ML20195H592

Integrated Matls Performance Program Review of Oregon Agreement State Program, 980810-13

ML20195H592
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Issue date:	10/28/1998
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lNTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF OREGON AGREEMENT STATE PROGRAM August 10-13,1998 FINAL REPORT U.S. Nuclear Regulatory Commission l

9811240047 981028

.PDR STPRO ESGOR PDR l

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Oregon Final Report Page 1 l

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1.0 INTRODUCTION

1 This report presents the results of the review of the Oregon radiation control program. The j

review was conducted during the period August 10-13,1998 by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of California. 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 Recister on October 16,1997, and the November 25,1997, revised NRC Management Directive S.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary l

results of the review, which covered the period July 11,1996 to August 13,1998, were discussed with Oregon management on August 13,1998.

A draft of this report was issued to Oregon for factual comment on September 16,1998. The State responded in a letter dated September 30,1998 (Attachment 1). The Oregon's factual comments were considered by the team and accommodated in the report. The Management Review Board (MRB) met on October 13,1998 to consider the proposed final report. The MRB found the Oregon radiation control program was adequate to protect public health and safety and compatible with NRC's program.

The Oregon Agreement State program is administered by the Radiation Protection Service (RPS)in the State Health Division of the Department of Human Resources. Organization charts for the Department of Human Resources are included as Appendix B.

At the time of the review, the Oregon RPS regulated 352 specific licenses, including limited and l

broad scope medical institutions, academic institutions, industrial radiography, fixed and portable gauge units, and nuclear pharmacy licensees.

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

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In preparation for the review, a questionnaire addressing the common and non common performance indicators was sent to the State on June 4,1998. The State provided a response to the questionnaire on June 26,1998. During the review, discussions with State staff resulted in the responses being further developed. A copy of their final response is included in Appendix l

F to the draft report.

l The review team's general approach for conduct of this review consisted of: (1) examination of l

Oregon's response to the questionnaire; (2) review of applicable Oregon statutes and l

regulations; (3) analysis of quantitative information from the RPS licensing and inspection data l

base; (4) technical review of selected licensing and inspection actions; (5) field accompaniments of two RPS inspectors; 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 RPS performance.

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Section 2 below identifies that there were no recommendations resulting from the follow-up

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review conducted in 1996. The previous full program review conducted in 1995 found the l

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I Oregon Final Report Page 2 Oregon program compatible, but withheld a finding of adequacy. The 1996 follow-up review closed all of the recommendations from the 1995 review, noted a delay in adoption of regulations, and found the Oregon program adequate. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 dircusses results of the applicable non-common performance indicator, and Section 5 summarizes the review team's findings, recommendations, and suggestions. The review team identified two good practices in the RPS. Recommendations made by the review team are comments that relate directly to program performance by the State. A response is requested from the State to all recommendations in the final report. Suggestions are comments that the review team believes could enhance the State's RPS. The State is requested to consider suggestions, but no response is requested.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous follow up review, which concluded on July 11,1996, no recommendations were made although one open item, concerning delays in rulemaking activities, was noted in the report. This open item is discussed further in section 4.1.

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 Proaram l

The review team focused on four factors in reviewing this indicator: (1) inspection frequency, l

(2) overdue inspections of licenses, (3) initial inspections of new licenses, and (4) timely dispatch of inspection findings to the licensee and corrective action. The review team's l

evaluation is based on Oregon's questionnaire responses relative to thi9 indicator, data gathered independently from the State's licensing and inspection data tracking system, the examination of completed inspection casework, and interviews with the RPS manager, the Radioactive Material Program (RMP) manager, and inspection and licensing staff.

l The State's inspection frequencies are compatible with NRC program codes and inspection priorities. They are the same as NRC's, with the exception that portable gauge licenses are inspected more frequently than NRC,4 years versus 5 years by NRC.

In their response to the questionnaire, Oregon indicated that as of June 26,1998 no licensees, i

which were identified as requiring core inspections in IMC 2800, were overdue. Throughout the review period, less than 10 percent of the number of core licensees were inspected at frequencies exceeding the intervals in IMC 2800 by more than 25 percent, The RPS policy, which adopts the guidance in IMC 2800, Section 04.03a, states that new i

l licenses are inspected within six months of issuance of the license. The RPS does not normally extend the 6 month period in cases where the licensee does not receive material or initiate i

licensed activities. There were 43 initial inspections of in-state licensees due during the review

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period. Of those due,24 (55%) were not inspected within the 6 month requirement. The team t=-

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Oregon Final Report Page 3 l

noted that 41 of the initial inspections were completed within 7 months and the remaining 2 l

Inspections were completed within 8 months. The team recommends that Oregon continue to implement its policy for inspecting new licenses.

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The RMP manager indicated that the RPS accelerated the inspection workload and eliminated j

the entire backlog by the end of July 1998. The accelerated workload resulted in 19 inspections being completed in June 1998 and 15 completed in July 1998. The team verified from the records that as of August 13,1998 there were 352 active licenses and all inspections were current.

An internally generated monthly report to management tracks inspections that are completed and overdue. All licenses are entered into the RPS database and printouts allow an easy determination of the status of inspections at a given time period.

Reciprocity licensees are handled in the following manner:

1.

Out-of state licensees that frequently perform work in Oregon are provided the option of requesting an Oregon State license. When the license is issued they are listed in the database under their home state address. The company is not required to have an address in Oregon and the license application process simply consists of a review of their home State or NRC license. Each license includes a special condition that requires notification to the RPS before the licensee enters the State to do work using licensed material. Six months after the out-of-state license is issued, the licensee is mailed an " inspection by mail" form which is mailed back to the RPS and is considered an initial inspection.

When the licensee notifies RPS that they are entering the State to do work, the RPS inspects them in the field if possible. The license is renewed annually by payment of a fee.

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Out-of-state licensees that infrequently perform work in Oregon may choose not I

to apply for an Oregon State license. In these cases, the licensees are identified in the RPS database using license numbers that are coded to indicate that reciprocity is granted on each occasion work is to be performed in Oregon.

When the licensee notifies RPS that they are entering the State to do work, the RPS inspects them in the field if possible. Seven of these licenses were listed on the August 1998 printout.

Two of the ten inspection reports of out-of-state licensees that were reviewed were inspected by mail. All others had an onsite inspection completed following their notification that they were entering the State to do work using sources. The State met the inspection percentage goals for conducting inspections of reciprocity licensees as outlined in Appendix 111 of NRC Inspection Manual Chapter 1220 (IMC 1220).

The review team did not consider the " inspection by mail" a valid inspection because the form only asks the make and model of devices used by the licensee and the names of their operators. The review team suggests that the RPS consider using another term such as

" status report" rather than call the " inspection by mail" process for out-of-state licenses an inspection.

Oregon Final Report Page 4 in 1984, the RPS instituted a program that tracks registered general license (GL) devices (i.e.,

gamma gauges and in-vitro test kits). Although other States track such devices, Oregon's implementation practices of the program are unique. In addition to requiring accountability of the devices, the State will also perform onsite inspections and request additional information (e.g., leak test results) from the general licensee. The program for registering these GL devices has been recognized by NRC which is considering adoption of a similar program nationwide. The review team recommends that the Management Review Board recognize Oregon's GL device tracking program as a good practice.

The RPS uses Safety inspection Form 591 for inspections to report the findings to the licensee l

at the conclusion of the inspection. The inspector indicates any violations found on the form 1

and the licensee signs it acknowledging receipt and understanding of the nature of any violations. The form requires posting by the licensee. If an inspector is not certain of a finding, l

he will return to the RPS and discuss the matter with the RMP manager, in these cases, the i

licensee will be sent a letter outlining the violations and requiring a written response. The letter requires posting by the licensee. The issuance of inspection findings is timely with letters to the licensee being sent within two weeks of the inspection.

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

The team notes that one finding from the 1995 full program evaluation was the development of a significant number of overdue inspections. However, at the time of the 1996 follow-up review visit, all overdue inspections had been eliminated.

3.2 Technical Quality of Insoections The team reviewed inspection reports, enforcement documentation, inspection field notes, and l'terviewed inspectors for 16 materials inspections conducted during the review period. The riaework included all of the State's materials inspectors, including the RMP manager, and covered: medical (5), medical (HDR) (1), mobile medical (1), industrial broad scope (1),

portable gauge (4), radiography (2), academic broad scope A (1), and pharmacy (1) inspections. A review team member performed accompaniments of two State inspectors on three separate inspections of licensed facilities. Appendix C lists the completed inspections reviewed with case-specific comments as well as the results of the accompaniments.

Inspection findings appear to lead to appropriate regulatory action. Although the RPS does not have administrative penalties, they can pursue penalties through the Attorney General's office.

The RPS also uses Office Hearings to achieve escalated enforcement. One escalated enforcement case that used an Office Hearing was reviewed. The licensee had several serious violations on their initial inspection and eventually requested termination of their license due to increased enforcement activities of the RPS. The review team noted that the participation of the RPS manager in the Office Hearing was not documented. The review team suggests that all attendees, including senior managers, be documented in future enforcement activities i

involving meetings or hearings with licensees.

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Oregon Final Report Page 5 All enforcement letters reviewed were written in the appropriate regulatory language and directed the licensee to post the enforcement letter as the State does not use a Notice of l

Violation form. Follow up to enforcement letters was evident and complete. All enforcement cases were resolved promptly.

There were 229 inspections performed during the review period. Through 1998 to date,89 inspections have been completed. The RPS uses NRC inspection guides and checklists. The team reviewed the inspection field notes and, with the exceptions noted below and in Appendix l

C, found them to be comparable with the types of information and data collected under NRC 1

Inspection Procedure (IP) 87100 and thorough with allitems checked and written comments where necessary. The inspection field notes provided documentation of the licensee's program including: posting; storage and use of radioactive material; receipt, transfer, and disposal of l

radioactive material; inventory; leak tests; radiation protection program; personnel monitoring; l

training; independent measurements; and inspection findings. The review team also noted the inspectors observed licensed operations or had operations demonstrated whenever possible.

The review team noted that the inspector used NRC's checklist for Nuclear Medicine operations to perform a high dose rate (HDR) inspection. It was also noted that the inspection reports did not use the most recent version of NRC checklists and, therefore, there was no section to document the scope of the operation. The review team suggests that the RPS obtain and use the HDR inspection checklist and the latest version of inspection checklists found in IMC 87100.

l The RPS management policy is to conduct unannounced inspections whenever possible.

l Announced inspections usually involve initial inspections or inspections at licensees in l

geographically-distant locations from Portland. Inspection repcrts were signed by management. The RMP manager was aware of inspection findings through de briefing by the inspector. In response to the questionnaire and through discussions with the RMP manager, the State reported the number and type of supervisory accompaniments performed during the I

review period. Allinspectors were accompanied annually. The RPS manager accompanied the RMP manager during various licensee management meetings throughout the review period.

The RPS use: a rating system to score the licensee after an inspection. A low score can lead to the shortening of the inspection frequency down to 75% of the actual due date or, if the score is extremely low, then the licensee is subject to escalated enforcement or a follow up review within 6 months.

The RPS employs a unique method for educating the licensee of Oregon's regulations as they i

pertain to the licensees' operation. At the conclusion of each inspection, the inspector provides a checklist to the licensee that specifies Oregon's administrative rule requirements applicable to the licensee. The licensee can use this checklist to facilitate the annual review of their radiation safety program. Additionally, the inspectors routinely utilize a form to document their " vertical slice" approach to their inspections where several types of radioactive sources are tracked from their receipt on through to disposal. The review team recommends that use of the checklist and the form and the resulting discussions with licensees during the inspection, be recognized as a good practice by the Management Review Board.

The RPS has an adequate supply of survey instruments to support the inspection program.

3 Each inspector and the supervisor have a kit with Ludlum meters and probes to monitor all isotopes. All survey equipment is calibrated annually by Oregon State University under a calibration license issued by Oregon. In addition, the RPS operates a small laboratory to count

4 Oregon Final Report Page 6 calibration license issued by Oregon. In addition, the RPS operates a small laboratory to count wipes and analyze samples obtained during inspections, follow-up actions, or licensing terminations. The laboratory participates in the routine Environmental Protection Agency (EPA) - Environmental Monitoring and Safety Laboratory (EMSL) cross-check program and is used routinely by inspectors taking wipe samples. Gamma spectroscopy quality assurance j

(QA)/ quality control (OC) appears adequate with routine use of a National Institute for Standards and Technology (NIST)-traceable mixed gamma standard. The RPS has a liquid scintillation counter and germanium detector system for gamma spectroscopy and a portable multichannel analyzer. Samples are also sent out to contract labs for analysis as necessary.

Two inspectors were accompanied by a review team member during the period of June 23-24, 1998. One inspector was accompanied during an unannounced inspection of an institutional nuclear medicine facility with brachytherapy on June 23,1998. The other inspector was accompanied on June 24,1998 during unannounced inspections of a research and development facility using americium-241, and another facility that manufactures lodine-125 test kits. These accompaniments are listed in Appendix C.

During the accompaniments, the State inspectors demonstrated appropriate inspection techniques and knowledge of the regulations. The inspectors were equipped with, and used, appropriate and calibrated survey and safety equipment. The inspectors were well prepared and thorough in their reviews of the licensees' radiation safety programs. Overall, the technical performance of the inspectors was excellent, and their inspections were adequate to assess radiological health and safety at the licensed facilities.

Based on the IMPEP evaluation criteria, the review team recommends that Oregon's 4

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

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

At the time of the review, Oregon's radioactive materials program was staffed by the RPS manager, RMP manager, three full time technical staff, and one full time administrative staff l

member. All staff have been with the RPS for the entire review period. One staff member each from the Electronics Products Program and the Emergency Response Program also provide partial support in rulemaking and event response activities, respectively. In general, the team found that the current staffing level is adequate, except the team noted that there was minimal i

staff time devoted to rulemaking efforts due to licensing and inspection needs. The State also identified this area as a weakness in the IMPEP questionnaire. Given the status of rulemaking actions as discussed in Section 4.1.2, the review team recommends that the RPS management assess whether additional staffing is warranted to complete overdue rulemaking actions and to ensure timely completion of upcoming rulemaking actions.

