains the PIM current for each facility, and it is used by the inspectors in the planning phase of the inspection, to focus cn areas that may be weak. The inspection effort does address past findings, and programs are in place to track the status of open inspection items.

The review team evaluated 12 inspection reports written during the review period. These reports covered inspecticas from all four plants in the Region's fuel cycle program and all seven fuel cycle inspectors. The review focused on the quality of the Region's inspection effort and Rill's focus on the safety significance of licensee performance. Additionally, the review team evaluated the Region's follow-up inspection effort to ensure that items opened during previous inspections were tracked and closed in a timely and technically sound manner.  !

In general, the review team noted strong regional performance in this area, with inspection i i

findings focusing on the facility's performance weaknesses, follow-up inspections addressing previously identified items, and inspection findings leading to prompt and appropriate regulatory action.

Allinspections were led by qualified inspectors and, in most cases, supervisory accompaniments were performed on an annual basis.

4.2.4 Technical Staffino and Trainina The staffing of the fuel cycle inspection program in Ritt has remained relatively stable during the review period. Rlll has a senior resident inspector and a resident inspector at both GDPs, and two safety inspectors based out of the regional office. Through a review of Rill's training and qualification records, the review team found that Rlli's fuel cycle inspectors met the qualification requirements of IMC 1246, " Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area," and the associated resident inspector training programs, with two exceptions. Both the senior resident and the resident at the Portsmouth Gaseous Diffusion Plant were appointed to their positions within this review period. Both of these individuals are qualified fuel cycle inspectors, and both will complete their specific position training for resident inspectors during CY 1999.

One challenge Rlll will face over the next few months will be to fill a regional-based fuel cycle inspector position that will become vacant in May 1999, when the incumbent moves to a reactor resident inspector position. The review team found that the current fuel cycle inspector performed a very high volume of inspection work over the past year. Rlll will be challenged to seamlessly fill the vacancy with someone who can quickly step into the position, with appropriate background and skills, and begin conducting quality inspections at the fuel cycle facilities. At a management retreat during the on-site IMPEP review, Rlll decided to post this position, and will begin actively recruiting to fill it.

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Region ill Draft Report Page 24 4.2.5 Incidents and Alleaations During the review period, Rlli received 47 allegations regarding activities at fuel cycle facilities.

As of March 18,1999, only 13 remained open. The review team examined the inspection reports used to close 12 allegations. These reports supported the timely closure of the allegations, and Rlli inspectors presented technically-sound findings in the inspection reports.

Rill's responses to fuel cycle events appeared to be appropriate, throughout the review period, and the Region coordinated with NMSS on fuel cycle incidents, as needed. During this review period, the Rlli incident Response Center (IRC) was activated once in response to a fuel cycle event, for a fire at a fuel cycle facility. The review team found that this activation was conducted appropriately. Ritt has a program in place to ensure full staffing of the IRC, and the region tracks and provides training for critical Branch personnel, to support their incident response duties. In general, the review team observed that the Rlli IRC is well-staffed, and appears prepared to support an event at a fuel cycle facility.

Based on the IMPEP evaluation criteria, the review team recommends that the Region's performance with respect to this non-common performance indicator, Regional Fuel Cycle Inspection Program, be found satisfactory.

4.3 SDMP The SDMP includes sites that involve unique and difficult issues requiring special attention to ensure timely decommissioning. The SDMP sites may have buildings, former waste disposal areas,large piles of tailings, and groundwater and/or soil contamination. In all cases the issues associated with the sites are sufficiently complex that they are included in this special NRC program.

4.3.1 Quality of SDMP Decommissionina Reviews Region 111 does not have project management or licensing responsibility for SDMP sites, which is the responsibility of NMSS/DWM. Therefore, the review team did not review this performance area.

l 4.3.2 Financial Assurance for Decommissionina As noted in Section 4.3.1, Rlli does not have responsibility for project management of SDMP sites. Financial assurance reviews for SDMP sites are not performed by Rill, so the review team did not review this performance area as it applies to SDMP sites. Section 3.4, " Technical l

Quality of Licensing Actions," addresses Rlll's financial assurance reviews for non-SDMP sites.

