ML20217K609

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Draft Rept, Integrated Materials Performance Evaluation Program Review of Washington Agreement State Program, 990830-0903
ML20217K609
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Issue date: 08/30/1999
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- INTEG. RATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF. WASHINGTON AGREEMENT STATE PROGRAM

- AUGUST 30 - SEPTEMBER 3,1999 DRAFT REPORT I

U.S. Nuclear Regulatory Commission l

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i Washington Draft Report . Page 1

1.0 INTRODUCTION

i This report presents the results of the review of the Washington rad'iation control program. The review was conducted during the period August 30 - September 3,1999 by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the

. Agreement State of Florida. Review team members are identified in Appendix A. The review was conducted in accordance with the " Implementation of the Integrated Materials Performance Evaluation Program and Rescission of a Final General Statement of Policy," published in the -

Federal Reaister on October 16,1997, and the November 25,1998, revised NRC Management l Directive 5.6, "Ir.!egrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review,' which covered the period June 24,1995 to September 3,1999, were discussed with Washington management on September 3,1999

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

-The Washington Agreement State program is administered by the Division of Radiation Protection (the Division) located in the Department of Health (the Department). The Division 4 consists of five sections managed by a Director. Two sections within the Division have  !

responsibilities for radioactive materials, the Radioactive Materials Section and the Waste Management Section. The Waste Management Section includes the Low-Level Radioactive

' Waste Program and the Uranium Mills Program. The only regional office is located at the low-level radioactive waste disposal facility at Hanford, Washington. Organization charts for the Division and the Department are included as Appendix B. The Washington program regulates approximately 390 specific licenses authorizing agreement materials. The review focused on the materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of i 1954, as amended) Agreement between the NRC and the State of Washington.

In preparation for the review, a questionnaire addressing the common and non-common performance indicators was sent to the State on June 15,1999. The Division provided a response to the questionnaire by e mail on July 9,1999. A copy of the questionnaire is included in Appendix G of the draft report.

The review team's general approach for conduct of this review consisted of: (1) examination of the Division's response to the questionnaire; (2) review of applicable Washington statutes and regulations; (3) analysis of quantitative information from the Division licensing and inspection 1 database; (4) technical review of selected licensing and inspection actions; (5) field accompaniments of four materials inspectors, one mill inspector, and one waste site inspector; and (6) interviews with staff and management to answer questions or clarify issues. The review team evaluated the information that it gathered against the IMPEP criteria for each common and applicable non-common performance indicator and made a preliminary assessment of the Division's performance.

Section 2 below discusses the Division's actions in response to recommendations made

- following the previous review. Results of the current review for the IMPEP common

' performance indicators am presented in Section 3. Section 4 discusses results of the applicable non common performance indicators, and Section 5 summarizes the review team's findings and recommendations. Recommendations made by the review team are comments that relate directly to program performance by the Division.

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. 2.0 - STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS l

The previous review of the Washington radiation control' program concluded on June 23,1995. j

The review consisted of an evaluation of 30 program indicators per the 1992 Policy Statement.  !

During the last review,11 :7, commendations were made in the November 21,1995 letter to l Mr. Bruce Miyahara, Secretary, Washington Department of Health. The items were discussed )

y  ; in the NRC's June 25,1996 letter to Washington in response to the Department's Aprl! 18,1996 L response letter.1The team's review of the current status'of the open recommendations is as follows:

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1. We recommend that the State revise the effective date of its regulations' equivalent to the safety requirements for radiographic equipment amendment to 10 CFR Part 34.20 l so that its effective date is compatible with that of the NRC, January 10,1996, or as i l close to that date as possible.

Current Status: The review team noted that the 10 CFR Part 34.20 regulation was revised subsequently by NRC (60 FR 28323) and became effective June 30,1995. The l

Division revised their regulations which became effective on March 9,1999 to be j compatible with 60 FR 28323. The team also noted that Part 34 has been amended l again (62 FR 28948) and is due for adoption by the State by June 27,2000. This ,

recommendation is closed. l

2. . We recommend that the State clarify its policy and review its procedures for handling allegations referred to them by the NRC from unidentified allegers. The State should assure that their policy and procedures ensure the proper investigation and follow up of

. these allegations.

Current Status: The Division has developed and implemented allegation procedures for the handling of all allegations. The Radioactive Materials Section and the Waste Management ~Section each developed procedures which were reviewed by the review

. team and were determined to meet the IMPEP criteria. This recommendation is closed.

3. We recommend that the State supplement the incident report form used by the emergency response section with forms specific to events and allegations involving radioactive materials, including misadministrations.

U - Current Status: The Division has supplemented their incident report forms to be specific to events and allegations involving radioactive material. This recommendation is closed.

4. We recommend that the State develop procedures specific to investigation and reporting allegations and misadministrations.

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Current Status: The Division has developed procedures specific to investigations and reporting allegations and misadministrations. This recommendation is closed.

5. . We recommend that the State deve,op a computer system for tracking and closing incident reports and investigations, including prompting management for reports requested by the NRC.

Washington Draft Report Page 3 Current Status: The Division has developed an; implemented a computerized tracking system for closing out incidents. This recommendation is closed.

' 6. We recommend the members of program management involve themselves in the escalated enforcement actions by attending all enforcement meetings with licensees and by assuring all escalated enforcement tools are used to carry out program policy and to provide documentation when management decides to deviate from the written policy.

Current Status: Division management objected to the prescriptive nature of the recommendation, and noted that the Division makes determinations regarding attendance at enforcement meetings on a case by case basis. However, Division management did agree that better documentation of deviations from the general rule that management attends all such meetings is needed. The review team did not identify any concems related to management's role in escalated enforcement actions during this review period. This recommendation is closed.

7. We recommend that the Radioactive Materials Section modify the medical inspection form to add a section applicable to radiopharmaceutical therapy.

Current Status: The Radioactive Materials Section has revised its form to include a review of radiopharmaceutical therapy. This recommendation is closed.

8. We recommend that a procedure and a form be developed for inspecting high-dose-rate remote afterloader (HDR) licensees.

Current Status: Due to the small number of HDR licensees, the Division does not see a need to develop a separate inspection form for this type of licenses. However, Division management has committed to use NRC's inspection procedure and related field notes for HDR inspections until such time as the Division develops its own procedure for this type of inspection. The review team did note some inconsistent use of forms for HDR inspections. See Section 3.2 for further discussion. This recommendation is closed.

9. In order to assure consistericy in inspection practices, we recommend that the use of

- the new short inspection form be discontinued and that tha standard forms be used until such time as the new form is evaluated and approved by program management. Once -

approved, the form should be used uniformly. Any new form developed should ensure I that all essential aspects of the inspections are correct and that adequate space is )

provided on the form for clear documentation of comments and evaluations.  !

l Current Status: The use of the form in question was discontinued. This l recommendation is closed.

10. . We recommend that the Waste Management Section revise the form used for the annual inspection of the low-level radioactive waste disposal site to include verification that inspectors reviewed the licensee's incident file, and also to document management's review of the report. j l

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Washington Draft Report Page 4 Current Status: The review team noted that both of these recommended changes have been incorporated in the inspection checklist currently being used for inspection of the

' low level radioactive waste facility. This recommendation is closed.

11. We recommend that the Waste Management Section revise the uranium millinspaction checklist to include review of a licensee's intemal audit program, review of a licensee's
ALARA program, management review, and subsequent correspondence.

Current Status: Based upon the review of the checklist and evaluation of the inspection files, the team determined that the Waste Management Section has revised the checklist and has implemented the previous recommendations. This recommendation is closed.

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

3.1 Status of Materials insoection Prooram The review team focused on four factors in evaluating this indicator: Inspection frequency, overdue inspections, initial inspection of new licensees, and timely dispatch of inspection findings to licensees. The review team's evaluation is based on the Division's questionnaire responses relative to this indicator, data gathered independently from the Division's licensing and inspection data tracking system, the examination of completed licensing and inspection casework, and interviews with managers and staff.

The review team's evaluation of the Division's inspection priorities revealed that inspection

' frequencies for most types of licenses were the same or more frequent than similar license types listed in NRC inspection Manual Chapter (IMC) 2800, with the following except >ns:

(1) licensees authorized for installation and maintenance of fixed gauging devices-(2) licensees authorized for training and servicing of portable gauging devices; ar.J (3) licensees authorized for sales demonstrations, installation, and calibration of gauging devices. Each of these license types were assigned a Priority 4 rather than the more restrictive Priority 3 designation found in IMC 2800. However, during the onsite portion of this review, the Radioactive Materials Section changed the inspection priority designation of these license types to Priority 3, in accordance with IMC 2800.

The staff uses a computer database program to track inspection due dates. This data is provided to inspection staff and management to monitor upcoming inspections. In their response to the questionnaire, the Radioactive Materials Section indicated that only one inspection was overdue by more than 25% of the specified frequency as of June 15,1999. This was a Priority 2 licensee that was subsequently inspected on July 29,1999. The review team verified that no inspections remained overdue past the 25% window. During the review period, the Radioactive Materials Section performed 438 inspections, including 70 initialinspections

, . and 24 reciprocity inspections.

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Washington Draft Report Page 5 LWith respect to initial inspections of new licensees, a list of licenses issued since the last review was requested and evaluated. The Radioactive Materials Section inspection database information and a sampling of inspection files were evaluated to determine their initial .
inspection date. The Division has a policy of hand-delivering initial licenses which gives the Radioactive Materials Section staff an opportunity to discuss the ramifications of the license with the new licensee. The review team noted that initialinspections were performed within six months of license delivery or material receipt, in accordance with IMC 2800 requirements.

Additionally, follow-up inspections were pe_rformed one year from the date of each initial inspection.

-The revim team also evaluated the status of reciprocity inspections.' During the current review period,188 requests for reciprocity were filed with the program. Ninety-eight of the reciprocity requests were from Priority 4 licensees. The review team noted a significant Improvement in the number of core reciprocity inspections performed by the Radioactive Materials Section each

- year since the last program review. However, the Radioactive Materials Section did not meet the inspection goal outiined in IMC 1220 for Priority 3 licensees during calender year 1998; two of the nine Priority 3 licensees granted reciprocity were inspected as compared to the IMC 1220 inspection goal of 30% Additionally, the Radioactive Materials Section did not meet the 100%

inspection goal for teletherapy and irradiator source installation and service licenses. The staff performed three inspections of the six service licensees granted reciprocity during 1997, and two inspections of the three service licensees granted reciprocity during 1998. The staff has performed two inspections of the three service licensees granted reciprocity thus far in 1999.

The review team discussed this issue with the Radioactive Materials Section Head and was informed that the blaff intends to continue its efforts to meet the inspection goals specified in IMC 1220, especially with regard to source installation and exchange licensees, while continuing to direct staff resources to licensed activities posing the highest safety risks. For example, the Radioactive Mat eials Section performed 24 field site inspections of radiography licensees during this review period. -This was considered by the review team to be a program strength.

The Radioactive Materials Section's policy is to. dispatch written findings of inspections to 1

- licensees within 30 days of completing an inspection. Initial communication of inspection i findings is provided at the conclusion of each inspection through an exit briefing with licensee management. The team's review of inspection files determined that written inspection findings were promptly communicated to licensees. Tne' majority of inspection reports were issued onsite using a form similar to NRC's Form-591. Of the 19 core licensee inspection files evaluated by the team, inspection reports and/orletters of noncompliance were issued less than 30 days following the exit briefing with the licensee with only one exception; the review team identified one reciprocity inspection performed during April 1998 whereby no inspection report was ever provided to the licensee due to an oversight. The review team also noted that the Radioactive Materials Section's review of licensee responses to letters of noncompliance were performed in a timely manner.

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

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' 3.2 Technical Quality of Inspections L The review team ~ evaluated the inspection reports, enforcement documentation and inspection field notes, and interviewed inspectors for 19 materials inspections conducted during the review period. The casework included each of the Radioactive Materials Section inspectors and covered inspections of various types including medical institutions, industrial radiography, medical broad scope, research and development, mobile nuclear medicine, nuclear laundry,

i. manufacturing and distribution, nuclear pharmacy, and reciprocity licensees. Appendix C lists the inspection casework evaluated in-depth, with case-specific comments.

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As of the date of the review, the Radioactive Materials Section did not have written inspection procedures to cleariy delineate what management's expectations are regarding the minimum

-level of review, and documentation requl red for, each type of inspection. Although the review team member did not identify any performance weaknesses during the inspector accompaniments, the review of inspection casework identified a need for improvement in documentation of areas covered during an inspection in the inspection report. Specifically, the

. amount of detail provided in the inspection reports was not always sufficient to describe the scope of licensed activities conducted at the facilities and all areas reviewed and/or observed by the inspector during _the course of the inspection. The reviewer noted that the Radioactive Materials Section had recently developed new field notes for nuclear medicine and radiography which are more comprehensive and contain sufficient space for the documentation of an inspector's observations and findings. The team discussed this area with the Radioactive

~ Materials Section staff since these newer field notes were not yet consistently used by each inspector (some inspectors continue to use the old field notes). The review team also noted that some inspectors utilize NRC's inspection field notes for HDR inspections, while other inspectors utilize a combination of Radioactive Materials Section inspection forms for teletherapy and brachytherapy. The team determined, however, based on interviews with inspection staff that routine inspections appeared to cover all aspects of the licensees' radiation safety programs. This issue was also discussed with the Radioactive Materials Section Head, who informed the team, although written inspection procedures are not in place, the Radioactive Materials Section staff has NRC's inspection procedures available to use as guidance as needed.

Each inspection report is reviewed by the Manager, Compliance Program. In addition,

. approximately 10% of the inspection reports are reviewed by the Radioactive Materials Section Head. Team inspections were performed when appropriate and for training purposes.

Inspections are normally unannounced; however, Radioactive Materials Section staff commented that inspectors may contact the licensee either the day before, or the moming of, an inspection to ensure that appropriate licensee personnel are available prior to dispatching an inspector to the facility.

As noted in the questionnaire, the Division has a variety of portable instruments available for routine confirmatory surveys and for use in incident response. All Radioactive Materials Section instruments are tracked in a database which includes the calibration due date. Instruments requiring calibration are delivered to the Northwest Radiation Instrument Calibration Facility at the University'of Washington. Allinstruments used for materials inspection activities possessed

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u Washington Draft Report Page 7 L The Radioactive Materials Section Head' accompanies inspectors at least once every other

, year. Additionally, each inspector is accompanied by a peer from the Radioactive Materials Section every other year. Notes are made during the accompaniments and the inspectors are provided with fcodback regarding their performance immediately following the inspection. A

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summary form is prepared and filed to document each accompaniment.

Four Radioactive Materials Section inspectors were accompanied during inspections by a review team member during the period of July 28 29 and August 2 3,1999. The accompaniments included two biomedical research laboratory licenses and two portable gauge licenses. These accompaniments are also identified in Appendix C.

' During the accompaniments, each inspector demonstrated appropriate inspection techniques

' and knowledge of the regulations. The inspectors were trained, prepared, and thorough in their

' audits of the licensees' radiation safety programs. Overall, each inspector utilized good health physics practices, their interviews with licensee personnel were performed in an effective manner, and their inspections were adequate to assess radiological health and safety at the licensed facilities.

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

- satisfactory.

3.3 Technical Staffino and Trainino issues central to the evaluation of this indicator include the Radioactive Materials Section

. staffing level and staff tumover, as well as the technical qualifications and training histories of the staff. To evaluate these issues, the _ review team examined the Division's questionnaire responses relative to this indicator, interviewed Division management and staff, and considered any possible workload backlogs.

At the time of the review, the Radioactive Materials Section was staffed by the Radioactive Materials Section Head and seven staff members inciuding five full time technical staff

- members. Three staff members act as " managers" for specific types of licensees: Manager,

- Industrial Licensing; Manager, Medical Licensing; and Manager, Laboratory Licensing. Each of these managers completes licensing actions and inspections focused on their primary license areas. The remaining two full time technical staff members conduct inspections (the Manager, Compliance Program and the Compliance Inspector). - One additional staff member, an Environmental Specialist, conducts administrative tasks as well as low risk inspections and

' licensing actions (gauge licensees).- In addition, two staff members from other sections of the l

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Department work part time in the radioactive materials section conducting inspections as necessary.  !

1 During the review period, staffing luels remained relatively constant. A vacant technical I position was. filled within a few months with the Compliance inspector. The stability of the program is reinforced by the experience of the senior staff members. The current staffing level appears to be adequate for the program. '

Through discussions with staff, the review team discovered that the Radioactive Materials l

Section Head is dedicated to providing training to personnel. When a training class is 1 I

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- announced, the Radioactive Matericls Section Head discusses the course with staff and determines who, if aayone, should attend the class.

,' The Radioactive Materials Section Head and each of the Managers are well trained and qualified from an education and experience standpoint. ' All have attended most of the training courses prescribed by IMC 1246 and are very familiar with Washington regulations, policies, and procedures ~. The remaining staff members that conduct technical work have degrees in appropriate fields or comparable experience, and are qualified to conduct their assigned activities.