Oregon Final Report Page 7 Based on the response to the IMPEP questionnaire and discussions with the RPS and RMP managers, the review team noted that during the review period one technical staff member retired from the radioactive materials program in March 1998. This vacancy was recently filled by an individual who is expected to receive a Master's Degree in Health Physics in December 1998. The review team also noted that the individual exceeds the minimum requirements for the position.

There are currently no vacancies in the radioactive materials program, however, the team was advised that the RMP manager will retire in December 1998. The RPS manager stated that he intends to fill the upcoming vacancy by making a nationwide announcement. Discussions with staff indicate that a significant loss of program history and knowledge of current procedural practices will be experienced. The review team suggests timely filling of the impending RMP manager vacancy with a well qualified individual and that revisions to written procedures to reflect current operations continue to be developed.

A written and RPS management approved training policy implements the guidelines in the October 1997 NRC/OAS Training Working Group Recommendations for Agreement State Training Programs. The RPS manager requires each staff member to successfully complete the basic courses identified for materials inspectors and license reviewers. Waivers from specific courses may be granted, at the manager's discretion, for individuals with extensive i

work experience and education in a specific topic area. The RPS manager indicated that funding for basic training is available. A review of Oregon's training records and interviews with the staff identified two staff members, a member of the technical staff and an administrative assistant who performs licensing assistant duties, that should attend the Licensing Practices l

and Procedures course or its equivalent to fully address their training needs. The technical j

staff member is currently registered for the September 1998 presentation of the course. The review team suggests that the administrative assistant attend the Licensing Practices and Procedures course or its equivalent to enhance effectiveness in performance of licensing assistant duties.

The review team also noted that the do. mentation of staff training is not up to date and does not have management sign-off when a course is completed or waived for an individual. The review team suggests that the RPS training form be updated to reflect the completion of the i

Teletherapy and Brachytherapy course by an inspech staff member and that the training form be modified to allow for management dgn-off of completed and waived courses.

In discussions with the RPS, the team found that there are no radiation oversight boards and, therefore, the team determined that there is no potential for conflict of interest issues.

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

3.4 Technical Quality of Licensina Actions The review team interviewed the RMP manager, evaluated the licensing process, and examined licensing casework for 32 specific licenses. Licensing actions were reviewed for completeness, consistency, proper radioisotopes and quantities authorized, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures

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Oregon Final Report Page 8 sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and its conditions, and overall technical quality. The casework was reviewed for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history on renewals, pre-licensing visits, supervisory review as indicated, and proper signature authorities. The files were checked for retention of necessary documents and supporting data including terminated licenses.

The licensing casework was selected to provide a representative sample of licensing actions j

which had been completed during the review period and included all amendments to the selected casework since the previous review. The cross-section sampling focused on the State's core licenses in priorities 1,2, and 3; new licenses issued; renewals; and licenses terminated during the review period. The sample included the following licensing types:

broadscope academic; broadscope medical; research and development; source material; industrial radiography; portable gauges, institutional nuclear medicine; private clinics, mobile l

nuclear medicine; therapy; and nuclear pharmacy. Licensing actions reviewed included 3 new, 7 renewals,38 amendments, and 4 terminations. A listing of the casework licenses with case specific comments can be found in Appendix D.

l Licenses are renewed on a 5 year frequency. Licenses that are under timely renewal are amended as necessary to assure that public health and safety issues are addressed during the period that the license is undergoing the renewal process. Each licensing action receives an initial review by one individual, then a second technical review by a senior health physicist. All licenses are signed by the RPS manager or his designee.

l The review team found that the licensing actions were generally very thorough, complete, of l

high quality, and with health and safety issues properly addressed. The licensee's compliance l

history is taken into account when reviewing renewal applications and amendments as determined from documentation in the license files and discussions with the license reviewers and inspectors. Some comments were made on files as identified in Appendix D. Following the team's discussion of these comments, the RMP manager initiated actions to resolve the comments. The review team suggests that the comments in Appendix D be reviewed for l

actions as appropriate.

The casework review also confirmed that, with one exception, the materials staff follows the State's licensing guides which have been patterned after the NRC guides. The State has one l

license for a HDR brachytherapy device (Appendix D, casework number 11), in which two license conditions do not contain the same information as similar conditions utilized as standard practice by NRC and other Agreement States. A copy of a model NRC license with standard practice license conditions for an HDR unit was provided to the State during the review. The review team recommends that the State adopt the NRC standard practice license conditions for HDR units for the casework #11 license and future HDR licenses.

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All licensing actions were signed by management. Deficiencies are addressed by letters and documented telephone inquiries which use appropriate regulatory l::nguage.

The State provided a listing of 58 licenses that have been terminated since the last review. A J

review of termination actions over the period showed that most of the terminations were for licensees possessing only sealed sources and/or for uses of radiopharmaceuticals with short i

f Oregon Final Report Page 9 half lives. Four termination files were selected for review based upon the potential for residual-contamination, and to confirm the State's termination procedures. The review team found that terminated licensing actions were well documented, showing appropriate transfer records or appropriate disposal methods and records, confirmatory surveys, and survey records.

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

- 3.5 Resoonse to incidents and Alleaations In evaluating the effectiveness of the State's actions in responding to incidents, the review team examined the State's response to the questionnaire regarding this indicator, reviewed selected incidents reported for Oregon in the " Nuclear Material Events Database" (NMED) against those contained in the Oregon files, and reviewed the casework and supporting documentation for 11 material incidents and 10 allegations. There were no medical related events during the review period that met the definition of a misadministration. A list of selected incident files examined along with case specific comments is contained in Appendix E.

The review team interviewed the RPS Manager, the RMP manager, and the individual responsible for Emergency Response tracking. The subject areas discussed with staff included the State's incident and allegation process, tracking system, file documentation, Freedom of Information Act, NMED, and notification of incidents to the NRC Emergency Operations Center.

The staff was familiar with NRC's " Handbook on Nuclear Event Reporting in the Agreement States" and Procedure Number: SA-300, " Reporting Material Events," dated February 1998.

Reports have been submitted appropriately for NMED entry. The review team noted to management the Commission's position that, under the Policy Statement on Adequacy and Compatibility of Agreement State Programs, it is mandatory for Agreement States to report events to the NRC.

i The State has consistently reported incidents, that require immed ate or 24-hour reporting by the State licensee, to the NRC Operationa Center. However, there were multiple written policies and procedures for incident response dated from 1984 to the present within the State's policy and procedure manual. The review team suggests that the policies and procedures for responding to incidents be consolidated into one policy or procedure.

When notification of an incident or an allegation is received, the individual receiving the report sends an electronic message to the staff providing information of the incident or allegation. The

- RMP manager usually directs the initial response and evaluates the need for an on-site investigation. An Incident Report Checklist and Summary form is used to document and track the staff's response to an incident or allegation.

The review team found that the State's actions were appropriate. Initial responses were prompt and well-coordinated, and the level of effort was commensurate with the health and safety significance. Insoedors were dispatched for onsite investigations in 7 of the 11 incidents reviewed. Of those 7 onsite investigations,6 were conducted on the same day of the notification, and 1 was conducted within 2 days of the notification. When appropriate, the State took suitable enforcement action that required corrective measures by the licensee.

f Oregon Final Repor1 Page 10 During the review period, there were 2 allegations referred to the State by NRC and there were 11 allegations that the State handled directly. The State promptly contacts the alleger, conducts an inspection when appropriate, and informs the alleger of the outcome of the investigation. Although the State's responses to allegations were satisfactory, the review team found that the State had no written policy or procedures for responding to allegations. The RPS advises allegers that they can provide reasonable assurance that any information they provide will be kept confidential but are not able to guarantee confidentiality unless all of the five criteria specified in State statute 192.502(4) are met. The review team recommends that the State develop a written policy with procedures for responding to allegations.

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

4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed l

Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Oregon recently turned back the sealed source and device evaluation program portion of their Agreement and Oregon's Agreement does not include uranium recovery program authority.

4.1 Leaislation and Proaram Elements Reauired for Comoatibility 4.1.1 Leaislation i

Along with their response to the questionnaire, the State provided the review team with the opportunity to review copies of legislation that affects the radiation control program. The currently effective statutory authority for the RPS is contained in Oregon Statua 453.625. The Radiation Protection Service is designated as the State's radiation control ager Oy. The review team noted that no legislation affecting the radiation control program was passed during the review period.

4.1.2 Proaram Elements Reauired for Comoatibility The Oregon Regulations for Control of Radiation, found in Oregon Administrative Rules 453.605-453.755, apply to all ionizing radiation, whether emitted from radionuclides or devices.

Oregon requires a license for possession and use of all radioactive material including naturally occurring materials, such as radium, and accelerator-produced radionuclides. Oregon also requires registration of all equipment designed to produce x-rays or other ionizing radiation.

The review team examined the State's administrative rulemaking process and found that the process takes up to six months after filing the draft administrative rule with the Secretary of State.. Prior to filing with the Secretary of State, the draft administrative rule is reviewed by management and legal counsel (for fiscal impact issues) within the Department of Human Resources Office of the Administrator. When an acceptable draft proposed revision to a rule has been prepared, it is sent to the Secretary of State, all potentially impacted licensees and registrants, and the NRC for comment. The Secretary of State announces a public

Oregon Final Report Page 11 comment / hearing period for the proposed revision to the rule. After responding to comments, the RPS forwards the proposed revision to the rule with the addressed comments to the Office of the Administrator for final approval. Comments are considered and incorporated as

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appropriate before the regulations are finalized. The State has the authority to issue legally i

binding requirements (e.g., license conditions) in lieu of regulations until compatible regulations become effective.

l The team evaluated Oregon's responses to the questionnaire and reviewed the status of l

regulations required to be adopted by the State during the review period. No regulations were adopted by the State during the review period. The review team noted that Oregon prepared initial drafts of the NRC regulation amendments required to be adopted, however, they have not l

been finalized and, therefore, they have not been adopted. As stated in Section 3.3, the State identified this area as a weakness. Discussions with management indicate that they believe the requirements in the revised NRC regulations are covered by license conditions and/or through incorporation by reference in their current administrative rules. No legal position has been made to this effect. The review team recommends that management obtain a State legal view on their interpretation that existing administrative rules require the implementation of all new requirements in the revised NRC regulations where required for compatibility purposes.

The State has not adopted the following regulations; however, they anticipated adoption by late 1999.

" Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 amendment e

(58 FR 7715) that became effective July 1,1993.

" Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for e

Medical Use," 10 CFR Parts 30,32, and 35 amendments (59 FR 61767 and 65243) that became effective January 1,1995.

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" Frequency of Medical Exan$1 nations for Use of Respiratory Protection Equipment," 10 CFR Part 20 amendment (60 FR 7900) that became effective March 13,1995.

" Low Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 e

amendments (60 FR 15649 and 25983) that became effective March 1,1998. The l

Agreement States are to promulgate their regulations no later than March 1,1998 so that i

NRC and the State would require this national system to be effective at the same time, i

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

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• ' Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 l

amendments (60 FR 38235) that became effective November 24,1995, e " Compatibility with the Intemational Atomic Energy Agency," 10 CFR Part 71 amendment j

(60 FR 50248) that became effect!ve April 1,1996.

l e " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 l

amendments (60 FR 48623) that became effective October 20,1995.

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Oregon Final Report Page 12

" Termination or Transfer of Licensed Activities: Record Keeping Requirements," 10 CFR e

Parts 20,30,40,61,70 amendments (61 FR 24669) that became effective June 17,1996,

" Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air e

Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.

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

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

" Licenses for industrial Radiography and Radiation Safety Requirements for Industrial e

l Radiography Operations," 10 CFR Parts 30,34,71,150 amendments (62 FR 28947) that became effective June 27,1997.

e " Radiological Criteria for License Termination," 10 CFR Parts 20,30,40,70 amendments (62 FR 39057) that became effective August 20,1997.

The State indicated they anticipate adoption of the overdue regulations and the regulations which require adoption through 2000, by late 1999. A recommendation that Oregon examine the rule procedures and adopt compatible regulations within the 3 year time frame was made during the' July 29,1995 full review. A delay in regulation adoption was also noted during the l

July 11,1996 follow up review. The review team recommends that RPS management evaluaterulemaking activities to ensure that NRC rule changes are adopted within the specified 3 year time period.

1

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

Based on the IMPEP evaluation criteria, the review team recommends that Oregon's performance with respect to the Indicator, Legislation and Program Elements Required for 1

Compatibility, be found satisfactory.

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4.2 Sealed Source and Device (SS&D) Evaluation Prooram l

In April of 1998, the Commission approved the tumback of the SS&D Program to NRC. There were two sealed source device actions completed by the State during the review period. One action involved the administrative reactivation of a terminated registry that formerly was registered by NRC, and the other action was a custom evaluation that is authorized for use only in the State of Oregon. The State has discussed these actions with NMSS and committed to forwarding these files to NRC at the conclusion of the review. The associated licensing actions 1

were reviewed under the Technical Quality of Licensing Actions (Common Indicator 3.4).

Therefore, this indicator was not reviewed.

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Oregon Final Report Page 13 4.3 Low-Level Radioactive Waste (LLW) Discosal Proaram In 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to allow a State to seek an amendment for the regulation of LLRW as a separate category. Those l

States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although Oregon has LLRW disposal l

authority, NRC has not required States to have a program for licensing a LLRW disposal facility l

until such time as the State has been designated as a host State for a LLRW disposal facility.

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

5.0

SUMMARY

i As noted in Sections 3 and 4 above, the review team found Oregon's performance for the common and non-common performance indicators to be satisfactory. Accordingly, the review l

team recommended and the MRB concurred in finding the Oregon Agreement State Program to be adequate to protect public health and safety and compatible with NRC's program.

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

RECOMMENDATIONS:

1. The team recommends that Oregon continue to implement its policy for inspecting new licences (Section 3.1).

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2. The review team recommends that the RPS management assess whether additional j

staffing is warranted to complete overdue rulemaking actions and to ensure timely l

completion of upcoming rulemaking actions (Section 3.3).

