ML18207A242

Letter to K. Steves Kansas 2018 Draft Impep Report

ML18207A242
Person / Time
Issue date:	08/01/2018
From:	Paul Michalak NRC/NMSS/DMSST/MSLB
To:	Steves K State of KS, Dept of Health & Environment
Rakovan L
References
Download: ML18207A242 (37)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 August 1, 2018 Ms. Kimberly Steves, Director Kansas Radiation Control Program Kansas Department of Health and Environment 1000 SW Jackson Suite 330 Topeka, KS 66612

Dear Ms. Steves:

The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) in the evaluation of Agreement State programs. Enclosed for your review is the draft IMPEP report, which documents the results of the Agreement State review held in Topeka on June 25-29, 2018. The teams preliminary findings were discussed with you and your staff on the last day of the review. Additionally, a follow-up call was held on July 25, 2018. The review teams proposed recommendations are that the Kansas Agreement State Program be found adequate to protect public health and safety, but needs improvement, and compatible with the NRCs program.

The NRC conducts periodic reviews of Agreement State programs to ensure that public health and safety are adequately protected from the potential hazards associated with the use of radioactive materials and that Agreement State programs are compatible with the NRCs program. The process, titled IMPEP, employs a team of NRC and Agreement State staff to assess Agreement States and NRC Regional Offices radioactive materials programs. All reviews use common criteria in the assessment and place primary emphasis on performance.

The final determination of adequacy and compatibility of each program, based on the teams report, is made by a Management Review Board (MRB) composed of NRC managers and an Agreement State program manager who serves as a liaison to the MRB.

In accordance with procedures for implementation of IMPEP, we are providing you with a copy of the draft report for your review and comment prior to submitting the report to the MRB.

Comments are requested within 4 weeks from your receipt of this letter. This schedule will permit the issuance of the final report in a timely manner that will be responsive to your needs.

The team will review the response, make any necessary changes to the report, and issue it to the MRB as a proposed final report. The MRB meeting is scheduled for September 20, 2018, at 1 PM ET. The NRC will provide invitational travel for you or your designee to attend the MRB meeting at the NRC Headquarters in Rockville, Maryland.

K. Steves If you have any questions regarding the enclosed report, please contact me at 301-415-5804.

Thank you for your cooperation.

Sincerely,

/RA/

Paul Michalak, Chief Agreement State Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosure:

2018 Draft IMPEP Report

SUBJECT:

KANSAS FY2018 DRAFT IMPEP REPORT Distribution: (SP08)

MBeardsley, NMSS KModes, NMSS BTharakan, RIV JCassata, RI BGoretzki, AZ TPruett, RIV LHowell, RIV RErickson, RIV DCollins, MSST SAtack, MSST LRoldan-Otero, ASPB State of KS AStrainingandtravel.Resource ML18207A242 OFFICE TL ASPB:PM ASPB:BC NAME MBeardsley LRakovan PMichalak DATE 07/20/18 07/26/18 08/01/18 OFFICIAL RECORD COPY

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE KANSAS PROGRAM JUNE 25-29, 2018 DRAFT REPORT Enclosure

EXECUTIVE

SUMMARY

This report presents the results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Kansas Agreement State Program covering the period June 14, 2014, to June 29, 2018. The review was conducted during the period of June 25-29, 2018, by a team comprised of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of Arizona.

Based on the results of this review, the Kansas Agreement State Programs performance was found satisfactory for two common performance indicators: Technical Staffing and Training and Status of Materials Inspection Program; satisfactory, but needs improvement, for two indicators:

Technical Quality of Licensing Actions and Compatibility Requirements; and unsatisfactory for two indicators: Technical Quality of Inspections and Technical Quality of Incident and Allegation Activities. The team did not make any recommendations and determined that the recommendation from the 2014 IMPEP review should be closed.

The team determined that the declining performance from the previous 2014 IMPEP review was mainly due to: (1) inadequate management oversight of inspection and event reports as described in Sections 3.3 and 3.5 of this report; (2) poorly communicated inspection findings to licensees; and (3) the pattern of untimely and insufficient responses to events (e.g.,

overexposure to an embryo fetus, extremity overexposure to a radiographer, medical events, etc.).

Based on the findings and the criteria in Management Directive 5.6, the team recommends that the Kansas Agreement State Program be placed on Heightened Oversight. Heightened Oversight is an increased monitoring process used by the NRC to follow the progress of improvement needed in an Agreement State program. It involves preparation of a program improvement plan, bimonthly conference calls, and submission of status reports prior to each call with the appropriate Kansas and NRC staffs. The team discussed placing the Kansas Agreement State Program on Probation versus Heightened Oversight based on the findings; however the team determined that Probation is not appropriate at this time because of the following:

• The last IMPEP review was satisfactory and the Program was not on any level of enhanced oversight (e.g., monitoring or heightened oversight) during the review period;

• The Program was receptive to the teams findings and committed to addressing the performance issues identified by the team; and

• The team is confident that the Program can resolve these issues in an expeditious manner.

Accordingly, the team recommends that the Kansas Agreement State Program be found adequate to protect public health and safety, but needs improvement, and compatible with the NRC's program. The team recommends that the next IMPEP review take place in approximately 2 years (April/May 2020 timeframe) with a periodic meeting in approximately 1 year.

Kansas Draft IMPEP Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Kansas Agreement State Program.

The review was conducted during the period of June 25-29, 2018, by a team comprised of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of Arizona. Team members are identified in Appendix A. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017, and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated February 26, 2004. Preliminary results of the review, which covered the period of June 14, 2014, to June 29, 2018, were discussed with Kansas Agreement State Program managers on the last day of the review.

In preparation for the review, a questionnaire addressing the common performance indicators and applicable non-common performance indicators was sent to Kansas on February 2, 2018. Kansas provided its response to the questionnaire on May 10, 2018.

A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using the Accession Number ML18151A731. Kansas updated its response to the questionnaire on June 26, 2018.

This updated response is available in in ADAMS using the Accession Number ML18186A683.

The Kansas Agreement State Program is administered by the Radiation Control Program (the Program) which is located within the Bureau of Community Health Services (the Bureau). The Bureau is part of the Department of Health and Environment (the Department). Organization charts for Kansas are available in ADAMS (Accession Number ML18151A735).

At the time of the review, the Kansas Agreement State Program regulated 270 specific licenses authorizing possession and use of radioactive materials. The review focused on the radioactive 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.

The team evaluated the information gathered against the established criteria for each common and the applicable non-common performance indicators and made a preliminary assessment of the Kansas Agreement State Programs performance.

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on June 13, 2014. The final report is available in ADAMS (Accession Number ML14261A157). The results of the review and the status of the recommendations are as follows:

Technical Staffing and Training: Satisfactory Recommendation: None

Kansas Draft IMPEP Report Page 2 Status of Materials Inspection Program: Satisfactory Recommendation: None Technical Quality of Inspections: Satisfactory Recommendation: None Technical Quality of Licensing Actions: Satisfactory but Needs Improvement Recommendation: The review team recommends that the State review all active medical licenses and verify that previously approved authorized physician users have the proper board certification or training requirements, and preceptor attestation, and develop and implement a process that will ensure proper verification and documentation of user qualifications for 10 CFR 35.300 (KAR 28-35-264) uses of byproduct material.(Section 3.4)

Status: In its response to the questionnaire, the Program indicated that it completed a review of all active medical licenses authorizing 10 CFR 35.300 uses, corrected an additional two licenses, and contacted all of the 10 CFR 35.300 medical licensees to confirm that users were only performing procedures that they were qualified to perform.

The previous team identified multiple licenses where authorized users were added for all 10 CFR 35.300 uses who were neither qualified for, nor who applied for, all of the uses in 10 CFR 35.300. The team reviewed the Programs processes for approving 10 CFR 35.300 users, and determined that the Programs corrective actions were effective and the issues found during the previous IMPEP review were not repeated. Additional information can be found in Section 3.4. The team determined that this recommendation should be closed.

Technical Quality of Incident and Allegation Activities: Satisfactory, but Needs improvement Recommendation: None Compatibility Requirements: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety and compatible with the NRC's program.

