ML20236W386

Draft Rept, Integrated Matl Performance Evaluation Program Review of Kansas Agreement State Program, 980615-19

ML20236W386
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Issue date:	07/22/1998
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l-INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF KANSAS AGREEMENT STATE PROGRAM June 15-19,1998 1

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DRAFT REPORT l

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i U.S. Nuclear Regulatory Commission )

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9800050244 980722 PDR STPRG ESOK l

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l Kansas Draft Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Kansas radiation control prograrn. The review was conducted during the period June 15-19,1998, by a revi3w team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Arkansas. 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 l Reaister on October 16,1997, and the November 25,1997, revised NRC Management  !

I Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period May 19,1995, to June 19,1998, were discussed with Kansas mariagement on June 19,1998.

[A paragraph on the results of the MRB meeting will be included here in the final report.]

The Kansas Agreement State program is administered by the Secretary, Department of Health and Environment (DHE), who reports directly to the Governor. The radiation control program is administered by the Radiation Control Sedion (RCS), under the direction of the Bureau of Air and Radiation, Division of Environment. DHC and RCS organ zation charts are included as l Appendix B. The radioactive materials inspectio,' program is administered by the supervisor of the X-Ray and Materials Unit, under the direction oi +he RCS radiation control program director (RCPD).

At the time of the review, the Kansas program regulated approximately 315 specific licenses, including manufacturers, broad academic programs, broad medical programs, brachytherapy, high dose afterloaders, nuclear pharmacies and industrial radiographer.

The review secused on the materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Kansas.

In preparation for the review, a questionnaire addressing the common and non-common performance indicators was sent to the State on February 25,1998. The State provided a response to the questionnaire on May 18,1998. During the review, discussions with the State ,

staff resulted in the responses being further developed. A copy of the final response is included  !

in Appendix F of this report.

1 The review team's general approach for conduct of this review consisted of: (1) examination of Kansas' response to the questionnaire; (2) review of applicable Kansas statutes and regulations; (3) analysis of quantitative information from the radiation control program licensing i and inspection data base; (4) technical review of selected licensing and inspection actions; j (5) field accompaniments of three Kansas inspectors; and (6) interviews with staff and management to answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator i and made a preliminary assessment of the radiation control program's performance. I Section 2 below discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-1 l i

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Kansas Draft Report Page 2 common performance indicators, and Section 5 summarizes the review team's findings, recornmendations, and suggestions. Recommendations made by the review team are comments that relate directly to program performance by the State. A response is requested from the State to all recommendations in the final report. Suggestions made by the review j

team are comments that the review team believes could enhance the State's program. The i State is requested to consider suggestions, but no response is requested.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVlOUS REVIEWS During the previous routine review, which concluded on May 19,1995, three comments and recommendations were made and the results transmitted to James O'Connell, Secretary, DHE, on October 31,1995. The team's review of the current status of these recommendations is as follows:

(1) The Kansas program had not adopted amendments equivalent to three NRC regulatory amendments: " Emergency Preparedness for Fuel Cycle and Other Radioactive Material Licensees," 10 CFR Parts 30,40, and 70; " Safety Requirements for Industrial Radiographic Equipment," 10 CFR Part 34; and " Notification of incidents," 10 CFR Parts 30,40, and 70. In addition, the requirements of the State's regulation on financial j assurance for decommissioning were not compatible since they differed significantly {

from the NRC 10 CFR Parts 30,40, and 70 Decommissioning Rule which became effective July 27,1988. It was noted in regard to the Emergency Preparedness Rule that at the time of the review, there were no major manufacturers or processors in Kansas and that perhaps no licensee was authorized to possess radioactive materials in excess of the criteria specified in 10 CFR 30.72, Schedule C, in which case the rule was not required. It was recommended that an audit of licenses be performed as soon as possible, to determine if adoption of the Emergency Preparedness Rule, as discussed 1 above, is required. The other rules should be promulgated as soon as possible, and license conditions should not be used in substitution for the Industrial Radiography Equipment Rule.

Current Status: The Notification of incidents Rule, the Emergency Preparedness Rule, and the revised Decommissioning Rule became effective November 1,1996. The industrial Radiography Equipment Rule was not formally adopted by the State. The State is currently enforcing this rule by license condition. The State advised that, immediately after the previous review, the former program director conducted a review of licensees and determined that none of the licensees met the possession limits i specified in the Emergency Preparedness Rule. The " Safety Requirements for Industrial Radiographic Equipment" Rule was re-evaluated under the new Commission Policy Statement on Adequaev and Compatibility and will be addressed in Section 4.1.2.

This recommendation is closet (2) The Kansas program should modify the informal policy of waiting for the Suggested State Regulation (SSR) to be issued before starting the adoption of a rule or amendm6nt which is required for compatibility. Consideration should be given to adding a policy provision which requires drafting a proposed rule based directly on the equivalent NRC rule if an SSR is not available in time to permit adoption of a Kansas rule which would become effective within 3 years after NRC adopts the rule.

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Current Status: The State advised they are aware of the importance of adopting rules j or amendments which are required for compatibility within the three-year time requirement. Therefore,if the SSR is not available, the State's policy is to base equivalent Kansas regulations on the NRC rule, with every effort made to meet the three-year time limit. This recommendation is closed.

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l (3) If the response to an actualincident is to be used as a basis to meet the NRC guideline l for emergency drills, we recommend that there should be a formal evaluation of the response actions compared to the planned actions to provide a feedback of lessons learned, and to form the basis for modifications to the plan or to provide additional training of responders, as indicated. The plan itself should also be modified, if necessary, to provide guidance for such a critique.

Current Status: As a result of this recommendation, procedure RHS-47 " Emergency Response Documentation" was developed to provide guidance for an evaluation of the  !

response actions compared to the planned actions. This recommendation is closed.

1 3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five conimon performance indicators to be uscd in reviewing both NRC Regional and Agreement State pwwains. These indicators are: (1) Status of Materials j 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 team's review of the State's inspection priorities, as documented in procedure RHS-7,

" Inspection Priority System Radioactive Materials" dated January 3,1986, showed that the State's inspection frequencies for the various types or groups of licenses are at least as frequent as similar license types or groups listed in the frequency schedule in the NRC inspection Manual Chapter (IMC) 2800. Some licensees, such as medical private practice and portable gauge licensees are inspected every 4 years while the NRC inspects them every 5 years.

The staff informed the team that the current tracking system projects the next inspection due date and is able to sort inspection data by type of license, name, priority, and inspection dates.

All history for a particular license, such as types and number of violations or recommendations from previous inspections and dates of previous inspections must be extracted manually from the specific licensee's file. Program management explained that their old D-Base ill program is outdated and that funding has been approved to acquire a new computer system that will i provide the capabilities needed to track inspection and ccmpliance data.

The supervisor stated that every 6 months, he prints a list of licenses with inspections due in the next 6 months. The inspectors are given the list and divide the inspections among themselves. Management does not assign inspections by priority and geographicallocation.

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Kansas Draft Report Page 4 Once an inspection is completed, the inspectcr updates the tracking system. The supervisor monitors the tracking system monthly to ensure that inspections have been performed and the dates in the tracking system have been changed by the inspector.

In their response to the questionnaire, Kansas indicated that as of May 20,1998, only four licenses identified as requiring core inspections in IMC 2000 were overdue by more than 25 percent of the NRC frequency. These inspections were performed during the week of June 1-5, 1998, with the inspector accompanied by an IMPEP review team member. The team verified l' from the records that as of June 15,1998, there were 315 active licenses and allinspections i were current. I The team looked at the State's experience with overdue inspections during the entire review period and concluded that for much of the period, the State operated with a significant backlog i of overdue inspections. The actual extent and severity of the backlog throughout the period could not be accurately determined because of the tracking system's inability to extract the status of the inspection program at earlier dates. Therefore, the conclusions made by the team are based on the results of file reviews and interviews with the staff. From the casework reviewed,6 of the 14 inspections for core licenses were conducted as overdue inspections, exceeding the 25 percent window allowed in IMC 2800. In reviewing 7 Priority 1 licenses for routine inspections, it was found tnat 5 were overdue by 6 months to 2 3/4 years.

The team noted in reviewing RHS-7 that the procedure allows for modification of the frequency based on experience with individual licensees; however, no specific criteria comparable to that stated in IMC 2800 for extension or reduction of inspection frequencies is included in RHS-7.