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4.3.3 Termination Radioloaical Surveys Within this performance area, the review team assessed how the Region ensures that f sufficient radiological surveys are being performed before license termination and site release, as outlined in IMC 2605, and that licensee survey results are validated by the Region through a closeout inspection or confirmatory survey, where necessary. Only one Rlli SDMP site, the

Region 111 Draft Report Page 25 former Clevite Corporation site in Cleveland, Ohio, has been removed from the SDMP list since the last IMPEP review. The review team examined the termination surveys for that site and also examined a survey for the release of " Area D" at the RMI Environmental Services site in Ashtabula, Ohio.

The review team concluded that Rlll's surveys and decommissioning inspections are adequate to ensure that residual radioactivity levels comply with release criteria. The review team also found that Rlli is performing confirmatory surveys for licensees' sites, as outlined in IMC 2605 and IP 87104," Decommissioning Inspection Procedure for Materials Licensees." Rlll routinely validates licensee survey results through a closecut inspection or confirmatory survey, given the extent and significance of any residual contamination. Section 3.2 of this report,

" Technical Quality of Inspections," also discusses Rill's performance of termination surveys for non-SDMP sites.

4.3.4 Inspections The review team examined the technical quality of inspections and surveys for SDMP decommissioning inspections. (See Section 3.2, " Technical Quality of Inspections," for additionalinformation on the performance of non-SDMP inspections by Rlli decommissioning staff.) As for the SDMP sites, the review team found that these sites are inspected in accordance with IMC 2602," Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees," and !P 87104.

Rlll's SDMP decommissioning inspections were planned, carried out, and documented in accordance with IP 87104. Inspection documentation was complete, and with one exception, Rill issued inspection results within 30 days. Inspections were well-coordinated with other groups, in a number of cases, SDMP project managers from NMSS/DWM participated in the inspections. In addition, State personnel accompanied the team on many decommissioning inspections. In the response to the questionnaire, Region lit stated that it has maintained an outstanding relationship with affected States for SDMP sites and other sites undergoing i

decommissioning, and the review team agrees with the Region's assessment, based on information obtained in interviews and in the inspection files. Appendix F identifies decommissioning cases reviewed by the team. l 4.3.5 Staff Qualifications Qualifications of the Decommissioning Branch staff are discussed in Section 3.3," Technical Staffing and Training." In general, Rlll's decommissioning staff were well-qualified through training and work experience to perform decommissioning license reviews and inspections. 1 1

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4.3.6 SDMP Milestones Within the SDMP program, Rlliis responsible for inspections and NRC surveys at SDMP sites.

SDMP milestones are often tied to the decommissioning and final survey plan reviews 3

conducted by NMSS/DWM and thus require close coordination between Headquarters and the i Regions. Rlil staff plans and schedules inspections in consultation with DWM to ensure that l the scope of each inspection is appropriate, and that the inspections are timely. In some j f cases during the review period, inspections were deferred by Rill and NMSS because no l

l Region ill Draft Report Page 26 l activities were being performed at the SDMP site. NMSS/DWM staff ar. companied Rill inspectors on many of the SDMP inspections during the review period. Except for coordinating SDMP inspection activities with NMSS/DWM, the Region has no specific responsibility to track decommissioning milestones or update the SDMP database. With respect to the SDMP inspection coordination with DWM, the review team observed that Rlli was performing in a successful manner in this performance area.

4.3.7 SDMP Summary Based on the IMPEP evaluation criteria, the review team recommends that the Region's performance with respect to this non-common performance indicator, SDMP, be found j satisfactory.

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found Region Ill's performance to be satisfactory for all common and non-common indicators. Accordingly, the review team recommends that the MRB find the Rl!I nuclear materiah, fuel cycle inspection, and SDMP programs to be adequate to protect public health and safety.

I Below is a summary list of recommendations, as mentioned in earlier sections of the report, for evaluation and implementation, as appropriate, by Rill and NMSS.