3.0 COMMON PERFORMANCE INDICATORS Five common performance indicators are used to review the NRC regional and Agreement State radioactive materials programs. These indicators are: (1) Technical Staffing and Training; (2) Status of Materials Inspection Program; (3) Technical Quality of Inspections; (4) Technical Quality of Licensing Actions; and (5) Technical Quality of Incident and Allegation Activities.

Kansas Draft IMPEP Report Page 3 3.1 Technical Staffing and Training The ability to conduct effective licensing and inspection programs is largely dependent on having a sufficient number of experienced, knowledgeable, well-trained technical personnel. Under certain conditions, staff turnover could have an adverse effect on the implementation of these programs, and could affect public health and safety. Apparent trends in staffing must be explored. Review of staffing also requires consideration and evaluation of the levels of training and qualification. The evaluation standard measures the overall quality of training available to, and taken by, materials program personnel.

a. Scope The team used the guidance in State Agreements procedure SA-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated Kansas performance with respect to the following performance indicator objectives:

• A well-conceived and balanced staffing strategy has been implemented throughout the review period.

• Agreement State training and qualification program is equivalent to NRC Inspection Manual Chapter (IMC) 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs.

• Qualification criteria for new technical staff are established and are followed or qualification criteria will be established if new staff members are hired.

• Any vacancies, especially senior-level positions, are filled in a timely manner.

• There is a balance in staffing of the licensing and inspection programs.

• Management is committed to training and staff qualification.

• Individuals performing materials licensing and inspection activities are adequately qualified and trained to perform their duties.

• License reviewers and inspectors are trained and qualified in a reasonable period of time.

b. Discussion The Kansas Agreement State Program is comprised of eight staff members which equals 6.8 FTE for the radioactive materials program when fully staffed. The 6.8 FTE is comprised of 2 FTE supervisory; 4.2 FTE for technical; and 0.6 FTE for administrative.

At the time of the on-site review, there were no vacancies.

During the review period, the Program experienced turnover at both the management and staff levels. Four individuals left the Program and four were hired. The Program Director has been in the position since July 2015 and the current Supervisor for Radioactive Materials/Licensing began on February 12, 2018. The three technical positions were vacant from 2 to 4 months. The team identified that the turnover in management contributed to a lack of management oversight of event response, evaluation of licensees root causes and corrective actions to items of non-compliance, and documentation of reactive and followup inspections as identified in Sections 3.3 and 3.5 of this report.

Kansas Draft IMPEP Report Page 4 The team determined that the Program has a training and qualification program compatible with the NRCs IMC 1248. Inspectors attend NRC required training, are provided on-the-job training, and a supervisor performs inspector accompaniments to determine qualification.

c. Evaluation The team determined that, during the review period, Kansas met the performance indicator objectives listed in Section 3.1.a., and recommends that Kansass performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.2 Status of Materials Inspection Program Periodic inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety practices. The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and kind of material, the type of operation licensed, and the results of previous inspections. There must be a capability for maintaining and retrieving statistical data on the status of the inspection program.

a. Scope The team used the guidance in State Agreements procedure SA-101, Reviewing the Common Performance Indicator: Status of the Materials Inspection Program, and evaluated Kansas performance with respect to the following performance indicator objectives:

• Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at the frequency prescribed in IMC 2800.

• Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 1220, Processing of NRC Form 241, Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and Offshore Waters, and Inspection of Agreement State Licensees Operating Under 10 CFR 150.20.

• Deviations from inspection schedules are normally coordinated between technical staff and management.

• There is a plan to perform any overdue inspections and reschedule any missed or deferred inspections; or a basis has been established for not performing any overdue inspections or rescheduling any missed or deferred inspections.

• Inspection findings are communicated to licensees in a timely manner (30 calendar days, or 45 days for a team inspection, as specified in IMC 0610, Nuclear Material Safety and Safeguards Inspection Reports).

Kansas Draft IMPEP Report Page 5

b. Discussion The Program performed 289 Priority 1, 2, 3, and initial inspections during the review period. Approximately one percent of the 289 inspections were completed overdue (three of the 36 initial inspections) and no Priority 1, 2, or 3 inspections were conducted overdue during the review period.

Kansas inspection frequencies are equal to, or more frequent than, similar license types in the NRCs IMC 2800.

A sampling of 25 inspection reports indicated that all inspection reports reviewed were communicated to the licensee within Kansas goal of 30 days after the inspection exit.

Kansas performed 21.4 percent (3 of 14) of reciprocity inspections in 2014; 4.5 percent (1 of 22) in 2015; 23.8 percent (5 of 21) in 2016; and 17.6 percent (3 of 17) in 2017. For 2018, Kansas has performed 36.4 percent (4 of 11) as of June 29, 2018. Reciprocity inspections have continued to challenge the Program. In the 2014 IMPEP report, it was stated that the reciprocity inspection rates were between 10-13 percent for 2011-2013, below the 20 percent target rates. Corrective actions since 2014 have not been effective as shown by the 2015 and 2017 statistics. The Program attributed the shortfall during this review period to: (1) a lack of management oversight that contributed to insufficient reciprocity inspections; and (2) the geographical size of Kansas in relation to the physical location of the Program office in northeast Kansas. The Programs current strategy for addressing these shortfalls is to inspect more candidates at the beginning of each year. The team determined that appropriate measures and supervisory oversight are now in place to meet the reciprocity inspection standards described in the NRCs IMC 1220.

c. Evaluation The team determined that, except as noted below, during the review period Kansas met the performance indicator objectives listed in Section 3.2.a.

• Candidate licensees working under reciprocity were not consistently inspected in accordance with the criteria prescribed in the NRCs IMC 1220.

Although reciprocity inspections have continued to challenge the Program, the team determined that appropriate measures and supervisory oversight are now in place to meet the reciprocity inspection standards described in the NRCs IMC 1220.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kansass performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

Kansas Draft IMPEP Report Page 6 3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide assurance that licensee activities are carried out in a safe and secure manner. Accompaniments of inspectors performing inspections, and the critical evaluation of inspection records, are used to assess the technical quality of an Agreement States inspection program.

a. Scope The team used the guidance in State Agreements procedure SA-102, Reviewing the Common Performance Indicator: Technical Quality of Inspections, and evaluated Kansas performance with respect to the following performance indicator objectives:

• Inspections of licensed activities focus on health, safety, and security.

• Inspection findings are well-founded and properly documented in reports.

• Management promptly reviews inspection results.

• Procedures are in place and used to help identify root causes and poor licensee performance.

• Inspections address previously identified open items and violations.

• Inspection findings lead to appropriate and prompt regulatory action.

• Supervisors, or senior staff as appropriate, conduct annual accompaniments of each inspector to assess performance and assure consistent application of inspection policies.

• For programs with separate licensing and inspection staffs, procedures are established and followed to provide feedback information to license reviewers.

• Inspection guides are consistent with NRC guidance.

• An adequate supply of calibrated survey instruments is available to support the inspection program.

b. Discussion The team evaluated the inspection reports and enforcement documentation, and interviewed inspectors involved in 25 materials inspections conducted during the review period. The casework reviewed included inspections conducted by six inspectors and covered medical, industrial, commercial, academic, and research licenses for initial, routine, and special inspections. The team noted that the internal inspection reports were effective at documenting the scope of each inspection to include placeholders for each area of concern and the ability of the inspector to enter observation information specific to that section. Once the team began to identify performance issues with reactive inspections, the team focused the review for this indicator on inspections that followed a reported incident.

The team determined that inspection findings were not well-founded or properly documented, inspections did not adequately address previously identified open items and violations, and inspection findings did not lead to appropriate or prompt regulatory action. When issues of non-compliance were identified, inspectors did not clearly communicate the specific regulation(s) that caused the licensee to be in

Kansas Draft IMPEP Report Page 7 non-compliance. The team determined that, although supervisory and management reviews of inspection documentation were timely, they did not adequately evaluate or address the inspectors determinations of the licensees root cause, extent of condition review, evaluation of effectiveness of corrective actions, or ensure the clear communication of inspection findings on inspection reports.

