ML20199F058

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Integrated Matls Performance Evaluation Program Review of New Mexico Agreement State Program, for Period 970714-18
ML20199F058
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Issue date: 12/30/1997
From:
NRC
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ML20199F051 List:
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NUDOCS 9802030044
Download: ML20199F058 (48)


Text

-. - . . .- - . .

Mr. M:rk E. W; idler, Secret *_ry Environment Department 1190 St. Fr:ncis Driva P.O. Box 26110 Santa Fei M 87502

Dear Mr. Wei er:

On October 23, Q97 and December 11,1997, the Management Review Board (MRB) met to consider the proposed final Integrated Materials Performance Evaluation Program (IMPEP) report on the New Mexico Agreement State Program. The IMPEP review was conducted July 1418,1997. Thh MRB had received for consideration the actions described in your letter of October 10,1997 an William M. Floyd's letter dated December 3,1997. The MRB found the New Mexico progra adequate but needs improvement, and compatible with NRC's program. Because of the qignificance of the concerns, the MRB recommenos heightened oversight of the New Mexicq program. I request that monthly conference calls take place with the appropriate New Mexico %nd NRC staffs to Ciscuss the status cf the program. The Office of State Programs will coordinatkthe monthly teleconferences. I also request that written progress reports addressing thd{MPEP team's suggestions and recommendations found in Section 5.0, page 19, of the enclosed final report be submitted to Richard L. Bangart, Director, Office of State Programs, every other month 4 rom 4ho er:#efthes-tetter *The first progress /

report is requested by February 1,1 .

Based on the results of the current IMP P review, the follow-up review will be scheduled for July 1998. The follow-up review will cc. ; the State's action on the recommendatiorl from the- /

July 1997 review.

I appreciate the courtesy and cooperation ext gded to the IMPEP team during the review, to me and my staff during our December 4,1997 rgeeting, and your continuing support of the _

Radiation Control Program. I look forward to our agencies continuing to work cooperatively in the future.

Si cerely,

\\ .

Hugh L\ Thompson, Jr.

Deputy Epecutive Director for Regulatory Programs

Enclosure:

As stated cc: Benito Garcia, NM bec: Chairman Jackson j Ed Kelley, NM Commissioner Dicus l William Floyd, NM Commissioner Diaz )

Distribution: DCD (SP01) . LRakovan .

Commissioner McGaffigan DIR RF PDR (YES/) KSchneider \

SDroggitis FCameron, OGC TFrazee, WA JHomor, RIV/WCFO HNewsome, OGC SMoore, NMSS CHackney, RIV GDeegan, NMSS New Mexico File i '

RScrano, RIV LHov :l, RIV ' ED0 r/f DOCUMENT NAME: G:\KXSt97FINLTR.NM, G:\KXStNMIMP97. FIN T* recchre a cop 7 of th6e document, $dicate in the box: "C" = Copy ethout attachment / enclosure "E" = Conf eth attachmerit/enclosuA "N" = No copy OFFICE Rlli ML OSP (Q[ OSP4/ k OSP:DM1 DED V I NAME JLynch:kk .l T % KNSchneid 'r' O PHLohau@ O RLBangart W' HLThom$6n DATE 12 7/97 V 12/N/97 4 12/M97 il 12# 497 12/h /97 9802030044 971230 OSP FILE CODE: SP-AG-19 PDR STPRQ ESGNM PDR _

l a rts t .. UNITED STATES.

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} NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30eeH001 e

p a%*****/ December 30, 1997

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l

$ Mr. Mark E. Weidler, Secretary

Environment Department 1190 St. Francis Drive
P.O. Box 26110 i Santa Fe, NM 87502 i

Dear Mr. Weidler; l

l On October 23,1997 and December 11,1997, the Management Review Board (MRB) met to l consider the proposed final Integrated Materiab Performance Evaluation Program (IMPEP) l j report on the New Mexico Agreement State Program. The IMPEP review was conducted July 14-1_8,1997. The MRB had received for consideration the actions described in your letter of October 10,1997 ano William M. Floyd's letter dated December 3,1997. The MRB found i

the New Mexico program adequate but needs improvement, and compatible with NRC's

. program. Because of the significance of the concems, the MRB recommends heightened

oversight of the New Mexico program. I request that monthly conference calls take place with

~

the appropriate New Mexico and NRC staffs to discuss the status of the program. The Office of State Programs will coordinate the monthly teleconferences. I also requ7st that written  !

progress reports addressing the IMPEP team's suggestions and recommendations found in

Section 5.0, page 19, of the enclosed final report be submitted to Richard L. Bangart, Director, Office of State Programs, every other month. The first progress report is requested by

. February ,1998.

l Based on the results of the current IMPEP review, the follow-up review will be scheduled for 4 July 1998. The follow up review wi'l cover the State's action on the recommendations from the 4

July 1997 review.- '

l l appreciate the courtesy and cooperation extended to the IMPEP team during the review, to g me and my staff during our December 4,1997 meeting, and your continuing support of the

. Radiation Control Program; . I look forward to our agencies continuing to work cooperatively in the future.

Sincer ly, ug L. Thompson, Jr.

y Executive Dire or for Regulatory Programs

Enclosure:

As stated cc: Benito Garcia, NM Ed Kelley, NM William Floyd, NM

4 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF NEW MEXICO AGREEMENT STATE PROGRAM l July 1418,1997 d

i 4

l

. FINAL REPORT' l

, U.S. Nuclear Regulatory Commission l

I s

W- - - - , .-

New Mexico Final Report Page1

1.0 INTRODUCTION

This report presents the results of the review of the New Mexico radiation control program. The review was conducted during the period Ju!y 14-18,1997, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Washington. Team members are identified in Appendix A. The review was conducted in accordance with the " Interim implementation of the integrated Materials Pettmance Evaluation Program Pending Final Commission Approval of the Statement c hciples and Policy for the Agreement State Progsm and the Policy Statement on Adequ ./; and Compatibility of Agreement State Programs," published in the Federal Reoister on October 25, 1995, and the September 12,1995, NRC Management Directive 5.6, "Irrtegrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period August 13,1994 to July 13,1997, were discussed with New Mexico management on July 18,1997.

A draft of this report was issued to New Mexico for factual comment on August 8,1997. Tne State requested and received a month's extensio for reolying to the draft report. The State of New Mexico responded in a letter dated October 10,1997 (Attachment 1). The State's factual comments were incorporated in the final report. The Management Review Board (MRB) met on October 23,1997 to cor' sider the proposed final report. At the time of the review, the review team found the State's performance to be satisfactory for the indicator, Technical Quality of Licensing Actions; satisfactory with recommendations for improvements for the indicators, Status of Materials inspection Program, Technical Quality of Inspections, Technical Staffing and Training; and unsatisfactoy for the indicator, Response to incidents sqd Aligations. The review team recommended that the New Mexico program be found adequate, but needs improvement, and compatible. Because of the significance of the concerns, the team also recommended that New Mexico be placed on probation and noted that heightened oversight is warranted. During the MRB meeting, three main issues were identified t'iat New Mexico had to address in terms of programmatic improvements: (1) level of program staff and amount of resource support, (2) technical quality of staff and training needs, and (3) level of management support, involvement and oversight of New Mexico Agreement program activities. The MRB found the New Mexico program adequate, but needs improvement, and compatible with the NRC's program. The MRB concluded that it would be appropriate for NRC management to meet with upper management of the New Mexico program before the MRB voted on the recommendation for probation status for the program.

On December 4,1997, Mr. Thompson, NRC and other NRC managers met with Secretary Mark l Weidler, New Mexico Environment Department and his staff to discuss performance concerns I

l associated with the New Mexico Agreement program. See Attachment 2, December 4,1997 NRC/New Mexico Management Meeting M:r.utas.

On December 11,1997, the MRB reconvened to discuss probation for the New Mexico program. Based on the New Mexico actions to date, and the commitments by Secretary Weidler, the MRB concluded probation was not warranted. Based on implementation of new procedures for response to incidents, the MRB directed the team to revise the finding for the common performance indicator, Response to incidents and Allegations, to a satisfactory with l

)

New Mexico Final Report Page 2 recommendations for improvements. The MRB directed that the follow-up review be conducted within one year of the IMPEP review, that monthly conference calls take place with New Mexico staff, and that written progress reports be submitted every other month.

The New Mexico Environment Department is the agency within the State of New Mexico that regdates, among other public health issues, radiation hazards. The New Mexico Environment Department Secretary is appointed by and reports to the Governor. Within the Environment Department, the radiation control program is administered by the Radiation Licensing and Registration Program (RLRP) under the direction of the Hazardous and Radioactive Matcrials Sureau (HRMB). The New Mexico Environment Department and HRMB organization charts are included as Appendix B. The New Mexico program regulates approximately 245 specific licenses, which includes a megacurie pool irradiator, manufacturers, broad academic programs, broad medical programs, nuclear pharmacies and industrial radiographers.

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

In preparation for the review, a questionnaire addressing the common and non-common performance indicators was sent to the State on April 10,1997. New Mexico provided its response to the questionnaire on June 16,1997. A corrected copy of the questionnaire was received on July 25,1997. A copy of that response is included as Appendix C to this report.

The review team's general approach for conduct of this review consisted of: (1) e. anation of New Mexico's response to the questionnaire, (2) review of applicable New Mexico statutes and regulations, (3) analysis of quantitative information from the radiation control program licensing and inspection database, (4) technical review of selected licensing and inspection actions, (5) field accompanii .ts of three New Mexico inspectors, and (6) 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 performance indicator and made a preliminary assessment of the radiction control program's performance.

Section 2 below discusses the State's actions in response to recommendations ma Wlowing the previous review. Results of the current review for the IMPEP common performa'.a indicators are presented in Section 3. Section 4 discusses results of the apolicab's non-common performance indicators and Section 5 summarizes the review term's findings, recommendations and suggestions. Suggestions made by the review team are comments that the review team believes could possibly enhance the State's program. Recommendations made by the review team are comments the review team believes are areas to be addressed to maintain performance by the State. A response will be requested from the State to all recommendations in the final report.

j

New Mexico Final Report Page 3 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS The previous routine review concluded on August 12,1994, and the results were transmitted to Judith M. Espinosa, Secretary, New Mexico Environment Department, on February 7,1995.

The review findings resulted in recommendations in two program indicators. The team's review of'.he current status of these recommendations is as follows:

(1) At the time of the 1994 review, the New Mexico radiation protection regulations had last been amended on March 10,1989. Compatibility was withheld because

'he State had failed to meet the three-year time frame required for adopting s egulations eouivalent to nine NRC regulations deemed matters of compatibility:

(1) bankruptcy notification, (2) quarterly audit of the performance of radiographers, (3) well logging requirements, (4) National Voluntary Laboratory Accreditation Program (NVLAP) certification of oosimetry processors, (5) decommissioning requirements, (6) emergency plans, (7) safety requirements for radiographic equipment, (8) 10 CFR Part 20 equivalent regulations, and (9) notifications of incidents.

Current Status: New Mexico's regulations equivalent to the nine NRC regulations listed above were part of a package of regulations which were adopted on April 3,1995, and which 5ecame effective on May 3,1995. After reviewing the drafts of these proposed regulations, in a letter dated January 9,1995, the Office of State Programs (OSP) offered the State a tentative finding of compatibility pending NRC review of the final, published regulations. The review team evaluated the published regulations against the equivalent NRC regulations. Pending review by NRC's Office of General Counsel (OGC), the team recommends that these regulations be found i

compatible with NRC requirements. This recommendation is closed.

(2) The 1994 review recommended that the State ieview and compile internal procedures for staff use in the interest of maintaining consistency in licensing and compliance activities.

. Technical staff members wrote procedures for licensing, inspection and l allegation follow up. The procedures have not been shared with all staff members, however, creating program inconsistencies which are discussed in I

Sections 3 and 4 of this report. This recommendation is closed.

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

New Mexico Final Report Page 4 3.1 Status of Materials insoection ProgIam 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 licensees. This evaluation is based on the New Mexico questionnaire responses relative to this indicator, data gathered independently from the State's licensing and inspection data tracking system, the examination of completed licensing and inspection casework, and interviews with managers and staff.

The team's review of the State's inspection priorities verified that the State's inspection frequencies for various types or groups of licenses are at least as frequent as similar license types or groups listed in the NRC Inspection Manual Chapter 2800 (IMC 2800) frequency schedule, with one exception. The New Mexico inspection frequency for nuclear pharmacies is 2 years as opposed to one year in IMC 2800. Staff indicated that this difference was due to an oversight as the State copy of IMC 2800 was out of date. The re.lew team recommends that the nuclear pharmacy inspection frequency be modified from 2 years to 1 year.

In reviewing the State's priority schedule, the review team noted that none of the New Mexico inspection frequencies exceed 3 years. Specifically, examples of license categories in wh ch the State requires more frequent inspections are as follows:

Tvoe of License New Mexico Freauency (vears) NRC Frecuenev (vears)

Welllogging 2 3 Medicalinstitution 2 3 or 5 Medical private practice 2 3 or 5 Academic Type B broad 2 3 Veterinary 2 5 Portable gauges 2 5 Fixed gauges 3 5 in response to the questionnaire, New Mexico indicated that no inspections were overdue by more than 25% of the scheduled frequency. The team identified severalinspections that were overdue compared to the State frequencies but would not be considered overdue with respect to IMC 2800 frequencies.

With respect to initial inspections of new licenses, the team evaluated the inspection tracking data system and verified that initialinspections were entered into the computerized tracking system together with existing licenses. Inspection due data generated by the system for new licenses are combined by inspection priority with those for other materials licenses. A review of the inspection tracking system showed that initial inspections are not differentiated from routine inspections, since the tracking system does not display a six month due date for initial inspections. From interviews, team reviewers found that 'he inspection staff was generaily able to identify licenses due for initial inspections by the license number. The higher-numbered licenses are new issues indicating an initial inspection is necessary.

i New Mexico Final Report Page 5 !

A review of 25 license files, with initial inspections due during the review period, identified eight licenses which had initialinspections performed within 6 months. Nine licenses had initial inspections performed late, ranging from 1 to 21 months past the six-month window, and eight l licenses were overdue for initial inspections at the time of the review, from 1 to 34 months past i the six-month window. The review team recommends that initial inspections of licensees be performed ,,, thin 6 months of license issuance or within 6 months of the licensee's receipt of material and commencement of operations, consistent with IMC 2800. Also, the review team recommends that the tracking system be revised to allow initialinspections to be readily identified to staff and management.

In their response to the questionnaire, RLRP reported that 148 reciprocal licenses were issued; however, only about one-half of the reciprocity licensees filed notifications and received authorization to conduct activities during the review period. Of the 148 reciprocallicenses issued,45 were industrial radiographers, 26 were well loggers and four were teletherapy /high dose rate afterloader source replacements. Approximately one-half of the reciprocities were for gauge or portable device uses. RLRP performed only three inspections of reciprocity licensees, two industrial radiographers and one gauge user, during the review period.

Reciprocity requests are recorded in a log and are availebte for review by inspectors but inspections are rarely performed. Both program management and staff indicated that short lead times and significant travel distances were impediments to performing reciprocity inspections. The review team recommends that the State increase the number of reciprocity inspections to better evaluate the health and safety implications of out-of-state companies working in New Mexico.

The timeliness of the issuance of inspection findings was also evaluated during the inspection file review. For the inspection findings examined, the correspondence for nine inspections was sent to the licensee within 30 days of the inspection date. Eight inspections were " clear," and in several cases the inspection correspondence was sent within 1 to 2 days after the inspection.

For three inspections, the correspondence was sent to the licensee greater than 30 days past the inspection date. All involved cases with deficiencies that were noted by the inspector.

(New Mexico's definition of " deficiency" is identical to NRC's definition of " violation." in this report, the two terms are interchangeable.) Inspection deficiency letters to New Mexico licensees require a higher level of signature (Chief, HRMB), rather than the inspector. Two of the three letters were dispatched within 40 days of the inspection date. The third was issued 3 months after the inspection date. In the longest (3-month) case, the inspector was relatively new ano did not understand the significance of quickly informing the licensee, in writing, of the inspection findings. While the New Mexico program has a few cases where inspection results were issued late (i.e., past the 30-day IMPEP criterion), the review team found that performance in this area was generally acceptable.

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

New Mexico Final Report Page 6 3.2 Technical Staffino and Trainino issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training and staff turnover. To evaluate thesa issues, the review team examined the State's questionnaire r,esponses relative to this indicator, interviewed program management and staff, and considered any possible workload backlogs.

The RLRP Manager stated that all technical staff positions require a bachelor's degree in the sciences. Positions are classified as either Environmental Specialists, requiring 4 years experience or as Environmental Scientists, with 2 years experience.

The RLRP has a staffing level of one manager, five Environmental 9pecialists and one secretary. One of the Environmental Specialist positions was vacated on July 1,1997, when a staff member retired. Another Environmental Specialist is expected to retire in 1997. This staff is responsible for the radioactive materials program, the Naturally Occurring Radioactive l

Material (NORM) program and the x-ray program. Approximately 55% of each Environmental l Specialist's time is allocated for the Radioactive Materials Program. This equates to  ;

approximately 2.75 technical FTEs for the 245 license program. Based on review results, this l staffing level appears to be a minimal level for a program of this size. With the recent departure 1 of a retired staff member, the staffing level is even lower and raises concems about the general effectiveness of the program.

The HRMB Chief indicated that the vacant position and the upcoming vacancy would likely be filled in the near future. The authority to fill these positions has been granted. The review team recommends that the State maintain the RLRP staffing level to at least the level which existed throughout the review period.

The radioactive materials staff is split between two offices, the main office in Santa Fe, with the RLRP Manager and two Environmental Specialists and an office in Albuquerque, with two (three until recently) Environmental Specialists. The RLRP Manager stated that he had tried to have staff perform inspection and licensing at both offices but he brought all of the licensing work back to the Santa Fe office to centralize and manage the licensing program more effectively. The Santa Fe office staff took full responsibility f;r licensing due to this reorganization of responsibility.

With the exception of the individual who recently left the program and one outstanding course for one staff member, technical staff have attended the core NRC training courses. Two areas of significant training need were identified during the review and inspector accompaniments.

The first area is irradiator technology, particularly important as the State licensed a megacurie pool type irradiator last year. Only limited training was received by one Environmental Specialist from the irradiator vendor as the facility was brought on line. The other area in which additional training is needed is medical brachytherapy. New Mexico has several medica!

licensees who uti;ize various brachytherapy modalities, including high dose rate afterloaders.

None of the program staff have attended a brachytherapy training course or have had any other significant training or experience in '.1is area.

i New Mexico Final Report Page 7 l The RLRP Manager stated that, as New Mexico does not charge fees to its licensees and the general fund allocation for training is extremely limited, there is little chance that RLRP 1 personnel will attend any conventional NRC training courses, unless NRC reassumes the cost l for such training. Program management was directed to All Agreement States Letter SP-97-040, dated June 9, 'iO97, which proposed criteria for States with financial need to receive training aid from NRC. The team believes that New Mexico may be a strong candidate for receiving funding from the NRC for training purposes. The team also discussed with the RLRP Manager potential alternative training methods which could be used to train staff in brachytherapy and irradiator technology. The review team recommends that the State provide training to technical personnel in the areas of medical brachytherapy and irradiator technology.

The RLRP Manager stated that he p ovides on-the-job training to staff, explaining program procedures, and accompanies each inspector on at least two inspections per year. There is no documented training and qualification program in place for the RLRP staff comparable to IMC 1246, " Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area.' As an example, the review team noted that licensing and inspection procedures had been developed by various staff members but that not all staff had been trained in these new procedures. The review team recommends that the State develop a formalized training program cornparable to IMC 1246, " Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area."

Based on the team's finding and the IMPEP evaluation criteria, the review team recommends that New Mexico's performance with respect to this indicator, Technical Staffing and Training, be found satisfactory with recommendations for improvement.

3.3 Technica! Quality of Licensino Actiom The review team examined completed licensing casework and interviewed the reviewers for 11 specific licenser. Licensing actions were evaluated for completeness; consistency; proper isotopes and quantities authorized; qualdications of authorized users; adequate facilities and equipment; and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and of its conditions and tie-down conditions, and overall technical quality. Casework was evaluated for timeliness; adherence to good health physics practices; reference to appropriate regulations; documentation of safety eva!uation reports, product certifications or other supporting documents; consideration of enforcement history on renewals; pre-licensing visits; peer c,r supervisory review as indicated; and proper signature authorities. The files were checked for retention of necessary documents and supporting data.

The license casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The cross-section sampi;ng included several of New Mexico's major licenses and included the following types: nuclear laundry; pool irradiator; well logging; nuclear medicine; fixed gauge; academic research and development; veterinarian; and industrial radiography. Licensing actions evaluated incluoed three new licenses, two renewals, one pending renewal, three amendments, and two terminations, in discussions with the RLRP Manager, it was noted that

New Mexico Final Report Page 8 there were no major decommissioning efforts underway with regard to agreement material in New Mexico. Also, there were no identified sites vith potential decommissioning difficulties equivalent to those sites in NRC's Site Decommbsioning Management Plan. A list of these licenses with case specific comments may be found in Appendix D.

The Interstate Nuclear Services (INS) license renewal was selected for review because the State has expended considerable staff resources with this renewal and is faced with opposition.

A series of public hearings were held in 1996 culminating when the Secretary of the Department issued an order to renew the license subject to INS completing several conditions to the satisfaction of the Department. However, the main point of contention between the State and the opposition to renewalis the issue of " solubility' of radioactive particulates in liquid effluents discharged to the sewage system and whether the State will accept INS's proposed waste water treatment system. The State requested techn cal assistance from NRC. The State has sought to identify potential contractors to evaluate the proposed waste water system and has queried other Agreement States to determ'ne how the ' solubility" criteria are being addressed in those States. INS has not yet submitted complete information to address a!!

conditions of the Secretary's order. The license reviewer intends to require the licensee to consolidate the interim submittals into a final renewal package. A final license application review will be performed when the renewal [ ackage is complete. Issuance of this renewalis still pending.

With resnect to the overall licensing program, the RLRP Manager stated that licensing quality had suffered when licensing actions were being handled out of two different offices. The RLRP Manager sought to improve licensing quality by bringing all licensing actions back to Santa Fe in early 1996. He also began performing many of the licensing reviews himself, concentrating on amendments and simple renewals to improve quality and consistency.

Licensing actions of all types appear to be completed in a timely fashion with most renewels being completed within 6 months of the expiration date. The RLRP Manager noted that

" construction" visits were performed for the new panoramic, wet-storage irradiator and that an in-office consultation was held with another license applicant but there were no other pre-licensing visits for the few complex licenses that New Mexico had issued. The RLRP Manager estimated that as many as 50% of new licenses were hand delivered as a means of establishing open communications with new licensees.

Retention of supporting documentation is a program weakness. Required documents were found to be missing in 9 of 11 files evaluated. These documents included: licensee application submittals, a renewal request, a licensee's response to a compliance letter that required a licensing change, detailed schedules for testing and maintenance, evidence of named users' training and experience, verification that sources had been transferred properly, misfiled correspondence, and the results of close-out inspections. Documentation of the license reviewers work was particularly weak. Deficiencies identified by reviewers were apparently communicated by telephone in many cases with no record of the deficiency or its resolution unless the licensee's correspondence was clear. Reviewer checklists were present in new license files. The review team suggests that documentation of license reviewers' actions be maintained in license files.

New Mexico Final Report Page 9 All new licenses are reviewed and signed by the HRMB Director before being issued. All renewed licenses and amendments are reviewed and signed by the RLRP Manager. However, the RLRP Manager performs approximately one-half of alllicensing actions and signs his own work without significant peer or supervisoy review. No potentially significant health and safety issues were identified.

The review team found that, despite documentation deficiencies, the licensing actions were thorough, complete, consistent, and of acceptable quality with health and safety issues adequately addressed. Speciallicense tie-down conditions were not observed. The licensee's compliance history was taken into account when reviewing renewal applications. New Mexico's licensing guides and license policy procedures were revised and updated after the last program '

review New Mexico's licensing guides and license conditions were adopted directly from the NRC's. Reviews of licensing actions showed reviewers appropriately used the revised licensing guides for new licenses and the absence of major findings indicates that the reviewers have a generally good understanding of applicable guidance.

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

l 3.4 Technical Quality of insoections 1

The team reviewed the inspection reports, supporting documentation and correspondence to licensees for 12 materials inspections conducted during the review period. The casework included the State's four fully-qualified materials inspectors and one inspector who left the program during the review period (another inspector left the program early in the review period, and her work was not reviewed), inspection reports were selected to cover the whole review period and to emphasize higher-priority licensees. The review team examined inspection casework of the following types of licensees: one medical institution; one pool-type irradiator; one nuclear laundry; one well logger; one nuclear pharmacy; one industrial radiographer; one portable gauge; two academic licensees; two research and development licensees (one of which " tagged" radionuclides to well logging tracers) and one broad medical that included a high dose rate (HDR) remote afterloader, brachytherapy, nuclear medicine. and academic research and development. Following the casework evaluation, the review team interviewed each of the four inspectors. Appendix E provides a list of the inspection cases evaluated in depth with case-specific comments.

Overall, the review team found that the inspector accompaniments and most inspection reports showed acceptable, but not strong, technical quality of inspections. Interviews with inspectors backed up the review team's findings that inspections were being conducted regularly, but moderate to significant areas that needed improvement were ap 4 rent in the State's inspection program.

Three inspector accompaniments identified in Appendix E were performed by a review team ,

member on June 16-18,1997. The other two New Mexico inspectors had been accompanied during past reviews. During the accompaniments, inspectors demonstrated a range in skills

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New Mexico Final Report Page 10 and abilities for the specific types of inspections they were performing, in two of the three accompaniments, inspection techniques were obsewed to be primarily records-review oriented, with missed opportunities when inspectors could have observed licensee operations. The accompaniments demonstrated that inspectors were not missing critical safety areas, but the inspections were not thorough, either. For example, on one accompaniment at a hospital, the inspector was not sufficiently trained in brachytherapy and missed opportunities to interview therapy technologists and ancillary personnel, in general, the inspections were adequate to assess the most significant radiological health and safety issues, although on some, the inspectors showed significant room for improvement.

Inspection reports were evaluated to determine if th? reports adequately documented the scope of the licensed program, licensee organization, personnel protection, posting and labeling, control of materials, equipment, use of materials, transfer and disposal. The review team also evaluated whether the reports adequately documented operations observed. interviews of workers, independent measurements, status of previous violations, substantiation of all violations and the substance of discussions during exit interviews with management. To assure consistency and quality of reports, the RLRP Manager provides review and signs inspection reports.

