ML20216C091
| ML20216C091 | |
| Person / Time | |
|---|---|
| Issue date: | 04/17/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Bangart R, Paperiello C, Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| NUDOCS 9805190092 | |
| Download: ML20216C091 (3) | |
Text
i MEMORANDUM TO:
Hugh L. Thompson, Jr.
V Deputy Ex:cutiva Dirtctor for
[82R 171993 Regulit2ry Progrrms Richard L. Bangary Director j
Office of State Programs Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
)
Karen D. Cyr, General Counsel j
j Thomas T. Martin, Director Office for Analysis and Evaluation of Operational Data 1
FROM:
Paul H. Lohaus, Deputy Director Original Signed By.
Office of State Programs PAUL H. LOHAUS
SUBJECT:
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW OF ARIZONA RADIATION CONTROL PROGRAM This memorandum transmits to the Management Review Board (MRB) a proposed final report (Attachment 1) documenting the IMPEP review of the Arizona Radiation Control Program.
The review of the Arizona program was conducted by an interoffice team during the period February 9-13,1998. The team issued a draft report to Arizona on March 19,1998, for factual comment. Arizona sent factual comments by letter dated April 2,1998, from Aubrey V. Godwin, Director, Arizona Radiation Control Agency (Attachment to proposed final report).
The review team found Arizona's performance with respect to each of the common and applicable non-common performance indicators to be satisfactory. Accordingly, the team
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recommends that the MR9 find the Arizona program to be adequate to protect public health and safety and compatible with NRC's program.
C' (1s The MRB meeting to consider the Arizona report is scheduled for Tuesday, April 28,1998, from 2:30 p.m. - 4:30 p.m. In One White Flint North, Room 4-B-6. In accordance with pi Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is i
attached (Attachment 2).
9 t
If you have any questions prior to the meeting, please contact me at (301) 415-2326 or l
{,
James H. Myers at (301) 415-2328.
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Attachments:
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As stated k
Distribution:
SMoore, NMSS BJSmith, MS DCD (SP01)
" DIR RF GDeegan, NMSS TCombs, OCA PDR (YES2) l C2 ? ~KSchneider, OSP TTaylor, NMSS HNewsc. e, OGC LMcLean, RIV CMaupin, OSP FCameron, OGC JHornor, RIV WCFO Arizona File DOCUMENT NAMES:
j Ta receiv% a copy of this document, indicate in the box: "C" = Copy withodDttachment/ enclosure [T Cgtn with attachment / enclosure "N" = No copy OFFICE OSP f_l OSP cf OSPdid OSP:D[l'[
PHLohais? '
RLBangart ' " "
l NAME LRakovan:gd %
JMyers f DATE 04//S 198 '
04/ 6/98 04/M/98 04//$/96 9805190092 9904i7 OSP FILE CODE: SP-AG ]
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UNITED STATES s
j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20666-0001
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April 17, 1998 MEMORANDUM TO:
Hugh L. Thompson, Jr.
Deputy Executive Director for Regulatory Programs Richard L. Bangart, Director Office of State Programs Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards Karen D. Cyr, General Counsel Thomas T. Martin, Director Office for Analysis and Evaluation 7
of Operational Data
/j FROM:
Paul H. Lohaus, Deputy Director N
Office of State Programs j kL kDf
SUBJECT:
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW OF ARIZONA RADIATION CONTROL PROGRAM This memorandum transmits to the Management Review Board (MRB) a proposed final report (Attachment 1) documenting the IMPEP review of the Arizona Radiation Control Program. The review of the Arizona program was conducted by an interoffice team during the period February 9-13,1998. The team issued a draft report to Arizona on March 19,1998, for factual comment.
Arizona sent factual comments by letter dated April 2,1998, from Aubrey V. Godwin, Director, Arizona Radiation Control Agency (Attachment to proposed final report).
The review team found Arizona's performance with respect to each of the common and applicable non-common performance indicators to be satisfactory. Accordingly, the team recommends that the MRB find the Arizona program to be adequate to protect public health and safety and compatible with NRC's program.
The MRB meeting to consider the Arizona report is scheduled for Tuesday, April 28,1998, from 2:30 a.m. - 4:30 p.m. In One White Flint North, Room 4-B-6. In accordance with Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is attached (Attachment 2).
If you have any questions prior to the meeting, please contact me at (301) 415-2326 or James H. Myers at (301) 415-2328.
Attachments:
As stated
i e
i*
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF ARIZONA AGREEMENT STATE PROGRAM February 9 -13,1998 i
PROPOSED FINAL REPORT U.S. Nuclear Regulatory Commission i
ATTACHMENT 1 98031g6>4'4-H % g).
l
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1.0 INTRODUCTION
This report presents the results of the review of the Arizona radiation control program. The i
review was conducted during the period February 9-13,1998, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Mississippi. Team members are identified in Appendix A. The review was conducted in accordance with the " Implementation of the Integrated Materials Performance Evaluation Program and Rescission of a Final General Statement of Policy," published in the Federal l-Register on October 16,1997 and, NRC Management Directive 5.6, " Integrated Materials l
Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period March 4,1995, to February 13,1998, were discussed with Arizona management on
' February 13,1998. The informal results were also discussed with the Arizona Radiation Regulatory Agency (ARRA) Director, Mr. Aubrey Godwin and a representative of the Governor's office, Mr. Steuart Goodman, on February 24,1998 during a conference call.
l (A paragraph on the results of the MRB meeting will be included here in the final report.]
The Arizona Agreement State program is administered by the ARRA. The Director of the ARRA reports directly to the Govemor of Arizona. The Agency has 23 employees of which five
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employees including a manager are dedicated to radioactive materials regulation under the Agreement. The manager spends approximately one half of his time on the radioactive materials program (RAM). An organization chart for the ARRA is included as Appendix B.
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At the time of the review, the Arizonc program regulated 353 specific licenses, including limited l
_ scope medical, broad scope, gamma knife, industrial radiography, and nuclear pharmacy licenses.
The review focused on the material's program as it is carried out under the Section 274b. (of l
the Atomic Energy Act (AEA) of 1954, as amended) Agreement between the NRC and the State of Arizona.
In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on November 12,1997. The State provided a response to the questionnaire on December 16,1997. During the review, discussions with the State staff l
resulted in the responses being further developed. A copy of the final response is included in Appendix C to this report.
I The review team's general approach for conduct of this review consisted of: (1) examination of Arizona's response to the questionnaire; (2) review of applicable Arizona statutes and regulations; (3) analysis of quantitative information from the radiation control program licensing l-and inspection data base; (4) technical review of selected licensing and inspection actions; and (5) interviews with staff and management to answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the radiation control program's performance.
Section 2 below discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable
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. Arizona Proposed Final Report Page 2 non-common indicators, and Section 5 summarizes the review team's findings and recoriimendations. Recommendations relate directly to program performance by the State. A l
response is requested from the State to all recommendations in the final report. Suggestions j
made by the review team are comments that the neview team believes could enhance the State's program. The State is requested to consider suggestions, but no response is requested.
2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS
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' During the previous routine review, which concluded on March 3,1995, comments and recommendations were made and the results transmitted to Mr. John Kelly, Executive
'I Assistant, Office of the Govemor, on June 7,1995. The review resulted in six recommendations. The team's review of the current status of these recommendations is as L
follows:
(1)
At the time of the March 1995 program review, compatibility was withheld because the
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State had not adopted the " Decommissioning" and " Notification of incidents" rules. We 1
recommended that the overdue regulations be adopted as soon as possible, and that l
work on upcoming regulation revisions be started well in advance of the three-year time limit. Because maintaining compatible regulations had been an ongoing problem in Arizona, we recommended that written procedures be developed within ARRA to expedite the promulgation process on a permanent basis. We recommended ARRA seek input into developing these procedures from other offices in the regulatory review chain, including the legal and budget offices. We also recommended an early opportunity for NRC comment be incorporated into the new procedures.
Current Status: This recommendation is closed. The team oiscussed the progress made on resolving this issue since the last review. The " Notification of incidents" rule was promulgated. ARRA has resubmitted the proposed _" Decommissioning" regulation, with additional language to meet subsequent NRC regulatory requirements, to the Governor's Regulatory Review Council (GRRC) in late 1995 and again in 1997. The GRRC was created by Executive Order in May 1981. The GRRC is composed of six members and is chaired by the Director of Administration or designee, who serves ex-officio. For most State agencies, the GRRC is the final step in the rule making process.
The Council reviews most rules to, ensure that they are necessary to avoid unnecessary duplication and adverse impact on the public. The Council also assesses whether the rules are clear, concise, understandable, legal, consistent with legislative intent, and whether the benefits of a rule outweigh the cost. If a rule does not meet these criteria, the Council retums it to the agency for further consideration. The rules are presently at the GRRC for review.
The team notes that the decommissioning regulations in question apply only to one ARRA licensee. To maintain compatibility with NRC's requirements, ARRA uses license conditions to implement the decommissioning requirements on the single licensee.
ARRA has indicated that they will continue to use license conditions in this situation, and similar situations, until the rule passes GRRC review.
l Arizona Proposed Final Report Page 3 (2) in order to retain qualified professional staff and effectively manage the program, we recommended an evaluation of the need for salary increases and an evaluation of managemert alternatives that can provide other incentives necessary to retain qualified staff or that are necessary to effectively manage a program that experiences such turnover.-
Current Status: This recommendation is closed. ARRA salaries have increasect only slightly since the last review. These increases are the result of cost of living increases and merit pay. Salaries were reported to be less than several adjoining Agreement j
States. However, ARRA experienced only low staff tumover during the review period.
ARRA management continues to plan and budget for improving staff salaries but these efforts have not been approved by the State legislature.