The State did not administratively extend the inspection frequency of any licensees during the review period.

With respect to initial inspections of new licensees, the State's policy is to inspect all new licensees within 6 months regardless of whether the licensee receives radioactive material.

Four of the 22 files reviewed were initialinspections, and all were overdue at the time of the initial inspection. The team also reviewed casework involving nine additional new licenses to ensure an accurate determination of whether the initialinspections were completed within the Kansas standard of 6 months after the license is issued. In 3 of the 9 additional files reviewed, the team found that the license had not been inspected in accordance with the Kansas policy, for a total of 7 of 13 overdue initial inspections. The inspections were completed 1 to 7 months late. Of the 46 new licenses issued within the review period, the tracking system identified only two recently issued licenses that had not been inspected.

On examination of the factors contributing to the lack of time!! ness in performing inspections at the stated frequency, the IMPEP team noted the program was not fully staffed during 6 months of the review period. The team also concluded that the lack of RCS management oversight during the period between the former section chief's retirement in mid-1996 until a new section chief was selected in January 1997 may also have contributed to the deficiencies found in the program during the review period.

Based on the record of overdue inspections during the review period, the review team recommends: (1) that Kansas heighten its management oversight of the inspection due dates of core licenses (Priority 1,2, and 3 licensees) to ensure inspections are performed at the required frequencies; and (2) that the new inspection tracking system currently under

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development include provisions for flagging initial inspections at an early date to ensure they are inspected within 6 months of date of license issuance. In addition, Kansas should consider updating procedure RHS-7 to incorporate procedures on initial inspections as stated in IMC 2800, Section 04.03 a.

The State reported in its response to the questionnaire that 73 licensees were granted reciprocity permits during the review period. Seven of 45 Priority 1 licensees were inspected; 1 of 9 Priority 2 licensees was inspected; and no Priority 3 licensees were inspected. Further review of the records showed that some licensees were granted permits for mcre than 1 year, and that 50 separate licensees were granted 214 reciprocity permits during the period.

According to the State's records,11 reciprocity inspections were performed during the review period,10 of which were in 1997 and 1998. The State did not meet the inspection percentage goals for conducting !nspections of reciprocity licensees as outlined in Appendix lli of NRC Inspection Manual Chapter 1220 (IMC 1220). RHS 7 lists reciprocity as a Priority 5 inspection frequency, as resources allow. The review team recommends that the State's " Inspection Priority System" be revised for reciprocity inspections to correspond to the inspection goals in IMC 1220. The review team recommends the State conduct reciprocity inspections at intervals equal to those stated in IMC 1220.

The timeliness of the issuance of inspection findings was also evaluated during the review of completed inspections. Of the casework examined,19 of 22 inspections performed during the review period had inspection correspondence issued to the licensee within 30 days after completion of the inspection. Sixteen of the 19 were issued within 10 days of the inspection. In the three remaining instances, two inspection findings were issued within 35 days and one was issued 6 months after the inspection.

Based on the IMPEP evaluation criteria, the review team recommends that Kansas' performance with respect to the indicator, Status of Materials Inspection Program, be found unsatisfactory.

3.2 Technical Quality of Inspections The team reviewed the inspection reports, enforcement documentation, and inspection i aid notes and interviewed inspectors for 22 materials inspections conducted during the review period. The casework included all five of the State's materials inspectors, including the supervisors, and covered inspections of various types including medical (broad scope, institutions, research, private practice and mobile services), radiography, well logging, fixed and portable gauge, self shielded irradiator, academic, service and other industriallicensees. A review team member performed accompaniments of three State inspectors on four separate inspections of licensed facilities. Appendix C lists the completed inspections reviewed in depth with case-specific comments as well as the results of the accompaniments.

Kansas Enforcement Procedures outlined in RHS-24 identify actions such as hearings, orders and civil penalties. In discussing the policy, the RCPD stated there had been only one ,

t escalated enforcement case during the review period. The 22 files reviewed by the team contained routine notifications to the licensees of clear inspections, except for one case in whicn violations resulted in a follow-up inspection.

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, Based on casework, the review team noted that the routine inspections covered all aspects of l the licensee's radiation safety program. Some deficiencies were noted and are documented in Appendix C. The team also noted the inspectors observed licensed operations or had i

operations demonstrated whenever possible. According to program management, the State occasionally conducts team inspections of licenses depending on the type, size, and inspection history of the licensee. The unit supervisor estimated that there were 3-5 team inspections per year during the review period.

The team reviewed the inspection field notes and found them to be comparable with the types of information and data collected under NRC Inspection Procedure (IP) 87100. The inspection field notes provided documentation of inspection findings in a consistent manner. The State uses one standard form of inspection field notes applicable to all types of licensees, such as nuclear medicine, portable gauges, radiography, and industrial / academic with a supplemental sheet added to cover additional specific requirements at medical and industrial radiography licensees. The inspection field notes provide documentation of the scope of the licensee's program including, posting; storage and use of radioactive material; receipt, transfer, and disposal of radioactive material; inventory; leak tests; radiation protection program; personnel monitoring; training; independent measurements; and inspection findings.

The team noted that the inspection reports did not document the names of allindividuals contacted and interviewed during the inspection other than those identified in the " Exit Summary" part of the form. The review team recommends that the inspection report form be strengthened by including names of individuals contacted and interviewed in greater detail. The inspection form also does not adequately document review of incidents and the licensee's corrective actions. This is addressed in Section 3.4 of this report.

The team noted that all Kansas inspectors used the inspection report form in procedure RHS-28 to ensure that all aspects of the program that could be reviewed were included in the scope of the inspection. Inspectors performed independent measurements whenever the licensee was using licensed material and also measured for radiation levels surrounding materials in storage. Inspectors' written comments in the field notes and the team member's observations during accompaniments indicate that safety issues were discussed with liccnsee personnel.

The inspection reports indicate, and the team member's observations during accompaniments support, that inspectors routinely toured licensee's areas such as laboratories, other locations of use, and storage areas. Operations were observed when licensed operations were being conducted by the licensee. Interviews with the licensee's users and staff were conducted by th9 State inspectors. The inspectors emphasized the observation of licensed activities to determine the effectiveness of the licensee's radiation safety progrrm and compliance to the requirements. The inspection reports indicated that the inspectors examined, and when I

appropriate, closed-out violations found in previous inspections.

A review team member accompanied three Kansas inspectors to four separate licensed

! facilities during the period of June 1-5,1998. The accompaniments included an inspection of a radiography program (office only); an initial inspection of a portable gauge licensee (office only);

an inspection at a hospital having diagnostic and outpatient radiotherapy authorization; and a hospital licensed for diagnostic, radiotherapy, brachytherapy, and teletherapy procedures, as well as nuclear pharmacy distribution. During the accompaniments, the Kansas inspectors demonstrated appropriate inspection techniques and knowledge of the regulations. The inspectors were well prepared and very thorough in their reviews of the licensee's radiation l

I Kansas Draft Report Page 7 safety program. Each inspector emphasized, to the extent possible, observation of the licensee's activities and interviews with personnel to assess the effectiveness of the licensee's radiation safety program. Three of these licensees were sent enforcement letters with recommendations and/or violations clearly documented. Overall, the technical performance of the inspectors was satisfactory, and their inspections were adequate to assess radiological health and safety at the licensed facility.

The IMPEP team noted that the State relies on the technical knowledge of the inspectors to evaluate licensees' assessments of root causes of noncompliance and poor licensee performance rather than having procedures in place which normally could be used to assist the inspectors in this evaluation. The review team recommends that Kansas develop a procedure for use by the inspection staff to help them identify poor licensee performance, identify when licensee root cause evaluations should be conducted, and to help them evaluate licensee root cause assessments. Staff members' skills could also be improved by attending a training course that teaches these techniques as part of the inspector qualification process.

In response to the questionnaire, the State reported only the number and type of supervisory  !

accompaniments performed during 1997 and 1998. In discussing accompaniments during the )

May 1995 to November 1997 time frame, which is not covered in the questionnaire, three staff I members recalled being accompanied by the previous program director. However, no records could be found documenting the earlier accompaniments. The new program management l explained to the review team that Kansas is now committed to conducting annual j accompaniments and that a new form has been developed to documint the accompaniments, l According to the questionnaire, two of the three inspectors, as well as both supervisors, were I accompanied within the past 12 months. The third inspector was accompanied within the past 15 months. The review team suggests that the State expedite the annual supervisory accompaniment of the remaining unaccompanied inspector and continue to adhere to their policy of annual supervisory inspector accompaniments.