3. The review team recommends that the State adopt the NRC standard practice license conditions for HDR units for the casework #11 license and future HDR licenses (Section 3.4),

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4. The review team recommends that the State develop a written policy with procedures for responding to allegations (Section 3.5).

5. The review team recommends that management obtain a State legal view on their interpretation that existing administrative rules require the implementation of all new requirements in the revised NRC regulations where required for compatibility purposes (Section 4.1.2).

6. The review team recommends that RPS management initiate rulemaking activities to ensure

[

that NRC rule changes are adopted within the specified 3 year time period (Section 4.1.2).

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Oregon Final Report Page 14 SUGGESTIONS:

1. The review team suggests that the RPS consider using another term such as " status report" rather than call the " inspection by mail

• process for out-of-state licenses an inspection (Section 3.1).

2. The review team suggests that all attendees, including senior managers, be documented in future enforcement activities involving meetings or hearings with licensees (Section 3.2).

3. The review team suggests that the RPS obtain and use the HDR inspection checklist and the latest version of inspection checklists found in IMC 87100 (Section 3.2).

4. The review team suggests timely filling of the impending RMP manager vacancy with a well qualified individual and that revisions to written procedures to reflect current operations continue to be developed (Section 3.3).

5. The review team suggests that the administrative assistant attend the Licensing Practices and Procedures course or its equivalent to enhance effectiveness in performance of licensing assistant duties.

6. The review team suggests the RPS training form be updated to reflect the completion of the Teletherapy and Brachytherapy course by an inspection staff member and that the training form be modified to allow for management sign-off of completed and waived courses (Section 3.3).

7. The review team suggests that the comments on Appendix D be reviewed for actions as appropriate (Section 3.4).

8. The review team suggests that policies and procedures for responding to incidents be consolidated into one policy or procedure (Section 3.5).

GOOD PRACTICES:

1. In 1984, the RPS instituted a program that tracks registered generallicense (GL) devices (i.e., gamma gauges and in-vitro test kits). Although other States track such devices, Oregon's implementation practices of the program are unique. In addition to requiring accountability of the devices, the State will also perform onsite inspections and request additionalinforrnation (e.g., leak test results) from the generallicensee. The program for registering these GL devices has been recognized by NRC which is considering adoption of a similar system nationwide. The review team recommends that the Management Review Board recognize Oregon's GL device tracking program as a good practice (Section 3.1).

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2. The RPS employs a unique method for educating the licensee of Oregon's regulations as they pertain to the licensees' operation. At the conclusion of the inspection, the inspector provides a checklist to the licensee that specifies the Oregon's administrative rule requirements applicable to the licensee. The licensee can use this checklist to facilitate the annual review of their radiation safety program. Additionally, the inspectors routinely utilize a form to document their " vertical slice" approach to their inspections where several types of radioactive sources are tracked from their receipt on through to disposal. The review team

=, - -. - -

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Oregon Final Report Page 15

. recommends that use of the checklist and the form, and the resulting discussions with licensees during the inspection be recognized as a good practice by the Management Review Board (Section 3.2).

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U' LIST OF APPENDICES AND ATTACHMENTS Appendix A iMPEP Review Team Members Appendix B Oregon Organization Charts Appendix C.

Inspection Casework Reviews Appendix D License Casework Reviews Appendix E incident Casework Reviews State's Response to Proposed Final Report Dated September 30,1998 i

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APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Tom O'Brien, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility i

Donald Bunn, California Status of Materials Inspection Program Technical Quality of Inspections Sally Merchant, NMSS Response to Incidents and Allegations Richard Woodruff, Region il Technical Quality of Licensing Actions t

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l APPENDIX B I

State of Oregon i

DEPARTMENT OF HUMAN RESOURCES l

OREGON HEALTH DIVISION RADIATION PROTECTION SERVICES ORGANIZATION CHARTS I

t i

4 Department of Human Resources N

Jean L Thome Acting Disector I

Bob Mink Deputy Director I

DIVISIONS OWice of the Director (Assistant PROCRAM OfTICES Directors)

(Assistant Directors)

Steve Minnsch Kay Toran t

~

Adult & Family Children's Servkes Services Division Division Hersh Crawford I

ushner g,f&i Ln'a2 "as" S.,Ahe, i

Division Services Division Chad Cheriel IhutiTerwn Orac.or VoTunteer loit Sou,thwen i

N*le NiCY g,,

Ornceof theDirector R

bih n

M*""

"' e and ADMINISTRATION Division DevelopmentalDisability (Assistant Directors)

Savkes Divmon I

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I

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ng:,t x-ui ream-gg:,y,*j-ce,rien Seners xenia. son gg m

nen h Audd

Z OFFICE OF THE ADMINISTRATOR Elimer Hall, Aanmunerasu Gram Higemeen, HealiliOfficer I CROSS AGENCY & SPECIAL PROGRAntS ADalINISTRATIVE & PROGRAh! SERVICES (hA= B@

(metas OfGre sf else Adailniserseer)

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CERTIFIGTE OF NEED HEALTil RELATED LICENSING y, pg PROCAkt See Wilson COBiblVNICATIONS & PLANNING BUDGET CES Donnie widerburs/Claudia Black OFFICE OF blULTICULTURAL pp g

'I Se a

lingun

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FACILITIES /BIAIL CENTER COkIMUNITY SERVICES

/

M 33""'8 Caroi A:!c:

/

\\.

PIANS REVIM f

\\

Roscoe Lawless f

q CENTER FOR ENVIRONMENT &

CENTER FOR DISEASE PREVENTION CENTER FOR PUBLIC IIEALTII IIEALTil SYSTEMS

& EPIDEMIOLOGY LABORATORIES CENTER FOR CillLD & FAMILY Tona Johnson Dave Flenung IIEALTil

~

M**""

if 3r he NEWIN)RN SCREENING DRINKING WATER ACUTE AND COMAIUNICARLE Rxhord kiryalura BIATERMAL & CillLD flEALTil Dave 12tand plSEASE SYSTESI Paul Cieslak VIROLOGY /IElMUNOLOGY Immine Duncan EklERGENCY BIEDICAL SERVICES ovatsassie Biggs

& SYSTEMS IllV/STIWTB WOhlEN/ REPRODUCTIVE IIEALTil Oregg Lander Mark towless CENERAL hilCROBIOIDGY Anne Olson Robert Sokolow IIEALTil CARE LICENSURE &

IIEALTil PROMOTION & CIIRONIC ClllLD/ ADOLESCENT IIEALTil CERTIFICATION DISEASE PREVENTION LABORATORY LICENSURE &

Jill Skrer3na Kathleen Senail Jane Moore CERTIFICATION Andrene florton IMMUNITATION RADIATION PROTECTIVE SERVICES ENVIRONAIENTAL OCCUPATIONAL torraine Duncan/ Betty Finemous Ray Paris

& INJURY EPIDEMIOLOGY OUALITY ASSURANCE &

Hards Tolentino OPERATRONS

),llq ENVIRONMENTAL SERVICES &

Wa3ne Jeffers Donalda Dochen CONSULTATION CENTER FOR IIEALTil STATISTICS Ron Itall Ede-5.d Jolaiman

.s j

1 Organizational Chart For The State of Oregon Health Division Prin. Exec.Mgr.E Radiation Protection Services Paris April 1,

1998 Section (19.0 FTE)

Manager X7008/310 l

l Admin. Spec.I Gibson C0107/446 l

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l Prin Exec Hqr. C Prin Exec.Mgr. C Prin. Exec.Hgr. C X7004 Dibblee 309 X7004 Hocken 465 X7004 Goevelinger B47 Radioactive Electronic Products Emergency Response &

Material Progrars Prograrn Non-ionizing Prograans 1

I I

I I

Chemist Envir.

Office Env.

. Office III Health Spec.I Health Spec.

Environ.

Program Environ.

Office Spec.

Spec.

II Health Rep. II Health Spec. II Martin Ilf Hinkle III Smith Spec.'I I' vaca'nf Spec.III Vacant Miller vacant Loomis Wilson Strand l

1.indsey Rapcinski C3717 C0103 Crawford C0104 C3818 C0817 C3819 C0104 848 C3819 706 Grant 300 922 213 387 388 707 920 308 C3819 464 924 157 392 39 3.%.

\\astlistsWrgest a.rtt* 4/3 #M-9:t36

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

~ COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

File No.:- 1 Licensee: Good Samaritan Hospital License No.: ORE-90008 Locribn: Portland, OR Inspection Type: Routine, Unannounced License Type: Healing Arts Diagnostic & Therapy Priority: 3 Inspection Date: 3/12/97 Inspector: TL File No.: 2-Licensee: Good Samaritan Hospital (HDR)

License No.: ORE-90790 Location: Portland, OR Inspection Type: Routine, Unannounced

. License Type: Medical HDR Priority: 1 Inspection Date: 1/16/98 Inspector: TL Comment:

a) Inspector Gd r:ot use HDR inspection form.

hk.%.

3 Licensee: Precision Castparts Corporation License No: ORE-90232 Location: Portland, OR Inspection Type: Routine, Announced

- License Type: Broad scope A, Industrial Priority: 2 Inspection Date: 12/16/96 Inspector: TL File No.: 4 Licensee: Willamette Engineering & Earth Sciences License No.: ORE-90843 Location: Dallas, OR inspection Type: Initial, Unannounced License Type: Portable Gauge Priority: 4 Inspection Date: 6/3/98 Inspector: TL File No.: 5 Licensee: Steelman-Duff, Inc.

License No.: ORE-90849 Location: Clarkston, WA. (Out of State licensee)

Inspection Type: Field, Unannounced License Type: Portable Gauge Priority: 4 Inspection Date: 5/20/98 Inspector: TL Comment:

c) No supervisory review.

File No.: 6 Licensee: Commercial Testing & Engineering License No.: 12-24674-02 NRC Locationi Lombard, IL.

Inspection Type: Field, Reciprocity License Type: Portable Gauge Priority: 5 l

Inspection Date: 5/18/98 Inspector: TL i

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. Oregon Final Report Page C.2 inspection File Reviews File No.: 7 l

Licensee: Medical Imaging Consultants License No.: ORE-90580 Location: Winderest, TX Inspection Type: Special Unannounced License Type: Mobile Medical Imaging Priority: 2 inspection Date: 3/24/98 Inspector: TL File No.: 8 Licensee: Westem Professional, Inc.

License No.: ORE-90344 Location: Salem, OR inspection Typ< Routine, Unannounced License Type: Radiography-Shielded Rm.

Priority:1 Inspection Date: 3/24'98 Inspector: TL File No.: 9 Licensee: Oregon Health Sciences University License No.: ORE-90731 Location: Portland, OR Inspection Type: Routine, Announced License Type: Academic R&D Broad Scope A Priority: 2 Inspection Date: 9/26/97 to 10/4/97 Inspector: MD, TL File No.: 10 L'censee: Oregon Central Pharmacy License No.: ORE-90703 Location: Eugene, OR inspection Type: Routine, Announced i

Lice'ise Type: Radiopharmacy Priority:1 Inspect;on Date: 7/24/97 Inspector: TL File No.: 11 l

Licensee: Bay Arca Hospital License No.: ORE-90358 Location: Coos Bay, OR inspection Type: Routine, Announced License Type: Medical Priority: 3 Inspection Date: 7/23/98 Inspector: TL j

File No.: 12 Licensee: Professional Service Industries License No.: ORE-90056 Location: Portland, OR Inspection Type: Routine, Announced i

License Type: Radiography / Field Sdes Priority: 1 l

Inspection Date: 10/28/97 Inspector: TL i-

- File No.: 13 i

Licensee: St. Anthony Hospital License No.: ORE-90353 Location: Pendleton,OR inspection Type: Routine, Unannounced License Type: Medical Priority: 3 inspection Date: 5/18/98 inspector: TL l

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Oregon Final Report Page C.3 Inspection File Reviews

. File No.: 14 Licensee: Good Samaritan Hospital License No.: ORE-90202 Location: Corvallis, OR inspection Type: Routine, Unannounced License Type: Medicel Priority 3 Inspection Date: 12/17-18/98 Inspector: TL Comment:

a) Inspection resulted in nine violations, two of which were repeats, and six recommendations.

There was no mention of a follow-up or subsequent inspection planned before the next scheduled inspections.

File No.: 15 Licensee: Earth Tech, Inc.

License No.: ORE-90840 Location: Long Beach, CA Inspection Type: Mailinspection i

License Type: Lead Paint Analyzer Priority: 4 j

inspection Date: 7/14/98 Inspector: N/A File No.: 16 Licensee: Nuclear Medical Imaging Consultants License No. ORE-90771 (Terminated)

Location: Albany, OR inspection Type: Initial, Unannounced License Type: Medical (Clinic)

Priority: 3 Inspection Date: 2/10/98 Inspector: TL In addition, the following inspection accompaniments were made as part of the on-site IMPEP review:

Accompaniment No.: 1 -

Licensee: Providence Portland Medical Center License No.: ORE-90053 Location: Portland, OR Inspection Type: Routine, Unannounced License Type: Institutional Nuclear Medicine Priority: 3 Inspection Date: 6/23/98 ~

Inspector: TL i

Accompaniment No.: 2 Licensee: Sentrol, OR License No.: ORE-90637 Location: Tualatin, OR inspection Type: Routine, Unannounced L-License Type: Manufacturing /Research & Development Priority 2 Inspection Date: 6/24/98 Inspector: MD Accompaniment No.: 3 Licensee: Neogenesis, Inc.

License No.: ORE-90618 Location: Portland, OR Type Inspection: Routine, Unannounced License Type: Manufacturing / Compounding Priority 3 Inspection Date: 6/24/98 Inspector: MD

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!o APPENDIX D LICENSE CASEWORK REVIEWS l

NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP l

TEAM.

File No.: 1 Licensee: Sentrol, Inc.

License No.: ORE 90637 L

l Location: Tualatin, OR.