4 (3)
We recommended that the State:
a)
' develop written procedures specific to investigating and reporting 1
misadministrations; Current Status: This recommendation is closed.- The team reviewed ARRA's present event and allegation procedures and recommended closing this issue, since the State now has a highly effective incident reporting system.
b) improve the procedures for closing incident investigations by revising the close-out cover sheet; Current Status: This recommendation is closed. ARRA revised their Standard Operating Procedure (SOP) for Response to incidents involving Radioactive Materials on January 25,199S. A review of the State's incident and allegations, discussed in Section 3.5, indicates that the ARRA is using the new guidance and close-out coversheet when conducting incident investigations.
c) develop a computer system for tracking and closing incident reports and investigations, including prompting management for reports required by the NRC.
Current Status: This recommendation is closed. ARRA continues to use a manual tracking system for following and closing out incident investigations. The manual tracking system works very well and meets their needs. ARRA indicated that it may consider developing a computerized tracking system as time and resources permit.
(4)
We recommended that:
a) program management monitor the progress of the proposed enforcement rule to expedite its enactment;
o e
Arizona Proposed Final Report Page 4 Current Status: This recommendation was closed with the adoption of Article 12, Aaministrative Provisions, Chapter 1, Radiation Reaulatorv Aaencv. Title 12, Natural ResoLEGag, of the Arizona Regulatory Code on January 2,1996.
b) the inspection tracking system be modified to trigger shorter inspection i
frequencies as part of the escalated enforcement process.
Current Status: This recommendation is closed. The team reviewed ARRA's
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procedures during this review and found that the Materials Inspection Program Guide, Section 2020-08, Reduction of Insoection Interval provides a process for reducing inspection intervals based on the seriousness of violations, current and i
prior findings. A point system is used. In general a reduction of the inspection interval should occur when the total of all re-inspection points for violations total 12, or more.' A severity level one violation is assigned 12 points, for example, that would result in a reduced inspection interval.
(5)
The State's inspection forms, which were being used on a trial basis, needed several improvements. Specifically, there was no place to document verification that emergency procedures or emergency procedure posting (other than xenon) were being followed; review of brachytherapy and radiopharmaceutical therapy patient release surveys and inventories; verification that HDR sfterloader procedures were being foll owed; verification that nuclear medicine technicians have adequate, signed procedures to act l
in the absence of an authorized user; observation of operations; or results of interviews l
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with ancillary workers. We recommended that the inspection forms be revised to correct 4
these deficiencies as well as other problems identified during trial use and that the j
inspection procedures should be updated to include the new forms.
Current Status: This recommendation is closed. While the State has made significant improvements to their inspection forms (field notes), the team's review of the licensing and inspection files indicates that the ARRA needs to continue to focus attention on this issue. The matter is readdressed in Section 3.2 of the report.
(6)
We recommended that when narrative reports are used for routine inspections, a procedure be established ta ensure the inspection covers and documents all areas of the licensee's program included in the inspection forms.
Current Status: This recommendation is closed. ARRA's Inspection Reports Program Guide, ARRA-PROG-2004, was revised on April 11,1996. The agency's procedure establishes guidance for preparing inspection reports and describes their standard content and format.
j Arizona Proposed Final Report Page5 3.0 ~
COMMON PERFORMANCE INDICATORS i
IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials
, inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.
3.1 Status of Materials insoection Proaram The team focused on four factors in reviewing this indicator: inspection frequency, overdue
. inspections, initial inspection of new licenses, and timely dispatch of inspection findings to liceriscas. This evaluation is based on the Arizona questionnaire responses relative to this indicator, data gathered independently from the St&te's licensing and inspection data trac' king system, the examination of licensing and inspection casework files, and interviews with managers and staff.
The State has a computer specialist working in the RAM to help maintain and retrieve statistical data. Information from filing systems is being updated in a new database to enhance the program.
The review of the State's inspection priorities showed that the State's inspection frequencies for various types of licenses are at least as frequent as similar license types listed in the NRC Inspection Manual Chapter 2800 (IMC 2800) schedule of frequencies. Licensee categories are specified from Priorities 1 through 7, and inspections are conducted at intervals from 1 to 5 years corresponding to the inspection priority. Priority 7 licensees are also inspected at the 5-year interval. Inspection file reviews indicated that the frequency of inspections that were conducted were consistent with the State's policy.
Several spot checks of industrial radiography licensees and an HDR licensee were performed to verify inspection frequencies. In almost every case the files indicated that the proper inspection frequency was followed.
Nine (9) reciprocity files were reviewed to see if the State was inspecting reciprocity licensees -
as specified in IMC 1220. The State stated in the questionnaire that in 1995 there were 40 licensees f.at were granted reciprocity with only 2 of these being inspected. In 1996 and 1997, both lice sees that performed source installations or exchanges were inspected (100%), as well as 4 industrial radiography licensees out of 9 that were granted reciprocity. However, in Priorities 4 through 7, only 1 inspection has been conducted out of 29 licensees that were granted reciprocity, less than the 10% frequency specified in IMC 1220.
The State's policy for conducting initial inspections of new licensees within a 6 month frequency appears to be followed. This frequency can be extended until the licensee has received radioactive material and may be announced. The State contacts these licensees to find out when licensed activities have started and performs pre-licensing visits. Of the 10 new licensee files that were reviewed, only 2 inspections had been conducted past ine 6 month interval.
Both initial inspections were conducted within 7 months of the licensae receiving material.
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- Arizona Proposed Final Report Page 6 According to the questionnaire, no inspections were overdue by more than 25% of the scheduled frequency. However, it was noted in the file review that during the review period from 1995 to 1997, several inspections were conducted later than the State's inspection -
frequency policy. The State appears to have conducted inspections according to their inspection frequency since July 1996. The interval between inspections may be extended beyond that specified by the priority system on the basis of exemplary performance on the part of the licensee. All of the licensees that were inspected past the recommended frequency had not been cited with violations during past inspections and received an extension by policy.
The timeliness of the issuance of inspection findings was evaluated during the review of completed inspections. Twenty-one (21) files were examined with several files having more than.1 inspection that was conducted during the review period, inspection correspondence was sent to the licensee within 30 days after an inspection with the exception of one of the more complex team inspections. Licensee responses to inspectioi&, dings appear to be retumed in a timely manner. The Agency Director sends out the acknowledgment to the licensee response and determines if further information is needed, it was noted in the correspondence that civil -
penalties may be assessed if the licensee does not take corrective actions or respond in a timely manner.
Based on the IMPEP evaluation criteria, the review team recommends that Arizona's performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory.
3.2 Technical Quality of Insoections The team reviewed the inspection reports, enforcement documentation, and inspection field notes, and interviewed inspectors for 21 materials inspections conducted during the review period. The casework included all 3 of the State's material inspectors and covered high priority inspections of various types including medical broad scope, academic broad scope, high dose rate (HDR) afterloader, industrial radiography, nuclear pharmacy and well-logging. Appendix E
. lists the inspection cases reviewed in depth with case specific comments.
Several files were reviewed in coordination with the licensing review. This allowed the review team members to make sure that inspection findings coordinated with licensing actions. Also, it appeared from the review that the inspectors verified that license condition requirements had been implemented and were being followed.
The Program Guides are issued to establish policies and procedures applicable to the Agency Staff for implementing specific programmatic activities, such as inspection guidance.
Inspection procedures and techniques were reviewed and were determined to be consistent with inspection guidance provided in IMC 2800. The inspection report forms provide documentation of inspection findings in a consistent manner. The State uses specific inspection report forms for various license types, such as medical, industrial radiography, well-logging, portable gauges, fixed in-plant gauges, laboratory, and service type licensees. The inspection form provides documentation of the radiation safety personnel, management, scope of the licensee's program, uses of materials, operating and emergency procedures, leak tests, surveys and wipes, instrumentation, personnel dosimetry, incidents, transportation, inspectors
Arizona Proposed Final Report Page 7 confirmatory surveys, items of noncompliance and items of concem, and exit interviews. Each report also documents close-out meetings with the ARRA Manager of RAM and Program Director. The reports are generated in a computer based format.
ARRA policy is to perform allinspections unannounced. The review of the inspection files verified this policy. However the ARRA is alsc allowed to announce inspections under certain conditions such as an initial inspection, verification that certain personnel will be available, or inspection of specific activities.
A review of the scope of inspections revealed that industrial radiography licensee inspections were only conducted during office visits. The team believes that these inspections cannot adequately verify that licensees are following operating and emergency procedures as well as
. ARRA regulations. The files that were reviewed were as complete as possible. However, since these licensees only worked at temporary job sites, the inspector could not inspect for posting, wearing proper dosimetry, surveys of radiographic devices and restricted areas, survey instrumentation, and transportation of devices. The review team recommends that industrial radiography inspections need to be conducted at temporary job sites in addition to office inspections, to verify compliance to operating procedures and regulations.
Also the supplemental inspection report form that is used for HDR afterloaders does not cover all safety feature checks and requirements of licensure. It was evident the inspectors were very well trained and stated they were observing all aspects of the licensees' activities, but the supplementalinspection report form for HDR afterloaders did not have space to allow them to document the scope of operations. The other inspection forms in use that were observed in the file review appeared to cover the scope of those licensed activities. The review team suggests that the supplemental inspection report form for HDR afterloaders be modified to cover the entire scope of licensee operations and procedures.
The files that were reviewed contained ccmplete inspection findings and enforcement correspondence. Telephone conversations with the licensee were documented on an ARRA form that was maintained in each file folder. The reviewer noted that inspectors conducted inspections in sufficient depth, discussed inspection findings with the manager, and followed up on enforcement actions after the licensee response was received.