RECOMMENDATIONS:

1. The review team recommends that NMSS revise all inspection field notes to include the location (s) that the inspection is performed. (Section 3.2)

2. The review team recommends that Rlli implement the tools prescribed in the Decommissioning Handbook for ensuring that decommissioning and license termination reviews are complete and fully documented. (Section 3.4)

3. The review team recommends that NMSS evaluate the causes for omission of reference documents from NMED reports, and take appropriate follow-up action in response to any findings. (Section 3.5)

4. The review team recommends that Rlli develop and implement a process to remove allegation material from the docket files. (Section 3.5)

5. The review team recommends that Rlll train the DNMS staff on what allegation language, if any, is acceptable to place into the docket file. (Section 3.5) l L

f Region !!! Draft Report Page 27 SUGGESTIONS: I l

The review team did not identify any suggestions for Rlli on this IMPEP review.

GOOD PRACTICES:

I l Although the review team noted a number of areas where Rlli exhibited strong performance, the review team did not identify specific " good practices" that differed greatly from processes

! used by other regional and Agreement State programs. The Rift materials program demonstrated sound, steady performance throughout the review period, using standard NRC practices.

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l LIST OF APPENDICES AND ATTACHMENTS A'ppendix A iMPEP Review Team Members ,

Appendix B Region lil Organization Charts (TO BE PROVIDED WITH THE PROPOSED FINAL REPORT]

Appendix C Inspection Casework Reviews l

l Appendix D License Casework Reviews Appendix E incident Casework Reviews Appendix F SDMP and Decommissioning Files Reviewed l

Appendix G - Region lil's Questionnaire Response f

(TO BE PROVIDED WITH THE PROPOSED FINAL REPORT]

Attachment 1 Region lil's Response to Review Findings

[TO BE PROVIDED WITH THE PROPOSED FINAL REPORT}

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APPENDIX A IMPEP REVIEW TEAM MEMBERS

! Name Area of Responsibility Scott Moore, NMSS/IMNS Team Leader l Status of the Materials inspection Program Technical Staffing and Training

! . Performance Against Operating Plan Goals ]

Sheri A. Minnick, Region I, DNMS Technical Quality of Inspections inspection Accompaniments Cynthia Sanders, State of Georgia Technical Quality of Licensing Actions Kevin Hsueh, OSP Response to incido,1ts and Allegations Garrett Smith, NMSS/FCSS ' Regional Fuel Cycle Inspection Program James Kenne. -., NMSS/DWM Decommissioning /SDMP l

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1 APPENDIX B l REGIONlli  !

DIVISION OF NUCLEAR MATERIALS SAFETY ORGANIZATION CHART

[TO BE PROVIDED IN HARD COPY WITH THE PROPOSED FINAL REPORTJ f

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APPENDIX C INSPECTION CASEWORK REVIEWS NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

File No. 01 Licensee: Mallinckrodt Medical, Inc. License No.: 24-17450-02MD Location: St. Paul, MN Inspection Type: Routine, unannounced License Type: 02500, Nuclear Pharmacy Priority: 1 Inspection Date: 4/29/97 Inspector: JC File No. 02 Licensee: RC Associates License No.: 21-25870-01 Location: Saginaw, MI Inspection Type: Routine, unannounced License Type: 03121, Portable Gauge Priority: 5 Inspection Date: 5/28/97 Inspector: AK Comments:

a) Branch Chief signature on field notes greater than 30 days post inspection.

File No. 03 Licensee: RC Associates License No.: 21-25870-01 Location: Saginaw, MI Inspection Type: Special, unannounced License Type: 03121, Portable Gauge Priority: 5 Inspection Date: 3/6/97 Inspector. JJ Comments:

a) Field note completion three months post inspection.

b) Incorrect License Type (03221) and priority (4) listed on field notes.

File No. 04 Licensee: Concordia College License No.: SNM-773 Location: Moorhead, MN Inspection Type: routine, unannounced License Type: 22120, PuBe source Priority: 5 Inspection Date: 6/2/97 inspector: RH L

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Region l11 Draft Report Page C.2 l l-inspection Casework Reviews File No. 05 Licensee: St. Mary's Medical Center License No.: 13-03226-04 Location: Evansville, IN Inspection Type: special, unannounced License Type: 02120, Medical QMP Priority: 3 Inspection Date: 6/12/97 Inspector: WS, TG i Comments:

a) Two locations of use authorized on license, however no place in field notes to document location (s) of inspection.