Amendment No.: 14 License Type: Mfg /Research & Development Type of Action: Renewal Date lasued: 9/26/97 License Reviewer: MD File No.: 2 i

Licensee: Neogenesis, Inc.

License No.: ORE-90618 i

Location: Portland, OR Amendment No.: 4 f

License Type: Research and Development Type of Action: Financial Assurance Date issued: 6/23/98 License Reviewer: MD File No.: 3 l

Licensee: Providence Portland Medical Center License No.: ORE-90053 Location: Portland, OR Amendment No.: 78 License Type: Institutional Nuclear Medicine with Therapy Type of Action: Entirety l

Date lasued: 10/29/97 License Reviewer: RC File No.: 4 Licensee: Sulzer Bingham Pumps, Inc.

License No.: ORE 90027 Location: Portland, OR 10247 Amendment Nos.: 76 thru 80 l

License Type: Industrial Radiography, Fixed Facility Type of Action: Amendments Dates issued: 7/30/96,11/13/96,4/18/97,10/2/97, and 1/27/98 License Reviewer:TL

. Comment:

. a) License condition 13.C. amendment 80, should be revised to reference the Oregon Administrative Rules (OAR) Chapter 33, Division 105. Section 330 (OAR 333-105-330).

File No.: 5

- Licensee: Teledyne Wah Chang Albany Licensa No.: ORE-90728 Location: Albany, OR Amendment No.: 12 License Type: Industrial Radiography, fixed facility Type of Action: Amendment Dates issued: 10/25/96 License Reviewer: TL, MD Comments:

a) Temporary job site license condition should not be on the licenso.

- b) License inappropriately authorizes the receipt, possession, and use of Iridium 192.

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i-Oregon Final Report Page D.2 License File Reviews File No.: 6 Licensee: Edwards Pipeline Services, LLC License No.: ORE 90860 Location: Tulsa, OK License Type: Industrial Radiography, temporary locations Type of Action: New Date lasued: 6/11/98 License Reviewer: SM, MD I

Comment:

a) License inappropriately authorizes the receipt, possession, and use of cobalt-60.

File No.: 7 Licensee: Oregon Central Pharmacy License No.: ORE-90703 Location: Eugene, OR Amendment No.: 8 i

License Type: Nuclear Pharmacy Type of Action: Amendment Date issued: 3/16/98 License Reviewer: SM, MD File No.: 8 Licensee: Braun Intertec, Inc.

License No.: ORE-90634 i

Location: Portland, OR Amendment No.: 16 License Type: Industrial Radiography Type of Action: Amendment Date issued:7/31/98 License Reviewer: SM, MD, TL File No.: 9 Licensee: Mallinckrodt, Inc.

License No.: ORE 90702 Location: Portland, OR Amendment No.: 7 L

License Type: Nuclear Pharmacy Type of Action: Amendment Dates issued: 3/13/98 License Reviewer: SM, MD File No.: 10 -

Lk:ensee: Oregon Health Services University License No.: ORE-90013 Location: Portland, OR Amendment Nos.: 80 and 81 l.

License Type: Broad Medical (Scope A)

Type of Action: Amendment Dates issued 1/16/97,5/14/98 License Reviewer: MD, TL i

File No.: 11 Licensee: Williamette Va!!ey Cancer Center License No. ORE-90862 Location: Eugene, OR License Type: Brachytherapy, High Dose Rate (HDR)

Type of Action: New Dates issued: 6/11/98 License Reviewer: SM, MD L

Comment:

l a) The license only designates the total curies allowed. The maximum possession limit condition should specify that two sources, one source not to exceed 12 curies, and one source not to exceed 10 curies, comprise the total activity. Additionally, the authorized use condition should specify that one source is to be used in a (name of afterloader) for l

interstitial, intraluminal, and intracavitary radiotherapy in humans, the source activity may l

not exceed 10 curies at the time of installation, and that the other source is to be stored in its shipping container for source replacement.

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Oregon Final Report Page D.3 License File Reviews File No.: 12 Licensee: Syncor International Corporation License No.: ORE 90509

. Location: Portland, OR Amendment No.: 23 License Type: Nuclear Pharmacy Type of Action: Amendment Dates lasued: 3/13/98 License Reviewer: SM, BC Comment:

a) Documents missing from license.

File No.: 13 Licensee: Community Cancer Center License No.: ORE-90422 Location: Roseburg, OR Amendment Nos.: 23 & 24 i

License Type: Medical Therapy Type of Action: Renewal Dates issued: 1/12/96,1/16/97 License Reviewer: SM,MD,TL j

File No.: 14 Licensee: Oncology Associates of Oregon License No.: ORE-90789 Location: Eugene, OR Amendment Nos.: 1,2 License Type: Brachytherapy Type of Action: New, Amendment Dates issued: 9/10/96 (initial), 9/24/97, 9/24/97 License Reviewer: SM,DB

' File No.: 15 Licensee: ABCT,Inc.

License No.: ORE-90502 Location: Roseburg, OR Amendment Nos.: 30,31, & 32 License Type: Mobile Nuclear Medicine Type of Action: Amendment Dates issued: 12/24/96, 3/10/97, 7/9/98 License Reviewer: SM,MD File No.: 16 Licensee: Welenco, Inc..

License No.: ORE-90762 Location: Bakersfield, CA Arnendment No.: 2 License Type: Well Logging -

Type of Action: Amendment Dates lasued: 12/7.3/97 License Reviewer: SM,MD,BC File No.: 17..

Licensee: Oregon Medical Laboratories License No.: ORE-90360 Location: Eugene, OR -

Amendment Nos.: 14,15,16, & 17 License Type: Self Shielded Irradiator Type of Action: Amendment Dates lasued: 7/14/97,1W23/97,12/23/97, 06/12/98 License Reviewer: SM,MD File No.: 18 Licensee: Health Physics Northwest, Inc.

License No.: ORE-90361

' Location: Tigard, OR Amendment No.: 18 License Type: Leak Test Service Type of Action: Renewal

[

Dates lasued: 3/12/98 License Reviewer: SM, BC, MD

File No.: 19 L

Licensee: PCC Structurals,Inc.

License No.: ORE 90232 Location: Portland, OR Amendment Nos.: 47,48,49,50, & 51 License Type: Broad Scope Type of Action: Amendment F

Dates issued: 8/8/90,1/9/97, 5/22/97,1/27/98, 3/18/98 License Reviewer: SM, BC t

I-

I Oregon Final Report Page D.4 License File Reviews File No.: 20 Licensee: University of Oregon License No.: ORE-90220 Location: Eugene, OR Amendment No: 28 License Type: Broad Scope Academic Type of Action: Renewal j

Dates lasued: 3/24/98-License Reviewer: SM, MD, TL l

l.

File No.: 21 I

L Licensee: Teledyne Industries, Inc.

License No.: ORE-90001 -

Location: Albany, OR Amendment No.: 45 License Type: Broad Scope Type of Action: Amendment Dates issued: 7/21/98 License Reviewer: SM,MD File No.: 22 i

Licensee: Reed College License No.: ORE-90010 Location: Portland, OR Amendment No.: 43C License Type: Broad Scope Academic Type of Action: Renewal i

Dates issued: 7/10/98

. License Reviewer: SM, MD File No.: 23

. Licensee: NDE Professionals License No.: ORE-90641 Location: Portland, OR Amendment No.: 8 License Type: Industrial Radiography, temporary locations Type of Action: Termination Date lasued: 7/23/96 License Reviewer: SM, MD File No.: 24 Licensee: SIRAD, Inc.

License No.: ORE-90604 Location: Portland, OR Amendment No.: 5 License Type: Research and Development Type of Action: Termination Dates issued: 4/30/96 License Reviewer: MD, BC File No.: 25 Licensee: Elm Street Nuclear Imaging.

License No.: ORE 90542 Location: Albany, OR Amendment No.: 7 License Type: Private Medical, diagnostic and therapy uses Type of Action: Termination Date issued: 7/23/96 License Reviewer: SM, TL File No.: 26 Licensee: Matsushita Electronic Material, Inc.

License No.: ORE 90683 Location: Forest Grove,' OR Amendment Nos.: 3,4, & 5 License Type: Fixed Gauge, custom evaluation Type of Action: Amendment Date issued: 4/16/97,10/3/97, 7/23/98 License Reviewer: SM, MD File No.: 27

. Licensee: Medite, Corp License No.: ORE-90595

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Location: Medford, OR Amendment Nos.: 3,4 License Type: Manufacturing & Distribution Type of Action: Termination Date lasued: 5/1/97,8/14/97 Ucense Reviewer: SM,MD i:

l Oregon Final Report Page D.5 License File Reviews File No.: 28 Licensee: GreCon License No.: ORE 90847 Location: Beaver 1on, OR Amendment No.: 1 License Type: R & D, Service Type of Action: Renewal Date issued: 10/6/97,11/13/97 License Reviewer: BC, MD File No.: 29 Licensee: Thomas Gray and Associates, Inc.

License No.: ORE-90794 Location: Orange, CA Amendment No.: 1 License Type: Waste Packaging Type of Action: Amendment Date issued: 5/21/97 License Reviewer: SM BC,MD Comment:

a) 10 CFR Part 61 requirements for uniform manifest have not been adopted by regulation or incorporated as a license condition.

File No.: 30 Licensee: Oregon Department of Transportation License No.: ORE 90829 Location: Milwaukee, OR Amendment No.: 1 License Type: Portable Gauge Type of Action: Amendment

' Date issued: 8/7/98 License Reviewer: SM,MD File No.: 31 Licensee: Century West Engineering Corp.

License No.: ORE-90746 Location: Portland, OR Amendment No.: 3 License Type: Portable Gauge Type of Action: Amendment Date issued: 3/19/98 License Reviewer: SM, MD File No.: 32.

Licensee: Century West Testing Corp.

License No.: ORE 90382 Location: Bend, OR Amendment No.: 24 License Typle: Portable Gauge Type of Action: Amendment Date lasued: 7/31/98 License Reviewer: SM, MD

1 APPENDIX E INCIDENT CASEWORK REVIEWS

' NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

File No.: 1 Licensee: Longview inspection Co.

License No.: ORE-90621 incident ID No.: 98-20 Location: Northwest Copper Co., Portland, Oregon

{

Date of Event: 3/30/98 Type of Event: Equipment and procedure failure investigation Date: 4/2/98 investigation Type: Onsite Summary of Incident and Final Disposition: The radiography source was cranked out and failed to completely retract when cranked back. The radiogrether (unaware that source did not j

retract) approached the source without the survey meter; because of noise in the shop, he apparently did not hear his rate alarm. The radiography assistant alerted him to the exposed l

source. The radiographer's TLD read 730 mR. It was found that the source did not retract l

because of a sharp bend in the guide tube. The State issued an N7V for failure to follow l

procedure. The licensee performed satisfactory corrective actions.

File No.: 2 Licensee: Smurfit Newsprint Corporation License No.: ORE 90266 incident ID No.: 98-14 Location: Newbeg, Oregon Date of Event: 2/24/98 Type of Event: Overexposure, damage to equipment investigation Date: 2/24/98 investigation Type: Ons?e L

Summary of incident anr Final Disposition: The licensee reported a possible personnel exposure during maintenance when a fixed gauge was deliberately cut from its mounting while the shutter remained open. The RSO was not called. The gauge contained 3.7 GBq (100 mci) l of Cs-137. The Stato issued an NOV for lack of corporate attention to safety, and enforcement l

action was taken.

File No.: 3 Licensee: Braun Intertec Corporation License No.: ORE 90634 incident 10 No.: 98-08 Location: Portland, Oregon Date of Event:1/24/98 Type of Event: Overexposure Investigation Date: 1/24/98 investigation Type: Onsite Summary of incident and Final Disposition: A State building inspector walked through a rai3ography barrier tape and warning signs while an exposure was in progress. The individual i

n.s warned away by the radiographer. The licensee provided a dose estimate for the exposed i

h,dividual. The individual (a State employee) was alerted to the importance of observing roped Mundaries and warning signs. A written report was sent to the exposed individual. No Aolations of State regulations were identified, and the case was closed.

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Oregon Final Report Page E.2 incident File Review File No.: 4 Licenseo: Oregon Health Sciences University License No.: ORE-90731 Incident ID No.: 97-82 Location: Portland, Oregon Date of Event: 12/16/97

. Type of Event: Contamination Investigation Date: 12/16/97 l

Investigation Type: Telephone Summary of Incident and Final Disposition: This broadscope licensee reported discovery of extensive C-14 contamination (estimated 510 mCl) in a cold room (walk-in cooler). The room had not be used for RAM in at least 10 years. Contamination was identified by a researcher l

while wipe testing the area after using RAM. The licensee's RSO supervised clean up. Walls l

were stripped and repainted, and the concrete floor was replaced. A permanent metal wall

- plaque was installed in the contaminated area detailing the C-14 spill.

File No.: 5 Licensee: Legacy Emmanuel Hospital License No.: ORE-90014 incident ID No.: 97-74 j

Location: Portland, Oregon Date of Event: 11/19/97 Type of Event: Medical Underdose l

Investigation Date: 11/19/97 l

Investigation Type: Telephone Summary of incident and Final Disposition: After implanting Pd-103 seeds in 9 patients, the licensee discovered the activity of the seeds to have been up to 10% less than reported. The vendor was contacted. The FDA was notified. None of the administrations met the threshold

. for a misadministration. The licensee will set-up a OA program, based on the recommendation 1

in the AAPM Task Group Report, TG 56, " Code of Practice for Brachytherapy Physics."