The Radioactive Materials Section issued a training and qualification procedure for staff on August 2,' 1999, which e based on the "NRC/OAS Training Working Group Recommendations  !

for Agreement State Training Programs." However, the document, Procedure RMS-61,." Staff Qualifications and Training," was not in use during the review period and Radioactive Materials

. Section staff members had not yet finalized their qualification Joumals.

Prior to ' August 2,1999, each manager and each individual employee remained knowledgeable of qualifications not yet achieved. A documented qualification Inspector Training Recoro was also used by the Radioactive Materials Section staff at the time of the review. Each record

details the inspections a staff member has helped with or been nbserved completing in order to be qualified to independently complete a certain type of an inspection. As part of RMS-61, in ,
addition to formal coursework, the Radioactive Materials Section uses a "leam, do, and be

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  • approach to qualifying individuals to complete a specific types of inspections. The Radioactive Materials Section does not have a qualification standard for determining when an inspector has qualified to independently complete a certain type of inspection beyond this approach. : A senior staff member determines when an individual has a sufficient amount of knowledge and experience and is thus qualified to complete a specific type of inspection or

~ licensing action on their own.

- Overall, there appear to be no direct performance-related problems associated with the training and qualifications of staff. Certain staff members could, however, benefit from additinnal

. training to strengthen their understanding of assigned tasks. For example, the Compliance inspector conducted an inspection of a gamma knife facility independently, without previously participating in gamma knife facility inspections. The Compliance inspector is considered '

qualified to complete all types of inspections, including medical inspections, through the State's

. leam, do, and be reviewed

  • approach. However, he has not taken the teletherapy /

brachytherapy course and dld not take the nuclear medicine course until August,1999. A senior stati member discussed areas that should be covered during the inspection with the Compliance inspector prior to the inspection. The review team evaluated the casework from the gamma knife inspection and found no performance issues, but the review team believes that the Compliance Inspector's knowledge of teletherapy / brachytherapy in general could be enhanced through formal coursework. The Compliance'Inspectoris planning to take the

- teletherapy / brachytherapy course in 2000.

. The Environmental Specialist who conducts low risk (gauge) inspections and licensing actions was not originally hired to complete radioactive materials licensing or inspection work. The Environmental Specialist does not have a science-related degree and has not taken an

. extensive health physics course. The Environmental Specialist has taken the licensing and

. Inspection courses, a course in the transportation of radioactive materials, was tutored by one

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of the senior staff members in health physics, and has received some health physics and 1

related training by completing a r. umber of classes pertaining to radioactive materials including

' the Troxler Gauge course. A team member accompanied tM Environmental Specialist on a

, portable gauge inspection;and determined that all pertinent aspects of the inspection were covered. However, the review team believes that the Environmental Specialist's knowledge of health physics in general could be supplemented by taking an extensive heath physics course.

LThe new training and qualifications procedure adopted by the Radioactive Materials Section will

. provide a complete inventory of staff qualifications and needs once it is fully implemented. The review team recommends that the State complete their efforts to document the qualifications of all Radioactive Materials Section staff members by fully utilizing the RMS-61 procedure, assess the training needs of the Radioactive Materials Section staff, and provide training necessary to fully qualify staff members to the requirements in RMS-61.

Based on the IMPEP evaluation criteria, the review team recommends that Washington's performance with respect to the indicator, Technical Staffing and Training, be found t satistactory.

3.4 i Technical Quality of Licensina Actions

The review team examined completed licenses and casework for 27 license files representing the work of six license reviewers. The license reviewers, Radioactive Materials Section Head and Waste Management Section Head were interviewed to supply additional information regarding licensing decisions or file contents.

Licensing actions were eval _uated for completeness, consistency, proper isotopes and quantitles used, qualifications.of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and of its conditions and tie-down conditions, and overall technical quality.l Casework was evaluated for adherence to good health physics practices, reference to appropriate regulations, supporting documents, peer or supervisory review and proper signature authorities. The files were checked for retention of necessary documents and supporting data.

The licensing actions reviewed included the following types of license: academic, medical and research and development (both broad scope and specific), industrial radiography, radiopharmacy, commercial services, irradiators, portable and fixed gauges, HDR, gamma knife, teletherapy, commercial distribution of devices to general and specific licensees, consulting service and commercial. waste processing and brokerage. Licensing actions included 3 new licenses,19 renewals,4 terminations, and 73 amendments. A list of these licenses with case-specific comments may be found in' Appendix D.

t All licensing actions in the Radioactive Materials Section are assigned a tracking number, logged into a computer tracking system,'and given to the license reviewer. A reviewer generates a deficiency letter as needed and upon final resolution of all deficiency items 1 produces a draft licensing action. The draft licensing action receives a quality assurance (QA)  !

review by peer license reviewers. Corrections are made as needed and the licensing action is l

- issued.. The QA review is documented and maintained for management review. Each license i reviewer in the Radioactive Materials Section has signature authority and sign their licensing I

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actions. The QA r'eviewerinitials each finallicensing action. Each license reviewer uses

' boilerplate licenses for their type of licensing .nctions (industrial, medical, laboratory) to ensure i consistency in standard licenses. Monthly reports on the status of each action are generated, reviewed, and discussed in monthly staff meetings.;

. The two license reviewers in the Waste Management Section perform licensing actions regarding the ATG Richland commercial waste processing license. The ATG license is drafted and a QA review is performed by the other license reviewer in the section Only the Waste Management Section Head has signature authority and signs all licensing actions after an additional management QA review.

s The review team found that the licensing actions were thorough, complete, consistent, and of high quality, with health and safety issues properly addressed. Tie-down conditions are generally _ backed by information contained in the license or sealed source and device registry  ;

files and are inspectable. Deficiency letters state regulatory positions, are used at the proper -

time, and identify deficiencies in the licensee's documents. Terminated licensing actions are well documented, showing appropriate transfer and survey records.' License files are complete

. - and organized. The Radioactive Materials Section uses a combination of NRC and Division application and regulatory guides. Checklists for each type of license are used and kept with 1 the license file. These documents are complete, well organized, available to reviewers, and Jappear to be followed.

Except for a few new licenses that involve a change in ownership with little management

changes, license delivery visits are conducted for all new applicants before the license is issued. If unresolved issues occur, the license is not issued until they are resolved. i k

The review team noted that two license renewals have been pending for extended periods without a written response by the program. The matter was discussed with Radioactive Materials Section management to ensure that these actions are given higher priority to ensure timely completion.

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

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

3.5 ~ Resoonse to incidents and Alleoations i

in evaluating the effectiveness of the Radioactive Materials Section's actions in responding to I incidents, the review team examined the Division's response to the questionnaire regarding this l indicator, evaluated selected incidents reported for the State of Washington in the " Nuclear j

. Material Events Database" (NMED) against those contained in the Washington files, and j evaluated the casework and supporting documentation for 20 material incidents. A list of  !

incident casework examined, along with case specific comments, is contained in Appendix E.

The team also evaluated the Radioactive Materials Section's response to five materials allegations, four of which were referred to the Division by NRC during the review period. l The review team discussed the Division's incident and allegation process, file documentation, the State's equivalent to the Freedom of Information Act, NMED, and notification of incidents to th_e NRC Operations Center with key Radioactive Materials Section and Waste Management j Section management and staff. There was one radioactive materials incident reported by the i

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Waste Management Section; incidents and allegations related to the low-level radioactive waste disposal and uranium recovery programs will be discussed under Sections 4.3 and 4.4 of this report.

~ When notification of an incident or an allegation is received, the Radioactive Materials Section and staff docuss the initial response and the need for an onsite investigation. The safety significance of,the incident / allegation is evaluated to determine the type of response that the

Radioactive Materials Section will take. After the investigation is completed, the pertinent incident information is forwarded to the NRC as appropriate.

.. The Department has policies on the disclosure of information. Department policy 17-005

addresses Employee Responsibilities with Confidential Information and Department policy 17-003 addresses Public Disclosure policy. All requests for public information must be sent to the Department Public Disclosure Coordinator for a determination whether the information can be disclosed or exempt from disclosure. The policies specify the information that is exempt from disclosure, including the protection of allegeridentity, and directs all divisions to have procedures and train employees in those procedures. Within the Division, both the Radioactive Materials Section and the Waste Management Section have developed separate incident and allegation procedures. The Radioactive Matedals Section has written guidance RMS-40, Investigations (Draft),' dated August 20,1999; RMS-41, Handling Allegations, dated August 23, 1999; RMS-42, Concemed Citizen Calls, dated August 24,1999; and RMS-43, incident Notification, dated August 22,1999 for handling incidents and allegations. The Radioactive Materials Section also maintains a computer listing for tracking the status of all incidents and

' allegations. After a review of the incidents and discussions with staff, the review team

' determined that all reportable materials events were appropriately reported to the NRC Operations Center and the NMED database contractor.

Nineteen' incidents selected for review included a contamination event at a waste processing j facility, three loss of control events, an unauthorized maintenance of an HDR unit, two gauge thefts, four damaged equipment problems, two misadministrations, one unauthorized use of i material, one overexposure, and five releases of licensed material or contamination events.

The review team found that the Radioactive Materials Section's responses to incidents were

. complete and comprehensive. Initial responses were prompt, well-coordinated, and the level of effort was com_mensurate with the health and safety significance. Inspectors were dispatched for onsite investigations when appropriate and the Radioactive Materials Section took suitable

enforcement action. The review team found the documentation of the response and follow up to incidents consistent and that incidents were followed up at the next inspection or in a timely
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During the review period, there were four materials allegations referred to the Division by the NRC and.one allegation reported directly to the program. The review team noted that

- allegations are maintained in a locked file. The review of the State's allegation files indicates that the State took prompt and appropriate action in response to the concems raised. All of the allegations reviewed were closed and information provided to NRC as requested on specific cases. However, with respect to the allegation received directly by the Division, the team could a' . not find any written documentation that informed the alleger of the outcome of the Radioactive Materials Section investigation or if the concem could be substantiated. The team observed that the tracking system contained dates for when the allegation was closed out, but there was no entry for written notification to the alleger conceming what actions were taken to resolve the

. Washington Draft Report . Page 12 allegation and if the concem could be substantiated. Notification to the alleger was discussed with the Radioactive Materials Section Head as one way to assure that allegations are closed

'out in a consistent manner. The review team noted that notification of the alleger is

incorporated into the new procedures. The review team recommends that when possible, the
alleger be notified in writing of the actions taken in response to the allegation and if the allegation could or could not be substantiated.

. Based on the lMPEP evaluation criteria, the review team recommends that the Division's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS -

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lMPEP identifies four non-common performance indicators to be used in reviewing Agreement
State programs:' (1) Legislation and Program Elements Required for Compatibility; (2) Sealed LSource and Device Evaluation Program; (3) Low Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Washington's Agreement includes all of the non-common  :

pedormance indicators.

14.1 Lealslation and Prooram Elements Reauired for Comoatibility 4.1.1 Leoislation ,

1 Washington became an Agreement State in 1966. Along with their response to the questiornaire, the Division provided the review team with the opportunity to review copies of

. legislation that affect the radiation control program. The currently effective statutory authority is contained in the Revised Code of Washington (RCW), Nuclear Energy and Radiation (RCW

,70.98) and Mill Tailings, Licensing and Perpetual Care (RCW 70.121). The Department is designated as the State's radiation control agency and implements the radiation control program.

? 4.1.2 - Prooram Elements Reauired for Comoatibility RCW applies to all lonizing radiation and the statutory authority for radioactive materials, the

low-level radioactive waste, and the uranium mill programs. Regulations are provided in the Washington Administrative Code. The program also is impacted by RCW 70.94, Washington Clean Air Act. Washington requires a license for possession and use of all radioactive material including naturally occurring materials, such as radium, and accelerator-produced radionuclides. :The State also requires registration of all equipment designed to produce x-rays

' or other ionizing radiation and tanning beds.

The review team examined the State's administrative rulemakir g process and found that the process takes about 6 to 8 months from the development stagt to the final adoption by the

< Secretary and filing with Revisor, after_which the rules become effective in 31 days. The public, the NRC, other agencies, and all 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, approved, and filed. The Division also has the authority to issue legally binding requirements (e.g., license conditions) in lieu of regulations until compatible regulations become effective.

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. Washington Draft Report Page 13 The team evaluated the Division's response to the questionnaire, reviewed the status of

l. regulations required to be adopted by the State during the review period, and verified the adoption of regulations with data obtained from the Office State Programs Regulation Assessment Tracking System. The review team noted that since the June 1995 review, the State updated the Department regulations for Radioactive Materials as follows:

e " Definition of Land Disposal and Waste Site OA Program," 10 CFR Part 61 amendment (58 FR 33886) that became effective on July 22,1993 and adopted by the State on November 20,1997.

e " Decommissioning Recordkeeping and License Termination: Documentation Additions,"

10 CFR Parts 30 and 40 amendments (58 FR 39628) that became effective on October 25,1996 and adopted by the State on May 1,1997.

e " Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards -

Part 40," (59 FR 28220) that became effective on July 1,1994 and adopted by the State on July 12,1997.

e " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 36026) that became effective on August 15,1994 and adopted by j the State on May 3,1997. ,

e " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32, and 35 amendments (59 FR 61767 and 65243) that became effective on January 1,1995 and adopted by the State on July 9,1998.

e " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 CFR Part 20 amendment (60 FR 7900) that became effective on March 13,1995 and adopted by the State on July 7,1998.

  • Low Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649 and 25983) that became effective March 1,1998. The Agreement States were to promulgate their regulations no later than March 1,1998, so that NRC and the State would require this national system to be effective at the same time. The State adopted the requirement on May 23,1998.

e " Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment 1 (60 FR 28323) that became effective on June 30,1995 and adopted by the State on l March 8,1999.  !

f e

  • Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts l 19 and 20 amendments (60 FR 36038) that became effective on August 14,1995 and j

, adopted by the State on March 8,1999. l l

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

by the State on May 3,1997.

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Washington Draft Report Page 14

  • " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective on October 20,1995 and adopted by the State on July 9,1998, 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 and adopted by the State on July 9,1998.

o " Transfer for Disposal and Manifests; Minor Technical Conforming Amendment," 10 CFR Part 20 (63 FR 50127) that became effective November 20,1998 and adopted by the State on May 23,1998.

The following regulation amendments were provided to the NRC on June 11,1999 for comment, and a public hearing was held by the State on July 9,1999. NRC reviewed the proposed rules for compatibility and had no comment on the rules as proposed. The proposed l rules are as follows:

e "10 CFR Part 71: Compatibility with the Intemational Atomic Energy Agency," 10 CFR Part 71 amendments (60 FR 50248) that became effective on April 1,1996.

e " Termination orTransferof Licensed Activ!!ies: Recordkeeping Requirements,"10 CFR Parts 20,30,40,61, and 70 amendments (61 FR 24669) that became effective on June 17,1996.

e " Resolution of Dual Regulation of Airbome Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendment (61 FR 65120) that became effective January 9,1997.

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

The team identified the following regulation changes and adoptions that will be needed in the future, and the Division management related that the regulations would be addressed in upcoming rulemakings or by adopting altemate legally binding requirements:

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

e " Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon 14 Urea," 10 CFR Part 30 amendment (62 FR 63634) that became effective January 2, 1998.

e " Deliberate Misconduct by Unlicensed Persons," 10 CFR Parts 30,40,61,70, and 150 amendments (63 FR 1890 and 13773) that became effective February 12,1998.

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I Washington Draft Report Page 15 l e- " Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial i

Radiographic Operations," 10 CFR Part 34 amendment (63 FR 37059) that became effective July 9,1998.

e " Minor Corrections, Clarifying Changes, and a Minor Policy Change," 10 CFR Parts 20, 32 and 39 amendments (63 FR 39477 and 63 FR 45393) that became effective October 26,1998.

It is noted that Management Directive 5.9, Handbook, Part V, (1)(C)(lll) provides that the above regulations should be adopted by the State as expeditiously as possible, but not later than 3 years after the September 3,1997 effective date of the Commission Policy Statement on Adequacy and Compatibility, i.e.. .Septernber 3,2000.

.Based on the IMPEP evaluation criteria, the review team recommends that Washington's

' performance with respect to the indicator, Legislation and Program Elements Required for Compat'bility, be found satisfactory.

i 4.2 Sealed Source and Device (SS&D) Evaluation Proaram in assessing the Radioactive Materials Section's Sealed Source & Device (SS&D) evaluation program, the review team examined information provided in the response to the IMPEP questionnaire on this indicator. A review of selected new and amended SS&D evaluations (Appendix F) and supporting documents covering the review period was conducted. The team observed the Radioactive Materials Section's use of guidance documents and procedures, and interviewed the Radioactive Materials Section Head and the two SS&D reviewers.