For 9 out of the 12 inspections reviewed, inspectors did not perform observations of licem se operations. In fact, on some inspection reports, the inspectors specifically noted that they had not observed licensee operations. In interviews, the inspectors asked the review team what type of operations should be observed, especially when conducting office inspections of industriallicensees and afternoon-inspections of diagnostic medicallicensees. The review team noted that licensees can demonstrate actions (such as surveys, transportation practices, interlock checks, and so on), but the State inspectors did not indicate that such demonstrations or observations were being conducted on a routine basis during inspections. Even though the inapectors have attended the NRC inspection training course, the principalinspection effort seems focused on records review, which is contrary to the national (NRC and Agreement State) trend in inspecting for licensee performance. The review team recommends that the State inspectors attempt to observe licensee operations or demonstrations during all inspections.

l On three of the 'nspections evaluated, inspectors did not conduct independent measurements.

In one case, the inspector's survey instrument malfunctioned. The inspectors could not provide adequate explanation regarding why independent measurements were not conducted during '

the other two inspections. In other cases, independent measurements were performed but no specific results were indicated in inspection reports. Inspectors were knowledgeable that they should conduct independent measurements during inspections, and some inspectors even performed confirmatory measurements (i.e., side by-side readii,gs with licensee survey instruments), which is commendable. Conducting measurements for radiation levels should be an essential element of routine byproduct materialinspections. The review team recommends that the State inspectors conduct independent measurements on all inspections.

The review team noted that, on a number of inspections evaluated, that the State was not examining complex, technical radiation safety / health physics issues in sufficient detail during inspections. For instance, on inspections of a medical institution using limited quantities of

l l

New Mexico Final Report Page 11 iodine-131 and on a tagging licensee, inspectors apparently did not review licensee eftluent releases, even though the licensees had potential for material release. Similarly, inspectors did not regularly review bioassay adequacy or estimate doses (when licensees did not conduct bioassays), review AnnualiJmits on Intake and Derived Air Concentrations, provide dosimetry results on several inspection reports, and provide sufficient detail on a licensee's respiratory protection program. In addition to this lack of technical complexity and detail, the review team observed that many of the inspections omitted key program areas or were not sufficiently broad. For instance, the review team observed instances where RLRP inspections did not sufficiently close previous violations, address training, .esolve emergency preparedness issues, address shipping or cover annual radiation protection program reviews. In response to these findings, the review team recommends that the State increase the rigor of revit. wing technical health physics issues during inspections, and increase the breadth and scope of inspections.

Additionally, the review team noted that few, if any, ancillary worker (such as facility housekeeping staff, students, administrative staff and medical assistants) interviews were conducted by the inspectors. The review team suggest" that the State inspectors attempt to interview ar'eillary workers during inspections.

On 8 of the 12 inspections evaluated, the inspector conducted exit meetings with the licensee's radiation safety officer (RSO) or a principal authorized user, in a few of these cases, the RSO was also a senior licensee manager. However, as determined through interviews, inspectors generally did ne. conduct exit meetings with senior licensee managers, or did not make substantial efforts to conduct exit meetings with senior licensee managers (i.e., raanagers who control the radiation safety program's authority, staffing, and resources). This is in conflict with the State's own policy that, "An exit interview with the highest available representative of administration or management shall be conducted by the inspector.. ." A cause of this may have been that few inspectors knew about the procedures. The review team recommends that the State inspectors attempt to conduct formai exit meetings with senior licensee management on all inspections.

The review team examined the State's performance regarding follov 'up on previously cited violations (deficiencies). On one of the inspections, the licensee was cited for failure to calibrate survey instrumentation. In response, the licensee stated what it had done to correct the problem. However, the licensee did not state what would be done to prevent this type of deficiency from occurring again in the future. On the same inspection, the licensee was cFed for an unauthorized user. The licensee was told to amend its license to add an individual as an authorized user (the individual apparently was using material at the time of the inspection), but the file does not indicate that the licensee ever submitted an amendment request. On the next inspection, the licensee was again given a deficiency for the same type of issue (i.e., told to I

amend its license to add authorized users). Similar licensing issues were identified on other inspections. These findings led the review team to conclude that New Mexico needs a mechanism to ensure that licensee responses to deficiencies are adequate to address the cited problems, and that the deficiency is closed and followed up on a future inspection. The review team recommends that the State develop a formal p;ocess for reviewing licensee responses to deficiency letters and closing open deficiencies. The State's inspection finding regarding the unauthorized user also indicates that the State does not have a formal mechanism for transfer of information from the inspector to the license reviewer, or vice versa, and the review team i

i

1 New Mexico Finct R'eport Page 12 confirmed this in interviews. The closest that inspectors come to passing along information to 1 the next license reviewer is by telling them verbally about needed licensing actions. In the case I nota,d above involving the unauthorized user, this method apparently did not work or was not -  ;

- used. TN review team suggests that the State develop a Srmal process for inspectors and Ucense reviewers to document and trensmit periinent inforation to each other for follow up.

The review team also examined whether the State's inspection Ales were complete. On two of the !nspection files reviewed, the files did not contain responses to the licensees acknowledging their responses and stating that the issues would be followed up on future inspections.

Through interviews' the review team learned that occasionally the licensee's r6sponse is filed in the license file in Santa Fe, without being transmitted to the Albuqueraa inspector for review.

The review team suggests that the State develop a process for ensuring that inspection files are

- complete, that all appropriate State documer,ts are prepared and filed, and that licensee responses are received and filed.

Also in the area of documentation, the review team examined the inspection casework for the State's new pwl-type irradiator. The review team found it,at the first full, documented inspection was conducted on July 1,1997. A site visit on October 28,1996, was also

_ documented in a note to the inspection file. However, the July inspection listed a number of

_ previous trips to the licensee's site where inspection activity was performed, but not documented (e.g., November 1996 source loading, December 1996 review of system

- operations and product dosimetry, etc.). Follow up interviews with the inspectors confirmed that the State had conducted site visits or inspections to the irradiator that were not documented. This is significant with respect to the pool irradiator, because it is a new operation in New Mexico involving an extremely large inventory of licensed material. The review team -

recommends that the $ ate begin dccumenting all trips to licer. sees' or applicants' facilities when inspecting licensed activities, performing special inspections, or performing pre-licensing site visits during construction. This documentation should be filed in the State's official inspection file.

The review team identified a number of problems, covering both content and documentation, in New Mexico's inspectian program. The review team concluded that the RLRP Manager, who signs each of the inspection reports as a reviewer, had the opportunity to identify many of these issues during the supervisory review'of the inspection reports. The review team recommends

- that the State management exercise more stringent supervisory review of inspection reports.

- In the area of the State's programmatic policy and management, the inspectiori procedures and techniques utilized by New Mex;co were evaluated and determined to be genen :'u consistent with, albeit in far less detail than, the inspection guidance provided in IMC 2800. f aw of the inspectors were aware of the preseno of !nspection guidance within the State. Training on the State's internal procedures is discussed in Section 3.2.

The State's inspection report forms were reviewed and found to provide general inspection areas consistent with the types of information collected under NRC's Inspection Procedure (IP) 87100 field notes. On the two most complex inspection cases reviewed (the irradiator and an

- HDR), the State ud NRC's field notes. On its own forms, the State already has developed an m --gm

- . - . . . - - - . - . .. . . - - . - - - - . . ~ - - - - -

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1 New Mexico Final Report

[ Page 13 f inspection report format with major subheadings and spaces for narrative responses, a move

- away from the checklist format, which is the approach that NRC is adopting for materials.

' inspectionse The State has been revising its inspection report for approximately the past 2 l '

years, according to the inspector with lead responsibility for the inspection form revision, anu in that interim time penod RLRP inspectors have used a variety of " draft" inspection report forms

[ - that the review team observed in the inspection files, in interviews, the review team learned

- that RLRP inspectors select their own forms for the type of inspection they are performing; the -

review team did not identify any intamal requirement or standardization within the State to use a specific report form for documenting inspections; The review team also concluded that, ,

because the inspection report forms frequently determine the areas examined during an

, inspection, the forms themselves may have contributed to the State's lack of breadth and technical complexity during its inspections. The review team suggests that the State complete -

its revision of the inspection report forms, insuring that each set of forms covers all key areas f for the type of licensee being inspected, and that RLRP inspectors begin using the standardited i- form (s),

i Most inspection forms, correspondence, and documents were found in the files. Documented

inspection findings generally led to appropriate deficiency letters. In interviews with the
inspectors, none could recall any escalated enforcement cases during the review period; Of the-p files reviewed the State cites deficiencies on about one third of its inspections In response to the questionnaire, the State reported that supervisory ,, .pector accompaniments were performed at least twice per year by the RLRP Manager for each inspector since the previous review, Performance evaluations are discussed with the inspector?

. and the accompaniments documemed. Accompaniments of less-experienced staff are also performed by senior inspectors.

The review team noted that RLRP has a sufficient number of calibrated, portable radiation

[ detection instruments for use during routine inspections and response to incidents and '

i emergencies, The State aiso has available the services of the State's Scientific Laboratory iL . Division in Albuquerque, which appeared to provide exceptional services on one of the

! inspections reviewed.

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

,-. . performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory with recommendations for improvement.

{

)' 3.5 Resoonse to incidents and Alleaations i

[ ' In evaluating the effectiveness of the State's actions in responding to incidents and allegations,

the review team examined the State's response to the questionnaire relative to this indicator and evaluated the incidents re'.rted for New Mexico in the " Nuclear Materials Events Database (NMED)" against those contained in the New Mexico casework and license files. The team

- evaluated casework in the license files maintained in the Santa Fe office and in filer, from the

! Albuquerque office which were delivered to the review team. The team compiled a list of 31 incidents that had occurred in the State during the review period, examined the list for possible I

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New Mexico Final Report Page 14 trends or generic issues, and chose 11 of the mere significant incidents for in-depth review.

The team also evaluated the State's response to the only two allegations reported by the State.

A list of the incidents with comments is included in Appendix F.

The review of the incident casework revealed five serious generic deficiencies in RLRP's response to incidents. First, circumstances in 5 of the 11 incidents indicated the need for onsite response from the State; however, only one of the five received an onsite response, and it was not documented, and thus could not be confirmed. The review team recommends that the State make onsite, documented investigations of incidents, allegations, or misadministrations with potential health and safety effects (i.e., source disconnects, possible overexposures, lost sources, contamination, etc.).

Second, in all cases, documentation of the State's response was either missing or incomplete.

The team found that the State hu no procedures or forms in place to record information ubtained in the incoming calls, to track the progress of the investigation, to document management involvement, or to close out the incident investigation, in evaluating the casework, the team found that in five cases, the individual taking the incident report was not identified. In addition, none of the files contained the investigator's signature, evidence of management involvement or review, or any notation that the investigation was completed and closed out. The review team recommends that the State create an incident and allegation reporting form that would, at a minimum, identify the person taking the initial report, list the name and telephone number of the reporting partf, provide the details of the incident or allegation as reported, record the State's conversation with the licensee or individual, describe corrective actions taken by the licensee, describe the investigation conducted by the State and the results, list citations or other regulatory actions, show the date the investigation was closed out and justification for closure, show date(s) incident was reported to the NRC or other agencies, and provide spaces for the signatures of the investigator and supervisor. A copy of the form should be maintained in the incident file and in the license file.

Third, none of the casework contained any indication that the State evaluated the licu1see's response or corrective actions. It appeared the State relied entirely on the licensee's reports of the incident and their corrective actions. The review team recommends that the State establish a protocol for making independeM investigations and evaluations of the licensee's actions.

Fourth, generic deficiencies were noted in five cases where the incident should have been followed up at the next inspection, but was not. The review team recommends that the State initiate procedures to ensure P .Ments are followed up at the next inspection to verify that the licensee's corrective acticm, rce been implemented.

Last, the team found that in five cases, licensees may have failed to comply with regulations but were not cited. The review team suggests that when evaluating incidents, the State cite appropriate deficiencies when applicable.

New Mexico does not have an incident tracking system. RLRP does not keep a centrallog of incident or allegation reports and does not maintain a separate incident file. Incidents may be reported by the licensee directly to the Albuquerque inspector assigned to their territory, or they

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1 New Mexico Final Report Page 15 I

may be reported to the RLRP office in Santa Fe and documents involving incidents may be kept either place. From interviews with staff, the team found that events are assigned to the inspector normally responsible for the licensee involved. The inspector then routinely requires the licensee to investigate the incident and fumish a report with the details and corrective actions. That licensee's report is used when necessary to complete the NRC Event Report (Form 565) and then filed in the license file. The State has no provision to file reports for incidents that do not involve New Mexico licensees. In conducting the file reviews, the team had difficulty in assembling information necessary to evaluate the State's incident response because documents could not be located and staff could not remember details of investigations.

The review team recommends that tho State (a) set up a separate incident and allegation file systsm in the Santa Fe office, keeping all documents and records pertaining to an incident in one location, with the data cross-referenced to the license / inspection files there and in the Albuquerque offix 9d (b) establish a system to centrally log and track the progress of incidents End allegations.

The New Mexico statewide emergency plan is the responsibility of the Department of Public Safety. If other State agencies encounter incidents nr emergencies related to radioactive materials, the responsibility is delegated to the RLRP. The team found through interviews with staff and management that RLRP has no written internsi piocedures for incident response other than a November 1995 memorandum explaining the NRC event reporting criteria in interviews with the review team, the inspectors stated that they were not aware of any emergency procedures and that they had not been trained in emergency response. The review team recommends that the State develop and implement written procedures for responding to events involving radioactive material and conduct training sessions until all technical staff are fully trained and qualified in emergency response. These procedures and training should address the use of the forms and trackir g system recommended above.

The State does have brief written procedures for investigating allegations. It is their policy to thoroughly investigate all alle0ations, including those made anonymously, to seek out and interview corroborative witnesses, to investigate the reasons for confirmed events, and to document all conversations. It is also their policy to respect anonymity to the highest possible extent. The team noted, however, that New Mexico law does not protect the identity of individuals making allegations. The review team suggests that the State keep expanding the allegation procedures, to includs p.acedures for notifying the person making the allegation of the results of the investigation and including the allegation procedures in the event reporting form, tracking system, and emergency response procedures.

The team evaluated the two allegations that occurred in the State during the review period. In both cases, the team found that the allegations were promptly evaluated to determine the validity and safety significance of tiie claims. Onsite investigations were conducted promptly in both cases. In one case, there was evidance that the State kept the individuals making the allegations informed of the resolution of thc!r concerns; in the other, there was not. In one complex and lengthy case, the State held public hearings on the renewal of the license at the request of the alleging parties.

New Mexico Final Report Page 16 Except for the period be ween July 1995 and May 1996, the State provided quarterly event reports to the NRC even though NRC has requested monthly reports. During the period between July 1995 and May 1996, the State did not provide reports to the NRC, and little to no documentation of events exists Two incidents that should have been reported were inadvertently omitted through oversights. The team instructed the State to report the events to NMED on the next monthly report. In the one case of a leaking source, the NRC and regulating agency of the manufacturer were both advised, As discussed above, the team found frequent examples of incomplete, inappropriate, poorly ,

documented, or delayed responses to incidents, and as a result, potential health and safety l problems may exist. Therefore, at the time of the review, based on the IMPEP evaluation I criteria, the review team recommended that New Mexico's performance with respect to the indicator, Response to incidents and Allegations, be found unsatisfactory, in response to the draft report, the State issued new pocWures on response to incidents that appeared adequate to address the concerns. The MRB noted that the new prtedures appeared adequate to address the concerns and if these procedures are properly implemented, New Mexico would receive a rating of " satisfactory with recommendations for improvement" for this indicator. At the time of the October 23,1997 MRB, no incidents had been reported since the new procedures were put into place. During the December 11,1997 MRB, it was noted that New Mexico had implemented new procedures for three incidents. Based on the implementation of the new procedures, the MRB directed the finding to be revised to satisfactory with recomtnendations for improvement.

4.0 WON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Regulations, (2) Sealed Source and Device Evaluation Program, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium Recovery Operations. New Mexico's agreement does not cover uranium roccvery operations, so only the first three non-common performance indicators were applicable to this review.

4.1 Leaislation ano Reaulations 4.1.1 Leaislative and Leaal Authority Along with their response to the questionnaire, the State provided the review team with copies of legislation that affects the radiation control program. Legislative authority to create an agency and enter into an agreement with the NRC is granted in New Mexico Statutes,1978 Annotated, Chapter 74, Environmental Improvement, Pamphlet 120 with 1989 Replacement Pamphlet, Article 3, Radiation Control Act, Sections 74-3-1 through 74 3-16. In the Act, the New Mexico Environmental Department is designated as the State's radiation control agency.

The review team evaluated the legislation which had not changed since the previous review and found State legislation to be adequate.

New Mexico Final Report Page 17 4.1.2 Status and Comoatibility of Reautations The review team compared the State's regulations against the latest Chronology of Amendments and found that the State had adopted equivalent rules for all amendments which were due for adoption by the Agreement States through July 1,1996. However, the State had failed to revise their equivalent regulations to the following NRC regulations identified as compatibility items:

" Decommissioning Recordkeeping and License Termination: Documentation Additions,"

10 CFR Parts 30,40,70, and 72 amendments (58 FR 39628) that became effective on October 25,1993, and which became due on October 25,1996.

"Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (58 FR 68726 and 59 FR 1618) that became effective on January 28,1994, and which became due sn January 28,1997. Note, this rule is designated as a Division 2 matter of compatibility. Pivision 2 compatibility allows the Agrcement States flexibility to be more stringent (i.e., the State could choose not to adopt self guarantee as a method of financial assurance), if a S! ate chooses not to adopt this regulation, the State's regulation, however, must contain provisions for financial assurance that include at least a subset of those provided in NRC's regulations, e.g., prepayment, surety method (letter of credit or line of credit), insurance or other guarantee method (e.g., a parent company gaarantee).

From reviewing the State's promulgation process ar.d from laterviewing program management, the review team found that the time frame for adopting revised regulations is at least 11 months from the date the process begins. The State advised the review team that the Decommissioning Recordkeeping and Self-Guarantee regulations are in planning stages and are expected to be adopted by May 30,1998.

The State was alerted that the following regulations will become due during the next 12 months:

" Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30, 40, and 70 amendments (59 FR 36026) that became effective on August 15,1994, and which will become due on August 15,1997.

" Preparation, Transfer for Commercial Distribution and Use of Byproduct . 'terial for Medical Use," 10 CFR Parts 30,32 and 35 amendments (59 FR E 1767,59,3R 65243, 60 FR 322) that became effective on January 1,1995, is under review and is expected to become effective by the due date of Muary 1,1998.

" Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,60 FR 25983) that will become effective March 1,1998, and which will become due en March 1,1998. The NRC delayed its effectiveness until the State could adopt compatible requirements so that the national manifest system will go into effect at one time. .

\

New Mexico Final Report Page 18 4

" Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 E CFR Part 20 amendments (60 FR 7900) that became effective on March 13,1995, and which will become due on March 13,1998. Note, this rule is designated as a Division 2 1 matter of compatibility. Division 2 compatibility allows ths Agreement States flexibility to l be more stringent (i.e., the State could choose to continue to require annual medical I examinations).

Each of the listed regulations and amendments are scheduled to be adopted by May 30,1998.

The review team recommends that the State expedite promulgation of the compatibility-related 7

regulations now overdue and those which are due wZhin the next 12 months.

The State was reminded of the following amendments which will need to be addressed:

" Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts

} 19 and 20 amendments (60 FR 36038) that became effective August 14,1995, and

, which will become due on August 14,1998, i

" Medical Administration of Radiation and Radioactive Materials" 10 CFR Parts 20 and

35 amendments (60 FR 48623) that become effective on October 20,1995, and which i

will become due on October 20,1998.

- Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995, and which will become due on November 24,1998.

i .

" Compatibility with the Internationa! Atomic Energy Agency," 10 CFR Part 71 4

' amendment (60 FR 50248) that became effective April 1,1996, and which will become

, due on April 1,1999. NRC delayed the effective date of this rule until April 1,1936, so that the Department of Transportation (DOT) cempanion rule could be implemented at i

the same time. Since the rule involves the transport of materials across state lines, the States are encouraged to adopt compatible regulations as soon as possible.

" Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR Parts 20 and 30 (61 FR 24669) that became effective on May 16,1996, and which will

become due on May 16.1999.

The team notes that NRC staff is currently reviewing all Agreement State equivalent regulations to Part 20, Standards for Protection Against Radiation. These reviews are being conducted outside the IMPEP process and the States will be notified of the results.

During the examination of the State's procedures for promulgating regulations, the team noted that proposed rules or revisions to rules must be publicly announced 60 days prior to adoption, i and a public hearing must be provided. The team examined the records of the last regulation package and found that the NRC was provided drafts of the proposed regulations early in the process and that the comments and suggestions made by the NRC staff were !acorporated into the final regulations. It is the State's policy to send copies of final regulations to the NRC; i

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i r,. . , - _ ._-

New Mexico Final Report Page 19 however, it could not be verified that copies of the prc /ious final regulations were sent to NRC.

The review team suggests that a file be maintained with the cover letters and ensuing correspondence of all draft or final regulations sent to the NRC.

Based on the IMPEP evaluation criteria, the review team recommends that New Mexico's performance with respect to this indicator, Legislation and Regulations, be found satisfactory.

4.2 Sealed Source and Device Evaluation Proaram The review team did not review the State's sealed source and device (SS&D) program even though New Mexico currently has responsibility for this area. The review team discussed with the Secretary, New Mexico Environment Department, as to whether New Mexico has considered returning its authority for the Sealed Source and Device Evaluation Program. The Secretary stated that he would have the Governor send a letter to NRC turning back the SS&D evaluation authorit, The State did not perform any SS&D evaluations during the period of the review.

4,3 Low-Level Radioactive Waste (LLRW) Discosal Procram in 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement"to albw a State to seek an amendment for the regulation of LLRW as a separate category. Those StatJs with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although New Mexico has LLRW disposal authority, NRC has not required States to have a program for licensing a LLRW disposal facility until such time as the State has been designated as a host State for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in New Mexico. Accordingly, the review team did not review this indicator.

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's performance to be satisfactory for the indicator, Technical Quality of Licensing Actions; satisfactory with recommendations for improv7ments for the indicators, Status of Materials inspection Program, Technical Quality of Inspections, Technical Staffing and Training; and unsatisfactory . - the indicator, Response to incicients and Allegations. Based on implementation of new proceduies for response to incidents, the MRB directed the team to revise the finding for the common performance indicator, Response to incidents and Allegations, to a satisfactory with recommendations for improvements. The review team recommersded that the New Mexico program be found adequate, but needs improvement, and compatible. Because of the significance of the concerns, the team also recommended that New Mexico be placed on probation and noted that heightened oversight is warranted. During the MRB meetir'g, three main issues were identified that New Mexico had to address in terms of programmatic

e

New Mexico Final Report - Page 20 1
improvements
(1) level cf program staff and amount of resource support, (2) technical quality of ataff and training needs, and (3) level of management support, involvement and oversight of

. New Mexico Agreement program activities. The MRB found the New Mexico program-adequate, but needs improvement, and compatible with the NRC's program. NRC management meet with upper management of the New Mexico program on December 4,1997, i

before the.MRB voted on the recommendation for probation status for the program.

The MRB reconvened to discuss probation for the New Mexice crogram ' Based on the New  !

Mexico actions to date, and the commitments by Secretary Weidler, tric MRB did not conclude  ;

probation was now warranted. The MRb directed that the follow up review be conducted within

) '

one year of the IMPEP review, that monthly conference calls take place with New Mexico staff, and that written progr9ss reports be submitted every other month.

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

-1. The review team recommends that the nuclear pharmacy inspection frequency be i modified from 2 years to 1 year. (Section 3.1) 72.. The review team recommends that initial inspections of licensees be performed within 6 1 months of license issuance or within 6 months of the licensee's receipt of material and commencement of operations, consistent with IMC 2800. (Section 3.1) -

3. The review team recommends that the tracking system be revised to allow initial inspections to be readily identified to staff and management. (Section 3.1)
4. The review team recommends that the State increase the number of reciprocity inspections to better evaluate the health and safety implications of out-of state

= companies working in New Mexico (Section 3.1)

5. . The review team recommends that the Stata maintain ths RLRP staffing level to at least i the level which existed throughout the review period. (Section 3.2)
6. - The review team recommends that the State provide training to technical personnel in the areas of medical brachytherapy and irradiator technology. (Section 3.2) 17, The review team recommends that the State develop a formalized training program comparable to IMC 1246, " Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area." (Section 3.2)
8. The review team suggests that documentation of license reviewers' actions be maintained in license files. (Section 3.3)
9. The review team recommends that the State inspectors attempt to observe licensee operations or demonstrations during allinspections. (Section 3.4)

1 b.

New Mexico Final Report Page 21 j- 10. ' The review team recommends tgat the State inspectors conduct independent measurements on allinspections. (Section 3,4)

, 11. - The review team recommends that the State increase the rigor of reviwing technical l . health physics issues during inspections, and increase the breadth and scone of '

- inspectionst (Section 3.4)

, 12. The review team suggests that the State inspectors attempt to interview ancillary

' workers during inspections. (Section 3.4) .

13. The review team recommends that the State inspectors attempt to conduct formal exit

. meetings with the senior licensee management on all inspections. (Section 3.4) -

, 14L The review team recommends that ihe State develop a formal process forl reviewing

. licensee responses to deficiency letters and closing open deficiencies. (Section 3.4) 2
15. The review team suggests thai the State develop a formal process for inspectors and license reviewers to document and transmit pertinent information to each other for follow up. (Section 3.4)

[ ~ 16. The review team suggests that the State develop a process for ensuring that inspection files are complete, that all appropriate State documents are prepared and filed, and that

' licensee responses are received and filed. (Section 3.4)

17. The review team recommends that the State begin documenting all trips to licensees' or >

applicants' facilities when inspecting licensed activities, performing special inspections, or performing pre-licensing site visits during construction.' (Section 3.4) s

18. The review team recommends that the State management exercise more stringent supervisory review of inspection reports. (Section 3.4) i- 19. The review team suggssts that the State complete its revision of the inspection report forms, insuring that each set of forms covers all key areas for the type of licensee being -

inspected, and that RLRP inspectors begin using the standardized form (s). (Section 3.4) .

l 20_. The _ review team recommends that the State make onsite, documented investigations of incidents, allegations, or misadministrations with potential health and safety effects (i.e.,

- source disconnects, possible overexposures, lost sources, contamination, etc.).