File No.: 6 l

Licensee: Geo Designs License No.: ORE-90822 incident ID No.: 97-61 L

Location: Lake Oswego, Oregon Date of Event: 10/19/97 Type of Event: Damage to Equipment i

investigation Date: 10/10/97 investigation Type: Onsite i

Summary of incident and Final Disposition: A portable moisture / density gauge run over by a dump truck wheel. Inspection showed that the sources were in place, and there was no contamination on the wipe. An NOV was issued for loss of control of RAM. Enforcement action was taken.

l a,

o Oregon Final Report Page E.3 incident File Review t

File No.: 7 Licensee: Longview Inspection Co License No.: ORE 90621 Incident ID No.: 97-53 Location: Forest Grove Industrial Alloy, Forest Grove, Oregon Date of Event: 8/29/97 Type of Event: Equipment failure investigation Date: 8/29/97 t

investigation Type: Onsite l

Summary of incident and Final Disposition: During use, the d.?/e cable of a radiography did not completely retract and a radiography source disconnect was the result. The radiographer l

pulled hard, and the tip of the drive cable hroke off. The manufacturer (Amersham) concluded that the connector was pulled off due to unusually high force. State investigation showed that i

cable failure was not generic, but was caused by licensee abuse of the equipment. The licensee performed good corrective action. No violation of State regulations was identified.

File No.: 8 Licensee: Salem Hospital License No.: ORE-90151 Incident ID No.: 97-40 Location: Brooks incinerator, Portland, Oregon Date of Event: 7/11/97 j

Type of Event: Contamination (Hospital waste) investigation Date: 7/11/97 investigation Type: Telephone 4

Summary of Incident and Final Disposition: Hospital waste containers set off the radiation alarm at the Brooks incinerator. The waste measured 43 R. There were at least 7 other incidents reported of Salem Hospital setting off the alarm at the incinerator. A State representative met l

with the licensee's Radiation Safety Committee to discuss compliance with hospital policies for

~

disposing of radioactive waste. The hospital has significantly improved its handling of radioactive waste since the meeting with the State.

File No.: 9 Licensee: Smurfit Newsprint Corporation License No.: ORE-90266 incident ID No.: 96-28 Location: Newberg, Oregon Date of Event: 10/1/96 Type of Event: Equipment failure investigation Date: 10/3/96 investigation Type: Telephone, Next inspection Summary of incident and Final Disposition: The licensee reported a fixed gauge with a shutter stuck in the open position. The gauge was on line, and the manufacturer was called to repair the gauge. No action by the State was needed. This was a required 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> report.

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Oregon Final Report Page E.4 incident File Review l

File No.: 10 l

Licensee: N/A License No.: None incident ID No.: 96-20 Location: Brooks incinerator, Portland, Oregon Date of Event: 8/13/96 Type of Event: Contamination i

investigation Date: 8/13/96 l

Investigation Type: Telephone Summary of incident and Final Disposition: A radiation alarm was set off at the incinerator. The source of the trash was residential, and the substance that set off the alarm was 1-131 contaminated " kitty litter." The State contacted a veterinarian who was licensed to treat cats, and reviewed his instructions to pet owners regarding release of the animals after treatment.

The instructions were adequate. Since the crigin of the waste could not be identified, the case was closed.

File No.: 11 Licensee: Private Citizen License No.: None incident ID No.: 97-55 Location: Private Home l

Date of Event: 9/29/97 Type of Event: Exposure of Member of the Public investigation Date: 9/29/97 investigation Type: Onsite Summary of incident and Final Disposition: A private citizen had collected " grey powder" in a jar that he believed was radioactive. He believed this powder was causing paranormal activity at his home. 799 inspector surveyed the material in the jar, and other areas on the site. No radioactiv;6 lbuve bao ground was detected. The findings were reported to the concerned individual.

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m, L

h 1a Department of Human Resources Health Division

%,% N, c.

800 NE Oregon Street e 21

/

Portisnd, OR 97232 2162 (503)73b(Q4QEmergency (503) m.40s September 30,1998 '

FAX (503) l TTYNonvoice (503)731-4031 Richard L. Bangart, Director i

Office State Programs US Nuclear Regulatory Commission

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i Washington, D.C. 20555 0001 l

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Dear Mr. Bangart:

This is in response to your September 16,1998 letter requesting comments on the

- draft report of the Integrated Materials Performance Evaluation Program (IMPEP) review of Oregon's Radioactive Materials Program on August 1013,1998.

The draft report includes six (6) recommendations that relate directly to j

perfom1ance by the State. The report requested that the State respond to each l

recommendation. The following are our responses:

1)

The team recommends that Oregon heighten its management oversight of the inspection due dates of new licenses to ensure inspections are performed in

- accordance with RPS policy.

Oregon has adopted the guidance in IMC 2800, Section 04.03a that states new licenses are inspected within six months ofissuance oflicense. The

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IMPEP teamfound that 55% of the (i.e. 24 out of 43) new licenses were not irupected within the 6 month requirement. However, the team alsofound l

that 95% (i.e. 41 out of43) of the new licenses were inspected within 7 l

months and all were completed within 8 months.

!/

It is true that Oregon did not specufically meet the criteria in Section 04.03a ofIMC 2800. However, it is important to keep in mind that "perfonnance" is a key word under the new IMPEP criteria. Seventy two percent, 72%, (31 out of 43) of the new licensees inspected within the 6 month period had no items ofnoncompliance. There were no (zero) items ofnoncompliance among the other 28% that affected the health and safety of the public or i

those using the radioactive material. This reflects the outstanding work RPS i

staffdoes during the initiallicensing process to educate new licensees on Assisting People to Become Independent, Healthy and Safe F

An Equal Opporkunity Employer u

ATTACHMENT 1 C fj00$0SkW f

health andsafety issues relating to the radioactive maten'ai they are about to possess.

It should be noted that the teamfound allinspections current with the 352 licensees and that the state met the inspection percentage goalsfor conducting inspections of reciprocity licensees as outlined in IMC 1220.

Therefore. Oreonn does not agree with the IMPEP team finding that the Status of Materiais inspection Program he found satisfactory with reconunendationfor improvement.

Wefully recogni:e the importance ofdoing on site inspections ofnew licensees and believe six (6) months to be a reasonable gnal within which to have thefirst on site inspection completed. The criteria in Management Directive 5.6 and Section 04.03a/2800 MC that reauires materiallixnsees to be inspected within 6 months should be reviewed against IMPEP perfonnance guidelines. To strictly adhere to 6 months wefeelis too prescriptive and reflects back to previous protocol NRC used to review Agreement State programs. There must be allowancesfor states to incorporate "perfornwnce" into their inspection protocol ofnew licensees.

Oregon's emphasis on educating new licensees on health andsafety issues during the licensure process has proven effective. We believe our initial impection process is adeaunte to protect health and saferv and feel the fin. ding for this Common Performance Indicator should he " Satisfactory. "

We recommend NRCseriously reevaluate IMC 2800 Section 04.05a and incorporate language to allow " performance" to be part of the detennination ofhow soon new licensees need to be inspected. The

" performance" would obviously not be based upon a particular licensee, but rather how new licensees generallyperfonn within a state. Specifically, we feelit would be bruer to use the word " goal" rather than "shall"for inspecting new licensees within 6 months. We plan to change our own policy to reflect the same.

2)

The review team recommends that the RPS management assess whether additional staffing is warranted to complete overdue rulemaking actions and to ensure timely completion of upcoming rulemaking actions.

RPS Management has assessed staffing and workload. Additional stafing 2

does not appear to be warranted at this time. Initialsteps already have been taken to update applicab!r Administrative Rules relating to the Radioactive Materials Program, as wellas ourX-ray and Tanning Device Programs.

3)

The review team recommends that the State adopt the NRC standard practice license conditions for HDR units for the casework Wil license and future HDR l

licensest i

RPS will adopt and incorporate in applicable licenses the above standard license conditionfor HDR wsits in the State.

4)

The review team recommends that the State develop a written policy with l

procedures for responding to allegations.

l The State has written the policy with proceduresfor responding to l

allegations.

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l 5)

The review team recommends that management obtain a State legal view on their interpretation that existinE administrative rules require the implementation of f

all new requirements in the revised NRC regulations where required for compatibility purposes.

The State has already taken initialsteps to update the Administrative Rules to adopt applicable languagefrom the revised NRC regulations where required for compatibility purposes. The State has noted the NRC regulations idennfed by the IMPEP team as needing to be addressed.

Since the State willsoon be adopting languagefrom applicable NRC regulations and amending the Administrative Rules accordingly, it is not deemed necessary to obtain a State legal view on existing Administrative Rules. Prospectively, the State willseek a legal opinion to determine if existing Administrative Rules and/or appropriate license conditions meet the criteriafor compatibilityfor new NRC regulations.

6)

• Ihe review team recommends that RPS management initiate rulemaking L

activities to ensure that NRC rule changes are adopted within the specified 3 year L

time period.

4 3

_. _ _ _ _ _ _. _ _ _l RPS management is well aware of the three year time period ofadopting NRC rule changes. Management discussed this issue with the IMPEP team.

It is imponant to keep in mind that State Radiation Protection Agencies have many more Administrative Rules to maintain than just those applicable to the Radioactive Materials Program. The administrative rule revision process is time consuming. Therefore, prior to initiating the process allprograms are evaluated to detennine the needfor amending applicable rules. Ifonly afew changes are needed, it is not uncommon to distribute information and/or enforcement bulletins to registrants and/or licensees as an interim measure.

Licenses may also be administratively changed as an interim measure in lieu of afullfonnal rule change. The State has the option ofincorporating an emergency rule ifa situation so warrants. Emergency rules become efective immediately. However, regularprocedures ofthe Administrative Procedures Act must be completed later, (i.e.fiscalimpact statements, public corrunent, etc.).

As mentioned above ofin thefuture license conditions are to be used in lieu of Administrative Rules, the State will have a legal review to detennine statutory authority as well as compatibility issues prior to implementation.

RPS management will continually strive to initiate rule making activities to ensure that NRC nde changes are adopted within the specsfied 3 year time period.

Thank you for the opportunity to conmient on the draft report. If you have any questions or need additional infoimation please let me know.

Sincerely, 3

g Awd Ray p. Paiis, Manager Radiation Protection Services c: Elinor Hall, MPH Administrator Health Division 4

Approved by OMB' No. 3150 0183 l

Expires 4/30/98 I

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE State of Oregon / Health Division /CEHS,RPS Reporting Period: July 11,1996 to August 10,1998 A. COMMON PERFORMANCE INDICATORS

, l.

Status of Materials Inspection Prooram

1. Please prepare a table identifying the licenses with inspections that a.c wardue by more than 25% of the scheduled frequency set out in NRC Inspection Mant,01 Chapter 2800. The list should include initial inspections that are overdue.

Oregon has no instate licenses with overdue inspections. The state has two out-of-sta:0 licenses' that show overdue dates, but we do not consider out-of state licenses to be overdue because they are inspected only when they notify us that they will be entering the state.

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

The state has no overdue inspections. Should there be overdue inspections, the state would prepare a plan to eliminate the backlog as it did in 1995.

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Estimated burden per response to comply with this voluntary collection request: 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-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 (3150-0052), Office of Management and Budget, Washington, DC 20503.- NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

'One licensee entered the state for one day but the time factor was too tight to inspect.

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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.

The state inspects at least as frequently as required in Manual Chapter 2800 (see Attachment A). In June 1998 the state changed inspection priority of selectedprogram codes from 7 to 5 or from 5 to 4, resulting in four gas chromatograph licenses showing due dates and one showing overdue date. Note: this change means that the state will inspect all specific license facilities within a five-year cycle. The state also assigned priority 7 to generallicenses (gauges and in vitro generallicenses). The current inspection docket includes inspection due dates for alllicenses.

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

The state issues out-of state (OOS) specific licenses to most persons who would be reciprocity licensees. The numbers below show how many OOS licensees notified the state of entry into Oregon (column a) and the number of OOS licensees that were inspected (column b). One licensee was granted a generallicense for reciprocity.

Number of Licensees Number of Granted Reciprocity Licensees inspected Priority Permits Each Each Year (b)

Year (a)

Service Licensees performing 2

1 teletherapy andirradiator source installations or changes 1

3 cone reciprocitylicense) 4 (one reciprocity license) 2 1

1 3

10 9

4 24 17 All Other 4

3

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

There were 3 fieldinspections of radiographers.

6. For NRC Regions, did you establish numerical goals for the number of inspections to l

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 i

goals and the actual number of inspections performed.

2

. II. Technical Quality of insoections

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

There were no revisions to the Compliance Inspection Procedures during the review period. However, there were several changes (updates) made to the inspection forms to make them compatible with NRC requirements and to incorporate new regulatory

(

requirements orpreviously missing inspection criteria. The state uses procedures adapted from the NRC 2800 manual.

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

l Insoector Suoervisor

_ License Cat. Qalf Crosby Dibblee gauge 2/25/98 Lindsey Dibblee alltypes 2/18-19/98 latest Loomis Dibblee gauge 1997 several Martin Lindsey various' 1997-98 Martin Dibblee gauge 1997 l

Dibblee Paris major various'

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.

RPS Policy 50-11, Inspection Policy, states in part that "Any person who is assigned to conduct license inspections will be periodically accompanied by a supervisor.

Accompaniments are documented using the Inspector Accompaniment Form. A senior inspector who accompanies a Junior inspector should document the accompaniment using the form, but this does not take the place of the periodic supervisory accompaniment " A copy of Policy 50-11 will be available during the on-site review.

Except for the supervisor, who occasionally does inspections, allinspectors were accompanied by the materials supervisor. The materials supervisor was accompanied

. by the RPS manager during licensee management meetings, which are considered supervisory accompaniment, since the RPS manager supervises the materials supervisor. Supervisory accompaniments were documented with the form described in the Policy.

Martin does not perform inspections alone. Martin is a peer inspector, but primarily is a license reviewer.

" Paris accompanied Dibblee during various licensee management meetings, which are considered management accompaniments. Dibblee's role as an inspector has been either j

as a peer inspector or during supervisory accompaniment.

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4 The state keeps extensive documentation of accompaniments. The inspector completes the form (see exhibit B) " Inspector Debrief Form"after each inspection. This form documents findings so that when the inspection findings are discussed, issues that may have been forgotten during an extended inspection trip may easily be recalled for discussion with peer staff and/or the supervisor. Unresolved noncompliance, marginal compliance, assignment of points, etc. come to play in with this invaluable form. In this i

capacity, the inspector Debrief Form becomes supervisory accompaniment in absentia.

