ML20153E694
ML20153E694 | |
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Issue date: | 09/16/1998 |
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM ,
REVIEW OF OREGON AGREEMENT STATE PROGRAM August 10-13,1998 1
i i l DRAFT REPORT l
U.S. Nuclear Regulatory Commission l
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e 1r i
[ 9809280212 980916 PDR STPRO ESGOR PDR l -__ _
Oregon Draft Report Page 1
1.0 INTRODUCTION
This report presents the results of the review of the Oregon radiation control program. The 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 v,ith the " Implementation of the Integrated Materials Performance Evaluation Program and Rescission of a Final General Statement of Policy," published in the Federal Reaister on October 16,1997, and the November 25,1997, revised NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period July 11,1996 to August 13,1998, were discussed with Oregon management on August 13,1998. l
[A paragraph on the results of the MRB meeting will be incluced here in the final report.)
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 4
cherts for the Department of Human Resources are included as Apoendix B.
l At the time of the review, the Oregon RPS regulated 352 specific licenses, including limited and i broad scope medical institutions, academic institutions, industrial radiography, fixed and l portable gauge units, and nuclear pharmacy licensees. l The review focused on the materials program as it is carried out under the Section 274b (of the 4
Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Oregon.
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 .
F of this report. 1
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The review team's general approach for conduct of this review consisted of: (1) examination of Oregon's response to the questionnaire; (2) review of applicable Oregon statutes and regulations; (3) analysis of quantitative information from the RPS licensing and inspection data 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 i and made a preliminary assessment of the RPS performance.
Section 2 below identifies that there were no recommendations resulting from the follow-up rev;ew conducted in 1996. The previous full program review conducted in 1995 found the Oregon program compatible, but withheld a finding of adequacy. The 1996 follow-up review 4 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 j IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common performance indicator, and Section 5 summarizes the
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Oregon Draft Report Page 2 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 indicaters are: (1) Status of Materials Inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.
3.1 Status of Materials Inspection Proaram The review team focused on four factors in reviewing this indicator: (1) inspection frequency, (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 evaluation is based on Oregon's questionnaire responses relative to this 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.
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, which were identified as requiiing 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 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 licensed activities. There were 43 initial inspections of in-state licensees due during the review period. Of those due,24 (55%) were not inspected within the 6 month requirement. The team noted that 41 of the initialinspections were completed within 7 months and the remaining 2 inspections were completed within 8 months. 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.
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l Oregon Draft Report ' Page 3 The RPM manager indicated that the RPS accelerated the inspection workload and eliminated the entire backlog by the end of July 1990. 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 intemally 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 l 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.
- 2. Out-of state licensees that infrequently perform work in Oregon may choose not 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 Ill 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 licensos an inspection.
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
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' b Oregon Draft Report Page 4 L
- (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 at the conclusion of the inspection. The inspector indicates any violations found on the form 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, i he will return to the HPS and discuss the matter with the RMP manager. In these cases, the 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 Matenals inspection Program, be found satisfactory with recommendation for improvement.
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 interviewed inspectors for 16 materials inspections conducted during the review period. The casework 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 involving meetings or hearings with licensees.
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 Violation form. Follow up to enforcement letters was evident and complete. All enforcement cases were resolved promptly.
Oregon Draft Report Page 5 There were 229 inspections performed during the review period. Through 1998 to date,89 i inspections have been' completed. The RPS uses NRC inspection guides and checklists. The l team reviewed the inspection field notes and, with the exceptions noted below and in Appendix C, found them to be comparable with the types of information and data collected under NRC i
Inspection Procedure (IP) 87100 and thorough with all items checked and written comments l where necessary. The inspection field notes provided documentation of the licensee's program l including: posting; storage and use of radioactive material; receipt, transfer, and disposal of radioactive material; inventory; leak tests; radiation protection program; personnel monitoring; l training; independent measurements; and inspection findings. The team also noted the l 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 team suggests that the RPS obtain and use the HDR inspection checklist and the latest version of inspection checklists found in IMC 87100. '
The RPS management policy is to conduct unannounced inspections whenever possible.
Announced inspections usually involve initial inspecticns or inspections at licensees in i geographically-distant locations from Portland. Inspection reports were signed by management. The RMP manager was aware of inspection findir.gs through de-briefing by the inspector in response to the questionnaire and through discussians with the RMP manager, the State reported the number and type of supervisory accompaniments performed during the review period. Allinspectors were accompanied annually. The RPS manager accompanied the RMP manager during various licensee management meetings throaghout the review period.
The RPS uses a rating system to score the licensee after an inspect.on. A low score can lead to the shortening of the inspection frequency down to 75% of the smual 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 uniaue me'i. .' for educating the licensee of Oregon's regulations as they pertain to the licensees' operath .. 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 " 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 these inspection approaches 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.
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 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 I
(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 i
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i l Oregon Draft Report Page 6 scintillation counter and germanium detector system for gamma spectroscopy and a portable l multichannel analyrSr. 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, 4 1998. One inspector was accompanied during an unannounced inspection of an institutional l nuclear medicine facility with brachytherapy on June 23,1898. The other inspector was i
accompanied on June 24,1998 during unannounced inspections of a research and l development facility using americium 241, and another facility that manufactures lodine-125 i j test kits. These accompaniments are listed in Appendix C.
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During the accompaniments, the State inspectors demonstrated appropriate inspection l 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 l 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 i performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.
3.3 Technical Staffina and Trainina Issues central to the evaluation of this indicator include the radioactive materials program l staffing level and staff turnover, as well as the technical qualifications and training histories of l the staff. To evaluate these issues, the review team examined the State's questionnaire l responses relative to this indicator, and interviewed RPS management and staff, and j considered any possible workload backlogs.
At the time of the review, Oregon's radioactive materials program was staffed by the RPS i manager, RMP manager, three full time technical staff, and one full time administrative staff 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 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 act5ns as discussed in Section 4.1.2, the review team recommends that the RPS management i assess whether additional staffing is warranted to complete overdue rulemaking actions and to ensure timely completion of upcoming rulemaking actions.
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 i
retired from the radioactive materials program in March 1998. This vacancy was recently filled j; 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.
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Oregon Draft Report Page 7 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 ntensive 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 and Procedures course or its equivalent to fully address their training needs. The technical 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 documentation 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 cf 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.
In discussions with the RPS, the team found that there are no radiation oversight boards and, therafore, the team determined that there is no poteritial 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 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.
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Oregon Draft Report Page 8 The licensing casework was selected to provide a representative sample of licensing actions 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 tile 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 nuclear medicine; therapy; and nuciear 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.
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.
The review team found that the licensing actions were generally very thorough, complete, of high quality, and with health and safety issues properly addressed. The licensee's compliance i 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. Fohowing 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 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 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.
Alllicensing actions were signed by management. Deficiencies are addressed by letters and documented telephone inquiries which use appropriate regulatory language.
The State provided a listing of 58 licenses that have been terminated since the last review. A 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 half lives. Four termination files were selected for review based upon the potential for residual contamina'. ion, 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.
Oregon Draft Repo.1 Page 9 3.5 Resoonse to incidents and Alleaations
' ,maiuating 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 materialincidents 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 1938.
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.
The State has consistently reported incidents, that require immediate or 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> reporting by the State licensee, to the NRC Operations Center. However, there were multiple written policies and procedures for incident response dated from 1984 to the present within the State's policy arid 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 4
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. Inspectors 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.
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
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Oregon Draft Report Page 10 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 wriMen policy with procedures for responding to allegations.
- 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 l State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed l Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Oregon recently turned back the sealed source and l device evaluation program portion of their Agreement and Oregon's Agreement does not l include uranium recovery program authority.
In 1981, the NRC amended its Policy Statement," Criteria for Guidance of States and NRC in l Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to l allow a State to seek an amendment for the regulation of LLRW as a separate category. Those States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although Oregon has LLRW disposal authority, NRC has not required States to have a program for licensing a LLRW disposal facility until such time as the State has been designated as a host State for a LLRW disposal facility. 1 When an Agreement State has beer' 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 l LLRW disposal facility in Oregon. Accordingly, the review team did not review this indicator.