File No. 06 Licensee: Midwest Imaging Diagnostic, Inc. License No.: 34-26753-01 Location: Cincinnati, OH inspection Type: Special, unannounced License Type: 02200, Medical Private QMP Priority: 3 Inspection Date: 7/21/97 Inspector: DW Comments:

a) _Two locations of use authorized on license, however no place in field notes to document location (s) of inspection.

File No. 07 Licensee: VA Edward Hines Jr. Med. Center License No.: 12-01087-01

' Location: Hines, IL Inspection Type: Routine,' unannounced License Type: 02110, Medical Broad Priority: 1 Inspection Date: 8/15/97 Inspector: JC Comments:

a) Field notes issued greater than 30 days post inspection.

File No. 08 Licensee: Oakwood Hospital License No.: 21-04515-01 Location:

Dearbom,

MI Inspection Type: Routine, unannounced License Type: 02230, HDR Priority: 1 Inspection Dato: 9/23/97 Inspector: SM File No. 09 Licensee: The Ohmart Corporation License No.: 34-00639-01 Location: Cincinnati, OH inspection Type: Routine, unannounced

- License Type: 03212, Manufacturing Priority: 3 inspection Date: 10/28/97 Inspector: DW l

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7 Region 111 Draft Report Page C.3 Inspection Casework Reviews

' File No.10 Licensee: Longview Inspection, Inc. License No.: 48-17480-01 Location: Brookfield, WI Inspection Type: Routine, unannounced l License Type: 03320, Radiography Priority: 1 Inspection Date: 11/3/97-11/5/97 Inspector: MM Comments:

a) Field site included in the inspection.

File No.11 Licensee: Longview inspection, Inc. License No.: 48-17480-01 Location: Brookfield, WI Inspection Type: Unannounced, field site License Type: 03320, Radiography Priority: 1 Inspection Date: 6/3/97 Inspector: TG File No.12 Licensee: SW Indiana Rad. Oncology Center License No.: 13-25945 01 Location: Evansville, IN Inspection Type: Routine, unannounced License Type: 02300, teletherapy Priority: 3 Inspection Date: 4/9/98 Inspector: SM File No.13 Licensee: University Hospital of Bedford License No.: 34-17783-01 Location: Bedford, Ohio inspection Type: Routine, unannounced License Type: 02120, medica: Priority: 3 Inspection Date: 4/7/98 Inspector: GP File No.14 Licensee: Denison University License No.: 34-06325-04 Location: Granville, Ohio inspection Type: Routine, unannounced License Type: 03620, R&D other Priority: 5 Inspection Date: 4/16/98 inspector: TG File No.15 Licensee: MQS Inspection, Inc. License No.: 12-00622-07 Location: Elk Grove Village, IL Inspection Type: Special

-License Type: 03320, Radiography Priority: 1 Inspection Date: 11/19/97-2/10/98 Inspector: DP

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4 1 Region ill Draft Report Page C.4 Inspection Casework Reviews File No.16 Licensee: Mallinckrodt Medical, Inc. License No.: 24-04206-10MD Location: Warren, Mt inspection Type: Rcutine, unannounced l License Type: 02500, Radiopharmacy Priority: 1 l Inspection Date: 1/8/99 Inspector: JC l I

Comments:

a) File reviewed for inspection of special condition regarding Y2K. Documentation under special license conditions or issues (Y2K) indicated "none".

File No.17 Licensee: Midwest Mobile Imaging License No.: 13-20658-01 Location: Valparaiso, IN Inspection Type: Routine, unannounced License Type: 02220, Mobile Nuclear Medicine Priority: 2 Inspection Date: 10/27-28/98 Inspector: RG Comments:

a) File reviewed for inspection of special condition regarding Y2K. Documentation under special license conditions or issues (Y2K) indicated "none".