The inspection findings are issued by the Program Manager. During the file review, it was noticed that licensees retumed their response to the Agency in a timely manner and enforcement actions did not have to be escalated. After the response was received by the Agency, it was reviewed by the inspector, Program Manager, and Program Director with the Program Director issuing the acknowledgment. Agency letters to licensees outlining inspection findings and enforcement actions are written formally using appropriate style, detail and regulatory language. The small size of the staff with its supervisory review process enhanced the quality of the inspection and enforcement documents.
An interview with staff indicated that follow-up inspections occur if there are open items and recurrent violations, inspection frequencies may be increased by 50% or more as needed.
None of the files reviewed indicated a follow-up inspection was needed.
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'g Arizona Proposed Final Report Page 8 The State has a variety of portable instruments for routine confirmatory surveys and for use during incidents and emergency response, it was noted that calibrated meters are available to monitor alpha, beta, neutron and gamma radiation. The State also has a very capable counting laboratory with liquid scintillation, sodium lodide and high purity germanium detectors for analyses of samples. Each inspector has his own air-mold case that contains a Ludlum Model 14-C with a GM detector, pancake probe,1x1 Nal detector, and thin crystal Nai detector.
There is also a Victoreen 450P lon chamber. The inspectors' survey meters are calibrated at a 3 month interval by a commercial calibration service in accordance with approved calibration procedures. The other available instrumentation is calibrated at least annually by a commercial L
calibration service.
In response to the questionnaire, the State reported that all three inspectors were accompanied by the Radioactive Material Program Director during the review period. One of the inspection files that was reviewed showed that inspectors had conducted an academic broad scope inspection and a medical broad scope under supervisory accompaniment. The evaluation critically assessed the inspector's ability to conduct inspections for specific types of licensees when an inspector is qualified to perform unaccompanied inspections. All inspectors were accompanied during the past year.
The review team did not perform any accompaniments of inspectors prior to the review or during the period of February 9-13,1998. The State's inspectors had been previously accompanied by IMPEP review team members and had demonstrated inspection techniques and knowledge of the State's regulations. The inspection files reviewed demonstrated their inspections conformed to State guidance and were adequate to assess radiological health and safety at the inspected facilities.
Based on the IMPEP evaluation criteria, the review team recommends that Arizona's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.
3.3 Technical Staffina and Trainina The ARRA is authorized 23 positions that are apportioned as follows: radioactive materials (RAM) activities,4; x-ray compliance,7; radiation measurements (laboratory),6; technician certification,1; non-ionizing compliance,1; emergency response,1; management, 3.
As noted, four personnel are assigned RAM duties and the number appears to be adequate to maintain the program. Also, a manager spends about % his time supervising radioactive materials activities. The RAM staff receives direct support from the radiation measurements l
laboratory that performs sample counting and assay services for the agency.
Resources within the RAM section are divided between licensing (1 FTE) and inspection (3 FTE) activities. Due to the low rate of tumover the ARRA RAM section consists of senior i
experienced personnel. No vacancies exist in the RAM section at this time and there is no expectation of losses in this area.
The only vacancy identified during the review is a position of State Health Physicist 11 (SHP 11) in the radiation measurements laboratory. The employee who was previously in this position took
Arizona Proposed Final Report Page 9 a new position within the ARRA as an x-ray inspector when a vacancy occurred in that section.
This position has been vacant for approximately 6 months and efforts are being made to hire a replacement. The present laboratory staff is able to adequately handle the RAM workload. The vacancy does not affect the capabilities of the program nor does it impact other IMPEP performance indicators because the position is in a support area that is otherwise well staffed.
The ARRA is fortunate in having an experienced and well seasoned staff. Work is assigned to all inspectors and reviewers commensurate with their training and experience. Tumover within the RAM section has been low since the last review. Minimum qualifications for a new hire is a baccalaureate degree with experience or a master's degree in health physics :,d experience.
Individuals may also qualify who have had a long period of on the job training and extensive experience in an appropriate science.
ARRA has outlined its training requirements for new employees in ARRA-PROG-1245. A training plan would be tailored for each new employee. A new hire is expected to complete
" core" courses, or their equivalent, to be fully qualified according to the ARRA's training guidelines. ARRA anticipates providing " core" course training by mixing courses from NRC and State resources. Consideration has also been given to participating in regional training opportunities with other Agreement States. To train personnel to the same standards within an approximate 2 year period will cost much more than in the past. The Authority receives a single annual appropriation and does not receive funds specifically for training. For planning purposes, ARRA estimated 2 - 4 individual training courses at a total estimated cost of $3,000 -
' $6,000. ARRA's estimate can provide for a modest amount of training and is adequate given the low staff tumover. In addition to completing required courses, the ARRA uses an apprenticeship concept to train new employees in inspection and licensing. Qualified inspectors or reviewers accompany new inspectors and coach them during the teaming process. When they have gained enough experience and confidence they are authorized to perform inspections or reviews independently. The ARRA also has an excellent management accompaniment and review program that assures highly consistent inspector and reviewer training.
The review team has no recommendations or suggestions in this area.
Based on the team's finding and the IMPEP evaluation criteria, the review team recommends that Arizona's performance with respect to this indicator, Technical Staffing and Training, be i
found satisfactory.
l 3.4 Technical Quality of Licensina Actions I
The review team examined completed licensing casework and interviewed the reviewer for 17 specific licenses. Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and of 1
its conditions and tie-down conditions, and overall technical quality. Casework was evaluated for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting l
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l l
Arizona Proposed Final Report -
Page 10
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l documents, consideration of enforcement history on renewals, pre-licensing visits, peer or
, supervisory review as indicated, and proper signature authorities. The files were checked for retention of necessary documents and supporting data.
l-The licensing casework was selected to provide a representative sample of licensing actions which had been completed in the review period.. The cross section sampling included all of the State's major licenses as defined by the State in the questionnaire and included the following types: academic and medical broad scope; industrial radiography; medical, including private i
practice; HDR afterloader; strontium-90 eye applicators; nuclear pharmacy; and well logging.
Licensing actions during the review period of 1996-1997 included 37 new licenses,90 renewals,-
j and 451 amendments, for a total of 616 licensing actions during the review period. In discussions with management, it was noted that there were no major decommissioning efforts
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underway with regard to agreement material in Arizona. A list of licenses reviewed with case-specific comments can be found in Appendix D.
l.
The licensing process was discussed with the primary license reviewer. Application packages containing guidance are sent to license applicants. The applications are reviewed following i
standard procedures which are similar to those used by the NRC. The reviews were generally complete, ensuring that all issues related to public health and safety were addressed.
Licensing checklists are not used routinely due to the experience of the reviewer. Alllicense actions are reviewed and signed by management. Deficiencies are addressed either by phone or by written letter for more complicated issues. For uncomplicated telephone deficiencies, there is a lack of detailed deficiency information in the license files. The review team recommends that staff include more detailed documentation related to telephone deficiency calls, describing the issues and notating the applicant's response. Additionally, the s aff should ensure that all requests within license applications are addressed, either in the ancA.d license or by letter, if certain aspects of the amendment request were denied.
I-Licensing guides, as well as other applicable guidance from NRC, such as that for HDR
. afterloading brachytherapy, are available. Standard License Conditions (SLC) are used and are maintained in the computer by license type. The SLC are similar to those used by NRC.
- Licenses are issued in entirety with each licensing action. License files are organized by license, license application correspondence, general correspondence, and inspection reports.
Pre-licensing visits are made for more complicated or unusual license applications, the latest of which was for a facility requesting a gamma stereotactic radiosurgery device. There is close interaction with the license reviewer and the inspection staff. Additionally, there are weekly staff meetings, which include discussions of major licensing and compliance issues.
There is a system to track licensing actions when they are received. State law now requires all actions to be completed within a specified time period, which varies depending on the complexity of the licensing action If the State fails to meet the time period, the State must reimburse the licensee's fee and pay a penalty. The State began this program in August 1997 as a trial, with full compliance expected in December 1998. Of concern to the team is the provision within the law that the State cannot go back to the license applicant with additional questions once an initial deficiency is addressed to the license applicant. This is of concern to the team should the licensee's response be deficient or raise additional questions. The staff is
l Arizona Proposed Final Report Page 11 evaluating options for working with this provision without compromising public health and safety, _
including the possibility for rejection of applications, pending submittal of all necessary information. The ARRA has not had sufficient time to study the impact of this law on a process that typically relies on more than one round of questions and licensee responses when issuing a radioactive materials license. The review team recommends that the State closely monitor the impact of this deficiency rule and provide NRC with information about the agency's j
experience with this law. The review team also suggests that staff and management continue i
to evaluate and develop a plan to accommodate the new legislation mandating time lines in which to process applications withoe'..npacting the technical quality of license reviews.
j Based on the IMPEP evaluation criteria, the review team recommends that Arizona's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.-
j 3.5 Resoonse to incidents and Alleaations l-l In evaluating the effectiveness of the State's actions in responding to incidents and allegations, l-the review team examined the State's response to the questionnaire relative to this indicator, reviewed the State's incident log and allegation files for the review period, and compared the incidents reported for Arizona in the " Nuclear Material Events Database (NMED)" against the l
Arizona incident files. The ARRA uses the Draft NMED guidance when reporting incidents to NRC. The team reviewed the incident log and briefly reviewed all 52 incidents that occurred during the review period. Nineteen of these incidents involved AEA material. Of these, seven were reviewed by the team in depth including two instances of stolen gauges, one abandoned source which tripped the alarm on a load of scrap steel, one stolen radioactive exit sign, and three accidents which damaged equipment or devices. A list of the incident casework with comments is included in Appendix F. The team also reviewed the State's response to the one allegation reported during the review period.