4.1 Leaislation and Proaram Elements Reauired for Comoatibility l This non-common performance indicator is evaluated in accordance with the Commission's 1997 Policy Statement on Adequacy and Compatibility of Agreement State Programs. It is I noted that Management Directive 5.9, Handbook, Part V, provides that (1) program elements I other than regulations, and (2) NRC regulations required for compatibility, should be adopted by I the State as expeditiously as possible, but not later than six months and 3 years, respectively, after the September 3,1997 effective date of the Commission Policy Statement on Adequacy and Compatibility.
4.1.1 Leaislation 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 Statute 453.625. The Radiation Protection Service is designated as the State's radiation control agency. The review team noted that no legislation affecting the radiation control program was passed during the j review period.
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Oregon Draft Report Page 11 4.1.2 Proaram Elements Reauired for Comoatibility The Oregon Regulations for Control of Radiation, found in Oregon Administrative Rules l 453.605-453.755, apply to all ionizing radiation, whether emitted from radionuclides or devices.
l Oregon requires a license for possession and use of all radioactive material including naturally l occurring materials, such as radium, and accelerator-produced radionuclides. Oregon also l requires registratiors of all equipment designed to produce x-rays or other ionizing radiation.
I l The review team examined the State's administrative rulemaking process and found that the l
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 i Resources Office of the Administrator. When an acceptable draft proposed revision to a rule i
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 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 ;
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 j become effective. l l The team evaluated Oregon's responses to the questionnaire and reviewed the status of 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 l 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 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 which were due for adoption prior to the Commission's 1997 Policy Statement on Adequacy and Compatibility of Agreement State Programs..
l l * " Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 amendment
! (58 FR 7715) that became effective July 1,1993.
1 e "Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (59 FR 1618) that became effective January 28,1994.
The State has not adopted the following regulations which, in accordance with the
. Commission's 1997 Policy Statement on Adequacy and Compatibility of Agreement State
! Programs, are due by September 3,2000 l
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Oregon Draft Report Pap 12
- " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32, and 35 amendments (59 FR 61767 and 65243) that became effective January 1,1995.
- " Frequency of Medical Examinations 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 Paris 20 and '61 amendments (60 FR 15649 and 25983) that became effective March 1,1998. The Agreement States are to promulgate their regulations no later than March 1,1998 so that NRC and the State would require this national system to be effective at the same time.
- " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995.
- " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995.
e " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996.
e " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective October 20,1995, e " Termination or Transfer of Licensed Activities: Record Keeping Requirements," 10 CFR 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 Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.
- " 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.
e " Fissile Material Shipments and Exemptions," 10 OFR Part 71 amendment (62 FR 5907) that became effective February 10,1997.
- " Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71,150 amendments (62 FR 28947) that t ecame 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.
- . -. -_ - - . -. . -~. -- . -
O
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l Oregon Draft Report Page 13 l
l The State indicated they anticipate adoption of the overdue regulations and the regulations I
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 l during the July 29,1995 full review. A delay in regulation adoption was also noted during the July 11,1996 follow-up review. 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.
l 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 Compatibility, be found satisfactory. ,
4.2 Sealed Source and Device (SS&D) Evaluation Proaram in April of 1998, the Commission approved the turnback 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 were reviewed under the Technical Quality of Licensing Actions (Common Indicator 3.4).
Therefore, this indicator was not reviewed.
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found Oregon's performance for the common performance indicators 3.2 through 3.5, and the non-common indicator, " Legislation and Program Elements Required for Compatibility, to be satisfactory. The State's performance for common performance indicator 3.1 was found to be satisfactory with recommendations for improvement. Accordingly, the review team recommends that the Management Review Board find 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 recommendr Mt Oregon heighten its management oversight of the inspcction due dates of new licenses to ensure inspections are performed in accordance with RPS policy and IMC 2800, Section 04.03a (Section 3.1).
- 2. The review team recommends that RPS management assess whether additional staffing is warranted to complete overdue rulemaking actions and to ensure timely completion of upcoming rulemaking actions (Section 3.3).
l 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 l 3.4).
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! Oregon Draft Report Page 14
- 4. The review team recommends that the State develop a written policy with procedures for !
responding to allegations (Section 3.5). J
- 5. The review tearn recommends that management obtain a State legal view on their 3
interpretation that existing administrative rules require the implementation of all new '
I requirements in the revised NRC regulations where required for compatibility purposes l (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).
SUGGESTIONS:
- 1. The review team suggests that the RPS consider using another term such as " status report" rather than call the " inspection by mall" process for out-of-state licenses an inspection
- (Section 3.1).
l l 2. The review team suggests that management oversight of enforcement actions be documented in future enforcement activities (Section 3.2).
1 3.' The review team suggests that the RPS obtain and use the HDR inspection check list and i the lateshersion of inspection checklists found in (MC 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, who performs licensing assistant duties, attend the Licensing Practices course or its equivalent for cross training l purposes (Section 3.3).
- 6. The review team suggests the RPS training form be updated to reflect the completion of the y Teletherapy and Brachytherapy course by an inspection staff member and that the training l form be modified to allow for management sign-off of completed and waived courses
[ (Section 3.3).
l l 7. The review team suggests that the comments on Appendix D be reviewed for actions as j
~
l appropriate (Section 3.4).
L j 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:
I
- 1. 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 i
O -
Oregon Draft Report Page 15 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).
- 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 " vertical slice" approach to their inspections where several types of radioactive sources are tracked from their receipt on through to disposal (Section 3.2).
i 4
0
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 Appendix F Oregon's Questionnaire Response
APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Tom O'Brien, OSP Team Leader Technical Staffing and Training Leg)slation and Program Elements Required for Compatibility Donald Bunn, California Status of Materials inspection Program Technical Quality of Inspections Sally Merchant, NMSS Response to incidents and Allegations Richard Woodruff, Region 11 Technical Quality of Licensing Actions l
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l APPENDIX B l-l State of Oregon DEPARTMENT OF HUMAN RESOURCES OREGON HEALTH DIVISION j i RADIATION PROTECTION SERVICES ORGANIZATION CHARTS l-l l
l -
l' 3
i I
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i j
Department of Human Resources *
+
lean L Thome Acting Director l !
Bob Mink Deputy Die i i
1 DIVISIONS Office of the Director ;
PROCRAM OFFICES $,s ;
(Assistant Directors)
SteveMinnich Kay Toran Adult & Farnity Children's Services Services Division Division IIersh Crawford leffKushner
( Alcohol & Drug Officeof h . 1 AbuseProgreens Binor Hall Jim Wdson Assistance Prog. Health Senior and Disabled Division Services Division ,
! Chad Cheriel "
Tumn Office of V unw Joil Southwell Health Policy W oggic.cf theOi,coor Vocational RehabilitaHon Be Mental ml Kad 3 ADMINISTRATION Division De g}y y ,
(Assistant Directors) l John Cuddy Ken M111er JohnHeilman Information and de Seik! Jim Sellers Ken Johnson C.pc, : al Prog.
Systems nce Services Coortl Communiations Audit 6
, *g ,
omCE OFTilE ADMINISTRATOR
- Elinar Hall, Aansameraser .
Grass Higgeman, Heshh Officer CROSS AGENCY & SPECIALPROGRAhl5 (Wishhe OfHee of the Adanimistraterl ,
S' ir HEALM REI,ATED LINSING CERTIFICATE OF NEED PROGAhl g y,g See Wilson COkikIUNICATIONS & PLANNINC .
Dannie WiderbwgClau&a Black OFFICE OF klULTICULTURAL \
\ PURCilASING IIEAI.Til Karil Schaefer Susanya Sockalaneam \
I FACILITIES /kIAllCENTER COkl%IUNITY SERVICES ,
' Dick IIenne i Carol Allen
\, j PLANS REVIEW \
Racce Lawless q CENTER FOR DISEASE PREVENTION t
< CENTER FOR ENVIRON AIENT &
CENTER FOR PUBLIC IIEALTil IIEALTil SYSTEkIS & EPIDEkIIOLOGY Dave Fleming LABORATORIES CENTER FOR C!!ILD & FAkIILY Tem Johnson kk* Sk'*i' !
IIEALTIl !
5/ sr i/ !