Notwithstanding, the primary inspector (who conducted about 70% of allinspections during the reviewpedod) was by default accompanied many times (15% of the time) by the supervisor because the supervisor was the other inspection team member.

10.

Describe or provide an update on your instrumentation and methods of calibration.

Are all instruments properly calibrated at the present time?

Allinstruments available for use are properly calibrated at this time The Division's instrumentation are calibratedcalibrated annually by OSU calibration facility. All instruments are logged into a database that periodically brings up a few instruments at a time. The materials program has three instrument kits comprised of a Ludlum Model 12 body & at least 4 matched probes. Probes include ECGM,

?

pancake GM, Nal(TI) 1"x t ", & alpha probe. One kit also has a beta scintillation probe and a thin Nal(TI) probe for beta detection and low energy gamma respectively. No more than one materials kit is out for calibration at a time. The section has a total of seven (7) kits, which also are used for emergency response, plus additional emergency response instruments.

111.

Technical Staffina and Trainina 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 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 among ottices, 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.lf 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 FTE%

Robert Crosby (Retired W1/98)

Health Administration 25 Physicist Licensing / Compliance 70 Emergency Response 5

Terry Lindsey Health Administration 5

Physicist Licensing / Compliance 90 Emeraency Response 5

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Name Position Area of Effort FTE%

Sylvia Martin Health Administration 5

Physicist Licensing / Compliance 90 Emergency Response 5

Dan Loomis Emergency Administration 5

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Response

Licensing / Compliance to Emergency Response 10 Chris Hinkle Secretary Administration 95 Licensing Licensing / Compliance O

Assistant Emergency Response 5

Martha Dibblee Health Administration 75 Physicist Licensin$ Compliance 20 Supervisor RML Emergency Response 5

Ray Paris Health Administration 90 Physicist LicensinWCompliance 5

an gerRP Emeroency Response 5

12.

Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

l No new personnel were hired during the review period, although the state will open Crosby's position approximately 15 June and intends to fill this position by 30 September 1998.

l 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.

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Qualification Reauirements for Oreaon a.

Materials License Reviewers Work Experience: Health Physics experience and completion of the NRC core classes orprevious documentedlicensing experience in another state or the NRC.

On the-Job training:

Formal Training Requirements

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H-109 Applied Health Physics

• • S-301 RERO G-108 Inspection Practices & Procedures G-109 Licensing Practices & Procedures l

H-304 Diagnostic & Therapeutic Medicine l

H-305 Safety Aspects of Industrial Radiography H-308 Transportation of Radioactive Materials

• • H-314 Safety Aspects of Well Logging b.

Materials License Inspectors Work Experience: Health Physics experience and completion of the NRC core classes orprevious documentedlicensing experience in another state or the NRC.

On-the-job training.

Formal Training Requirements H 109 Applied Health Physics

• • S-301 RERO G 108 Inspection Practices & Procedures G-109 Licensing Practices & Procedures H-304 Diagnostic & Therapeutic Medicine H 305 Safety Aspects of Industrial Radiography H-308 Transportation of Radioactive Materials

• • H-314 Safety Aspects of WellLogging c.

ProfessionalStaffIn Training:

Sylvia Martin Terry Lindsey d.

Proposed Training Schedule Sylvia Martin: H-308 Transportation of Radioactive Materials (June 22-26,1998)

Terry Lindsey: G 109 Licensing Practices & Procedures (September 1998)

• • • optionalcourses that are not part of the core courses.

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14.

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

Mr Robert Crosby left the program 28 February 1998.

15.

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

The only vacant position in the materials program is Crosby's position, which the state plans to fillby the end of September 1998.

IV.

Technical Quality of Licensina Actions 16.

Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated, decommissioned, bankruptcy i

l notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.

Major, unusual, or Complex Licenses License Number issued During the Review Period (Program Code) l University of Oregon (01100) 90220 (renewal)

Wah Chang (1170CVBroad) 90001 (amendment only) l GreCon (03240) 90847(device reactivation) l Medite (03240)

T 90578 (device inactivation) l Matsushita (03120) 90683 (custom device)

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Reed College (01100) 90010 (renewal) l.

Precision CastDarts Cord (11800) 90354 (renewaf) l No Oregon Radioactive Material Licensee is required to have an Emergency Plan.

17.

Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

I All medicallicensees have a license condition that waives the requirement to follow package inserts if the patient's well being would be Jepoardized'.

'The state expects that this license will have been issued by the time of the review.

A.

Notwithstanding the requirement to prepare and use drugs in accordance with the package insert, if, in the Judgment of the physician authorized user, departures from the package Insert, or use of unapproved drugs, is indicated, the physician may perform such procedures consistent with good professional medical practice as judged by the Oregon Board of Pharmacy, the Oregon Board of Medical Examiners, and/or the Oregon Radiation Advisory Board, as appropriate.

B.

Procedures shall be done by, or under the supervision of, persons whose training meets the requirements in OAR 333 116 and shall be in accordance with safe radiation safety 7

.----_,.-~----

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- A waiver for all users of Molybdenum 99/ Technetium 99m generators was issued because of a potentialdisruption of the supply of these generators. The waiver allowed licensees to prepare reagent kits with the use of the generator for up to 2t days, and to use Technetium 99m eluants for up to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> with certain conditions. This waiver is in effect now. A copy of the enforcement bulletin willbe available during the on site review.

The state issued an exemption from rules when NRC Implemented the exempt distribution of C-14 urea for diagnosis of H. pyloriin January 1998. This allows exempt distribution of this drug. The Oregon Board of Pharmacy wasjoint in this decision.

18.

What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

No substantive changes were made to licensing procedures. Policy 50-11 was l

updated to Include inspection program codes.

19.

For NRC Regions, identify by licensee name, license number and type, any l

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

V. Resoonses to incidents and Alleaations 20.

Please provide a list of the reportable incidents (i.e., medical misadministration,

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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 3150-l 0178). The list should be in the following format:

i i

During the reviewperiod, there were approximately 160 incidents that required response. There were about 60 incidents that were ma}or involved licensee.

Attachment C shows incidents during the reporting period.

i 21.

During this review period, did any incidents occur that involved equipment or j

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?

There were incidents that involved both equipment or source failure and deficient procedures.

1 i

procedures and ALARA in OAR 333-120-020. Radiopharmaceuticals shallnot be used in humans until their pharmaceutical quality and assay have been established. Records documenting radioactive material used described in A. of this condition shall be kept by the licensee untilWnection by the Agency.

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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.

Information was adequate to determine if there were a generic problem. The p

following are summaries of those incidents:

1.

RCS No 96 28 (10W96): Fixed gauge licensee reported shutter that wouldn't clo se. RPS investigation showed that gauge may have been underengineered 1

for the conditions to which it was subjected. Gauge was mounted to a hopper that M as shaken periodically with a pneumatic blast. It appeared that gauge shutter disintegrated from vibration. Licensee discoveredproblem when handle to close shutter fell out because it no longer was attached to the shutter. AOR l

sent to NRC Region 5. Gauge was repaired & is back in service *.

l 2.

RCS No 96-31 (10'22/96): Portable gauge licensee reported failed welds after agency sent bulletin notifying of possible defects. Dye penetrant studies were

(

forwarded to NRC NMSS, which then were forwarded to NC for evaluation &

followup. Four Oregon devices were retumed to manufacturer. No capsules broke off.

3.

RCS No 97-53 (&'29/97): A radiography licensee reported a source disconnect caused by the tip of the drive cable breaking off. RPS investigation showed that the cable failure likely was not generic but was caused by licensee abuse of the equipment. NRC, which also investigated this event, had documented similar l

problems with cables *. RPS concluded that 1) the cable didn't retract fully into the cable casing; 2) cables typically were storedin darkrooms on a floor where they were likely to contact corrosive developer chemicals; and 3) cable tip l

sticking out contacted corrosive _ chemicals causing the metalstrength compromise. RPS received word-of-mouth report that the source / cable manufacturer modified the cable / sheath to include a permanent cap to protect the end of the cable. RPS contacted NRC Region V but did not send AOR because this problem already was being investigated and did not appear to meet the criteria of a generic defect. This case is not closed becuase the Stats stillhas received no written reports from the licensee, the manufacturer, or the NRC (except as notedbelow).

~23.

In the period covered by this review, were there any cases involving possible wron0doing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

• NMSS Bulletin 98-1 received June 15,1998 described actions that NRC plans to take to alleviate this situation.

i V

'NMSS Bulletin 98-1 received June 15,1998 described actions that NRC plans to take to j

alleviate this situation.

r A:\\lMPEP.0VE* September 17. 1998 9

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One case may have met the criteria of wrongdoing, but did not involve a licensee (RCS No. 97-66,10/23f97). During a plea bargain process, an individual made statement he had radioactive materials that were taken from the military. He allegedly had them in a glass mason Jar located on BLM property. Federal authorities followed up because the individual allegedly was involved in drugs and the allegation of radioactive material theft was managed by the FBI.

24.

Identify any changes to your procedures for handling allegations that occurred

~ during the period of this review.

a.

For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.

l There are no allegations referred by NRC in the reporting period that l

have not been closed. RCS No 96-37 (12/6/96) was an allegation reported from NRC and was closed. RCS No 97-41 (7/13/97) was reported from the National Response Center about a barrel that washed ashore on the coast. The barrel contained hydraulic fluid & the Coast Guard di sposed of barreII & contents. The case is closed.

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.

The NRC review of the Oregon Agreement State Program concluded July 11,1996 l

showed that all outstanding issues from the 1995 review were closed. Issues from l

the 1995 review included need for increased management oversight, overdue

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inspections, unclosed and incomplete cross referenced incidents, inadequate l

inspector field evaluations, proceduralinadequacies for enforcement, procedural l

inade_quacies forinspections, and untimely implementation of rules required for compatibility. Of these issues, only one, the rulemaking issue, remains open at this time. Oregon has not revised rules since the 1995 NRC review. Comments made by Division Administrator Hallin letter dated February 14,1996 to NRC about implementation of Part 36 rulemaking remain valid. Oregon has no large irradiators, and there are no proposed facilities subject to the rule. Should there be such an I

application before rules are implemented, the state wouldincorporate applicable portions of Part 36 as license conditions. The state plans to implement rules compatible with Part 36 in 1999 when a general rule revision is planned.

26.

Provide a brief description of your program's strengths and weaknesses. These i

strengths and weaknesses should be supported by examples of successes, problems or difficulties that occurred during this review period.

l Strenaths:

1.

Licensing staff process actions efficiently and in a timely manner with maximum client service 2.

Technicalpersonnel are well credentialed and eager to do a goodJob 3.

Revenues are adequate to support the materials program e

f A:\\lMPEP.0VE* September 17. 1998 10 1

I A

1 4.

Ucensing support person is well trained and knowledgeable about materials actions 5.

Salaries are adequate to retain personnel 6.

Materials team includes a fraction of Emergency Response program staff 7.

Materials staff are innovative, smart, and hard working, and use a common-sense approach to problem solving; staff use available tools without added program costs.

8.

Materials program staff compliment each other both in philosophy and dilligence of task completion.

Weaknesses:

1.

Support staff often ' bogged down'resulting in bottleneck

• forlicense wordprocessing & slow delivory oflicensing actions 2.

Extremely limited legal support (ver, costly and limited to special cases) 3.

Limited financial support for continuing education (attenaance at professional meetings or conferences).

4.

Current staffing levels do not support tasks beyond routine licensing and compliance (statf does not include expert radiation safety support such as CHP or medicalphysicist for rulemaking or consultation).

5.

Rulemaking efforts remove technicalstaff from essentiallicensing and inspection tasks 6.

Complicated licensing actions or inspections or enforcement actions cannot be billed by the hour (statutes don't support hourly charges, only

" licensing fees').'

7.

There is little cross-training among either technical or support staff within the RPSprograms.

8.

Formalpolicy/ procedure revisions are seimm updated because these tasks remove technical staff from essent illisensing and inspection tasks B. NON-COMMON PERFORMANCE INDICATORS Leaislation and Proaram Elements Reauired for Comoatibility 27.

Please list all currently effective legislation that affects the radiation control program (RCP).

Statutes: Oregon Revised Statutes ORS 453.605-453.755 28.

Are your regulations subject to a " Sunset

• or equivalent law? If so, explain and include the next expiration date for your regulations.

Oregon rules are not subject to any " sunset" law provisions.

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 eny actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

1 A:\\lMPEP.00E* September 17. 1998 11

The State completed the attached table.

30.

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

The state plans an aggressive rulemaking and will adopt all required regulations that have been designated as compatibility items through 2002.

II.

Sealed Source 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 i

OR-1035-D-101 B Fagus Grecon Gauging Systems Source Holder 9/25/97 OR-8092-D-801-G Medite Industrial Gauging Device 7/7/97 32.

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

NRC SS&D guidance was used to evaluate the application for reissue (re-activation) and the inactivation of a device during license termination.'*

33.

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

The state reactivated a NRC rogistration listed in item 31. The reactivation proca.m did not require the state to evaluate any engineering criteria. The state used existing ?.RC engineering data" to s'aow that the device was identical to that which was registered by the NRC. The re registration was administrative rather than technicalin scope. The licensee's consultant, a Certified Health Physicist (CHP), prepared the application for registration and the State reviewed the pertinent documents. The registration was based only on one component of the former registration.

Technical Staffing and Training - A.lli.11-15

" Commission review of Oregon's request to terminate the SS&D portion of the Oregon Agreement program was scheduled for Spring 1998. Email from NRC OSP dated 4/13/98 documented the FRN and Chairman's signed letter. The state will transfer the two SS&D registrations to NRC per NMSS procedures.

"The state obtained copies from NMSS of all original registration supporting documents prior to review of tha device registration reactivation, including engineering data.

A:\\lMPEP.0VE* September 17. 1998 12

__m 4

!1-Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 111. Low-LevelWaste Proaram

34. -

Please include information on the following questions in Section A, as they apply to the Low-level Waste Program: NOT APPLICABLE Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.lli.11-15.

Technical Quality of Licensing Actions - A.IV.16-18 i

L Responses to incidents and Allegations - A.V.20-23 IV. Uranium Mill Proaram 35.