- (Section 3.5)

21. - The review team recommends that the State create an incident and allegation reporting 1.

form that would, at a minimum, identify the person taking the initial report, list the name 1- and telephone number of the reporting party, provide the details of the incident or allegation as reported, record the State's conversation with the licensee or individual, describe corrective actions taken by the licensee, describe the investigation conducted

?

g-

LIST OF APPENDICES AND ATTACHMENTS 4 1

l Appendix A IMPEP Review Team Members Appendix B- New Mexico Organization Charts Appendix C - New Mexico's Questionnaire Response Appendix D -License File Aeviews Appendix E Inspection File Reviews Appendix F Incident File Reviews Attachment 1 New Mexico's Response to Review Findings October 10,1997 Attachment 2 NRC/New Mexico Management Meeting Minutes, December 4,1997

1 APPENDIA A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility James Lynch, Rill Team Leader Status of Materials inspection Technical Staffing and Training Terry Frazee, Washington Technical Quality of Licensing Actions Scott Moore, NMSS Technical Quality of Inspections Jack Hornor, RIV, WCFO Response to incidents and Allegations Legislation and Regulations

-1 I

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APPENDIX C NEW MEXICO'S IMPEP QUESTIONNAIRE RESPONSE i

l i

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2MPEP OURSTIONRATRE i . t'ame : New Mexico .

j Reporting Period August 13, 1994-July 13, 1997 i

2. STATUS OP MkTER141a ENSPECTIos PROGRAM:

! 1. Please prepare table identifying the lioenees with inspections j

that are overdue by more than 25% of the scheduled frequency  :

est out in NRC Inspection Manual Chapter 2000 (issued '

4/17/95).  !

I 1. There are no licenses with inspections overdue by more j

  • than 254 (see Attachment il for echedule.of inspection i frequencies). '

!. 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. '

f 2. M/A ,

3. Please identify individual licensees or groups of licensees i

i the state / Region is inspecting less frequently than called for .

! in NRC Inspection Manual Chapter 2000 (issued 4/17/95) and

state the reason for the change.

4

3. Inspections are conducted more frequently than shown in

, NRC Inspection Manual Chapter 2000, issued 4/17/95, j because staff is adequate to handle the number of-inspections in the inspection categories we have.

4. Now many licensees filed reciprocity notices in the reporting
period?

l 148 reciprocal licenses were issued in the reporting period.

4 4 a. of these, how many were industrial radiography, well-logging  ;

! or other users with inspection frequencies of three years or less?

i

[ 4.a. See following table-of reciprocities: i 1

DM TT IR EDR WL BD NORM R&D GA PA i

i 97 11 0 7 1 5 0 1 1 4 1 96 13 0 10 1 6 0 3 2 2 5 i 95 11 1 16 0 6 1 0 2 3 4 l 94 11 0 12 1 6 2 0 1 1 4

)4 Total: 148- *see legends next page.

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y .ww n cNOTE: D/M-density TT -Telethe/rapy moisture gauge IR -Industrial Radiographer RDR-Eigh Dose Remote Afterlosdes NL -Nell Lgging/Tacer 3D -Bone Density NORN-Naturally Occuring Radioactive Material R&D-Research and Developos.t GA -Gauge (fixed Measuring levels)

PA -Paint Analyser 4.b. For_ those identified in da, how many reciprocity inspections were conducted?

4.b. of the 149 out-of-state licensees granted reciprocity during the review period, 67 actually came into the state to perform work at temporary ch sites. NRC priority one and two licensees that came to the state included 18 industrial radiogra 8 well loggera and 6 source exchange services. phers,Three inspections we,re conducted, consisting of two industrial radiographers and one gauge licensees.

5. Other than reciprocity licensees, how many field inspections of radiographers were performed? ,
5. During the review period one field inspection of an industrial radiography operations was accomplished out of the totals inspected IR licensees, 1997-12, 1996-12, 1995,-11, 1994-8.
6. For NRC Regions, did you establish numerical goals for the number review of inspectnons to be performed during this period? If so, please describe your goals, the number of inspections actually performed, and the reason for any differences between-the number of inspections performed. goals and the a.ctual
6. M/A 7.

Please provide a staffing plan, or complete a listing using the suggested format below, of the rofessional (technical) person-years of offort appli to the agreement or radioactive material program by individual. Inchude the name time, spent in the following areas: position, of and, for Agreement Administration, Materials states, the fraction Licensing & compliance, Emergency Response,1.IM, U-aills, and other.- If these regulatory responsibilities are divided between- offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior Personnel assigned to monitor work of junior personnel.

3

1

  • i 4

If consultants were used to carr out the program's i radioactive materials responsibilities,yinclude their efforts.

j The table heading should bo I

7A. MANE Po8ITION AREA EFFORT (PTE4)

William M. Floyd Program Manager Administration 75%

] Material Licensing

] & Compliance 154 4

Emergency Response 24 I other O%

Margaret M. Lopez Environmental Materials Licensing specialist & Compliance 554 EmergencyResponse2%

Other 43%

i John A. Martines Environmental Materials Licensing i Specialist & Compliance 55%

4 Emergency Response 24 Other 43%

Walter J. Medina Environmental Materials Licensing l Specialist & Compliance 55%

Emergency Response 2%

i Other 43%

i Ralph Manchego Environmental Materials Licensing l~

Specialist & compliance 55%

EmergencyResponse2%

other 43% . '

l Jerrie Moore Environmental Materials Licensing Specialist & Compliance 554 Emergency Response 24

other 434
8. Please provide a listing of all new professional personnel

, hired since the last review. indicate the degree s) they l received, if applicable, and additional training and (years of.

! experience in health physics, or- other disciplines, if i appropriate.'

S. See Attachment $2.

d i 9.- Please list all professional staff who have not yet met the

qualification requirements of license reviewer / materials inspection staff (for NRC, Inspection Manual Chapters 1245 and

! 1246; for Agreement States, please describe your qualifica-4 tions and requirements for anatorials 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.

7 3 i

i

g. Radiation Licensing and Registration Section staff have attended most all U. S. NRC courses available to Agreement State licensing and inspection (including the S-weeks health physics course). personnel Training 4

in teletherapy and Srachytherapy are needed fer the

staff. A minimum of six months experience is required before a newly-hired individual is allowed to attend U.S. '

NRC-sponsored ocurses.

10. Please identify the technical staff who left the RCP/ Regional I DNN8 program during this period.

10.- Debra McElroy left the RCP during this review period.

f' III f3CENICAL SURLITI OF LICERSING &ct2058 4

11. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, or that were terminated or renewed in this period.
11. Th's new licenses issued that were complex and unusual

, included the followings i

1997- 1. The first NORN license was issued under the new i Subpart 14 of the 20NNAC 3.1 regulations;

2. A Research & Development laboratory license was  !

issued that authorized the use of in - vitro radioisotopes i: stead

, of animals for toxicological research; 1996- 1. A Co-60 Gamma Pool Irradiator was issued to Ethicon Endosurgery, a Johnson & Johnson subsidiary, to irradiate surgical supplies; 1995 1. A Radiopharmacy license was issued in Las cruces.

Major Amendments included the following:

1) The renewal process of Interstate Nuclear Services, a nuclear laundry in Santa Fe, resulted in a public hearing. The hearing has taken up a great deal of time and effort. The Secretary of the Department authorized renewal, but the City of fanta Fe will not allow discharge of radionuclides into the Santa Fe Sewage system. The issue of non-soluble radionuclide discharge
is unresolved and technical assistance is being sought; e

4 84

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2) A license that authorised the cleaning up of the depleted uranium at New Mexico Tech was terminated after the job

] was completed and material disposed of at an authorized j facility; j 3) All Indumcrial Radiography licenses were checked and a 1

eurvey conducted to determine compatibility of equipment

, - and associated parts, with 10CFR, Part 34.20 and 20NPAC 3.1, Subpart 5, paragraph 806; I

4)- The TNA/Eberline license was amended to allow for bench-d scale testing of their the Segmented Gate System to volume-redece soils contaminated with radium, transferred  !

i to the New Mazioo site from a New Jersey site; l l

5) All Medical Institution licenses were amended to include i brachytherapy and high dose-rate remote after-loader i standard conditions.

I

12. Please identify any new or amended licenses added or removed

! from the list of licensees requiring emergency plans?

e 12. A Radioactive Material License was issued to Ethicon Endosurgery, a Johnson & Johnson Subsidiary, during this reporting period and requires an emergency plan.

. 13. Dioeuss any variances in licensing policies and procedures or j exemptions from the regulations granted during the review

! period.

13. No variances were granted during this reporting period.

i 14 What, if an changes were made in your written licensing j procedures (y,new procedures, updates, policy memoranda, etc.)

j during the reporting period?

i l 14. Radioactive Material license application evaluation form was revised, radioactive material application form was updated. Reciprocal license log-in procedures were revised and computerized. Inspection forms for industrial radiographers, medical institutions and density / moisture gauges were revised.

J

15. Por NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending ior one year or more.
15. N/A ,

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IV. TECENICAL QUALITY OF IBSPECTIONS:

16. What, if any, changes were made to your written inspection procedures during the reporting period?
16. No changes were made to written inspection procedures during this reporting period.
17. Prepare a table showing the number and types of supervisory
  • accompaniments made during the review period. Include:
17. supervisor InnMdar TAcansa cat. Agta 1994 Bill Floyd John Martinait AN 09 94 Jerrie Moore Ralph Manchego IR 09 94 Ralph Manchego Jerrie Moore TA 12 94 1995 Bill Floyd John Martinez RD 04 95 Bill Floyd John Martinez IV 04 95 Bill Floyd Jerrie Moore CS 05 95

, Bill Floyd Jerrie Moore DM 05 95 John Martinez Margaret Lopez TA 06 95 Bill Floyd Jerrie Moore MI e 07 95 Margaret Lopez Walter Medina MI 07 95 Bill Floyd Margaret Lopez AN 07 95 l Margaret Lopez Ralph Manchego BH 08 95 l

Bill Floyd Margaret Lopez LA 08 95 Bill Floyd Walter Medina MI 09 95 John Martinez Margaret Lopez GA 09 95 Ralph Manchego Walter Medina IR 10 95 Bill Flo d Walter Medina IR 12 95 Bill Flo d Walter Medina DM 12 95 Bill Flo d Walter Medina GA 12 95 Bill Flo d Walter Medina WL 12 95 Bill Floyd Ralph Manchego MI 12 95 f

1996 Bill Floyd Ralph Manchego DM 12 96 Bill Floyd Ralph Manchego MI 12 96 Bill Floyd Margaret Lopez WL 19 96 Bill Floyd Margaret Lopez WL 07 96 Bill Floyd Jerrie Moore IR 07 96 Bill Floyd Margaret Lopez GA 07 96 Bill Floyd Margaret Lopez DM 07 96 Bill Floyd Margaret Lopez WL 07 96 Bill Floyd Margaret Lopez WL 07 96 Bill Floyd Jerrie Moore DM 04 96 Bill Floyd John Martinez TA 06 96 Bill Floyd ' John Martinez DM 02 96 Bill Floyd John Martises RD 02 96 Bill Floyd John Martinez MI 02 96 John Martinez Margaret Lopez MI 02 96

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I Bill Floyd John Martines $LD 02 96 Bill Floyd John Martines IV 02 96

)

Bill Floyd Margaret Lopes MD 01 96 1-1997 Bill Floyd Jerrie Moore MI 02 97 3111 Floyd John Martines RD 03 97

3111 Floyd Margaret Lopes RP 01 97 l Margaret Lopes Malter Medina GI 03 97 i Walter Medina Margaret Lopes MI 01 97 i

Walter Medina Mar aret Lopes MI 01 97 Bill Floyd Ra1 h Manchego MI 01 97 Aill Floyd Ra1 h Manchego DM 01 97 l ,

l III TECESIChL 90hLITI 0F LICENSING ACTIONS:

18. Describe internal procedures. for conducting supervisory

, accompaniments of inspectors in the field. If supervisory ,

i accompaniments were documented, please provide copies of the j documentation for each acca-pa4=nt. -

i 18. The Program Manager of th's Radiation Licensing and Registration Section accompanies each inspection staff member on a minimum of two inspections per year.

, Additionally, senior inspection staff iccompany junior j staff on occasion as part of internal training protocol.

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

! 19. See attachment 63.

v. RESPONSES TO INCIDENTS AND ALLEGATIONS:

i

20. Please provide a list of the most significant incidents i.e.,

medical misadministration, overexposures, lost and aban(doned i

}

sources, incidents requiring 24 hour- or less notification, etc.) that occurred in the Region / State during the review period. For Agreement States, .information included in

' previous submittals to NRC need not be repeated. Tha list 1

should be in,the following format: *

20. Reports on all incidents have been forwarded to NRC.

l 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?

7 4

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21. On July 15, 1996, a radiographer in Farmington found unusually high readings while surveying a radiography camera the source tubes (35 mR/h). Leak tests were sent to camera manufacturer, International Nuclear Corporation (INC), and INC requested the camera and tubes be returned for further testing.

On July 22, INC found a small defect in the weld on the source, SN9510. Nr. Filbert Fong of the State of california was notified at the Berkeley office. Mr Fong latar observed the defect.

On July 24, a preli= h=*y notification was sent out by Region IV staff in Arlington, Tx, regarding the defect.

(see Attachment 44).

21.a. For states, was timely notification made to the office of State Programs? For Regions, was an appropriate and timely FN generated?

21a. Yes, U.S. NRC, Region IV, informed HMSS, OSP and discussed the subject with the states of New Mexico and California. ,

22. For incidents involving failure of equipment or sources, was
  • information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficioney? Please provide details for each l

case.

22. See above. Region IV was notified by the manufacturer.
23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.
23. See Attachment (5.
24. Identify any changes your to procedures for handlin allegations that cecurred during the period of this review.g
24. No substantive changes occurred in the procedures for handling allegations during this reporting period. All allegations, including anonymous m'. legations, continue to be investigated thoroughly.

24a. For Agreement states, please identify any allegations referred to your. program by the NRC that have not been closed.

24a. We are unaware of any allegations that have been referred to our program that have not been closed.

s s g e

IV. SENERAL:

25. Please prepare a sununary of the status of the State's or Region's actions taken in response to the comunents and -

recommendations following the last review.

25. Nine regulations that had not been adopted as matters of compatibility with U.S. NRC regulations at the time o9 the last review have now been adopted. These include the following:
1. Bankruptey Notificationi
2. Quarterly Audit of the Performance of Radiographers;
3. Nell Logging Requirements;
4. National voluntary Laboratory Accreditation ?rogram
5. Certification of Dosimetry Processors;
6. Emergency Plans;
7. Safety Requirements for Radiographic Equipment;
8. 10 CFR, Part 20 Equivalent Regulations; and
9. Notification of Incidents.

The New Mexico Radiation Protection Regulations filed at

, the State Records Center on April 3, 1995 ( and which became effective May 3, 1995) include these nine regulatory requirements. Although we are still awaiting -

l final word trea WRC, The January 9, 1995 letter (attachment $6) from NRC signed by Dennis M. Sollenberger (for Paul B. Lohaus) offered a tentative finding that the revised regulations are compatible with the equivalent regulations of the Commission.

At the time of the previous review it was recommended that the New Mexico Radiation Control Program's internal procedures be reviewed and compiled in a manual that is easily referred to by all staff members in order to maintain consisteney an staff licensing and compliance activities. As a result of this recommendation, procedures covering internal processing of license applications, scheduling and documenting inspections, and enforcement activitiest escalated enforcement actions, and other functions have been incorporated by the New Mexico RCP.

S. NON-CONNON PERFORMANCE INDICATORS:

2. REGULATICES AND LEGEL AUT50RITY:
26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be ou orted by examples of successes problems or difficulties ch occurred during this review p,eriod.

9 4

26. strenaths:
1. The ability to establish new priorities for inspections of RAN licensees by assignment with emphasis on the most hasardous to the least hasardous. i.e., each staff moaber has begun updating his har own inspection database)
2. The streamlining of the license review process and inspection process by providing cross-training thereby allowing all staff to participate in licenslag procedures. (i.e., inspections are assigned by individuals on rotating basis).
3. Staf f has reviewed all ra.dioactive material licenses to determine which licen ees fall under the decomunissioning rule, and all Industrial Radiography' licensees have been checked for compatibility with 10 CFR, Part 34.31 and NNAC3.1, Subpart 5, Paragraph 506 equipment rule. *
4. All scaff have been trained with the exception of

. training in Brachytherapy.

l 5. License inspections are up-to-date.

Weaknessest

1. Programs under the Bazardous and Radioactive Materials Bureau have been streamlined by assignment of a Secretary to each program. Retraining is needed for the secretaries; this action should turn out to be a positive one, but time is needed for training and for adjustment to the workload.
2. The existing forms, standard conditions, license and inspection regulatory guides are in need of revision and implementation, (e.g. The Medical Euman Use Guide).

~

3. There is a need for an additional Environmental specialist option F, for the NORN regulation workload in licensing and inspection.
4. The creation of program databases for all general licensees, reciprocal licensees, and vendor providers of radiation related services with the help of the Information services Bureau's is needed.

The computer systems are being worked on with changes projected for the coming year. Along with this is the need for computer training for the newly- purchased personal computers, not only in the

-10

/ / .,,

word perfect mode, but with the capability of '

gathering and generating data on the same system for reports.

Examnies of successest i

1. In 1996 The ERMB-RLRS hosted the National Conference of Radiati,n o Control Program Directors in Albuquerque.

staff participated in all aspects of the five-dsy conference.

2. staff kept up with workload in spite of lengthy public l hearing process involving the renewal of the Interstate Nuclear services Radioactive Material Z.icense.
27. Please list all currently effective legislation that affects the radiation control program (RCP).
27. Sections 74-1-9, 74-3-5 and 74-3-9 MHSA 1978.
28. Are your regulations subject to a " Sunset" or equivalent law?

~

If so, explain and includt the next expiration date for your regulations.

28. The New Mexico Radiation Protection Regulations are not subject to a " Sunset" or equivalent law.
29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and any actions being taken to adopt them.
29. See attachment i7.
30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibi.lity with the NRC, showing the normal length of time anticipated to complete each step.

& 1. Proposed regulations presented to Radiation Technical Advisory council for advise and consent.;.

2. Proposed regulations presented to Environmental Improvement Board EIB for public hearing EIB approves or disappro(ves ) based on hearing record.
3. Amended regulations filed at State Records Center.
4. Amended regulations effective 30 days af ter filing.

II. SEALED SOURCE AND DEVICE PROGRAM

31. Prepare a table listing new and revised SSED registrations of sealed sources and devices issued during the review period.

11

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. . 1 The table heading should bei ss&D Manufacturer, Type of Registry Distributor or Devico Buahar custan user nr pource

21. Notes No ss&D registrations are pending. If any are will contract for evaluation received, assistance we a lther with private industry or will pay U.S. NRC for assistance in evaluation. l
32. What guides, standards and ' procedures are used to evaluate registry applications?
32. N/A
33. Please include information on the following questions in section A, as they apply to the ss&D Program Technical staffing and Training - A.II.7-10 Technical Quality of Licensing Actions - A.III.11, A.III.13-Responses to Incidents and Allegations - A.V. 20-23
33. N/A
  • III. IAnt-LEVEL WASTE PROGRAM:

-34. Please include information on the following questions in section A, as they apply to the Low-level Maste Programs status of Materials Inspection Program- A.I.1-3, A.I.6 Technical staffing and Training - A.II.7-10 Technical Quality of Licensing Actions -A.III.11, A.III.13-1(

Technical Quality of Inspections - A.IV.16-19 Responses to Incidents and Allegations -A.V.20-23

34. N/A IV. URARItSt MILL PROGRAM .
35. Please include information on the following quastions in section A, as they apply to the Uranina Mill Programs status of Materials Inspection Program -A.I.1-3, A.I.5 Technical staffing and Training -A.II.7-10 Technical Quality of Licensing Actions -A.III.11, A.III.13-14

, Technical Quality of Inspections -A.IV.15-19 Responses to Incadents and Allegations -A.V.20-23

55. N/A 12 u

NRC INSPECEION PRIORITIES INSPECTION MANUEL 3500,4/17/88 TTPE OF LICENSE 8 NRC PRIORITT MNED PRIORITE i PRIORITE 2 RN BROAD MEDICAL 1 YEAR 1 YEAR CI GMeth IRRADIATOR (POOL) 1 YEAR 1 YEAR IR INDUSTRIAL RADIOGRAPBY 1 YEAR 1 TEAR TA TAGGING 2 YEARS 1 YEAR RP RADIOPEARMACT 1 YEAR 1 YEAR PRIORITY II AC RCADEMIC 2 YEARS 2 YEARS RB BROAD LICENSE, TYPE 3 3 TEARS 2 YEARS D/M DENSITY / MOISTURE GAUGE 5 YEARS 2 YEARS GL GENERAL LICENSE 5 TEARS 2 YEARS IA LAUNDRT 2 YEARS , 2 TEARS MD MEDICAL DOCTOR-PP 3-5 YEARS 2 YEARS

MI MEDICAL INSTITUTION 3-5 YEARS 2 YEARS

- RD RESEARCS & DEVELOPMENT 2 YEARS 2 YEARS VT VETERINARY 5 YEARS 2 TEARS 1

WL WELL LOGGING 3 TEARS 2 YEARS I PRIORITIY III AN IABORATORY ANALYSIS 3 YEARS 3 YEARS ,

CS CALIBRATION SERVICE 3 YEARS 3 YEARS '

DU DEPLETED URANIUM 5 YEARS 3 YEARS GA GAUGE 5 YEARS 3 TEARS IX ION EICRANGE 3 TEARS 3 YEARS IV IN-VITRO 5 TEARS 3 YEARS PA PAINT ANALTZER 3 TEARS 3 YEARS SO STORAGE ONLY 3 YEARS 3 YEARS TW TRANSPORTATION / WASTE 3 YEARS 3 TEARS e

I a

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E'DUCATION AND RADIATION RELATED COURSES ATIT.hBY WALTER J. MEDINA ED10m0&

BS Derw, New Mexico 1891=a4 University,1974 M(or: Biology mor: Chemistry and Math Registered Medical Technologist (MT ASCP)

'IRAINING/NMED

1. Safety Aspects ofIndustrial Radiography (H 305), June 4 9,1995.
2. Medical Use ofRadionuclides, August 13-18,1995.
3. IJeandag Practices and Procedures Course (G-109), September 11 15,1995.
4. !=r+I-:E Procedures Course (G 108), September 25-29,1995.
5. Safety Aspects ofWelllogging (H 314), October 30 November 3,1995.
6. Applied Health Physics (H 109), February 5 March 8,1996.

l 7. DOE Workahop On Risk Aasessment, June 11 12,1996. .

' 8. Troxler Electronic Laborstories, Inc. Training Course For The Use ofNuclear Testing Equipment, October 23,1996,

9. Cal ~ Mas and Understanding Rbk From Radionuclides Released To The Envirer==t. April 28 -May 2, 1997.

TRAINING /LOS ALAMOS NATIONAL LABORATORY

1. PlutoniumMetallurgy, April 23,1981.
2. Nuclear Criticalhy Safety, June 1416,1982.
3. Introduction to Materials Science, November 1517,1932. .
4. L=ia2 Electron Microscopy and X-ray Microanalysis, fe% 17 20,1984.
5. Advanced Scanning Electron Miswy and X-ray Microanalysis, March 18-22,1985.
6. Materials Science and hPa-fwg H, January 20 23,1986.
7. X-ray Safety: Analytical, March 20,1987.
8. Physical Metallurgy of Uranium and Plutonium, January 18 22,1988. -
9. Resource Conservation and Recovery Act Waste Generator Awareness, August 15,1990.
10. Furdamaat=1s of Chemistry, January i11 15,1993. '  %

k$CkA4&fY E-

a RADIATION LICENSING AND REGISTRATION INSTRUMENTS JUNE 1997 HODEL TYPE SERIAL) USER CALIBRATION / CONDITION / REPAIRS i

RO-3C ION 133 JAN

  • RD-3C 135 12/96 i

RO-3C 06 97 137 RALP5 06 97 RO-3C 624 JERRIE RO-3C 06 97 646 NNL q 06 97 l RO-3C 635 JORN 06 97 E-520 G/M 4602 JORN 12 96 '

! E-520 4605 E-520 06 97 4609 E-520/EP270 4176 06 11/97 FOR CALIBRATION RALPB 10 96 E-530 BP270 847 JERRIE E-330 BP270 049 10/96 E-530 BP270 1665 PRM 6 1053 PRM 6 06 97

' 1055 SF 06 97 PRM 6 1245 SF 06 97

' PRM 6 AC-37 1235 SF 10 96 PRH 6 AC-37 1306 ALB 02 97 PRM 7 uR 107 JOHN 06 97 PRM 7 164 ALB PRM 7 06 97 167 JOFN 06 97 PRM 7 696 PRM 7 RALF3 06 97 697 JERRIE 11 96 URMOD-3 88237 JERRIE PRM 4 ALPEA 107 ALB LUDLUM INSTRUMENT /S.P. 06/97 PNR-4/NRD 4331 06/97 PNR-4/NRD 4365 02/97 ALB -

KVP METER 223 ,

JOHN OK ,

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i TNLE FOR QUEST]DN 29.

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DATE i DATE i 10CNtauLE DUE ADOPTED CURRENT l

EXPECTED  !

i STATUS ADOPTION  !

twamw dum panWAes.. weemsy 04/03/95 2w-py plan adopted April 3,1995, eLfective  :

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l INVESTIGADON OF ALLEGATIONS OF IMPROPRINTIES *AT*THS 111= nation Findhg ,

polution

1. Use of larger mesh 1* on Sweco f.ilter than 1. In'one it was instance 1.

noted that Entire new fil-tration system the 50 micron mesh larger mesh was has been in-specified in license i

  • application. ordered (and it stalled. Only was ordered by a proper filter M , who made size will be the allegation). used.

, 2. Spray heads on air 2. Apparently this 2. Preventative filtration system was true; one

. +

sometimes became maintenance

  • elogged, allowing estimate was that program put in lint to escape to spray heads became place..EEPA

-

  • clogged twice a environment. year. filter will repla'ce water scrubber.
3. Tank #1 leaked. 3. It did leak, but

- it was no longer 3. Tank repaired.

. need after leak was discovered. *

  • 4. Wash water holding 4. Did happen at
  • tanks sometimes least once 4. Alarm will sound -

overflowed, allowing is unclear).(why ence tank is wash water to run full. '

out beneath garage door onto ground. ,

4 LOPEE REBUTTAL EKHIBIT l 4

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s. Venting of sludge s. sas fixed dryer dryer out window. s. All air exhaust apparently used at will go through one time but ceased IEPA futer with being ased when it alarm to notify '

didn't work. Some of malfunction.

former esqpl s renseber At booked up to EEF

  • 111ter. No way asists .

to calculate what was exhausted out window. -

Swlpe from window ,'

sill showed no evi-dance of contautuation.

5. Not spot (44mR/hr) 6. Not spot did exist on waste water 's. Ma'unways cut holding tank fl. (identified in in- .into tanks all ternal audit in 1994 ~ ludge (in-s and was monitored on ciudnng hot regular basis simoe spot) removed that time).
  • and barreled ige burial as '

waste.

7. Overflow of wash water pits in wash 7. One former employee 7. Rhgular room. oonfizmod they did maintenance overflow at least
  • program onoe due to elogging instigated.

with limt.