NEWDORN SCREENING DRINKING WATER ACUTE AND COkiklUNICABLE Richard kliyahira blATERNAL & CIIILD IIEALT11 Dave I. eland plSF,ASE SYSTEkl Paul Caeslak VIROLOGY /lkiBlUNOLOGY
- ermine Duncan EnlERCENCY AIEDICAL SERVICES Christaanne Bigg
& SYSTERIS IllV/STD/TB WOklEN/ REPRODUCTIVE IIFALTil Gregg Lander klark Imh CENERAL hilCROBIOIA)GY ,
Anne Olsen Robert ScLelow IIEALTil CARE LICENSURE & IIEALTII PROklOTION & CIIRONIC ClllLD/ ADOLESCENT IIEALTIl CERTIFICATION DISEASE PREVENTION IADORATORY UCENSURE &
Jall Skrez3ne Kathleen Smail Jane bloore CERTIFICATION Audrene tierton IBIklUNIZATION RADIATION PROTECTIVE SERVICES ENVIRONkIENTAL OCCUPATIONAL laraine Duncan/ Betty Finemout Ray Paris & INJURY EPIDEBIIOLE OUALITY ASSURANCE &
Harda Tolentino OPERATIONS W[G ENVIRONhlENTAL SERVICES & Wayne Jeffm Donalda Dodson CONSULTATION CENTER FOR IIEALTil STATISTICS Ron Itall Edward Johnaan
-m e
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
Admin. Spec.I Gibson C0107/446 t 1
3 I I Prin Exec Nqr. C Prin Exec.Mgr. C Prin. Exec.Hgr. C X1004 Dibblee 309 .X1004 Hocken 465 X7004 Goevelinger B47 Radioactive Electronic Products Emergency Response & ,
Material Program Program Non-ionizing Programs 1 I I I
! ! I I Chemist Envir. Office Env. l Office III Health Spec.I Health Spec. Environ. Program Environ. Office Spec. Spec. II Health Rep. ~II Health Sp~ec. II Martin III Hinkle III Smith Spec."II' vacanE spec.III' Vacant Miller vacant Loomis Wilson Strand Lindsey Rapcinski C3117 C0103 Crawford C0104 C3818 C0817 C3819 C0104 848 C3819 706 Grant 300 922 213 387 388 707 920 308 C3819 464 924 157 392 r
I agn i usu t etswegnes s. cat
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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 l TEAM.
File No.: 1 ,
Licensee: Good Samaritan Hospital License No.: ORE 90008 Location: Portland, OR Inspection Type: Routine, Unannounced j 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: i
. a) Inspector did not use HDR inspection form. 1 File No.: 3 Licensee: Precision Castparts Corporation License No: ORE-90232 Location: Portland, OR inspection Type: Routine, Announced 1 License Type: Broad scope A, Industrial Priority: 2 l Inspection Date: 12/16/96 Inspector: TL File No.: 4 i
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 q
- 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
. Location: Lombard, IL. Inspection Type: Field, Reciprocity License Type: Portable Gauge Priority: 5 Inspection Date: 5/18/98 Inspector: TL
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.e Oregon Draft Report Page C.2 Inspection File Reviews File No.: 7 Ucensee: 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 Type: 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 Licensee: Oregon Osntral Pharmacy License No.: ORE-90703 Location: Eugene, OR Inspection Type: Routine, Announced License Type: Radiopharmacy Priority:1 1 Inspection Date: 7/24/97 Inspector: TL File No.: 11 Licensee: Bay Area 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 File No.: 12 Licensee: Professional Service industries License No.: ORE-90056 l Location: Portland, OR Inspection Type: Routine, Announced License Type: Radiography / Field Sites Priority: 1 .
Inspection Date: 10/28/97 Inspector: TL File No.: 13 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: T/.
I Oregon Draft Report Page C.3 Inspection File Reviews File No.: 14 .
l Licensee: Good Samaritan Hospital License No.: ORE-90202 Location: Corvallis, OR inspection Type: Routine, Unannounced
! License Type: Medical Priority 3 Inspection Date: 12/17-18/98 Inspector: TL l
L Comment:
l 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 Liceasee: Earth Tech, Inc. License No.: ORE-90840 Location: Long Beach, CA inspection Type: MailInspection
- License Type: Lead Paint Analyzer Priority: 4 Inspection Date: 7/14/98 Inspector: N/A
( File No.: 16 i Licensee: Nuclear Medical Imaging Consultants License No. ORE-90771 (Terminated)
Location: Albany, OR Inspection Type: Initial, Unannounced
, License Type: Medical (Clinic) Priority: 3 l Inspection Date: 2/10/98 Inspector: TL L in addition, the following inspection accompaniments were made as part of the on-site IMPEP review:
Accompaniment No.: 1 Lic0nsee: Providence Portland Medical Center License No.: ORE-90053 l
Locawn: Portland, OR Inspection Type: Routine, Unannounced l=
License Type: Institutional Nuclear Medicine Priority: 3 inspection Date: 6/23/98 Inspector: TL l
Accompaniment No.: 2 Licensee'. Sentrol, OR License No.: ORE-90637 Location:Tualatin, OR Inspection Type: Routine, Unannounced License Type: Manufacturing /Research & Development Priority 2 Inspection Date: 6/24/98 Inspector: MD l Accompaniment No.: 3 Licensee: Neogenesis, Inc. License No.: ORE-90618 Location: Portland, OR Type inspection: Routine, Unannounced i License Type: Manufacturing / Compounding Priority 3 j .. Inspection Date: 6/24/98 Inspector: MD L
I
APPENDIX D -
LICENSE 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: Sentrol, Inc. License No.: ORE-90637 Location: Tualatin, OR Amendment No.: 14 License Type: Mfg /Research & Development Type of Action: Renewal Date issued: 9/26/97 License Reviewer: MD File No.: 2 Licensee: Neogenesis, Inc. License No.: ORE-90618 Location: Portland, OR Amendment No.: 4 License Type: Research and Development Type of Action: Financial Assurance Date issued: 6/23/98 License Reviewer: MD File No.: 3 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 Date issued: 10/29/97 License Reviewer: RC File No.: 4 Licensee: Sulzer Bingham Pumps, Inc. License No.: ORE 90027 Location: Portland, OR 10247 Amendment Nos.: 78 thru 80 License Type: Industrial Radiography, Fixed Facility Type of Acticn: 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 License No.: ORE-90728 i Location: Albany, OR Amendment No.: 12 l License Type: Industrial Radiography, fixed facility Type of Action: Amcadment Dates Isr.ued: 10/25/96 License Reviewer: TL, MD Comments:
a) Temporary job site license condition should not be on the license.
b) License inappropriately authorizes the receipt, possession, and use of iridium-192.
l I
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l Oregon Draft Report Page D.2 License File Reviews I File No.: 6 i ; Licenese: Edwards Pipeline Services, LLC License No.: ORE-90860 1- Location: Tulsa, OK
- License Type
- Industrial Radiography, temporary locations Type of Action: New
- Comment:
a) License inappropriately authorizes the receipt, possession, and use of cobalt-60. 1 File No.: 7.
j Licensee: Oregon Central Pharmacy License No.: ORE-90703 ,
Location: Eugene, OR Amendment No.: 8 l
. License Type: Nuclear Pharmacy Type of Action: Amendment i i Date issued: 3/16/98 License Reviewer: SM, MD ;
F File No.: 8 !
Licensee: Braun Intertec, Inc. License No.: ORE-90634
- Location
- Portland, OR Amendment No.: 16 1 i
License Type: Industrial Radiography Type of Action: Araendment l
1 i File No.: 9 i Licensee: Mallinckrodt, Inc. License No.: ORE-90702 P Location: Portland, OR Amendment No.: 7
. License Type: Nuclear Pharmacy Type of Action: Amendment Dates issued: 3/13/98 License Reviewer: SM, MD File No.: 10.