As noted in the questionnaire, the State has available a variety of portable instruments for routine confirmatory surveys and use during incidents and emergency conditions. The instruments are a mix of low and high range Geiger-Mueller (GM) detectors and a variety of probes, micro R meters, neutron and alpha detectors, ion chambers, rate meters, and a multi-channel analyzer. The portable instruments used during the inspector accompaniments completed by the review team were observed to be operational and calibrated. The reviewer noted that the instruments are calibrated on an annual basis against radiation standards which are traceable to the National Institute of Standards and Technology.

The IMPEP reviewer inquired as to the Kansas policy on unannounced versus announced i inspections. Program management indicated that the policy was to conduct unannounced l l inspections whenever possible. Announced inspections usually involved initial inspections or l inspections at licensees in geographically-distant locations from Topeka. The IMPEP reviewer j noted that 14 of the 22 files reviewed were unannounced inspections. To ensure the presence of knowledgeable licensee staff, all of the inspections performed with a review team member  ;

l accompaniment were announced inspectors have been delegated the authority to sign all routine enforcement correspondence.

inspection findings generally lead to appropriate and prompt regulatory action. However, the supervisor apparently did not review and sign the field notes documenting the findings of the

Kansas Draft Report Page 8 inspection prior to the issuance of the inspection findings letter for 13 out of 22 of the inspections reviewed by the team. It was noted that for the five cases reviewed for inspections performed in 1998, all had management review as indicated by the materials supervisor's signature. This is a marked improvement from the lack of review in the May 1995 to December 1997 time frame. The review team recommends that the State continue to increase management oversight of the inspection program.

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

3.3 Technical Staffino and Trainina lssues central to the evaluation of this indicator include the radioactive materials program staffing level and staff turnover, as well as the technical qualifications and training histories of the staff. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed program management and staff, and considered any possible workload backlogs.

The RCPD identified 3 FTEs of technical effort in the materials program. At the time of the review,2 of these 3 FTEs were devoted exclusively to the radioactive materials program, and 1 FTE was devoted exclusively to mammography inspections. The RCPD stated that the technical staff member currently completing mammography inspections would soon be working in the radioactive materials program except for a minimal 12 x-ray inspections per year. These technical staff members perform both inspection and licensing functions. The RCPD also identified 0.5 FTE devoted to the materials program from the X-Ray and Materials Unit Chief, who provides both administrative and technical effort.

The RCPD directs all areas of the RCS including radioactive materials, x-ray, radon, emergency response, environmental monitoring, and emergency preparedness. There are two units in RCS: the Environmental Monitoring and Emergency Preparedness Unit and the X-Ray and Materials Unit, each headed by a supervisor.

Based on the response to the IMPEP questionnaire and discussions with program management, the review team noted that during the review period, the RCPD position was vacant from June 1996 to January 1997 when an RCS staff member was promoted to fill the position. The position of X-Ray and Materials Unit Chief was created during a reorganization and filled in October 1997. One new radiation materials inspector / reviewer was hired during the review period. Based on review results, this staffing levelis adequate for a program of this size.

Although no vacancies existed in the radioactive materials program, one environmental l technician position and one x-ray inspector position within the section were vacant at the time of

. the review. Also, one of the radioactive materials inspectors was working almost exclusively in

! the mammography inspection program. During interviews, staff commented that the use of radioactive materials staff for other radiation-related tasks could affect the ability of the staff to complete assigned duties. The review team suggests that the State evaluate the impact of the open positions in the RCS and the effect of these vacancies on radioactive materials staff to determine if added staffing or reassignment of duties is necessary.

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The review team determined that successful candidates for technical positions are required to have a Bachelor's degree in science or comparable education and experience. From the review of technical qualifications of current staff, the review team concluded that Kansas has been able to hire qualified individuals.

The State does not have a documented training program; however, the State has a formal

" Training Qualification Form" modeled after the recommendations made by the joint NRC/OAS Training Working Group Recommendations for Agreement State Training Programs. Thus,if an employee has not taken a required class, it may not be apparent that they are still expected to take it.

The Kansas staff is lacking formal course work in a number of different areas. Although formal course work on the transportation of radioactive materials was designated as being required for radioactive materials inspectors, none of the current radioactive materials inspectors in the State have had this class. Also, none of the current inspectors have had formal training in teletherapy / brachytherapy even though two inspectors who have been with the program for 6 i and 12 years, respectively, complete such inspections routinely. In interviews, staff members I expressed the need for training in several areas, including teletherapy / brachytherapy and refresher training in a variety of subjects. Also, the unit supervisor has not received formal training in licensing work, although one of his primary tasks is a supervisory review of all licensing actions. Staff members expressed concern about completing some assigned tasks without the proper training. The review team recommends that the State document a training and qualifications program equivalent to that contained in NRC's Inspection Manual 1246,

" Formal Qualifications Programs in the Nuc! ear Materials Safety and Safeguards Program Area," assess the current training needs of all radioactive materials staff, and provide the necessary training to ensure that all staff are properly trained to complete assigned tasks.

Based on the team's finding and the IMPEP evaluation criteria, the review team recommends that Kansas' performance with respect to the indicator, Technical Staffing and Training, be found satisfactory with recommendations for improvement.

3.4 Technical Quality of Licensina Actions The review team examined completed licensing casework and interviewed the reviewers for 18 specific licenses. Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for l licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and its conditions, tie-down conditions, and overall technical quality. Casework was evaluated for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authorities. The files were checked for retention of necessary documents and supporting data.

The licensing casework was selected to provide a representative sample of licensing actions, which had been completed in the review period, and to include work by all reviewers. The cross section sampling incluoed all of the State's major licenses as defined by the State in the questionnaire and included the following types of licenses: broad academic; broad medical; I

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academic; industrial radiography; medical- private practice and high dose remote afterloader; nuclear pharmacy; well logging; portable gauges; manufacturing and distribution. Licensing j actions included three new licenses, five renewals, nine amendments, and three terminations. I Licensing actions during the review period included 46 new licenses and 474 amendments ]

(including 65 terminations), for 520 licensing actions. A list of the licenses reviewed with case-specific comments can be found in Appendix D.

Overall, the IMPEP review indicated chronic problems with respect to thoroughness, completeness, consistency, and clarity of licensing actions. Of the 18 licensing files reviewed, 16 had documentation missing. In evaluating the thoroughness and completeness of the licenses, the following deficiencies were found: tie-down documentation missing from the license file; amendment issued without a management signature; letter for amendment request with supportive documentation not referenced as tie-down condition; and evaluation for financial surety and required emergency planning for licensee with a significant increase in their possession limit of H-3 and C-14. One file was missing four separate tie-down documents. in another license, the applicant did not designate a Radiation Safety Officer (RSO), yet the authorized user was named RSO when the license was issued even though there was no documentation indicating that the mater was addressed with the licensee. It was also noted in the terminated file reviews that there was lack of documentation of a licensee's close-out survey and determination of transfer of a radiography camera.

Inconsistencies between similar licenses were noted, including in the use of the Kansas Standard License Condition for transportation of radioactive material, application of the Quality Management Plan, and requirements for a radiation protection program. Another inconsistency found was the application of a standard license condition involving radiographic exposure devices and associated equipment requirements for radiographer. This topic is discussed further in Section 4.1.2. l t

Clarity of licensing actions was also a problem in the licensing casework reviewed. In one of the Academic, Broad A licenses, the frequency of audits was not addressed during the reviews, and it was unclear who would conduct these reviews. In a similar license, the frequency of the annual audits was listed as " periodic."

The lack of documentation throughout the entire licensing review process affects the technical qua!ity of licenses, and could lead to potential health and safety problems. For example, two separate licenses reviewed did not adequately address proper radiation protection procedures, even though they were licensed to use plutonium-238 in any form, and uranium-233 and 235 in ,

research and development procedures, respectively. The pharmacy incorrectly licensed to use l plutonium was also licensed to transfer the plutonium as well as nickel-63 to an authorized recipient "to possess and use the radiopharmaceuticals." As discussed previously, a Quality Management Plan was not requested or reviewed for a medicallicensee. These items are discussed in greater detailin Appendix D. The magnitude of the potential health and safety l issues due to licensing inadequacies cannot be accurately assessed because of the lack of file documentation. l The review team recommends that program management consider increasing supervisory oversight to ensure that all pertinent items are adequately and properly addressed during the review process to provide quality assurance and to improve the technical quality of licenses.