The team identified examples where inspection findings were not well-founded or properly documented, these included: (1) the Program performed a routine inspection of a medical licensee and cited the licensee for a failure to train, but the inspection report noted that there were no gaps in training; this language contradicts the violation; (2) the inspection report addressed a Y-90 contamination event that occurred the previous month, but the inspection report did not confirm whether the licensees corrective actions were effective or its root cause was correct; and (3) the Program did not address a medical event in which a patient received approximately 24 percent of the prescribed dose of Y-90 microspheres. The inspection documentation contained no information on the Programs assessment or confirmation of the licensees root cause and corrective actions of the medical event. A reactive inspection for the medical event was not performed as described in Section 3.5 of this report.

A complete list of inspection casework reviewed by the team can be found in Appendix C. Below is a synopsis of risk significant inspections where the team identified performance issues:

On June 29, 2015, a licensee reported that a declared pregnant woman had a measured dose to the embryo fetus of greater than 500 mrem during the gestation period. The Program conducted a routine inspection on September 3, 2015, and cited the licensee with a failure to report the event in a timely manner, but did not cite the licensee for the overexposure or the non-uniform exposure over the gestation period. The inspection report had no indication of thoroughness of the reactive inspection, and no indication that the Program followed up on a discrepancy in the dose reported by the licensee from that identified in monthly dosimetry reports. The team reviewed the dosimetry records in the case file and identified that the total doses added up to 579 millirem for the gestation period and not 535 millirem as reported by the licensee. The team questioned Program staff about this discrepancy. The Program explained that according to the licensee, one of the monthly dosimetry reports was incorrect. However, the dosimetry records did not confirm the error, and neither the team nor the Program could find any conclusive evidence to support the 535 millirem dose reported by the licensee. The Program accepted the licensees correction action for the overexposure, but failed to request corrective actions for the failure to report within 30-days.

The Program did not perform an immediate special reactive inspection for a reported radiographers extremity overexposure. There also was no documentation of the review of this event during the next routine inspection.

There was no indication that the Program adequately reviewed the licensees evaluation of the event or that the Program did an independent assessment to

Kansas Draft IMPEP Report Page 8 confirm the overexposure. The Program did not issue a violation for the overexposure.

During a routine inspection of a medical licensee, the Program reviewed a contamination event involving Yttrium-90 (Y-90), but did not review a medical event at the same facility where a patient received an under dose of Y-90 microspheres. Since this licensee had a similar medical event 2 years previous, the Program could have reviewed the licensees previous root cause and corrective actions to determine if they were valid and effective. The team determined that the Program missed the opportunity to evaluate the licensees root cause and corrective actions after the first event in order to prevent recurrence.

Based on the teams findings, the team determined that there was a supervisory and management over-reliance on the inspectors ability to fully assess, evaluate, follwup, and document violations and licensees response to specific events. The team determined that supervisor and management personnel missed opportunities to provide inspector guidance for further evaluation or improved reporting. Additionally, through interviews with staff, the team found that the inspectors do not routinely review the relevant NRC inspection procedures, or an equivalent procedure as part of their inspection preparation. The team determined that the Programs inspection procedures are not equivalent to the NRCs Inspection Procedure 87100 series.

The team determined that the root causes of the performance issues identified in this section of the report led to the Programs inappropriate and inadequate handling of reactive inspections as described in Section 3.5 of this report.

A team member accompanied three inspectors on April 10-12, 2018. The inspector accompaniments are identified in Appendix B. The inspectors conducted routine unannounced inspections. During the accompaniments, no items of licensee non-compliance were found by the Program inspectors, and no issues of inspector concern were determined by the team member performing the accompaniments. The team noted that during the inspection accompaniments, the routine inspections appeared to be properly performed and led to clear inspections. However, given the issues the team identified during the reviews of inspection files, the team questions whether Program inspectors would have identified specific conditions of poor performance, and critiqued the licensees root cause evaluations and corrective actions.

The Program provided licensees with the results of their inspections within 30 days of the exit. The Program performed annual supervisory accompaniments for all inspectors each year during this review period. The Program maintained an adequate supply of calibrated and operable survey instruments available to support the inspection program.

c. Evaluation The team determined that, except as noted below, during the review period the Kansas program met the performance indicator objectives listed in Section 3.3.a.

Kansas Draft IMPEP Report Page 9

• Inspection findings are not consistently well-founded nor properly documented in reports.

• Procedures do not help identify root causes and poor licensee performance.

• Inspections do not consistently address previously identified open items and violations.

• Inspection findings do not in all cases lead to appropriate and prompt regulatory action.

• Inspection guides are not consistent with NRC guidance.

The team determined that inspection findings were often not well-founded or properly documented in the inspection reports reviewed. The Program did not clearly communicate the specific regulation that caused the licensee to be in non-compliance.

The Programs inspections often did not adequately address previously identified open violations. Although supervisory and management reviews of the inspection documentation were timely, they did not adequately identify or address the inspectors evaluation of the licensees root cause, extent of condition review, evaluation of effectiveness of corrective actions, or ensure the clear communication of inspection findings on inspection reports. Although inspection procedures were in place, they lacked the detail and specificity to ensure proper review of root causes and/or poor licensee performance.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kansas performance with respect to the indicator, Technical Quality of Inspections, be found unsatisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.4 Technical Quality of Licensing Actions The quality, thoroughness, and timeliness of licensing actions can have a direct bearing on public health and safety, as well as security. An assessment of licensing procedures, actual implementation of those procedures, and documentation of communications and associated actions between the Kansas licensing staff and regulated community is a significant indicator of the overall quality of the licensing program.

a. Scope The team used the guidance in State Agreements procedure SA-104, Reviewing the Common Performance Indicator: Technical Quality of Licensing Actions, and evaluated Kansas performance with respect to the following performance indicator objectives:

• Licensing action reviews are thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed.

Kansas Draft IMPEP Report Page 10

• Essential elements of license applications have been submitted and elements are consistent with current regulatory guidance (e.g., financial assurance, increased controls, pre-licensing guidance).

• License reviewers, if applicable, have the proper signature authority for the cases they review independently.

• License conditions are stated clearly and can be inspected.

• Deficiency letters clearly state regulatory positions and are used at the proper time.

• Reviews of renewal applications demonstrate a thorough analysis of a licensees inspection and enforcement history.

• Applicable guidance documents are available to reviewers and are followed (e.g.,

NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.).

• Licensing practices for risk-significant radioactive materials are appropriately implemented including increased controls and fingerprinting orders (Part 37 equivalent).

• Documents containing sensitive security information are properly marked, handled, controlled, and secured.

b. Discussion During the review period, Kansas performed 854 radioactive materials licensing actions.

The team evaluated 34 of those actions. The licensing actions selected for review included 4 new applications, 21 amendments, 5 renewals, and 4 terminations. The team evaluated casework which included the following license types and actions: broad scope; medical diagnostic and therapy; accelerator; commercial manufacturing and distribution; industrial radiography; research and development; academic; nuclear pharmacy; portable and fixed gauges; self-shielded irradiators; well-logging; service providers; decommissioning actions; bankruptcy actions; changes of ownership; and financial assurance. The casework sample represented work from nine license reviewers.

The team identified repeated examples of deficiencies with respect to thoroughness, completeness, consistency, clarity, technical quality, and adherence to existing licensing guidance and procedures. For example, the team identified issues with the Programs application of financial assurance program requirements. At the time of the review, the Program identified four licensees that were authorized for possession of radioactive materials in excess of the quantities that would require financial assurance. The team verified that the proper financial assurance documentation was on file, and that the information was appropriately secured for these four licensees. The team found an additional three licensees that were authorized for radioactive materials in excess of the financial assurance quantities; however, in these cases the Program did not possess the required financial assurance documentation. All three of the licensees were State universities that the Program believed already met the financial assurance requirements because they were government entities.

The team found that the Program added a license condition that allowed visiting authorized users to be able to work on a Kansas radioactive materials license for up to 60 days as long as they were already listed on another Agreement State or NRC license.

Kansas Draft IMPEP Report Page 11 This condition was not submitted to the NRC for a compatibility review. Based on the teams review, the Program decided to remove this condition from all licenses. This issue is further described in Section 4.1 of this report.