The Radioactive Materials Section instituted a policy that the Manager, Industrial Licensing, will review and sign the applications, with a concurrence review by the other reviewer who also signs the registration certificates prior to issuance. These reviews are technical in naiure, to ensure the technical soundness, readability, and understandability of the registration -

certificates.

4.2.1 Technical Quality of the Product Evaluation Prooram During the review period seven SS&D certificates were issued by the Division. Three new SS&D certificates were issued and four certificates were amendments for two devices. One of the amended certificates was originally issued to contain non AEA material and later amendments were made to include AEA material.

Analysis of the files and interviews with the staff confirmed that the Division follows the recommended guidance from the NRC SS&D training workshops. The registration files contained all correspondence, photographs, engineering drawings, radiation profiles, and results of tests conducted by the applicant. In addition, the SS&D review checklist received at

' the NRC SS&D workshop was used to assure all relevant materials had been submitted and l . reviewed. The checklist was contained in the registration file. The Division management l Indicated that the guidance in NUREG 1556, Volume 3, issued September 1997, will be utilized t

for future reviews. All pertinent ANSI Standards, Regulatory Guides, and workshop references were confirmed to be available and are used when performing SS&D reviews. The Radioactive Material Section Head related that the non-AEA material reviews are performed in the same

Washington Draft Report Page 16 procedural manner using the same references as used for AEA sources and devices.

s4.2.2 3 chnical Staffino and Trainino

. The Manager, industrial Licensing, conducts the SS&D reviews and a second reviewer

. performs the concurrence reviews. Both individuals sign the registry sheet and both have attended the SS&D workshops sponsored by NRC and both have had several years experience reviewing license applications and SS&D applications. The Manager is committed to

maintaining a high degree of quality in their SS&D reviews and related that additional training and/or another workshop is needed to update' staff skills and knowledge. The team related to the reviewers that another workshop is being planned. The Manager also stated that additional engineering support is available from the Waste Management Section if needed. The team

' determined that the reviewers meet the technical training required for SS&D reviews as described under the guidance.

4.2.3 Evaluation of Defects and incidents Reaardino SS&Ds No incidents or defects related to SS&Ds were reported with these devices during the review

. period. The team also verified that there were no reported incidents through discussions with the reviewers and the Radioactive Materials Section Head, and an on line search by device and manufacturer utilizing the NMED system was conducted by the team prior to the review.

Based on the IMPEP evaluation criteria, the review team recommends that Washington's performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

4.3 Low-Level Radioactive Waste (LLRW) Disoosal Proaram US Ecology, Inc. (USE) is licensed by t'he Division to receive, handle, process, store, and

. dispose of LLRW for the Richland, Washington site. The license establishes regulatory conditions and procedures that USE must comply with regarding waste acceptance, site cperation, and environmental monitoring. Commercial disposal of LLRW at the Richland site began in 1965. Twenty-five license amendments have been issued primarily to address changes ir, license conditions. The last amendment was issued February 17,1999. An 1 application for license renewal has been in timely renewal since 1996. The Waste Management Section has completed its review of the site closure plan; however, a decision on

.,- the license renewalis pending complehn of an Environmental Impact Statement (EIS) that will consider various options for closure of the site. The EIS is tentatively planned for completion in

- November 1999.

Vhe LLRW disposal program review was initiated through an early evaluation of relevant t ackground materials, including th '.*!aste Management Section's Technical Evaluation Report for the 1996 US Ecology Site Stabilization and Closure Plan, Technical Evaluation Report on Potential Dose Pathways for Disposal of the Portland General Electric's Trojan Reactor Vessel, and responses to the questionnaire. A one-day site visit to the Richland LLRW disposal facility was conducted on September 1,1999, by a review team member, to accompany the Division's i site inspectors in their routine inspection of the facility.

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Washington Draft Report' Page 17

_In condusting this IMPEP review, five sub-indicators were used to evaluate the Division's performance regarding its low-level radioactive waste disposal program. These indicators include': (1) Status of Low-Level Radioactive Waste Disposal Inspection; (2) Technical Quality

. of inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions;

and (5) Response to incidents and Allegations. The results of the LLRW disposal program review will be discussed under each of these sub-indicators.

4.3.1 Status of Low-Level Radioactive Waste Disposal Insoection The review team found that the Richland L! RW disposal site is inspected annually as

' prescribed in NRC Inspection Manual Chapter 2800. Inspection of the site, by the Waste

'_ Management Section senior inspectors, is designed to ensure compliance with the requirements of the facility standards manual, the site radiological operating procedures,

. licensing conditions, and regulations. ' Partial inspections are performed approximately four

times per year at the LLRW site, with each inspection focusing on different areas. All of the

, inspection areas are covered at a min: mum frequency of once per year. In addition to the annual inspections, the Waste Management Section onsite representative performs a monthly inspection of the site looking at a shorter list of site requirements. The review team confirmed the frequency of inspections inrough review of the inspection report files.

The review team analyzed the Division's capability for maintaining and retrieving data on the istatus of the inspection program. Based on an interview with the Waste Management Section 4 Head, the review team found that an official electronic database which summarizes the

' inspection status has not been established; however, one of the senior inspectors maintains his own electronic database.~ Printouts are kept in the inspection files. Given that partial inspections are conducted at the site, such a database'is important in identifying which specific

- requirements have not been addressed in prior inspections.

. The review team found that inspection findings are communicated to the licensee in a timely

. manner. In reviewing the inspection files, the team found that inspection findings ~are communicated to the licensee using a form similar to NRC's Form 591 issued onsite or in a aotice of correction letter. These forms are generally used for smallinfractions. Notice of correction letters are issued for significant infractions and/or for a large number of infractbos.

, The team found these to be routinely issued within 30 days of the inspection.

o 4.3.2 Technical Quality of insoections

. A review team member accompanying inspectors combined with a review of inspection files indicate inspection findings are well founded and well documented. The Waste Management Section inspections were thorough, technically accurate, cornplete, consistent, and of high quality with sufficient documentation to ensure that the licensee's performance with respect to health and safety were acceptable.

~

The team reviewed inspection files for 1995-1999. The team reviewed the inspection files for

~

L 1998 and 1999 in greater detail than the other years. A review of completed Inspection reports indicates that inspections are complete and reviewed promptly by the Waste Management Section Head. The team found that follow-up inspections addressed previously identified open

' items and/or past violations. An annual summary is provided in each file identifying open items for the year and whether or not they were closed. The files contain the inspection checklist, n _ _ _ _ _ _ _ _ _ _ _

1 Washington Draft Report . Page '18

, field notes, notices to the licensees, and some digital photographs of the site. The team also

- found through examination of these files that a supervisory accompaniment of the site inspectors is regularly made (on an annual frequency).

s The team also reviewed notebcoks and files maintained by the onsite inspector at the site. The

onsite inspector maintains files on waste generators. In addition, notebooks are kept documenting a weekly summary of shipments, fence-line surveys perfomied by the inspector,  !

, p 'and waste container inspections, which included sore,e digital photographs. 1

~ The Waste Management Section has recent'y developed inspection procedures which spell out l

the frequency of inspections, inspection preparation roqukments, inspection reporting i requirements, and the checidist of licensirig requirements. The procedures also include  !

appropriate forms and sample letters for documenting findings. The Waste Management Section also maintains, at the site,' a set of more speciCo inspection procedures for the onsite l

~ inspector.

4.3.3 Technical Staffina and Trainino 1 The review team evaluated the Waste Management Section staffing in support of the LLRW program. The team identified nine staff members currently supporting the LLRW program, ,

. including the Waste Management Section Head, an administrative assistant, and staff with I

. backgrounds in health physics, nuclear engineering, hydrogeology, mechanical engineerc.g, j

. and civil engineering. _ Based mostly on interviews with the staff, the team found that all technical staff hold bachelors degrees or higher, or equivalent training and experience.' In ~ l addition, the team noted that contractual support is commonly used to acquire additional expertise as needed. The review found that the qualifications of the technical staff are  ;

generally commensurate with the expertise identified as necessary to regulate an LLRW j

. disposal facility.- Waste Management Section staff tumover has been low. i in review of staff training files, the review team found the staff training records to be incomplete.

Some files had no training information at all, and for some staff no file had been established in addition, only one file contained adequate information (e.g., resume and training history) to j allow an independent assessment of the staff qualifications. The Waste Management Section has recently developed staff qualifications and training procedures. These procedures call for

- staff to work with their supervisor in identifying and attending appropriate training courses. In

- addition, the supervisor is to maintain a central training record for each staff member and track 4

.the progress of staff toward qualification in specific program areas. Basea upon the team's l

review of the staff training files, this procedure is still in the early stages of implementation. The only list of training courses identified in any of the files is the core courses listed in IMC 1246.

No other pertinent courses were identified. The team found that some staff has taken several .!

of the core courses identified in IMC 1246, while other staff has taken none. None of the staff has completed all of the core courses or equivalent training as identified in IMC 1246. Some .

staff has taken other training courses; however, these are not included in the list of courses to I be tracked by the supervisor. The review team recommends that management fully implement the training program that was recently established for the Waste Management Section.

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7 L Washington Draft Report. Page 19

. 4.3.4 Technical Quality of Licensina Actions

. USE's license to operate the LLRW disposal facility was placed in timely renewal in 1997. The existing license, which was set to expire after May 31,1997, will remain in effect while the renewal application is reviewed. The Waste Management Section is currently developing an EIS which will look at various options for closing the site. The Waste Management Section has decided to forego renewal of the operating license until completion of the EIS. In interviews

. with the Waste Management Section staff, the team has determined that the EIS process has had public involvement. Concems and issues raised by various stakeholders are being -

consideredin the EIS. .

t

= In~accordance with condition number 66 of their license, USE is required to submit, every four j

years for the Waste Management Section's review, an updated facility closure and stabilization plan. The last plan was submitted in September 1996. The Waste Management Section has
Written a technical evaluation report (TER) documenting their review of the closure plan. The

.' review team primarily evrJuated the technical quality of licensing actions for the LLRW program by reviewing this TER since the majority of the Waste Management Section technical staff worked on it. In addition to reviewing the TER for the USE site closure plan, the team also reviewed the TER developed for the Portland General Electric's Trojan Reactor Vessel

' disposal. The team's review of these documents found that license reviews within the LLRW .

. program are thorough, complete, consistent, and of acceptable technical quality. In reviewing ,

USE's site closure plan, the Waste Management Section performed a detailed assessment of USE's performance assessment, including identifying potential shortcomings. For both the review of the site closure and review of the reactor vessel disposal, the Waste Management Section used NRC' guidance as appropriate'and published research conducted at the Richland site. In addition to reviewing the Waste Management Section's performance assessment, the Waste Management Section performed their own confirmatory analyses using contractors to support and review their analysis as needed. The Waste Management Section is currently L undertaking a probabilistic assessment to' gain additional insights into the USE site's performance in cupport of the EIS. As part of the review of the site closure plan and in support of the EIS, the Waste Management Section has als_o performed an independent cost estimate for site closure and long-term perpetual care and maintenance of the site. This information will

.be used in determining whether or not there are adequate funds currently available or will be I

' available when the site is closed.' The review team found the Waste Management Section staff i to be appropriately utilizing insights from their assessments in establishing licensing condJions and managing the operation of the facility.

In addition to reviewing the TER for the site closure and the reactor vessel disposal, the review

. team also reviewed license amendments 20-25 to the USE license and the waste acceptance <

L variance requests for.Moravee Biochemical, Siemens, and M.F. Physics Corporation. The review team found the technical quality of these licensing ~ actions to be generally acceptable; however, better documentation is needed to explain the nature and rationale for the given -

licensing action. For example, Amendment No. 22 of the USE license was initiated by the Waste Management Section to change several licensing conditions; however, the team found l no documentation explaining the need for changing the conditions or the rationale for why ths intended change was deemed to be appropriate.

The Waste Management Section has recently developed license review procedures for the LLRW program.' These procedures encourage the use of NRC and intemational guidance as

y -

Washington Draft Report Page 20 appropriate. However, the procedures do not specifically identify which guidance should be J used or how specific aspects of the review should be found to be acceptable (i.e., the technical

- basis for accepting specific aspects of the license).

~4.3.5 Resoonse to incidents and Alleaations 1 i

The review team' examined the casework on incidents and allegations within the LLRW

~ program. During 1996, the team found that two incidents were reported and one allegation l which was referred to the Division by NRC. The team found that actions taken by the Waste 1

. Management Section were generally appropriate and very timely.~ Incidents and allegation were l

? quickly investigated (within a day) and closed within a week. The review team found the level of  !

effort to be appropriate for the given incident. Neither of the two incidents warranted notification . '

' of the NRC.

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The Waste Management Section has rece'ntly' developed procedures for handling incidents and allegations, which were issued August 30,1999. The procedures for handling allegations include information on protecting the identity of the alleger, documentation of the allegation, and tracking the allegation by management. The procedures for handling incidents include information on what constitutes an incident, appropriate documentation of the incident, reference to abnormal occurrences criteria for States, and tracking the incident by  ;

management. Based on review of the documentation and tracking, it appears that the '

procedures are stillin the early stages of implementation.

Based on the IMPEP criteria, the review team recommends that Washington's performance with respect to the indicator, Low Level Radioactive Waste Disposal Program, be found satisfactory.

4.4 - Uranium Recoverv Prooram i

in conducting this IMPEP review, five sub-indicators were used to evaluate the Division's performance regarding its uranium recovery program. These indicators include: (1) Status of Uranium Recovery 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. The results of the uranium recovery program review will be discussed under each of these sub-indicators.

4.4.1 Status of the Uranium Recoverv inspecilon Proaram The review team focused on several factors in evaluating the Waste Management Section's performance for this sub-indicator, including inspection frequency, overdue inspections, timely issuance of inspection reports and findings to licensees, inspection follow up, and retrievability of uranium recovery inspection materials. The review team's evaluation is based on a review of the Waste Management Section's responses to the questionnaire, the uranium recovery inspection schedule, inspection casework files, and interviews with inspection staff and

_. management.

During the review period, the Waste Management Section reviewed licensee submittals and

-inspected uranium recovery faciliti_es in various stages of operation. The program regulates two conventional uranium mills: Dawn Mining Company (Dawn), that operated during the review-

y y-Washingt_on Draft Report Page 21 period; and Westem Nuclear, Inc., Sherwood (Sherwood), that is currently under reclamation.

= Based on review of the inspection files, it was determined that inspection frequency is more l

. frequent than IMC 2801, " Uranium Mill and 11e.(2) Byproduct Material Disposal Site and Facility inspection Program." Partial inspections are performed approximately four times per year at

. the Dawn active mill, with each inspection focusing on different areas. All of the inspection areas are covered at a minimum frequency'of once per year. This guarantees that a compicie

  • Inspection is performed at least once per year, but since previous issues and deficiencies are evaluated in the next quarterly inspection, the problem areas are inspected more frequently. j The. team finds this practice to be satisfactory. h should be noted that for the Sherwood site,

' inspections and construction reviews are numerous and sometimes performed two times a month by Waste Management Section staff that are located in the area of the mill.~ As a result -

of the frequent inspections, the team concludes that there are no overdue inspections.

Based on review of the inspection casework files, the team noted that inspection reports are

~

written within 30 days' of. the inspection, appropriate follow-up actions are conducted if.

deficiencies are identified, and casework files are easily retrieved and accessible. The reports

' are review by management and receive appropriate attention.

4.4.2 Technical Quality of Insoections

. In reviewing this sub-indicator, the review team examined inspection files, inspection reports, and enforcement documentation for the uranium mills identified in Appendix C. The review covered severalinspections conducted during the review period representing a range of uranium recovery inspection activities in various stages of license operations. Inspectors and

, i management were interviewed to assess the adequacy of their preparation for the inspections,  ;

the depth and content of the actualinspections~, and the appropriateness of inspection findings. i The review team's findings are discussed below.

' Most inspections are team inspections. The inspection team will review relevant inspection procedures identified in a checklist format and also review previous inspection reports and other j background information prior to the inspection.

The reviea determined that, during a typical inspection, inspectors observe licensee operations; interview workers, managers, and contractors; review facility records; examine site operating plans and procedures; and make independent measurements during inspections, as appropriate. ;These activities were also verified through an inspection accompaniment that was performed during the review. Although the Waste Management Section. inspectors primarily

' focus on health physics and radiation safety issues, they also routinely inspect for .

environmental monitoring, management and organizational issues, and general housekeeping

  • practices.

The' review team found that the inspection reports provided appropriate depth of coverage.

They addressed compilance conditions for the licensees,' and demonstrated that the inspectors pursued root causes where problems or violations were identified.

The review team determined that during the review period, the uranium recovery inspectors had

, been accompanied by their supervisors on several occasions. These accompaniments were l

, t 5

l Washington' Draft Report Page 22 adequately documented. The review team found that the Waste Management Section Head

. routinely meets with the uranium recove.y inspectors after their inspections to review inspection findings and to plan follow-up strategy..