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Kansas Draft Report Page 11 The review team also recommends that the State begin a self-evaluation of all existing licenses to determine the technical quality and to identify potential health and safety issues. This evaluation should be accomplished as soon as possible to identify and correct other possible license deficiencies. In addition, the State should ask licent ses to supply copies of any missing documents that should be included with the application.

The review process was discussed with the primary reviewers and staff. Application packages containing guidance are sent to each license applicant. Reviewers use this guidance as the main reference to verify that all appropriate items are adequately addressed in the licensing actions. Other applicable guidance frorn the NRC is available for additional reference.

Inspection compliance history is evaluated to determine license adequacy and to identify potential health and safety issues. During interviews with the staff, it was indicated that the latest Kansas regulations, issued in 1996, are not reflected in the license guidance. The review team recommends that RCS update the license guidance to address and parallel the current Kansas Radiation Protection Regulations to assist in the consistency and accuracy of the license review process.

License applications are reviewed following standard procedures, which are similar to those used by the NRC. Reminder notices are sent to the licensees 30-60 days prior to the expiration date. Timely renewalletters were found in the license files. Staff typically use Standard Licensing Conditions similar to those used by the NRC. Licenses are issued for 2 years and can be easily renewed if there are no significant changes in the radiation protection program.

Licenses are amended in entirety after 10 years or if five major amendments are requested.

Renewals are processed, reviewed and often completed within 30 d6ys of receipt. Currently, there is no licensing backlog. License files have all current inspection data, providing license reviewers with incident reports and inspection reports during the renewal period. Incidents are, for the most part, cross-referenced in the licensing files.

Alllicensing actions receive supervisory review and were signed by management. These reviews are conducted by the unit supervisor or RCPD. Requests for additional information or clarifications are returned to the primary reviewer as needed. The RCPD conducts a final review prior to signature and issuance of the license. There is no documented checklist or verification of secondary reviews, and only the signature of the RCPD indicates that the licensing actions are complete.

Primary and secondary reviewers do not use check lists or document verification of the thoroughness and completeness of the licensing actions. Staff members indicated that, based on their technical experience and familiarity with the licensees, the license reviews are assumed to be thorough and complete, and there is no unique documentation of the reviewer's assessment. Interviews with the staff indicated that unless additionalinformation was requested, it is assumed that all items are satisfactory. Deficiencies are addressed in letters to the licensee using appropriate language. License reviewers frequently use telephone conversations to communicate with the licensee requesting additional information.

Documentation of telephone conversations was not available in many files during the IMPEP evaluation. The review team recommends that licensing check lists be developed, used, and l

retained in the file to ensure that all elements of the application have been submitted and that the license is complete.

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l Kansas Draft Report Page 12 RCS staff perform pre-licensing visits on a case-by-case basis for unusuallicensing requests.

These visits are at the discretion of the reviewers. During interviews with staff members, one member indicated that he conducted pre-licensing visits approximately 10-15 percent of the time and that he hand-delivered licenses occasionally if there were inspections due in that part of the State. No documentation of pre-licensing visits or hand-delivered licenses was observed or reviewed during the IMPEP evaluation. The review team recommends that the State place documentation of all pre-licensing visits in the appropriate licensing file.

Of the 18 licensing files reviewed, only four deficiency letters were found, and the deficiencies identified in the letters were minor. Though it is not impossible for so few problems to be present in this size sample of licenses, the review team is concerned about the small number of deficiencies identified by the State in this casework, the quick turn around time for license reviews, and the technical quality of the licenses reviewed.

Based on the IMPEP evaluation criteria, the review team recommends that the Kansas' performance with respect to the indicator, Technical Quality of Licensing Actions, be found unsatisfactory.

3.5 Resoonse to incidents and Allegations in evaluating the effectiveness of the State's actions in responding to incidents and allegations, the review team examined the State's response to the questionnaire relative to this indicator, reviewed the incidents reported for Kansas in the " Nuclear Material Events Database (NMED)"

against the Kansas records, interviewed the incident respondents, and reviewed in depth the four reportable incidents that occurred during the review period. The team also reviewed the State's response to two allegations including the one allegation referred to the State by the NRC during the review period. A list of the incident casework with comments is included in Appendix E.

The records showed that 41 incidents and two allegations were reported to the State during the review period. The team reviewed the incident log and performed a cursory review of the incident files and found that only four of the incidents involving AEA material required a report by the licensee.

The Kansas Department of Emergency Management (DEM) has the lead for all hazardous materials accidents within the State. Except for reports from licensees during office hours, all events are reported to DEM, which sends first responders equipped with survey meters to isolate and barricade the area until the RCS can respond and assume responsibility for handling the event. Allegations and incidents involving Kansas licensees are traditionally handled by the RCS X-Ray and Materials Unit, while all other incidents are assigned to the Environmental Monitoring and Emergency Preparedness Unit. However, staffs of both units are cross-trained and respond as needed.

The team found that incident response procedures are in place except for misadministration.

The incident response procedures were last revised in 1983 and have not been revised to l incorporate NMED per OSP procedure " Reporting Material Events - SA-300," dated l February 25,1998. The team recommends that the State revise their incident response i

procedure to conform with OSP procedure, SA-300, including medical events.

l Kansas Draft Report Page 13 The team found the procedures for handling allegations were adequate (note, the State refers to allegations as " complaints").

In the incident and allegation cases reviewed in depth, the State responded promptly with on-site investigations; however, the quality of the investigation and documentation was inconsistent. In four of the six, the investigations were thorough and well documented; necessary follow-through and close-out actions were taken; violations were cited or other corrective actions were taken to ensure prompt licensee compliance; proper notifications were made; and there was good coordination with other agencies. However, in the case of one incident and one allegation, there was no management closure, no indication of management input or review, and no record of the incident in the licensee's file. The casework for this incident had apparently been lost for months, and thus there was no information that the investigation was complete. In response to the allegation in question, the State did respond by sending an inspector to interview the Radiation Safety Officer at the facility where the alleged exposure occurred, but from the documentation it appeared that the investigative actions were incomplete. There was no evidence of interviews with the former employee allegedly involved, no re-enactment, and no indication the alleger was notified of the State's actions or the results of the investigation. The State contacted the out-of-state company involved ar.d they responded that they had no knowledge of any potential exposure.

The RCS procedures call for management involvement and evaluation of incident responses.

In reviewing the incident log and non-reportable incident records, the team found several instances where a copy of the incident investigation report was missing from either the incident file or the licensee's file. Only about half were signed off with management review and evaluation and/or closure information. The review team recommends that a system be established to track the progress of incident investigations and to verify that each investigation is evaluated by management, that all reporting requirements are met, that follow-up acticns and close-out information are documented.

The inspection reports indicated that nearly all incidents were reviewed at the next inspection.

However, the inspection report form uses only a check mark to indicate the review, and the results of the review or corrective actions taken by the licensee are not fully documented. The review team recommends that the inspection procedure be revised to include narrative documentation of the inspector's review of incidents and description of the licensee's corrective actions.

Records showed that the four reportable events reviewed by the team were initially promptly reported to the NRC operations center and to Region IV, and all appeared in the NMED listing.

However, no follow-up or close-out information was provided to the NRC unless the State was specifically asked. The review team recommends the State send copies of final close-out reports to the NRC in accordance with the OSP procedure, " Reporting Material Events - SA-300."

Based on the IMPEP evaluation criteria, the review team recommends that Kansas' i

performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory with recommendations for improvement.

1 J

l' Kansas Draft Report Page 14 4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement l State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed l Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Kansas' Agreement does not include a uranium recovery program, so only the first three non-common performance indicators were applicable to this review.

l-4.1 Legislation and Proaram Elements Reauired for Compatibility

-4.1.1 Legislation t

i Along with their response to the questionnaire, the State provided the review team with the opportunity to review copies of legislation that affects the radiation control program. Legislative authority to create an agency and enter into an agreement with the NRC is granted in Article 16

- Nuclear Energy Development and Radiation Control Act, Kansas Statutes, K.S.A. 48-1601 to 48-1619. The Bureau of Air and Radiation, RCS, is designated as the State's radiation control agency. The review team noted that the legislation had not changed since being found adequate during the previous review.