As noted in Section 2.0 of this report, the team believes that the recommendation from the previous IMPEP review should be closed. The team reviewed medical licenses to verify that the Programs corrective actions in response to this recommendation were effective. The Programs database uses a new function that allows the user to enter information about each authorized users training and experience. If an authorized user is given a use that it is not authorized for, a message flags the reviewer of the discrepancy. In addition, the Program changed its licensing format from authorizing by exception (e.g., 35.300 except for the treatment of thyroid carcinoma) to authorizing by individual use (e.g., 35.300 for the treatment of hyperthyroidism). During this review of license amendment requests to add new authorized users, authorized medical physicists, and radiation safety officers, the team noted that the license reviewers were not verifying the qualifications of the preceptor for licenses that were issued by another Agreement State or by the NRC. The team found that the reviewers would verify that the preceptor was adequately qualified for the modalities that the proposed user was seeking authorization, as long as the license listed for the preceptor was issued in Kansas. License reviewers assumed that they could only verify authorized users who were listed on a Kansas license, and the Program did not have a process to reach out to other Agreement States or to the NRC to obtain preceptor license confirmation and verification. Once this was brought to the Programs attention, the Program indicated that it would contact all of the affected licensees and get documentation to verify that all of the preceptors had the proper qualifications. The Program further committed to revise procedures to ensure that the qualifications of preceptors are properly verified to attest to the training for new authorized users, authorized medical physicists, or radiation safety officers that are to be added to the licenses.

The team examined the Programs licensing practices with respect to requests for Risk Significant Radioactive Material. The team determined that the Program has a licensing procedure to identify new and amended licenses that should be subject to additional security measures, and that it is implementing the procedure correctly. In addition, the team assessed the Programs implementation of the pre-licensing guidance. The team determined that the Program had the documentation to support a basis of confidence that the radioactive material would be used as requested.

c. Evaluation The team determined that, except as noted below, during the review period Kansas met the performance indicator objectives listed in Section 3.4.a.

• Licensing action reviews are thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed.

• Essential elements of license applications have been submitted and elements are consistent with current regulatory guidance (e.g., financial assurance).

Kansas Draft IMPEP Report Page 12 A review of the licensing casework indicated repeat examples of problems with respect to thoroughness, completeness, consistency, clarity, technical quality, and adherence to existing licensing guidance and procedures. As noted above, the Program had a misunderstanding on obtaining preceptor verification from other Agreement States and the NRC for 10 CFR 35.300 users. The Program also did not understand that State government licensees still needed to provide financial assurance based on the limits authorized on the license. In addition, the Program utilized a license condition on several licenses without submitting it to the NRC for a compatibility review.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kansas performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory, but needs improvement.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.5 Technical Quality of Incident and Allegation Activities The quality, thoroughness, and timeliness of response to incidents and allegations of safety concerns can have a direct bearing on public health and safety. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures, internal and external coordination, and investigative and followup actions, are a significant indicator of the overall quality of the incident response and allegation programs.

a. Scope The team used the guidance in State Agreements procedure SA-105, Reviewing the Common Performance Indicator: Technical Quality of Incident and Allegation Activities, and evaluated Kansas performance with respect to the following performance indicator objectives:

• Incident response, investigation, and allegation procedures are in place and followed.

• Response actions are appropriate, well-coordinated, and timely.

• On-site responses are performed when incidents have potential health, safety, or security significance.

• Appropriate followup actions are taken to ensure prompt compliance by licensees.

• Followup inspections are scheduled and completed, as necessary.

• Notifications are made to the NRC Headquarters Operations Center for incidents requiring a 24-hour or immediate notification to the Agreement State or NRC.

• Incidents are reported to the Nuclear Material Events Database (NMED).

• Allegations are investigated in a prompt, appropriate manner.

• Concerned individuals are notified of investigation conclusions.

• Concerned individuals identities are protected, as allowed by law.

Kansas Draft IMPEP Report Page 13

b. Discussion During the review period, 32 incidents were reported to Kansas. The team evaluated 19 radioactive materials incidents, which included seven lost/stolen/abandoned radioactive materials, two overexposures, three medical events, four reports of damaged equipment, two contamination events, and one unauthorized transfer of radioactive material. The Program dispatched inspectors for onsite followup for five of the cases reviewed. The onsite responses ranged from 2 days to 65 days after notification of the event.

For this indicator, the team focused on the completeness of the review of the incident, the timeliness of the Programs response to the incident, and the Programs actions taken in response to the incidents. In evaluating the effectiveness of the Programs response to incidents, the team conducted interviews, examined case files, and reviewed the Programs response to the questionnaire.

The Programs procedure requires an onsite investigation for all incidents, medical and industrial, within 5 days of the notice. If the Program Director determines that an onsite response is not warranted, the justification must be documented. The Program uses local NMED software to document all incidents, allegations, and miscellaneous reports or queries. The Program uploads this information to the national NMED database using a transfer file built into the local NMED software. As noted in Appendix D of this report, the Program reported incidents in a timely manner to the Headquarters Operations Center except in two cases.

In the response to the questionnaire, the Program addressed the previous rating of satisfactory, but needs improvement, for this indicator and provided an explanation, a determination of root causes, and the corrective actions taken. The Program identified that the root causes were insufficient management oversight of the investigation and that the Programs procedures did not provide enough guidance on when to conduct an onsite investigation. The Programs corrective actions included management having greater oversight of incidents and investigations, and revising the incident and investigation procedure to include a preliminary priority evaluation, based on initial information, to determine when an onsite investigation would be warranted. As part of this procedure revision, the Program modified its internal policy to investigate all medical events within five days.

The team determined that the lack of management oversight of incidents continued.

The Programs response to risk-significant incidents during the review period was in many cases incomplete, inappropriate, and/or not timely. The team identified frequent examples of performance deficiencies involving responses to incidents. As a result, health and safety risks may persist. A complete list of incident casework reviewed by the team can be found in Appendix D. Below is a synopsis for five risk significant incidents that occurred at three Kansas licensees facilities during this review period:

On May 6, 2015, a radiography licensee reported a potential overexposure to a radiographer during licensed activities being performed at a refinery that occurred earlier that day. According to the information reported, a radiographers assistant misinterpreted radio communications from the refinerys quality control

Kansas Draft IMPEP Report Page 14 lead as the signal to start radiographic operations and cranked the source out while the radiographer was adjusting the source collimator. Based on the information in NMED, when the radiographer felt the vibration of the source, he dropped the collimator, exited the area, and retracted the source. On May 29, 2015, the licensee provided updated dose measurements and calculations to the Program. The licensee reported that the radiographers whole body dosimeter read 33 millirem, the year-to-date dose was 262 millirem, and the extremity dose was between 50 and 100 rad. The Program did not perform an onsite investigation of this incident. The local NMED records indicated that the response was by telephone and email. Since the staff that documented this incident in the local NMED was no longer employed by the Program at the time of the review, the team was not able to conduct an interview and gather additional information. The next routine inspection of the licensee was performed on July 27, 2015, and the incident was not reviewed. The incident was uploaded to the national NMED on June 20, 2016, but was not reported to the NRC. A subsequent inspection was performed on July 6, 2016, and the incident was not reviewed. Based on the documentation in the files, it appears that there was no review of this incident except a telephone call and e-mail exchange. The Program did not respond to the licensees facility to interview the persons involved, perform a dose re-enactment to validate the dose estimates, and determine if an overexposure occurred. The Program did not issue any violation for the extremity overexposure, and the Program did not report the overexposure to the NRC.

On April 30, 2015, a medical licensee received a declared pregnant womans final monthly fetal badge dosimetry results, which indicated the fetal dose had exceeded 500 millirem for the gestation period. On June 29, 2015, the licensee reported to the Program that the total fetal dose received during the gestation period was 535 millirem. The licensees notification was past the 30-day reporting requirement for overexposures. The Program reported the incident to NMED on July 16, 2015. The team considered this timely because it was within 30 days of receiving the report from the licensee. The Program conducted an inspection on September 3, 2015. The Program issued a violation for the late reporting of the incident, but failed to issue violations for the overexposure and the variance in dose distribution. The Program accepted the licensees corrective actions for the overexposure, which included closer monitoring of fetal exposure and reviews at 10 and 30 percent of the dose limit, but did not request corrective actions for the late reporting. As noted in Section 3.3 of this report, there was a discrepancy in the dose reported to NMED. The team noted that, at the time of the review, the Program had not updated the NMED report with the correct exposure data.