Based on a site visit with the Department of Energy (DOE) to the Sherwood site and review of inspection files, the review team leamed that Waste Management Section inspectors are not

using any specifb inspection written procedures. As an example, one NRC_ inspection procedure, On-Site Construction, is available for use by Agreement States and specifically addresses onsite construction reviews and placement of erosion protection. This inspection procedure suggests spec 5fic activities that inspectors should perform when checking the depth, gradation, and adequacy of rock place _ ment.. The team considers that use of this inspection procedure, or an equivalent, may have improved the riprap inspections and alerted inspectors to potential problems at the Sherwood site. This is especially important because inspections were conducted at the Sherwood site (about every two weeks for four months), and the placement was not detected.

4 The review team also leamed that inspections are performed using mill-specific and license-specific checklists. Although the team finds this practice acceptable and has led to an - 1 adequate inspection program, the team believes that the State should develop specific inspection procedures in the uranium recovery area containing information similar to the NRC inspection procedures for uranium recovery. For example, NRC inspection procedures cover such areas as Management Organization and Controls, On Site Construction, and Emergency '

Preparedness. The review team believes that the inspection staff would benefit from having procedures with details of how inspectors should evaluate each specific inspection area with <

criteria for acceptability. The review team discussed the usefulness of such procedures with ,

the Waste Management Section in assuring consistency and continuity between inspections, l and in the event of staff tumover. The review team recommends that the State develop specific inspection procedures for the uranium recovery program.

'4.4.3 Technical Staffino and Trainina in reviewing this sub indicator, the review team evaluated the uranium recovery staffing level, the technical qualifications of the staff, staff training, and staff tumover. This evaluation included general examination of training records of the uranium recovery staff and the 4 qualifications of the reviewers assigned to perform specific reviews of surface water hydrology and erraion protection aspects of site closure.

Various members of De Waste Managament Section staff participate in inspections and licensing activities at the two uranium recovery sites. The amount of participation varies, depending on the individual, their qualifications, and their workload. During the review period, there was no staff tumover in the uranium recovery program. Based on discussions with management, no tumover is expected in the immediate future.

Review of the Waste Management Section staff qualifications indicates that the inspectors and technical reviewers generally have strong health physics or radiation safety backgrounds, and the health physics focus of the inspections has been strong. The engineering staff i. ades a mechanical, nuclear and civil engineer. In the areas of surface water hydrology and hydraulic engineering, much of the' expertise by the Waste Management Section has been gained by licensing experience for the Dawn and Sherwood reclamation plans. Through numerous

s' L

s, W'ashington Draft Report. Page 23 reviews of engineering analyses and interactions with licensees and consultants, this experience has been used to develop conclusions re'ated to the adequacy of several site  !

closure plans. Waste Management Section expertise and exper!ance is further supplemented by the use of professional engineers and technical experts from cther State agencies, including

. surface water hydrology experts, dam safety engineers, and geotechnical engineers.

However, the review team noted from the review of training records and discussions with staff, that staff has limited experience and has not received specific training in certain areas, such as

~

the construction and placement of erosion protection. This may have led to construction-related issues regarding the placement of erosion protection at the Sherwood site.- Possible discrepancies between actual placement of riprap and placement required by construction specifications were noted by the review team member during a post construction site visit with DOE personnel on May 20,1999, prior to the IMPEP onsite review. The site visit report was L provided to the Waste Management Section Head by letter dated August 12,1999. The review team concludes that additional training and experience of the inspection staff is needed in this

- area and could have prevented this occurrence. The team also concludes that this may be a broader issue that may be helpful in evaluating construction at the Dawn site and the Richland LLRW site.-

Based on discussions with Waste Management Section staff and management, this training could be accomplished by allowing Waste Management Section staff to directly observe the placement of riprap at several sites that have been completed and were found acceptable. The

' team believes that significant experience and trahing could be achieved by such a visit to completed sites. This training would be particularly useful in the evaluation of information that wil1 be submitted in the near future by Sherwood and would also be useful in evaluating erosion protection at the Dawn and Richland sites. Wasto Management Section staff believes that this 1

training would be useful and should be accomplished within the next 2-3 months to help the- l reviewers to determine the acceptability of any upcoming repairs or design changes performed by the licensee. In addition, the Waste Management Section believes it would be helpful during >

these site visits to have discussions, meetings, and interactions with licensees, contractors, l

,- . DOE long term surveillance experts, and NRC staff. The review team offered to facilitate this training. The review team also concludes that this training would be helpfulin the review of any upcoming reclamation / closure submittals for the Dawn site and the Richland site. Additional

' discussion may be found in Section 4.4.4 of this report.

Based on examination of training files and discussions with Waste Management Section staff

and . management, formal training in several specific program areas, such as surface water hydrology, has not been received. The review team leamed that Waste Management Section staff would like to receive formal training in various areas such as flood analysis, water surface profile analysis, erosion protection design, sediment analysis, and rock durability. The review

. team agrees with Waste Management Section staff that additional training would be useful, particularly in areas where new models and analytical techniques for calculating floods, sediment yield,' and other design conditions have recently been developed. The review team recommends that Waste Management Section management develop and implement a training

' plan to include training in specific technical areas related to flood analysis, water surface profile analysis, erosion protection design, rock durability and erosion protection placement.

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-Washington Draft Report ' Page 24 Overall, based on review of two site closure plans for the Dawn and Sherwood sites, the team 1 concludes that the qualifications of the reviewers and inspectors tre sufficient to regulate ,

uranium recovery facilities. l 4.4.'4D Technical Quality'of Licensino i

The Waste Management Section normally uses a team approach to review various aspects of a i reclamation plan or other licensing actions. Any expertise that is not available in the Waste

. Management Section is supplemented through the use of other State agencies such as the

~ Washington Department of Ecology, where various engineers and professionals are employed.

The review team reviewed groundwater hydrology, surface water hydrology, and erosion I protection aspects of two closure plans currently under review by the Waste Management Section.' The team did not review other areas such as geotechnical engineering or radiological cleanup. l 1

Based on this review, the team determined that the Waste Management Section analyses are i of acceptable technical quality. All major review areas are addressed by technical evaluations I in areas such as flood determinations, water surface profiles,' erosion protection design, sediment analyses, and rock durability. The Waste Management Section analyses followed design practices recommended in various NRC technical publications (NUREGs) or other ,

guidance documents developed by the NRC staff, l

The team also evaluated licensirig actions related to the Dawn mill, in active production. Based I on an inspection accompaniment and a review of the licensing file, the team concludes that '

licensing actions are appropriate and that the license conditions are clear and well written.

Requirements associated with these conditions are based on a need to meet the Department's regulations and to protect health'and safety.

. In follow-up activities related to the construction problem identified at Sherwood, the Waste Management Section staff has further evaluated the existing site construction conditions, developed reports documenting their findings, issued questions and comments to the licensee, and has acted to resolve any potential issues related to rock placement and rock durability.

The review team concludes that the rock placement training identified in Section 4.4.3 should

be completed within the next 2-3 months, so that the Waste Management Section staff will be i i

. able to better evaluate licensee responses to the recent Waste Management Section questions and comments.

4.4.5 ? Incidents and Alleoations For this sub-indicator, the review team examined several files related to uranium recovery incidents and allegations. The review team determined that the Waste Management Section process, procedures, and overall performance for uranium recovery facilities were acceptable.

l During the review period, the Waste Management Section responded to three allegations in the I uranium recovery area.4 Based on review of the casework files, the team determined that the

Waste Management Section acted promptly and appropriately in resolving the concems.

i i

L L 1 Washington Draft Report' Page 25 The Waste Management Section also responded to four incidents that occurred during the

. review period. The review team found the level of effort to be appropriate for 'he given incident.

- None of the incidents warranted notification of the'NRC.'

t Based on the IMPEP evaluation criteria, the review team recommends that Washington's .

Jperformance with respect to the indicator, Uranium Recovery Program, be found satisfactory.  !

, 5.0 ' "

SUMMARY

~

As noted in Sections 3 and 4 above, the review team found Washington's performance to be

satisfactory for all nine performance indicators. Accordingly, the review team recommends that

, the Management Review Board find the Washington Agreement Stato program to be adequate

- 2 to protect public health and safety and compatible with NRC's program.

' Below is a summary list of recommendations, as mentioned in earlier sections'of the report, for

. implementation and evaluation, as appropriate, by the State.

l RECOMMENDATIONS: 1

1. The review team recommends that the State complete their ef[ orts to document the ,
qualifications of all Radioactive Materials Section staff members by fully utilizing the ,

RMS-61 procedure, assess the training needs of the Radioactive Materials Section staff, and provide training necessary to fully qualify staff members to the requirements in  !

RMS-61. -(Section 3.3)

- 2. ~ WThe review team recommends that when possible, the alleger be notified in wr! ting of the cetions taken in response to the allegation and if the allegation could or could not be substantiated. (Section 3.5) '

3. The review team recommends that management fully implement the training program that was recently established for the Waste Management Section. (Section 4.3.3)
4. The review team recommends that the State develop specific inspection procedures for the uranium recovery program.'(Section 4.4.2)

- 5. The review team recommends that Waste Management Section management develop

. and implement a training plan to include training in specific technical areas related to flood analysis, water surface profile arialysis, erosion protection design, rock durability

- and erosion protection placement. (Section 4.4.3) _

r

)

F7

[ LIST OF APPENDICES AND ATTACHMENTS .,

( .-..

Appendix A iMPEP Review Team Members l Appendix B -

Washington's Organization Charts Appendix C Inspection Casework Reviews -

! Appendix D <

License Casework Reviews l Appendix E incident Casework Reviews l

Appendix F Sealed Source and Device Casework Reviews Appendix G Washington's Questionnaire Response 1

l l

l t ,,

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Richard L. Woodruff, Region ll Team Leader Response to incidents and Allegations Legislation and Program Elements Required for Compat 5llity Mark Shaffer, Region IV Accompaniments Status of Inspection Program Technical Quality of Inspections Lance Rakovan, OSP Technical Staffing and Training Michael Stephens, State of Florida TechnicalQualityof Licensing j Sealed Source and Device Evaluation Program Mark Thaggard, NMSS Low Level Radioactive Waste Disposal Program Terry Johnson, NMSS Uranium Mill Program l

. ~ . .

- .g i ,,;

L(/ .

'6 c' 1: 3 APPENDIX B STATE OF WASHINGTON DEPARTMENT OF HEALTH

  • and DIVISION OF RADIATION PROTECTION ORGANIZATION CHARTS l

l' l

l-

1996-97 Organization Chart 9 W,e ashingtonStateGovernment Sta ed . -- a ,

legislative Branch luscutive Branch JudicialBranch 0 same maneenaernemaam  := rem caeri E hnt tegrstatwe Audt and Revew Commmu Offee of the State Actuary Court of Appeats $@reme Court Clerk Law tbrary p tegeisive Trucponaion Commmee Joint tegewwe Syuems Commen Suppor Couns S@reme Court Commissener Reporterof Decisons A -'**""*'8d "**'ng Comm sen minct Courts Aennsirator sor the Courts Commesen on JudcolCondLct Legislatwo Evaluaten and Accountabhty P ogram Muncpal Courts Omce of Pshe Defense R

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Health Care Polcy Board I Amencan Aftars Lottery Commason Councd for the Prevenhon of Commeson on Hmpanc Department of Financial Chad Abuse and Noglect ggg,,,  ;

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Fsh and Wildife Personnel Appeals Board Trancportalen Commssen Human Rights Commason Higher Educatiun Convenlon and Trade s Commsson Osswtmeir et Treworform" Coordnatmg Board Center i Lquor Conted Board Indeterminate Sentence Ospemer WFain wir war Boerdof Pdotage Reven Board Goveening Boards of Four Housing Finance Pathe Employment Parks and Recreation Commeserers Board ofIndusinalinsurance Year institutens of Higher Commrsson ,

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&wd guthonty I pfe.4capp a ,v Gambkng Comm7sen Boerd of Health TechncalW q Conservaten Commason Hbrse Racog Commesion g I t>hlites and Transportalon commry cassges Columbe Rwer Gory '

Commesen rechnicar cassges Commeson investment Board Joint Center for ngher j Grown Management Ed; cation i Heanngs Boards Statute Law Commmee fassem teashrigen cadr Asmar Lbrary Commason i CeearPgstSciad ' Sla* *wy 1 MuncpalResearch Council "5"* ***h'"8"" Econome and Revenue Higher Edxaton Facibles

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Boerd of NaturalResources Authonty Forscast Cource Washington State Hstantal Forense investiptions Sacey Councs Eastein Washmgton State Citizens'Commissen on Hakocal Sotey l Salanes for Elected Offcels State Capitd Committee l State Fnance Committee PiinanzD sy tia ,

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1 p APPENDIX C INSPECTION CASEWORK REVIEWS NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR

! COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE  !

REVIEW TEAM.

File No.: 1 Licensee: Lab Perfonnance Specialist License No.: LO148-1 Location: Redmond, WA Inspection Type: Routine, Announced License Type: Laboratory Priority: 3

-Inspection Date: 1/20/98 Inspector: BB Comments:

a) Inspection was performed 9 months past 25% overdue window. 4 b) . Acknowledgment letter not sent to licensee following receipt of corrective actions letter.

i File No.: 2 i

Licensee: Northwest Hospital Gamma Knife Center License No.: M0201-1 Location: Seattle, WA .

Inspection Type: Routine, Unannounced License Type: Gamma Knife Priority: 3 Inspection Date: 3/17/99 Inspector: BB Comment: l a) Field notes do not Indicate review of quality management plan and treatment planning data.

File No.: 3 Licensee: Aerofab, incorporated .

License No.: 10315-1 Location: Aubum,WA . Inspection Type: Routine, Unannounced License Type: Thorium-232 (For Possession Only) Priority: 3 Inspection Date: 2/2/99 Inspector: RV File No.: 4 Licensee: St. Joseph Hospital License No.: M0164-1

  • Location: Seattle, WA Inspection Type: Routine, Unannounced License Type: Medical Priority: 3 inspection Date: 8/27/97 Inspector. RV Comment:

a) Field notes do not indicate review of quality management plan for brachytherapy.

s t

a

)

l

: Washington Draft Report - Page C.2

- Inspection Casework Reviews

~ File No.: 5 Licensee: Scientech, incorporated License No.: 10340-1 Location: Pullman, WA Inspection Type: Routine, Unannounced License Type: Manufacturing & Distribution Priority: 3 Inspection Date: 4/12/99 Inspector: RV File No.: 6 Licensee: Inspection Services, Inc. License No.: IR064-1

, Location: Kennewick, WA Inspection Type: Routine, Unannounced '

License Type: Radiography .

Priority: 1 Inspection Date: 10/29/98 & 11/5/98 Inspectors: ME, CD ]

Comment: ,

a)  ! Licensee remains under " Order to Cease and Desist Operations." j File No.: 7

- Licensee: Tacoma RLdiology License No.: M0205-1 L Location: Tacoma, WA Inspection Type: Routine, Announced

' License Type: Mobile Nuclear Medicine Priority: 3

-Inspection Date: 6/12/98 Inspector: RV )

File No.: 8 -

' Licensee: Seattle Nuclear Medicine License No.: M0163-1 l Location: Seattle, WA Inspection Type: Routine, Unannounced License Type: Medical j

Priority: 3 Inspection Date: 1/25/99 Inspector: BB File No.: 9 L Licensee: Deaconess Medical Center - License No.: M005-1 Location: Spokane, WA Inspection Type: Routine, Unannounced License Type: Medical .

Priority: 3 inspection Date: 8/19/98 Inspector: CD Comment:

l ~)a Field notes do not indicate review of quality management plan for brachytherapy.

L File No.: 10 -

l . Licensee: Spokane Central Pharmacy License No.: NP008-1 1 Location: Spokane, WA inspection Type: Initlal, Unannounced License Type: Nuclear Pharmacy Priority: 1

! Inspection Date: 6/2/99 inspector: CD l l

m 1-1 7

' Washington Draft Report Page C.3 ,

inspection Casework Reviews .  !

File No.: 11

' Licensee: INS Corporation License No.:10414-1

!.' Location: Richland,'WA inspection Type: Routine, Unannounced L

License Type: Nuclear Laundry._ .

Priority: 2 inspection Date:2/1819/99 Inspector: LW File No.: 12 -

l Licensee: Troxler Electronic Labs, Inc. License No.: 1046611

' i

' Location: Puyallup, WA inspection Type: Routine, Announced  ;

License Type: Gauge Services . Priority: 3 ~

- Inspection Date: 2/17/98

)

Inspector: BB '

File No.: 13 '

! Licensee: Spokane Industries, Inc. License No.: IR049-1

- Location: Spokane, WA - Inspection Type: Routine, Announced  ;

License Type: Radiography Priority: 1 Inspection Date: 6/30/98 Inspector: RV File No.: 14 Licensee: The Boeing Company License No.:1005 1 Location: Seattle, WA Inspection Type: Routine, Announced License Type: Broad Scope (R&D)' Priority: 1

- Inspection Date: 4/19-21/99 Inspectors: AS, BB

~ Comment:

a)- Field notes'do not indicate review of radiation safety committee meetings and reviews, an overview of licensed activities (scope of the program),'or to what extent gamma Irradiators were reviewed.

i File No.: 15 .