The NMED report for the review period lists 11 incidents reported by the State. Review of the Arizona incioent files showed that one of the incidents on the NMED list occurred at an NRC licensee located in the State, not an Arizona licensee. The team found files for two incidents-that the State had reported to the NRC but which were not included in the NMED report. Both of these incidents occurred early in the NMED program and the records indicated the State had reported the incidents to NRC Region IV. Presently, the State faxes the report directly to the NRC Operations Center and follows up with a telephone call to the Center to make certain the information is received and is clear and complete. Although this practice appears to be working well, it was noted that the State does not consistently advise the NRC Operations Center of closure information. The review team suggests that the State advise the NRC Office for Analysis & Evaluation of Operational Data when incidents are closed so that the NMED records may be updated.
Arizona's hazardous materials response plan assigns ARRA responsibility for responding to incidents and allegations involving radioactive materials. Procedures for response to materials incidents are contained in ARRA's SOP, last updated in August 1997. The review team evaluated the SOP and found it provides adequate guidance for emergency response actions.
Within ARRA, the Emergency Response (ER) Program Manager has the primary responsibility
l
[
Arizona Proposed Final Report Page 12 for coordinating all emergency responses including notification of the Director or Acting Director. If the incident involves a licensee, ER Program Manager will coordinate the response with the radioactive materials (RAM) Program Manager and normally will assign an inspector as primary responder. However, responders may include any of ARRA's technically qualified staff.
An ER Duty Officer is designated to provide response capability during non-working hours.
This duty is performed on a rotating basis by designated technical staff members. The team noted that Arizona inspectors respond on site to all incidents involving lost or missing radioactive material and to all incidents that present an actual or potential hazard to public health and safety. Six of the seven incidents reviewed included on-site investigations. The team found the investigations were prompt, thorough, and resulted in appropriate enforcement actions. Information provided by the licensee was verified and independent measurements were made. Incidents were consistently followed up in the next inspection. The team verified that allincident and allegation responses are discussed and approved by program management.
Apparently, because of the readily available resale market for portable gauges south of the U.S.
border, approximately 50 percent of the Arizona incidents involve stolen gauges. When a portable gauge is reported stolen, the State investigates, has the licensee file a police report, makes a press release, notifies the NRC Operations Center, contacts the adjacent Agreement States, and the regulatory agency in Mexico. A small percentage of the gauges are recovered.
The team reviewed the State's system of tracking and following incidents The SOP instructs the individual taking the initial incident report to enter background information on the ARRA form, " Radiological incident or Event Report." Because there are no written procedures for maintaining and distributing incident records, the team relied on interviews with program management and staff to determine the current practice. During these discussions, the team learned that a copy of the form is placed in an incident file folder in the ER section, and if the incident involves an Arizona license, another copy is placed in the licensee's file. The incident is entered in the incident log and assigned a unique incident identification number. Incidents meeting the NMED reporting requirements are faxed to the NRC Operations Center, and as explained previously, followed up by a telephone call. When appropriate, First Notices (similar to NRC Preliminary Notifications) are issued. Incidents meeting the routine event reporting criteria were not being forwarded to the NMED reporting system at the time of the review. The SOP requires that the staff member responding to an incident prepare a follow-up report for the Director, the ER manager, and the incident file. According to program management, the incident is reviewed and, if possible, closed at the next inspection. The incident report form is
~ then updated with the final disposition and dates nf closure, and an updated copy placed in the licensee's file. However, in reviewing the incide;a log and casework, the review team found that the incidents are not being recorded or filed consistently Some incidents were reported only by memos and others only by First Notices. Closure information was not always included in the file, and incident reports were not always found in the license / compliance files. The review l
team recommends that all incident reports be recorded and closed out as directed in ARRA's SOP, and that written procedures be developed to ensure that the reports are consistently i
maintained, distributed, and cross-referenced between the incident and licensee files. The l
team also recommends that the State follow the procedural guidance for reporting all incidents to NRC as described in the latest NMED manual.
i i
Arizona Proposed Final Report
. Page 13 Misadministrations are handled in the same manner as other incidents, but the forms and records are logged separately and kept in a separate file. It is the State's policy to respond on site to any misadministration that exceeds the new reporting criteria. The review team
' examined the records of the 76 misadministrations reported during the review period and agreed with the State that no therapeutic misadministrations or diagnostic misadministrations exceeded the reporting levels. At the time of the review, Arizona was in the process of adopting the revised misadministration rule. The review team suggests that ARRA develop written 1
procedures to be used as guidance for tracking, evaluating, and reporting misadministrations at j
the time the rule becomes effective.
The team reviewed the State's allegation procedures and reviewed in depth the one allegation that had been received during the review period. This allegation, which was referred to the State by NRC Region IV, was reviewed in depth by the review team, and the State's actions were found to be prompt and appropriate during the almost three-year investigation of this lengthy and complicated allegation. In handling allegations, the State must follow Arizona law which protects the identities of individuals. ARRA's written allegation procedure requires prompt evaluation of the allegations and an initial written response to the alleger. The procedure was revised on February 12,1998, to include the requirement to furnish the alleger with a copy of the finalinvestigative report.
Based on the IMPEP evaluation criteria, the review team recommends that Arizona's performance with respect to the indicator, Response to incidents and Allegations. be found satisfactory.
i 4.0 NON-COMMON PERFORMANCE INDICATORS
)
IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Arizona's agreement does not authorize regulation of uranium recovery activities.
4.1 Leoislation and Prooram Elements Reauired for Comoatibility 4.1.1 Leoislation Along with their response to the questionnaire, the State provided the review team with the opportunity to review copies of legislation that affects the radiation control program. Legislative 1
authority to create an agency and enter into an agreement with the NRC is granted in Arizona Revised Statutes, Title 30, Chapter,4. The ARRA is designated as the State's radiation control agency. The team noted that the legislatiori had not changed since the previous review, and j
finds that the State's legislation is adequate. It is noted that the ARRA is subject to a review every 10 years to ascertain the continued need for the agency.
i
Arizona Proposed Final Report Page 14 4.1.2. Proaram Elements Raouired for Comoatibility The team verified that the State's present regulatory agenda includes those NRC regulations that are necessary to assure the regulation compatibility criteria are satisfied. ARRA
- regulations are reviewed every five years to determine if the requirements are still appropriate and necessary. The ARRA provides, under State law, opportunity fu public comment on propmed regulation changes. Draft regulations are sent to NRC for aproval and when nece sary, changes suggested by NRC are incorporated before final adoption.
The ARRA provided, in its response to the questionnaire, a rulemaking schedule. Regulations required since the last review have been adopted or are in the final approval stage with the GRRC Regulations not yet required are on the schedule and if the pace is maintained the agency will meet its timeliness goals in the future. Since the last review, the ARRA has designated a single staff member the rulemaking responsibility and to maintain a schedule to assure continued compatibility of State regulations. This process appears to be working well, and, if continued, should assure that ARRA will maintain timely promulgation of necessary regulations. While several other agreement States have implemented similar mechanisms, the team notes that identifying a single point of contact 'or rulemaking and maintaining a regulatory schedule is a good technique.
The team notes that several minor Decommissioning Rule changes, identified in the 1995 review, have not been fully implemented. The ARRA has attempted to implement this rule since 1993. It was resubmitted in 1995 and 1997 to GRRC, and is presently being reviewed.
The agency indicated several times during the review that they have imposed the requirements on the single licensee several years ago pending completion of the rule. Implementation of a legally binding requirement is an acceptable way of maintaining consistency and compatibility with NRC requirements.
Based on IMPEP evaluation criteria, the review team recommends that Arizona's performance with respect to this indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.
4.2 S.ealed Source and Device (SS&D) Evaluation Proaram 4.2.1 Technical Quality of the Product Evaluation Proaram During the review period, only one SS&D certificate was issued by the State. The team preformed an in-depth review of the State's evaluation of this SS&D, a luminous calibration light
' source. All necessary elements were covered and a second full evaluation was performed by another qualified individual. The SS&D certificate is identified and listed with case-specific comments in Appendix G.
I i
The team found that the State's evaluation of the background information was complete and
. technically accurate and that the State determined that the device has adequate safety features. The State visited the manufacturer to verify the quality assurance program before the device was approved for distribution. Prototype testing for this device is not required by American National Standards Institute (ANSI) N540. The registry certificate, however, had two I
4 Arizona Proposed Final Report Page 15 errors that need to be corrected. First, the sheet did not list the maximum amount of radioactive material used in the device. Second, the certificate authorizes distribution to persons exempt from licensing as well as to general and specific licensees, however, the authority to approve exempt distribution is reserved for the NRC. The review team recommends the certificate AZ 244 D 102S, for TLS Systems model 40111 be amended to include the maximum amount of radioactive material used in the device and to remove the authorization for exempt license distribution.
Also, it was noted that the licensee's license for distribution does not list model 40111. The review team recommends that the TLS license for distribution (10-135) be ananded to include model 40111.
Review of this file and interviews with the staff indicated that Arizona follows the recommended guidance from the NRC SS&D training workshop. The registration file contained all correspondence, photographs, engineering drawings, radiation profiles, and results of tests conducted by the applicant, in addition, the checklist received at the workshop was used to assure all relevant materials had been submitted and reviewed. The checklist was contained in the registration file. The team observed that the staff willissue the guidance in NUREG-1556, V.3, issued September 1997. All pertinent ANSI Standards and Regulatory Guides are available and will be used.