8. Leaklag of black plastic line feeding 8. Probably did coeur, S. DEubly but leak repaired water from post- ~

encapsulated filtration pits into as soon as it was flow lines wash water tank discovered. Installed. .

building. *

9. Workere instructed 3. Not verifiable; to allow air samples samples standardly p. Written pro-to decay for up to a read at .24 and 72 oedural manuals month to show lower hours mocording to followed.

readings also, procedural manual.

workers instrooted Air filters run to allow air to fil-whenever employees ter to run 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> are present regard-

  • day even when dryer s/

not running to cause less of whether .

lower readings. dryers are running.

4

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10. License application 10. Only one scrubber 10. Drawing sub-schematic shows exi.sts, but it has water scrubber to mitted two heads.

consist of two dif-farent systemst in .

actuality, only ese water scrubber exists.

al. Workers told to 11. No proof that work- 11. asanways out shovel sludge out ers instreated to

  • of holding tanks, shovel sindge slaae into ends in violation of oomfined space rule of tanks to confined space .

went into effect. No allow for

  • rule.
  • evidemos that anyone cleaning of tanks.

en eerporate level -

instracted workers to

. shovel sindge as *

, alleged.

12. Water saapies taken 12. Yes, since this from drip line fra .12. Bolding holding pits not allows for a more - tanks re-from holding, tanks. homogenous mixture. plumbed so sample can be taken at point where

, ' waterenters sewer.

13. Washing machines sometimes run empty 13. but Theyonly are to runrinse empty, 13. procedural to -lilute copper and manuals will sino concentrations. out machines between be followed.

loads so cross-oontamination of laundry from dif-farent sources is ,

less likely to '

Do#Rr.

14. Liquid waste has , .

been seeping into 14. Tank drained and 24. Weak will be

  • 16,000 gallon under- cleaned in 1985. removed.

freund storage tank ,A recent inspection by ING showed it to ,

since the 1960's. contain a few inches of leakag;e.

of water no evidence t

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15. Voltage regulated 15. Voltage regulated 15. Procedural on clothing monitor ' based on customer -

manuals so that beta-gamma specifications. followed.

would not be read. Some customers pay for elothing with a higher degree of

, dooontam hation.

16. There is no way of 16. Wash water has never 16. New fil-returning waste even approached ex- tration water emoeeding eesdence of effinent systea acceptamoe level release levels; if it using

)

to wash bnL1 ding. -

did, then rtable- combination '

pumps o d return it of swooo to wash building for filter and additional filtration. sand filters installed.

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[ Etdpk, UNITED STATES I

e NUCLEAR REGULATORY COMMISSION WASHlW410N D.C.. AAAS48M January 9,1995 Mr. William H. Floyd, Program Manager Radiation Licensing and Registration Section I8 Department of Environment fDJ 1190 St. Francis Drive P.O. Box 26110 ,

Santa Fe, m 87502

Dear Mr. Floyd:

This New 1994 is to document Mexico the nsults Radiation . Protection of our review Regulations, of the as submitted

  • on draft revisio September 1 and the revised draft dated December 8, 1994. ,

in co,mparison to the equivalent NRC Federal Regulations regulations The rules were reviewedin Title 10 of the C and the equivalent rule's in the suppested State Regulations for the, Control of Radiation (55R).

In our review of the first draft as provided to you by facsimile a,nd discussed in telephone conversatio November 29 and December 6, 1994.

offer a tentative finding that the revthed Based on draft this rethat the prev with the equivalent regulations of the Cosnission. gulations are compatible, we A final determination adopted will beeffective.

as final rules and become made after the New Mexico regulations are We req final regulations be provided to us when they are pr'uPJt that a copy of the slished.

please contact me or Mr. Richard Blanton of sty staff a ,

Sincerely, ,

M 8. ep '

Paul H. Lohaus, Deputy Director Office of State Programs M ropacese gf

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! 1 rus post-amanruo avar,uarzox l SUSKIsSION SUFFLEMENTAL INFORMATION 3-7-97 F1 MAL ORDER NOV. 04-1996 {

SUBJECT CONDITIONS FOR INS RENEWAL 4

c.

install a new water filtration system; .

i 2,etter of February 20, 1997

! and final testing is .pending.-states that inatallation, t inspection Fetfrunky 24, 1997-testing and 4

results Santa Fepending not allowinbecause of EPA protocol question by the City of cffective on March 1,g discharge into STP.

materials by an industrial user until their criteria 1997 disallow i Letter from Jeoffrey Sloan to Caron Balkany, March 51997,isstates anet.

i that Ims will suhait its operating procedures qua, prot ocol for l that routinely BRHB pretreating will approve andortesting its wastewater for insolubles and i reject the submission' pending 1 installation and final testing evaluations.

! b.

install a new air filter systems i

i i

Filtration, MeasurementFigure a. 2 showsAppendix EEPA Air C IV filtration

  • Air syste:n.

fromtothe prior exhaust. dryers passes, through a 3" stage BEPA airfilter sys i

em downstream of the Representative offluent sampling is perforsned filter system in the discharge stack. The

[

cear isokinetic conditions are cchieved (air campling inlet nozzle is slightly less than surrounding air volocity).

velocity annrenrnate. Air samples for alpha, beta and gamma activity Ag Qu0stion:

i Maintenance schedule-neriodie' based on-alarm system? Will this be routine or -

neu sketch be submitted forWhat about filter backups? N'ill system. specifics for this new o.

alarm etfluent release sites for water and Air Air hadMa= system is equipped with a catastrophic filter f il

~

l alarm pro:sure and slutdown system. a ure as would result in a filter or sealing gasket failureIn event o an alarm,will dryers in opsration sound, will shut the off ashaust as well. blower fan will shut off, a

installed. Santa Fe facility but pending construction permitsSystems are at the

! , etc. not yet l

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

2 d.

Provide more detailed reporting to the ERNB:

All information requested has been forthcoming and BRMB believes it will be continued when 2Ns is allowed to resume operations.

o.

schedule waste shipments by accumulated volumet Appendix C-Waste disposal and Effluent Treatments I.

On-hand quantities of processed cadioactive waste will be limited to a ==winn= of 1,000 cubic feet. . Waste items may

' also be returned. to oustomer," d'opending on contractual arrangements.

III. Solids produced from wastewater processing: Backwash sequence

' for s' ulids settling in a =Niag chamber where a polymer is added via pump and coagulated riatorial flows to a conical-

. bottomed sludge thickener tank-Free water on top of thickener tank will be removed by decant lines located on the side of the tank and returned to the beginning of the' system.

Accumulated solid-laden, material in the bottom of sludge frame filter press for further dewatering before batch. discharge r** Supernatant will be returned to the begiaaiag of the pr' stem. Pressed filter cake will be loaded into a batch ~

Dried material will be packaged and shipped per regulationsoc .

Questions:

When will supernatant and water on top of conical tankthere Will be returned be if it is stated as periodically?

conical bottomed tank?a necessity for survey of sludge for any employee necessary for this tasks?What kind of exposure time

f. , , .

institute a regula:r equipment maintenance programs Appendix D-L,

  • scheduled Equipment Preventive Maintenance": r Should be anddetermined manufacturersbased on suggested schedules as provided by equipment or lacking that, experience o f onsit9 maintenance person,and advice from other INS locations.

g.

improve its doonmentation of in-house traiaiag Appendix D, " Radiation Safety Program

  • I and B, " Training:*

D.2.

consultant. Training is to be conducted by a qualified employee or Questions should not a statement concerning 150 duty of training or designating, in writing, the individual qualified to conduct training be written in this Appendices?

S $

. s i-3 i 3.4. All training, including general employee and inside/outside i

management training shall be documented and retained in each respective employee file.

Evaluator's casaments

I Need reviewed TABLE OF CONTENTS, on file 5/9/96 to incos:porate cupplemental infornation of 3-7-97 and any iorthocaing infornation

j. for renewal. i Add duty of maintenanos under Appendix I or Appendiz D. and add who 10 responsible for this task.

l .

etion: Shouldheaf verif layout sketch as submitted. Need

! fled air filtration - lag system sketch.

Yorify how much waste on-hand before resumption of operations.

I Need statement added to reference Appendix D, 3-7-97 a.(1),

  • Ef fluent Concentration 2daits"

! referring to protocol on waste water disposal to sanitary sewerage

treatment system, and statement for reference to see Appendix C for
Discharge air on Appendix D-3. c.(1).

I Quest 8.on: Appendix D.3.c. , Contaminated areas action level of ten times Appendix F. What should it be?

i Appendix D-D. Personnel Monitoring,1. Re<iiation Dosimeters. Seems +

too conservative to base radiation control on 10% of allowable

in any one calendar
exposureShould quarter. limits specified it not be annually in Appendix or 50sGles D (2) (1)/ year.

J

! Look up gasuna chest count >2E6 dpa as per Report 30, ICRP. and i

Uranium Bioessay action levels, 5 micrograms per liter.

i Appendix D.3.a. " Records", records should be kept fccilities for the required length - of time, not as statedboth

' at at fccility or at the corporate records vault.

  • l Appendix D-E.2." Wastewater Sampling " Compliance reports for City
  • 4 ef Santa Fe will be sent to ERND as well as the city on the rcporting requirements.

4 Need Portal monitoring specifications and installation date.

Need date of stainless steel shaker screen installation and complimentary hold-up tank system. Need explanation on waste water system echematic as submitted on 5-9-96.

N;ed timetable for installation of IEPA unit filtration system.

33ve no contamination levels in our regulations concerning cceeptable contamination levels. Ne have been using Appendix F as cubmitted with this_ application and for other facilit:.es.

e w w ,-- -p e - w w ~- + w e- ,rws,m--,------n---wmm-n , - , - , , , , ,, , - - - , ~ , - - - ,-,r-ee

I 4 Thio cospletes the fina-, thisrenewal order for evaluationof INS. as submitted and as it relates to Margaret.M. Lopez, Environmental Specialist, April 16,~1997.

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CERONOLOGY OF RADIO 7:11VE MATERIAL LICENSE RELD BY INS's SANTA FE FACILITY Chronology of INS file data prior to hearings cune 28, 1968 Application for renewal to AEC license for INS '

decontamination laundry services included amendments 1 through 7 on renewal of the referenced July 26, 1961 licens.e by AEC.

January 1, 1970 Amendmed 48 to AEC license.

December 30, 1974 Application to EID for the licensing under the eccepted authority.

March 24, 1975 First license issued by IID to INS as found in file. .

March 4, 1980 Amendment number NH-IIL-IA-06 axtended expiration date in Item 4 to March 31, 1985.

April 25, 1985 Application for renewal, signed by Gregg A Johnston, Corporate Bealth Physicist.

July 25, 1985 Rewritten license number WM-IIL-IA-7. A ,

extending erpiration date to July 31, 1990, signed by Benito Garcia, Program Manager. .-

July 18, 1990 Application Echolt, and for renewal, signed by C. Renee George J. Bakevich, General Manager.

September 26, 1990 Rewritten license number RM-IIL-IA-13, ext 6nding expiration date to June 30, 1995, signed by William M. Floyd, Program Manager.

March 15, 1995 '

Press thereof.release on INS laundry and the existence

  • March 15, 1995 Bill and Margaret from MNED attended press conference held at 107 Cienga St by CCNS where Bill was interviewed about . INS licensing and statedrequest upon that records were Office.

at the RLRS available for review CCNS requested a list of RAM licensees in the santa Fe Area, and requested the state to provide testing of effluents at the sewage outflow, and compile a history in sludge and water emanating from INS and waters downstream from the sewage plant.

1

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o March 16, 1995 Bill Williams issued for immediate release NMED's official response to CCNS press release.

April lo, 1995 Application for renewal and supplemental documentation including SOP's is received by NMED for review. (Note: This application would have been evaluated for license renewal had not INS voluntarily sulaitted its September 5, 1995, application to conform with the NMRPR which became effective May 3, 1995).

June 30, 1995 INS's specific license for laundry decontamination servloes expiration date.

July 21, 1995 A letter to INS requested INS re include proprietary information in the application and be made available to the public.

July 28, 1995 Public Notice published on July 28, 1995 on renewal for INS.

83ptember 05, 1995 A revised application, signed by Kent Anderson, dcted August 31, 1995 was submitted. The primary reason for resubmission was the issuance of the New Mexico Radiation Protection Regulations, filed May 3, 1995, and INS's decision to come into compliance with the revised regulations. Additional minor changes were made to standardize format and content with the 12 other RAM licenses held by INS under the NRC's jurisdiction and that of other Agreement States. Changes made were minor changes in format and content, but included all necessary criteria on facility, security, equipment, and radiation protection program.

References were revised to reflect changes in exposure limit cl.anges. ,

S0ptember 12, 1995 A letter to Mark Reilder, NMED Secretary, requested a public hearing on the INS license renewal.

S;ptember 19, 1995 A letter to Thomas Duker, Public Records officer, requesting NMED to access to INS file records. provide the public Ocptember 22, 1995 Public Notice appeared in the New Mexican which informed any interested party the hearing was set for November 2 and 3, starting at 9:00 AM at the Barold Runnel's Building Auditorium.

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Ccptember 27, 1995

MMED's response to September 19, 1995 request to provide the public access to infonnation on INS files. Response stated records are available at 2044 Galisteo in the Santa Fe office, during working hours, except for
proprietary information.
October 13, 1995 All files were made available for public review j

by any request received, including to CCNS.

The files were picked up from.Kinko's Copies on St. Michael's Drive after a request by CCNS to have all the information in the INS files copied as agreed after a brief review at the

' Santa Fe office on October 11, 1995. The SOP's for the April 10, 1995 application for renewal

  1. were not in the file on October 11, 1995, but were copied and provided to CCNS' as preiriously agreed to by Kathleen Sabo and Margaret on i

October 13, 1995.

October 23, 1995 Deadline of 10 days prior tn set hearing to

  • provide the Secretary with a list of witnesses 4

and a summary of testimony is required.

l R3ference to Section (3075) The requirement for an Environmental i Impact Statement because INS is a commercial waste facility? INS is

! not a waste disposal facility. Any

' waste produced is incidental to j decontamination services provided as i

a laundry. The SOP states that any

. contaminated items that do not meet

INS criteria (> 50 mR/hr}as being fit for laundering will be sent back to the client for disposal.

INS chronology continued:

1 August 7, 1995 , .

, I,etter from Mark Weidler, Secretary BMED, to Mr.

Ray Schmidt,- informing of the public

{ hearing to be held on IRS license renewal.

j August 31, 1995 Re submittal application for INS renewal, and

> request for withholding proprietary information j Sections B-1;C-1;C-2; and Figures B-1;B-2;B-3; and D-2 from public disclosure.

Ocptember 22, 1995 Memo from William Floyd to Tracey Bughes, I,egal i

Counsel, requesting attorney assAstance in

preparation for public hearing.

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October 3, 1995 Letter to Mark Weidler, secretary, from CCNS requesting an evening session for public comment and replacement of Edgar Thornton, as hearing officer for Nov hearing on INS renewal.

October 10, 1995 Letter to Rathleen sabo, CCNS, from Tito Madrid, Bearing appointed hearing officer.

October 17, 1995 Letter free CCNS to Tito Madrid in response to his letter - of October 10, IP96 requesting postponement of Nov. 2 & 3 hearing due to procedural and substantive irregularities by INS and MMED (the re-submittal of INS renewal application, claim of proprietary information, and other clean air act and disposal issues).

October- 17, 1995 ERMB's motion for Prehearing Order to establish deadlines, statements and party status by interested persons and non-parties with the

  • o portunity to submit oral relevant issues, v.: ws or arguments and to examine witnesses.

October 20, 1995 Letter to ~ Tito Madrid from REAL-Responsible Environmental Action League to be regarded as-

" Interested Persons".

October 20, 1995 Letter to Mike Bovino, INS, form U.S. EPA-Bank May, Radiation Project Co ordinator, Region 6, Dallas, Texas -Ret

" Direct" Radiation vs.

Radiation from Emitted Radionuclides" (NESEAP)

October 23, 1995 Letter to Tito Madrid from REAL submitting the filing of witness, awhihits, and summary of testimony on Nov. 2 and 3 hearing.

October 23, 1995 Letter from Tito Madrid to "all interested '

persons", on Postponement of INS hearing in order to address certain significant procedural '

issues week. raised for the first time in the past October 24, 1995 Letter to Tito Madrid frca Potter, Mills &

Bays, INS attorneys in response to CCNS letter of October 17, 1995 and to raise points to be considered & ruled upon on in renewal proceedings.

October 26, 1995 Letter from the Dept. .to INS on Financial Assurance Requirements, Subpart 3, Section 311.

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November 1, 1995 i Prehearing Order-Bearing Officer finds and Orders that:

1.

I INS renewal application was submitted more than 30 days prior to June 30th, 1995 I

2. expiration date and therefore is timely.

INS August 31, 1995 letter does not

3. constitute a new renewal application.

Clean Air Act violations not relevant to 4.

licensure issues under RPA.

5.

Proprietary issue claims not evaluated.

IMS 15 days from this order shall support

! each claim of proprietary information or withdraw claim within two days of INS's

, submission to the Bearing Officer has made

,. a ruling, and cause ap repriate notation to be placed in the j, lic file.

6, 7, 8, proprietary issue.

i 9.

Significant interest expressed merits 10.

public hearing of the application.

11.

310 A,B & D have been complied with.

References l'

to " Parties", " Interested Persons" and "Any Person Who is or maybe Affected" are confusing ,and resolves as

follows

i

a. INS & BRMB are deemed to be parties; i

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b. Information presented that is relevant and not cumulative or

- otherwise objectionable, any i interested person shall be permitted to testif to cross yexamination; under oath and is subject

c. No interested- person will be permitted organization to testify on behalf of an
unless they have a signed, sunnary , of l

4 testimony. profiled

,' November 9, 1995

Letter from CCNS to Tito Madrid, Response to -

I 'ERMB's motion for Prehearing Order and Response

{ to INS letter, dated October 24, 1995. (CCNS

( desires a set time on public testimony but no

further restrictions other than relevancy);
detemination of propr(ietary infornation that should be made available for public review; and
refrain from entering a Prehearing order until after Prehearing Conference is convened).

November 14, 1995 Letter to Kathleen Sabo, CCNS, Sloan providing a list of documents withheldfrom Geoffrey i

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e November 15, 1995 by BRMB, not proprietary infornation clahned.

. Certificate of Service from Thomas C.H. Mills, INS Attorney on Justification for withholdin certain information for proprietary reasons g November 15, 1995 Letter from Thomas Mills to William Floyd, MMED, INS submittal of information for public
record of Justification for Withholding Certain Information for Proprietary Reasons.

Covember 17, 1995 Letter from Geoffrey Sloan to Thomas Mills, on INS Decommissioning Funding Plan.

november 21, 1995 Letter to Tito Madrid from Geoffrey Sloan to transmit the original figures B-1;B-2; and D-

. 2 provided in 8-31-95 renewal application. No copies of these figures were made by BRMB. ,

November 2B, 1995 Letter to Keith Eye,. INS Plan Manager, from

' the State of Washin DOB, Division of Radiation Protection, gton, on site Use Permit-Point of 1995, Origin Inspection conducted on November 18, on rules governing th's use of the commercial low-level waste' disposal facility.

After a review of waste handling operations, no found. deficiencies pertaining to the program were November 30, 1995 Letter for Party to Tito Madrid from Kathleen Sabo, CCNS,-

Status.

December 4, 1995 Letter to from REAL November 30, to Tito Madrid, in response Status. 95 CCNS letter for Party D'ecember 12, 1995 Letter to Tito Madrid from Geoffrey Sloan on error of copy given as proprietary, Figure B-1 instead of B-2 as ordered on November-20th.

(Figure B-1, INS, SF Site Drawing). .

January 9, 1996 .*

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Letter from William Floyd to Mike Bovino, INS, Follow-up to December 19,1995, i plan & separation of proprietary information. decommissioning January 11, 1996 Order from Status. Bearing Officer denying CCNS Party January 25, 1996 Request from CCNS to Bearing Officer to reconsider the order denying CCNS Party Status.

February 20, 1996 Letter petition form and CCNS to Tito affidavits for Madrid additional reconsideration of Party Status.

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Fchruary 26, 1996 REAL response to CCNS affidavits.

February 29, 1996 Letter from - William Floyd to Mike Bovino, approving INS Decosedssioning Funding Plan.

March 1, 1996 Letter from INS attorney to Tito Madrid, Response in opposition-to CCNS' Party Status Petition reconsideration request.

March 4, 1996 CCNS ' letter to Tito Madrid,, Party Status Reconsideration Request and to present evidence

& witnesses in the public hearing in more than a generalised interest.

March 7, 1996 Department was informed of allegations by Leroy Romero and met with representatives from CCNS, and the City of Santa Fe.

March 11, 1996 order denying CCNW amended petition for Party Status.

March 26, 1996 Notice of Bearing-Renewal hearing May 20th and 21st from 9:00AM .to 5:00PM, at State Capitol Building, Room 322, Corner Paseo de Peralta and Old Santa Fe Trail, and evening session at 7:00PM to 9:00PM reserved for public comment on May 20,1190 St Francis Auditorium, Copy of PreBearing Order may be obtained from Joyce Croker, Bearing Clerk-(505) 827-2824.

March-28, 1996 Inspection of INS by MNED and City of Santa Fe, on March 28 through April 1,1996, (See report dated April 4, 1996).

April 2, 1996 Letter.from IMS to William Floyd, in response to Letter of Credit, Deccamissioning Funding Plan and standby Trust Agreement, and question on page 3 of Appendix F, the setting asiC of .

funds to remove the buried sewer pipe arca their city tanks to the point of connection to the sewer main on siler Road. The term

  • manhole" used to represent this connection point.

on AprilDecommissioning 30, 1996.

Plan document expected April 4, 1996 Letter from INS and News paper article copy on the State's Inspection of March 28 through April' 1,1996, and reference to the Inspection Order filed in District Court on April 3,1996.

April 9, 1996 Analytical results from Scientific Laboratory 7

5

t Division of swipes taken on INS inspection on March 29, 1996 ziled in hearing folder 1 of 2.

AUGUST 6, 1996 CONTINUATION OF REARING April 9, 1996 New Mexican Article of March 28, 1996, INS Inspection by MNED.

April 22, 1996 SLD analytical results of samples taken on March 28, Water Tank-2.

April 26, 1996 SLD analysis, Sludge from Bolding Tank 42, April 29, 1996 Official copy of April 26 Sampling Analysis.

April 26, 1996 Journal North Article on protestors that condemn ZANL plans and pre hearing Public Meeting on April 29, at the Barold Runnels Bldg., 1190 St Francis Drive, Santa Fe for parties to discuss hearing stipulations.

May 9, 1996 INS- Letter of Credit and Standby Agreement, May 1, 1996 between INS, The Trust Bank of Boston, and NMED.

May 10, 1996 Letter from INS, Mike Bovino to Royallynn Allen, Water Quality Division,, City of S.F.,

in response to violations Notice of April 12, 1996.

Letterby be completed outlined June mitigation measures to 15, 1996:

May 14, 1996 City oftoSanta Order INS. FeCeaseu=histrative Compliance discharge into city sewer.and Desist from any May 15, 1996 '

Journal North news article on the fines imposed .

on INS over sludge in-holding tanks.

May 17, 1996 SLD analytical reports of roof lint cather of samples collected on May 16, 1996.

May 17, 1996 CCNS copied information from files 315 pages.

May 17, 1996 Letter to Bill Z.andin PE., Engineer II City of S.F. Water Quality programmatic and Division from INS to make prevent facility modification recurrence of cited violations, to eliminate possible sludge into sewer system and May 22,'996 1 new New ecapliance sampling point.

Mexican Article on waste a,t INS on 8

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i Testimony that laundry lint is Radioactive.

May 22, 1996 Memo to file from Bill Floyd, report of fire at INS. NMED verified that the welders were cutting doors for man-ways in holding tanks.

May 24, 1996 Pax from City of Santa Fe to Mike Sovino, INS on proposed facility modifications no written approval granted until review of May 21 plans.

May 29, 1996 INS l'atter outlining Engineering controls taken for man-way installation & sludge removal from tanks.

May 23,1996 Radiation Survey of areas surrounding INS by John Martinez and Walter Medina.

May 29, 1996 Second Stipulated Supplemental Pre-Bearing Order from INS attorneys to Jeff Sloan, NMED.

May 30, 1996 From INS attorney's to Jeff Sloan, MMED attorney Draft Notice of Resumption of Bearing.

May 30, 1996 Article to Bill Floyd from Jeff Sloan on the Nation and Nuclear Wea' pons.

May 31, 199,6 City of Santa Fe, Peter Dwyer, to Jeff Sloan, a resolution for the city of appear before the Environment Dept. to intervene in renewal of IMS RAM license. Attorney Privilege.

May MNED Notice to all interested persons in the renewal of INS. license, that the hearing-conducted on May 20 and 21 will resume ont he 6th day of August at 9 A.M. to S P.M. and will continue until concluded. These notice supersedes notice in Alb. Journal on June 6, 1996 and the New Mexican on June 13.

No Date Article by Kay Bird, Santa Fe Reporter on

  • Stricter City." StWards set for Nuclear Laundry by May 31, 1996 CCNS to Jeff Sloan concerning information on proposed clean-up.

expansion areas and contamination June 3,1996 Letter before tosludge Mike Bovino, INS to notify the State removal from tanks or any processing taken.

of sludge and protective measures June 5, 1996 Representative from Yellow Freight concerned e

9

about possible exposure by INS to employees.

Recommended he contact INS from WB counting.

Provided INS. him with information of surveys at June 6, 1996 INS to Bill Landin City Water Quality, response to supply requ,ested information on TSS treshold limits.

June 7, 1996 Letter from INS keeping MNED informed of documents from City of SF to .TNS and meeting scheduled on Tuesday June 11 inspection" to release cease, & 9 A.M.

desistfororder.

" final June 13, 1996 City of SF Resolution to City Attorney and Public Utilities Dept. to revise and strengthen the waste water discharge permit held - by INS

.and prohibiting radionuclide discharge in the city sewer and directing that such prohibitions be made part of all existing permits.

June 14., 1996 New Mexican article on City rule . to keep radioactive waste out of sewer June 27, 1996 Letter from City of Santa Fe to INS regarding administrative Order. AO will continue in effect until all changes are in place.

June 28, 1996 New Mexican Article INS files suit against the City of Santa Fe to reopen facility.

June 28, 1996 To Jeff Sloan from City of SF on upcoming local radionuclide regulatory requirement council meeting of June 12 resolution was adopted regulating radionuclides into sewer.

July 2, 1996 New Mexican Article SF Prep, sampling paper. quoting Jay Shelton, July 10, 1996 -

Journal being North Article required by City on Radionuclide Council and affects Tests on private residences.

July 17, 1996 Unopposed motion for Issuance of Deposition Subpoena hearing. to Leroy Romero and CCNS before July 17, 1996 Brief. in support of unopposed motion for issuance ~of Deposition Subpoena from INS.