Licensee: University of Washington License No.: C001-1 Location: Seattle, WA Inspection Type: Routine, Announced License Type: Broad Scope Medical Priority: 1

inspection Date
10/1315/98 inspectors: RV, BB, AG j l 1
' File No.: 16 l
Licensee: Nucletron License No.: 1039-2 Location: Seattle, WA .

. InspectionType: Routine, Announced License Type: HDR Source Exchange (Reciprocity) Priority:1 p Inspection Date: 4/7/98 Inspector: AG l l , Comment: . .

L ' a) " An inspecSon report was not issued for this inspection. l t

I

, i a

3 Washington Draft Report Page C.4 Inspection Casework Reviews File No.: 17 Licensee: J.L. Shepherd .

License No.: CA-1777-19 Location: Seattle, WA Inspection Type: Routine, Unannounced Lbense Type: Irradiator Installation & Service (Reciprocity) Priority: 3

. Inspection Date: 4/7/99- Inspector: BB File No.: 18 Licensee: Longview Inspection License No.: ORE-90621 l Location: Longview, WA' Inspection Type: Routine, Unannounced License Type: Radiography (Reciprocity) Priority: 1 Inspection Date: 1/6/98 Inspector: CD Comment:

a) ' As of 9/3/99, the Radioactive Materials Section had not received a corrective actions letter from the licensee following the Notice of infraction issued January 1999.

File No.: 19 Licensee: Yaki.ma Valley Memorial Hospital License No.: M054-3

. Location: Yakima, WA Inspection Type: Routine, Unannounced License Type: HDR Brachytherapy Priority: 3 Inspection Date: 9/22/98 Inspector: BV Comment:

a) Inspector used a combination of Radioactive Materials Section teletherapy and brachytherapy inspection field notes to document the inspection rather than HDR field notes.

File No.: 20 Licensee: Dawn Mining Co. License No.: WN-lO43-2 Location: Ford, WA ~ Inspection Type: Routine, Announced License Type: Source Material Priority: 1 Inspection Date: 10/14/97,10/13/98, 8/12/99 Inspector: EF, DS, ME File No.: 21 Licensee: Westem Nuclear, Inc.. License No.: WN lO133-1

' Location: Washington inspection Type: Routine, Announced License Type: Soarce Material Priority: 1 Inspection Date: 3/28/96,4/3/96,4/5/96,6/5/96,6/26/96 inspector: EF, DS, JB 7/2/96, 7/24/96 l- Comment:

[ 'a) ' Inspectors did not document problems with rock placement and rock gradations.

I i

n l

l .; Washington Draft Report Page C.5 l- ' Inspection Casework Reviews .

l l

ACCOMPANIMENTS In addition, the following inspection accompaniments were performed as part of the onsite IMPEP review.

' Accompaniment No.: 1 .

p Licensee: Clark County Dept. of Public Woks ' License No.: 1094 Location: Vancouver, WA

  • Inspection Type: Routine, Announced l - License Type: Portable Gauge - Priority: 5

! . Inspection Date: 7/28/99' Inspector: AG -

~

' Comment:

a)l Inspector unaware of HAZMAT 3-year refresher training requirement.

h ' Accompaniment No.: 2 Licensee: City of Poulsbo License No.:10439 Location: Pouisbo, WA Inspection Type: Routine, Announced License Type: Portable Gauge - Priority: 5 Inspection Date: 7/29/99 Inspector: PW i Accompaniment No.: 3

- Licensee: Oridigm Corporation ' License No.: LO181 Location: Seattle, WA Inspection Type: Routine, Announced 1

. License Type: R&D Laboratory Priority: 5 Inspection Date: 8/2/99 Inspector. LW Accompaniment No.: 4

~ Licensee: Dendreon Corporation License No.: LO187

- Location: Seattle, WA - Inspection Type: Initial, Announced

License Type: R&D Laboratory Priority: 5 j inspection Date: 8/3/99 Inspector: BB

- Accompaniment No.: 5

Licensee: Dawn Mining Co. License No.: WN-lO43-2

- Location: Ford, WA ' inspection Type: Routine, Announced

- License Type: Source Material Priority: 1 l Inspection Date: 8/12/99 Inspector:

1 i

l 4

)

t

i I

l

, )

I APPENDIX D LICENSE CASEWORK REVIEWS NOTE: ALL LICENSES LISTED WITHOU1 COMMENT ARE INCLUDED FOR

- COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE REVIEW TEAM. ,

File No.: 1 Licensee: Panther Systems - License No.: WN-10401-1 Location: Vancouver, WA Amendment No.: 7-12 License Type: SS&D Distributor Type of Action: 5 Amendments, Renewal Date Issued: 4/16/96, 8/20/96,12/2/96 License Reviewers: PW, AS 12/5/96,3/12/97,9/5/97 Comment:

a)- License renewal amendment number 12 does not list any of the previous SS&D registration information from previous SS&D reviews in the tie-down condition. The license was revised to' include the tie-down condition the week of September 27,1999

by the State.

File No.: 2 -

Licensee: Boeing ~ License No.: WN-1005 Location: Seattle, WA Amendment No.: 21-27 License Type: Broad Scope Ind. R&D Type of Action: 6 Amendments, Renewal

. Date issued: 8/21/95, 9/11/95, 5/23/96, 7/2/97 License Reviewer: AS 9/19/97,5/29/98,5/4/99-

. File No.': 3 Licensee: Professional Services industries, Inc. License No.: WN-IR021-1

- Location: Seattle, WA Amendment No.: 41

' License Type: Industrial Radiography / Portable Gauge Type of Action: Renewal Date issued: 2/23/99 License Reviewer: AS File No.: 4 Licensee: Georgia - Pacific West, Inc.

License No.: WN-10361 Location: Bellingham, WA Amendment No.: 19,20 Ucense Type: Fixed Gauge Type of Action: Amendment, Renewal Date issued: 10/10/96,8/11/98 License Reviewers: PW, AS -

. File No.: 5 -

Licensee: Superior Asphalt 7 Concrete, Company License No.: WN-10370-1 Location: Yakima, WA Amendment No.: 2,3 License Type: Fixed Gauge Type of Action: Renewal, Amendment-Date issued: 3/26/96,5/19/96 ~ License Reviewer: PW k

\

k.

IWashington Draft Report Page D.2 License Casework Reviews L File No.: 6

- Ucensee: Taylor Engineering, Inc. License No.: WN-10293-1 Location: Spokane, WA l Amendment No.: 8-10 License Type: Portable Gauge . Type of Action: Renewal,2 Amendments

' Date issued: 12/11/97, 3/18/98, 2/16/97 License Reviewer: PW File No.: 7 Licensee: Central Washington Hospital License No.: WN M0171-1 Location: Wenatchee, WA i .

Amendment No.: 9-11

License Type: Medical, Institutional

~ .

Type of Action: 2 Amendments, Renewal Date lssued: 4/29/97, 2/17/98, 7/1/98 - License Reviewer: CD Comments:

a). Hospital performs radiopharmaceutical therapy but does not possess dose calibrator.

b)- Procedures to ensure that therapy doses within 10 percent of written directive are not addressed in license.

f' File No.: 8

Licensee: Spokane Cardiology License No.: WN-M01581

. Location: Spokane, WA . Amendment No.: 11-13 License Type: Medical, Private Practice Type of Action: 2 Amendments, Renewal-Date issued: 1/22/96, 2/8/96, 2/21/97 License Reviewer: CD Comment:

3= a) . License authorizes facil1ty and authorized user for all diagnostic imaging and localization procedures when licensee only requested cardiac imaging procedures.

File No.: 9 Licensee: Thomas, Dean & Hoskins,inc. License No.: WN-10455-1 Location: Spokane,' WA Amendment No.: 1,'2 License Type: Portable Gauge Type of Action: Amendment, Renewal Date issued: 12/5/95,8/30/99 License Reviewers: AS, PW File No.: 10 '

Licensee: D.M.D., Inc. License No.: WN-10417-1 n Location: Vashon, WA Amendment No.: 2,3 License Type: Gas Chromatograph Type of Action: Amendment, Renewal

?- Date issued: 1/9/96,12/19/97 License Reviewers: PW, AS

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i Washington Draft Report Page D.3 License Casework Reviews-File No.: 11 .

Licensee: Northwest Hospital Gamma Knife Center License No.: WN M0201-1 Location: Seattle, WA Amendment No.: 3-5 License Type: Medical, Gamma Knife . Type of Action: 2 Amendments, Renewal Date issued: 1/3/97, 6/16/97, 6/26/98 License Reviewer: CD

' Comment:

a) Licensee did not submit a quality management program.

File No.: 12 Licenseet Northwest Hospital License No.: WN-M0041 Location: Seattle, WA Amendment No.: 37-47

' License Type: Broad Scope-Medical . Type of Action: New,10 Amendments Date issued: 2/16/96, 9/18/96, 5/16/97,1/28/98, 3/27/98 License Reviewer: CD 4/24/98,6/17/98,10/12/98,5/19/98,6/4/99,7/20/99 Comment:

a) Amendment 37 is a license upgrade to a broad scope and was treated as a new license.

- File No.: 13 '

Licensee: Yakima Valley Memorial Hospital License No.: WN-M054-3 Location: Yakima, WA _

Amendment No.: 14-19 License Type: Medical, Institutional, HDR, Type of Action: Renewal,5 Amendments ]

Teletherapy, Blood irradiator  !

. Date issued
8/21/96, 3/11/97, 9/29/97, 7/22/97, 3/15/99, 6/8/99 License Reviewer: CD I File No.: 14 Licensee: Syncor Intemational Corporation License No.: WN-NP003-1 l Location: Seattle, WA Amendment No.: 4-8 i License Type: Nuclear Pharmacy Type of Action: 4 Amendments, Renewal Date issued: 5/12/97,12/15/97, 4/13/98, 2/17/99, 2/19/99 License Reviewer: CD File No.: 15 l Licensee: The McAndrews Group, Ltd. License No.: WN-10477-1 Location: Bellevue, WA Amendment No.: 0-4  ;

License Type: Portable Gauge .

Type of Action: New,3 Amendments, Termination  !

l Date issued: 6/14/96,10/23/96, 5/27/97, 4/22/98, 9/24/98 License Reviewer: PW File No.: 16 Licensee: Health Physicist Northwest License No.: WN L0147-1 Location: Seattle,WA Amendment No.: 3 License Type: Service Consultant Type of Action: Termination .

Date issued: 10/1/97 License Reviewer: LW j l

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y Washington Draft Report Page D.4 License Casework Reviews File No.: 17 Licensee: Ames Construction License No.: WN-10388-1 Location: Tukwila, WAl _

Amendment No.: 2,3 License Type: Portable Gauge - Type of Action: Amendments, Termination

! Date issued: 5/28/96,11/5/96 License Reviewer: PW l

File No.: 18 Licensee: The Heart institute of Spokane' License No.: WN-M0195-1 Location: Spokane, WA Amendment No.: 7,8

. License Type: Medical, Private Practice Type of Action: Renewal, Termination Date issued: 12/18/95,4/14/97 License Reviewer: CD ,

i Comment:

a) Department performed a confirmatory close-out survey and found contamination.

. Required licensee to decontaminate prior to termination of license.

' File No.: 19 i Licensee: Dynacare Northwest, Inc. . License No.: WN L0116-1 Location: Seattle, WA Amendment No.: 8-11 License Type: Lab-R&D/In vitro Type of Action: Renewal,3 Amendments

' Date issued: 1/12/98, 6/3/98,6/24/98,12/21/98 License Reviewer: LW File No.: 20 '

Licensee: PN Se_rvices License No.: WN-10252-1 Location: Richland, WA Amendment No.: 11,12,13 License Type: Broad Scope-industrial, Type of Action: Renewal,2 Amendments R&D, Waste Technology _ License Reviewer: LW Date issued: 4/30/97, 5/6/99, 6/21/99 i File No.: 21 LLicensee: Mason General Hospital '

License No.: WN M0214-1 Locationi Shelton, WA Amendment No.i 0 License Type: Medical, Institutional Type of Action: New Date issued: 8/30/99 License Reviewer: CD

' Comment:

a) . Licensee was authorized for diagnostic iodine possession and usage when they indicated that they do not want diagnostic iodine.

File No.: 22 Licensee:ICOS Corporation License No.: WN-LO142-1

Location: Bothell, WA _ Amendment No.: 9,10 License Type: R&D Laboratoryf Type of Action:2 Amendments

' Date issued: 12/9/97,1/27/99 License Reviewer: LW

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. Washington Draft Report Page D.5 License Casework Reviews

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File No.: 23

- Licensee: Epoch Phdrmaceutical License No.: WN-LO120-1 l' Location: Redmond, WA - Amendment No.: 6-8

. License Type:In vitro Laboratory Type of Action: Amendments, Renewal ,

' Date issued: 11/12/96 10/7/98,11/3/98 License Reviewer: LW I File No.: 24 I Licensee: Fred Hutchinson Cancer Research Center License No.: WN LO42-1 Location: Seattle, WA Amendment No.: 35 38 l License Type: Broad Scope R&D Laboratory, Irradiator Type of Action:4 Arnendments Date issued: 8/12/97, 2/27/98,10/20/98,11/18/98 L License Reviewer: LW l

E File No.: 25 -

Licensee: University of Puget Sound ' License No.: WN C002-1 i.

Location: Tacoma, WA - Amendment No.: 23-25 L . License Type: Academic Type of Action: Renewal,2 Amendments Date issued: 6/30/95, 3/10/97, 3/3/99 License Reviewer: DM, LW

.. ' File No.: 26 J s . Licensee: ATG Richland Corporation License No.: WN-10393-1 ll ~l .ocation: Richland, WA .

Amendment No.: 7,8 License Type: Commercial Waste Processor / Broker /R&D Type of Action:2 Amendments Date issued: 12/24/98,5/24/99 License Reviewer: GR

, File No.: 27 Licensee: C-thru Technologies Corporation License No.: WN-10282-1

~ Location: Kennewick, WA Amendment No.: 13-22 l  : License Type: Manufacture / Distributor . Type of Action:10 Amendments

' Date issued: 8/7/95,1/8/96, 8/29/96,11/27/97, 3/24/97 License Reviewer: AS 5/13/97,8/25/97,3/10/98,10/5/98,1/20/99 File No.: 28 '

Licensee: Dawn Mining Co. License No.: WN-1043-2 Location: Ford, WA' Amendment No.: 22 License Type: Source Material Type of Action: Amendments Date issued: 1/29/99 - License Reviewer: Waste Management Section File No.: 29 Licensee: Western Nuclear, Inc. - License No.: WN !0133-1

. Location: Washington Amendment F.o.: N/A L .. License Type: Source Material . Type of Action: Review of reclamation plan and

! , development of TER L . Date' Issued: TER issued June 1998 License Reviewer: Waste Management Section

! _( Final approval pending licensee completion of site construction requirements) r 4

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p - APPENDIX E

. INCIDENT CASEWORK REVIEWS 1

NOTE: ALL INC'IDENTS LISTED WITHOUT COMMENT ARE INCLUDED FOR l COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE i REVIEW TEAM.

File No.: 1:

Licensee: ATG, Waste Processor incident ID No.: 951121 Location: Richland, WA License No.: WN 10931 Date of incident: 8/17/95 Type of Incident: Contamination

' investigation Date: 8/21-24/95 Investigation Type: Onsite -

Summary of incident and Final Disposition: A night shift radiation technician entered a potentially contaminated facility _without the required respiratory protection to collect wipe samples for evaluation. Upon exit, two nasal smears indicated 5000 counts per minute each.

_ He was sent for bioassay analyses, which included a lung count, a whole body count, a liver

- scan, and a bone scan as well as urine and fecal analyses. The preliminary data indicated

- approximately 1.33 nanocuries of Am-241 in his lungs. All other employees in the adjacent areas were also tested, but no radioactive material was found to be in their bodies. The State responded with an onsite inspection on August 21,1995, and ordered the building secured and the work stopped until a complete analysis is done and a written report is reviewed by the State.

The licensee cleaned up the affected area and provided a detailed report dated January 8, '

4 1996 and the State closed out the case on January 9,1996.