The team identified issues with multiple events involving Yttrium-90 (Y-90) microspheres. On September 30, 2015, a medical licensee reported an under dose of Y-90 microspheres administered to a patient the day before. This event was reported to the NRC on October 1, 2015. The licensee determined the root cause to be a weak battery in the digital electronic radiation dosimeter. The licensees procedure requires the use of a digital electronic radiation dosimeter to

Kansas Draft IMPEP Report Page 15 confirm post-injection that the microspheres were no longer in the vial. The licensees corrective actions included changing batteries in the electronic dosimeter prior to each microsphere administration to ensure optimum power.

The Programs records did not indicate if an onsite investigation was conducted, and the inspection following the event did not appear to independently evaluate and confirm that the licensees root cause was acceptable. This medical event was not reviewed until an inspection was conducted in September 2017.

At this same facility, on July 19, 2017, a similar incident occurred where a patient received an under dose of Y-90 microspheres. The licensee later discovered that the microspheres had collected in the catheter and not in the patient; even though a digital electronic radiation dosimeter read zero at the conclusion of the administration. There was not an onsite investigation for this medical event.

There was no documentation of exposures to personnel or patients from the microspheres that remained outside of the patient. There was not a validation of the root cause and corrective actions. The corrective actions noted by the licensee were not commensurate with the root cause which indicates that the root cause was not correct. The Program reported this event to the NRC on July 19, 2017.

On August 25, 2017, the same medical licensee reported a contamination event involving Y-90 microspheres which occurred the day before. A technologist did not follow the proper procedure and became contaminated. This technologist tracked contamination down a hallway and into several rooms. The Program reported the incident to the NRC on the same day they were notified by the licensee, and conducted an onsite investigation on September 27, 2017, as part of the routine inspection of this licensee. An interview with the technologist revealed that she was distracted. The event was closed by the Program; however the information in NMED indicates an additional review was being conducted. The licensees corrective actions were reviewed as part of the routine inspection; however, the corrective actions do not appear to match the causes of the event.

As described in Section 3.1 of this report, the team determined that management did not provide sufficient oversight of reactive and followup inspections to ensure a prompt response to incidents.

During the review period, eight allegations were received by Kansas. The team evaluated three allegations, including two allegations that the NRC referred to Kansas, during the review period. The team determined that the Program was adequately responding to allegations, following procedures, maintaining documentation to close the allegation, and was able to protect the identity of concerned individuals. In one of the cases referred to the Program by the NRC, the team identified that a concerned individual was not notified about the Programs investigation results. The Program performed an onsite investigation within 6 days of referral, and determined that the concerns could not be substantiated. While the allegation response was prompt and thorough, there was no indication that the concerned individual was notified of the results. Once the team raised this question, the Program committed to notify the

Kansas Draft IMPEP Report Page 16 concerned individual about the results of the investigation. With the exception of this one isolated case, the Program followed its procedure.

c. Evaluation The team determined that, except as noted below, during the review period Kansas met the performance indicator objectives listed in Section 3.5.a.

• In one isolated case, the concerned individual was not notified of investigation conclusions.

• Incident response and investigation procedures are not consistently followed.

• Response actions are not always appropriate, well-coordinated, or timely.

• Onsite responses are not consistently performed when incidents have potential health, safety, or security significance.

• Appropriate followup actions are not always taken to ensure prompt compliance by licensees.

• Followup inspections are not consistently scheduled and completed, as necessary.

• Notifications are not always made to the NRC Headquarters Operations Center for incidents requiring a 24-hour or immediate notification to the Agreement State or NRC.

The teams evaluation identified frequent examples in which responses to incidents were incomplete, inappropriate, poorly coordinated, or not timely. As a result, potential health and safety problems persisted. The team also identified two instances where the Program failed to notify the NRC of incidents, as appropriate.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kansas performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found unsatisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

4.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs: (1) Compatibility Requirements; (2) Sealed Source and Device (SS&D)

Evaluation Program; (3) Low-Level Radioactive Waste Disposal (LLRW) Program; and (4) Uranium Recovery Program. The NRCs Agreement with Kansas retains regulatory authority for a uranium recovery program; therefore, only the first three non-common performance indicators applied to this review.

Kansas Draft IMPEP Report Page 17 4.1 Compatibility Requirements State statutes should authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of protection of public health, safety, and security. The State must be authorized through its legal authority to license, inspect, and enforce legally binding requirements, such as regulations and licenses.

NRC regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety should be adopted in a time frame so that the effective date of the State requirement is not later than 3 years after the effective date of the NRC's final rule. Other program elements, as defined in Appendix A of State Agreements procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements, that have been designated as necessary for maintenance of an adequate and compatible program, should be adopted and implemented by an Agreement State within 6 months following NRC designation.

a. Scope The team used the guidance in State Agreements procedure SA-107, Reviewing the Non-Common Performance Indicator: Compatibility Requirements, and evaluated Kansas performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be found on the NRC website at the following address: https://scp.nrc.gov/regtoolbox.html.

• The Agreement State program does not create conflicts, duplications, gaps, or other conditions that jeopardize an orderly pattern in the regulation of radioactive materials under the Atomic Energy Act, as amended.

• Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted no later than 3 years after the effective date of the NRC regulation.

• Other program elements, as defined in SA-200 that have been designated as necessary for maintenance of an adequate and compatible program, have been adopted and implemented within 6 months of NRC designation.

• The State statutes authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement.

• The State is authorized through its legal authority to license, inspect, and enforce legally binding requirements such as regulations and licenses.

• Impact of sunset requirements, if any, on the States regulations.

b. Discussion Kansas became an Agreement State on January 1, 1965. The Kansas regulations governing radiation protection requirements are found in Kansas Administrative Regulations 28-35-133 through 28-35-505, and apply to all ionizing radiation, whether

Kansas Draft IMPEP Report Page 18 emitted from radionuclides or produced by machines. No legislation affecting the Program was passed during the review period except a new bill was approved on June 7, 2018, that now requires the review and approval by the Kansas Division of Budget, in addition to the Department of Administration, and the Attorney General for all rulemakings.

Kansas administrative rulemaking process takes approximately 2 to 3 years from drafting to finalizing a rule. The public, the NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments are considered and incorporated, as appropriate, before the regulations are finalized and approved by the Kansas Attorney General. Based on the new bill that was approved on June 7, 2018, the Program could not estimate the additional time that will be added to the legislative process, but it believes it could be significant. The team noted that the States rules and regulations are not subject to sunset laws.

During the review period, the Program submitted one proposed regulation amendment (Regulation Amendment Tracking System Identification Number (RATS ID) ( 2013-1)),

nine final regulation amendments (RATS IDs 2001-1, 2011-1, 2011-2, 2012-1, 2012-2, 2012-3, 2012-4, 2013-1, and 2013-2), and one legally binding license condition (10 CFR Part 37) to the NRC for a compatibility review. Eight final regulation amendments (RATS IDs 2001-1, 2011-1, 2011-2, 2012-2, 2012-3, 2012-4, 2013-1, and 2013-2) were overdue for State adoption at the time of submission. The NRCs review of these amendments identified provisions in which the Kansas rules were not written essentially identical to the NRCs regulations. On June 7, 2018, the Program submitted its revised final regulations incorporating some of the NRCs comments, and indicated that a rulemaking package to address the remainder of the comments is undergoing Kansas legislative review.

At the time of this IMPEP review, the following two amendments were overdue and had not been submitted to the NRC for a compatibility review:

• RATS ID 2015-1: Domestic Licensing of Special Nuclear Material - Written Reports and Clarifying Amendments Part 70 (79 FR 57721, 80 FR 143) that was due for State adoption on January 26, 2018.