July 17, 1996 Letter .from INS to Tito Madrid with unopposed 10

motion for issuance of de position subpoena to grant anotion and issue snapoenas.

July 17, 1996 Joint motion denying INS City of SFand MMED Party to amend order Status.

July 25, 1996 Amended order denying City of SF Party 6tatus.

July 30, 1996 SP City Council Resolution to include NMEd as stakeholder in task force on regulation of radionuclide release to sewer.,

July 30, 1996 Accompanied Jay Shelton and SF Prep student on

- taking sludge samples and surveys at the SF Sewage Treatment Plant.

August 1, 1996 Meeting with INS attorney and CCNS attorney for Leroy subpoenaRomero before Tito Madrid to squash int deposition.

Tito ruled that a subpoena could be issued and CCNS and Leroy Romero may not testify until these depositions are taken.

August 2, 1996 SLD results on six sludge / soil samples from INS samples taken on July 15, 1996.

t 9

g4 11 4

a.

APPENDIX D LICENSE FILE REVIEWS File No.: 1 Licensee: Espanola Hospital License No.: M1073 Location: Espanola Amendment No.: 20 License Type: MedicalInstitution Type of Action: Amendment Date Amendment issued: 04/24/96 License Reviewer: WMF Comment:

a) No documentation in this file to indicate that the individual named as a temporary authorized user is qualified (by virtue of his own license issued by the State).

File No.: 2 Licensee: New Mexico Institute of Mining and Technology License No.: AC049 Location: Socorro Amendment No.: 4 License Type: Academic Type of Action: Amendment Date Amendment issued: 01/23/96 License Reviewer: RM Comments.

a) License was amended on the basis of an intended licensee response to a compliance letter that was required but never received.

- b) The license had an April 30,1996 expiration date but no documentation pertaining to the renewal was in the file. The renewal (amendment 5) was found on a computer and

.rinted out for the file but the licensee's letter requesting renewal was not found.

File No.: 3-Licensee: Ethicon Endo-Surgery License No.: Gl3;6 Location: Albuquerque Amendment No.: 0 License Type: PoolIr adiator Type of Action: New Date Amendment issued: 01/19/96 License Reviewer: ML Commeras:

a) Documents ( financial surety and a hospital's commitment to treat potential radiation injuries) were required to be submitted after the construction license was issued and prior to operational approval. These were missing from the license file but found in the Albuquerque office with the inspector's facility application.

b) Detailed schedules for testing and maintenance were also required to be provided prior to operational approval. Only the quarterly mechanical maintenance schedule was in the license file. Others were thought to be in the Albuquerque office. There is no documentation that these documents were reviewed by the licensing reviewer.

c) A source wipe test procedure was approved but no specifications for the required meter were provided nor were detection limits discussed.

l l

New Mexico Final Report Page D.2 License Fils Reviews File No.: 4 Licensee: Continental Testing and inspection License No.: IR323 Location: Signal Hill, CA/ Aztec, NM Amendment No.: O License Type: Industrial Radiography Type of Action: New Date Amendment issued: 07/11/96 License Reviewers: MLM/JM Comments:

a) RSO qualification and facility diegram submittals were not tied to license, b) No training and experience was documented for one of the named radiographers.

file No.: 6 Licensee: Desert Industrial X-Ray License No.: IR062 Location: Hobbs Amendment No.: 11 License Type: Industrial Radiography Type of Action: Termination Date Amendment issued: 07/31/96 License Reviewer: WMF Comments:

a) No record of close-out survey b) No verification that sources were received by company's office in another State.

c) Licensee's request for termination was misfiled. Found in " reciprocity" file.

File No.: 6 Licensee: John A. Ronnero, DVM License No.: VT234 Location: Santa Fe Amendment No.: 6 License Type: Veterinarian Type of Action: Renewal Date Amendment issued: 12/09/96 License Reviewer: WMF Comments:

a) Checklist from previous renewal in 1987 was deemed acceptable by reviewer.

b) Tie down clause inappropriately included letter from 1992 in which licensee sought approval to use flushable litter in place of holding animal waste for decay.

File No.: 7 Licensee: The BDM Corporation License No.: RD027 Location: Albuquerque Amendment No.: 6 License Type: Research and Development Type of Action: Termination Date Amendment issued: 03/18/96 License Reviewer: ML Comments:

a) No record of close-out survey by State. Indirect reference in licensee's request for termination noting use of a survey meter by State inspector. Licensee had possessed mainly tritium in sealed neutron source targets. No indication that smears were taken.

b) No verification of transfer of sources. Licensee had been cited in 1995 for failure to have records of transfer for three multicurie tritium sources. No record of licensee response to citation.

c) Termination amendment did not reference licensee's request (omitted date).

New Mexico Final Report Page D.3 '

License File Reviews File No.: 8 Licensee: IMC Global Operations, Inc. License No.: GA099 Location:- Carlsbad Amendment No.: 17 License Type: Fixed Gauge Type of Action: Amendment Date Amendment issued: 11/30/95 License Reviewer: JLM Comment:

a) Transfer of source verified but not documented. (It was also noted that this file was -

missing the original license application and supplemental information as referenced in -

the license tie 4own condition and that recent operating and emergency procedures that ,

were included in the file were not referenced in the license.)

File No.:' 9 Licensee: Atomic inspection Lab License No.:- lR022 -

Location: Albuquerque - Amendment No.: 14-License Type: Industrial Radiography Type of Action:- Renewal Date Amendment issued: 04/04/97 License Reviewer:-WMF

! Comment:

L a) No example examination was submitted for in-house training program.

. File No.: 10 Licensee: Interstate Nuclear Services - License No.: LA110 -

Location: Santa Fe Amendment No.: 54 License Type: Nuclear Laundry Type of Action: Renewal Date Amendment Issued: Pending - License Reviewer: ML Comments:

a) No indication that all items identified as deficiencies in the undated License Application Evaluation "The New Mexico Environment Department Lic. #2" and discussed with the licensee in the meeting on May 8,1996 had been resolved to reviewer's satisfaction.

(Although the Post Hearing Evaluation of Supplemental Information, dated March 7, 1997, covered some of the same items.)-

b) The practice of replacing pages in the licensee's renewal package as updated information is submitted without removing the outdated information has resulted in a confusing master document.-

l l

I New Mexico Final Report Page D.4 License File Reviews File No: 11 ,

Licensee: Rotary Wire Line Service, Inc. License No. WL300 Location: Hobbs Amendment No. O teense Type: Well Logging Type of Action: New T ate Amendment issued: 07/10/95 License Reviewer: WJM Comments:

a) Procedure manual (from predecessor license) was not tied down.

b) Telephone deficiency call was not documented in the license file. The reviewer found docume '!on in his personal notes.

l

APPENDIX E INSPECTION FILE REVIEWS File No.: 1 Licensee: Kleinfelder, Inc. License No.: DM318 Location: Albuquerque Inspection Type: Unannounced, Initial License Type: Moisture / Density Gauge Priority: 2 Inspection Date: 10/07/96 Inspector: JLM Comments:

a) Operations not observed; independent measurements were performed.

b) Exit meeting held with RSO, not senior licensee management.

c) Only RSO was interviewed. Other staff not around during the inspection, according to the inspector.

d) Annual review of radiation protection program not addressed.

File No.: 2 Licensee: Mobile inspection Serv:ce, Inc. License No.: IR138 Location: Farmington Inspection Type: Unannounced, Routine License Type: Industrial Radiography Priority: 1 Inspection Date: 08/29/96 Inspector: WM Comments:

a) Operations not observed, b) A few areas not inspected / addressed, including required annual review of the radiation protection program.

c) Exit meeting held with Alternate RSO, not senior licensee management. Inspector reported that Owner and RSO not present.

d) Inspection report form in draft.

File No.: 3 Licensee: Petro Wireline Service Licence No.: WL162 Location: Farmington Inspection Type: Unannounced, Routine License Type: Well Logging Priority: 2 Inspection Date: 09/05/95 Inspector: WM/WF Comments:

a) Citation from previous inspection not followed up. 7/92 inspection informed licensee to amend license to add individual as an authorized user. Licensee did not submit amendment request. This 9/95 inspection makes a repeat finding regarding amending license to indicate authorized users. Individual still has not been added to the license.

b) Deficiency letter sent to licensee late - 3 months after the inspection, which exceeds the 30 day post exit criterion.

c) Operations not observed.

d) Exit meeting held with a non-authorized user, not senior licensee management.

e) Acknowledgment letter (responding to licensee's reply to deficiencies) not in file.

New Mexico Final Report Page E.2 inspection File Reviews f) Key areas not inspected / addressed (training, inventory, and shipments not inspected; condition of equipment not reviewed; licensee conducting tracer studies, but bioassays not inspected).

g) Licensee's response to repeat deficiency on survey meter calibration does not address how future violations will be prevented.

File No.: 4 Licensee: Northeastern Regional Hospital License No.: M1153 Location: Las Vegas Inspection Type: Unannounced, Routine License Type: Medical Institution Priority: 2 Inspection Date: 09/10/96 Inspector: ML Comments:

a) Operations not observed; independent measurements not made (inspector's survey meter malfunctioned).

b) Key areas not inspected /sddressed (dosimetry results not documented; did not inspect annual review of the radiation protection program; no inspection of I-131 effluents; dose calibrator linearity not checked, even though this was a previous deficiency),

c) Exit meeting with RSO, not senior licensee management.

d) Inspection report form in draft.

File No.: 5 Licensee: Science Applications Intemational Corp. License No.: RD249 Location: Albuquerque Inspection Type: Unannounced, Routine License Type: Research and Developmer t Priority: 2 Inspection Date: 05/15/96 Inspector: JAM Comments:

a) Operations not observed; independent measurements not made (licensee did not have material at the time of inspection).

b) No supervisory review of inspection report indicated.

c) Exit meeting with RSO, not senior licensee managemeni.

d) Key areas not mspected/ addressed (insufficient information on security practices, receipts of material, transfers of waste, licensee surveys; waste disposal practice regarding holding for decay to background then disposal / transfer to Defense Nuclear Agency is not appiopriate, since cobalt-60 has a half-life longer than appropriate for decay-in-storage).

New Mexico Final Report Page E.3 Inspection File Reviews File No.: 6 Licensee: Ethicon Endo Surgsry License No.: Gl316 Location: Albuquerque Inspection Type: Unannounced, Initial License Type: Poolirradiator Priority: 1 Inspection Date: C7/01/97 Inspector: JLM Comments:

a)- Independent measurements were made (but actual dose levels in control room were only characterized as "no abnormal readings," values not given).

b) Key areas not inspected / addressed (note on emergency response indicates that the fire department "will be contacted" and that the fire chief has inspected the plant, but fire department not yet trained on fighting fires at this large irradiator; insufficient inspection on whether domineralizer resins are surveyed, other than on-line monitoring, before release to commercial company for unrestricted use).

c) Reference made in inspection report to previous trips, but only 10/28/96 visit documented. Others not documented at all.

d) Ancillary workers (administration, cleaning, warehouse workers) apparently not interviewed. Mainly spoke to RSO, engineers and Alternate RSOs.

e) - Exit meeting with RSO, Alternate RSOs, and some staff, not senior licensee management.

File No.: 7 Licensee: Biotech Pharmacy License No.: RP301 Location: Las Cruces Inspection Type: Unannounced, Routine License Type: Nuclear Pharmacy Priority: 2 Inspection Date: 01/15/97 Inspector: ML/WF Comments:

a) Operations not observed; independent measurements were made, but levels not documented, b) Key areas not inspected / addressed (insufficient detail on wsste disposal; inspector does not recall whether inspection included wipe tests for removable contamination).

c) Inspection report form in draft.

d) Unclear follow up on licensing; 3/21/97 license revision did not follow through, as indicated, and make named individual the RSO. Reason for making the individual the A! ternate RSO, instead of changing the RSO, not documented e) Nuclear pharmacy used 1-131 during review period, but no bioassays performed. No estimates of worker intemal doses provided by licensee or inspectors. Licensee did not

  • state, to the inspector, quantities of I-131 used.

f) Delivery drivers not interviewed, although delivery and pick-ups occurred during the inspection.

g) Inspector signed form for supervisor, h) Deficiency letter dated 02/25/97, more than 30 days post exit.

1

New Merico Final Report Page EA

- InsNion Ra Reviews --

Me No.: 8 Licensee: New Mexico Institute of Minine and Technology License No.: AC304-Location: Socorro inspection Type: Unannounced, Routine License Type: Academic . Priority: 2 Inspection Date: 02/18/97 Inspector: RM Comments:

- a) laspection dates inconsistent: inspector reports 2/18/97, inspection form shows 2/20/97, .

letter to licensee states 2/10/97,

- b) Operations not observed; independent measurements not made, c) Key areas not inspected / addressed (surveys, security, receipt / inventory, transfers / shipping, and intomal audits not addressed in inspection report; inspector does not recall whether he looked at licensee surveys; insufficient detail on worker doses; l

- process for waste disposal described, but no information regarding whether waste was

being disposed).

l d) No interviews of students in authorized user's laboratory.

(- e) Exit meeting with RSO and authorized user, not senior university management.

File No.: 9

, Licensee: ProTechnics Intemational, Inc. License No.: TA172 Location: Albuquerque Inspection Type: Unannounced, Routine License Type: Tagging (similar to R&D, Distribution) Priority: 1 Inspection Date: 06/04/96 Inspector: JAM /WF Comments:

a) Reinspection recommended in June 1998, although this is a priority 1 licensee with two past incidents, b) - Operations not observed.

c) Key areas not fully inspected / addressed (shipments not fully addressed, although the licensee distributes; examination of annual audits not addressed; insufficient detail on bioassays, extremity doses, emergency response, and gaseous effluent levels).

File No.: 10-Licensee: University of New Mexico License No.: BM233 Location:- Albuquerque Inspection Type: Unannounced, Routine License Type: Broad Medical _ _ Priority: 1 Inspection Date: 05/13-17/97 Inspectors: ML/JLM/WF Comments:

a) File notes " human subjects are used" for research. Inspector reports that licensee is performing radiation experiments on people. Inspector did not ask what the licensee was doing.

b) ALis and DACs not evaluated.

c) Inspection report makes reference to a " diagnostic misadministration." That is unlikely, since almost all diagnostic doses of Tc-99m will not result in misadministration, as defined in the regulations.

New Mexico Final Report Page E.5 Inspection File Reviews d) Effluents from laboratories not completely evaluated. Licensee told inspectors that the records were in boxes, but State apparently did not follow up.

e) The 1995 and 1996 inspection reports were not in the file although the staff indicated that the inspections had been performed, f) Deficiency letter dated 06/26/97, more than 30 days post exit.

g) Some areas (laboratories, nuclear medicine) documented appropriately. Other areas (HDR, brachytherapy, pool irradiator source) not thoroughly documented.

h) Some inspection report forms in draft.

1) Respiratory protection program not fully inspected / addressed.

File No.: 11-Licensee: New Mexico State University License No.: BB151 Location: Las Cruces _

Inspection Type: Unannounced, Routine License Type: Broad License Type B (similar to Academic) Priority: 2 Inspection Date: 08/28/96 Inspector: RM Comments:

a) Operations not' observed; independent measurements not documented.

b) Key areas not fully inspected / addressed (security not fully described, receipt / procurement not completely inspected although this institution had an NRC violation at a remote facility, dosimetry results not provided).

c) Students not interviewed regarding trai.9ng. One signifMant authorized use under this _

license is to train students in the use of portable gauges.

d)- Acknowledgment letter (responding to licensee's reply to deficiencies) not in file.

e) Exit meeting with RSO and users, not senior university management.  !

f) Inspector examined storage area; reports that he did not observe gauge, itself.

File No.: 12 Licensee: Interstate Nuclear Services License No.: LA110

! - Location: Santa Fe inspection Type: Unannounced, Special License Type: Nuclear Lacndry Priority: 2

. Inspection Date: 03/28/96 - 04/01/96 Inspector: ML/WM/WF Comments:

a) Effluent levels (quantities released to sewer and air) not addressed in inspection report or cover letter. Processes for handling effluents are described.

b) Good to conduct late-shift inspection.

c) This was the most technically detailed inspection examined by the review team, and it was well documented.

J

New Mexico Final Report Page E.6 Inspection File Reviews in addition, a team member made the following inspection accompaniments as part of the -

onsite IMPEP review:

Accompaniment No.: 1

- Licensee: ProTechnics Intemational . License No.: TA172-Location: Albuquerque _. _

inspection Type: Unannounced, Routine License Type:- Manufacturing and Distribution - Priority: 1 Inspection Date:- 06/16/97.- Inspector: JAM Comments:

a) . -_ Missed opportunities to interview personnel using RAM and ancillary personnel.

- b) No wipe tests taken although potential for contamination existed.

Accompaniment No.: 2 Licensee: St. Joseph Hospital . License No.: Ml210 Location: Albuquerque inspection Type: Unannounced. Routine License Type: Brachytherapy Priority: 2 Inspection Date: 06/17/97 Inspector: ML g _ Comments:

a) Inspector was not sufficiently trained in brachytherapy. _ _

b) Therapies in progress were not observed (LDR, eye plaque, Ir-192 ribbons).

c)  : Missed opportunities to interview therapy technologists and ancillary personnel.

d)- Exit interview not with appropriate level of management.

Accompaniment No.: 3 _

Licensee: Atomicinspection Labs,Inc. License No.: IR022 Location: Albuquerque - Inspection Type: Unannounced, Routine License Type:- Industrial Radiography Priority: 1-Inspection Date: 06/18/97 Inspector: WJM

- APPENDIX F.

INCIDENT FILE REVIEWS -

File No.: 1 Licensee: ProTechnics International License No.: TA172 -

Incident ID No: NM 97-04 Location: Albuquerque Date of Event: 3/25/97 Type of Event: Contamination

~ Investigation Date: 3/26/97 Summary d incident and Final Disposition: Appiaximately 20 mci Ir-192 in oil soluble tracer and nitric acid under pressure blew lid from vial, burning and contaminating employee.

Licensee performed decontamination, notified State who had them send employee to University -

of New Mexico hospital for further decontamination and internal eve!uation in interview with review team, inspector stated he thought he remembered conducting onsite investigation the next day. Licensee sent State report with medical and radic!cgical evaluations and changes in-  !

l procedure to prevent future occurrences. Report showed no radiation limits were exceeded.

Comments:

a) Incident significant enough to require immediate onsite response with in-depth review of-circumstances, including reenactment, verification of dose calculationsiand confirmatory measurements of cleanup. Memorandum or report of results of onsite investigation never located; no record of inspector visit on licensee sign-in log ior dates -

in question.

b) incomplete documentation of State's response actions, c) No evidence State reviewed licensee's response for adequacy.

d) Not clear whether State evaluated event for possible regulatory action.

e)- No close out information or signature; no record of management involvement or review, f) Reported to NRC in quarterly report.

' New Mexico Final Report Page F.2

-Incident File Reviews  !

File No.:, 2 Licensee: NOL X NDT Services -

- License No.: IR152 -

incident ID No: NM 96 Location:- Temporary Job Site, Farmington Date of Event: 7/15/96-Type of Event: Contamination investigation Date: 7/16/96 Summary of incident and Final Disposition: Radiographer found ~35 mr/hr contamination when surveying guide tubes _with source retracted. At State's suggestion, camera was retumed to manufacturer, Industrial Nuclear Corporation (INC), a Califomia licensee. INC reported leaking source to Califomia Radiation Control Program, who reported it to NRC RIV (PNO-IV 96-040).

Cause apparently pin-hole leak in source, considered to tse one-time failure.

Comments:

a) No documentation of State's response actions; information taken from reports fumished to the State by NOL-X NDT Services, and Califomia Radiation Control Program.

._ b) No close out information or_ signature; no record of management involvement or review, c)- Incident was followed up_in September 1996 inspection.

d) -- Reported to NRC in quarterly report.

t File No.: 3 Licensee:-_ H&G Inspection Co, Inc.

License No.: IR268 incident ID No: NM 96-11 Location: Santa Fe Date of Event: Between 8/10/96 and 9/9/96 Type of Event: Possible Overexposure

- Investigation Date: 9/30/96 Summary of incident and Final Disposition: When licensee retumed dosimetry to vendor, they ,

were advised of an exposure reading of 198 rem for a radiographer. Licensee reported H immediately to State, who ordered licensee to investigate and report back. Report from licensee included two medical evaluations concluding that the exposure was not real and statement that individual was assigned 242 mem, for period.

Comments:

a) -- Significance of potentially high overexposure warranted onsite investigation by State with in-depth review of radiographsr's work schedule, comparison of dosimetry records

- with fellow workers, possible reenactment of individual's routine work habits and independent calculation of probable dose for period; no evidence State performed any independent investigation, b)- No documentation of State's response actions other than copy of letter to licensee, c) No documentation of State's evaluation of licensee's response.

d) No close-out information or signature; no record of management involvement or review.

e) - No evidence that inspector reviewed any issues concerning incident during next inspection.

I

L New Mexico Final Report Page F.3 incident File Reviews File No.: 4 3<

Licensee: Syncor,Inc.

License No.: RP261 incident ID No.: NM 95-03

- Location: Albuquerque Date of Event: 3/22/95 Type of Event: Incorrect Dose investigation Date: 3/22/95 z

Summary of incident and Final Disposition: Syncor sent hospital correct dose quantity but-wrong tagging agent (pharmaceutical). Hospital advised Syncor that patient was injected with incorrect radiopharmaceutical. Syncor reported error caused by not fn!!owing procedures and

-promised improvement.

Comments:

a)- No documentation of State's investigative or regulatory actions; no citation.

b) No documentation in file to identify person taking report from licensee; no close-out l

information or signature; no record of management involvement or review.

c)L Same ID number assigned to two different incidents (X Ray Associates).

d). ~ No documentation of State's evaluation of licensee's response, e) No evidence incident reviewed at next inspection.

File No.: 5 Licensee: Syncor, Inc.

License No.: RP261-Incident ID No.: NM 96-11 Location: Albuquerque '

Date of Event: 11/11/96

. Type of Event: Incorrect Dose Investigation Date: 11/12/96 Summary of incident and Final Disposition: Syncor sent hospital correct dose quantity tut.

wrong tagging agent (pharmaceutical). Hospital advised Syncor that patient was injected with incorrect radiopharmaceutical. Syncor reported error caused by not following procedures and promised improvement.

Comments:

< a) No documentation of State's investigative or regulatory actions, b)' No record of citation or follow through on repeated error by Syncor, c) No documentation in file to identify person taking report from licensee; no close-out information or signature; no record of management involvement or review.

d) Same ID number assigned to two different incidents (see File No. 3).

e) No documentation c1 :e's evaluation of licensee's response.

. f) No evidence incident reviewed at next inspection.

New Mexico Final Report Page F.4 incident File Reviews File No.: 6 Licensee: Halliburton License No.: WLOS7 incident ID No.: NM 95-09 Location: Russell well site, San Juan County Date of Event: 5/11/95 Type of Event: Abandoned Source Investigation Date: 5/11/95 Summary of incident and Final Disposition: Welllogging source lost and abandoned down hole. Company sent complete report to State and NRC RIV indicating they followed appropriate capping procedures; copy of plaque was included in report.

Comments:

a) No record of State's response. Only documentation of incident was licensee report tt State.

b) No documentation in ble to identify person taking report from licensee; no close-out information or signature; no record of management involvement or review, c) No documentation of State's evaluation of licensee's actions.

d) Next inspection report states that no incidents had occurred.

e) State did not report event to NRC for inclusion in NMED.

File No.: 7 Licensee: H&G Inspection Co., Inc.

License No.: IR268 Incident ID No.: NM 95-02 Location: Gas pipeline near Colorado border l Date of Event: 1/22/95 I Type of Event: IR Source Disconnect investigation Date: 2/27/95 Summary of incident and Final Disposition: Radiographer failed to annect the pigtail properly to the drive cable (human error). Licensee reported error was discovered when camera was surveyed, at which time emergency procedures were followed; RSO returned source to camera.

Exposures were reported to State.

Comments:

a) Although incident was eignificant enough to require immediate onsite response with in-uepth review of circumstances, including reenactment, verification of dose calculations, worker interviews, etc., State did not send investigator to location.

b) Documentation of State's response incomplete. License file did contain copies of two letters to licensee requesting more information along with licensee's response, but no evidence of investigation as to cause (training, inadequate procedures, etc.) and no evidence of evaluation oflicensee's response, c) Licensee not cited for event nor for late report.

d) No close-out information or signature; no record of management involvement or review, e) Incident not followed up during next inspection.

f) included in NMED.

9

_ .i.

. New Mexico Final Report- Page F.5 Incident File Reviews-File No.: ' 8 -

Licensee: University of New Mexico License No.: BM233-Incedent ID No.: NM 97-01

__ Location: Albuquerque Campus Date of Event: 2/24/g7. .

Type of Event: Lost RAM Investigation Date: Unknown _

I Summary of incident and Final Disposition: Two vials of 250 uCi each of P 32 was taken fiom the radiation safety office.' Only one vial was found in the box on receipt. Vial presumed disposed of in ordinary waste; Licensee report dated 3/12/g7 states they investigated,-

estimated probable dose, and changed procedures as corrective action.

Comments:

a) No evidence of investigative actions taken by State although review team found six

-instances of lost sources at the University during the review period.- Repeated _ instances -

of lost sources significant enough to trigger onsite investigation by State in order to evaluate licensee's radiation safety program and to determine reasons for loss of radioactive materlat b)_ No record of any contact between State and licensee other than letter report from licensee to State dated 3/12/g7.

c) Ir.apector's report for next inspection states that problem was discussed with RSO[who attributed problems to new computer system, but no citation was issued end discussion u of incident was not included in enforcement letter to licensee.

d) - No documentation in file to identify person handling report from licensee; no close- out information or signature; no record of management involvement or review, e) Reported to NRC in quarterly report.

File No.: 9-Licer.see: AGRA Earth and Environmental License No.: . DM201 incident ID No.: NM 97-03 Location: Las Cruces .

F Date of Event: 3/28/g7 Type of Event: Transportation Investiga1 ion Date: 3/28/97-

- Summary of incident and Final Disposition: Vehicle carrying boxed and secured portable moistnre den ,ity gauge was involved in serious accident in which driver wcs killed. Police arrived soon after, contacted State, and were told to secure area. State contacted licensee's Jassistant RSO and gave instructions for safely removing gauge from scene and transporting to -

licensee's facility _ for tests for damage or leakage. Licensee reported gauge was not damaged and all wipe tests were negative.

Comments:

a) No documentation of State's response actions; the only record of the incident was licensee's report to State which referred to telephone conversation at time of incident.

New Mexico Final Report Page F.6 Incident File Reviews b)- No evidence licensee's actions were verified, or that licensee's assessment of condition of gauge was evaluated, c) No documentation in file to identify persan taking report from licensee; no close-out informat!on or signature; no record of management involvement or review.