Licensee: Oregon Health Services University License No.: ORE-90013 4
Location: Portland, OR Amendment Nos.: 80 and 81 l License Type: Broad Medical (Scope A) Type of Action: Amendment j Dates issued 1/16/97,5/14/98 License Reviewer: MD, TL L
Fiie No.11 Licensee: Williamette Valley Cancer Center License No.: ORE-90862 Location: Eugene, OR License Type: Brachytherapy, High Dose Rate (HOR) Type of Action: New Dates !ssued: 6/11/98 Licenso Reviewer: SM, MD Comment:
a) The license only designates the total curies allowed. The max: mum 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 interstitial, intraluminal, and intracavitary radiotherapy in humans, the source activity may 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.
l Oregon Draft Report Page D.3 License File Reviews File No.: 12 i Licensee: Syncor International Corporation License No.: ORE-90509 Location: Portland, OR Amendment No.: 23
, License Type: Nuclear Pharmacy Type of Action: Amendment Dates issued: 3/13/98 License Reviewer: SM, BC i Comment: I l a) Documents missing from license.
l File No.: 13 Licensee: Commun'ty Cancer Center )
l License No.: ORE-90422 l Location: Roseburg, OR Amendment Nos.: 23 & 24 )
License Type: Medical Therapy Type of Action: Renewal l Dates lasued: 1/12/96,1/16/97 License Reviewer: SM,MD,TL l l File No.: 14 l
! Licensee: Oncology Associates of Oregon License No.: ORE-90789 l Location: Eugene, OR Amendment Nos.: 1,2 i License Type: Brachytherapy Type of Action: New, Amendment i Dates issued: 9/10/96 (initial), 9/24/97, 9/24/97 License Reviewer: SM,DB j l File No.: 15 l Licensee: ABCT,Inc. License No.: ORE-90502
- l. - 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 l
File No.: 16 Licensee: Welenco, Inc. License No.: ORE-90762 1 Location: Bakersfield, CA Amendment No.: 2 l License Type: Well Logging Type of Action: Amendment l.
Octes issued: 12/23/97 License Reviewer: SM,MD,BC File No.: 17 .
Licensee: Oregon Medical Laboratories License No.: ORE 90360 l Location: Eugene, OR Amendment Nos.: 14,15,16, & 17 1 License Type: Self Shielded Irradiator Type of Action: Amendment Dates issued: 7/14/97,10/23/97,12/23/97, 06/12/98 License Reviewer: SM,MD L File No.: 18 l Licensee: Health Physics Northwest, Inc. License No.: ORE-90361 I Location: Tigard, OR Amendment No.: 18 l License Type: Leak Test Service Type of Action: Renewal Dates issued: 3/12/98 License Reviewer: SM, BC, MD
, File No.: 19 i 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 Dates issued: 8/8/96,1/9/97, 5/22/97,1/27/98, 3/18/98 License Reviewer: SM, BC I-l l
O Oregon Draft 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 Dates issued: 3/24/98 License Reviewer: SM, MD, TL File No.: 21 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 Licensee: Reed College License No.: ORE-90010 Location: Portland, OR Amendment No.: 43C License Type: Broad Scope Academic Type of Action: Renewal 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 issued: 7/23/96 License Reviewer: SM, MD File No.: 24 Licensee: SIRAD, Inc. Uunse 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
- Ucensee: 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 Reviewar: 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 Location: Medford, OR Amendment Nos.: 3,4 License Type: Manufacturing & Distribution Type of Action: Termination Date issued: 5/1/97,8/14/97 License Reviewer: SM,MD
.. - - - ~ _ _ _ _ _ _ __ _ ___ _ .. - ___
4 Oregon Draft Report Paged.5 License File Reviews File No.: 28 Licensee: GreCon License No.: ORE-90847 Location: Beaverton, OR Amendment No.: 1 -
" License Type: R & D, Service Type of Action: Renewal Date issued: 10/E/97,11/13/97 - Licsase 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 Type: Portable Gauge Type of Action: Amerdment Date issued: 7/31/98 License Reviewer: SM, MD
e 3- 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 radiographer (unaware that source did not 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 source. The radiographer's TLD read 730 mR. It was found that the source did not retract because of a sharp bend in the guide tube. The State issued an NOV for failure to follow 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 InvestigaJon Type: Onsite Summary of Incident and 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) of Cs-137. The State issued an NOV for lack of corporate attention to safety, and enforcement action was taken.
File No.: 3 Licensee: Braun Intertec Corporation License No.: ORE-90634 incident ID 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 wa'ked through a i radiography barrier tape and warning signs while an exposure was in progress. The individual was warned away by the radiographer. The licensee provided a dose estimate for the exposed
- individual. The individual (a State employee) was alerted to the importance of observing roped
, boundaries and warning signs. A written report was sent to the exposed individual. No violations of State regulations were identified, and the case was closed.
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Oregon Draft Report Page E.2 incident File Review File No.: 4 1 Licensee: Oregon Health Sciences Unl/ersity ;
License No.: ORE-90731 ;
incident ID No.: 97-82 '
Location: Portland, Oregon Date of Event: 12/16/97 l Type of Event: Contamination Investigation Date: 12/16/97 Investigation Type: Telephone Summary of Incident and Final Disposition: This broadscope licensee reported discovery of extensive C-14 contamination (estimated 5-10 mci) in a cold room (walk-in cooler). The room l had not be used for RAM in at least 10 years. Contamination was identified by a researcher while wipe testing the area after using RAM. The licensee's RSO supervised clean-up. Walls were stripped and repainted, and the concrete floor was replaced. A permanent metal wall 1 plaque was installed in the contaminated area detailing the C 14 spill. i File No.: 5 l Ucensee: Legacy 9mmanuel Hospital !
License Nc,.: ORE-90014 !
Incident ID No.: 97-74 Location: Portland, Oregon l Date of Event: 11/19/97 Type of Event: Medical Undardose
, Investigation Date: 11/19/97 l
Investigation Type: Telephone Summary of Incident and Final Disposition: After implanting Pd-103 seeds in 9 patients, the licerisee 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 misadmir.:stration. The licensee will set-up a OA program, based on the recommendation in the AMM Task Group Report, TG 56," Code of Practice for Brachytherapy Physics."
l File No.: 6 Licensee: Geo Designs License No.: ORE-90822 incident ID No.: 97-61 Location: Lake Oswego, Oregon Date of Event: 10/19/97 Type of Event: Darnage to Equipment Investigation Date: 10/10/97 investigation Type: Onsite 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.
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! Oregon Draft Report Page E.3 I
incident File Review File No.: 7 f Licensee: Longview inspection Co License No.: ORE-90621 l Incident ID No.: 97-53 l Location: Forest Grove Industrial Alloy, Forest Grove, Oregon i Date of Event: 8/29/97 l
Type of Event: Equipment failure l Investigation Date: 8/29/97 Investigation Type: Onsite Summary of incident and Final Disposition: During use, the drive cable of a radiography did not completely retract and a radiography source dis',onnect was the result. The radiographer pulled hard, and the tip cf the drive cable broke off. The manufacturer (Amersham) concluded that the connector was pulled off due to unusually high force. State investigation showed that 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 l
Type of Event: Contamination (Hospital waste)
Investigation Date: 7/11/97 investigation Type: Telephone 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 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.
l File No.: 9 l Licensee: Smurfit Newsprint Corporation License No.: ORE 90266 Incident ID No.: 96-28 Location: Newberg, Oregon Date of Event: 10/1/96 i Type of Event: Equipment failure l Investigation Cate: 10/3/96 investigation T ype: Telephone, Next inspection i Summary of Incident and Final Disposition: The licensee reported a fixed gauge with a shutter l stuck in the open position. The gauge was on line, and the manufacturer was called to repair j the gauge. No action by the State war 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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I Oregon Draft Report Page E.4 Incident File Review l
File No.: 10 Licensee: N/A License No.: None incident ID No.: 96-20 4 Location: Brooks incinerator, Portland, Oregon l Date of Event: 8/13/96 Type of Event: Contamination investigation Date: 8/13/96 investigation Type: Telephone l Summary of Incident and Final Disposition: A radiation alarm was set off at the incinerator. The
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- 4. source of the trash was residential, and the substance that set off the alarm was 1-131 I contaminated " kitty litter." The State contacted a veterinarian who was licensed to treat cats, l and reviewed his instructions to pet owners regarding release of the animals after treatment. :
The instructions were adequate. Since the origin of the waste could not be identified, the case l was closed.