Please include information on the following questions in Section A, as they apply l

l to the Uranium Mill Program: NOT APPLICABLE l

Status of Materials inspection Program - A.I.1-3, A.l.6 i.

Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 l

1 l

l1 l

L A:\\lMPEP,0VE* September 17. 1998 13

1

. TABLE FOR QUESTION 29.

4

.i OR

+

DATE DATE M CFR RULE DUE ADOPTED CURRENT.

EXPECTED t

STATUS ADOPTION

. i.

A1y amendmert due prior to 1991. identify prior to I

each regulation (refer to the Chronology of 1995 Amendemnds)

)

i Decommissionmg, 7/27/91 1995 Parts 30,40,70

[

b Emergency Planmng, 4/7/93 1995

[

Parts 30,40,70 Standards for Protection Agamst Radiahon, 1/1/94 1995 I

Part 20 l

i Safety Requwements for Radiographic 1/10/94 1995 7

Equipment; Part 34 i

Nohfication of incidents, IL -194 1995 Parts 20,30,31,34,39,40,70 Quahty Management Program and 1/27/95 1995 Meadministrations; Part 35 k

Licensing and Radiation Safety Requwements 7/1/96 DRAFTED 1999 for Irradiators; Part 36 l

Definshor,of Land Disposal 7/22/96 N/A Pio land disposal allowed in oregon f

and Waste Site OA Program; Part 61 t

Decommissionmg Recordkeepmg 10/25/96 1995

{

Documentation Addshons: Parts 30,40,70 t

Self-Guarantee as an Addihonal Financial 1/28/97 DRAFTED; Oregon AG has reworkod to fit its requirements 1999 Mechanism; Parts 30,40,70 t

Uranium Mill Tashngs: Conforming to EPA 7/1/97 N/A No mill taihngs under Agroement State authonty i

Standards; Past 40

?

Tirnelmess in Decommissionmg 8/15/97 1995 l

Parts 30. 40. 70 4

i t

.I A:\\lMPEP.0VE*Septerter 17. 1998 14 I

i E

n

OR' DATE DATE 10 CFR RULE -

DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Preparation, Transfer for Commercial Dis-1/1/9ts Drafted 1999 tnbution, and Use of Byproduct u terial for n

Medical Use; Parts 30,32,35 Frequency of Medcal Exammations for Use of 3/13/98 Drafted 1999 Respiratory Protechon Eqtapment Low-LeveiWaste Stupment Marufest 3/1/98 Drafted 1999 information and Reportmg Performance Requirements for Radography 6/30/98 Drafted 1999 Enuspment Radation Protechon Reqtarements Amended h/14/98 Drafted 1999 Defmitions and Criteria Clarification of Decomrmssioning Fundmg 11/24/98 Drafted 1999 Requirements l 10 CFA Part 71: Compatibility with the 4/1/99 To be drafted 1999 intemational Atomic Energy Agency Medcal Administrabon of Radiation and 10/20/98 To be drafted 1999 Radoactive Materials.

Termmation or Transfer of Licensed Activities.

6/16/99 To be drafted 1999 Recordkeepmg Requirements Resolubon of Dual Regulation of Airbome 1/9/00 To be drafted 1999 Effluents of Radioactive Materials; Clean Air Act Fissile Material Shipments and Exemphons 2/10/00 To be drafted 1999 Recognehon of Agreernent State Licenses in 2/27/00 To be drafted 1999 Areas Under Exclusive Federal &nsdebon Within an Agreerient State Criteria for the Release of Indivwhals 5/29/00 To be drafted 1999 Administered Radioactive Material Licenses for Industnal Radography and 6/27/00 To be drafted 1999 Radiation Safety Requirements for Industrial Radoaraohv Operations: Final Rule A:\\ DmEP.0UE* September 17. 1998 15

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MATERIALS REQUESTED TO BE AVAILABLE FOR THE ONSITE PORTION OF AN IMPEP REVIEW ORGANIZATION CHARTS Clean, sized 8% X 11" including names and positions a One showing positions from Governor oown to Radiation Control Program Director (RCPD) o One showing positions of current radiation control program with RCPD as Head o' Equivalent charts for LLRW and mills progtams, if applicable j

LICENSE LISTS o Printouts of current licenses, showing total, as follows:

Name License #

Location License Type Priority Last inspection Due Date

]

Sort alphabetically Also, sort by due date and by priority (if possible)

J THE FOLLOWING LISTS o List of open license cases, with date of original request, and dates of follow up actions a List of licenses terminated during review period.

O Copy of current log or other document used to track licensing actions a Copy of current log or other document used to track inspections a List of Inspection frequency by license type a Listing or log of allincidents and a!!egations occurring during the review pe:iod. Show whether incident is open or closed and whether it was reported to the NRC r

THE FOLLOWING DOCUMENTS o A!! State re;;ulations a Records of results of supervisory a Statuk:L affecting the regulatory authority accompaniments of inspectors of the state program o Emergency plan and communications list n Standard license conditions a Procedures for investigating allegations o Technical procedures for licensing, model a Enforcement procedures, including licenses, review guides procedures for escalated enforcement, a SS&D review procedures severity levels, civil penalties (as o Instrument calibration records applicable) o inspection procedures and guides a Copies of job descriptions o inspection report forms l

I

~A:\\lMPEP.0VE*Septembar 17, 1998 17 l

_ _ ___. ~ _. _ _ _ _

^

ATTACHMENT A l,

COMPARISON OF OREGON LICENSE TYPES NRC PROGRAM CODES, & PRIORITIES Inspection l

Fee- - OHD/0 AR NRC Frequency code License Tvoe Proaram Code (s) vears (a)

Analyti:al/ Leak Test 03220 5

(b)-

Basic Ll:ense 03232 2

03225,03800 3

03221,03710,11220,11210, 22130,22160,22161 5

(c)

Brachytt erapy 02120 3

l (d)

Broad S.: ope A 01100,03610 2

02110,03211 1

(e).

Broad Scope B 01110,03212,03611 3

(f)

Broad Scope C 01120,03213,03612 5

(g)

Distribution 02511,02513 3

03240,03241,03242,03243,03244, 11230,22170 5

(h)

Fixed Gauge 03120 5

(i)

High doserate brachytherapy 02230,02231 1

(j)

Imaging and Localization 02121,02201 4

f (k) in Vitro Laboratory 02410 5

(I)

Industdal Radiography 03310,03320 1

(m)

Instrument Calibration 03222 3

(n)

Investigational New Drug 02121,02201 5

02120,02200 3

(o)

Irradiator Self-Shiekied 03510 5

03511 3

.(p)

Manufacturing / Compounding 03214 3

[

-(q)

Mobile Nuclear Medicine 02220,02240 2

l (r)

NORM (no processing) 11200 5

l

-(s)'

Nuclear Pharmacy 02500 1

l -.

(t)

Other Measuring Device 03123 (GC), 03124 (xrf) 5 (u)

Portable Gauge 03121,03122 (laad xrf) 4 r

(v)

_Radiopharmaceutical Therapy 02120,02200,02400 3

l (w)

RAM /NOS Facility 03112,03113,03520,11700,23300 3 l

03218,03219 2

03233,03235,03521,03613,03900, 11900,22162,22200 1

(x)

- Research & Development 03620 5

(y)

Sealed Sources for Diagnosis 02121,02201 5

(z)

Source Material 11221,11300,11800 3

(aa). Special Nuclear Material (sealed) 22120,22140,22150,22151 5

l (bb)

Special Nuclear Material (unsealed) 22110,22111 2

l (cc)

Teletherapy. (external beam) 02300 3

(dd)

Unique 03710,03620 5

l (ee)

Uptake and Dilution 02121,02201 4

fff)

Use of Xenon Gas 02121,02201 4

(gq). Waste Packaging 03234 1

(hh)

Well Logging 03111 3

N I

[Ai\\lMPEP,0VE'* September 17. 1998' 18

ATTACHMENTB INSPECTOR DEBRIEF INTERVIEW Inspector Date ofInspection Licensee License Number License Type Inspection Frequency Expiration Date RSO I.

License Review O Adequate O License deficiencies" J

General comment on inspector's view oflicensed program:

i II.

Inspection Overview (box checked means adequate)

O RAM (isotope)

O Inventory (x-check w/ c.opy of records)

O 6,7,8,9 of license O Place of use, temporary jobsites O Validation Cert O RSO O RSC D Authorized users O Dosimetry O Training.

O Incidents O Security O License Conditions O Leak tests O Radiation Measurements O Operating Procedures O Emergency Procedures O Waste Procchk.1 O Posting Signs, Labels, Notices O Transportation Requirements III.

Inspector impressions

.IV.

Findings (Items of noncompliance):

SLI SL2 SL3 Rating Points O Tracking form prepared l

l

(

"If there are licensing deficiencies, use the form " Recommendations to the License Rev; ewer

• to i

recommend changes or identify deficiencies in the license, l

A:\\lMPEP.00E*Septanber 17, 1998 19

ATTACHMENT C O

INCIDENTS REPORTED DURING THE REVIEW PERIOD LICENSEE LICNO RCSNO NOTIFY INCIDENT TYPE CASE CLOSE DATE CLOSED DATE 96-01 19960101 Other - no RAM - Gas leak yes 19960105 Longview inspection-OC 90621 9G-02 19960118 Other - erroneous report of suspected leaking yes 19960123 Group source St Elizabeth Hospital 90705 96-03 19960206 Other - device damaged in transport yes 19960228 96-04 19960305 Other - report of stolen anti-static devices yes 19961030 St. Vincent Hospital 90104 96-05 19960305 Other - medical error yes 19960318 96-06 19960328 Other - GL source material (chemical waste) yes 19960412 96-07 19960409 Other - contaminated metal scrap yes 19960430 96-08 19960418 Other - contaminated metal scrap yes 19960517 96-09 19960429 Other - contaminated metal scrap yes 19960513 Professional Serv.

90056 96-10 19960502 Other - dosimetry badge artifact yes 19960528 Industnes 96-11 19960506 Other - no RAM yes 19960513 Syncor intemational Corp.

90509 96 12 19960528 Other - no RAM yes 19960528 96-13 19960605 Other - contaminated metal scrap yes 19960614 96-13A 19960531 Other - notification of theft of portable gauge yes 19960531 Salem Hospital 90151 96-14 19960610 Other-conte anated garbage yes 19960611 9&15 19960607 Other - notification of lost pauges from Canada yes 19970117 96-16 19960612 Other - contaminated garbage yes 19961030 96-17 19960619 Other - contaminated metal scrap yes 19960801 Professional Service 90056 96-18 19960710 Allegation - radiation exposure during IR yes 19960711 Irdust.

Precision Castparts Corp.

90354 96-19 19960710 Allegation - RAM contamination in demolition area yes 19960816 96-19A 19960730 Other - Notification by agreement state of theft yes 19960730 Doug Enns, DVM 90562 96-20 19960813 Other - contaminated garbage yes 19960904 96-21 19960816 Allegation - theft of ' enriched uranium' yes 19961030 Gary 4 Strait &

9M51 96-22 199C0822 Allegation - radiation exposure during IR yes 19961015 Associates Salem Hospital 90151 9623 19960829 Other - contaminated garbage yes 19960906 96-24 19960904 Other - no RAM yes 19960912 96-25 19960904 Other - Public inquiry yes 19960906 Salem Hospital 90151 96-26 19960906 Other - contaminated garbage yes 19961015 96 27 19960927 Other - contaminated metal scrap yes 19961030 Smurfit Newsprint 90M6 96-28 19961003 Equipent failure - shutter failure yes 19961030 Corporation Salem Hospital 90151 96-29 19961008 Other - medical error yes 19961111 96-30 19961017 Other - contaminated metal scrap yes 19961023 A:\\lMPEP.0VE* September 17. 1998 Attachment C -- Page 20

~

m m

LICENSEE LICNO -

RCSNO NOTIFY INCIDENT TYPE CASE CLOSE DATE CLOSED DATE i-Br un intertec Northwest 90633 96 31 19961022 gugi ent failure - portable gauge cracked source yes 19980502 96 32 19961115 Other - contaminated metal scrap yes 1 % 70117 D;ve Notley and Assoc.

90770 96 33 19961115 Allegation - unsafe use of RAM yes 19970117 Oregon State University 90005 96 34 19961119 Loss of licensed material yes 19961125 Dee Forest Producst 93164 96 35 19961120 Other - Fire yes 19961129 96 36 19961210 Other - contaminated metal scrap yes-19970117 Longview inspection-OC 90621 96-37 19961206 Altogation contacted by NRC yes 19970813 Group Precision Castparts Corp.

90232 96-38 19961211 Other-Contaminated garbage yes 19961223 96-39 19961213 Other-contaminated metal scrap yes 19970117 96 40 19961212 Other - contaminated garbage yes 19970117 Kaiser Sunnyside Hospital 90464 96-41 19961213 Other - contaminated garbage yes 19961223 96-42 19961220 Other - NRC courtesy notification (NRC Misadmin in yes 19961223 OR)

Precision Castparts Corp.

90232 96 43 19961220 Other-contaminated garbage yes 19970110 i

Good Samaritan Hospita!