• RATS ID 2015-2: Safeguards Information - Modified Handling Categorization, Change for Materials Facilities Parts 30, 37, 73 and 150 (79 FR 58664, 80 FR 3865) that was due for State adoption on January 28, 2018.

The team questioned the Program as to why the regulations were submitted overdue, and why the Program did not submit legally binding requirements in the interim. The Program indicated that the eight overdue amendments were undergoing legislative review, and that resources were not available to address all of the rulemakings by legally binding requirements. The Program noted that the legislative review process is outside of their control.

Kansas Draft IMPEP Report Page 19 The team found that the Program issued a license condition that was not previously reviewed and approved by the NRC. The license condition allows specific medical licensees to approve visiting authorized users. Since this license condition is a legally binding requirement, which may not be compatible with NRC regulations, the Program should have submitted the proposed license condition to the NRC for a compatibility review prior to placing the condition on any licenses. After a discussion with the team, the Program decided to remove this license condition immediately from the medical licenses; contact the affected licensees to determine whether any authorized users were added using this license condition, and, if so, will request the training and experience documentation of these visiting authorized users for the Programs review and approval.

c. Evaluation The team determined that, except as noted below, during the review period Kansas met the performance indicator objectives listed in Section 3.5.a.

• Regulations adopted by the Agreement State for purposes of compatibility or health and safety were, in some cases, adopted greater than 3 years after the effective date of the NRC regulation.

Several regulations adopted by Kansas for purposes of compatibility, or health and safety, were adopted later than 3 years after the effective date of the NRC regulation.

The team took into consideration that Kansas administrative rulemaking process can take 3 years from drafting to finalizing a rule and any delay would lead to an overdue submission. The team discussed whether a finding of satisfactory, but needs improvement, versus unsatisfactory would be appropriate. Due to the following, the team concluded that a finding of satisfactory, but needs improvement would be appropriate: (1) Kansas has final regulations adopted and effective as of this review, and has a rulemaking package to address all outstanding NRC comments in process; (2) the two rulemakings overdue at the time of the review were not significant; (3) the legislative process is outside the control of the Program; and (4) new Program management is committed to ensuring that all efforts will be made to promulgate regulations on time, and, if not, will issue legally binding requirements. The team determined that the Kansas radiation control program is compatible with the NRCs program at this time.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kansas performance with respect to the indicator, Compatibility Requirements, be found satisfactory, but needs improvement.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

4.2 Sealed Source and Device (SS&D) Evaluation Program The Kansas Agreement State Program has authority to conduct sealed source and device (SS&D) evaluations for byproduct, source, and certain special nuclear materials;

Kansas Draft IMPEP Report Page 20 however, Kansas did not conduct any SS&D evaluations during the review period.

There are currently no SS&D manufacturers in Kansas. If Kansas were to receive an application for a SS&D action, it has a procedure in place to outsource or contract the action. Accordingly, the team did not review this indicator. The Program manager indicated that the Program is considering returning this portion of the Agreement to the NRC.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program 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 for an amendment. Although Kansas has such authority to regulate a LLRW disposal facility, the NRC has not required States to have a program for licensing a disposal facility until such time as the State has been designated as a host State for LLRW disposal. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, it is expected to put in place a regulatory program that will meet the criteria for an adequate and compatible LLRW program. There are no plans for a commercial LLRW disposal facility in Kansas. Accordingly, the team did not review this indicator.

5.0

SUMMARY

As noted in Sections 3.0 and 4.0 above, Kansas performance was found to be satisfactory for the performance indicators: Status of Materials Inspection and Technical Staffing and Training. Kansas performance was found to be satisfactory, but needs improvement, for the performance indicators: Technical Quality of Licensing Actions and Compatibility Requirements. Kansas performance was found to be unsatisfactory for the performance indicators: Technical Quality of Inspections and Technical Quality of Incident and Allegation Activities. The team did not make any recommendations, and determined that the recommendation from the 2014 IMPEP review should be closed.

Accordingly, the team recommends that the Kansas Agreement State Program be found adequate to protect public health and safety, but needs improvement, and compatible with the NRC's program. The team determined that the declining performance from the previous 2014 IMPEP review was mainly due to: (1) inadequate management oversight of inspection and event reports as described in Sections 3.3 and 3.5 of this report; (2) poorly communicated inspection findings to licensees; and (3) the pattern of untimely and insufficient responses to events (e.g., overexposure to an embryo fetus, extremity overexposure to a radiographer, medical events, etc.).

Based on the criteria in MD 5.6 and the findings of this IMPEP review, the team recommends placing the Kansas Agreement State Program on Heightened Oversight.

Heightened Oversight is an increased monitoring process used by NRC to follow the progress of improvement needed in an Agreement State program. It involves preparation of a program improvement plan, bimonthly conference calls, and submission

Kansas Draft IMPEP Report Page 21 of status reports prior to each call with the appropriate Kansas and NRC staffs. The team discussed placing the Kansas Agreement State Program on Probation versus Heightened Oversight based on the findings; however the team determined that Probation is not appropriate at this time because of the following:

• The last IMPEP review was satisfactory and the Program was not on any level of enhanced oversight (e.g., monitoring or heightened oversight) during the review period;

• The Program was receptive to the teams findings and committed to addressing the performance issues identified by the team; and

• The team is confident that the Program can resolve these issues in an expeditious manner.

Accordingly, based on the results of the current IMPEP review, the team recommends that the next full IMPEP review take place in approximately 2 years (April/May 2020 timeframe), with a periodic meeting in approximately 1 year.

LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspection Accompaniments Appendix C Inspection Casework Reviews Appendix D Incident Casework Reviews

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Michelle Beardsley, NMSS Team Leader Compatibility Requirements Kathy Modes, NMSS Team Leader in Training Technical Staffing and Training Inspection Accompaniments Binesh Tharakan, Region IV Status of Materials Inspection Program Technical Quality of Incident and Allegation Activities James Cassata, Region I Technical Quality of Inspections Brian Goretzki, Arizona Technical Quality of Licensing Actions

APPENDIX B INSPECTION ACCOMPANIMENTS The following inspection accompaniments were performed prior to the on-site IMPEP review:

Accompaniment No.: 1 License No.: 18-C753-01 Licensee: Via Christi Hospitals Wichita Priority: 1 License Type: Medical Broad-scope (with HDR) Inspector: JH Inspection Date: 4/10/2018 Accompaniment No.: 2 License No.:21-B165-01 Licensee: Coder X-ray Service Priority1:

License Type: Industrial Radiography Inspector JU:

Inspection Date: 4/11/2018 Accompaniment No.: 3 License No.:38-C011-01 Licensee: Kansas State University Priority: 1 License Type: Academic Broad-scope (with R&D) Inspector: AS Inspection Date: 4/12/2018

APPENDIX C INSPECTION CASEWORK REVIEWS NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS File No.: 1 Licensee: Prime Health Care Services - Providence License No.: 19-C182-01 Inspection Type: Medical Institution - Diagnostics - Priority: 2 Special Inspection Date: 9/3/2015; Report Date 12/21/2015 Inspector: JAH Comment: This inspection included a review of an overexposure to an embryo fetus for a declared pregnant woman. The Program cited a violation for the failure to file a 30 day report notifying the Program of the overexposure, but the Program did not cite the licensee for the overexposure. The inspection documentation was not thorough for a reactive inspection (e.g.,

there was no documentation that the inspector validated the dose received). There was no indication that the Program followed up on a discrepancy in the dose reported by the licensee of 535 mrem for the overexposure that differed from the summation of the monthly dosimetry reports that totaled 579 mrem. Described in Section 3.3 of this report.

File No.: 2 Licensee: Prime Health Care Services - Providence License No.: 19-C182-01 Inspection Type: Medical Institution - Diagnostics - Priority: 2 Routine Inspection Date: 12/9/2015; Report Date 12/30/2015 Inspector: JAH Comment: The inspection documentation did not close the previous violation from the September 3, 2015 inspection. On the Programs internal computer inspection database report, it was stated that not enough time had elapsed to determine the overall effect of the licensees policy changes. The Program did not decrease the inspection frequency in order to perform a review of the licensees policy changes.