4.2.2 Technical Staffina and Trainina Although Arizona has only one manufacturer who infrequently manufactures and distributes a new or changed device, the State wishes to keep the SS&D evaluation program. They are willing to provide sufficient resources to maintain an adequate program. The principal SS&D reviewer has been through the current NRC training and has been evaluating SS&Ds in Arizona
' for several years. He also evaluated SS&Ds during his military service prior to joining ARRA.
He has a degree in nuclear engineer cs with a minor in mechanical engineering. A second mechanical engineer is available in ARRA as necessary for assistance with engineering problems. The third individual trained and qualified for SS&D evaluation is the ARRA Director, a Certified Health Physicist. In order to provide more depth to the SS&D evaluation program, the State intends to send an additional person to the NRC SS&D workshop the next time it is offered.
4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds No incidents related to SS&Ds occurred during the review period, nor were there any defects reported.
Based on the IMPEP evaluation criteria, the review team recommends that Arizona's performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.
l Arizona Proposed Final Report Page 16 5.0
SUMMARY
l As noted in Sections 3 and 4 above, the review team found that Arizona's performance with respect to each of the performance indicators to be satisfactory. Accordingly, the team recommends that the Management Review Board find the Arizona program to be adequate to protect public health and safety and compatible with NRC's program.
l l
Below is a summary list of recommendations and suggestions, as mentioned in eartic sections
.of the report, for evaluation and implementation, as appropriate, by the State.
l RECOMMENDATIONS:
1.
The review team recommends that industrial radiography inspections need to be conducted at temporary job sites in addition to office inspections, to verify compliance to operating procedures and regulations. (Section 3.2) 2.
The review team recommends that staff include more detailed documentation related to telephone deficiency calls, describing the issues and notating the applicant's response.
(Section 3.4) 3.
The review team recommends that the State closely monitor the impact of this deficiency rule and provide NRC with information about the agency's experience with this law. Additionally, the staff should ensure that all requests within license applications are addressed, either in the amended license or by letter, if certain aspects of the amendment request were denied. (Section 3.4.)
4.
The review team recommends that allincident reports be recorded and closed out as directed in ARRA's SOP, and that written procedures be developed to ensure that the reports are consistently maintained, distributed, and cross-referenced between the incident and licensee files. (Section 3.5) 5.
The team also recommends that the State follow the new reporting procedures for all incidents as described in the latest NMED manual. (Section 3.5) 6.
The review team recommends the certificate AZ 244 D 102S, for TLS Systems model 40111 be amended to include the maximum amount of radioactive material used in the device and to remove the authorization for exempt license distribution. (Section 4.2.1) 7.
The review team recommends that the TLS license for distribution (10-135) be amended to include model 40111. (Section 4.2.1) i l
l l
L.
)
i Arizona Proposed Final Report Page 17 i
SUGGESTIONS:
1.
The review team suggests that the supplemental inspection report form for HDR i
l afterloaders be modified to cover the entire scope of licensee operations and
)
procedures. (Section 3.2) 2.
The review team suggests that staff and management continue to evaluate and develop a plan to accommodate the new legislation mandating time lines in which to process i
applications without impacting the technical quality of license reviews. (Section 3.4) 3.
The review team suggests that the State advise the NRC Office for Analysis &
Evaluation of Operational Data when incidents are closed so that the NMED j
records may be updated. (Section 3.5) 4.
The review team suggests that ARRA develop written procedures to be used as guidance for tracking, evaluating, and reporting misadministrations at the time the rule becomes effective. (Section 3.5)
I l
4 L
l l
i LIST OF APPENDICES AND ATTACHMENTS l
Appendix A iMPEP Review Team Members Appendix B Arizona Organization Chart l
Appendix C Arizona's Questionnaire Response Appendix D inspection File Reviews Appendix E License File Reviews Appendix F Incident File Reviews Appendix G Sealed Source and Device Reviews l
l Arizona's Response to Review Findings l
l l
I i.-
APPENDIX A l
IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility James Myers, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility B. J. Smith, Mississippi Status of Materials Inspection Program l
Technical Quality of Inspections Torre Taylor, NMSS Technical Quality of Licensing Actions 1
Jack Hornor, WCFO Response to incidents and Allegations Sealed Source and Device Evaluation Program i
i i
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l APPENDIX B l
ARIZONA RADIATION REGULATORY AGENCY ORGANIZATION CHART
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l APPENDIX C i
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE l
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Approved by OMB' No. 3150-0183 Expires 4/30/98 l
INTEGR ATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Arizona Radiation Regulatory Agency Reperting Period: Jan 95 to Jan. 97 A.
COMMON PERFORMANCE INDICATORS l.
Status of Materials inspection Proaram 1.
Please prepare a table identifying the licenses with inspections that are overdue i
i by more than 25% of the scheduled frequency set out in NRC inspection Manual Chapter 2800. The list shoLid include initialinspections that are overdue.
Insp. Frequency Licensee Name (Years)
Due Date Months O/D None 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.
3.
Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequ6rf / than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.
The Agency's inspection schedule is the same as the NRC's, thus we have no '
licensees or groups of licensees that are inspected less frequently than called for in inspection Manual Chapter 2800, Appendix E (issued 4/15/95).
3 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 o currently valid OMB control number.
4.
Please complete the following table for licensees granted reciprocity during the reporting period.
Number of Licensees Granted Reciprocity -
Number of Licensees Priority Permits Each Year inspected Each Year Service Licensees performing YR YR teletherapy and irradiator source YR 199E 1
YR 1995 0 installations or changes YR 1996 1
YR 1996 1 YR 1997 2
YR 1997 2
YR YR 1
YR 1995 6
YR 1995 0 YR 1996 3
YR 1996 0 YR 1997 6
YR 1997 4 YR YR 2
YR YR YR YR YR YR YR YR 3
YR 1995 16 YR 1995 1 YR 1996 16 YR 1996 2 YR 1997 16 YR 1997 4 4
All Other YR 1995 17 YR 1995 1
YR 1996 17 YR 1996 1
YR 1997 12 YR 1997 0 5.
Other than reciprocity licensees, how many field inspections of radiographers were performed?
1 We have inspected 4 industrial radiography licensee's field operations in 1996 and 1997.
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.-
)
11.
Technical Quality of Insoections 7.
What, if any, changes were made to your written inspection procedures during the reporting period?
We prepared our reports by computer. Copies were available at the last review. Some minor changes may have been made, therefore a copy of each is enclosed. See ARRA-PROG-2020 l
2
. I
J 8.
Prepare a table showing the number and types of supervisory accompaniments made
'l during the review period. Include:
Insoector Suoennsor License Cat.
Dent A)
John Neal William A. Wright 2120 7/31-8/11/95 Jeff Short John Wilson B)
John Neal William A. Wright 1110 04/25-26/96 C)
John Wilson William A. Wright 2121 02/11/97 Aubrey V. Godwin D)
John Wilson William A. Wright 1100 06\\16-24/97 John Neal 2120 Jeff Short E)
John Wilson William A. Wright Reciprocity 12/04/97 3320
)
9.
Describe intemal procedures for conducthg supervisory accompaniments of inspectors in ite field. If supervisory accompaniments were documented, please provide copies of the i
documentation for each accompaniment.
Accompaniments are made during a large inspectior. Such that all inspectors may be accompanied during one span of time. The accompaniments are documented in the inspection report.
10.
Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?
We have added ionization detectors to our equipment list to assure that our inspectors have botn low and high range instrumentation available. In addition, the Agency has added field gamma spectrography so that we can identify the isotopes in use in the field.
Ill.
Technical Stafnna and Trainina 11.
Please proside 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 between offices, the table should be consolidated to include all personnel contributing to the radioactive matetials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the pro l; ram's radioactive materials responsibilities, include their efforts. The table heading should be:
3
NAME POSITION AREA OF EFFORT FTE%
AubreyV. Godwin Director Administration 100 l.
Mary Ann Bcrton SHPll X-Ray Compliance 100 l
l Robert Cope Program Manager X-Ray Compliance 100 William Dotter SHP ll Radiation Measurements 100 i
Gary Freeland Program Manager -
Radiation Measurements 100 I
John Gray SHP11 Technician Certification 100 Shana Hellmuth SHP li X-Ray Compliance 100 Russell Hudson SHP11 X-Ray Compliance 100 Joyce Hoefle SHP11 Radiation Measurements 100 Leroy Klotz SHPll X-Ray Compliance 100 Robert Kovalcik SHP11 Radiation Measurements 100 l
Daniel Kuhl SHP11 RAM Compliance 100 John Lamb SHPll Non-lonizing Compliance 100 John Lutton Program Manager Emergency Response 100 l
Dale Mescher SHP11 X-Ray Compliance 100 Toby Morales SHP11 Emergency Response 100 John Neal SHP ll RAM Compliance 100 James Parkerson SHP11 Radiation Measurements 100 B. Rosen SHP11 X-Ray Compliance 100 Geoffory Short SHP11 RAM Compliance 100 John Wilson SHPll Ram Compliance 100 William Wright Program Manager Ram - Non-ionizing Comp.
100 l
Vacant SHP11 Radiation Measurements 100 l
i l
12.
Please provide a listing of s.ll 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.
4 l
u-
NAME POSITION AREA OF EFFORT Dearee Mary Ann Burton SHP11 X-Ray Compliance B.S.
Russell Hudson SHP11 X-Ray Compliance B.S.
John E. Lamb SHPll Non-lonozing Radiation OJT Dale Mescher SHP11 X-Ray Compliance B.S., M.B.A.
James Parkerson SHP11 Radiation Measurements B.S.
Sue E. Palen Network Sp.
Infor. Transfer B.A.
B. Rosen SHPll X-Ray Compliance B.S.,M.S.,M.D.
13.
Please list all professional staff who have no; 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.