90006 97-01 19970110 Other - self-discovery of noncompliance yes 19971105 Good Samaritan Hospnal 90006 97-02 19970110 Loss of pkg effectiveness - sealed calibration source yes 19971031 in LSC pjem Hospnal 90151 97-03 19970116 Loss of licensed thaterial yes 19970131 97-04 19970117 Other - contaminated garbage yes 19970117 97-05 19970127 Other - beam Rx overdose yes 19971106 l

Kiiser Sunnyside Hospital 90464 97-06 19970203 Other - contaminated garbage yes 199'711 4 97-07 19970205 Other - contaminated garbage yes 1997Cf4 Salem Hospital 90151 97-08 19970310 Other - contaminated garbego yes 199703u 97-09 19970212 Other-contaminated garbage yes 19970303 97 09 19970212 Other - contaminated garbage yes 19970303 97 10 19970214 Other - contaminated geronge yes 19970303 97 11 19970225 Other - contaminated garbage yes 19971106 97 12 19970225 Other - contaminated garbage yes 19971105 97 13 19970307 Other - contaminated prbage yes 19970321 97 14 19970311 Other - contaminated garbage yes 19970321 97 15 19970312 Other - contaminated metal scrap yes 19970321 PCC Structurais 90232 97 16 19970319 Other - contaminated garbage yes 19970329 Portland Adventist Modecal 90158 97-17 19970325 Other - contaminated garbage yes 19970409 Ctr 97 18 -

19970326 Other - contaminated garbage yes 19971118 Salem Hospital 90151 97 19 19970331 Other - contaminated garbage yes 19980605 Providence Milwaukie 90312 97 20 19970404 Other - contaminated garbage yes 19970421 Hospital l

-A:\\lMPEP.0VE*5eptember 17, 1998 Attachment C -- Page 21 L.

.~

. ~. -

I*

LICENSEE LICNO RCSNO NOTIFY INCIDENT TYPE CASE CLOSE J

DATE CLOSED DATE 4

Smur$t Newsprint 90266 97-21 19970407 Other - public exposure yes 19970416 i

Cn.poration

^

97-22 19970415 Other - contaminated metal scrap yes 19371117 97-23 19970421 Other - contaminated metal scrap yes 19971105 Good Samaritan Hospital 90008 97-24 19970417 Other - beam Rx overdose yes 19971105 a

4 97 25 19970503 Other - Nat1 Resp Center Transportation incki.nt -

yes 19970601

].

no RAM Willamette Industries 90141 97 26 19970505 Other - damaged fixed gauge mounting track yes.

19971031 l

97 27 19970515 Othor -- Report of Chemical Fire & Explosion yes 19971106 f'

97-28 19970521 Other - contaminated metal scrap yes 19971117 i

Oregon Health Sciences 90013 97-29 19970522 Other-medical error yes 19970527 4

97 29A 19970530 Other - Contaminated lead aprons yes 19970701 9

l 97-30 19970606 Other - contaminated metal scrap yes 19970818 Longview Inspectum4C 90621 97-32 19970610 Allegation - radiation exposure during IR yes 19971105 Group i

97 33 19970618 Other - contamins.ted metal scrap yes 19971117 Willamette Falls Hospital 90294 97-34 19970618 Other - contaminated garbage yes 19970630 t

l 97-35 19970619 Other-contaminated garba[,

yes 19971006 l_

St. Vincent Hospital 90104 97 36 19970624 Other - medcal error yes 19971105 6

97-37 19970626 Other - contaminated garbage yes 19970701 1

97 38 19970627 Other - transportation / survey yes 19970701 97-39 19970707 Other - contaminated garbage yes 19970813 Galem Hospital 90151 97 40.

19970711 C*r - contaminated garbage yes 19970806 97-41 19970713 Other - Natl Resp Ctr reported Unusual event - no yes 19970715 a

RAM 1

i Meridian Park Hospital 90293 97-42 19970714 Other - contaminated garbage yes 19970818 97-43 19970718 Other - contaminated metal scrap yes 19971117 97-44 19970728 Other-contaminated garbage yes 19970801 97-45 19970731 Other - contaminated metal scrap yes 19970806 j

97 46 19970803 Other - Prank yes 19971105 Comforth Consultants 90652 97-47 19970806 Other - device incident - Portable gauge accident yes 19971006 i

97-48 19970808 Other - contaminated metal scrap yes 19971105 97-49 19970811 Other-NORM hazardous waste yes 19971105 1

Emanuel Hospital 90014 97-50 19970814 Other - delivery to wrong licensee address yes 19970903 97-51 19970819 Loss of licensed material yes 19970903 Reed College 90010 97-52 19970827 Other - Leaking Triga reactor fuel element yes 19970903 Longview inspection-OC 90621 97 53 19970829 Oth6r -IR disconnect Group 97-54 19970929 Other - contaminated garbage yes 19971001 A:\\lHPEP.00E* September 17, 1998 Attachment C -- Page 22

~

?s UCENSEE LICNO RCSNO NOTIFY INCIDENT TYPE CASE CLOSE DATE CLOSED DATE 97 55 19970929 Other - no RAM yes 19971001 97-56 19970929 Other - contaminated metal scrap yes 19971006 G7 57 19971001 Other - contaminated garbage yes 19971117 97-58 19971001 Other - contaminated garbage yes 19971117 97-59 19971002 Otheri contaminated metal scrap yes 19971006 97-60 19971006 Other - contaminated garbage yes 19971027 GeoDesigns 90822 97-01 19971010 Other - device incident - Portable gauge accident yes 19971117 Columbia Willam Vallcy 90712 97-62 19971008 Other - medical error yes 19980612 Med Ctr 97-63 19971017 Other - contaminated metal scrap yes 19980209 97-64 19971013 Other - contaminated metal scrap yes 19971105 97 65 19971016 Other - contaminated garba'it yes 19971027 97-66 19971023 Allegation - plea bargain; drug issue; loss / theft of yes 19980520 material 97-67 19971023 Other - contaminated garbage yes 19971027 Westem Professional 90344 97-68 19971024 Other - X-ray overexposure yes 19980515 McKenzie-Willamette 90298 97-69 19971031 Other-contaminated garbage yes 19971117 Hospital 97 70 19??1105 Other - contaminated metal scrap yes 19980209 97-71 19971110 Other - contaminated metal scrap yes 19980209 97 72 19971117 Other - contaminated metal scrap yes 19980209 97 73 19971111 Other - contaminated garbage yes 1997120f Legacy Emanuel Hospital 90014 97 74 19971119 Misadministration caused by Rx seeds being yes 19980319 undercalibrated 97 75 19971124 Other - contaminated metal scrap yes 19980209 Oregon State University 90005 97 76 19971125 Other - Mixed waste spill yes 19971209 97 77 19971204 Other - Chemical incident (Radiation levels from yes 19971210 K-40) 97-78 19971201 Other - contaminated garbage yes 19971209 l

97 79 19971208 Other - contaminated metal scrap yes 19971217 97 80 19971210 Other - RAM disposal problem yes 19980123 Northwest industries 90763 97-81 19971211 Allegation - environmental contamination--S/IWSNM yes 19980319 l

Oregon Health Sciences 90731 97-82 19971216 Other - comtamination ' incident yes 19980319 l

Univ.

Intemational Paper 90012 97-83 19971219 Other - Fire & Explosion yes 19980109 Company Mission MedicalImaging 90583 97-84 19971231 Other - contaminated garbage yes 19980209 Dave Notley & Associates 90770 97 85 19971230 Other - untimely death of licensee yes 19980529 98-01 19980105 Other-contaminated metal scrap yes 19980529 98-02 19980113 Other - contaminated metal scrap yes 19980529 l

A:\\lMPEP.0VE* September 17, 1998 Attachment C -- Page 23 i

.... _. ~ - - - _ _ -. - -

Ia LICENSEE LICNO RCSNO NOT;FY INCIDENT TYPE CASE CLOSE

y DATE CLOSED DATE 1

98-03 19980119 Other - contaminated garbage yes 19980120 t

98-04 19980121 Other-contaminated metal scrap yes 19980209 i

98-05 19980119 Other - contaminated metal scrap yes 19980209 Sacred Henri Medical 90270 98-06 19980123 Other - medical error Center yes 19980319 i

i j

98-07 19980122 Other - notification of theft of RAM gau9e yes 19980529 B. sun Intertec Corporation 90634 98-08 19980126 Allegation - radiativn exposure during IR yes 19980223 98-09 19980127 Other - hazardous materials notification yes 19980529

)

98 10 19980203 Other - contaminated garbage yes 19980319 98-12 19980220 Other - contr'minated garbage yes 19980529 Oregon State University 90005 98-13 19980219 Other - ieportable Es eC4eactor yes 19980529 Smurfit Newsprint 90266 98-14 19980224 Other - Gauge incident caused by not following i

Corporation procedures 98-15 19980305 Other Chemicalincident yes 19980306 98-16 19980312 Other - contaminated metal scrap yes 19980529 98-17 19980323 Other - contaminated metal scrap yes 19980529 i

98-18 19980324 Other - contaminated rnetal scrap yes 19980529 98-19 19980325 Other - contaminated garbage yes 19980529 Longview Inspection 90621 98-20 19980402 Other - IR incident caused by not following yes 19980515 proedures 98-h'1 19980409 Other-contaminated metal scrap yes 199R0529 l

96-22 19980410 Other - contaminated metal scrap yes 19980529 98-23 19980420 Other - contaminated metal scrap yes 19980529

'.d.nnbia Meinorial 90343 98 ' 1 19980409 Other - medical error yes 19980529 Psspital Columbia Douglas Medical 90'"4 98-25 19980416 Other - medical error yes 19980529 Ctr.

98-25 19980416 Other - medical error yes 19980529 98-26 19980417 Other - contaminated metal scrap yes 19980529 98-27 19980421 Other - contaminated metal scrap yes 19980529 98-27 19980421 Other-contaminated metal scrap yes 19980529 98-28 19980513 Other-contaminaud metal scrap yes 19980529 98 29 19980515 Other-contaminated metal scrap yes 1998M20 98-29 19980513 Other-contaminated metal scrap yes 1998052J 98-30 19980527 Other-contaminated metal scrap 98-31 19980527 Other-contaminated metal scrap 98-32 19980605 Other - report of Co-60 contaminated cookware yes 19980605 A:\\IMPEP.0VE Attachment C -- Page 24

?

Ms. Elinor Hall, Administrator Oregon Health Division Department of Human Resources 800 NE Oregon Street, Suite 925 Portland, OR 97232

/

Dear Ms. Hall:

On October 13,1998, the Management Review Board (MRB) met to consider the proposed final Integrated Materials Performance Evaluation Prograny'(IMPEP) report on the Oregon Agreement State Program. The MRB found the Oregon program adequate to assure public health and safety and compatible with NRC's program.p/

/

Section 5.0, page 13, of the enclosed final report presents the IMPEP team's recommendations 5mber 30,1998 letter which described the and suggestions. We received Mr. Ray Paris' Sep)dations. We request no additiona actions taken in response to the team's recommeri information.

Based on the results of the current IMPEP review, the next full review will be in approximately 4 years.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your support of the Radiation Controlpogram. I look forward to our agencies continuing to work cooperatively in the future. /

Sincerely, Hugh L. Thompson, Jr.

. Deputy Executive Director for Regulatory Programs

Enclosure:

As stated cc:

Ray D. Paris, Manager Oregon H alth Division David Stewart-Smith Oreg ' State Liaison Officer Distribution:

DIR RF EDO R/F DCD (SP01)

SDroggitis TCombs, OCA (2)

PDR (YES_f_ NO

)

RWoodruff, Ril CHackney, RIV HThompson, EDO SMerchant, NMSS LMcLean, RIV RBangart, OSP bec:

DBunn, OAS,CA DCool, NMSS CPaperiello, NMSS Chai man Jackson FCam;ron, OGC KSchneider KCyr, OGC Com+.isssioner Diaz HNowsome,DGC LRakovan SRubin, AEOD Com missioner McGaffigan Oregon File' GDeegan, NMSS

• SEE PREVIOUS CONCURRENCE.

DOCUMENT NAME: G:\\lMPEP\\98FINLTR.OR / G:\\lMPEP\\OR98 FIN.WPD

. g, ce,..'em or ini. ooeum.nt, indic.i. in in. i,or: c - copy wirnout attachmente.ncio.or. e copy witn c.traenment/arx osure N* = No copy

" OFFICE OSP l

OSP:DD OSP:D /l, l DEDR NAME TO'Brien:nb PHLohaus RLBangart W6 HLThompson DATE 10/22/98

• 10/22/98

• 10dle/98 10/

/98 OSP FILE CODE: SP-AG-23 i

4 I

i 1

Ms. Elinor Hr.II, Administrator Oregon Health Division i

Department of Human Resources 800 NE Oregon Street, Suite 925 Portland, OR 97232

Dear Ms. Hall:

On October 13,1998, the Management Review Board (MRB) met to c sider the proposed j

final Integrated Materials Performance Evaluation Program (IMPEP)/eport on the Oregon i

Agreement State Program. The MRB found the Oregon programpequate and compatible with l

NRC's program.

j Section 5.0, page 13, of the enclosed final report presents tt)e MPEP team's recommendations and suggestions. We received Mr. Ray Paris' September

,1998 letter which described the actions taken in response to the team's recommendatio. We request no additional information.

I 1

Based on the results of the current IMPEP review, he next full review will be in approximately 4 years.

j l appreciate the courtesy and cooperation extended to the IMPEP team during the review and your support of the Radiation Control Prograln. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely, I

Hugh L. Thompson, Jr.

Deputy Executive Director for Regulatory Programs J

f

Enclosure:

As stated j

cc:

Ray D. Paris, anager Oregon Heal Division David Stew /

art-Smith Oregon State Liaison Officer Distribution:

DlR RF EDO R/F DCD (SP01)

SDroggitis TCombs, OCA (2)

PDR (YES_(_ NO

)

RWoodruff, Ril CHackney, RIV HThompson, EDO l

SMerchant, NMS LMcLean, RIV RBangart, OSP bec:

)

DBunn,OAS,9 DCool, NMSS CPaperiello, NMSS Chairman Jackson FC:meron,001C KSchneider KCyr, OGC Commisssioner Diaz l

HN wsome LRakovan SRubin, AEOD Commissioner McGaffigan l

Oregon File /, dGC GDeegan, NMSS

{

DOCUMEtdT NAME: G:\\lMPEP\\98FINLTR.OR / G:\\lMPEP\\OR98 FIN.WPD

/

Ta receive a copr of this docurnsat, Indicate in the bot: "C" = SogyJwitrdut attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE OSP

,l OSMMl OSP:D l

DEDR l

l o

NAME TO'Brien:nf5l#5 PHLolVatik ' )

RLBangart HLThompson l

DATE 10/21/98 10/22/98 10/ /98 10/

/98

{

OSP FILE CODE: SP-AG-23

_