File No.: 2 Licensee: Earth Consultants, Inc. Incident ID No.: 980812 Location: Bellevue, WA License No.: WA-WN LO61 1

~ Date of incident: 7/16/98 Type of incident: Loss of Control Investigation Date: 7/17/98 investigation Type: Onsite Summary of Incident and Final Disposition: The licensee reported that a Troxler moisture / density gauge containing 40 millicuries of americium 241 and 8 mill l curies of cesium-137 was hit by the blade of a bulldozer at a temporary job site near Federal Way,

Washington. The gauge was not in use at the time and the source rod was in the safe (up) position. Staff from the Division examined the gauge and determined by wipe test that no leakage occurred and that the gauge could be safely retumed to the manufacturer for repair.

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. Washington' Draft Report Page E.2 J

- Incident Casework Reviews  !

. File No.: 3 -

+ ' Licensee: Deaconess Medical Center : Incident ID No.: 981056 I Location: Spokane, WA License No.: WA WN-M005-1 1 Date of incident: 9/18/98 Type of incident: Unauthorized Maintenance  !

Investigation Date: 9/30/98 Investigation Type: Telephone l Summary of incident and Final Disposition: The licensee .eported an equipment problem with an Omnitron/Varian "Varisource" HDR Unit containing an Omnitron 9.5 Curies Ir-192 source.  !

An authorized user noted that the movement of the dummy source wire was not very smooth in j a test run before a planned patient treatment and decided to lubricate the catheter with a lubricant (which was unauthorized). This appeared to work initially, since the dummy wire then :

ran smoothly and the patient treatment was completed successfully, However, when the patient retumed on 9/25/98 for another treatment, it was noted that the dummy wire would not advance completely and the unit malfunctioned. Varian personnel determined that the unit was full of a foreign substance which had caused the machine to malfunction and the unit was rebuilt. No patients or personnel received any exposure of any kind from this incident. The State took enforcement action on October 8,1998 and the licensee's corrective actions were received on I November 6,1998. The license was last inspected on August 19,1998. I i

File No.: 4 Licensee: Emcon Northwest, Inc. Incident ID No.: 980537

Location: Spokane, WA License No.: WA WN-103091 Date of Incident: 4/26/98 Type of Incident: Stolen Material Investigation Date: 5/5/98 investigation Type: Onsite Summary of incident and Final Disposition: The licensee reported a theft of a Troxler density gauge containing 47.6 millicuries of americium-241 and 9.73 millicuries of cesium-137. The device was secured to the bed of a truck which was locked and secured in a fenced area at the licensee's facility. ' Local police investigated the robbery. On 5/5/98, the State reported to NRC that a fisherman had spotted the device on an island in the Spokane River in Spokane, Washington directly under a bridge. The gauge had apparently been dropped a distance of roughly 200 feet. Radiation surveys were performed and the gauge was retumed to the licensee's Spokane office where staff from the Division examined the gauge and performed a leak test. There was no leakage of radioactive material.

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I Washington Draft Report Page E.3 Incident Casework Reviews.

f File No.: 5 :

- Licensee: Equilon Puget Sound Refinery incident ID No.: 981153

' Location: Anacortes, WA License No.: (Generallicensee)

' Date of incident: 11/25/98 Type of Incident: Equipment damage Investigation Date: 11/25-26/98 investigation Type: Telephone Summary of incident and Final Disposition: The Ecensee reported an explosion and fire at a _

- refinery which caused the loss of six lives and also threatened six generally licensed Kay-Ray source housings. Each housing contained a 500 millicurie Am-Be sealed source. The manufacturer's representative (RSO), who was on site, determined that the sources were not in the explosion area and were not damaged as verified by direct survey, leak test, and shutter on-  !

. off test. The sources were locked out pending repair of nearby process equipment. The i Division hcd several telephone conversations with the general licensee and the gauge representative during the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the event.

File No.: 6 Licensee: Columbia Asphalt & Gravel Inc. Incident ID No.: 980831  !

Location: Yakima, WA License No.: WA WN-104041  !

Date of incident: 8/4/97 Type of incident: Equipment Damage

' Investigation Date: 8/20/97 . investigation Type: Onsite ,

Summary of incident and Final Disposition: The licensee reported that a twelve ton asphalt l roller smashed a Troxler 3440 moisture / density gauge containing 40.millicudes of Am Be End 8 l millicuries of Cesium 1371 The site was secured until Department staff arrived to survey the

- area and the bits and pieces of the gauge. No release of radioactive material was found. The

' gauge was retumed to the manufacturer for disposal.  ;

File No.: 7 Licensee: Geoengineers. Incident ID No.: 980732

. _ Location: Redmond, WA < License No.: WA-WN 10204-1 Date of Incident: 6/24/98 Type of incident: Stolen Material

_ investigation Date: 6/25/98 Investigation Type: Telephone Summary of incident and Final Disposition:. The licensee reported the theft of a Troxler moisture / density' gauge model 3440, containing 40 millicuries of americium-241 and 8 millicuries of cesium-137 taken from a temporary job site in Kent, Washington. The gauge had -

been chained and locked to the wall in the garage of a house being used for storage of

- construction tools. Entry was obtained by kicking in the side door to the garage. The transportation case was broken and the case was pried open enough to remove the gauge and calibration block. The case remained chained to the wall. Other power tools were also stolen from the garage. Local police investigated the incident. No other follow up was conducted in view of the circumstances. A formal report was obtained from the licensee and the local police Edepartment.'

Comment:

a) The file did not contain any information as to whether the device keys were also stolen.

Washington Draft Report - Page E.4 Incident Casework Reviews File No.: 8 Licensee: Giles Engineering ' Associates, Inc.

Incident ID No.: 980922 Location: Bothell '~ License No.: WA-WN-lO490-1 Date of incident: 8/26/98 ' Type of Ircident: Damaged Device -

Investigation Date: 8/27/98 Investigation Type: Onsite Summary of Incident ar* Final Disposition: The licensee reported that a CPN moisture / density gauge containing 50 millicuries of americium-241 and 10 millicuries of cesium 137 was struck by a large loader at a temporary job s;te of a new middle school.in Tacoma, Washington. The gauge was not in use at the time of the event. The gauge operator had finished a test using the gauge and while his back was tumed, the loader backed into the portable gauge, cracking the j case open. The gauge operator immediately isolated the area, initiated notification to the licensee RSO, and contacted the Division. The Division immediately sent staff to investigate, check for contamination, and survey the transport package prior to retum to the licensee's  !

office. Damage appeared to be limited to the case. No con %.mation was found, the

, packaged gauge was authorized for transport, and was retumed to the manufacturer for repair.

File lYo.' 9 -

' Licermee: Harrison Memorial Hospital incident ID No.: 981078 Location: Olympia, WA License No.: WM-M0168-1 Date of incident: 2/20/98 Type of incident: Contamination Event Investigation Date: 2/20/98 -Investigation Type: Onsite Summary of incident and Final Disposition: The licensee reported that a patient that received  ;

12 millicuries of lodine-131 was released, and on the way _home, the patient became nauseous {

and vomited in the parking strip of a busy street in Seattle. The patient reported this to the l

' licensee who determined that the patient's car had little to no contamination and that

]

approximately half the dose had been vomited. Due to local weather conditions, an onsite j response was delayed until the next day. A Division inspector was able to locate a  !

contaminated spot on the pavement using a survey meter. With exception of a very small spot.

of non-removable contamination, all the contaminated vomitus had been washed away and no other detectable contamination was found. No member of the public is believed to have been j exposed, i i

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Washington Draft Report : Page E.5 l incident Casework Reviews File No.: 10 4

' Licensee: Nycomed Amersham Imaging incident ID No.: 990338 l Location: Seattle, WA '

License No.: WA WN-NP002-1 1 l

Date of Incident: 11,30/98 : Type of incident: Misadministration L Investigation Date: 4/21/99 Investigation Type: Next inspection )

l Summary of incident and Final Disposition: The licensee reported three diagnostic I misadministretions, involving mislabeled tecnetium-99m dosages, that were sent to three l

lc different hospitals. Upon administration and imaging, it was determined that the radionuclides j and dosages were correct, but that the chemical forms were not. All three patients and their '

referring physicians were notified of the events. The cause of the mislabeling at the pharmacy 1 L was determined to be human error. The pharmacist drawing the doses apparently didn't read ' l the label of the vials before fi!Iing the syringes.

Comment-l a)_ The incident was addressed with the licensee during the next inspection, but the file had 1

) . no details of the corrective actions, or any items of noncompliance related to the event.

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l Flie No.: 11 - l

!. Licensee: none incident ID No.: 990345 - l Location: Seattle, WA License No.: NA ,

, Date of incident: 6/1/99 Type of incident: Unlicensed Material I Investigation Date: 6/1/99_ investigation Type: Onsite  ;

Summary _ of incident and Final Disposition: The United States Customs at the Seattle / Tacoma intemational Airport, reported detaining a passenger whose luggage was detected to be radioactive. The passenger was a physician in-bound from Thailand on his way home to i Alaska. >The physician admitted that he was carrying 1131 and was taking it to his home in l Alaska, where he intended to treat his cat for hyperthyroidism. lie did not have a license or any ,

other authorization for the radioactive material. It was determined that the glass vial, containing i approximately 6 millicuries of I-131, was being carried with no shielding and appeared to constitute a public health threat. The Department immediately asked the United States

Customs to seize the material under state law prohibiting possession of radioactive material without a license. The Division responded, conducted surveys, placed the vialin a lead shield.

No contamination was detected. Besed on interviews with the physician, United States Customs and airline staff, there were no overexposures associated with this event. The two situations having the most potential for exposures were: 1) the physician and possibly a US Customs official who handled the bare vial. These two individuals had an estimated dose of 300 millirem to the fingers and a whole body dose of less than 10 millirem; and 2) a passenger

seated directly above the baggage hold for the 10 hour1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> flight had an estimated whole body dose of less than 5 millirem.

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h, I ij Washington Draft Report ,

Page E.6 Ee Incident Casework Reviews l

, File No.i12

Licensee
Professional Service Industries, Inc. Incident ID No.: 981231  !

Location: Seattle, WA License No.: WA-WN-lR021-1 1 Date of Incident: 12/16/98 Type of incident: Overexposure Investigation Date: 12/17/98 investigation Type: Onsite Summary of incident and Final Disposition: The licensee reported an overexposure to a l contractor employee (member of the public) to a 60 Curie, Iridium-192 radiography source.while L

working in the parking garage of an office building in Seattle, Washington. During one shot, one of the contractor employees approached the source collimator and caused the collimator to become dislodged from the source guide tube. The contractor employee reassembled the source and guide tube before the radiographer became aware of the situation. The -

radiographer immediately shouted a waming, retracted the source, began an immediate I b investigation, including an re-enactment, and notified the Division. Preliminary dose estimates '

for the extremities range from 600 to 1,700 rem. The whole body exposure is estimated to be approximately 50 rem. The Division responded to the event, conducted a re-enactment, and j estimated that the individual received less than 5 rem whole body,680 rem to the right thumb, i

100 rem to the right index finger, and 170 rem to the palm of the left hand. A cytogenetic study verified that the whole body dose was in the range of less than 1 to 15 rem. No physical signs of radiation damage to the contractor employee's hands were observed during the weeks following the exposure. The cause of the incident is attributed to the inattention of the radiographer. The licensee committed to re-train and complete an accelerated schedule of field audits on radiography personnel prior to resumption of radiography. Depositions were taken and arrangements were subsequently made for an analysis by REACTS. Enforcement actions j were taken on December 22,1998.  ;

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, . Washington Draft Report - Page E.7 Incident Casework Reviews l

File No.:~13 -

Licensee: Providence Medical Center incident ID No.: 990084 Location: Seattle, WA License No.: WA WN-M045-1

- - Date of Incident: 12/16/98 Type of incident: Misadministration investigation Date: 3/8/99. Investigation Type: Next inspection JSummary of incident and Final Disposition: The licensee reported a misadministration involving a clinical trial of the Guidant intravascular Radiotherapy project and a dose to an unintended

treatment site. The project uses a modified Nucletron high dose rate afterloader and an -
Omnitron Intemational, Inc. phosphorus 32 brachytherapy source with an activity of

. approximately 150 millicuries. Following a planned treatment, the Guidant Coordinator

. informed the licensee that the new catheter required the use of a different connector on the -

front end of the device, and if this connector was not used, the source would not be at the proper treatment site and therefore this treatment would not have been correct. The licensee's review indicaes that the source .was approximately 34 cm from the intended treatment site.

The licensee's estimated dose to the vessel wall was between 7,000 rad and 10,800 rad. Items of concem about the misadministration include: (1) the inability to confirm the location of the L source using fluoroscopy when fluoroscopy visualization is indicated in the project's. description and procedures as an essential verification for the use of this device; and (2) the incomplete training and direction provided to the licensee by the Guidant personnel when device equipment changes were made on 12/16/98. The licensee discontinued the project until the new source wire was in place and thoroughly tested for visibility ur. der fluoroscopy. The Division conducted an investigation (follow up) during.the next inspection and verified the corrective actions.

File No.: 14 Licensee: Spokane County Engineering - Incident ID No.: 980832 Location: Spokane, WA License No.: WA-WN-106',-1 Date of incident: 10/15/97 Type of incident: Lost Ma'arial Investigation Date: 11/3/97 Investigation Type: Enforcement Letter Summary of incident and Final Disposition: The licensee reported the loss of a CPN moisture / density gauge containirig 50 millicuries of americium-241 and 10 millicuries of cesium-  !

137. A field technician failed to secure the gauge and its transportation case in the back of a pickup truck during transport. The gauge fell off the tailgate on the retum trip to the office. The

. gauge was recovered by a Spokane area contractor shortly thereafter and prior to the licensee initiating a search that same evening. The contractor called the licensee the next moming and

'the gauge was retrieved. Damage to the gauge shell was noted but no leakage of radiation occurred.

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I e Washington Draft Report Page E.8

?lncirient Casework Reviews I

File No.: 15 :

. Licensee: Washington State University incident ID No.: 980867 i Location: Pullman, WA 1 . License No.: WA WN-C003-01 Date of incident: 8/5/98 - . Type of Incident: Release of licensed material

Investigation Date: 8/798 investigation Type: Onsite I

l . Summary of incident and Final Disposition: The licensee reported the release of low level i  ; radioactive waste solution from the sewer line used for the discharge from research laboratories

to the sanitary sewer. On 8/5/98, it was discovered that the sewer line used for the discharge L

had been broken by a backhoe working in the area sometime in the previous two years and the

' discharge was creating a small channel down the hillside near the facility. The total volume of

. the discharge was small with most of the water coming from a sump pump for cooling tower i condensate. The licensee stopped further discharges of radioactive waste and to's pupt action to identify the extent of contamination, assess the radiological hazard, arn amp ate the l clean-up. Initial clean-up consisted of removal of fourteen barrels of contaminao.d re. The j licensee contracted with an independent firm to perform a site assessment to aid in aetermining I the nature and extent of decontamination work needed. A site specific clean up plan was i developed after consultation with the Division. The Division conducted confirmatory surveys of the soll and vegetation following the licensee's clean-up.

File No.: 16 1

< Licensee: Harrison Memorial Hospital incident ID No.: 981079 l' Location: Bremerton, WA License No.: WN M0168-1 Date of incident: 9/11/98. Type of Incident: Contamination Event Investigation Date: 9/11/98 Investigation Type: Telephone

-t. Summary of incident and Final Disposition: The Division reported that a patient received a 20 millicurie dose of I-131 from the licensee and was released from that facility. On the way home,

- the patient became nauseous and vomited in the dirt at the street-side near a church school parking lot.' The patient reported this to the licensee who went to the site and confirmed that

'approximately half the dose had been vomited into the dirt. The licensee roped off the area, consulted.with the Division and cleaned up the site by digging up and double-bagging the contaminated dirt, and subsequently held for decay at the licensee's facility. No member of the .

public is believed to have been exposed. A follow-up report was received from the licensee, and the Division determined that appropriate actions were taken.

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s Washington Draft Report Page E.9 ;

J . incident Casework Reviews l

L File No.: 17-

[ Licensee: University of Washington. Incident ID No.: 990329

! Location: Seattle, WA License No.: WA-WN-C001-1 Date of incident: 11/21/98 Type of Incident: Loss source Investigation Date: 2/24/99 Investigation Type: Report Review l l Summary of incident and Final Disposition: The licensee reported the loss of a Perkins-Elmer I l ' gas chromatograph source containing 15 millicuries of Ni-63. The licensee reported that an

! "ownertess" surplus gas chromatograph (and detector cell) was stored in a hallway at the University. An inventory check in late December 1998, noted that the unit was no longer in the hallway and was presumed to have been put into better storage. By late January 1999, further l checking revealed that the unit had probably been taken to the licensee's Surplus Property Department.L Records indicated that the unit could have been sold at auction on 11/21/98 but contacts with the buyers at the sale failed to produce the source. The licensee's RSO believes ' .

that the unit was most likely discarded in the trash in November either by the licensee's Surplus

' Property Department or by one of the buyers. The Division determined that there is little likelihood of human exposure to the radioactive source if it was sent to the landfill for disposal with the other trash. The Ni-63 source was last leak tested on 9/19/98, and had no indication of j leakage., No enforcement action was taken. j

. File No.:.18 Licensee: General Testing Laboratories, Inc. incident ID No.: WA-96-007 Location: Poulsbo, WA License No.: WA-WN-10100-1 Date of Incident: 1/15/96 Type of Incident: Loss gauge ,

.Investigetion Date: 1/17/96 Investigation Type: Telephone

]

Sumnsary of incident and Final Disposition: The licensee notified the Division by telephone that a portable Troxler gauge fell from a vehicle during transit and was temporarily lost for 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> K cn ih6 day of the incident. The device contained 8.5 millicuries of cesium-137 and 4 millicuries ,

o americium-241. The Division's conversation records show that the device was recovered on i the same day by another truck driver. The State responded to the incident and conducted I surveys and a leak test. The licensee conducted an operational test. Based on the surveys and tests,~ the device was determined to be operational and not leaking. The incident was not l reported to the NRC because the licensee recovered the device later the same day. The  !