File No.18 Licensee: Abott Northwestern Hospital License No.: 22-04588-01 Location: Minneapolis, MN Inspection Type: Routine, unannounced License Type: 02120, Medical, QMP Priority: 1 Inspection Date: 10/21/98 Inspector: DP File No.19 Licensee: Lester E. Cox Medical Center License No.: 24-01143-06 Location: Springfield, MO Inspection Type: Routine, unannounced License Type: 02230 HDR Priority: 1 Inspection Date: 12/3/98 Inspector. TY File No. 20 Licensee: Wendt-Bristol Healthcare Services Corp. License No.: 34-32104-01 l.ocation: Columbus, OH Inspection Type: initial, announced License Type: 02230, HDR Priority: 1 Inspection Date: 1/14/99 Inspector. TG

Region til Draft Report Page C.5 Inspection Casework Reviews INSPECTOR ACCOMPANIME :TS The following inspection accompaniments were performed as part of the on-site IMPEP review.

Accompaniment No.: 1 Licensee: Cardiovascular Clinics License No.: 13-32122-01 Location: Merrillville, IN Inspection Type: Initial, announced License Type: 02201, Medical Priority: 5 Inspection Date: 3/9/99 Inspector: SM Accompaniment No.: 2 Licensee: Purdue University License No.: 13-02812-04 Location: West Lafayette, IN Inspection Type: Routine, unannounced License Type: 01100, Academic Broad Priority: 2 Inspection Date: 3/10/99-3/11/99 Inspector: KN Accompaniment No.: 3 Licensee: Wabash College License No.: 13-07419-02 Location: Crawfordsville, IN Inspection Type: Routine, unannounced License Type: 03620,22120, R&D Other, PuBe Priority: 5 Inspection Date: 3/11/99 Inspector: RH I

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

File No.: 1 Licensee: Advanced Cardiac Health Care doing business as (d/b/a) Bronson Medical Group License No.: 21-26784-01 Location: Kalamazoo, M1 Amendment No.: NA License Type: Medical Private Practice Type of Action: New Date issued: 04/28/97 License Reviewer: GW File No.: 2 Licensee: MNC, Inc.,

d/b/a Metropolitan Imaging Center License No.: 48-32008-01 Location: Milwaukee, WI Amendment No.: NA License Type: Mobile Nuclear Medical Services Type of Action: New Date issued: 10/31/97 License Reviewer: CC File No.: 3 Licensee: East Jordan iron Works, Inc. License No.: 21-13462-02 Location: East Jordan, MI Amendment No.: 09 License Type: Fixed Gauge Type of Action: Renewal Date issued: 11/03/98 License Reviewer: LH File No.: 4 Licensee: Soil Materials Engineering, Inc. License No.: 21-17158-02 Location: Plymouth, M1 Amendment No.: 09 License Type: Portable Gauge Type of Action: Renewal l Date issued: 12/17/97 License Reviewer: JM File No.: 5 Licensee: Saint Louis University License No.: M-00196-07 Location: St. Louis, MO Amendment No.: 23 License Type: Medical Institution Broad Type of Action: Renewal Date issued: 07/11/97 License Reviewer: KN

Region ll! Draft Report Page D.2 Licensing Casework Reviews File No.: 6 Licensee: American Engineering Testing, Inc. Licente No.: 22-20271-02 Location: St. Paul, MN Amendment No.: NA License Type: Industrial Radiography Temporary Job Site Type of Action: New Date issued: 03/16/98 License Reviewer: JM File No.: 7 Licensee: Padia Environmental; inc. License No.: 34-32101-01]

Location: Worthington, OH Amendment No.: NA License Type: Portable Gauge Type of Action: New Date issued: 07/07/98 License Reviewer: WR Comment:

a) The LTS program code for this license was listed as 3212 (Manufacturing and Distribution Type B Broad). A review of the license revealed that this is a Portable

-Gauge license, so the program code should have been 3121. This finding was discussed with the license reviewer, and Region 111 took action to correct the program code.