4.1.2 Proaram Elements Reauired for Compatibility l The Kansas Regulations for Control of Radiation, found in KAR 28-35-133 through l, KAR 28-35-363 of the State of Kansas Radiation Protection Regulations apply to alllonizing radiation, whether emitted from radionuclides or devices. Kansas requires a license for possession, and use, of all radioactive material including naturally occurring materials, such as radium, and accelerator-produced radionuclides. Kansas also requires registration of all i l

equipment designed to produce x-rays or other ionizing radiations. 1 Kansas has a nine-step process to adopt regulations including 61-day minimum period for public comment and holding a public hearing. The process normally takes 16 to 25 weeks from the regulations being submitted to their taking effect. The RCPD has responsibility for maintaining the State's regulations.

The team evaluated Kansas' responses to the questionnaire and reviewed the regulations adopted by the State since the May 19,1995, review to determine the status of the Kansas regulations under the new Commission Policy Statement on Adequacy and Compatibility. The team also verified that the compatibility table in the questionnaire was accurate.

1 All regulations adopted by the State during the review period (adopted November 1,1996) were sent to the NRC as both draft and final regulations for approval. The NRC reviewed these regulations, and the State's final rules reflected the NRC's comments.

l The team found that the State had adopted all regulations required for compatibility as of the time of this review except for the " Safety Requirements for Industrial Radiographic Equipment" rule which is currently being enforced by license condition. The team checked a sampling of 14 industrial radiography licenses and found that nine had been amended to include the equipment j requirement. The review team recommends that the State review and amend all remaining I

Kansas Draft Report Page 15

)

industrial radiography licenses with license conditions necessary to meet the " Safety Requirements for industrial Radiographic Equipment" requirement, and expedite adoption of the rule which was due January 10,1994.

Also, two regulations adopted by the State, prior to the review period, were adopted before the NRC rules were published as final in the Federal Reaister:

• " Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendrnents (60 FR 15649) that became effective March 1,1998. This amendment was published in final form March 27,1998.

• " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR 19 and 20 amendments (60 FR 36038) that became effective August 14,1998. This amendment was published in final form July 13,1995.

Both of these rules were adopted by Kansas on October 17,1994. Because the drafts of these NRC rules were revised prior to being published in their final form, the Kansas regulations may contain incompatibilities. The review team recommends that the State compare the Kansas regulations invo! rad with the " Low-Level Waste Shipment Manifest information and Reporting" and " Radiation Protection Requirements: Amended Definitions and Criteria" amendments against the final NRC rules and make any necessary changes to ensure compatibility.

The State has not adopted the following regulations, but intends to address them by rulemaking or by adopting generic legally binding requirements:

e " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995.

• ' Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996, e " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective October 20,1995.

• " Termination or Transfer of Licensed Activities: Record Keeping Requirements,"

J 10 CFR Parts 20,30,40,61,70 amendments (61 FR 24669) that became effective l June 17,1996. I I

e " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.

o " Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective February 27,1997.

e " Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Parts 20 and 35 amendments (62 FR 4120) that became effective May 29,1997.

i

Kansas Draft Report Page 16 e " Fissile Material Shipments and Exemptions," 10 CFR Part 71 amendment (62 FR 5907) that became effective February 10,1997.

e " Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71,150 amendments (62 FR 28947) that became effective June 27,1997.

e " Radiological Criteria for License Termination," 10 CFR Parts 20,30,40,70 amendments (62 FR 39057) that became effective August 20,1997, it is noted that Management Directive 5.9, Handbook, Part V, paragraph (1)(c)(iii), provides that the above regulations should be adopted by the State as expeditiously as possible, but not later than 3 years after the effective date of the new Commission Policy Statement on Adequacy and i Compatibility, i.e., September 3,2000.

Based on the IMPEP evaluation criteria, the review team recommends that Kansas' performance with respect to the indicator, Legislation and Program Elements Required for q Compatibility, be found satisfactory. '

4.2 Sealed Source and Device (SS&D) Evaluation Proaram At the time of the review, Kansas had no sealed source or device manufacturers nor were any I applicants anticipated in the near future. The State, however, does not wish to relinquish the authority to regulate SS&D manufacturers in the future. The State has committed in writing in a memorandum to their files to have a program in place prior to performing evaluations.

Accordingly, the review team did not review this indicator.

4.3 Low-Level Radioactive Waste (LLRW) Dic90 sal Proaram In 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to allow a State to seek an amendment for the regulation of LLRW as a separate category. Those States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although Kansas has LLRW disposal authority. NRC has not required States to have a program for licensing a LLRW disposal facility until such time as the State has been designated as a host State for a LLRW disposal facility.

When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Kansas. Accordingly, the review team did not review this indicator.

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found that Kansas' performance with respect to the performance indicators Technical Quality of Inspections and Legislation and Program Elements Required for Compatibility, be found satisfactory. The State's performance with respect to the performance indicators, Technical Staffing and Training, and Response to incidents and Allegations, were found to be satisfactory with recommendations for improvement. The State's performance with respect to two indicators, Status of Materials

i Kansas Draft Report Page 17 Inspection Program and Technical Quality of Licensing Actions, were found to be unsatisfactory. Although the inspections are currently up to date, the team found that a backlog of overdue in.spections ex!sted for much of the review period. The team was concerned by the unsatisfactory quality of the licensing actions. The team found that, in some cases, the reviewers failed to address health and safety concerns and that repeated problems existed with respect to thoroughness, completeness, consistency, clarity, and technical quality of the licenses.

l The team recomrnends that the Management Review Board (MRB) find the Kansas Agreement l State Program " adequate, but needs improvement" and " compatible." The team also

recommends placing the Kansas program on heightened oversight, a process that would

! involve monthly teleconferences with the State and bimonthly written progress reports from the State. A follow-up review is recommended for FY 1999.

I i Below is a summary list of suggestions and recommendations, as mentioned in earlier sections 1 of the report, for evaluation and implementation, as appropriate, by the State.

RECOMMENDATIONS: i

1. Based on the record of overdue inspections during the review period, the review team I recommends: (1) that Kansas heighten its management oversight of the inspection due dates of core licenses (Priority 1,2, and 3 licensees) to ensure inspections are performed at the required frequencies; and (2) that the new inspection tracking system currently under development include provisions for flagging initial inspections at an early date to ensure they are inspected within 6 months of date of license issuance. In f addition, Kansas should consider updating procedure RHS-7 to incorporate procedures on initialinspections as stated in IMC 2800, Section 04.03 a. (Section 3.1)

2. The review team recommends that the State's " Inspection Priority System" be revised for reciprocity inspections to correspond to the inspection goals in IMC 1220.

(Section 3.1)

3. The review team recommends the State conduct reciprocity inspections at intervals equal to those stated in IMC 1220. (Section 3.1)

4. The review team recommends that the inspection report form be strengthened by including names of individuals contacted and interviewed in greater detail. (Section 3.2)

5. The review team recommends that Kansas develop a procedur6 for use by the inspection staff to help them identify poor licensee performance, identify when licensee root cause evaluations should be conducted, and to help them assess licensee root cause evaluations. Staff members' skills could also be improved by attending a training course that teaches these techniques as part of the inspector qualification process.

(Section 3.2)

6. The review team recommends that the State continue to increase management oversight of the inspection program. (Section 3.2) t l

Kansas Draft Report Page 18

7. The review team recommends that the State document a training and qualifications program equivalent to that contained in NRC's inspection Manual 1246, " Formal Qualifications Programs in the Nuclear Materials Safety and Safeguards Program Area;"

assess the current training needs of all radioactive materials staff, and provide the necessary training to ensuro that all staff are properly trained to complete assigned tasks. (Section 3.3)

8. The review team recommends that program management consider increasing supervisory oversight to ensure that all pertinent items are adequately and properly addressed during the review process to provide quality assurance and to improve the technical quality of licenses. (Section 3.4)

9. The review team also recommends that the State begin a self-evaluation of all existing licenses to determine the technical quality and to identify potential health and safety issues. This evaluation should be accomplished as soon as possible to identify and correct other possible license deficiencies. In addition, the State should ask the licensee to supply copies of any missing documents that should be included with the application. (Section 3.4)

10. The review team recommends that RCS update the license guidance to address and parallel the current Kansas Radiation Protection Regulations to assist in the consistency and accuracy of the license review process. (Section 3.4)

11. The review team recommends that licensing check lists be developed, usad, and retained in the file to ensure that all elements of the application have been submitted and that the license is complete. (Section 3.4)

12. The review team recommends that the State place documentation of all pre-licensing visits in the appropriate licensing file. (Section 3.4)

13. The team recommends that the State revise their incident response procedure to conform with OSP procedure, SA-300, including medical events. (Section 3.5)

14. The review team recommends that a system be established to track the progress of incident investigations and to verify that each investigation is evaluated by management, that all reporting requirements are met, that follow-up actions and close-out information are documented. (Section 3.5) i

15. The review team recommends that the inspection procedure be revised to include narrative documentation of the inspector's review of incidents and description of the licensee's corrective actions. (Section 3.5)-

16. The review team recommends the State send copies of final close-out reports to the NRC in accordance with the OSP procedure, " Reporting Material Events - SA-300."