Division took appropriate enforcement action.

File No.19 Licensee: Keith Ransom - Incident ID No.: not applicable  :

Location: Lakewood, WA- License No.:WN 10387-1

- Date of incident:' January 1,1996 Type of incident: Improper disposal Investigation Date: January 1,1996 Investigation Type: Telephone l i

Summary of incident and Final Disposition: A Seamans Nuclear density gauge was improperty  !

disposed in a dumpster. The device was removed from the location. The Sheriff is  !

investigating for possible illegal dumping. 1 i

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- Washington Draft Report Page E.10 Incident Casework Reviews File No. 20 Licensee: U.S. Ecology Incident ID No.: not applicable

. Location: Richland, WA License No.: WN 1019 2

. Date of incident: May 2,1996 Type of incident: Contaminated material outside of the restricted area.

! Investigation Date: May 2,1996 Investigation Type: Onsite Summary of incident and Final Disposition: A 23-foot trailer being refurbished was surveyed prior to being removed from the restricted area; however, after being removed from the -

restricted area contamination was found under a M-inch thick particle board. The contamination was found not to be loose contamination; therefore, the trailer was properly

. marked, and the contaminated area was covered v.'ith plywood.

File No. 21 Licensee: Dawn Mining Co. Incident ID No.: not applicable Location: Ford, WA License No. WN-lO43-2 Date of incident: 4/10/96 Type of incident: Spill Investigation Date: 4/10/96 investigation Type: Onsite Summary of incident and Final Disposition: The incident involved the spillage of two gallons of mildly radioactive sludge along a State highway. The incident was resolved within a matter of hnurs when Waste Management Section staff arrived at the scene and verified the licensee's clean-up of the spill. Final resolutiora was documented, and all activities were coordinated with the Spokane Tribe.

File No. 22

. Licensee: Dawn Mining Co. Incident ID No.: not applicable Location: Ford, WA License No. WN-lO43-2 Date of Incident: 7/27/99 - Type of Incident: Pipe break investigation Date: 7/27/99 Investigation Type: Onsite Summary of I icident and Final Disposition: The incident involved a pipe break and .elease of 1000 gallons of fluid on the licensee's property. The incident was resolved when Waste Management Section staff arrived promptly at the scene, concluded that no fluids were released outside the tailings disposal area, and verified licensee clean-up of the spill.

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l APPENDIX F SEALED SOURCE AND DEVICE CASEWORK REVIEWS

~ NOTE: ALL SEALED SOURCE AND DEVICE CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM File No.: 1 Registry No.: WA-0296-D-105G SS&D Type: Gamma Gauge .

Manufacturec TAPIO Technologies, Inc. Model No.: AS 1H13 Date issued: 6/17/96 File No.: 2 Registry No.: WA 0296 D-106G SS&D Type: Beta Gauge Manuf acturer: TAPIO Technologies, Inc. Model No.: BW-2h55 and BW Sh23 Date issued: 11/30/96 File No.: 3 Registry Nc.: WA-0296-D-107-G SS&D Type: Beta Gaugo

' Manufacturer: TAPIO Technologies, Inc. Model No.: BW-K2h52 Date issued: 3/14/97 File No.: 4 Registry No.: WA 653 D-102-S SS&D Type: X Ray Fluorescence Manufacturer: C-Thru Technologies Corporation Model No.: MAP-3 Series Date issued: 1/20/99 Comments:

a) The registry sheet had only " Amended" and should have " AMENDED IN ITS ENTIRETY" as discussed in NUREG 1556, Volume 3.

b). i The electronic version of the sheet amendment did not have a " diagram"(it was blank),

and the original file ~ copy had a cut and paste diagram on the registry sheet. The State's file copy had the diagram.

c) The " Limitations and other considerations of use" section on the registry sheet had an old reference to the "SCITEC Corporation"instead of the new company name.

File No.: 5 Registry No.: WA-0653 D 106-8 SS&D Type: X-Ray Fluorescence Manufacturer: C-Thru Technologies Corporation Model No.: MAP-4 Series Date issued: 1/20/99 i

l i.... .. . . . . .

' l APPENDIX G WASHINGTON'S QUESTIONNAIRE RESPONSE l F

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w Approved by OMB' No. 3150-0183 Expires 5/31/2001 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Name of State: LWashington

!- Reporting Period: June 23,1995 through September 3,1999 DATA given is VALID as of June 23,1999 -

A.  : COMMON PERFORMANCE INDICATORS

- 1. Status of Materials insoection Procram

1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual l Chapter 2800. The list should include initial inspections that are overdue.

Insp. Frequency Licensee Name- (Years) Due Date Months O/D Cardiovascular Consult. 2- May 31, '99 1 month (initial)

2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire,-

All overdue inspections are noted and discussed at semi-monthly staff meetings.

The' overdue inspection noted, was being held for use as an inspector accompaniment opportunity; it is scheduled for the month of July.

3. Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 ~ and state the reason for the change.

Group - Nuclear Medicine - priority 2 (NRC is priority 3) per supervisor Group - R&D Labs - priority 3 (NRC is priority 5) per supervisor Estimatcd burden per response to comply with this voluntary collection request: 45 hours5.208333e-4 days <br />0.0125 hours <br />7.440476e-5 weeks <br />1.71225e-5 months <br />.

Forward comments regarding burden estimate to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to '

the Paperwork Reduction Project (3150-0183), Office ~of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number,

, NRC rnay not conduct or sponsor, and a person is not required to respond to, the information collection.

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Group - Portable Gauges - priority 4 (NRC is 5 ) per supervisor

[ Group - Fixed Gauges - priority 4 (NRC is 5) per supervisor l L  : Group - Blood irradiators - priority 4 (NRC is 5) per supervisor '

l _ Group - Gas Chromatographs - priority 5 (NRC is 7) per supervisor

. Washington State University - priority 1 (NRC is 2) Major broad scope Battelle Memorial Institute - priority 1 (NRC is 2) Major bread scope NeoRx Corp. - priority 1 (NRC is 2) Major broad scope i

Fred Hutchinson Cancer - priority 1 (NRC is 2) Major broad scope Interstate Nuclear Laundry - priority 1 (NRC is 2) Major laundry Genelex Corp. - priority 1 (NRC is 3) Major R&D, manufacturer Moravek Biochemicals - priority 1 (NRC is 3) Major manufacturer C-Thru Technologies - priority 1 (NRC is 3) Major manufacturer Acrowood Corp. - priority 1 (NRC is 3) Major manufacturer AlliedSignal Avionic - priority 1 (NRC is 5) Major manufacturer NW Hospital Gamma Knife - priority 1 (NRC is 3) New technology ATG (Yakima)- priority 1 (NRC is 3) pending D&D closeout Westem Fire & Safety - priority 1 (NRC is 5) escalated oversight l Eisenhart -- priority 4 (NRC is 3) installation, maintenance of fixed gauges Troxler Electronics - priority 4 (NRC is 3) training, sales demo of portable 4 gauges Hevley - priority 4 (NRC is 3) training, service of portable gauges .

Siemens Medical Systems - priority 4 (NRC is 3) sales demo, set-up & calibr.

These are our " official priorities". We have set an administrative goal of inspecting priority 2 licenses annually, and priorities 3 and 4 licenses every other year.

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There are no licensees in the Waste banagement Section that are inspected .

more or less frequently than required by the U.S. Nuclear Regulatory Commission. However, certain licensees in both the Materials Section and the Waste Management Section are inspected in "piecomeal" fashion. These include the LLRW facility, ATG, WSU and the University of Washington. Over the course of a year, the entire program is reviewed.

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-4. Please complete the following table for licensees granted reciprocity during the

reporting period.

Number of Licensees Granted Reciprocity Number of Licensees

. Priority Permits Each Year inspected Each Year 5

Service Licensees performing 6 99 0 teletherapy and irradiator source 1997 6 1997 2 installations or changes 1998 6 1998 3 1999 3 (TO DATE) 1999 2 (To DATE) 1995 4 1995 1 1996 3 1996 2 i

1997 2 1997 2 r

( Number of Licensees j Granted Reciprocity Number of Licensees Priority Permits Each Year Inspected Each Year 1998 3 1998 2 1999 1 (To DATE) 1999 2 (To DATE) 1995 1 1995 0 1996 1 1996 0 2

l 1997 0 1997 0 1998 0 1998 0 l 1999 0 (To DATE) 1999 0 (ToDATE) 1995 14 1995 0 3

1996 11 1996 0 1997 11 1997 0 1998 9 1998 ~ 2 l 1999 4 (To DATE) 1999 3 (To DATE) 18 9 0 4

1996 '21 1996 0 1997 22 1997 0 1998 24 1998 3 1999 13 (To DATE) 1999 0 (To DATE)

All Other NONE NONE l

5. Other than reciprocity licensees, how many field inspections of radiographers I were performed?

From January 1995 through May 1999,24 radiography field inspections of licensees were performed.

6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed.

Per sections B. Ill. 34 and B. IV. 35., the goal for inspections in the Waste Management Section is to complete all LLW and uranium millinspections once per year. This goal has been attained.

l ll. Technical Quality of Inspections l

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7. What, if any, changes were made to your written inspection procedures during e the reporting period?

ALL PROCEDURES ARE CURRENTLY IN THE PROCESS OF BEING REVIEWED AND UPDATED. Inspection checklists for the LLRW facility have been updated and are -

currently in use, inspection checklists for the Dawn uranium mill and the mine have been developed but are currently under revision due to the renewal of these licenses. An inspection checklist for ATG has been developed and is currently being revised. A procedure on Root Cause Analysis has been added and revisions are currently underway for Handling incidents and Allegations, Training, Confidentiality, and Escalated Enforcement..

! 8. Prepare a table showing the number and types of supervisory accompaniments made during the review period, include:

Insoector Supervisor License Cat. Qalt (Radioactive Materials Section)

DeMaris - Frazee. HDR 12/95 Waite Frazee Lab 12/95 Scroggs _ Frazee Lab .

12/95 McBaugh Frazee Academic Broad 12/95 Walsh -Frazee Port. gauge 12/95 Verellen Frazee Port gauge 12/95

. Walsh Frazee- Port. gauge 7/96 Eisen Frazee Port. gauge 12/96 Wainhouse Frazee Academic limited 12/96 (plus Eisen, Verellen, DeMaris by peer accompaniments in 1996)

Scroggs Frazee Radiography 3/97 Grumbles Frazee Port. gauge 11/97 Verellen _ ~ Frazee Radiography 12/97 DeMaris' Frazee _

Cardiology 12/97 (plus Scroggs, Walsh, and Wainhouse by peer accompaniment in 1997)

Busby Frazee Lab 3/98 Scroggs Frazee Port. gauge 4/98 Walsh Frazee Port. Gauge 12/98 Wainhouse . Frazee Lab close-out 12/98 (plus Verellen, DeMaris, Gumbles, and Eisen by peers in 1998)

'(Waste Management Section)

Fordham Robertson On-site LLRW duties 12/95

'Ahmad Robertson On-site LLRW duties 1/96 Eisen Robertson On-site LLRW duties 1/96 .

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i Fordham Eisen On-site LLRW duties 6/96 Blacklaw Robertson PE duties at DMC 2/97 Eisen . Robertson LLRW facility 5/97 Stoeffel Robertson Hydro duties DMC 5/97 Fordham Robertson LLRW facility 5/97 Blacklaw Robertson PE duties at DMC 3/98 ,

! ' Stoeffel ' - Robertson Hydro duties DMC 3/98 Fordham Robertson LLRW facility 6/98 Eisen Robertson LLRW facility 6/98 l Eisen Robertson LLRW facility 6/99

9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

i For the Ma'terials Section, staff needing accompaniment are asked to provide a list of upcoming inspections and the supervisor chooses a conveniently located and representative inspection. The supervisor accompanies the inspector and observes all aspects of the inspection. Notes are made during the ,

accom'paniment and the inspector is informed of any findings immediately '

following the inspection. A summary form is prepared and filed to document the accompaniment. These documents are available for NRC review in the office.

Fnr the Waste Management Section, draft procedures require that the supervisor or design.Zd ::..b,' ;ospector accompany each inspector at least once per year.

Senior inspectors are accompanied by the supervisor once every three years, The supervisor evaluates how well the inspector has prepared for the inspection, and debriefs with the inspector prior to closeout with management to make sure that the items of noncompliance are clear and correct. After the inspector prepares the Notice of Correction, the supervisor reviews the items of noncompliance with the inspector. The response letter as well as the inspection report is reviewed and the report is then closed out. The accompaniment is l documented on the inspector Field Evaluation form.

10. - 10. Describe _or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?

All field staff have available as their basic instruments ion chambers, GM meters and scintillators. Typical instruments, including multiple backup units of each, are Eberline's RO-2, Technical Associates'TBM 3s, and Ludium's Models 2 and 19 microR meters. Other brands and models are also represented in our panoply of instrumentation including portable MCAs, low energy scintillation probes, alpha meters and a neutron meter.

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[ All survey instruments for the Radioactive Materials Section are tracked in a database which includes the calibration due date, instruments in need of cal'bration are collected and delivered twice a month to the Northwest Radiation Instrument Calibration Facility at the University of Washington.' All instruments in use are currently in calibration.

Instruments in the Waste Management Section are sent directly to Ludlum for calibration. At the present time, three (3) instruments are at Ludlum for

, . calibration. Only one instrument is not in calibration. That instrument is the L Femto-Tech Radon detector.

! ' lli. Technical Staffino and Trainino

, '11. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the I agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas; administration, materials licensing & compliance, emergency response, LLW, U mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior '

personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

Name Position Area of Effort EIg%

(Materials)

L T. Frazee WMS2 Administration 100 %

C. DeMaris HP3 . Medical Lic/Compi 100 %

L. Wainhouse HP3 Lab LidCompi 100 %

A. Scroggs HP3 Indust. Lic/Compi 100 %

R. Verellen HP3 Investigations 100 % -

B. Busby HP2 inspections 100 %

P. Walsh ES2 Research/Lic/ Compt 50 %

A. Grumbles HP2 -

Inspections 30% -

M. Eisen HP3- Inspections 10%

J. Blacklaw EE3 SS&D PE 1%

t TOTAL 6.91 (Radwaste)

G. Robertson  : WMS2 Administration 50 %

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p M. Eisen HP3 Licensing /HP 75 %

p ' A. Thatcher HP3 Performance Assess. 95%

J. Ahmed HP2- - Licensing / Engr 45%

E. Fordham EE3 Compliance / Engr 50 %

M. Dunkelman 'HP2 ' Lic/ Compt / Geologist 50 %

J, Blacidaw EE3 Engineering 24 %

N. Darling ' Geohydr. EIS 45% l

~ D. Stoffel Geohydr. Lic/ Comp / Closure 25 J. Riley - _

Geochem. Performance Assess. 3% -

Others combined Environmental 10%

Others combined Laboratory .

50 %

U.S. DOE Performance Assess. 75%

TOTAL 6.97 )

l (Uranium Mills) -

G. Robertson WMS2 Administration 50 %

~ J. Ahmad HP2 Closure - 18%

M. Eisen .HP3 Compliance 15%

D. Stoffel Geohydr. Lic/ Comp / Closure 75 % .

J. Blacklaw EE3 Closure / Compliance 75% l E. Fordham EE3 Closure 20%

N. Darling Geohydr, Closure 5%

D. Wells Rl3 Performance Assess. 3%

J. Riley .

Geochem. Closure 2%

Others combined . Environmental 10%

Others combined Laboratory 50 %

TOTAL 3.23

12. Please provide a listing of all new professional personnel hired since the last - ,

review, inoicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

Bruce Busby -MS, Radiological Health; BS, Physics (emphasis in HP);

Radiological Supervisor training (1987), Naval Nuclear Power training (1982-1984); over 15 years experience in health physics and related fields; and has passed part 1 of CHP exam.