All of the above staff have not met the qualifications for a materials inspector. If one of these are selected to be a materials inspector, they will be sent to the 5 weeks HP course, the required inspection courses and on-the-job training.
14.
Please identify the technical staff who left the RCP/ Regional DNMS program during this period.
William P. Pitchford RRO 11 X-Ray Compliance 1
Ralph R. Whitman RRO Il X-Ray Compliance Brent D. Jacquemart RROll X-Ray Compliance Jon M. Milner RROI X-Ray Compliance James N. Reed RROll X-Ray Compliance i
15.
List the vacant postions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.
l Radiation Monitoring Laboratory SHP!!
Vacant 3 months IV.
Technical Quality of Licensina Actions i
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.
5
l.
[*
None at this time, t.
17.
Discuss any variances in licensing policies and procedures or exemptions from the L
regulations granted during the review period.
None.
18.
What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
l See attached policies /
19.
For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.
V.
Resnonses to incidents and Allea=+ians 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 A reement States 0
i l
for additional guidance.) that occurred in the % ion / State during the review period. For j
A0reement States,information included in t vious submittals to NRC need not be e
l repeated (i.e.,-those submitted under OMB 3150-0178). The list should be in the following format:
LICENSEE NAME License #
Date ofincident/
Tvpe ofincident Report L
A.
Arizona Dept. of 07-031 03/20/95 Lost moisture Transportation Depth Probe Downhole l
B.
Speedie and Assoc's,Inc.07-209 03/30/95 Stolen Troxler
[
L C.
Western Technologies,Inc.07-080 05/31/95 Lost Troxler l
Construction inspection 07-098 10/11/95 Stolen Troxler And Testing Co.
AGRA Earth and 07-095 02/05/96 Stolen CPN Moisture Environmental Density Gauge F.
Westem Technologies,Inc.07-080 08/18/96 Stolen Troxler 6
United Metro Matts.,Inc.07-227 12/17/96 Stolen Troxler Asphalt Content Gauge H.
Ricker, Atkinson, McBee 07-406 01/11/97 Stolen Troxler And Associates Moisture Density Gauge 1.
Desert Cardiology 10-128 08/11/97 Stolen Cobalt-57 Flood Field Source J.
Speedie and Assoc's,Inc.07-209 10/17/97 Stolen Troxler Moisture Density Gauge 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 NRC? For Regions, was an appropriate and timely PN generated?
See attached First Notices.
22.
For incidents invoMng failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.
- None, i
23.
In the period covered by this review, were there any cases invoMng possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.
See 24.a. below 24.
Identify any changes to your procedures for handling allegations that occurred during the period of this review.
a.
For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.
Peter Capin Whistleblower Complaint Suspended investigation until his lawyer allows him to answer questions.
VI.
General
- 25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.
A.
Status and compatibility of Regu}ations (such Please see response to 29.
A 7
B.
Staff Continuity The Radioactive materials staff has been constant for the last 4 years. We have had some staff turnover in the X-Ray and Non-lonizing programs. Salaries are low but we have been able to retain our materials staff. The turn over in X-Ray would be a problem if the Agency is order to shift personnel from the materials staff to X-Ray. The Auditor General has reported to the legislature that we are extremely far behind in our X-Ray inspection and they will be reviewing the Agency again next year.
C.
Responses to incidents and Alleged incidents Attached are ARRA Policy 31.01, and Memorandum, Standing Operating Procedures for Response to incident involving Radioactive Material.
D.
Enforcement Procedures See the attached Administrative Procedure.
E.
Inspection Procedures Attached are the current inspection check lists, S87100. These are revised as appropriate. See the attached Program Guides relating to inspections.
F.
Inspection Reports See response to 5. above.
- 26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.
The Agency is weakened by the tumover rates both in clerical and professional staff. Further, there is minimal growth opportunity within the Agency. Further weakness is the lack of equipment resources for inspection team members. This includes data processing capability as well as radiation survey instrumentation.
The strengths are the excellent personnel, their dedication and willingness to work under such conditions.
B. NON-COMMON PERFORMANCEINDICATORS 1.
Leoislation and Proaram Elements Reauired for Con.na hility n
- 27. Please list all currently effective legislation that affects the radiation control program (RCP).
All are references to Arizona Revised statutes.
$30451 through $30-723, $32-2801 through $32-2843 and $41-1001 through $41-1092.11.
- 28. Are your regulations subject to a
- Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
All references are to Arizona Revised statutes.
8
1 l
)
541-1056 requires the Agency to review all regulations every 5 years. For each regulation, the Agency must describe the effectiveness of the regulation, indicate the statutory authority to issue the regulation, demonstrate that the regulation is consistent with other Agency regulation, the regulation is clear and understandable, and the economic impact on small business and the consumer.
- 29. Please complate 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 requiremer.ts other than regulations.
See attached table.
- 30. If yt,u have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.
We adopt the rule changes first by license condition, then by rule. The following time line applies when adopting rule changes.
STEP TIME TO COMPLETE Draftini6a! rule Varies, usually 1-2 months File notice of Docket Opening 1 week Have Hearing Board review the proposal 1-2 months Rodraft with suggested changes 1-2 months Send to Gov. Reg. Revicw Council for initial review 1-2 months Send to Gov. Reg. Review Council for formal review 1 month 1
Conduct public hearing, receive public comments 35 days minimum Redraft based on comments 2 months Submit for Gov. Reg. Review Council hearing 2 months Rodraftin accord with Gov. Reg. Review Council comments 1 week-2 months Final publication TotalTime in Process 10 to 17 months See attached flow chart, Regular Rulemaking Process.
11.
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:
e l
SS&D Manufacturer, Type of Regk,try Distributor or Device Date Number Custom Use.r or Source issued l
AZ244D101S TLS Systems Inc.
Ref. Light Source 03/05/93
.AZ244D102S TLS Systems Inc.
Ref. Light Source 03/08/96 32.
What guides, standards and procedures are used to evaluate registry applications?
We followed the procedures and standards outlined in the USNRC Sealed Sources and Devices Certification guidance.
33.
Please include information on the following questions in Section A, as they apply to the Sealed l
Source and Device Program:
Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - AN.16-18 Responses to incidents and Allegations-A.V.20-23 The sealed sources evaluations are made by Mr. William A. Wright, with a degree in engineering and retiewed by Aubrey V. Godwin, CHP. Further, on the ARRA staff is another engineer who is available for consultation as needed.
l I!!.
Low-Level Waste Proaram 34.
Please include information on the following questions in Section A, as they apply to the Low-level Weste Program:
Status of Materials inspection Program - A.L1-3, A.I.6 i
Technical Quality of Inspections - A.ll.7-10 l
Technical Staffing and Training - A.lli.11-15 l
Technical Quality of Ucensing Actions-AN.16-18 l
Responses to incidents and Allegations - A.V.20-23 Does not apply.
4 IV.
Uranium Mill Proaram 35.
Please include information on the following questions in Section A, as they apply to the Uranium l
Mill Program:
l Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Quality of inspections - A.ll.7-10 Technical Staffing and Training - A.lll.11-15 Technical Quality of Licensing Actions - AN.16-18 Responses to incidents and Allegations - A.V.20-23 Does not apply.
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MATERIALS REQUESTED TO BE AVAILABLE FOR THE ONSITE PORTION OF AN IMPEP REVIEW ORGANIZATION CHARTS Clean, sized 8% X 11"ir'cluding names and positions D One showing positions from Govemor 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 o Printouts of current licenses, showing total, as follows:
Name License #
Location License Type Priority Last inspection Due Date Sort alphabetically Also, sort by due date and by priority (if possible) l THE FOLLOWING LISTS List of open license cases, with date of original request, and dates of follow up actions a
a List oflicenses terminated during review period.
1 0 Copy of current log or other document used to track licensing actions j
c Copy of current log or other document used to track inspections o List of inspection frequency by license type
{
o 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 l
THE FOLLOWING DOCUMENTS a All State regulations a Records of results of supervisory a Statutes affecting the regulatory authority of accompaniments of inspectors the state program o 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, i
l o SS&D review procedures severity levels, civil penalties (as applicable) j o instrument calibration records a Copies of job descriptions o inspection procedures and guides o inspection report forms j
13
)
APPENDIX D INSPECTION FILE REVIEWS NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.
File No.: 1 License No.: 10-84 Licensee: Syncor Int. Corp.
Inspection Type: Unannounced, routine, completa Location: Tucson Priority: 1 License Type: Nuclear Pharmacy inspector: JN, JS Inspection Date: 1/15/97 Comment:
a)
Inspection overdue / exceeded the 1 year frequency by 6 months.
File No.: 2 License No.: 10-024/10-044 Licensee: University of Arizona inspection Type: Unannounced, routine, complete, team Location: Tucson Priority: 2&1 License Type: Academic Type A Broad &
Inspector BW, JN, Medical Institutional Broad JW, JS Inspection Date: 6/16-26/97 Comment:
a)_
Inspections performed 23 months after previous inspection.
File No.: 3 License No.: 7-024 Licensee:' St. Joseph's Hospital &
Inspection Type: Unannounced, routine, complete Medical Center Priority: 3 Location: Phoenix Inspector: JS, JN, JW License Type: Teletherapy (Gamma Knife)
Inspection Date: 8/11-13/97 File No.: 4 License No.: 14-2 Licensee: Yuma Regional Medical Center Inspectior, Type: Unannounced, routine, complete Location: Yuma Priority: 3 License Type: Medical Limited Inspector: JN inspection Date: 3/24/97 File No.: 5 License No.: 14-29 Licensee: Yuma Cardiology Associates inspection Type:
Location: Yuma License Type: Medical Private Practice Priority: 5 Inspection Date: NA Inspector: NA Comment:
a)
License issued 10/8/97. Not due for initialinspection yet.