(Section 3.5)

17. The review team recommends that the State review and amend all remaining industrial )

radiography licenses with license conditions necessary to meet the " Safety

Kansas Draft Report Page 19

18. The review team recommends that the State compare the Kansas regulations involved with the " Low-Level Waste Shipment Manifest information and Reporting" and

" Radiation Protection Requirements: Amended Definitions and Criteria" amendments against the final NRC rules and make any necessary changes to ensure compatibility.

(Section 4.1.2)

SUGGESTIONS:

1. The review team suggests that the State expedite the annual supervisory accompaniment of the remaining unaccompanied inspector and continue to adhere to their policy of annual supervisory inspector accompaniments. (Section 3.2)

2. The review team suggests that the State evaluate the impact of the open positions in the RCS and the effect of these vacancies on radioactive materials staff to determine if added staffing or reassignment of duties is necessary. (Section 3.3) l

UST OF APPENDICES AND ATTACHMENTS Appendix A iMPEP Review Team Members Appendix B Kansas Organization Charts Appendix C Inspection Casework Reviews Appendix D Licensing Casework Reviews Appendix E incident Casework Reviews Appendix F Kansas' Questionnaire Response Attachment 1 Kansas' Response to Review Findings l

t

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Jack Hornor, RIV, SAO Team Leader Response to incidents and Allegations Jenny Johansen, RI Status of Materials inspection Program Technica! Quality of Inspections Lance Rakovan, OSP Technical Staffing and Training Legislation and Program Elements Required for l

Compatibility l

l Jared Thompson, Arkansas Technical Quality of Licensing Actions 1

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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.: 1 Licensee: Wichita State University License No: 31-C155-01 Location: Wichita, Kansas Inspection Type: Routine, Unannounced License Type: Academic Priority: 2 Inspection Date: 5/2/96 Inspector: JJ Comment:

a) No manager's signature indicating supervisory review of inspection report.

File No.: 2 Licensee: University of Kansas Medical Center License No: 18-C054-01 Location: Kansas City, Kansas inspection Type: Routine, Announced License Type: Broad Medical Priority: 1 Inspection Date: 4/24/98 Inspector: JJ Comments:

a) input error into computer inspection date/next inspection due date tracking system.

Inspection entered as performed 3/24/98.

b) Prior inspection occurred on 10/2/95. Licensee was not inspected in 1996 or 1997.

c) Documentation of misadministration review inconsistent with prior inspection reports.

File No.: 3 Licensee: Coleman Company,Inc. License No: 37-B739-01 Location: Wichita, Kansas inspection Type: Initial, Unannounced License Type: Industrial Distribution -

Priority: 2 Inspection Date: 1/29/98 Inspector: BL Comment: .

a) License issued 7/26/96. Initial inspection did not occur until 1/29/98.

File No.: 4 l

Licensee: Certainteed Corporation License No: 22-B452-01 1 ocation: Kansas City, Kansas Inspection Type: Routine Unannounced License Type: Fixed Gauge Priority: 4 Inspection Date: 2/23/96 Inspector: JJ Comment:

a) No manager's signature indicating supervisory review of inspection report 1

4 L____ _ _ _ _ _ _

i Kansas Craft Report Page C.2 Inspection File Reviews File No.: 5 Licensee: Proctor & Gamble Manufacturing License No: 22-B022-01 Location: Kansas City, Kansas inspection Type: Routine Unannounced License Type: Fixed Gauge Priority: 4 inspection Date: 9/1/95 Inspector: JJ File No.: 6

' Licensee: Beta Chem Laboratory License No: 25-C686-01 Location: Leawood, Kansas -

Inspection Type: Initial, Unannounced License Type: Industrial Laboratory Priority: 1 Inspection Date: 3/5/97 Inspector: JJ Follow up Inspection: 5/27-28/97 ,

Commen:s: '

a) No inspection report written for initial inspection other than inspector's hand written notes to support enforcement letter issued 3/11/97.

b) License issued 3/12/93. Initial inspection did not occur until 3/5/97.

c) Construction of citation does not convey exactly what parts of regulation licensee needs to address to correct program.

d) Normally a Priority 3 inspection frequency but kept at Priority 1 based on initial ,

inspection.

e) No manager's signature indicating supervisory review of inspection report File No.: 7 Licensee: Thomas Construction, Inc License No: 22 B665-01 Location: Fort Scott, Kansas Inspection Type: Routine Announced License Type: Portable Gauge Priority: 3 inspection Date: 3/15/96 Inspector: JJ Commerits: .

a) No manager's signature indicating supervisory review of inspection report b) The license type is normally a Priority 4. Inspector recommended change to Priority 4, but the priority was not changed.

' File No.: 8 Licensee: Intermountain Testing License No: 21-8389-01 Location: Liberal, KS Inspection Type: Routine Announced ,

License Type: Radiography Priority:1 l Inspection Date: 6/12/97 Inspector: JJ i Comments:

a) Prior inspection occurred on 6/3/93. Licensee should be inspected on an annual basis.

l b) Inspector did not sign report . No manager's signature indicating supervisory review of inspection report.

i 1

I

)

Kansas Draft Report Page C.3 Inspection File Reviews File No.: 9 Licensee: CC Enviroklean License No: 21-B389-01 Location: Kansas City, Kansas inspection Type: Routine Unannounced License Type: Industrial Service Priority: 1 Inspection Date: 6/16/97 Inspector: BL Comments:

a) Prior inspection occurred on 9/14/95. Licensee should be inspected on an annual basis.

b) No manager's signature indicating supervisory review of inspection report c) No copy of 12/22/97 enforcement letter to licensee in file.

d) Report and letter to license not issued until 6 months after inspection completed.

File No.: 10 Licensee: Cornish Wireline Service License No: 27-B128-01 Location: Chanute, Kansas Inspection Type: Routine Unannounced License Type: Well Logger Priority: 3 Inspection Date: 12/6/95 , inspector: JJ -

Comments:

a) Prior inspection occurred on 7/20/89. Licensee should be inspected every 3 years.

b) No manager's signature indicating supervisory review of inspection report File No.: 11 Licensce: Log Tech, Inc. License No: 27-8565-01 Location: Hays, Kansas inspection Type: Routine Unannounced License Type: Well Logger Priority: 2 Inspection Date: 4/3/96 Inspector: JJ Comment:

a) No manage. N s'gnature indicating supervisory review of inspection report File No.: 12 Licensee: Kansas Blood Bank License No: 24-B733-01 I Location: Topeka, Kansas inspection Type: Initial, Unannounced l License Type: Irradiator, Self-Shielded Prionty: 3 Inspection Date: 8/8/97 Inspector: JJ Comments:

a) No manager's signature indicating supervisory review of inspection report.

b) License issued 3/19/96. Initial inspection did not occur until 8/8/97.

1 l

I l

Kansas Draft Report Page C.4 1 Inspection File Reviews File No.: 13 Licensee: IBT Reference Lao License No: 15-B539-01 Location: Lenexa, Kansas inspection Type: Routine Unannounced Ucense Type: Medical Private Practice Priority: 4 Inspection Date: 3/24/98 inspector: BL Comment:

a) Prior inspection occurred on 1/5/90. Licensee should be inspected every 4 years.

File No.: 14 Licensee: Rivest Testing U.S.A., Inc. License No: 21-B682-01 Location: Tulsa Oklahoma inspection Type: Routine Announced License Type: Radiography Priority: 1 Inspection Date: 12/16/97 Inspectors: DG/TC Comments:

a) Inspection limited to records review and discussion with licensee representative.