File No.: 11 ,
Licensee: Private Citizen i License No.: None l Incident ID No.: 97-55 Location: Private Home !
Date of Event: 9/29/97 Type of Event: Exposure of Member of the Public l 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. The inspector surveyed the materialin the jar, and other areas on the site. No j radioactivity above back ground was detected. The findings were reported to the concerned '
individual.
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APPENDIX F State of Oregon DEPARTMENT OF HUMAN RESOURCES OREGON HEALTH DIVISION RADIATION PROTECTION SERVICES QUESTIONNAIRE RESPONSE f
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Approved by OMB' No. 3150-0183 l Expires 4/30/98 l
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
- 1. Status of Mattrials Insoection Proaram
- 1. Please prepare 9 table identifying the licenses with inspections that are overdue by l more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter l 2800. The list should include initial inspections that are overdue.
Oregon has no instate licenses with overdue inspections. The state has two out-of-state l licenses" that show overdue dates, but we do not consider out-of-state licenses to be l 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 or provide a written copy with your response to this questionnaire. !
, The state has no overdus inspections. Should there be overdue inspections, the state would prepare a plan to eliminate the backlog as it didin 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 selected program l 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 andin 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.
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The state issues out-of-state (OOS) specific licenses to most persons who would be j 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 (one reciprocity ticense) 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 be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed.
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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 or previously 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:
Insoector Suoervisor License Cat. Qalg Crosby Dibblee gauge 2J25/98 Lindsey Dibblee all types 2/18-19/98 latest Loomis Dibblee gauge 1997 several Martin Lindsey various' 1997-98 Martin Dibblee gauge 1997 Dibblee Paris major various"
- 9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supen/isory accompaniments were documented, please provide copies of the documentation for each accompaniment. ,
i RPS Policy 50-11, inspection Policy, states in part that "Any person who is assigned to 1 conduct license inspections will be periodically accompanied by a supervisor. l Accompaniments are documented using the Inspector Accompaniment Form. A senior l 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 willbe available during the on-site review.
Except for the supervisor, who occasionally does inspections, allinspectors were accompanied by the materials suparvisor. 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. Superviscry accompaniments were documented with the form describedin 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 as a peer inspector or during supervisory accompaniment.
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l The state keeps extens've documentstion 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 l compliance, assignment of points, etc. come to play in with this invaluable form. In this capacity, the inspector Debrief Form becomes supervisory accompaniment in absentia.
Notwithstanding, the primary inspector (who conducted about 70% of allinspections during the review period) was by default accompanied many times (15% of the time) by the supervisor because the supervisor was the otherinspection team-member.
- 10. Gescribe 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 tha t periodically brings up a few instruments at a time. The materials program has three instrument kits comprised of a L.udium 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(T)) 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.
Ill. 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 effices, the table should be consolidated to include til 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 efforte. T he table heading should bc:
"Name Position Area of Effort FTE%
Robert Crosby (Retired S!V98) Health Administration 25 Physicist L, censing! Compliance 70 Emergency Response 5 Terry Lindsey Health Administration 5 Physicist Licensing! Compliance 90 Emeroency Response 5 4
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Name Position Area of Effort FTE%
Sylvia Martin Health Administration 5 Physicist LicensinWCompliance 90 Emergency Response 5 Dan Loomis Emergency Administration 5 Response Licensin$ Compliance 10 Emergency Response 10 Chris Hinkle. Secretary Administration 95 Licensing LicensinWCompliance O Assistant Emergency Response 5 i Martha Dibblee Health Administration 75 Physicist UcensinWCompliance 20 Supervisor RML Emergency Response 5 Ray Paris Health Administration 90 Physicist LicensinWCompliance 5
""*0*' 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.
No new personnel were hired during the review poriod, 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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4 Qualification Reauirements for Oreoon
- 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.
1 On-the-Job training:.
- Formal Training Requirements I H-109 Applied Health Physics l **S-301 RERO l G-108 Inspection Practices & Procedures G-109 Licensing Practices & Procedures H-304 Diagnostic & Therapeutic Medicine H-305 Safety Aspects ofIndustrial Radiography H 308 Transportation of Radioactive Materials "H-314 Safety Aspects of Well Logging
- b. Materials License Inspectors l Work Experience: Health Physics experience and completion of l l 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 Radiosctive Materials "H-314 Safety Aspects of Well Logging I
- c. ProfessionalStaffIn Training:
Sylvia Martin Tony Lindsey
- d. Proposed Training Schedule Sylvia Martin: H 308 Transportation of Radioactive Materials (June 22-26,1998)
Teny Lindsey: G-109 Licensing Practices & Procedures (September 1998)
- optional courses that are not part of the core courses.
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l l 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 l
[ been vacant, and a brief summary of efforts to fill the vacancy.
l 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 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)
University of Oregon (01100) 90220(renewal)
Wah Chang (11700/ Broad) 90001 (amendment only)
GreCon (032^0) 90847(device reactivation) ,
Medite (03240) T-90578 (device inactivation)
Matsushita (03120) 90683 (custom device)
Reed CoIIege (01100) 90010 (renewal)
Precision Castoarts Coro (11800) 90354 (renewat)
No Oregon Radioactive Material Ucensee 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. l 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 l such procedures consistant with good professional medicalpractice as judged by the l Oregon Board of Pharmacy, the Oregon Board of Medical Examiners, and/or the Oregon Radiation Advisory Doard, as appropriate.
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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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d 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 allowedlicensees to prepare reagent kits with the use of the generator for up to 21 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 waiveris in effect now. A copy of the enforcement bulletin will be available during the on-site review.
l 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 \
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- 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 updated to include inspection program codes.
- 19. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.
I V. Responses to Incidents and Alleaations I l 20. Please provide a list of the reportable incidents (i.e., medical misadministration, )
overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB 3150- l 0178). The list should be in the following format:
During the review period, there were approximately 160 incidents that required response. There were about 60 incidents that were major involved licensee.
l Attachment C shows incidents during the reporting period.
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- 21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC7 For Regions, was an appropriate and timely PN generated?
There were incidents that involved both equipment or source failure and deficient procedures.
procedures and ALARA in OAR 333-120-020. Radiopharmaceuticals shall not be used in humans until theirpharmaceutical quality and assay have been established. Records documenting radioactive material used describedin A. of this condition shallbe kept by the licensee untilinspection by the Agency.
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- 22. For incidents involving failure of equipment or sources, was information on the l incident provided to the agency responsible for evaluation of the device for an j assessment of possible generic design deficiency? Please provide details for j each case.
Information was adequate to determine if there were a genericproblem. The l following are summaries of those incidents:
- 1. RCS No 96-28 (10/3/96): Fixed gauge licensee reported shutter that wouldn't close. RPS investigation showed that gauge may have been underengineered for the conditions to which it was subjected. Gauge was mounted to a hopper that ma chaken periodically with a pneumatic blast. It appeared that gauge
- shutter disintegrated from vibration. Ucensee discovered problem when handle l- to close shutter fell out because it no longer was attached to the shutter. AOR sent to NRC Region 5. Gauge was repaired & Is back in service'.
- 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 l broke off.
- 3. RCS No 97-53 (&'29/97): A radiographylicensee 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 stored in 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 l
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 l the criteria of a generic defect. This case is not closed becuase the State stillhas l received no written reports from the licensee, the manufacturer, or the NRC (except as noted below).
- 23. In the period covered by this review, were there any cases involving possible
!- wrongdoing that were reviewed or are presently undergoing review? If so, please describc the circumstances for each case.
i *NMSS Bulletin 98-1 received June 15,1998 described actions that NRC plans to take to
, alleviate this situation.
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'NMSS Bulletin 98-1 received June 15,1998 described actions that NRC plans to take to alleviate this situation.
I k\lHPEP.QUE* 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. 97-66,1W2N97). 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 masonjar 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, clease identify any a! legations 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 have not been closed. RCS No 96 37 (12/6/96) was an allegation reported from NRC and was closed. RCS No 97-41 () '1W97) 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 barrell & 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 showed that all outstanding issues from the 1995 review were closed. Issues from the 1995 review included need for increased management oversight, overdue inspections, unclosed and incomplete cross-referenced incidents, inadequate inspector field evaluations, proceduralinadequacies for enforcement, procedural i inadequacies for inspections, and untimely implementation of rules required for compatibility. Of these issues, only one, the rulemaking issue, remains open at this time. Oregor: has not revised rules since the 1995 NRC review. Comments made by Division Administrator Hallin letter dated February 14,1996 to NRC about impbmentation 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
. application before rules are implemented, the state would incorporate 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
- 6engths and weaknesses should be supported by examples of successes, problems or difficulties that occurred during this review period.