File No.: 8:

Licensee: Purdue University License No.: 13-02812-04 Location: West Lafayette, IN Amendment No.: 66 License Type: Academic Type A Broad Type of Action: Amendment Date issued: 07/18/97 License Reviewer: CF File No.: 9 Licensee: Shared Imaging Services License No.: 48-20331-01 Location: Prairie Du Sac, WI Amendment No.: 18 License Type: Mobile Nuclear Medical 3ervices Type of Action: Amendment Date issued: 08/01/97 License Reviewer. MW File No.: 10 Licensee: Sterigenics international License No.: 04-19644-01 Location: Fremont, CA Amendment No.: 36 License Type: Irradiators other >10,000 Curies Type of Action: Termination Date issued: 01/20/98 License Reviewer PP Comment:

a) License Number 04-19644-01 was terminated, and was replaced with the issuance of a new NRC License Number 34-32057-01. This termination was due only to a change in the licensee's mailing address.

r-Region til Draft Report Page D.3

! Licensing Casework Reviews File No.: 11 Licensee: University Laboratories, Inc. License No.: 21-26212-01 Location: Novi, MI Amendment No.: 02 License Type: Byproduct Material Possession Only Type of Action: Termination -

Date Issued: 05/04/98 License Reviewer: CG Comment:

a) This action involved the termination of a nickel-63 detector cell authorized for storage only, incident to final disposition. It was returned to the manufacturer for disposition.

File No.: 12 Licensee: Hitachi Medical Corporation of America License No.: 34-26756-01 Location: Twinsburg, OH Amendment No.: 01 License Type: Research and Development Type of Action: Amendment Date issued: 11/05/97 License Reviewer: PP Comment:

a) The LTS program code for this license was listed as 3620 (Research and Development). A review of the license revealed that this is a Measuring Systems -

Other license, so the program code should have been 3124. This finding was discussed with the license reviewer, and Region ll1 took action to correct the program code.

File No.: 13 Licensee: SMV License No.: 34 26121-01 Location: Twinsburg, OH Amendment No.: 10 License Type: Measuring Systems Other Type of Action: Amendment Date issued: 04/13/98 License Reviewer: GW File No.: 14 Licensee: Battelle Columbus Division License No.: 070-00008 Location: Columbus, OH Amendment No.: 14 License Type: Hot Cell Operations Type of Action: Amendment Date issued: 11/24/97 License Reviewer MM File No.: 15 Licensee: Department of the Army License No.: 12-00722-07 I Location: Rock Island, IL Amendment No.: 21 License Type: Measuring Systerns Other Type of Action: Renewal Date issued: 04/25/97 License Reviewer: KN L

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l APPENDIX E

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I i INCIDENT CASEWORK REVIEWS NOTE: ALL INCIDENTS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP  !

TEAM.

i File No.: 1 l Licensee: Cleveland Clinic Foundation Licensee No.: 34-00466-01 Site of incident: Cleveland, OH Incident Log No.: PNO-ill-98-043 Date of incident: 8/11/98 Type of incident: Misadministration Investigation Date: 9/9/98 Type of Investigation: On-site Summary of incident and Final Disposition: A misadministration event involved the l administration of approximately 17 mci of Y-90 labeled antibody instead of 28.5 mci to a patient. The event occurred because a project scientist who prepared the dose relied on readings from a dose calibrator, which did not coincide with volumetric calculations that were based on assay data provided by the Y-90 supplier. The project scientist decreased the volume of the dose until calibrator readings were within acceptable levels. The change in the injection volume resulted in the underdose to the patient.

Comments: Inspection report (NUDOCS accession number: 9810200085) could not be found l on the corresponding NMED records. 1 i

File No.: 2 Licensee: Harper Hospital Licensee No.: 21-04127-02 Site of Incident: Detroit, MI incident lod No.: PNO-ill-98-028 Date of incident: 3/19/98-3/20/98 Type of incident: Misadministration Investigation Date: 3/26/98-3/27/98 Type of Investigation: On-site Summary of Incident and Final Disposition: Treatments to wrong site. During the course of treatment, the licensee used a High Dose Rate (HDR) remote afterloader with a sealed source containing approximately 6.6 Ci of Ir-192. The primary cause of the misadministration was due to programmatic weakness in the implementation of the licensee's quality management program.