File No.: 6 License No.: 10-37 Licensee: Tucson Cardiology Ltd.
Inspection Type: Unannounced, routine, complete Location: Tucson Priority: 5 License Type: Medical Private Practice inspector: JN Inspection Date: 4/25-27/97
Arizona Proposed Final Report Page D.2 Inspection File Reviews File No.: 7 License No.: 7-407 Licensee: Tri-City Cardiology inspection Type: Unannounced, complete, routine Location: Mesa Priority: 5 License Type: Medical Private Practice Irispector: JS Inspection Date: 2/22/95 File No.: 8 License No.: 3-31 Licensee: Peabody Coal Inspection Type: Unannounced, routine, complete Location: Flagstaff Priority: 5 License Type: Gauge inspector: JS i
inspection Date: 7/19/95 Comments:
I a)
Inspector did not check for calibrated survey instrumentation. Licensee authorized for i
gauge installation / removal.
b)
Annual training records not verified. Inspector stated that licensee had not installed or I
removed any gauges since last inspection. Not authorized for installation / removal on I
renewalin its entirety File No.: 9 License No.: 10-59 Licensee: Southwestern Radiation inspection Type: Unannounced, routine, complete Oncology Ltd.
Priority: 3 Location: Tucson inspector: JS License Type: Medical Private Practice Limited inspection Date: 11/15/95 Comment:
1 a)
RSO not available for closeout with management.
File No.: 10 License No.: 7-120 Licensee: Columbia Medical Center inspection Type: Unannounced, complete, routine Location: Phoenix Priority: 1 License Type: HDR Afterloader inspector: JW Inspection Date: 7/1/97 j
i Comments:
a)
Initial inspection for HDR performed 5/14/96.
b)
Inspection report compliance oriented instead of performance based.
c)
Report does not document whether worker interviews performed.
d) inspection needs to cover entire scope of license
- naerations. Detail of operations not documented in report.
File No.: 11 License No.: 7-311 Licensee: Lincoln Health Center inspection Type: Unannounced, routine, complete Location: Phoenix Priority: 3 License Type: MedicalInstitutional Inspector: JS Inspection Date: 8/20-21/96 l
1
p l..
l.
L Arizona Proposed Final Report Page D.3 inspection File Reviews File No.: 12 License No.: 7-209
' Licensee: Speedie & Associates Inspection Type: Unannounced, complete, special Location: Phoenix Priority: 5
. License Type: Portable Gauge inspector: JW Inspection Date: 10/17/97 Comments:
a)
Special inspection performed after stolen gauge incident.
File No.: 13 License No.: 7-300 i
Licensee: Welenco Inc.
Inspection Type: Unannounced, complete, routine Location: Chandler Priority: 3 -
License Type: Well-logging Inspector:- JW Inspection Date: 1/15/97 l
Comments:
l a)
Inspection did not cover entire scope of licensee operations. No documentation of inspection of records required for temporary job sites. No observance of transport i
vehicles to check if placarding was available or required.
b)
No calibration date for survey meter inspector used.
I i
File No.: 14 License No.: 15-44 l
Licensee: MOS Inspection inspection Type: Unannounced, routine, office, complete Location: Phoenix Priority: 1 l
License Type:. Industrial Radiography Inspector: JN Inspection Date: 7/9/97 Comments:
l a)
No field inspections have been performed to verify observance of operating procedures l
and adherence to regulations.
~
l b)
- Inspection did not cover scope of operations.
File.No.: 15 License No.: 15-69 Licensee: Professional Service industries inspection Type: Telephone Location: Salt Lake City, UT Priority: 1 License Type: Industrial Radiography inspector: JN Inspection Date: 9/30/96 Comments:
a)
Licensee has not notified ARRA of any work that was perforrned in Arizona.
l b)
No inspection performed since license issued in 1994.
File No.: 16 License No.: 15-5 Licensee: El Paso Natural Gas inspection Type: Telephone Location: El Paso, TX Priority: 1 License Type: Industrial Radiography inspector: JW Inspection Date: 6/27/95
- Comments:
a)
Previous inspections performed 12/4/91.
b)
. Licensee notified ARRA about 40 times since 1995 about temporary job sites.
p
- L Arizona Proposed Final Report Page D.4 Inspection File Reviews -
File No.: 17 License No.: 7-369
- Licensee: AGRA Earth and inspection Type: Unannounced, complete, routine, office Environment Priority: 1 Location: Phoenix Inspector: JS License Type: Industrial Radiography inspection Date:- 11/12/97 Comments:
~)
Previous office inspection performed 6/10/96. Not performed within time frame of a
l procedures.
l b)
No field inspections performed c)
Inspection did not cover scope of operations.
File No.: 18 License No.: 7-049 Licensee: Western Technologies inspection Type' Unannounced, routine, complete, office Location:- Phoenix Priority: 1 License Type: Industrial Radiography inspector: JN Inspection Date: 9/3/97 Comments-a)
Prevbus office inspection performed 4/4/96. Not performed within time frame of
' procedcres.
b)
Last field inspection performed 6/2/93.
c)
Inspectica did not cover scope of operations.
File No.: 19 License No.: 7-415 Licensee:.. Phoenix National Labs Inspection Type: Unannounced, complete, routine, office i
i Location: Tempe
' Priority: 1
- License Type: Industrial Radicgraphy inspector: JN l
l
. Inspection Date: 11/13/97 Comment:
a)
No field inspections performed to verify adherence to operating procedures and
-regulations.
File No.: 20 License No.: 11-13 Licensee: CASA Grande Oil Mill inspection Type: Unannounced, complete, routine Location: Casa Grande Priority: 5 License Type: Fixed Gauge inspector: JN Inspection Date: 6/28/95 File No.: 21 License No.: 10-67 Licensee: El Dorado Hospital inspection Type:
. Location: Tucson
' unannounced, routine, complete Priority: 3 License Type: Medicalinstitution Inspector: JW Inspection Date: 7/17/97
APPENDIX E LICENSE FILE REVIEWS NOTE: ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.
File Noa 1 Licensae: Welenco,Inc.
License No.: 7-300 Location: Chandler License Type: C15-Well-logging Type of Action: amendment, renewal Date issued: 11/4/97,12/11/97, 7/22/97 License Reviewer: DK Comments:
a)
Address change,11/10/97 deficiency call placed regarding close-out; indication of " call done" but nothing else in file. Talked with inspector - sealed source only, no close-out needed.
' File No.: 2 Licensee: St. Joseph's Hospital and Medical Center License No : 7-424 Location: Phoenix Amendment No.: 1 License Type: B5-Medical Teletherapy (gamma knife)
Type of Action: new, amendment Date issued: 6/10/96,1/21/97 License Reviewer: DK F4e No.: 3 Licensee: AGRA Earth and Environmental License No.: 7-95 Location: Phoenix Amendment No.: 29,30 License Type: C5-portable gauge Type of Action: amendments Date issued: 8/12/97, 9/4/97 License Reviewer: DK File No.: 4 Licensee: Lawrence Spitalny, M.D.
License No.: 7-166 Location: Phoenix Amendment No.: 7 License Type: B4-Medical Materials, Class C (Sr-90 eye applicator)
Type of Action: renewal Date issued: 3/27/96 License Reviewer: DK Comment:
a)
September 22,1996 letter submitted as part of renewal: additional address, second user; letter should have been included in tie-down; user not added. An oversight to be fixed the week of 2/16/98.
j' File No.: 5 i
i.
Licensee: Southwest Veterinarian Oncology License No.: 10-132 Location: Tucson Amendment No.: 2 License Type: C13 -irradiator (veterinary use)
Type of Action: new, amendment Date issued: 5/24/94,5/12/95 License Reviewer: DK File No.: 6
)
Licensee: Canyon State inspections License No.: 10-101 I
Location: Tucson License Type: C1 -Industrial Radiography, Class 1 Type of Action: renewal Date issued: 2/21/95 License Reviewer: DK i
1
)
l I
9 l
1
[+
l Arizona Proposed Final Report Page E.2 License File Reviews i
i File No.: 7 L
Licensee:- Arizona Oncology License No.: 2-16 l
. Location: Sierra Vista -
E License Type: B3 - Medical Materials, Class B Type of Action: new Date issued: 9/25/95 License Reviewer: DK File No.: 8 Licensee: Yuma Regional Medical Center License No.: 14-2 Location: Yuma Amendment No.: 63 l
License Type: B2-Medical Materials Class A Type of Action: amendment Date issued: 11/26/97 License Reviewer: DK l
. File No.: 9 Licensee: TLS Systems License No.: 10-135 Location: Tucson Amendment No.: 1 License Type: D1 - Distribution Type of Action: new, amendment Date issued: 8/30/95, 3/6/97 License Reviewer: DK
- File No.: 10
- Licensee: El Paso Natural Gas License No.: 15-5 Location: El Paso, TX Amendment No.: NA License Type: Industrial Radiography, Type' A Type of Action: NA-Date issued: 8/17/93 License Reviewer: JW Comment:
a)
The authorized location of use includes the licensee's physical address in'El Paso, Texas, in addition to temporary job sites within Arizona. This was corrected at the time of the review. No specific action reviewed.
File No.: 11 Licensee: Syncor International, Inc.