Previous inspection in 1/17/96 was also a records review, b) Prior inspection occurred on 1/17/96. Licensee should be inspected annually.

c) No manager's signature indicating supervisory review of inspection report. Supervisor was one of the inspectors.

File No.: -15 Licensee: Bryan Enterprises License No: 12-B712-01 Location: Lincoln, Nebraska inspection Type: Initial, Announced License Type: Mobile Medical Service Priority: 1 Inspection Date: 6/10/98 Inspectors: DG Comments:

a)' License issued 12/10/94, initial inspection did not occur until 6/10/98. Not ident!fied on Kansas questionnaire as being overdue.

b) Results prepared but not sent yet to licensee as of 6/19/98 File No.: 16 Licensee: Miami County Medical Center License No: 19-B734-01 Location: Paola, Kansas inspection Type: Special Announced License Type: Medical Priority: 3 Inspection Date: 1/9/97 Inspector: JJ

, Comment:

l a) No manager's signature indicating supervisory review of inspection report.

Kansas Draft Report Page C.5 Inspection File Reviews File No.: 17 Licensee: Quintile Inc. License No: 16-B678-01 Location: Lenexa, Kansas inspection Type: Routine Unannounced License Type: Medeial Research Priority: 1 Inspection Date:11/26/97 Inspectors: JJ Comments:

a) Inspection limited to records review and discussion with licensee. No radioactive materials on hand.

b) Prior inspection occurred on 10/11/95. Licensee should be inspected annually.

c) Recommended change to Priority 2 for this licensee by inspector not approved by Supervisor.

d) Letter to licensee with results of inspection issued at 35 days after inspection.

File No.: 18 Licensee: Audrey V. Wegst License No: 33-B462-01 Location: Mission, Kansas Inspection Type: Routine Announced License Type: Service Priority: 4 Inspection Date: 12/1/95 Inspector. "O Comments:

a) Prior inspection occurred on 5/22/87. Licensee should be inspected every 4 years.

b) Change of priority from 3 to 4 based on 12/1/95 inspection.

c) No manager's signature indicating supervisory review of inspection report.

File No.: 19 Licensee: Mid-America Calibration License No: 33-C749-01 Location: Shawnee Mission, Kansas Inspection Type: Routine Unannounced License Type: Service Priority: 3 Inspection Date: 8/25/97 Inspector: JJ Comment:

a) No manager's signature indicating supervisory res,v ciinspection report.

File No.: 20 Licensee: Augusta Medical Complex, Inc. License No: 19-B358-01 Location: Augusta, Kansas inspection Type: Routine Unannounced License Type: Medica' Priority: 3 Inspection Date: Inspector: JJ Comment:

a) Letter to licensee with results of inspection issued after 35 days.

Kansas Draft Report Page C.6 Inspection File Reviews l File No.: 21 Licensee: Coffeyville Regional Medical Center License No: 19-C251-01 Location: Coffeyville, Kansas inspection Type: Routine Announced License Type: Medical Priority: 1 Inspection Date: 2/27/98 Inspectors: JJ Comment:

a) Inspection Due date tracking lists licensee as Priority 1. Report states previous Priority is 2 and recommends inspection Priority 2.

File No.: 22 Licensee: Hutchinson Hospital Corp. License No: 19-8081-01 Location: Hutchinson, Kansas inspection Type: Routine Unannounced License Type: Medical Priority: 1 Inspection Date: 5/26/98 Inspectors: DG NEW LICENSES REVIEWED FOR ISGUE AND inn IAL INSPECTION DATE File No.: 1 Licensee: Sherwin-Williams Company License No: 22-B719-01 Location: Coffeyville, Kansas issue Date: 5/5/95 License Type: Portable Gauge Priority: 4 Initial Inspection Date: 12/6/95 Inspector: JJ Comment:

a) Exceeded the 6 month inspection window of RHS-7.

File No.: 2 Uconsee: Log Tech of Kansas License No: 27-8722-01 Location: Great Bend, Kansas issue Date: 6/12/95 License Type: Industrial Priority: 2 Initial Inspection Date: 2/20/96 Inspector: JJ Comment:

a) Exceeded the 6 month inspection window of RHS-7.

File No.: 3 Licensee: The Medical Center License No: 19-B724-01  !

l Location: Hutchinson, Kansas issue Date: 9/22/95 l l License Type: Medical Priority: 3 i initial Inspection Date: 11/21/95 Inspector: VC File No.: 4 Licensee: Wilson County Hospital License No: 12-B726-01 Lccation: Neodesha, Kansas issue Date: 12/5/95 License Type: Medical Priority: 3 initial Inspection Date: 2/2/96 Inspector: VC

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( Kansas Draft Report Page C.7 l Inspection File Reviews

- File No.: 5 4 Licensee: QWAL Laboratories License No: 22-B743-01 Location: Pittsburg Issue Date: 3/11/97

< Type: Portable Gauge Priority: 4 l Initialinspection Date: 8/25/97 Inspector: JJ i

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i- File No.: 6 I l~ Licensee: Williams Engineering & Industrial License No: 22-B742-01 l Location: Carbondale, Kansas issue Date: 11/13/96 Type: Portable Gauge Priority: 1 initial Inspection Date: 10/1/97 Inspector: JJ Comment:

a) Exceeded the 6 month inspection window of RHS-7.

l l File No.: 7 i Licensee: Environmental Management Resources License No: 22-B756-01

! Location: Lawrence, Karsas issue Date: 12/16/97 Type: Portable Gauge Priority: 4 Initial inspection Date: Not Yet Inspector: BL l

Comment:

a) Assigned to BL to inspect by 5/15/98, however not yet inspected as of 6/15/98 according to inspector.

File No.: 8 Licensee: West Wichita Family Physic:ans, PA License No: 12-C757-01 Locahon: Wichita, Kansas issue Date: 12/11/97 Type: Portable Medical Priority: 3 Initial Inspection Date: 4/9/98 Inspector: DG File No.: 9-Licensee: Bliss Energy Consultants License No: 26-B767-01 Location Manhattan, Kansas issue Date: 6/9/98 Type: Portable Industrial Lab Priority: 1 initial inspection Date: Not Yet inspector: BL Comment:

a) BL performed a pre-licensing visit 5/26/98 which appears to be an inspection date in the tracking system as the next date due for an inspection is 5/29/99. The inspector stated the license had not yet been inspected as of 6/15/98. Based on discussions with the Director the initial inspection due date should be 12/9/98, not 5/29/99.

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Kansas Draft Report Page C.8 Inspection File Reviews in addition the following inspection accompaniments were made as part of the on-site IMPEP review:

Accompaniment No.: 1 Licensee: H. R. Inspection Service,Inc. License No: 21-B126-01 Location: Shawnee, Kansas Irspection Type: Routine, Announced License Type: Radiography Priority: 1 Inspection Date: June 1,1998 Inspector: JJ Accompaniment No.: 2 Licensee: St Francis Hospital & Medical Center License No: 19-B272-04 Location: Topeka, Kansas inspection Type: Routine, Announced License Type: . Medical / Teletherapy / Radiopharmacy Priority: 1 Inspection Date: June 2-3,1998 Inspector: B L Comment:

a) Recommendations made to licensee.

Accompaniment No.: 3 Licensee: C.P. Engineers & Land Surveyors, Inc. License No: 22-8732-01 Location: Topeka, Kansas inspection Type: Routine, Announced License Type: Portable Gauge Priority: 1 Inspection Date: June 3,1998 Inspector: JJ Comment:

a) Violation identified, recommendations noted.

Accompaniment No.: 4 Licensee: Lawrence Memorial Hospital License No: 12-b161-01 Location: Lawrence, Kansas .

Inspection Type: Routine, Announced License Type: Nuclear Medicine / Radiotherapy Priority: 2 inspection Date: June 4,1998 inspector: DG Comment:

a) Two violations and one recommendation noted.

APPENDIX D LICENSING CASEWORK REVIEWS NOTE. ALL LICENSES LISTED WITHOUT COMMENT ARE INCLUDED FOR l COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM File No.: 1 Licensee: Line Medical, Inc. License No.: 20-B708-01 Location: Wichita, Kansas Amendment No.: 4 License Type: Nuclear Pharmacy Type of Action: Amendment Date issued: 9/13/96 License Reviewer: JJ Comments:

a) Amendment ist,ued for use of Plutonium-238 in any form without a proper radiation protection program implemented. Requests indicate that both sealed sources and "any form" were desired.

b) Incorrect use for the Plutonium 238 and Nickel-63 listed on the license amendment for the transfer to an authorized recipient to possess and use radiopharmaceuticals.