File No.: 3 Licensee: Prime Health Care Services - Providence License No.: 19-C182-01 Inspection Type: Medical Institution - Diagnostics - Priority: 2 Routine Inspection Date: 12/6/2017; Report Date 12/12/2017 Inspectors: JW, JAH Comment: The inspection documentation did not address the previous violation from the September 3, 2015, inspection report which remained open. This inspection documentation did not address the evaluation of the licensees policy changes that went into effect in 2015 as a result of the failure to report an overexposure to an embryo fetus.

File No.: 4 Licensee: DBI Inc. License No.: 21-B805 Inspection Type: Industrial Radiography - Routine Priority: 1 Inspection Date: 7/27/2015; Reported on 8/17/2015 Inspector: DL Comment: None File No.: 5 Licensee: DBI Inc. License No.: 21-B805 Inspection Type: Industrial Radiography - Routine Priority: 1 Inspection Date: 7/6/2016; Reported on: 7/14/2016 Inspector: JW Comment: The Program issued a clear safety and security inspection, despite the overexposure event. On May 6, 2015, the licensee notified the Program of an extremity overexposure of 50 -

100 rad to a radiographer. However, the Program did not address this matter during this inspection. There was no documentation to show that the Program reviewed the licensees dosimetry results or the evaluation of the event. There was no indication that the Program did an independent assessment and validation of the dose.

File No.: 6 Licensee: DBI Inc. License No.: 21-B805 Inspection Type: Industrial Radiography - Routine Priority: 1 Inspection Date: 4/18/2017; Reported on: 4/20/2017 Inspector: JU Comment: The Program cited the radiography licensee for using a dark room truck with an inoperable pin sensor. A pin sensor is used as part of their security system. The Program wrote in their internal database the error was not serious enough to stop the alarm, but merely delay it. This statement does not convey a clear picture of the problem encountered. The report does not indicate if the radioactive material was left unattended in the dark room truck. In the Programs inspection report, this is noted as a non-cited violation, but in the letter to the licensee it was identified as either a minor violation or corrected at the time of the inspection. The inspection report and letter to the licensee are inconsistent. The citation is vague and ambiguous in the letter to the licensee.

File No.: 7 Licensee: DBI Inc. License No.: 21-B805 Inspection Type: Industrial Radiography - Routine Priority: 1 Inspection Date: 5/4/2018; Report Date: 5/22/2018 Inspector: DL Comment: This was a clear inspection. The previous minor violation for 10 CFR 37.49 was not reviewed and not closed.

File No.: 8 Licensee: University of Kansas Hospital Authority License No.: 18-C801 Inspection Type: Type A Medical Broad Scope with Priority: 1 Self-Shielded Irradiator - Routine Inspection Date: 9/27/2017; Reported on: 10/5/2017 Inspector: JW Comment: The Program performed an inspection of a medical licensee on September 27, 2017.

The Program cited the licensee for a failure to train, but the inspection report noted that there were no gaps in training. This language contradicts the violation. The inspection report addressed a Y-90 contamination event that occurred on August 24, 2017, but the inspection report did not confirm that the licensees corrective actions were effective or their root cause was

correct. The incident caused the department to restrict access for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> due to contamination.

The inspection conducted on September 27, 2017, did not address a medical event that occurred on July 18, 2017, where a patient received approximately 24 percent of the prescribed dose of Y-90 microspheres. The inspection documentation contained no information on the Programs assessment or confirmation of the licensees root cause and corrective actions of the medical event. A reactive inspection for the medical event was not performed. Described in Sections 3.3 and 3.5 of this report.

The inspection conducted on September 27, 2017 did not address a similar medical event where a patient was administered 64 percent of the prescribed dose of Y-90 microspheres in September 2015. Since this licensee had a similar medical event in 2015, the Program could have reviewed the licensees root cause and corrective actions from the 2015 event to determine if the root cause and corrective actions were valid and effective. There was no indication in the documentation that the Program had ever properly evaluated the licensees root cause for the 2015 medical event. Described in Section 3.3 of this report.

File No.: 9 Licensee: Wesley Medical Center, LLC License No.: 19-C041-01 Inspection Type: Type A Medical Broad Scope - Priority: 1 Routine Inspection Date: 4/26/2016; Reported on 5/4/2016 Inspector: JAH, JW Comment: None.

File No.: 10 Licensee: Wesley Medical Center, LLC License No.: 19-C041-01 Inspection Type: Type A Medical Broad Scope - Priority: 1 Routine Inspection Date: 5/3/2017; Reported on 5/19/2017 Inspector: JU Comment: The Program did not address and did not close the previous seven violations. The Program issued three new violations during this inspection. Two of the three new violations are identified as violations in the report to the licensee, but they were identified as non-cited violations in the database inspection report. However, both of these violations were vague and ambiguous.

File No.: 11 Licensee: Wesley Medical Center, LLC License No.: 19-C041-01 Inspection Type: Type A Medical Broad Scope - Priority: 1 Routine Inspection Date: 5/15/2018; Reported on 5/31/2018 Inspector: JAH Comment: The previous 2017 violation was properly closed on this inspection. The seven violations from the 2016 inspection remain open. The focus of this inspection was a review of an incident where the incorrect radioactive material was administered to a patient.

File No.: 12 Licensee: Chanute Manufacturing Co. License No.: 21-B189-01 Inspection Type: Industrial Radiography - Fixed Priority: 1 Location - Routine Inspection Date: 10/20/2017; Reported on 10/31/2017 Inspector: JU Comment: Two security violations cited for access authorization program requirements (10 CFR 37.23) and access authorization program review (10 CFR 37.33). The regulations were poorly paraphrased and non-specific as to the subsection in the regulation resulting in unclear communication with the licensee. As written in the report, 10 CFR 37.23, implied a failure for trustworthiness and reliability determinations, a failure to perform background screenings, and a failure to remove from the access authorization list within seven days. For the citation against 10 CFR 37.33, it was unclear if the annual access authorization program review was completed and not documented, or if the annual review was not performed.

File No.: 13 Licensee: Coder X-Ray Service, Inc. License No.: 21-B165-01 Inspection Type: Industrial Radiography - Routine Priority: 1 Inspection Date: 5/3/2016; Reported on 6/21/2016 Inspector: DL Comment: The inspection report with a violation for failure to perform leak tests was issued beyond 30 days due to the Program waiting on information from the licensee.

File No.: 14 Licensee: Coder X-Ray Service, Inc. License No.: 21-B165-01 Inspection Type: Industrial Radiography - Routine Priority: 1 Inspection Date: 5/9/2017; Reported on 5/19/2017 Inspector: AS Comment: The previous 2016 violation for failure to perform leak tests was not mentioned in this inspection report and was not closed.

File No.: 15 Licensee: Coder X-Ray Service, Inc. License No.: 21-B165-01 Inspection Type: Industrial Radiography -- Routine Priority: 1 Inspection Date: 4/11/2018; Reported on 4/18/2018 Inspector: JU Comment: None File No.: 16 Licensee: Taylor Forge Engineering License No.: 21-B108-01 Inspection Type: Industrial Radiography and Portable Priority: 1 Gauge - Routine Inspection Date: 2/17/2015; Reported on: 2/18/2015 Inspector: JW Comment: The inspection documentation noted one non-cited violation for the failure of conspicuous visible and audible warning signals to warn of the present of radiation. There was ambiguous language used in the Programs report to the licensee such as, checked until bell sounded. This language could infer that the audible signal was operational and may be the visible signal was not working. The report stated that there was a similar problem with this system in 2014, but did not explain the similarities or why the problem persisted if the licensee had implemented effective corrective actions. Since this may have been a repetitive violation, there was no justification to issue a non-cited violation in lieu of a violation.

File No.: 17 Licensee: Taylor Forge Engineering License No.: 21-B108-01 Inspection Type: Industrial Radiography and Portable Priority: 1 Gauge - Routine Inspection Date: 2/28/2018; Reported on 3/2/2018 Inspector: AS Comment: None File No.: 18 Licensee: Saint Francis Health Center Medical License No.: 19-B272-04 Institution Inspection Type: Radiopharmacy - Routine Priority: 1 Inspection Date: 9/7/2017; Reported on 9/29/2017 Inspector: JU Comment: None File No.: 19 Licensee: VIA Christi Hospitals - Pittsburg License No.: 18-C753-01 Inspection Type: Type A Medical Broad Scope and Priority: 2 Self-Shielded Irradiator - Routine Inspection Date: 4/13/2017; Reported on 4/29/2017 Inspector: JU, AS, JH Comment: The inspector cited two security violations (10 CFR 37.23 and 37.41), but the citations were vague and ambiguous. Described in Section 3.3 of this report.