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Region ill Draft Report Page E.2 i Incident Casework Reviews File No.: 3 J Licensee: McLaren Regional Medical Center Licensee No.: 21-04171-04 Site of incident: Flint, MI incident Log No.: PNO-Ill-97-090 Date of incident: 11/10/97 Type of Incident: Misadministration ,

investigation Date: 11/17/97 Type of investigation: On-site j l

Summary of Incident and Final Disposition: A patient was administrated 4.6 mci of I-131 ]

instead of the prescribed 8 mci. The patient was being treated for a hyperthyroid condition. l The cause of this event was that the technologist administering the dosage failed to read the label on the dose container and to vetify that dose container was empty prior to completing the administration.

Comments: Inspection report (NUDOCS accession number: 9712300053) could not be found 1 on the corresponding NMED record.

File No.: 4 Licensee: Community Hospitals of Indiana, Inc. Licensee No.: 13-06009-01 Site of Incident: Indianapolis, IN Incident Log No.: PNO-lll-98-053 Date of incident: 11/3/98 Type of Incident: Lost Source  !

Investigetion Date: 12/1/98-12/2/98 Type of Investigation: On-site Summary of incident and Final Disposition: Loss of three 376 pCi1-125 brachytherapy seeds.

The cause of this event was that the licensee did not secure from unauthorized removal or limit access to the I-125 brachytherapy sources, nor did the licensee control and maintain constant surveillance of this licensed material.

I Comments: Inspection report (NUDOCS accession number: 9901190197) could not be found on the corresponding NMED records.

File No.: 5 Licensee: Bowser-Morner, Inc. lacensee No.: 34-17390-01 l l

Site of Incident: Dayton, OH Incident Log No.: PNO-ill-97-060 Date of incident: 7/25/97 Type of incident: Stolen source Investigation Date: 7/25/97 Type of Investigation: On-site Summary of Incident and Final Disposition: A Troxler moisture / density gauge was stolen from the back of a locked pickup truck parked at an employee's residence. The truck door was forced open, and the chain securing the device was cut. The gauge contained 9 mci of Cs-137 and 40 mci of Am-Be.

Comments: Licensee report (NUDOCS accession number: 9709080023) could not be found on the corresponding NMED records.

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Region 111 Draft Report Page E.3 Incident Casework Reviews File No.: 6 Licensee: Geotechnical Consultants, Inc. Licensee No.: 34-26022-01 i Site of incident: Westerville, OH Incident Log No.: N/A j Date of incident: 6/13/98 Type of incident: Stolen source

. Stolen Source investigation Date: 7/8-7/9/98 Type of investigation: On-site i

Summary of Incident and Final Disposition: Theft and recovery of a moisture / density gauge.

The gauge was stolen form a parked vehicle in a parking lot. The gauge contains a 50 mci f' Am Be source and a 10 mci Cs-137 source. An individual contacted the licensee RSO, approximately three hours after the theft, and reported that he had found the device.

File No.: 7 Licensee: Wisconsin Centrifugal,Inc Licensee No.: 48-11641-01 Site of incident: Waukesha, WI Incident Log No.: PNO-Ill-98-005 Date of Incident: 1/13/98 Type of incident: Equipment Malfunction investigation Date: 1/14/98,1/15/98,1/20/98 Type of Investigation: On-site Summary of incident and Final Disposition: A failure of a spring-loaded shutter on a i

radiography device which is located in a shielded room. The unit contains a 669.5 Ci Co-60 source and has a spring-loaded shutter that is closed when the unit is not energized. The cause of the unretracted source event was that the broken shutter spring did not maintain the source in the shielded position after the exposure time had elapsed.

File No.: 8 Licensee: University of Minnesota Licensee No.: 22-00187-46 Site of incident: Minneapolis, MN Incident Log No.: PNO-ill-98-021 Date of incident: 2/6/98 Type of incident: Loss of control of radioactive material investigation Date: 3/2/98-3/4/98 Type of Investigation: On-site Summary of incident and Final Disposition: A ribbon containing six tr-192 seeds, with a total activity of approximately 3 mci, was found to nave been left in an applicator following a brachytherapy procedure. The incident occurred because the personnel responsible for performing an inventory of brachytherapy sources and performing surveys of the applicator / needles after source removal, did not follow the procedures.