File No.: 2 Licensee: University of Kansas License No.: 38-C019-01 Location: Lawrence, Kansas Amendment No.: 53,54 License Type: Academic, Broad A Type of Action: Renewal, Amendment Date issued: 11/14/96,3/18/98 License Reviewer: BL, JJ Comments:

a) License correction for Amendment 53 completed at request of the licensee on 12/23/96.

b) Amendment 53 issued for use of Uranium-235 for research studies without a proper radiation protection program implemented, c) Frequency of annual audits not addressed during the review for Amendment 53. The licensee indicated " periodic."

d) Emergency procedures were not submitted with the renewal application. There was no indication that emergency procedures were requested or reviewed by license reviewer.

e) Amendment 54 issued for use of Uranium-233 in tracer studies for R&D without a proper radiation protection program implemented.

File No.: 3 Licensee: Kansas State University License No.: 38-C011-01 Location: Manhattan, Kansas Amendment No.: 60 License Type: Academic, Broad A Type of Action: Renewal Date issued: 3/26/96 License Reviewer: BL Comments:

a) The renewal application was submitted and signed by the assistant RSO.

b) Frequency of annual audits not addressed during the review. It was unclear 16 the application who would conduct the annual audits.

Kansas Draft Report Page D.2 License File Reviews File No.: 4

Licensee

Providence Medical Center License No.: 19-C182-01 Location: Kansas City, Kansas Amendment No.: 52 License Type: Medical, Institutional Type of Action: Renewal ,

Date Amendment issued: 4/5/96 License Reviewer: BL Comments:

a) Correspondence from the Department dated 12/29/96 signed for Director of Radiation i Control Program by a secretary.

l b) Quality Management Plan (QMP) not submitted by licensee and there is no indication that the QMP was requested or reviewed by the license reviewer.

c) File documentation incomplete for information received from the licensee dated 2/12/96. No documentation of correspondence or telephone conversation requesting this information was available.

File No.: 5 Licensee: Donna Lee Oil Company License No.: 27-B595-01 Location: Independence, Kansas Amendment No.: 8 License Type: Well Logging Type of Action: Amendment Date issued: 8/21/97 License Reviewer: JJ Comments:

a) This amendment was for the transfer of ownership of the radioactive material and the Kansas License. There was no documentation available that indicated the new owner would accept the current license, including all license conditions and previously licensed procedures. Also, there was no documentation of the sale or date of transfer. Welllogging sources were licensed for storage only.

b) Amendment issued yet licensee indicated that survey meter was to be purchased and not  !

yet received.

c) On application, the applicant indicated that a radiation protection program was not applicable. There was no indication that this was questioned by license reviewers.

l l File No.: 6 Licensee: Syncor International License No.: 20-C495-01 Location: Wichita, Kansas Amendment No.: 21,22 License Type: Nuclear Pharmacy Type of Action: Amendment Date issued: 1/23/97,9/4/97 License Reviewer: BL Comments: .

a) No documentation was available indicating that financial assurity for decommissioning had been addressed due to the increase in the possession limit for Mo-99/Tc-99 generators from 10 Curies to 35 Curies. The license reviewer indicated that current procedures were adequate.

b) Documentation from licensee regarding this amendment #22 request was not in the license file.

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Kansas Draft Report Page D.3 License File Reviews File No.: 7 Licensee: Gem Testing License No.: 22-B762-01 Location: Garden City, Kansas License Type: Portable Gauge Type of Action: New Date issued: 4/20/98 License Reviewer: DG l

Comment:

a) The applicant did not designate a Radiation Safety Officer on the application. The authorized user was named th? RSO on the license when issued. Documentation was not available to indicate any correspondence or telephone conversation occarred to address 1 this matter. I J

File No.: 8 Licensee: Taylor Forge Engineered System, Inc License No.: 21-B108-01 Location: Paola, Kansas Amendment No.: 24 License Type: Radiographer Type of Action: Renewal Date issued: 9/9/97 License Reviewer: DG Comment:

a) Letter dated 8/27/97 should have been included as a tie-down condition.

File No.: 9 Licensee: Via Christie Regional Medical Center License No.: 18-C753-01 Location: Wichita, Kansas License Type: Medical, Broad A Type of Action: New Date Amendment issued: 10/1/97 License Reviewer: BL Comments:

a) This as the consolidation of two existing licenses.

' b) Tie-down documentation was missing from the file at the time of the IMPEP evaluation. The missing dates were 5/20/97,5/23/97,7/25/97 and 9/19/97. This information was retrieved from the licensee.

c) Typographical error in tie-down letter dated 5/23/97. The letter is actually dated 5/27/97.

d) Licensee indicated that liquid radioactive material would be disposed in the sanitary sewer and there was no correspondence or telephone conversation requesting the release rates or verification of compliance with the regulations.

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Kansas Draft Report Page D.4 License File Reviews File No.: 10 Licensee: Kenyon Clinic License No.: 12-C731-01 Location: Overland Park, Kansas Amendment No.: 2 License Type: Medical, Private Practice Type of Action: Amendment Date issued: 1/30/98 License Reviewer: BL Comment:

a) Amendment issued and copy in the file were not signed by Division Director of Radiation Control Program. It could not be determined if the licensee had received a signed, official copy. Amendment was signed and reissued during the IMPEP evaluation.

File No.: 11 Licensee: Eagle-Picher Industries License No.: 25-B561-01 Location: Lenexa, Kansas Amendment No.: 13 License Type: Manufacturing / Distribution Type of Action: Amendment Date issued: 5/8/97 License Reviewer: JJ a) There was no documentation available indicating that financial surety and emergency plans were addressed or reviewed by the license reviewer.

File No.: 12 Licensee: North American NDT, Inc. License No.: 21-B715-01 Location: Wichita, Kansas Amendment No.: 2 License Type: Industrial Radiography Tyoe of Action: Amendment Date issued: 4/27/97 License Reviewer: JJ

Comment:

a) The standard license condition for compatibility with 10 CFR Part 34 for radiographic exposure devices and associated equipment was not in this license file.

File No.: 13 Licensee: Como Tech, Inc. License No.: 21-B629-01 Location: Lenexa, Kansas Amendment No.: 7 License Type: Industrial Radiography Type of Action: Renewal Date issued: 5/5/97 License Reviewer: BL Comment:

l a) There was no documentation available that indicated that the radiography equipment was l

compatible and that source / camera and source / changer compatibility was verified.

Kansas Draft Report Page D.5 License File Reviews File No.: 14 Licensee: Radiological Solutions License No.: 33-B755-01 Location: Lenexa, Kansas License Type: Service Type of Action: New Date issued: 10/27/97 License Reviewer: BL Comments:

a) No documentation of verification for financial assurity, emergency plan, or annual audit of a radiation protection program by license reviewers.

b) No documentation on procurement and receipt procedures for additional radioactive material were included in the application.

File No.: 15 Licensee: Fort Hays State University License No.: 31-8049-01 Location: Hays, Kansas Amendment No.: 20 License Type: Academic-Other Type of Action: Amendment Date issued: 12/6/96 License Reviewer: BL File No.: 16 Licensee: Holton Community Hospital License No.: 19-B608-01 Location: Holton, Kansas Amendment No.: 5 License Type: Medical, Institutional Type of Action: Termination Date issued: 9/23/97 License Reviewer: JJ Comments:

a) This licensee had not performed nuclear medicine studies since May 1995. All material and waste were appropriately transferred to another authorized recipient.

b) Licensee did not submit a close-out survey. Close-out survey was performed by license reviewer as part of a routine compliance inspection.

c) Inspection report and review of inspector close out did not have supervisory review. No signature on inspection report dated 9/8/97.

File No.: 17 Licensee: List & Clark Construction Company License No.: 22-B571-01 Location: Overland Park, Kansas Amendment No.: 6 License Type: Portable Gauge Type of Action: Termination Date issued: 1/13/98 License Reviewer: BL Comment:

a) Close-out survey and inspection conducted on 1/6/98. Typographical errors due to change in year were noted.

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