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Anine Grumbles - BA, Nutrition; Nuclear Power Plant HP,5 years NBC Officer, US Army Reserves,8 years; WA Division of Radiation Protection cmergency L response program,8 years.

. Nancy Darling - BS, Hydrology / Soils Science L

Doug Wells - Ph.D. Physics Drew Thatcher- MS Health Physics, C.H.P.

13. ~ Please list all professional staff who have not yet met the qualification -

. requirements of license reviewer / materials inspection staff (for NRC, inspection .

Manual. Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For

' each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

Bruce Busby - needs NRC's Nuclear Medicine course (scheduled for August

- 1999), Ucensing Practices and Procedures course (anticipated for FY 2000), and .

Tele / brachytherapy course (anticipated for FY 2000).

Anine Grumbles -- needs Liersing Practices and Procedures course (anticipated FY 2000), Industr

(anticipated for FY 2001). )

i In general, for the Radioactive Materials Section, the qualification requirements for license reviewer / materials inspector are: completion of NRC " core courses";

on-the-job training; and demonstrated ability over a series of different license l types for both licensing and inspection duties.

Since the Waste Management Section only has four licensees, it has been determined that there will be only two senior lead inspectors, who are required to meet the license reviewer / materials inspector criteria. All other staff provide technical assistance for the senior lead inspectors during team audits. The senior inspectors are Earl Fordham and Mike Eisen; both are fully trained. Other Waste Management staff receive training as feasible.

14. Please identify the technical staff who left the RCP/ Regional DNMS program during this period.

L Alex Waite, April 1997 8

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1 Sheila Pachemegg .

15. . List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of effo-ts to fill the vacancy.

There are no vacancies in the Materials Section.

l Although there is currently one vacant position listed in the organization che'1 for

the Waste Management Section, it is actually being filled by several intermittent staf (Doug Wells, John Riley, Brigid Walsh). .

IV. Technical Quality of Licensino A@ns -

16. Please ide' ntify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period. Also identify any new cr amended licenses that now require emergency plans.

Biocoll Laboratories - LO166-1; termination of large lab - 3/98 Biomembrane institute - LO124-1; termination of large lab -- 7/96 Boeing - 1005-1; renewal of broad scope licensee - 5/96 Bristol-Myers Squibb - LO98-1; renewal of large lab - 7/95 Bristol-Myers Squibb - LO98-1; termination of large lab - 1/98 Corixa Corp. - L0169-1; amend to add 125 mci in-111 for R&D - 9/95 '

Group Health - M021-1; renewal of rnajor medical facility -- 2/97 Hot Cell Services -- 10163-1; renewal of decon licensee -- 10/98 ICOS Corp - LO142-1; amend for second location, increased possession - 1/99 Inland Cancer care - LO184-1; new R&D, source manufacturer - 5/98 Inland Cancer Care - LO184-1; amend for new xenon process - 6/99 Interstate Nuclear Services - 10414-1; renewal of laundry -- 2/99 Moravek Biochemicals - LO183-1; new manufacturer, tagged compounds - 6/98 NeoRx Corp. - LO114-1; amend to add Ra-224 generator - 4/97 NeoRX Corp. - LO114-1; renewal of broad scope R&D - 4/99 Northwest Hospital-- M004-1; amend to add hoods for 1-131 use - 9/96

' Northwest Hospital - M004-1; amend to add Ra-223 for research - 3/98 Northwest Hospital Gamma Knife - M0201-1; renewal - 4/98 Pacific Nuclear - PN Services -10252-1; renewal of broad scope - 4/97 Panther Systems - 10401-1; renewal of device manufacturer - 9/97

. Providence Medical - Seattle - M045-1; renewal of major facility - 9/97 Qualls - LO161-1; renewal of field study licensee - 6/99 Siemens Power Corp. -- 1062-1; renewal of major facility - 4/98 University of Washington - C001-1; closeout primate research center - 4/97- .

. Washington State University- C003-1; field use study authorized - 8/98 9

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. Washington State University - C003-1; field use study authorized - 5/99 Weyerhaueser Technology Center - LO83-1; renewal of major facility - 5/99 Yang Laboratory - LO45-1; termination of in vitro test kit manufacturer - 6/96 Zymogenetics - LO101-1; renewal of large lab - 1/98 US Ecology, Inc.1019-2' Amendment # 24- October 6,1997- transfer of SNM license from USNRC to i WDOH.

' Dawn Mining Company, license # WN-1043-2 (uranium mill)

Amendment #22- January 29,1999- license renewal.

Amendment # 21- June 1,1998 - amended to include highway mitigation. for the transport of 11.e.(2) material.

Westem Nuclear, Inc.,1033-1 l' Amendment #31 - March 12,1998 - amended in entirety, deleted several

. unnecessary license conditions due to mill reclamation.

l_ Amendment #30 - December 18,1996 - amended to reduce environmental sampling requirements.

Allied Technology Group,10393-1 (waste processor / broker)

Amendment #5 - February 27,1998 - change in license expiration date, license -

activity increase, new RSO, change in authorized users, AROM, and operating procedures. Added return clause to license. Removed RTG portion.

Amendment #7 - December 28,1998 - increased site activity limits, changed RAM onsite time limit, authorized users and updated operating procedures list.

Added Emergency Plan and Safglas treatment.

Amendment #8 - May 24,1999 - increased levels for specific isotopes and lowered source materiallimits, updated AROM, administrative and operating procedures, delineated site storage area requirements, and added standard l LLRW disposal site license conditions.

17. Discuss any variances in licensing policies and procedures or exemptions from  !

the regulations granted during the review period. '

No variances or exemptions were granted by the Radioactive Materials Section.

LLW LICENSE VARIANCES REQUESTED 1995-1999 l ACTION . DATE REC'D COMPANY SUBJECT APPROVED 10 4

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I V-1-95 ~ 2/14/95- National Science solidification of biologicals Y Foundation V-2-95 ! 3/6/95 Supragen solidification of biologicals - Y L L V-3-95 5/22/95- Volvo GM use of supersacks for NARM Y

! V 4 6/1/95 . WPPSS engineered barriers for chelates Y V-5-95 6/12/95 USE Storage of waste > 6 months

.Y

. V-6-95 6/30/95  ; USE/ Ft. St. Vrain Storage of waste > 6 months Y 4V 96-01 6/11/96 USE- chelates in engineered barriers Y V-96-02: 8/12/96 USE Extend audit of vendor (Siemens) Y V-1-97 :1/22/97- ATG dispose oil >10% by weight Y V-2  ; 2/11/97 .ATG dispose of vials layered in sorbent Y V-6 97 '7/21/97 PGE: dispose of concrete blocks Y V-8 9/2/97 US Army - exempt source material for backfill N

. V-10-97. 9/30/97 _ US Armyi aircraft parts with no container Y

.. V-11-97 11/24/97 EMC' packaging biological waste N

V-6-98, 3/2/98 EMC absorbed / solidified Iqd. As DAW Y V-9-98 3/19/98 Pearl Harbor NS - disposal of solidified oil Y V-15 98 9/8/98 US Airforce aircraft parts with no container Y

' V-16-98 ' - 9/28/98 US Navy missile & aircraft parts Y '

V-17-98 10/8/98 PGE: concrete blocks with no container Y

' V-18-98 ' 10/15/98 Moravek Biochemical Class B& C with Aquaset N

V-20-98 12/1/98- Lockheed Martin aircraft & missile parts  ;

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1V-23 11/25/98- - Siemens SNM not uniformly distributed N'

V-2-99 4/9/99 USE. design of trench 12A Y License variances issued to ATG, Richland June '1995 to present l Date of Letter l' Subject l Approved: Y/N l 11/15/95 Allow increase in Pu onsite to 0.0228 grams Y 9/18/96 Add liquid to chemical form for store-for-decay material Y i 12/17/96- Increase Ra-226 activity limit to'225 mCl Y '

4/30/97 Processing schedule for eliminating waste backlog Y

'6/24/97 ' increase Ra-226 activity limit to 200 mCl Y

7/1/97 : Increase Ra-226 activity limit to 350 mci Y 1/6/98 increase Ra-226 activity limit to 350 mci Y

'1/22/98 Increase Zn-65 activity to.4 Cl . . Y 2/5/98- Increase Ra 226 activity limit to 350 mci Y 7/16/98 Increase C-14 activity limit to 10 Cl Y 11 7

m 9/30/98' Continuation of increased C-14 activity limit at 10 Cl Y 11/30/98; Increase in Zn-65, Fe-55, and Cs-137 activity limits Y 12/2/98.. _

increase in H-3, C-14, and total site activity limits Y 12/11,14/98_

(1) Increase in H-3, Ni-63, and total site activity limits & (2) high H-3 in (1) Y (2) N BPU U 12/31/98 Increase in Fe-55, Ni-63, Mn-54, and 2n-65_ activity limits Y

'1/13/99 Onsite storage for QCEP (out-of-state) material Y 2/299- Increase Fe-55 activity limit Y f 2/11,25/99 - (1) High H-3 in BPU and (2) increa'se H-3 activity limit (1) N (2) Y 3/22/99 j Consolidate MFP variances, reduce source material limits, extend - Y storage of high H-3 containing drums -

5/28, 6/3/99 increase overall site activity limits to 250.Cl and extend allowable Y onsite storage limit for 30 days . . .

.6/23-24/99 ' Extend storage time for early (Feb.) QCEP material Y

' 18. What, if any, changes were mad' e in your written licensing procedures (new

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procedures, updates, policy memoranda, etc.) during the reporting period?

The application forms for both the LLRW facility and the uranium mills have been revised to be specific to each type of licensee.

19. For NRC Regions, identify'by licensee name, license number and type, any -

renewal applications that have been pending for one year or more.

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V.- Resoonses to incidents and Alleastions 20.~ Please~ provide a list of the reportable incidents (i.e., medical misadministration.

' - overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-0178, Nuclear Material Events Database). The list should be in the following format:

Licensee Name License # Date of incident /Reoort Tvoe of Incident 12

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GeneralTesting Lab 10100-1 11/15/96 Gauge lost / recovered Agra Earth & Enviro LO93-1 5/21/96 Gauge crushed Kiewit Pacific 1069-2 8/20/96 Gauge crushed Deaconess Med Ctr M005-1 . 9/19/96 l-125 seeds lost Hong West 10176-1 11/18/96 Gauge damaged Shields Bag & Print R-0040 10/21/96 GL static bars lost Spokane County 1061-1 6/26/97 Gauge buried Geo Group NW 1366-1 7/3/97 Gauge crushed Multicare Med Ctr M017-1 11/12/97 Deceased; Pd-103 Krazan 10431-1 6/26/97 Gauge stolen /found No reportable incidents for the Waste Management Section

21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC7 For Regions, was an appropriate and timely PN generated?

Providence Medical Center reported an equipment problem with the Novoste Beta-Cath I

system. This was reported to NRC in early 1998 and became part of an NRC bulletin.

Deaconess Medical Center reported an AUR who used unapproved lubricant (September 1998); jammed HDR. Reported to NRC; appears in NMED.

Providence Medical Center, Seattle, reported HDR problem when new catheter used (December 1998); reported to NRC and appears in NMED.

Not applicable for the Waste Management Section.

-- 22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of

. possible generic design deficiency? Please provide details for each case.

The catheter mismatch was reported to Louisiana RCP which was already aware of the problem from other sources. A revised SS&D was issued shortly by Louisiana.

23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

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E-l The department received a complaint of wrongdoing, involving the improper transfer of l source material from a Washington State uranium mill company to a private citizen outside of Washington State. No evidence of wrongdoing could be substantiated. '

in April 1998, an employee claimed possible retaliation when safety concems were expressed. No evidence of wrongdoing could be substantiated.

24. Identify any changes to your procedures for handling allegations that occurred during the period of this review. EXISTING POLICY AND PROCEDURE WERE RECENTLY FORMALIZED IN WRITTEN FORM.
a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed. ALL HAVE BEEN CLOSED.

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I i

VI. General

25. Please prepare a summary of the status of the State's or Region's actions taken in response to

- the comments and recommendations following the last review.

.a. Effective date of radiography equipment rule should be January 1996 - no action l taken because health and safety benefits of changing the date from January 1,1998 did not justify the expense of rule making. The rule is now in effect and therefore a .I moot point. Item closed at time of 1998 Annual Meeting with the state.

b. Clarification of Allegation policy and procedures was recommended - This was discussed at the Washington Annual Meeting in 1998 and clo. sed at that time based l on our commitments. Since then we have updated and issued a procedure for l

handling allegations.

l c. Recommendations were made on documenting and tracking incidents - improved forms were designed and implemented; an electronic tracking system was developed; i and written procedures were developed recently.

d. Program management needs to be involved in all escalated enforcement or document

. why, if not involved - we objected to the prescriptive nature of this requirement, noting that we make such determinations on a case by case basis but did agree that better documentation of deviations from the general rule that management attend all '

such meetings is needed. The item was closed at the time of the 1998 Annual i Meeting.

e. Recommended revising a medical inspection form to include section on radiopharmaceutical therapy - this was done and this item was closed at the time of the 1998 Annual Meeting. l
f. Recommended a procedure and form be developed for HDR inspection - we have too few HDR licensees to warrant developing a separate form and will use the NRC procedure and form until the situation changes. Item closed at the Annual Meeting.

l_ g. Objection was raised to the use of a series of shorter inspection forms - the forms in question were discontinued and the item closed at the time of the Annual Meeting.

h. Revised form for the annual inspection of the LLW site was recommended - this was done and the item was closed at the time of the Annual Meeting.
l. Revised checklist for the uranium mill inspections was also recommended - this was also done and the item was closed at the time of the Annual Meeting.

L 15 I

r ]

l

10. .

[' Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

1 We believe 'our program is technically strong, with low staff tumover and a diversified staff which includes three certified health physicists, plus professional engineers, geologists, and hydrologists. We have an excellent state laboratory and funding is adequate and stable.

Our program weaknesses are in documentation of procedures and in keeping up with regulations changes required for compatibility.

B. NON-COMMON PERFORMANCEINDICATORS

1. Leaislation and Proaram Elements Reauired for Comoatibility J

l 11. Please list all currently effective legislation that affects the radiation control program (RCP). l RCW 70.98 Nuclear Energy and Radiation RCW 70.121 Mill Tailings, Licensing and Perpetual Care RCW 70.94 Washington Clean Air Act

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next -  !

, expiration date for your regulations. NO l 29.- Please complete the enclosed table based on NRC chronology of amendments. Identify those

- that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations. SEE TABLE

30. If you have not adopted all amendments within three years from the date of NRC rule l promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normallength of time anticipated to complete each step.

(For" EXCEPTION" RULES only):

l Obtain approval from Assistant Secretary to develop rule - three weeks l

Draft rule language, prepare required backup documents - four weeks Assistant Attorney General review, revisions -- three weeks Obtain Department approvals & file with Code Reviser - two to four weeks Publication of Proposed Rule in State Register - two weeks Public hearing follows publication by minimum of three weeks

, Review of public comments, revisions & final documents -- one to four weeks Adoption by Secretary & filing with Code Reviser - two to four weeks 1

f 16

- Effective Date of Rule is 31 days after filing - four weeks .

- (Minimum time required for an " easy" rule change is 6 to 8 months) ll. .. SagigsLSource and Device Proaram

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period. The table heading should be:

-SS&D Manufacturer, Type of Registry Distributor or Device Date Number Custom User or Source Issued WA-0296-D-.105-G Panther Systems NW Fixed gauge 6/17/96 WA-0296-D-106-G _ Panther Systems NW Fixed gauge 11/30/96 WA-0296-D-107-G Panther Systems NW Fixed gauge 3/14/97 WA-0653-D-106-B Scitec Corp. Port. analyzer 4/24/97 WA-0653-D-102 S Scitec Corp. Port, analyzer 4/24/97 WA-0653-D-106-B Scitec Corp. Port, analyzer 1/20/99 WA-0653-D-102-S Seitec Corp. Port analyzer 1/20/99

32. ' What guides, standards and procedures are used to evaluate registry applications?

Current NRC guides, standards and procedures are used.

33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:

Technical Staffing and Training - A.llt.11 See the section Technical Quality of Licensing Actions - A.IV.16 See the section Responses to incidents and Allegations - A.V.20 See the section

~

ill. Low-Level Waste ProararD
34. Please include information on the following questions in Section A, as they apply to the Low-

~ level Waste Program:

Status of Materials inspection Program - A.I.1-3, A.I.6 I Technical Quality of Inspections - A.ll.7 l Technical Staffing and Training - A.llt.11-15  ;

Technical Quality of Licensing Actions - A.IV.16-18 I Responses to incidents and Allegations - A.V.20 IV. Uranium Mill Prooram . ,

17 i i

35. -

. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:

Status of Materials inspection Program - A.'l.1-3, A.I.6 Technical Quality of inspections - A.ll.7-10 Techr.ical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.lV.16-18 Responses to incidents and Allegations - A.V.20-23 l

l l

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