- File No.: 10 Licensee: None License No.:N/A Incident ID No.: NM 94-01 Location: New Mexico Tech University, Socorro Date of Event: B/3/94 Type of Event: Contamination -

Investigation Date: 8/3/94 Summary of incident and Final Disposition: Radioactive contamination found on bed of Tri l State Motors truck that came onto New Mexico Tech campus. University called State and was

( advised that since contamination was below DOT limits that truck driver should be advised to return to home State of Missouri.

Comments:

a) Incomplete record of State's response; in-house memorandum dated 8/4/94 does'not identify person taking report or who made decision. Some documents appeared to be missing from file, b) NRC RIV reported State kept them abreast of situation and worked closely with them, c) Although incident occurred at end of last review period, it was reported to NRC in quarterly report during this period.

W

New Mexico Final Report Page F.7 incident File Reviews File No.: 11 Licensee: ProTechnics International License No.: TA172 Incident ID No.: None Location: Albuquerque Date of Event: 9/22/94 Type of Event: Contamination Investigation Date: 9/26/94 Summary of Incident and Final Disposition: Licensee reported 100+ mci 1 131 spilled in hood during routine laboratory work. Contamination not initially noticed, but when discovered licensee reported they took corrective actions including decontamination, air samples, bioassay, dose estimates by consultant.

Comments:

a) Incident and licensee's delay in reporting significant enough to require immediate orisite response with in depth review of circumstances, including reenactment, verification of dose calculations and confirmatory measurements of cleanup. State did not go to facility until 3 months later on routine inspection.

o) Only documentation of incident is memo to file after telephone call which does not I contain names and shows spill as 100 uCl, contrcy to licensee's report of 100 mCl.

c) No evidence State reviewed licensee's response for adequacy.

d) Licensee not cited for events causing incident nor for late reporting.

e) No closc<out information or signature; no record of management involvement or review.

f) Not reponed to NRC.

1

y - ___ . - _ _ _ _ _ _ - _ _ _ . _ _ . _

. s. StatecfN:w Mexico

( )t ENVIRONhiENTDEPARThfENT '

] Harold Runnels Building

.'* 1190 St. Francis Drive, P.O. Drawer 26110 Santa Fe,New Mexico 87602 0110 M M E.M DDLER (605) 827 2855 ucmrar CARYL JOHNSON covanNos Fax:(605)8272836 October 10,1997 Mr. Richard Bangart, Director Office ofState Programs 6

U.S. Nuclear Regulatory Commission M

Washington, D.C. 20555 7.

o a r.n

.c u Re: On Site IMPEP Review New Mexico, July 14-18,1997

s 9

State Program Response to DraA Report U

cn

Dear Mr. Bangart:

he New Mexico Radiation Control Program (RCP) thanks the IMPEP team for their preliminary fmdings for consideration to the Management Review Board (MRB). In addition to the information provided by Benito J. Garcia in his letter to Richard Bangart, dated July 28,1997, below is our esponse keyed to the review team's findings, t vuestions, and recommendations. Our focus is on fmdings requiring action by the State. We submit that we comprehend the new emphasis the review team believes our efforts should have. We can show that we are deliberately on that path. Probation is not wananted, especially in comparison to issues arising in cases of other state programs.

1.

The review team recommends that the nuclear pharmacy inspection frequency be modified from 2 yean to 1 year. (Section 3.1) -

4

Response

As Attachment 1 indicates, the RCP has increased the inspection frequency for nuclear pharmacies to annually, ne two-year inspection fr%uency being used previously was based on a frequency recommended in an out-dated copy ofIMC 2800 which we believed to be current.

De RCP has centralized the IMCs in a file which will be maintained by a technical staff person assigned by the RCP Program Manager.

2. De review team recommends that initial inspections ofnew licensees be performed within 6 months aAer license issuance or within six months aRer the licensee's receipt of material and commencement of operations, consistent with IMC 2800. (Section 3.1)

Response

The Bureau Chief, who signs newly issued, fint time licenses, now has a hard copy file for new licenses in his office and will track new license inspections on a six month basis. Also, the RCP Program Manager has established a tickler Sie and will prompt inspectors to inspections conting due during a two-month block at least a month in advance. The computer database used by

, , 2, ,, , ,s

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1 ~

2

e 4 Mr. Bangart October 10,1997 Page 2 the RCP will likewise flag newly issued licenses which need to be inspected within the first six months. Additionally, a standard condition has been added to the RCP list of standard conditions to be inserted in newly issued licenses instructing licensee to notify the RCP within ten days after receipt oflicensed material.

3.

De review team recommends that the tracking system be revised to allow initial inspections to be readily identified to staff and management. (Section 3.1)

Response

See Response No. 2, above. Also, the computer printouts of licensees showing inspections coming due will be generated by an assigned technical staff person during the last week of every month and a copy will be delivered to the Program Manager, the Bureau Chief, and all inspection staff. De Program Manager shall insure that the staff person responsible for the appropriate geographical area of the state completes any due or overdue inspection. De Bureau Chief will be respon:ible for notifying the Program Manager in writing of any initial inspections due for first time Ucmsees still held on file at the end of the first six month period.

4.

The review team recommends the number of reciprocity laa:=+!ons be increased to better evaluate the health and safety implications of out of state w-ysios working in New Mexico.

(Section 3.1)

Response

When the 3-day noti 5 cation is received of an out of-state licensee's I-rs; ling entry -

into the state, the RCP Program Manager will make a duplicate copy of the noti 5 cation form and deliver it to the assigned inspector. Our goal is to make every reasonable attempt to conduct an unannounced inspection of at least 50% of the Priority I and Priority 2 rwir..cel licensees. If F

unannounced inspections are not possible because directions for locating the licensee's activity are -

needed, documented phone calls will be made to obtain directions or to coordinate meeting up and uccompany visits to the 5 eld site. If RCP staff workload, staffunavailability or other condderations do not allow for inspections ofidy..cel limaaan in field locations, the RCP Program Manager will write onto the noti 5 cation form why an inspection was not conducted. A new master reciprocity inspection Sie has been created and will be maintainad by the Program Manager in Santa Fe.

Rev.y. cel license inspections will be coordiantad with already pending routine inspections of state li-- to innvirni= use ofin-etate travel fkmding. Since the IMPEP review, three Priority I and 2.dy. cal licensees have been inspected at their temporary field sites in southeast New Mexico.

5.

The review team recommends that the state maintain the RCP stafEng level to at least the .

level which existed throughout the review period. (Section 3.2)

Respone:

As ve6 ally committed by Secretary Weidler at the IMPEP team outbrief on July 18, 199;, the two Environmental Specialist positions vacated since the IMPEP review have been approved for hire and have been advertised for applicant interviews. The positions will be 511ed

)..., .. . . . .

~

Mr. Bangart October 10,1997 Page 3 '

following the interview process. Based on past experience, the new personnel will require extensive specialized training to be able to Ametion independently a fully pro 8cient staff. Prompt, appropriate training may need to be provided or supplemented through the NRC State Agreement Program (Attachment 2).

6. The review team recommends training for RCP personnel in the areas of medical brachytherapy and irradiator technology. (Section 3.2)

Response

The Program Manager has arranged with Dr. Tom Kirby, Medical Physicist at the University of New Mexico Cancer Treatment Center, for him to provide brachytherapy training to RCP staff on October 14,1997, with refkesher training thereaAer annually (Attachment 3). There are currently brachytherapy programs at four hospitals in the state.

Paul Ripley, RSO at Ethicon EndoSurgery's 5 million curie Co.60 irradiator in Albuquerque, has approved RCP staff attendance at pool irradiator training to be offered by Nordion sometime in November,1997. This training will be updated on an annual basis (Attachment 4). There are currently two pool irradiators in the state: the one at Ethicon and a 20,000 curie Co.60 model used for instructional and research purposes at the University of New Mexico School of Medicine, i 7.

The review team recommends that the RCP develop a formatirart training program comparable to IMC 1246, " Formal Quali6 cation Programs in the Nuclear Material Safety and Safeguard Program Area."(Section 3.2)

Response

The RCP Program Manager is developing an explicit formativM training program comparable to IMC 1246. The developed program will be submitted to the Bureau Chief by the Program Manager for review and approval. Current RCP Amding does not support out-of-state training. Once again, the New Mexico RCP requests assistance Dom NRC for newly hired staff.

Justi5 cation for this assistance will be L0 swig in an ofEclal request to NRC. Regardless of the availability of formativM training assistance, the RCP will continue to expend in-house had on-the-job training and obtain training Bom the private sector and other state institutions.

8.-- he review team suggests that compl63 h=aa+=tian oflicanas reviewer's actions be entered and maintained in license files. (Section 3.2)

Response: The RCP Program Manager is h.lvyLg standard operational procedures to assure that all calls, letters, and supplesnental information generated dwing license review and amendment are documented in the license file (Attachment 5). The final SOPS will be provided to the Bureau Chief for review and approval. Since the IMPEP review, all files have been returned _ to the centralized Santa Fe RCP ofEce. The iisyeitance of documentation for every action taken by staff

4 Mr. Bangstt October 10,1997 Page 4 l

in response to licenseos' requests has been discussed at RCP staff meetings. A telephone log sheej

- (Attaebment 12) has been inserted at the front of every license folder for documenting conversations. All requests for additional material from licensees will henceforth be in wMas The  ;

' RCP license review form (Attachment 5) has been modified to permit greater detail.

9. The review team recommends that the state inspectors make observations of licensee-operations or demonstrations during all inspections. (Section 3 A) 1 Response: New inspection forms incorporate routine review of operations or observation of l

demonstrations (Attachment 6). The Program Manager and Bureau Chief have begun more  ;

frequent accoir.yealments ofinspection staff and will continue to do so. One such =sstaniment has been conducted by the Bureau Chief and one RCP inspector u a training exercise which included a radiographer field site operational inspection. The Program Manager has accompanied an le==*w on another training inspection for a research and development laboratory licensee which included the observation of the use and disposal of material and the safety practices involved. The __

" Standard Operating Procedures Manual for License in.,-* ions" has been revised (Attachment 7),

and a copy has been delivered to each staff member. The i gnance of performance-based inspections has been discussed at RCP staff meetings and inspection forms have been finalized reflecting performance-based inspections. The imanence ofinterviews with workers, independent measurernents, status of previous violations, and the saha-= ofdiscussions during exit interviews with management are reflected in the newly revised inspection report forms. With the relocation of -

all but one inspector to the central RCP office in Santa Fe, the Program Manager will now be able to discuss inspections face-to face with inspectors and thereby will be able to ascertain what was found and what additional factors need to be addressed. The one non-central inspector will personally bring all inspection fanns to the central office and discuss Wi=== with the Program Manager as inspections are accomplished. The New Mexico RCP submits it should be noted that .

with the exception of one inspector, all laWon staff attended the U.S. NRC sponsored

" Inspection Procedures Course" prior to the advent ofperformance-based inspection guidelines and not since. Before our first IMPEP review this July, RCP inspectors have never in the past been criticized for the type ofinspections they were conducting.

- 10. i The review team recommends that the state inspectors conduct independent measurements at allinspections. (Section 3.4)

Response: The i.pn.uce of taking independent measurements on all i=--* ions has been  :

discussed at staffmeetings since the IMPEP review. Ins;*: tion SOP documents have been changed to reflect the procedures for conducting independent measurements with portable survey instruments i and for obtaining laboratory samples when it is deemed necessary as part of the inspection.

r,.,,, vy--, - , , , . - --m-. , , . . , ,c -w-,,----a, -= mm m .. w .,m e , w ,.m-4%,_..c~.-,e.re.nm ++w,----n

4 4

i Mr.Bangart October 10,1997 Page$ ,

, 11. The review team recommends that the state increase the rigor of reviewing technical healt physics issues during inspections, and increase the breadth and scope ofinspections. (Section 3.4) '

Response: Inspection forms and Inspection Guidance Documents (Attaebaseats 6 & 7) have been revised to broaden the scope of scheduled inspections. The revised forms and guidance documents have been and will continue to be discussed at staff meetings. The Program Manager 4 will, by written memo, report to the Bureau Chief aRer each training session which forms and topics have been covered during the training sessions.

' 12. The review team suggests that the state inspectors httempt to interview ancillary workers during inspections. (Section 3.4)

Response: De Program Manager has emphasized the ig.imi .w of ancillary worker interviews during inspection as per the SOP on General Provisions for Inspection Procedures (Attachment 7).  ;

The provisions of Subpart 10, Section 1005, of the New Mexico Radiation Protection Regulations,  :

pertaining to consultation with workers during inspections have been discussed during staNmeetmgs and included u an item for the monthly staNtraining meetings, f

13. The review team recommends that the state inspectors attempt to conduct formal exit meetings with senior licensee management on all inspections. (Section 3.4) '

f

! Response: - 1aWon forms and inspection guidance documets have been changed to indicate

, that "the closcout conference abould be held with the licensee's highest level of management available," and that " inspectors should always contact upper management upon staring a facility." f The importance of following-up with upper management, even if unavailable at time of'a==+ ion, .

has been stressed at staNmeetings.

14. The review team rammmends that the state develop a formal process for reviewing and closing out for scheduled follow-up, all licensee responses to desciency letters. (Section 3.4) 4 Response: De Program Manager has implemented a response tracking system using a period timed tickler Sie to be maintained by the 7. , Manager. The RCP Program Manager (initially) and the Bureau Chief will sign oNon the adequacy oflicenses response. Requests for additional information are always in writing, with copies of all correspondence to be placed in each licensee's l

2 folder. Failure to respond to letters of de6ciency within the response period, is pursued by enforcement action as per the " Guidance and Policy for Escalated Enforcement Action" (Attachment 3). A form (Attaebment 3-B) has been developed to track inspection follow up activities, j

r

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l Mr. Bangart October 10,1997 Page 6 15.

The review team suggests thet the state develop a formal process for inspectors and license reviewers to document and transmit pertinent information to each other for respective follow up.

(Section 3.4)

Response:- - Weekly staffmeednas now include discussion of the previous week's activities.' The Program Manager and inspectors can routinely discuss and timely identify information resulting from previous week's inspection efforts. Any need for remaining documentation needs will be satis 6ed in writing, and the Program Manager will reiterate what is rieeded by E Mail to the inspector.

16.

De review team suggests that the state develop a process for ensuring that inspection files are complete, that all appmpriate state documents are prepared and Sled, and that licensee r==paam are received and filed. (Section 3.4)

Response

Accordingly, each inspector is responsible for ensuring that all their inspection files are complete, that all check list items are fully answered, and that responses to letters of violation are received. The adequacy of responses is re' viewed and approved by both the Program Manager in writing. Letters in reply to licensee responses are signed by the Program Manager, ne Program Manager reviews license files each time " circle of correspondence" is completed pertaining to licensing actions, inspections, and incidents.

17.

The review team recommends that the state begin documenting all trips to licensees' and applicants' facilities when inspecting licensed activities, performing special inspections, and performing pre licensing site visits during constmetion. (Section 3.4)

Response

The significance of documentation has been discussed at RCP staff meetings. All information gained through trips to licensed facilities will be documented in memoranda to file reviewed and approved by the RCP Program Manager.-

13.

_ ne review team recomcands that management exercise more stringent supervisory reviev' ofinspection reports. (Section 3.4)

Response

By relocating all but one of the RCP inspectors to the osotral of5ce in Santa Fe, inspection reports will not accumulate in Sold of5ces without management review. _The RCP

- Program Manager now reviews inspector field notes and inspection reports, and the Program '

Manager reviews licensee responses to violation notices. De Program Manager's written review and approval are entered into the licensee's file.

4

0 Mr. Bangart October 10,1997 Page 7

19. -

The review team suggests that the state complete its revision of the inspection report forms, ensuring that each set of forms covers all key areas for the type oflicensee being inspected, and that RCP inspectors begin using the standardized form (s). (Section 3.4)

Response: New inspection report forms are in Attachment 6. Copies have been distributed to staff and are in use. Staff have been instructed on how inspection forms are to be completed, and the importance of completeness.

20. The review team recommends that the state make onsite, documented investigations of incidents, allegations, or misadministrations with potential health and safety effects (e.g., source disconnects, possible overexposures, lost sources, contamination). (Section 3.5)

Response: Revised guidance documents are in Attachments 9 & 10. Copies have been distributed to staff and are in use. Staff have been instructed on the contents of the incident response documents and incidents and allegations is an agenda item for monthly staff training meetings.

21. The twiew team recommends that the state create an incident and allegation reporting form that would, at a minimum, identify the person taking the initial report, list the name and telephone number of the reporting part", provide the details of the incident or allegation as reported, record the State's conversation with the licensee or individual, describe corrective actions taken by the licensee, describe the investigation conducted by the State and the results, list citations or other regulatory actions, show the date the investigation was closed out and justification for closure, show date(s) incident was reported to the NRC or other agencies, and prmide spaces for the signatures of the investigator and supervisor. A copy of the form should be maintained in the incident Sie and in the license file. (Section 3.5)

Response: This suggestion is the summary and at the heart of the review team's findings and its overall recommendation that the RCP be given probationary status by the MP". We believe that the state progrcm provides excellent public health and safety protection. We acknowledge, however, that our concentration on file building and attention to the relatively new (at least new since cur last NRC program rwiew) implementation approach encouraged by IMPEP has been less than focused.

Of course we have excuses, including a two year long license renewal proceeding full of public controversy and our own on going investigation and administrative hearing preparation.

Nonetheless, we recognize the significant improvement our program implemmtation will realize by adjusting our approach. We are dedicated to it. We shall do it without probation. New incident and allegation report forms are in Attachment 11. Guidance document procedures have been developed for incident and for allegation investigations (Attachments 9 & 10). Copies have been disaibuted to staff and are in use. Finally, on September 16,1997, Mr. Sam Pettijohn of the NRC trained New Mexico, Colondo, and Arizona Radiation Control Program Staffin use of new NMED software to track data intemally and forward data to the NRC.

i Mr Bangart ~

October 10,1997 '

Page 8 ,

i-1

22. _ ne review team recommends that the state establish a protocol for making independent '

j investigations and evaluations of the licensee's actions. (Section 3.5) l Response:- - Attaebment 7 contains the protocol to be followed for making independent investigations and evaluating the licensee's actions. The protocol has been distributed to staff and is in use.

I

23. The review team recommends that the state initiate procedures to ensure incidents are

!' followed up at the next inspection to verify that the licensee's conective actions have been

- implemented. (Section 3.5) ,

I

Response

A separate section entitled "lacidents/ Reports" has been incorporated into inspection  ;

forms which provides for listing information on types ofincidents that occur aAer the last inspection, ,

3 including noti 5 cation reports and corrective actions, ne importance of completing this section has i been emphasized in staff meetings and inspection reviews by management. His will also be an

, agenda item at monthly staff training sessions.

L

24. De review team suggests that when evaluating incidents, the state include citations to l'

! appropnate regulatory authority (when applicable). (Section 3.$)

a ,

Response: . In the past, the RCP has handled some deSciency notices verbally. De routine now l requires Notice of De6ciency letters in all cases where a t. k&m of procedures occurred or may

!. have occuned to cause a reportable incident. Interviews with licensee management are conducted to discuss cause ofincident, consequences and conective actions taken. '

25. De review team rwamm-la that the state: (a) set up a separate incident and allegation file system in the Santa Fe oEce so that all daan= ants and records pertaining to an incident are available

} in one location, with the data cross-referenced to license and inspection Ales osotrally and in the '

i Albuquerque oEce, and (b) establish a system to osotrally log and track the progress ofincidents - 1 l and allegations. (Section 3.5) '

e Response
- ne incident and allegation Ales have been moved Aom the Albuquerque osce to the Santa Fe oEce. A new Incident / Allegation N4He has been developed, as well as a new

, Incident / Allegation Report Fonn (Attachament 11). De NMED database is now utilized to track  :

allincidents and allegations and to forward tN data to the NRC. A chronology Ale (hard copy)is also kept in the Santa Fe oEce, and a tit.2er Sle has been established to_ track the progress of incidents and allegations and prompt follow up. The Program Manager is responsible for this tracking system.

4 d

0 Mr. Bangart October 10,1997 Page 9

- 26. De review team recommends that the state develop and implement written procedures for reponding to events involving radioactive material and conduct training sessions until all staff are fully trained and qualified in emergency response. (Section 3.5)

Response: _ Written procedures are in place for responding to events involving radioactive material and staff has boon instructed in their use. De RCP staff are not tasked with first responder duties but program staff have participated in various emergency response exercises, including the week long DOE-sponsored " Digit Pace II" exercise in May 1997. Additional emergency response training is being sought.

27. De review team suggesta that the state keg merc4 ire the allegation procedures to include procedures for notifying the person making the allegation of the results of the investigation and including the allegation in the event reporting form, tracking system, and emergency response procedures. (Section 3.5)

Response: A new guidance document is in Attachment 10. Copies have been distributed and are in use by staff. Allegations will be tracked by the Program Manager and entered into the NMED database as ifit were a reportable incident. Response deadlines and next inspection prompts are tracked.

28.

The review team recommends that the state expedite promulgation of the compatibility.

related regulations now overdue and those which are due within the next 12 months. (Section 4.1.2)

Response

A. De RCP requested a meeting of the Radiation Technical Advisory Council (RTAC). The RTAC met on September 24,1997 to entertain the RCP request to forward to the Environmental improvement Board (EIB) the recommendation to promulgate NRC regulations needed from a I

compatibility standpoint, The RTAC took action on the two most critical compatibility regulations and withbeid action on the others until a ibture meeting. De RCP will request a hearing fkom the EIB as soon as the.RTAC formally submits the recommendation on the two compatibility regulations and will request another meeting of the RTAC to consider the remaining compatibility regulation requirements by the end of 1997. Subpart 3, Section 311. O.4.a. through d. (pages 3-32 through 3-33) of 20 NMAC 3.1 aheady =*ains the compatibility language for " Decommissioning Recordkeeping and License Termination; Documentation Additions" as adopted by the New Mexico EIB, April 3,1995, effective May 3,1995. De additional ecc.e atibility language from the Federal Register (61 FR 24669) was approved by the RTAC for inclusion under Subpart 3, Section 311.0 (page 3 32) 20 NMAC 3.1 by the Environmental Improvement Board.

=

O e

Mr. Bugart October 10,1997 Page 10 B. "Self Guarantee as an Additional Financial Mecharasm",10 CFR Parts 30,40, and 70 l amendments (58 FR 68726 and 59 FR 1618) that became effective on January 28,1994, and which l became due on January 28,1997 was also approved by the RTAC at the September 24,1997 meeting  !

for inclusion in Subpart 4,20 NMAC 3.1 by the Environmental Improvement Board, i C. Work has begun on inserting language for the following additional amendments to the New Mexico Radiation Protection Regulations. Once the insertions have been made, the amended regulations will be taken before the RTAC for approval and recommendations prior to tubmittal to the Environmental Impmvement Board. (These will be proposed for adoption no later than May 1998):

(1) " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40 and 70 amendments; (2) " Preparation, Transfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32, and 35 amendments; (3) " Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR parts 20 and 61 amendments, t

(4) " Frequency ofMedical Examinations for Use ofRespiratory Protection Equipment," 10 CFR Part 20 amendments; (5) " Radiation Pmtection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 and 20 amendments; (6) " Medical Ad=ial*ation ofRadiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments; (7) " Clarification for Decomminaioning Funding Requirunents," 10 CFR Parts 30,40, and 70 amendments; 4

(8) " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment;

, and (9) " Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR Parts 20 and 30 amendments.

29. The review team suggests that a file be maintained with the cover letters and ensuing correspondence of all draft or final regulations sent to the NRC. (Section 4.1.2) 4 l

[

Mr. Bangart October 10,1997 Page11

Response

All regulation promulgation and NRC approval correspondence is now kept in discrete files for easy access. l in closing, we ask that the MRB take account of our struggles, recognize our improvements, and ovemde the review team's recommendation for a period ofprobation. New Mexico's RCP will work 1 diligently and in concert with the NRC to make any beneficial changes needed to improve the RCP.

Resp >

ar E. er, Secretary New Mexico Environment Department ec: Maul H. Lohaus, OfBee of State Programs, U.S. NRC Jim Lynch, State Agreements Program, U.S. NRC, Region III

LIST OF ATTACHMENTS l

Attachment 1: . Schedule ofinspections  ?

Attehrnard 2: Vacancy Ah #::1 x-;-Personnel Anr-acama=*a  !

l Not Available As OF October 10,1997 Attachraani 3: Brachytherapy Ceirse Outline l

Attachment 4: Irradiator Safety Training Awh===* 5: -Pih ForIJcensing ActionvNew Ucenses j Evaluation Form Attachment 6A: -General faaa-*lon Report Form Instructions For Inspection And Preparation Of General la==*Jon Report Attachment 6B: -Medical Lwpection Form *

-Instruchons For Medical Inspection Report F

Attachment 6C: -Density / Moisture Gauge Inspection Form ~

Instructions For Portable Gauge la==*Jon t%eMie Portable Gauge Inspection Checklist 4

-Portable GaugeInspection By Mail l Attachment 6D: Industrial Radiography Inspection Form Instructions In Preparation For Industrial Radiography lamaae+jon Report

-Industrial Radiography Field Site Inspection Report Attachment 7: -Ir* Mon Procedures

. Attachment SA: -Enforcement Procedures -

i Attachment SB: -Follow-up OnInspection Letter Attachment 9: Standard Operating Procedure For Response To Incident Involving Radioactive Materials

-Incident Investigation Procedures

-Incident Reporting System / Abnormal Occurrence Criteria 4

Attaclament 10: Allegation Response Guidance Document (being developed, to be presented to MRB on October 23,1997) -

1 Attachment 11: -Incident Report For Radioactive Material Ucensees Attachment 12: -Telephoneleg v.,,,~~ .- ,...---n .,-a.--- , - . . . -,-].,, - - , . , , - . . - - , - , , . - , - . - . , , , -,,---,--,-__n,,-.. - - , .. ,,,, r..n.-,. ., . _ ,,

1 ATTACHMENT 1 SCHEDULE OFINSPECTIONS 4

SCHEDULE OFINSPECTIONS Priority Type ofLicase Subsequent inspection

1. Broad License, Type B, Field ladustrialRadiographers,laplant 1 Year Industrial Radiographers, Radio-pharmacies, Genuna Irradiators.

Well Logging Tagging Operations.

(BM,IR, RP, GI, TA).

2. Broad 13cese, Type B or C, Industrial with Multicurie Sources or Unsealed, except Gauge Licenses. 2 Years Medical Institutional with Therapy, Generator or Airborne Sources.

(BB, MI, GL, WL).

l 2. Academic SpeciSc, Industrial Gauge s Licenses, Industrial, Curie or Less Sealed Sources, Medical Institution, Medical 2 Ya rs Private P setice. MedicalIn Vitro Only, Research & Development.