License No.: 10-84 j
Location: Tucson Amendment No.: 36 l
License Type; B3-Medical Materials Class B Type of Action: renewal (nuclear pharmacy)
License Reviewer: DK j
Date issued: 2/26/97 3
Comment:
a)
- Telephone deficiency record was not clear regarding issue with authorized nuclear l
pharmacists, approval of authorized nuclear pharmacists per NRC license, and self-approval of users. Documentation in a license file not clear as to discussion and t
resolution of this issue. The license authorized users per NRC's license, but documentation showing that NRC approved Syncor's self-approval of users was not in the license file. Staff contacted Syncor during the review,. requesting a fax of this NRC approval.
m Arizona Proposed Final Report Page E.3 License File Reviews i
File No.: 12 Licensee: Columbia Medical Center-Phoenix License No.: 7-120 Location: Phoenix Amendment No.: 56 License Type: B2-Medical Materials Class A Type of Action: amendment Date issued: 1/22/98 License Reviewer: DK Comment:
a)
The wrong source is authorized for the HDR unit - all documentation indicates that the licensee has correct source, but that an error occurred on the license during the last renewal (early 90's, different reviewer). Staff requested to contact Nucleotron to ensure that they have the most current license. Error will be fixed week of 2/16/98.
L File No.: '13 Licensee: ClGNA Health Care License No.: 7-289 Location: Sun City Amendment No.: 15 L
License Type: Medical-Clinic Type of Action: amendment, renewal I
Date Amendment issued: 4/26/96,10/10/95 License Reviewer: DK, JN(renewal)
Comments:
- a)
Renewal did not request Sr-89, incoming mail log sheet (10/10/95) noted physician wants Sr-89; no other documentation. Renewed license authorized Sr-89, b).
Changed film badge exchange frequency from monthly to quarterly; no justification; licensee authorized for 1-131 at level not requiring hospitalization.
l l
File No.: 14 Licensee: University of Arizona License No.: 10-24 Location: Tucson Amendment No.: 52 l
License Type: Broad Academic Type of Action: renewal Date issued: waiting signature of Director License Reviewer: DK t
Comment:
. a)
Licensee was denied request (per discussion with staff) to incinerate low-level radioactive material (C-14), but there was not any documentation to licensee specifically t-stating this; correspondence from licensee included in tie-down condition. Unclear if j
licensee is aware that incineration is not authorized. Staff indicated that it was not allowed and that licensee knew this.
- File No.:' 15 Licensee: Impath/Onccgenetics License No.: 7-397 Location: Phoenix Amendment No.: 5 License Type: R&D lab / radioactive material storage only Type of Action: amendment
= Date issued: 7/11/97 License Reviewer: DK Comment:
a)
Licensee requested storage only status as well as change in RSO in letter dated 6/7/97; the amendment did not change the authorized use for storage only. Note left for
' Arizona staff reviewer to research - reviewer was out during most of review due to illness.
r, Arizona Proposed Final Report Page E.4 License File Reviews -
File No.: 16 Licensee: University of Arizona License No.: 10-44 Location: Tucson Amendment No.: 40 License Type: Broad Medical Type of Action: renewal Date issued: 2/5/98 License Reviewer: DK File No.: 17 Licensee: Arizona Public Service Co.
License No.: 9-5 Location: Joseph City Amendment No.: 19 License Type: Industrial, Type A (fixed nuclear gauge)
Type of Action: renewal Date issued: 7/15/97 License Reviewer DK Comment:
a)
Actions memo states " waiting for disposal information;" no other information in file, but renewalissued.
APPENDIX F INCIDENT FILES REVIEWED NOTE: ALL INCIDENT FILES LISTED W11HOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.
]
File No.: 1 Licensee: Speedie & Associates I
License No.: 7-209 Incident ID No.: AZ 97-016 NMED No.: 970991,970992 Location of Event: Phoenix Type of Event: Stolen gauges Date of Event: 10/18/97 Investigation Type: Phone, site Investigation Date: 10/21/97 Summary of incident and Final Disposition: Chains cut and two portable gauges stolen from trucks parked at two driferent employee's homes. One recovered next day following proposed civil penalty, second not recovered, case still open.
File No.: 2 Licensee: unknown incident ID No.: AZ 06-005 NMED No.: 960093 Location of Event: National Metals, Phoenix Type of Event: Abandoned RAM in scrap steel Date of Event: 2/20/96 l
Investigation Type: On site Investigation Date: 2/20/96 Summary of incident and Final Disposition Railcar of scrap steel was returned to Phoenix after it tripped radiation alarm at Colorado foundry. State responded immediately after notification and found a portable gauge source rod in load. RAM was secured and returned to manufacturer. File closed when State received verification that source had been received by l
manufacturer.
l File No.: 3 l
l Licensee: Arizona State University i
License No.: 07-037 incident ID No.: AZ 96-17 NMED No.: 960659 Location of Event: Tempe Type of Event: Stolen RAM l
Date of Event: 10/28/96 i
Investigation Type: phone, site j
Investigation Date: 11/4/96 Summary of incident and Final Disposition: Campus security camera showed five individuals l
stealing a campus exit sign containing 20 Ci Tritium (H-3), but police were not able to identify
(
individuals. RSO took wipes of area immediately and State conducted on-site investigation with additional wipes on 11/4/96. No contamination was found. Source not recovered and file remains open.
Comment:
a)
Incident report form was not in license or incident file.
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v Arizona Proposed Final Report Page F.2 incident File Review File No.: 4 Licensee: North Star Steel License No.: 8-026 Incident ID No.: AZ 97-008 NMED No.: Did not meet reporting criteria Location of Event: Kingman Type of Event: Partially melted gauge Date of Event: 6/7/97 investigation Type: phone, site investigation Date: 6/9/97 Summary of incident and Final Disposition: Molten steel spilled on gauge, partially melting lead shielding. Source container not damaged, no exposures resulted. Licensee cleared area and called State and manufacturer. Manufacturers' representative surveyed and removed RAM under observation by Arizona inspector. Gauge packaged in accordance with DOT requirements and returned to manufacturer.
Comment:
(a) incident report not in licensee's file (was in incident file).
File No.: 5 Licensee: Construction Testing License No.: 7-98 incident ID No.: AZ 95-009 NMED No.: none Location of Event: Phoenix Type of Event: Stolen gauge Date of Event: 10/11/95 (reported)
Investigation Type: site Investigation Date: 10/11/95 Summary of Incident and Final Disposition: Portable gauge stolen from truck parked overnight at employee's home. Investigation same day verified chains cut. Licensee cited for improper storage. Gauge never recovered, file open.
. Comment:
(a)
Incident reported by FAX to NRC RIV on 10/11/95. Was not included in NMED report.
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Arizona Proposed Final Report Page F.3 i
incident File Review File No.: 6 Licensee: Western Technologies i
License No.: 7-080 l.
Incident ID No.: AZ 97-012 NMED No.: Did not meet reporting criteria Location of Event: Tucson i
Type of Event: Damage to equipment Date of Event: 9/15/97 (reported 9/16/95) investigation Type: phone Investigation Date: 9/16/97 Summary of incident and Final Disposition: Portable gauge run over by a sheeps-foot compactor at job site. Area isolated, licensee's RSO responded and put source rod back in shield and transported to storage. Leak test negative, returned gauge to manufacturer.
6 Comment:
(a) incident report not filed; never officially closed.
File No.: 7 Licensee: Arizona Department of Transportation License No.: 7-31
- Incident ID No.: AZ 95-001 NMED No.: 950612 l:
Location of Event: Phoenix l
Type of Event: Source stuck down-hole i
Date of Event: 3/20/95 Investigation Type: Immediate on site L
Investigation Date: 3/20/95 Summary of incident and Final Disposition: Model 500 moisture density gauge cable broke, leaving probe with source 140' down hole. State responded immediately, secured area, made measurements, sent First Notice. Licensee advised source recovered on 3/22/95, leak test was l
negative.
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l APPENDIX G SEALED SOURCE AND DEVICE REVIEWS File No.: 1 Registry No.: AZ 244 D 102S SS&D Type: Luminous calibration light source Manufacturer: TLS Systems Model No.: 40111 Date issued: 1/24/96 Reviewer: WW Comments:
a)
Manufacturer not authorized to distribute Model 40111 b)
Device approved for exempt as well as general and specific license distribution; recommend remove approval for exempt.
c)
Sheets should specify the maximum amount of radioactive material permitted in device.
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Aaenda for Manaaement Review Board Meetina Tuesdav. Aoril 28.1998. 2:30 o.m.. OWFN. 4-B-6 l
1.
Convention. MRB Chair convenes meeting (H. Thompson) 2.
New Business - Consideration of Arizona IMPEP Report A.
Introduction of Arizona IMPEP Team Members (J. Myers)
B.
Introduction of Arizona representatives and other State representatives participating through teleconference. (L. Rakovan)
C.
Findings regarding Arizona Program (IMPEP Team)
Status of Inspection Program 1
Technical Quality of Inspections Technical Staffing / Training Technical Quality of Licens!ng Response to incidents / Allegations Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program D.
Questions. (MRB Members)
E.
Comments from State of Arizona F.
MRB Consultation / Comments on issuance of Report (H. Thompson)
Recommendation for next IMPEP review 3.
Oid Business (L. Rakovan)
Massachusetts MRB Minutes Handling of New York IMPEP 4.
Status of Upcoming Reviews (L. Rakovan) 5.
Adjoumment invitees:
Hugh Thompson, MRB Chair, EDO Richard Bangart, MRB Member, OSP Karen Cyr, MRB Member, OGC Carl Paperiello, MRB Member, NMSS Thomas Martin, MRB Member, AEOD Roland Fletcher, Agreement State Liaison to MRB Aubrey Godwin, AZ James Myers, IMPEP Team Leader, OSP l
B. J. Smith, IMPEP Team Member, Mississippi j
Jack Hornor, IMPEP Team Member, RIV WCFO Torre Taylor, IMPEP Team Member, NMSS Paul Lohaus, OSP Don Cool, NMSS Lance Rakovan, OSP ATTACHMENT 2