(

F-Region 111 Draft Report Page E.4 incident Casework Reviews File No.: 9 Licensee: Syncor International Corp. Licensee No.: 04 26507-01 Site of Incident: St. Louis, MO Incident Log No.: PNO Ill-97-040 Date of incident: 5/6/97 Type of Incident: Contamination Investigation Date: 5/27/97-5/30/97 Type of Investigation: On-site Summary of Incident and Final Disposition: A Syncur driver picked up two empty packages from a client facility. Upon return to the Syncor facility, Syncor personnel detected removable contamination on the outside of the packages of 1,400,000 dpm. The cause of the event was a dropped needle at the client's facility which contained Tc-99m. This dropped needle resulted in contamination of the outside of the packages retuming to Syncor.

File No.: 10 Licensee: Mallinckrodt Medical, Inc. Licensee No.: 24-04206-01 Site of Incident: Maryland Heights, MO Incident Log No.: PNO-Ill-97-045 Date of incident: 5/14/97-5/15/97 Type of incident: Overexposure Investigation Date: 5/16/97,5/22/97,5/29/97 Type of Investigation : On-Site Summary of incident and Final Disposition: An employee went home without properly frisking himself for contamination. When returned to work the next day, he performed a contamination survey of himself and detected significant levels of contamination on his left thumb. The isotope was determined to be Re-186. The employee became contaminated while handling contaminated materials with a faulty glove. Contaminated locations in the employee's vehicle and home were decontaminated by the licensee to remove loose contamination.

Comments: Licensee report (NUDOCS accession number: 9707250074) could not be found on the corresponding NMED records.

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APPENDIX F REGION lil SDMP AND DECOMMISSIONING FILES REVIEWED File No.1-Licensee: Aerospace America (formerly Wellman Bronze m.1d Aluminum Company)

Location: Bay City, MI License No.: STB-00136 (terminated)

License Type: Source Material File No. 2 Licensee: General Electric Co., Tungsten Products Plant

' Location: Euclid, OH License No.: SMB-191 -

License Type: Source Material File No. 3:

Licensee: ' Department of the Army Location: Independence, MO (Lake City Ammunition Plant)

License No.: SUB-1380 License Type: Source Material File No. 4:

Licensee: RMI Environmental Services Location: Ashtabula, OH License No.: SMB-602 License Type: Source Material File No. 5 Licensee: Bayer Corporation

. Location: Kansas City, MO License No.: 24-03830-01 License Type: Measuring Systems, Fixed Gauges File No. 6 Licensee: Battelle Memorial Institute Location: Columbus, OH License No.: - SNM-7 License Type: Reactor and Fuel Research File No. 7 Licensee: American' Smelting and Refining Co.

Location: Whiting, IN License No.: SUB-0465 (terminated)

License Type: Source Material

F l

Region !!! Draft Report Page F.2 SDMP and Decommissioning Files Reviewed Files No. 8,9, & 10.

Licensee: Clevite Corporation (now Gould Electronics)

Location: Cleveland, OH l

License No.: SNM-183 (terminated)

License Type: Source Material File No.11 Licensee: Metropolitan Council Wastewater Services Location: St. Paul, MN License No.: 22-18829-03 License Type: Measuring Systems, Gas Chromatograpns File No.12 Licensee: Mallinckrodt Specialty Chemical Co.

Location: St. Louis, MO l License No.: 24-0584-04 l License Type: Research and Development Type B Broad l

1 I

File No.13 Licensee: Monsanto Company )

l Location: St. Louis, MO License No.: 24-01113-23 l License Type: Research and Development l File No.14 Licensee: University of Cincinnati Location: Cincinnati, OH License No. 34-06903-09 License Type: Exempt Distribution File No.15:

Licensee: Merrill Pharmaceutical (now Hoechst Marion Roussel)

Location: Cincinnati, OH License No.: 34-03643-01 License Type: Research and Development Type B Broad File No.16 Licensee: McDermott Technology, Inc.

Location: Alliance, OH License No.: 34-03043-03 SUB-1259 License Type: Research and Development Type A Broad Source Material

n ATTACHMENT 1 REGION lil'S RESPONSE TO REVIEW FINDINGS ldd

- [The response from Rlli on this DRAFT IMPEP REPORT will be inc u e here, in full, as part of the PROPOSED FINAL REPORT,  !

and pro,ided to the MRB,]

I l

l