(AC, DM, MD PP, RD)

3. Industdal Calibration Sonicos, Gas Chromatograph, Laboratory Analysis with Microcurie Sources. Storage Only. Depleted 3 Years Uranium. Fixed Gauges, Bone Analyzer, Transportation Waste, Paint Analyzer, Eye.

Applicator Sr 90).

- (AN, GC, IX, GA, DU, SO, PA, MA, TW, BA)_

AC Academic GI GammaIrradiator RD Research & Development AN Lab. Analysis GL General License RP Radiopharmacy BB Broad Type B IR Indust. Radiography SO Storage Only BM Broad Medical IX lon Exchange TA Tagging CS Calibration Service IV In Vitro TW- Transportation / Waste DM Density / Moisture LA 1.aundry VT Veterinarian Gauge MA Bene M Analyzer WL Well14gging DU Depleted Uranium MD Medical Doctor-PP -

GA Gauge MI MedicalInstitution GC Gas Chromatography PA- Paint Analyser 1

6 k

ATTACHMENT 2 VACANCY ADVERTISEMENT-PERSONNEL ANNOUNCEMENTS NOT AVAILABLE AS OF OCTOBER 10,1997

l l

F:sf

rr4 l

,$I ATTACHMENT 3 BRACHYTHERAPY COURSE OUTLINE 9

-- - moucau o. emmes v.= esim =is=6o6G ~w Gce R$ nA$d~~~

FAX l Date: Friday, September 20,1997 Tirne: 8.24:17 AM 3 Pages To: Mr. Bill Floyd From: Thomas H. Kirby, Ph.D.  !

, Hr2ardous / Radioactive Materials Bureau UNM CRTC Medical Physics i

Fax: ,1,5058271544 Fax: (505)2724 973 Volos: Volos: (505) 272-4986 E

Commetyts:

Mr. Floyd, Sorry for the delay. I have been working on this at home and did not have the latest outline at work. Although the sequence and toples are a little dl*ferent than what you forwarded, the materialis about the same. We can adapt it sa needed. I will fax my resume in a few minutes.

Tom Kirby Pager: 768-9422

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Brachytherapy omrvienfor State Nudeer Mderid Irmpeders October 14,1Pg7 Course Droctor.

Thomas Nrb/, Ph.D., CNef Physicist and Assodde Prdsesor Cancer Research and Treement Center The Uriverotty W New Medeo Health Sdences Center

1. SchacMe a- 09.00- 09 30 Fad!rty tour
b. 09.30 10.r10 Intrcducticn
c. 10.00 1030 Appicable regtjations d 10.30 11:00 Radoedive sources usedin bns:hytherapy
e. 11:00 11:30 Handing and sWety
f. 11:30 1230 Lunch and docussion g 1230- 13:30 Loadone rate procedures
h. 13.30 - 14:30 Hgh dose rate procedures
1. 14:30 15:00 Rooords and reporting procedures J. 15:00 15.30 Wrap and docussion 2 Intrcduction a Defiritions b PhysicW lams a#icable to brachytherapy
c. Uses d brachytherap/ in cancer treatments d Typcai procedures
3. Applicable reptistions and trairing a Federa': 10CFR Parts 20 and 35
b. State d NowMedco
c. Universtty d NeNMedeo d Certrfication and trairing d Medcel Ph#dsto
4. Radonctive sources uwd in brachytherapy a Suppiers
b. Calibration and source strength specification
c. Types d sources andisotopes used
5. Handing and safety d sources a Source handirg dstance, sNeidng and tirne
b. Ghipping and rocsiving sources
c. Leaktesting l d Storage d permanent and temporary irtwntory i
e. Record keepng i f. Transport from storage area to patient rooms l 6. Londose rate procedures I a Gyn treatments *Cs tubes, *lr treatments
b. Vdumelm# ants
c. End Aie schiW procedures A\ Brachy course outline.vpd Se# ember 26,1997 .

a m e ,. m m Ws enim Wi h n ,=, ,

ses %. w a==emm=

d Personnel protection

e. Patient surwys andirwentorycontrd
f. RestHeted -

g Emergency procodres

7. Hgh dose rate procodres a QAfor sourcerapiscoment
b. MontNy CA
c. Trestrnerk QA '

d Procodres

e. Emergency procedres
8. Records and Repcdre a Quarterlytruri.ory and surwy b Radmotinmeteriads trerufer record
c. IrW'contrd for patient treatments
d. Source strength records a Calibratien and survey ineNmentation rooords A\Bixhy course outline.v9d September 26,1997

w mua u_2__ coa wce i l

SUMN%RY OF QUAUFICATIONS Thomas H. Nrty, PttD.

Decernber,1994 AcaduTiq casitions' Research Aesodate Professor at University of New Modoo Hostth Sdence Center Assists 1t Prdessor at University d New Modoo Medcal School (6 years)

Assistant Prdessor at Lodelana State University Medcol School (2 years)

Instructor at Unbr. Tees Houston Graduate Schod of Somedesi Sdences (6 years)

Edacation Ph D. In 1980 (Bomedcol Sdences) University of Tees at Houston M S.1975 (Physics) MempNs State Unrversity B A 1973 (Physics and Mathematics) Southern Illinois Universtty Teachino / educational arr=4 Mvitv. .

Instructor for 3 courses at UNM (RTT 350, 300, 370) i to 3 semester hours. 11 ful acaderric courses at various levels from RTT schod to reduste level (most of them mJtipe years) at dfferer:t uriversities, indud ng Abb u ivoir lab and lecture, General ph)eics lectures and labs, RTT physics, Sdid state physics, Doolmetry, Bootremagnetic theory, Rectchaogy. I cAJoped the course currieda for most of these ocurses. All vare regdarty schedded courses for academic credt, mostly 2 to 4 semester hours. The number of students vwied from 4 to 30.

Schdarshio / Research / Creative verk

1) Author or co author d 10 reiereed published scientific artides
2) Irwited speaker twice for nationsi redoN courses
3) Author or co author for 18 national presentations and abstracts
4) Author or ex> author for 5 refereed techrid reports
5) Two papers sutxtrtted for publication
6) Numerous crher presentations and lectures for state or local organtzstions
7) Copas d several papers are induded in the packet which are representative d my research interests irt Imadng. Friethc.4 used to review dosimetry of national dinical trials, and basic physical mewurements related to redsticri therapy.
8) Member d, or consuttant for 4 national sdentific task youps (1 current)
9) Member of 7 cm a ritiees for nationsi radotherapy dirical trisi youps
10) Prindpal or cx>4rwestigator for 3 research grart5
11) Chain non of 1 naconal sdentific task group (current)
12) American Bouro d Raddogy certified in Therapeutic Raddodesi Physics
13) ReAeusr for Medeal Pnymics (peer reAemed sciersficjoumal of AAPM)
14) Member d national sdentific csv.Jdoe (currently in 2nd three year term) 1 of 2 pages

-La--m wn. ames' aus = = esenw oi====,ame======= n==, e=s.:aw pa==.e -a.wr me Thames H. Nrtsy, Ph.D.

amMan and Achinistrean

1) CNet phye!det, Ut44 Cancer Reneerch ard Trastnant Center (6 years).

Responelt2 ties indude dwelopment ud implementdan of new radotherapy techniques, doelmstry and treatment #anning, adrinistration cf phpics section (8 enydayees),-

teacNng endneering cpsitty assurance, etc. The physics section has the general responalbility for treatment #anning and cpsitty assuranos cf raddon therapy treatments, mooNne mairtanunce, tesoNng RTT students, cpulity assurwies and resserch and dwesopment, etc.

2) Phpicist at M.D. Anderson Cancer Center, Houston (8 yess). Duties included dwelcpment and implementdan of rm4ews for ndensi diniced trids, temoNng in ym*
  • and RTT schocis, supervision d peduste students.
3) CNef Physicist, Chartty Hosptad in New oriaans. RougNy the same chties as at Uf44, but included superv6sion W RTT personnel.
4) Judge for New Madoo Hgh School Swi Ang Challenge (last 5 years).
5) CQI coordnetor for Redation Onodogy I
6) Lacturw for Nuclear Endneering Department's Ngh school teacher science sympania
7) Participated in amord redation treatments W arimals for concer in oorjunction ydth arenveterinarians.
8) Assisted in organizing nationd AAPM tmeting (1982).
9) Served as scientific session chair at sword national meetings.
10) Orgentzed two nabonsi / intomational vertshops.
11) UNM HSC RTT currictAurn committee member
12) Addsor or member W 8 yaduate student superMacry committees.  !

j Assisted swaral other paduate/ i --M-A .; students from Uf44 and Los Aamas Natiensi Lab while at UNM.

14) Gracbete student liaiscm for Univ. Tess Houston Department cf Physics for sevend years. TNs facdty peeltion served as initid contact for prospective geduste students
15) Partial list of clirical redetherapy techriques domicped and impamented total tm#

photon irredstion for bone memzwtranspants; tctal sidn electron treatments for mycosis fungoides; storectactic brain implarts using redomettve seeds; l-125 sye plaque implants for octJar melanomes; high done rate aftericador brachytherupt, deterrninstion cf neutron

! w iv m.- af high energy phcton beams; edibration of neutron therapy beurra; many other routine techriques and doelmstry prooechres for redation therap/.

16) h *M 'sete site tests for Computertmed Modest Systems, Inc. redation therapf l

treatment planning systern

17) Supervisor for Hesith Careers opportunity F.,-n hi#i schad studerts for the post ,

,. 5 years. Average 2 Ngh schad students each summer whovdsh some exposure to the I health carefield l 18) Redewed veil cuer 100 radctherap/ departments for the NCl while at MCACC.

19) President, Computerized Medcod Systems, Inc. users youp.

[ 2 cf 2 pages

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- .. - -m , m a a.we-wa Thomas H Nrb/, Ph.D.

CURRICULUM VITAE A:ril,1995 Nang Dxrnas H h1rb /, PtsD.

Present TMie: CNet Pny.ddst UniversRy d NewMedeo Cancer R maarch andTreatment Corter jlED: Ncamber 10,1951

, St.LoiJs,MO Otizenshio U.S A Sodal Securttv. 350-46-3740 ,

Home Address- 5015 LXc.hiiiciit, tE AbuquerqJe, NeNMedeo 87111 (505) 271 0156 Omoe Address Radation Onoclogy Departmat Universityof NewMedeo Cancer Research and Treatment Carter 4

900 Camino de Salud, NE

, Albuquerque, NewMedoo 871315331

, (505) 277 6141 Educcon Ph.D. (1980) Biomedcad Sdenous The Unwrsity of Tees at Houston

, MS. (1975) Physics

  • Memphis State Unrversity BA (1973) Physics and Mathematics Southern Illinois Unhorsity at Caroondale Soeolatty Bearde and Ucenses' Certrfied in Therapeutic Raddopeal Physics, Arnerican Board d Raddogy (1988).

State of New Medco Ucense in Radation Safety and Radation 1 d 9 pages

m;, x ww we em. w e- me v esim = ,.:= me.n o-,= ===.we aw % -a== em ma Thanes H Nrb/, Ph.D.

Thorsp/ MacNne Ceibrabon 9

9 9

2 of 9 pages

v.: w o en w mu . o, ea Thomas H. Krb/, Ph.D.

A ' ,Je and M- - 'M A-- 4 L,- A 1989. present CNW, Physics Secean, Radation Onodogy Depstment UnNwWty d NwModoo cancer Repearch and Treatment Center Assistalt Prdessor Univendty W NouModoo Sdxd d Modoine 1986 1989; Assistant Physicist, instructor 1983 1986: Assists 1 tin Physics Department d Radation Ph>elos UnNorsity d Teen M.D. Anderson Cancer Center W Houston 1986 1989: Associate Facuty Member

! . Univendty d Tees Hesith Scionee Center at Kauston 1961-1983; Stan Cliniosi Physiciet & Constitant Pi1yaldet West Janerson Generad Hospitsi, Merrero, LA CNel Clitlical Physidst Chanty Hes#tal d Laulslana, Neu orleans, LA Assistant Prdessor l Loulelens state UdverWty Modesi Sdusal, New Orleans, LA 1980 19C1: Assist =1 tin Ph3 eles Depwtment d Radation PH)eics

Unhorsity W Tees M.D. Anderson Cancer Center at Houston

(

3 d 9 pages

=- , - .. - - - . ~ . . - -- , - - - , ,,,,,..n-.-,- , ,--.,m., , ,- , . . . . - - , , , . . - - , . , ,-._.,.,,--m---..,-.a+ -

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Thomm H. Mrby, Ph.D.

Wonal 5dentific Ccrmittesp 1990. pnseent Amerleen Association of Physics in Meddne (AAPM)

Raddon Thorspy Commmee(RTC) 1993. prunent AAPM RTC Task Group 54 (Unear Accelerator Primary / Scatter Radstion), Chairman 1989 94: AAPM RTC Task Group 46 (Unser Accelerstar Data) 1988 89. AAPM RTC Task Group 18 (Fast Neutron Danimatry) 1963 86; AAPM RTC Task Group 29 (Total Body irradation Techniques),

Cons e

]

1983 89. AAPM RTC Task Group 31 (Quainy Assuranos) i Mdanal dinical trial ma =:

1983 1986; Radation Therapy and P%m Commmtse, '

t Brain Tumor Cooperselve Group" i 1980 1986: Radetherapy Quality Contrd Subconvrvttee Southeastem Cancer Study Grouff 1967- 1989. Raddon Therapy Oncolog/ Group' 1986 1989; Member cr attomate Exmouthe Commhtee, Radation Therapy and

! Physics Comrrittee, Data Sdety and MonMoring CommRtee Celleborative ocular Melaname Study, Nationed Eye Insetute 1984-1989. Radation ThornpyCommMee, Radation Therapy Qudty Contrd Shi...im Southmet Onodog/ Group *

  • Funded bythe Ndonal Cancer Institute for nationsi diniosi trials 1988 1989. South-North Center for Hestth Studes i

4 of 9 pages E

<,-,,,---,r, r- r --.-.---.--.,----.y-. .m.,,-r.., . , , - - - - -,,-,,r--.-m,--- - , . -- .----,-,,v....,,,.4. ,.p , . - ., i ,, ---, , . ,- , - -- . , -- , - - - - - , - - .-e, c- r-

a m N E mim nw W . T..me o m ,e .cu. , ,o.=,en==

Thomas H. Nrty, Fb v.

Wcriehco Coordnator.

Laboratory Drector, "Practicei Course d PNys!-1 Dosimetriin Radatherapy for Latin Amerleen Physicists (in Spanish)", San Antorio, Touss, August 34,1988.

"Radation Therapy and Physics W Ocdar Melanomer', Cdabordve ocdar Melanoma Study Annusi Meadne, Sun Vdey, ichho,19er7.

Edtorial Ekerds:

ReAser, hiedcas Ptweios Honors and Awards:

Rosalie B. Hte Schdar, Unhwstty d Texas GSBS,1978 1980 Presidert's Schdar, Southern Illinois Un}versity,1989 1973 Soody Membershins.

i 1977- prosent American Assodation d Dtysleists in Meddne AmerloanInstitute d Ph#es 1989- present. Amortonn Soday for Therapeutic Radation Oncology 1994 - present President, Computerized Medcal Sptoms, Inc. Users Group 1988 present American;-6 t. ewers' Assodation 1978 1961: Sodety d Photographic Scientsts and Endneers Grant Sumoort 1987-1989; CA10953, Co Irweebgetor, Raddadeel Ptysics Centar ($3M) 1992 UNM Research Allocation Committe, Project WC-1041 Dwelopment d a Pamelve TNiieM implant ($1500) 5 W 9 pages

u ~~ 7 -- Lhw QLme,gst ee'ug'^^ ~

Thomas H. Mrb/, MtD.

WN Wort Ham Mannarino PrM(s21oo) l l

i 4

i

?

4

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d

'l 6 of 9 pages

gg _, , , ,,

Thomas H Mrby, Ph.D.

Courser Taucht.

1989- proport Physim I & 11, Queitty Assurance Radation Therapy Technology Prograrn Universy W New Modco School d Allied Heefth Sdences 1984- 1988 Introduction to Radation Physics, Physics for Residents in Radatherapy Department d Radation Therapy UriversMy W Tees MD. & 1erson Cancer Center 1984- 1988: Radation Therapy Physics br Technclogsts Rarf,ation Therapy Technology Program 1982- Physics for RaddogyTechridans

' Radobidog/ for Nuc. Med. Techaciadsts Lousiano State Ursvarsity Medesi Sched 1980- 1987: Atomic and Solid State Physics University W Tees Graduate School d Biomedcol Sciences 1976 - 1989; Extemel Beam Desimetry- Principles and Calibratiers Extemel Beam, Interstitial and Irvecewttery Desimetry, %>wt and Computer Methods d Calculation Danimatry d Hgh Energy Electron and Kray Therapy Machines Department d Radation Physics University W Tees M.D. Aw.cn Cancer Center 1973-75; General S u iu ny W nu y, Introchetory Physics -

Department d PN)eics, Memphis State University 1972- 73: General PWcs 1-uy -

Department d Physics, Southem lilincis University Student 9 Wsorv Comenttees and Other Rdes:

Randell Saiyer, MS., Universityd Neu Mexico, Nudeer Eng M.S. Cu . . ,1995 Cynthia Malmer, M.S., University W New Medco, Nuclear Engneering Summer Practicum in Madcol Physics 1994.

R. Cde RcNnson, MS., Uruversity d Tees GSBS, 1967- 1989, Chairman," Energy 7 W 9 pages

....s . . . .

M

u_3% w .sms=== seesaddi===eens she==== %ss ms6 hun easti ~~

i-l Thort,es H. Nrby, Ph.D.

Responso d UF TLD.100 to Hgh Energy Photons" audus suoervisorv committees and other Rdes (cont'dt i

' Pei Fong Wong, M.S., Univ, d Tees GSBS, 1985- 57,"Canpenson d Bactron Beam Depth dose and CM-eds Pronies vdth Various % in Water and Plastic" Richard Umeh, M.S.,1988, University W Tees GSBS, "Deterministion d )fersy Beam l

Quellty Changes d Unser Accelerator From ionization Measurements in Phntom" l Charles Able, M.S., University W Tees GSBS,1985 - 1957, "Evolustion d the MCAH I

Total Seelp Eactron irradation TodiniqueF David Voehringer, Summer Student,1988,"l-125 Dosimacy vdth Thin T1.D Chips"

[ Ann M. Mnter, Summer Ah r*=1t,1985, "Hgh Energy Pheten Baciecetter Factors" Doudas A Cates, Summer Student,1984, 'Tetal Body Photon irradation DesimetrV' BBUOGRAPHY A Published Rdereed Artidas:

1. Zermeno A, Nrby TH, Court R, Mush L Laser Reedout d Sectrostatic Images, l SPIE And .d Oct. Inst in Med Vll. 173:81-87,1979.

4 2 Zermano A, Marsh L, Cmmrt R, Ong P, NrtyTH: Ught Beam Res&ut d i

Bactrostatic Images, >01 Irt Cert on Madcol and Bd. Ern. Jerusalem, Isreal, i 1979.

j 3. Nrb/ TH, Zermano A Residual Potentief in ATep;,cus Selenium Phots-- -p -.,

SPIE Amd. d Oct Inst in Med 3:61 64,1980.

4

4. Gastorf RJ, Hanson WF, Berldey LW, Nrb/TH, Chu C, Shelek RJ: A Comparison
W Hgh Energy Accelerator Depth Dose Data Medcol Ptwsics. 10.881-885,1983.

i j 5. Nrby TH, Gesterf RJ, Hanson WF, Berldey LW, Gagnon WF, Hade JD, Shelek RJ: Bactron Beam Central Aids Depth-Dose Measurement's, Moded Phaics.

12 357-361,1985.

6. Nrb/ TH, Hmson WF, Gesterf RJ, Connel C, Shalek RJ: MailableTLD System i

8 d 9 pages

/

1 9

m === == v.na ==amem.e===== e eemseen m essman wm.m.a o in ne,aww u.u,r eaw js Thomas H. Nrby, Ph.D.

for Photon and Beatron Beams, Irt J. PM one. Bo. Pha 12 261-285,1985.

A Published Reformand Arti+= (cont'di:

7, Nrb /TH, Hermon WF, Cates EW Verification W Total Body Photon irredation DesimetryTechniaues Medcol Phvnics 15:364:309,1988.

t 8. Nrby TH, Henson WF, M m- Dr. Uncertainly Ansiysis d Absorbed Dose Cdculations frun Thermoluminesconos Dosimeters, Medcol Physics 31427 1434,1992.

9. Hede J, Nrby TH and Henson WF; Reedts of absorbed done measuremer:ts for TG 21 protocol, Med Phwaics (WM for oublication),1994.
10. Karleson U, Nrby TH, Orrison W and Uonberger M Ocdar Gabe Topographyin Radotherapy, int J. Rad Onc Bo PHws. (acxepted for publication),1994, i

B. layttedToms:

5

Thermduminescence DesimetrV', Physics Department, Steven F. Austin Univ.,198S.

"Radathersp/ Beam Calibration Techriques", Madcol Physics ReviewCourse, AAPM

. Annual Meetirs Detroit,1987.

"Medcol Uses of Radation" Workshop for Hgh School ScienceTeachers, University of NewMexico Nudeer ErWneering Department, Albucperque, NM, 1992-94.

C. Abstracts andTalks Presentact

1. Nrb/TH, Hanson WF: Cuvig ;.cn of Graphite end Nylon Thimtde Farmer P Chambers in the Suponmitage Repon, AAPM meelirs Temple, TX,1974.

2 Zermano A, Marsh L, Ccmart R, Ong P, Nrb/ TH. Ught Beam Reedeut of Bectrostatic Images, 201 Intemmionsi Conference on Medcol and Bdogical ErWneering, Jerusalem, Israel,1979.

3. Nrb/TH, Zermeno A: F@es of the Duodelectric Image Receptor, SPIE l Applications of Optical instrumentation in Medcine Vill Conference, Las Vegas,
  • Nevada,1980.

9 of 9 pages i

+

e - - n - - - . , -. -,

en,, .w A weeenmen Easim.= Eisi.4aGIG= C weu A c.an^ ..,

i Thomas H Nrb /, Ph.D.

4. Kirb/ TH, Gasterf RJ, Hanson WF, Shalek RJ, Hade JD Sectron Beam Central Axis Depth-Dese Measurements, Moded Physics 11:399,1984.

4 3 C ekstracts andTalks Presorted(cont'd):

j 5. Nrb/ TH, Chu CH, Gastorf RJ, Hanson WF, Shalek RJ: Mailed TLD Sptern for Meritoring Output of Beatron ProdLxing MacNnes, Med Physics 11:405,1984.

6. ReddoWcal Physics Center: Research Activities of the RaddoWesi Physics Center, Scientific Exhitit. FYoosedngs of the Inter-Arnencen Meeting of Modemi Physics, Chicago, IL,1984.

1

7. Task Group 29, Radation Therapy Commhtee of the American Association cf

, Physidets in Meddre Physiced Aspects cf Total and Half Body Photon irradation.

, 8. Nrby TH, l L -on WF, Cates DA Tctal Bod/Irradation Dosimetry Modcel Physics 12523,1985.

l

9. Smrth SA Hddgo-Salvatierra 0, Mrb/TH Energy Response and Fadng Characteristics of Different Batches of UF-TLD. Medcal Physics 12543,1965.

. 10. Hade JD, Hanson WF, Nrb/ TH, Gastorf RJ, Shalek RJ: ResuHs of Absorbed Dose Measurements for Photon Beams Using the AAPM TG-21 Calibration

{ Protoed. Medcel Physics 12518,1985.

i i

11. Nrb/ TH, ; ; =cn WF, Gastorf RJ, Hade JD, Agtirre JF, Kenned / PM, Wright EM:
Experience of the Raddopcal Physics Center Wth the NewAAPM Calibration Protocol Modcel Physics 13
5g7,1986.

1

, 12 Hansen WF, Nrb/ TH, Kennedy PM, Hade JD, @rre JF, Wright EM: Techrical

Reports frorn the Raddadesi Physics Center. Medcal Physics 13
596,1986.

! 13. Kalend AM, Reinstein LE, NrbyTH Dependence cf Wedge Factor Upon Measurement Depth. Udcil Phvstes 14:490,1M7.

s 14. Rotinson RC, Nrb /TH: Energy of Response of UF T1.D-100 to Hgh Energy Photon Beams. Phys. Med End. 33 Sul:plement 1:7,1988.

1 15. Hansen WF, Kenned / PM, Krem GB, Agtdrre JF, Kirb/TH lmprcuementin Desirnetry Pradices Over 20 Years: A Hstorical Account From the RPC,1989, 4

ASTRO Meetirs 10 of 9 pages

.-a .-a .-m , - , , ,

_ _ _ _ _ _ _ _ . _ _ _ _ _ _ . _ _ _ _ _ . ~ _ . _ _ . _ . . _ _ _ . _ _ _ _ . . _ _ _

o m ,. == am e- esimers = esim n: , ,. . . u nu %. , awe e .

Thomas H Nrby, Ph.D.

16. Kirby TH, Hanson WF, Midwi DA Uncertainty Analysis W Absort:ed Dese
Caledations From Thermduminescent Domimeters,1989 AAPM Mosting
17. Karteson UL, Nrby TH. Orrison W and Wonberger M Localizedian Predelen d the Ocder Lans for Radetherspoutic Simdation, Raddopool Sodsty W North j Americe,1993 Annual meetits i 18. Orcutt FV, Karlsson UL, MrbyTH, Firocabakhsh KK The SNeidng Effect d i

Spinsi Implants During Therapeutic Radation d the Spine, North American Spine

, Sodety Annud Meeting, San Dego CA,1993.

l

, D. Books and Chanters' i

l 1. Nrby TH: The Effect uf Neutron Redelion in Tiesue, Thesis, MSU,1975.

i 2 Nrby TH Oripn d Rosicial Potentisi in AriWiws Scienium Photoreceptors,

, Ph.D. Desertation, Uruversity d Tees et Houston,1980, -

4 E. Technical Reoorts W redemed

1. Hanson WF, Shdek RJ, Nrby TH, Kennedy PM: Infcrmation That Should be included in Every Patient's Redotherapy Record (Extemel Beam). Raddagcol Physics Center Technical Report 18,1985.

. 2 Kirby TH, Mnter AM, Hanson WF: Peakscatter Factors for Hgh Energy Photon

, Beams. Raddedcol PN)eics Center Technical Report 19,1986.

3. Nrby TH, Hanson WF, Wong PF: Estirnate d the Mrimum Radstion Dose i Delivered to the Meninges From 10 MV X-Rays Raddopcel Physics Center Technical Report 20,1986.
4. Wright BA, NrbyTH, Hanson WF
Peticipation of the Raddoscol Physics Center in the MSS Ferrous Sdfate Danimater Sectron Beam Monitoring Prayern.

RaddoWcel Physics Center Technical Report 21,1986.