4 Strenaths:
[ 1. Licensing sta'lprocess 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 i
j 'A:\lMPEP.0VE* September 17, 1998 10
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- 4. Licensing support person is well trained and knowledgeable about materials 1 actions
- 5. Salaries are adequate to retain personnel
- 6. Materials team includes a fraction of Emergency Response program staff i
- 7. Materials staff are innovative, smart, and hard-working, and use a common. l sense approach to problem salving; statf use available tools without added l l program costs. j B. Materials program staff compliment each other both in philosophy and l dilligence of task completion. j Weaknesses: j
- 1. Support staff often ' bogged down'resulting in ' bottleneck' for license j wordprocessing & slow delivery oflicensing actions l
- 2. Extremely limited legal support (very costly and limited to special cases) l
- 3. Limited financial support for continuing education (attendance at l professional meetings or conferences). 1
- 4. Current staffing levels do not support tasks beyond routine licensing and compliance (staff does not include expert radiation safety support such as CHP or medicalphysicist for rulemaking or consultation). l S. Rulemaking etforts remove technicalstafil rom essentiallicensing and 1 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 1 the RPSprograms.
- 8. Formalpolicyforocedure revisions are seldom updated because these tasks remove technical staff from essentiallicensing andinspection tasks B. NON COMMON PERFORMANCE INDICATORS Leaistation 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 any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.
A:\iMPEP.0VE* September 17. 1998 11
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The State completed the attached table.
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- 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 regulatione in order to maintain compatibility with the NRC, showing the normal l
length of time anticipated to complete each step.
The state plans an aggrossive 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 l
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? l NRC SS&D guidance was used to evaluate the application for reissue (re-activation) and the inactivation of a device during license termination.'*
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- 33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:
The state reactivated a NRC registration listedin Item 31. The reactivation l
process did not require the state to evaluate any engineering criteria. The state used existing NRC engineering data" to show 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 fcr Spring 1998. Email from NRC OSP dated 4/13f98 documented the FRN and Chairman's signedletter. 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 l ' prior to review of the device registration reactivation, including engineering data.
A:\lMPEP.0VE* September 17. 1998 12 l
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1 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23
!- Ill. Low Level Waste 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.l.6 l Technical Quality of Inspections - A.II.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 IV. Uranium Mill Proaram
- 35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program: NOT APPLICABLE i
Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Quality of lbspections - A.ll.7-10 Technical Staffing and Training - A.Ill.11-15 Technical Quality of Licensing Actions - A.IV.1618 Responses to incidents and Allegations - A.V.20-23 l
A:\lMPEP.0UE* September 17. 1998 13
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TABLE FOR QUESTION 29.
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DATE DATE- :
10 CFR RULE DUE ADOPTED CURRENT EXPECTED ,
STATUS ADOPTION ;
Any amendmerd due prior to 1991. Identify prior to ;
each regulabon (refer 4 the Chronology of 1995 i Amendments) f j- Decommesseorung: 7/27/91 1995 l Parts 30,40,70 ,
[
- E..e er.cy v Planning; 4/7/93 1995 Parts 30,40,70
.[
- 5 Standards for Protechon Agamst Radahon, 1/1/94 1995 i Past 20 t Safety Requirements for Radiographic 1/10/94 1995 Equepment; Part 34 i Nohficahon of incidents, 10/15/94 1995 [
Parts 20,30,31,34,39,40,70 Quakty Management Program and 1/27/95 1995 [
Mesadmenestrations; Part 35 {
' i Ucensmg and Radiation Safety Requerements 7/1/96 DRAFTED 1999 j for Irradiators; Part 36 p
- Defwntion of Land Desposal 7/22/96 N/A . No land desposal allowed in oregon and Waste Site OA Program; Part 61 l
Decommessioneg Recordkeepag- 10/25/96 1995 !
Documentation Addihons; Parts 30,40,70 t i
l Self-Guarantee as an Addebonal Financial 1/28/97 DRAFTED; Oregon AG has reworked to fit its requirements 1999 [
Mechanism; Parts 30,40,70 !
i 4 Uransum Mill Tashngs: Conforming to EPA 7/1/97 N/A No mill tailmgs under Agreement State authonty I Standards; Part 40
[
Tunelmess in Decommissioneng 8/15/97 1995 [
Parts 30. 40. 70 ,
i f
I t
A:\lMPEP.00E* September 17. 1998 14 l
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10 CFR RULE DUE ADOPTED CURRENT EXPECTED :
' STATUS ADOPTION i e
Preparation. Transfer for Commercial Dis- 1/1/98 Drafted 1999 tnbubon, and Use of Byproduct Material for Medical Use; Parts 30,32,35 Frequency of Medical Exammations for Use of 3/13/98 Drafted 1999 Resperatory Protection Equipment ,
Low-Level Waste Shepment Manifest 3/1/98 Drafted 1999 information and Reportog ;
Performance Requirements for Radiography 6/30/98 Drafted 1999 :
Equipment i i
Radiation Protechon Requirements. Amended 8/1N98 Drafted 1999 j Defmitions and Criteria l Clarification of Decommissioning Fundmg 11/2W98 Drafted 1999 j Requirements ;
t 10 CFR Part 71: Compatibility with the N1/99 To be drafted 1999 i Intemational Atomic Energy Agency ;
Medical Admenistration of Radiation and 10/20/98 To be drafted 1999 Radioachve Matenals _
j l
Termnation or Transfer of Licensed Actnnhes- 6/16/99 To be drafted 1999 Recordireepmg Requirements.
Resolubon of Dual Regulation of Awbome 1/9/00 To be drafted 1999 Effluents of Radioactive Materials; Clean Air Act Fissile Material Shepments and Exemphons 2/10/00 To be drafted 1999 Recognition of Agreement State Licenses in 2/27/00 To be drafted 1999 1 Areas Under Excluswe Federal Jurisdichon .
Within an Agreement State Criteria for the Release of Indnnduals 5/29/00 To be drafted 1999 Administered Radioactive Material Licenses for Industnal Radiography and 6/27/00 To be drafted 1999 Radiation Safety Requirements for Industnal Radioaraphy ODerations: Final Rule
~
A:\IMPEP.0VE* September 17. 1998 15
OR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED ,
STATUS ADOPTION Radiologeal Criteria for License Temunahon &"20/00 To be drafted 1999 t
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A:\IMPEP.0VE* September 17. 1998 16 !
MATERIALS REQUESTED TO BE AVAILABLE FOR 4 THE ONS;TE PORTION OF AN IMPEP REVIEW ORGANIZATION CHARTS Clean, sized 8% X 11" including names and positions ,
o One showing positions from Governor down to Radiation Control Program Director (RCPD) o One showing positions of current radiation control program with RCPD as Head a Equivalent charts for LLRW and mills programs, if applicable LICENSE LISTS a 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)
THE FOLLOWING LISTS a List of open license cases, with date of original request, and dates of follow up actions a List of licenses terminated during review period, a 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 allegations occurring during the review period. Show whether incident is open or closed and whether it was reported to the NRC THE FOLLOWING DOCUMENTS a All State regulations a Records of results of supervisory a Statutes affecting the regulatory authority accompaniments of inspectors of the state program a Emergency plan and communications list a Standard license conditions a Procedures for investigating allegations a 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 a Instrument calibration records applicable) o inspection procedures and guides a Copies of job descriptions a inspection report forms A0IMPEP.QUE* September 17. 1998 17
_ .-.m . _ _ _
l ATTACHMENT A l COMPARISON OF OREGON LICENSE TYPES. NRC PROGRAM CODES. & PRIORITIES l Inspection Fee- OHD/ OAR NRC Frequency code License Tvoe Proaram Code (s) vears L
(a) Analytical / Leak Test 03220 5 l (b) Basic License 03232 l 2
! 03225,03800 3
! 03221,03710,11220,11210, 22130,22160,22161 5 (c) Brachytherapy 02120 3-(d) Broad Scope A 01100,03610 2 02110,03211 1 (e) Broad Scope B- 01110,03212,03611 3 (f). Broad Scope C 01120,03213,03612 5 i; (g) Distribution. 02511,02513 3 i 03240,03241,03242,03243,G3244, l I
11230,22170 5
- i. (h) Fixed Gauge 03120 5 (i) H;gh doserate brachytherapy 02230,02231 1 (j) Imaging and Localization 02121,02201 4
, (k) in Vitro Laboratory 02410 5 (i) Industrial Radiography 03310,03320 1 (m)- Instrument Calibration 03222 3 (n) Investigational New Drug 02121,02201 5 !