File No.: 20 Licensee: VIA Christi Hospitals - Pittsburg License No.: 18-C753-01 Inspection Type: Type A Medical Broad Scope and Priority: 2 Self-Shielded Irradiator - Routine Inspection Date: 4/10/2018; Reported on: 4/26/2018 Inspector: JAH Comment: None File No.: 21 Licensee: Front Range Nuclear Services License No.: 12-B860 Inspection Type: Medical Mobile Service - Diagnostics Priority: 2

- Routine Inspection Date: 1/11/2017; Reported on 1/31/2017 Inspector: DL Comment: None File No.: 22 Licensee: Gemini Wireline, LLC License No.: 27-B928 Inspection Type: Well Logging - Routine Priority: 2 Inspection Date: 11/16/2017; Reported on 12/4/2017 Inspector: DL Comment: None File No.: 23 Licensee: Rural Health Resources License No.: 12-B1024 Inspection Type: Medical Institution - Unsealed Priority: 3 Diagnostic - Initial Inspection Inspection Date: 5/20/2018; Reported on 5/21/2018 Inspector: JAH Comment: None

File No.: 24 Licensee: Heartland Oncology, LLC License No.: 12-B1007 Inspection Type: Medical Institution - Diagnostic - Priority: 3 Initial Inspection Inspection Date: 8/23/2016; Reported on 9/6/2016 Inspector: JAH Comment: None File No.: 25 Licensee: SOFIE Bioscience Inc. License No.: 10-C0122 Inspection Type: Cyclotron - Initial Inspection Priority: 1 Inspection Date: 2/15/2018; Reported on 2/18/2018 Inspector: JU Comment: None

APPENDIX D INCIDENT CASEWORK REVIEWS NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS File No.: 1 License No.: 19-C041-01 Licensee: Wesley Medical Center NMED Item No: 180223/KS180004 Incident Date: 5/4/18 Incident Type: Potential Medical Event Investigation Date: 5/7/18 Investigation Type: Phone/Email Comment: None File No.: 2 License No.: Unknown Licensee: Unknown NMED Item No: KS180003 Incident Date: 4/24/18 Incident Type: Abandoned RAM Investigation Date: 4/24/18 Investigation Type: Site Comment: None File No.: 3 License No.: 18-C800-01 Licensee: Kansas University Medical Center NMED Item No: KS180001 Incident Date: 2/6/18 Incident Type: Lost RAM Investigation Date: 2/6/18 Investigation Type: Phone/Email Comment: None File No.: 4 License No.: 18-C801-01 Licensee: University of Kansas Hospital Authority NMED Item No: 170410/KS170008 Incident Date: 8/24/17 Incident Type: Contamination Investigation Date: 9/27/17 Investigation Type: Site Comment: Personnel and room contamination during Y-90 treatment. Described in Section 3.5 of this report.

File No.: 5 License No.: 18-C801-01 Licensee: University of Kansas Hospital Authority NMED Item No: 17035/KS170006 Incident Date: 7/18/17 Incident Type: Medical Event Investigation Date: None Investigation Type: Phone/Email Comment: Medical Event involving Y-90 microspheres. Described in Section 3.5 of this report.

File No.: 6 License No.: NA Licensee: Feralloy Corporation NMED Item No: KS170005 Incident Date: 2/15/17 Incident Type: Unauthorized transfer Investigation Date: 2/15/17 Investigation Type: Phone/Email Comment: None File No.: 7 License No.: 22-B683-01 Licensee: Kirkham Michael & Associates NMED Item No: 170185/KS170004 Incident Date: 4/3/17 Incident Type: Damaged Equipment Investigation Date: 4/5/17 Investigation Type: Phone/Email/Site Comment: None

File No.: 8 License No.: 22-B580-01 Licensee: Bartlett & West Engineers NMED Item No: 160332/KS160006 Incident Date: 8/1/16 Incident Type: Stolen Gauge Investigation Date: 12/22/16 Investigation Type: Phone Comment: None File No.: 9 License No.: GL 2016-052 (AL 1266)

Licensee: Building & Earth Sciences NMED Item No: 160308/KS160005 Incident Date: 7/19/16 Incident Type: Damaged Equipment Investigation Date: 7/19/16 Investigation Type: Phone Comment: None File No.: 10 License No.: GL-878 Licensee: Pace Analytical Services, Inc. NMED Item No: KS160004 Incident Date: 4/1/16 Incident Type: Damaged Equipment Investigation Date: 5/9/16 Investigation Type: Phone Comment: None File No.: 11 License No.: NA Licensee: Advantage Metals Recycling (non-licensee) NMED Item No: 160003 Incident Date: 4/29/16 Incident Type: Abandoned RAM Investigation Date: 6/23/16 Investigation Type: Site Comment: None File No.: 12 License No.: 38-C011-01 Licensee: Kansas State University NMED Item No: KS160002 Incident Date: 1/19/16 Incident Type: Lost RAM Investigation Date: NA Investigation Type: Phone Comment: None File No.: 13 License No.: 18-C753-01 Licensee: Via Christi Regional Medical Center Wichita NMED Item No: Not Reported Incident Date: 1/15/16 Incident Type: Contamination Investigation Date: 1/28/16 Investigation Type: Phone Comment: Unreported I-131 patient room contamination. On January 15, 2016, a medical licensee reported that a patient had contaminated a hospital room after being treated with 159.8 millicuries (mCi) of Iodine-131 on January 13, 2016. The room was isolated for approximately 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> over the weekend to allow for decay and to reduce exposure of individuals decontaminating the room. The room was decontaminated and released back into service on Monday morning, January 18, 2016.

The Program did not perform an onsite investigation. The incident was closed on January 28, 2016, with no additional actions by the Program. The Program reported this incident to the NRC on July 2, 2018, after the IMPEP team identified that this was a reportable incident due to the room being isolated for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for radiation safety reasons. The Program has not entered this information into NMED.

File No.: 14 License No.: 18-C801-01 Licensee: University of Kansas Hospital Authority NMED Item No: 150545/KS150009 Incident Date: 9/29/15 Incident Type: Medical Event Investigation Date: 9/30/15 Investigation Type: Phone/Email Comment: Medical Event involving Y-90 microspheres. Described in Section 3.5 of this report.

File No.: 15 License No.: 19-C182-01 Licensee: Prime Healthcare Services NMED Item No: 150427/KS150006 Incident Date: 4/30/15 Incident Type: Overexposure Investigation Date: 9/03/15 Investigation Type: Site Comment: Declared Pregnant Worker Fetus Overexposure. Described in Section 3.5 of this report.

File No.: 16 License No.: 22-B952-01 Licensee: Cornejo and Sons NMED Item No: 150413/KS 150008 Incident Date: 7/16/15 at 0100 Incident Type: Damaged Equipment Investigation Date: 7/16/15 afternoon Investigation Type: Phone/Email Comment: None.

File No.: 17 License No.: 21-B805-01 Licensee: DBI, Inc. NMED Item No: 160272/KS150004 Incident Date: 5/6/15 Incident Type: Overexposure Investigation Date: None Investigation Type: Phone/Email Comment: Radiographer extremity overexposure. Described in Section 3.5.

File No.: 18 License No.: GL-281 Licensee: Mid-America Trucking Equipment, Inc. NMED Item No: 140617/KS140014 Incident Date: 9/2/14 Incident Type: Lost RAM Investigation Date: 9/22/14 Investigation Type: Phone/Email Comment: None.

File No.: 19 License No.: GL-750 Licensee: Bonanza Bioenergy, LLC NMED Item No: 140616/KS140013 Incident Date: 8/25/14 Incident Type: Lost RAM Investigation Date: 9/17/14 Investigation Type: Phone/Email Comment: None.