02120,02200 3 (o) rradiator Self-Shielded 03510 5 03511 3 i (p) Manufacturing / Compounding 03214 3 (q) Mobile Nuclear Mediche 02220,02240 2 (r) NORM (no processing) 11200 5 (s) Nuclear Pharmacy 02500 1 (t). ' Other Measuring Device 03123 (GC),03124 (xrf) 5 (u): Portable Gauge - 03121,03122 (lead xrf) 4 (v) Radiopharmaceutical Therapy 02120,02200,0240C 3 lw) RAM /NOS Facility : 03112,03113,03520,11700,23300 3 03218,03219 2 03233,03233,03F21,03613,03900,
, 11900,22162,22200 1 l (x) Hesearch & Development 03620 5
[ .(y) Sealed Sources for Diagnosis 02121,02201 5 l (z) Source Material ,
11221,11300,11800 3 l (aa) . Special Nucleer Material (sealed) 22120,22140,22150,2215I 5 (bb) . Spev:nl Nuclear Material (unsealed) 22110,22111 2 i (cc) Teletherapy (external beam) 02300 3 (dd) Unique 03710,03620 5 (ne). Uptake and Dilution 02121,02201
- 4
[ .(ff) Use of Xenon Gas 02121,02201 4
' (gg) Waste Packaging 03234 1 l (hh) Well Logging 03111 3 h A:\1MPEP.0VE'Septenter .1/.1998 .18
. . . ~ _ _ ._ _ . . . _ - _ _ . _ _ . _ _ . _ - - -_ _ _ _ _ _ . _ _ _ _ . . .
a ATTACHMENT B INSPECTOR DEBRIEF INTERVIEW Inspector Date ofInspection i Licensee License Number License Type Inspection Frequency l Expiration Date RSO' i
I. License Review O Adequate O License deficiencies" i
General comment on inspector's view of licensed program:
II. Inspection Overview (box checked means adequate) i O RAM (isotope)
O Inventory (x-check w/ copy of records)
O 6,7,8',9 of license O Place of use, temporary jobsites O validation cert O RSO O RSC O 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 Procedures O Posting Signs, Labels, Notices O Transportation Requirements III. Inspector impressions IV. Findings (Items of noncompliance):
SL1 SL2 SL3 Rating Points O Tracking form prepared N
if there are licensing deficiencies, use the form
- Recommendations to the License Reviewer
- to recommend changes or identify deficiencies in the license.
A:\lMPEP.0UE* September 17, 1998 19
d
. ATTACHMENT C INCIDENTS REPORTED DURING THE REVIEW PERIOD l LICENSEE LICNO RCSNO NOTIFY INCIDENT TYPE CASE CLOSh DATE CLOSED DATE 96-01 19960101 Other - no RAM - Gas leak yes 199601 Longview inspection-QC 90621 96-02 19960118 Other - erroneotr . /wrt of suspected leaking yes 199601 Group source St Elizabeth Hospital 90705 06-03 19960206 Other - device damaged in transport yes 199602 96-04 19960305 Other - report of stolen anti-static devices yes 19961E St. Vincent Hospital 90104 96-05 19960305 Other - medical error yes 19960; 96-06 19960328 Other - GL source material (chemical waste) yes 19960d 96-07 19960409 Other - contaminated meta' scrap yes 19960d 96-08 19960418 Other - contaminated metal scrap yes 199601 96-09 19960429 Other - contaminated metal scrap yes 199601 Professional Serv. 90056 96-10 19960502 Other - dosimetry badge artifact yes 199601 Industries 96-11 19960506 Other - no RAM yes 199601 Syncor Intemational Corp. 90509 96-12 19960528 Other - no RAM yes 199601 96-13 19960605 Other - contaminated metal scrap yes 199604 96-13A 19960531 Other - notification of theft of portable gauge yes 19960!
, Salem Hospital 90151 96-14 19960610 Other - contaminated garbage yes 199604 96-15 19960607 Other - notification of lost gauges from Canada yes 19970' 96-16 19960612 Other - contaminated garbage yes 199614 96-17 19960619 Other - contaminated metal scrap yes 199601 Professional Service 90056 96-18 19960710 Allegation - radiation exposure during IR yes 19960:
Indust.
Precision Castparts Corp. 90354 96-19 19960710 Allegation - RAM contamination in demolition area yes 199601 96-19A 19960730 Other - Notification by agreement state of theft yes 19960:
Doug Evans, DVM 90562 96-20 19960813 Other - contaminated garbage yes 199601 96-2'. 19960816 Allegation - theft of ' enriched uranium' yes 199611 Gary J. Strait & 90651 96-22 19960822 Allegation - radiation exposure during IR yes 199611 Associates Salem Hospital 90151 96-23 19960829 Other - contaminated garbage yes 19960 96-24 19960904 Other - no RAM yes 199601 96-25 19960904 Other - Public inquiry yes 19960 Salem Hospital 90151 96-26 19960906 Other - contaminated garbage yes 199611 96-27 19960927 Other - contaminated meta; scrap yes 199611 Smurfit Newsprint 90266 96-28 19961003 Equipent failure - shutter failure yes Corporation 199611 balem HospPal 90151 96-29 199610v Other - medical error yes
...A 19961 96-30 1996101] {.%r - contaminated metal scrap yes 199611 A:\lMPEP.0UE* September 17. 7.998 Attachment C -- Page 20 t
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1_a . .. . n .e - a arew-..,-w_, _.2 + .s-i.n 1..--,a.a _a e .= a - a , s. a m ,s. . u .- .e e a a, ., a ans_= n. s-.w e x.---s , , , , .
.N 9
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!28 11 8 11 2 l
' 63 0 i
11 7 l 11 3 12 8 11 3 52 8 11 4 53 1 III 117 13 0 501 i
N1 81 6 f30 330 21 5 ,
312 106 31 7 r
111 323
- k. w - - , y,- ..w..- . - - , --
. . . . - - - - . . - . ~ . - - - . - - . - _ . . - . . _ - . - . . . - - . . . - . . - - - - . - -
?
4 . LICENSEE LICNO RCSNO NOTIFY INCIDENT TYPE CASE CLOSE DATE CLOSED DATE o
Braun Intertec Northwest 90633 96-31 19961022 Equipment failure - portable gauge cracked source yes 19980502 rod welds 96-32 19961115 Other - contaminated metal scrap yes 19970117 Dave 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 19931125 Dee Forest Producst 93164 96 35 19961120 Other - Fire yes 19961129 96-36 19961210 Other- contaminated metal scrap yes 19970117 Longview inspectkm-OC 90621 96-7 19961206 Allegation 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 l i
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 Good Samaritan Hospital 90008 97-01 19970110 Other- self-discovery of noncompliance yes 19971105 l Good Samaritan Hospital 90008 97-02 19970110 Loss of pkg effectiveness - sealed calibratKm source yes 19971031 in LSC Salem Hospital 90151 97-03 19970116 Loss of licensed material yes 19970131
)
97-04 19970117 Other - contaminated garbage ycs 19970117 97-05 19970127 Other - Laam Rx overdose es 19971106 Kaiss; cunnyside Hospital 90464 97-06 19970203 Other - contaminsted garbage yes 19971104 97-07 19970205 Other - contaminated garbage yes 19970224 Salem Hospital 90151 97-08 19970310 Other - contaminated garbage yes 19970319 97-09 19970212 Other - contaminated garbage yes 19970303 97-09 19970212 Other - contaminated garbage yes 19970303 97 10 19970214 Other - contaminated garbage yes 19970303 97 11 19970225 Other - contaminated garbage yes 19971106 97 12 19970225 Other - contaminated garbage yes 19971105 97 13 19970307 Other - contaminated garbage yes 19970321 I 97 14 19970311 Other - contaminated garbage yes 19970321 97 15 19970311 Other - contaminated metal scrap yes 19970321 PCC Structurais 90232 97 16 19970319 Other- contaminated garbage yes 19970329 Portland Adventist Medical 90158 97-17 19970325 Other - contaminated garbage yes 19970409 Ctr 97 18 19970326 Other - contaminated garbage yes 19971118 Salem Hosprtal - 90151 97 19 19970331 Other - contaminated garbage yes 19980605 Providence Milwaukie 90312 97-20 19970404 Other - contaminated garbage yes 19970421 Hospital A:\lMPEP.0VE* September 17, 1998 Attachment C -- Page 21
I C'
4 LICENSEE - LICNO RCSNO NOTIFY INCIDENT TYPE CASE CLOSE DATE CLOSED DATE
- 1 Smurfit Newsprint !
90266 97 21 19970407 Other - public exposure yes 19970416 -
Corporation 97 22 19970415 Other - contaminated metal scrap yes 19971117 i l
97-23 19970421 Other - contaminated metal scrap yes 19971105 l 1
Good Samaritan Hospital 90008 97 24 19970417 Other - beam Rx overdose yes 19971105 I 97 25 19970503 Other - Natl Resp Center Transportation incident - yes 19970601 no RAM 1 i
Willamette industries 90141 97 26 19970505 Other - damaged fixed gauge mounting track yes 19971031 l
97 27 19970515 Other - Report of Chemical Fire & Explosion yes 19971106 '
97-28 19970521 Other - contaminated metal scrap yes 19971117 l Oregon Health Sciences 90013 97-29 19970522' Other - medical error yes 19970527 Uruv.
97 29A 19970530 Other - Contaminated lead aprons yes 19970701 97-30 19970606 Other - contaminated metal scrap yes 19970818 Longview lrispw^uerrOC 90621 97-32 19970610 Allegation - radiation exposure during IR yes 19971105 Group ,
97 33 19970618 Other - contaminated metal scrap yes 19971117 l
Willamette Falls Hospital 90294 97 34 19970618 Other - contaminated garbage yes 19970630 97 35 19970619 Other - contaminated garbage yes 19971006 l St. Vincent Hospital 90104 97-36 19970824 Other - medical error yes 19971105 ;
1 97 37 19970626 Other - contaminated garbage yes 19970701 97-38 19970627 Other - transportation / survey yes 19970701 97 39 19970707 Other - contaminated garbage yes 19970813 Salem Hospita.1 tH151 97-40 19970711 Other - contaminated garbage yes 19970806 97-41 19970713 Other - Natl Resp Ctr reported Unusual event - no yes 19970715 RAM Meridian Park Hospital 90293 97-42 19970714 Other - contaminated garbage yes 19970818 97-43 19970718 Other - contaminated metal scrap yes 19971117 l l
97-44 19970728 Other- contaminated garbage yes 19970801
]
97 45 19970731 Other - contaminated metal scrap yes 19970806 97-46 19970803 Other - Prank yes 19971105 Comforth Consultants 90652 97-47 19970806 Other - devk,e incident - Portable gauge accident yes 19971006 97-48 1997080e Other - contaminated metal scrap yes 19971105 97-49 19970811 Other - NORM hazardous waste yes 19971105 Emanuel Hospital 90014 97 50 1ris7G114 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 Trigs reactor fuel element yes 19970903 Longviewlr ps'uvirOC 90621 97 53 19970829 Other -IR d6sconnect Group 97-54 19970929 Other - contaminated garbage yes 19971001 1
A:\lMPEP.00E* September 17, 1998 Attachment C -- Page 22 l L
__ ___ _ - _ _ _ -.. __. _ _.. . _ . ___ .i
.-- - - . . . ~ . .~ . - . _ . _ _ . . - _ . . ~ - - - . - . . - . . . . ....-. _ _ ...- - . - . . .
(.
, LICENSEE 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 97 57 19971001 Other - contaminated garbage yes 19971117 97-58 19971001 Other- contaminated garbage yes 19971117 l l 97-59 19971002 Other - contaminated metal scrap yes 19971006 l
1 97 60 19971006 Other - contaminated garbage yes 19971027 j GeoDesigns 90822 97-61 19971010 Other - device incident - Portable gauge accident yes 19971117 Columbia Willam Valley 90712 97 62 19971008 Other - medkal 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 garbage yes 19971027 97-66 19971023 Allegation - pies bargain; drug issue; loss / theft of yes 19980520 material 97-67 19971023 Oher - 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 l
97 70 19971105 Other - contaminated metal scrao yes 19980209 97 71 19971110 Other - contaminated metal screp yes 19980209 97 72 19971117 Other - contaminated metal scrap yes 19980209 97-73 19971111 Other - contaminated garbage yes 19971209 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 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/M/SNM yes 19980319 Oregon Healtn Sciences 6 731 97 82 19971216 Other - comtamination incident yes 19980319 Univ.
Intemabonal Paper 90012 97-83 19971219 Other - Fire & Explosion yes 19980109 Compariy Mission Medicalimaging 90583 97 84 19971231 Other - contaminated garbage yes 19980209 Dave Notley & Associates 90770 97-85 19971230 Other - untimey death of licensee yes 19980529 98 01 19980105 Other - contaminated metal scrap yes 19980529 98-02 19980113 Ot%r - contaminated metal scrap yes 19980529 A:\lMPEP.00E* September 17, 1998 Attachment C -- Page 23
. - . . - . . - _ ~ . - ._
. - _ ~ - _ ~ _ - - ~ . - - - - ~ . - . ~ . - . _ . -
A~ '
i l e LICENSEE LICNO RCSNO NOTIFY INCIDENT TYPE CASE CLOSE
_, DATE CLOSED DATE 9843 19980119 Other - contaminated garbage yes 19980120 98-04 19980121 Other - contaminated metal scra;, yes 19980209 f- 98-05 19980119 Other- contaminated metal scrap yes 19980209 Sacred Heart Medcel 90270 98-06 19980123 Other - medical error yes 19980319 Center 98-07 19980122 Other - nobfication of theft of RAM gauge yes 19980529 l Braun intertec Corporation 90634 98-08 19980126 AHegation - radiation exposure during IR yes 19980223 98-09 19980127 Other - hazardous materials nonfication yes 19980529 98 10 19980203 Other- contaminated garbage yes 19980319 l 98 12 19980220 Other- contaminated garbage yes 19980529 l Oregon State University 90005 98 13 19980219 Other- Reportable Event Reactor yet 19980529 l Smurnt Newsprint 90266 98-14 19980224 Other - Gauge incident caused by not following Corporabon procedures 98-15 19980305 Other - Chemical incident yes 19980306 98-18 19980312 Other - contaminated metal scrap yes 19980529 98-17 19980323 Other - contaminated metal scrap yes 19980529 98-18 19980324 Other - contaminated metal scrap yes 19980529 98-19 19980325 Other - contaminated garbage yes 19980529 Longview inspection 90621 98-20 19980402 Other - lR incident caused by not following yes 19980515 proedures 98-21 19980409 Other - contaminated metal scrap yes 19980529 98-22 19980410 Other - contaminated metal scrap yes 19980529 98-23 19980420 Other - contaminated metal scrap yes 19980529 Columbia Memorial 90343 98 24 19980409 Other - mtdical error yes 19980529 Hospital Columbia Douglas Medical 90374 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 - contaminated metal scrap yes 19980529 98 29 19980515 Other - contaminated metal scrap yes 10980520 98-29 19980513 Other - contaminated metal scrap yes 19980526 98-30 19980527 Other- cornarnineted metal scrap 98-31 19980527 Other - contaminated metal scrap 98-32 19980605 Other - report of Co-60 contaminated cookware yes 19980C05 L
i A:\!MPEP.0UE Attachment C -- Page 24
, - . _ _ _ -