5. Nrby TH, Hanson WF, Gastorf RJ, Heele JD, Agurre JF, Kennedy PM, Wright EM:

l Experience d the Raddadcol Physics Center with the New AAPM Calibration i Protocci. Raddopcsi Physics Center Technical Report 22,1986.

i

11 of 9 pages

1 1

1 1

1 I

l ATTACHMENT 4 FI' IRRADIATOR SAFETY TRAINING

, ."p-GO-07 CD COP P.01 ETHICON ENDO SURGERY s'* '

_ n -g'  : commy eo.su 2s202 Aevouwwr. New uneo a7t2s 25 September 1997 To:

William Floyd New Mexico Environment Department Hazardous & Radioactive Materials Bureau Radiation Licensing and Registration Section FAX (505) 8271544 From:

Paul Ripley Radiation Safety Officer Ucense G1316 01

Subject:

Summarv of Trainino Subinets and Period of Trainino Attached is one sheet listing the initial and pe,riodic training requirements por 20 NMAC3.1 Section 1517.

This is what I am using for guidance on annual retraining.

Let me know if you need more.

? f }) v' f

.At>--4CJ '

Paul A. Ripley p

/

. D0p-03-07 OD 07P-P.02 ETHlCON ENDO SURGERY Training Requirements M647 -

%g 2:10 PM Uoorse 013S01 20 NMAC 3.1 Pened Section 1617 Subject (Weeks)

A1 Fundamentals 1 To Operate A.2 Regulebone (SA 0401) To Operate A.3 Operaten ofirradiator To Operate A.4 Procedures To Operate l

A5 Acciennt Re xwis To Operate B Opershons "'est To Operate C On The Job Trammg To Operate D1 Procedure Review 52 D.2 ReBulaton Revow (SA 0401,5.1.3) 52 D.3 Anomesy Review 62 D.4 Safety Performance Review 52 0.5 Equipment Performance Review 52 D.6 Emergency Onli 52 E Performance Review 52 TRAIN.XLS Page 1 of 1 1

ATTACHMENT 5 PROCEDURES FOR LICENSING ACTIONS /NEW LICENSES i EVALUATION FORM 9

. PROCEDURES FOR LICENSING ACTIONS NEM LICENSES New license applications go into loose-leaf RAM file folders.

PART I:.NEW~ LICENSE APPLICATION REQUESTED

1. Print mailing label for person requesting license application.
2. Prepare LICENSE APPLICATION PACKET --(Application form, instructions,-- NMED Form 045, and cover letter with infomation as- to where copy of New Mexico Radiation Protection Regulations may be obtained).

3.

Identify the LICENSE TYPE from application infomation- (e.g. ,

Well Logging, D/M Gauge, Medical, etc.).

4. Create TEMPORARY FILE.- Include in this file a LICENSE

' APPLICATION' REVIEW CHECKSHEET and a TRACKING SHEET as well as a copy of the cover letter -[sent with the license packet to applicant].

5. Place TEMPORARY FILE in NEW LICENSE PENDING filing drawer. New license applicants- do not have a deadline to submit an application. File ALPHABETICALLY.

PART'II: NEW APPLICATION RECEIVED I. Date stamp, log, and assign a docket number to NEW APPLICATION in accordance with standard procedures.

2.

Retrieve TEMPORARY FILE from NEW LICENSE PENDING file drawer.

3. Mail a copy of a NEW APPLICATION RECEIVED LETTER to applicant.

Place a copy of the NEW APPLICATION RECEIVED LETTER in the

-TEMPORARY FILE.

4.

Place NEW LICENSE APPLICATION in TEMPORARY FILE. Put license review checksheet with APPLICATION.

5. Obtain price quote for printing public notice in legal notice section of newspaper of general circulation in area where 1

licensee will be located. Once purchase order is approved, send public notice to newspaper for publication.

6.

Forward TEMPORARY FILE with NEW LICENSE APPLICATION to materials licensing supervisor or to designated . license reviewer.

PART III: ISSUING NEW LICENSES 1.

If DEFICIENCY LETTERS are written by TECHNICAL STAFF during the. license review, support staff should process them within 5 days and TICKLE the file for the indicated amount of time.

2.

When a response _to a DEFICIENCY LETTER is received, support staff retrieves the TEMPORARY FILE from the TICKLE FILE drawer, places the document received in the TEMPORARY FILE, and forwards the file to the materials supervisor.

3. Wnen the NEW APPLICATION review is complete, staff processes the license in draft using a DRAFT LICENSE as designated by '

technical staff.

l

.4.

Staff returns DRAFT LICENSE to RLRS Program Manager for final review.

5..

Program Manager reviews draft license and submits to Bureau

' Chief-for review.

6.

Bureau Chief approves or disapproves draft & returns draft license for final typing, incorporating any recommended changes.

7. Bureau. Chief signs license and keeps copy in tickle file for inspection within six months of date of issue.

8.

After final reviews by technical and management staff, support staff makes copies of documents and mails license in accordance with MAILING Procedures. Support Staff completes data entry and files one copy of license in License file, and one copy in chronological file.

2

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

\

RENEWALS  !

PART'I: RENEWALS COMING DUE-

1. On the last Monday of.each month, prepare mailing labels for

-licenses on the database report called UPCOMING RENEWAL LIST for the- current month. This report lists all licenses expiring three (3) months from the 'date of the report.

2.

Identify the LICENSE TYPE for each expiring license. Prepare LICENSE PACKETS, including application for renewals,

' instructions, and cover letter notifying license of -impending.

expiration.

3. Mail RENEWAL PACKETS 4.

Make TEMPORARY _ FILE with copy of cover letter for each licensee to whom a RENEWAL PACKET was mailed. Include in this file a LICENSE APPLICATION REVIEW CHECKSHEET and a TRACKING

. SHEET.

5. TICKLE for 60 days from the date the packets are mailed (this is one month before the license expires) .
16. File temporary file under appropriate date in TICKLE FILE.
7. If._ the RENEWAL APPLICATION is' not received by the TICKLE DATE, give the TEMPORARY FILE to the radioactive materials Program Manager.for action.

PART II: RENEWAL APPLICATION RECEIVED 1.. Date stamp, log, prepare TRACKING SHEET.

2.

Retrieve TEMPORARY FILE from TICKLE FILE drawer.

3.

Mail a copy _of the TIMELY RENEWAL LETTER (signed by Program -

Manager) to licensee. Place a copy of the TIMELY RENEWAL LETTER in the TEMPORARY FILE.

4. Place LICENSE RENEWAL in TEMPORARY FILE.

3

5. Forward TEMPORARY FILE with RENEWAL APPLICATION to Program Manager or reviewer.

PART III:-ISSUING RENEWAL LICENSES 1.

If DEFICIENCY LETTERS are written by TECHNICAL SIAFF during the license review, support staff should_ process them within 5 days and TICKLE the file for the indicated amount of time.

2. When a response to a DEFICIENCY LETTER is received, staff retrieves the TEMPORARY FILE from tha TICKLE FILE drawer, places the document received in the TEMPORARY FILE, and forwards the file to the Program Manager.
3. When the RENEWAL APPLICATION review is complete, staff processes- the license in draft using a DRAFT LICENSE as designated by Program Manager.

4.

Staff returnt DRAFT LICENSE to Program Manager for final review.

5. Staff completes processing, signo off on TRACKING SHEET, and forwards finished document to Program Manager for final review.

7.

After final review by Program Manager, staff makes copies of documents and mails license in accordance with MAILING procedures. Staff completes data entry.

AMENDMENTS PART I: ADMINISTRATIVE AMENDMENTS NOTE:

ADMINISTRATIVE AMENDMENTS are used for corrections to licenses or to make administrative changes to licenses, - e.g. ,

correct typographical errors.

1.

When the ADMINISTRATIVE AMENDMENT OR CORRECTED COPY is complete, staff processes the license in draft using DRAFT LICENSE.

2. Staff returns DRAFT document to Program Manager for final review.

4

3.

Staff prints final license and forwards finished document to Program Manager for final review.

4.

Af ter final review and signature by Program Manager, staff makes copies of documents and mails license in accordance with MAILING procedures. Two copies are made: One for license folder and one for chronological file.

PART II: LICENSEE-REQUESTED AMENDMENTS

1. Date stamp AMENDMENT REQUEST LETTER.
2. Place AMENDMENT REQUEST LETTER and TRACKING SHEET in TEMPORARY FILE FOLDER.

3.

l Forward TEMPORARY Program Manager or reviewer. FILE with AMENDMENT REQUEST LETTER to 4.

If DEFICIENCY LETTERS are written by TECHNICAL STAFF during the AMENDMENT REQUEST review, support staff should process them within 5 days and TICKLE the file for the indicated amount of time.

  • 5.

When responses to a DEFICIENCY LETTER are received, support staff retrieves the TEMPORARY FILE from the TICKLE FILE, places the document received in the TEMPORARY FILE, and '

forwards the file to the Program Manager.

6.

When the AMENDMENT REQUEST review is complete, support staff processes the AMENDMENT in draft using a DRAFT LICENSE.

7.

Staff returns DRAFT LICENSE to Program Manager for final review.

8.

Staff prints final license, signs off on TRACKING SHEET, and forwards finished document to Program Manager for final review.

9.

After final review and signature by Program Manager, support staff makes copies of documents and mails AMENDMENT in accordance with MAILING procedures.

5 m I

TERMINATIONS 1.

Send Certificate of Disposition with Technical ~ staff business card.

2.

Create pending file with telecon document or letter requesting termination of license.

3. Tickle.for 30 days.
4. Data entry for milestone tickle.

WORD PROCESSING Support staff are expected to be able to use Wordperfect 6.0.

The Agency program. provides training to use the word processing The following STANDARD LETTERS are included in computer generated files:

LICENSE APPLICATION REQUESTED LETTER.

NEW LICENSE APPLICATION-RECEIVED LETTER AMENDMENT LETTER RENEWAL DUE LETTER TIMELY RENEWAL LETTER NOTICE OF NONCOMPLIANCE LETTER I

' NO ITEMS OF NONCOMPLIANCE LETTER CLOSE LOOP INSPECTION LETTER The following STANDARD DRAFT LICENSES are included; MEDICAL FIXED AND PORTABLE GAUGE INDUSTRIAL RADIOGRAPHY GAS CHROMATOGRAPH BROAD SCOPE INDUSTRIAL 6

s _d

LICENSE APPLICATION EVALUATION FORM

1. Applicant Name:

License Number:

Expiration Date:

2. Address:

Actual 1.ocation:

Telephone #:

. 3.

Contact:

Contact:

4.

Is the location listed identifiable from the description offered? (P.O. Box alone not acceptable) Yes No

5. Is the applicant a corporation? Yes No l

i I

If yes, is the corporation registered with the State Corporation Commission?

Yes No.

If No, request that registration be made prior to preceding with application miew.

6.

If applice.nt is not a corporation, has registration been made with Taxation & Revenue Dept.? Yes No 7.

If the reviewer considers the application acceptable for review, has the reviewer issued a certified letter of acceptance to the applicant? Yes No if yes, has the reviewer issued a Public Notice to the local paper nearest the proposed facility on a 60-day public comment peried and possible hearing? Yes No.

Name oflocal paper:

Publication Date:

Application Date:

1 J

O REVIEWERS EVALUATION COMMEhTS:

(Adequacy must be evaluated by the reviewer. Reference Licensing Guides and 20NMAC 3.1 for all Applicants for Radioactive Materials License).

8.

Facility and Equipment: The facility sms be evaluated for proper radioactive material use and storage requested (design, abielding, etc.). Evaluation mas include a consideration ofhealth and emironment impact from exposure and probable release of material to restricted and unrestricted areas: (See 20NMAC 3.1 - Subpart 3, Section 308 and licensing guidance specific to type oflicense , (e.g. Reg. Guide 10.8,"Use of Radioisotopes for Human Use") and Applicant's SOPS).

l 9.

Uvaluate the application and assume sufScient description is outlined for the isotopes and gantities to be used: (See Scaled Source and Device Catolog or Specific Regulatory Guidance for specific license type).

Radioisotopes Mass No. Form (Chem / Phys 3 Model # Onantitv/ Activity I

10.

Evaluate applicants description outlined for the uses to be made of each radioisotope and quantity:

2

11.

Evaluate the credentials of the Individual User (s) Training (See resume) for the use and possession of the material requested. Tmining documentation uma include a Preceptor Statement, proof ofNM licensure, and any Board Certi6 cation. (Reference yymedate 20NMAC 3.1 regulations and applicable licensing guides), (See Subpart 7, Section 712 A-M):

I 12.

Evaluate the duties of the Medical Isotope Committee. Members shall meet quarterly and keep minutes. (For Broad Scope and Medical licensing, see 20NMAC 3.1, Section 702 C).

13.

Evaluate all General Technical Requirements and equipment utilized in association with radioactive materials used. (For Medical licensing see 20NMAC 3.1, Section 703 and Regulatory Guide 10.8).

3

- 1

14 Evaluate procedures for ordering and receiving radioactive mtterial and procedures for safely opening packages containing radioactive materials. (See 20NMAC 3.1, Subpart 4, Section 432, or Subpart 7, Section 703 H).

15.

Evaluate instrumentation used and survey procedures and frequencies by area, designated with action levels, and calibration frequencies by an NVLAP certified provider and certified by the State. (See 20NMAC 3.1, Subpart 4, Section 416, or Section 703B and 703 M, Survey Instrumentation and also Dose Calibrator Requirements, Subpart 703A).

16.

Determine whether adequate dosimetry is being utihzed. (NVLAP prosider and frequency) and type of bioassay if required by license condition or application commitment. (See 20NMAC3.1, Subpart 4 or, Section 707, Control of Aerosols and Gases).

4

17.

Evaluate the possibility ofradioactive waste production by the applicant and the ability to adequately store and dispose of such waste. (General Disposal requimnents20 NMAC 3.1, Section 433, " Waste Disposal General Requirements," and 435, " Disposal by Release into Sanitary Sewage", or " Disposal by Decay-in-Storage" and " Disposal by contracted Disposal Facility." See Standard Licensing Conditions, or other shielding requirements in 20NMAC 3.1.; ( Section 703G., " Vial and Syringe Shields and Labels")).

18.

Evaluate the adequacy of the Radiation Protection Procedures, including General Rules For Safe Use of Radioactive Material and Emergency Plans, of the applicant's SOP Manual. (Radiation Protection Program,20NMAC 3.1, Subpart 404 B. or 702.B). Keep doses as low as reasonable achievable (ALARA): The licensee shall at intervals not to exceed 12 months, review the radiation protection program content and implementation.

RSO daily oversight. The following should be reviewed and evaluated:

Fire Protection described in safety manual.

All placarding and labeling according to U.S. DOT regulations.

Good housekeeping committments.

Effluent concentration limits in accordance with 20NMAC 3.1, Subpart 4: i A. Section 406, " Compliance with Requirements For Use Summation of External & Internal Doses.", or may be more restrictive; B. Bioassay Program Yes No; C.

3ection 417 as appropriate, Radiation Survey Program; Daily surveys and contamination daily smears, action levels in accordance with Appendix F, Table F-1, Reg. Guide 8.23; D. Section 428 and 429, " Radiation Signs & Symbols," and

" Exceptions to Posting Requimnents";

E.

Section 432, " Procedures for Receiving & Opening Packages,"in accordance with U.S. DOT regulations,. In accordance with Section 325, "Ly..Gon of RAM for Tr.uspor%" exposure rate levels. See applicant's procedures.

Subpart 1, Section 108 & 441, " Records for Radiation Protection Provisions of Program," aball be kept tmtil termination oflicense. Records of audits and reviews of program content and implementation maintain'for 3 years after record is made. Other reporting procedures in specific areas were records and reports are required 5

U

Training as described for specific license types. (See 20NMAC3.1 and Applicant's SOPS for type oflicense requested).

19.

For purposes of complying with the requirements of 20NMAC 3.1, Subpart 3, Section 311 F.,"Decosunissioning and Surety Plan for the Facility", is documentation requested attached. Send applicable letter of deSciency upon final evaluation or if this section does not apply to this applicant, answer N/A.

20.

This application, after this review, is considered to be complete and adequate for license issuance. Xtg bh; -

IfYes, License number assigned  ;

If No, Indicate what actions were taken:

Reviewed by Date: ,

NMED/RLRS.REV.10/97 6

MEMORANDUM TO:

New Mexico Radiation Material Licensee FROM: William M. Floyd, Program Manager Radiation Licensing & Registration Section DATE: October 3,1997

SUBJECT:

Review Content ofNew/ Amended License Please carefully review content of enclosed New Mexico Radioactive Material License.

Requested changes are indicated by bold lettering. Please report any errors or omissions to this section immediately. Licensees are to be thoroughly familiar with license content.

When requesting future license amendments, please include license name and amendment number to ensure that correct license is amended.

NOTE:

Copies of the New Mexico Radiation Protection Regulations (20NMAC 3,1-May-3-1995) may be obtained from Santa Fe Printing,1424 Second Street, Santa Fe, New Mexico, 87501, telephone number (505) 982-8111.

Should you have any questions, please call the office at (505) 827-1862.

I O l APPLICATICN FOR RADICACTIVE MATERIAL LICENSE HUMAN USE 525 Camino de los Marquez

  • P.O. Sox 26110, Sants fe, NMtew Mexico Environment A131 Montgomery 8 tvd. NE, Atbutp.er@e, WM87502 871096110 + (505)S27
  • (505)s41 4300 9465 lustRUCT10NS:

Conplete items 1 through 26 (f this is en inittat application or en application for renewet septementet sheets where necessary. Item 26 aust be completedof and a license. Use Retain on signed.

of the above addresses. Upon approvet of this application, the applicant willcense. receive a Rad 1.s. WAME AND MAllING ADDRESS OF APPLICANT (institution, fits, tilnlc, physician, etc.) INCLtbt ZIPCODE 1.b.(ifSTREET ADDRESS (ES) AT WN]CH RAD 10 ACTIVE MAT different from 1.a.) INCLUDE ZIPCODE TELEPHONE NO.3 ( ) *

2. PERSON TO CONTACT REGARDlWG THIS APPLICATION
3. TNIS 15 AN APPLICAT10W FOR: (Cirett. appropriate ites)
a. NEW LICENSE TELIPNONE NO. ( )
  • _ b. AM NDMENT 70 LICENSE No.
c. RENEWAL OF LICENSE NO.

INDIVIDUAL USERS (hame Individuals who will use or __

directly supervise use of radioactive asterlat. 5. RADIATION PROTECTION OFFICER (RPC) (Name of pe* son designated Casplete setements A and a for each individual.) es a radiation protection officer if other than Individuet user, complete resume of training and experience as in supplement A) 6.a. RADIDACTIVE MATERIAL FOR MEDICAL USE MAXImJM ,

CHECK POSSES $10W MAxlMuM RAD 10 ACTIVE MATERIAL ITEMS LISTED IN: LIMITS CHECK POSSESSION DESIRED ADDITIONAL ITEMS:

(allticurles) ITEMS LIMITS 3 220 F FOR IN V11R0 $1LCIIS DESIRED (mitticuries)

As Required 2001NE 131 AS ItDIDE FOR TREATMENT PART 3, SCHEDULE C, GROUP ! OF NTPERTNTR01013M As Remired PARY 3, SCNELOLE C, CROUP 11 PHOSPHORUS 32 AS SOLUBLE PHOSPNATE As Required FOR TREATMENT OF POLTCYTNEMIA VERA, LEUKEMIA ABC SONE METASTASES PNOSPMCRU$a32 AS COLLDIDAL CNROMIC PMosPRATE FOR INTRACAVITART TREAT-MENT OF MALIGNANT EFFUS10NS 90LD 196 AS COLLDID FOR INTRA-CAVITARY TREATMNT OF MALIGNANT EFFUSIONS 100lNE 131 AS ItalDE FOR TREATMENT OF TNTR0!D CARCINOMA FilWN 133 AS GAS OR GAS IN SALINE FOR BLOOD FLOW STUDIES Ale PULMONAAT FUNCTION STn21ES 6.b. RADICACTIVE MATERIAL FOR UEES NOT LISTED IN ITEM 6.a.

For seated sources incluse annufacturer and model or drawirg rumber.

CNEMICAL MANilut NupSER ELEMNT ABC MASS NUMBER AIC/OR OF MILLICLAIES PNYSICAL FORM DESCRISE PURPOSE OF USE OF EACH FettM C) 016 EJ

. PAGE 1 ee e i . .

O for itemitems 7 through on a seperate 23, check the appropriate boates) and s@lt e detailed description of Sheet.

att the reg >ested Information. segin each indicate that an appendia to the medical licensing guide tritt be followed, do not s4 . holt the pop If you

, but specify the cate of the guice.

7. MEDICAL ISOTOPES COMMITTEE
15. GENERAL RULES FOR fng SAFE USE OF Names and Speclettles Attached; and ( "

Duties as in Appendia B; or *E ""I'* E*II'"'d!

Equivalent Duties Attached ' ' ' ** ""**^*d

8. TRAINING A@ Expit][NCE
  • R S @ eck one)

Setements A & B Attached for Each truf tvidast User;end Appendia N ProceeJres Followed; or Swlement A Attached for RSO t wivatont Procedures Attached

9. Ik8iRUMENTATlON (Check one) VET PROCEDURES (Check one)

Appendia C form Attached; or 18 I Pr followed; or L1st by Name and ModeL N m r EsNivaiont Procedros Attached '

10. Call 8 RATION OF INSTRUMENTS DI N (Cher* one)

Appendia D Procedures Fottowed for Survey Appendia J Form Attached; or Instruments; or lEwivalent Inforention Attached twivelent Procedares Attached; and

19. THERAPEUTIC USE OF RADIOPRARMACEUTICALS (Check one) typendia O Procedures Followed for Dose Cattbretor; or Appendia K Procedres followed; or

!quivstent Procedures Attached s t ached

11. FACILITIES AND EQUIPMENT 2 . InERAPEUTIC USE OF SEALED SOURCES Description und Diegram Attached I

l

12. PER$0NNEL TRAINING PROGRAM Appendia L Procedures Followed; or (Check one)

Description and Diagram Attached

13. PROCEDURES FOR ORDERING AND RECE!Vlu*, EW RADIDACTIVE MIERI AL ADIMCTIVE GASES (e.g., menon-133)

Detailed Information Attached 8 Info on Att M CON 1 NG  ! m RAD CT VE ETER AL  ! $

Appendia F Procedures Fottowed; or Detailed Infonmotion Attached Echeck one)

Emivelent Procochree Attached 23. PROCEDURES AND PRECAUTIONS FOR USE OF RADIDACTIVE MATERIAL SPECIFIED IN ITEM 6.b.

Detailed Information Attuhed ED 016 NU .

PAGE 2 O

24. PERSONNEL 0051METRT __

(Check oppropriate box)

SUPPLIER FILM ExCNAuct rgygogwcy

e. WHOLE 80Dt TLD -

OTHER l&pecify)

FILM

b. FlWGER TLD CTWER (Specify)

FILM

c. WRIST TLD OTHER (Specify)
6. OTHER (specify)
25. FOR PRIVATE PRACTICE APPLICANTS ONLT
e. N05PITAL AGREElWG TO ACCEPT PATIENTS CONTAINING RADICACTIVE MATERIAL
b. ATTACM A COPY OF THE AGREEMNT LETTER Name of Nespital SIGNED ST THE NosPITAL ADMINISTRATOR Melting Address
c. WNEN REGUEETING TNERAPT PROCEDURES, ATTACN A COPY OF RADIATION SAFETY PRECAUTION %

City 10 SE TAKEN AND LIST AVAILABLE RADIAfl0N State DETECTION INSTRUMENTS Zip

26. GRTIFICATE (This item sust be egleted by the applicant)

C. The applicant eruf any official executing this certificate on behalf of the applicant named in item 1 a

. . certify that this herein, including any swtements attached hereto, is true and correct to the bes and belief.

b. APPLICANT OR MRTIFYING OFFICIAL (signature) m4ME O ype or print)

TITLE DATE ED O W Wu PAGE 3  :-

-e

TRA!NING AND EXPERIENCE AUTNORIZED USER OR RADIATION SAFETT OFFICER

1. RAME OF AUTNDRIZED USER OR RADIATION SAFETY OFFICER 2.
3. CERTIFICATION SPEtlALTT 30MtD CATEGORT A

8 MONTN AND TEAa CERTIFIED C

=

4. TRAlWING RECEIVED IN BASIC RAD 10lSOTOPE NANDLING TECHNIP.ES TYPE AND LENClu 0F TRAINING f! ELD OF TRAINING A LOCAT10N AND DATE(S) 0F TRAINING LECTURE / SUPERylSED 5

IA W ATORT LA80RATORY COURSES EXPERIENCE (Nours) (Nours)

C D

e. RADIATION PNYSICS AIC INSTRUMENT &T10N
b. RADIAfl0N PROTECTION
c. MATNEMATICS PERTAINING TO TNE USE AND MEASUREMENT OF RAD 10ACTIVITT
d. RADIOPNARMACEUTICAL CutMISTRY
5. EXPERIENCE WITN RADIATION (Actual use of Radleisotopes or Ewivelerit Emperience) is0TOPt M4ximuM AMouM1 WNERE EXPERIENCE WAS GAINED DURATION OF EXPEtitmCE TYPE OF USE ED C16 NU SUPPLEMENT A
  • e 6 e e e n w _-

PRECEPTOR STATEMINT Septement 8 mat be completed by the applicent physiclan's preceptor.

Caperience, oestein a seperate st.tomett from each. If more then one pr9ceptor is necessary to docuwnt

1. APPLICANT PNYSICIAN'S NAME AND ADDRESS EIY 70 COLWN C FULL aw c Personst porticipation should consist of
1. Swervised examinetten of pottents to deter 1nine the tuttability for redit,lsotope diagnosis and/or treatment and recaneendellen for prescribed dosage.

STREET ADDRESS

2. Collaboretten in dose calibration and actuet sceninistration of dose to the patient including calculation of the redletten dose, ntated areeurements and t, totting of ote.

CITT STATE 21P

3. Adegate period of training to enable physician to movge redleective petients and follow patients through diagnosis and/or egJrse of treatment.
2. CLINICAL TRAINING AND EXP!RIENCE OF ABOVE NAMED PNYSICIAN IRMBER OF s ISOTOPE CASES InfVOLVING Coe!TIONS DIAGNOSED OR TREATED Co mENTS PERSONAL PARTICIPAfl0N (Additlanal informatten er comments may A B be ednittwd on separate sheets.)

C D

DIAGNDEls 0F TNTR0!D FUNCTION 1+131 DETERMINATION OF SLOOD AND or SLOCO PLASMA VOLtME l 125 LIWR FUNCTION STUDIES FAT A880RPTION STWlES ElDNET FUNCTION STa lES IN Vlft0 STt21ES OTNER 1+125 DETECTION OF THROM80$lt 1 131 inR010 IMAGING P 32 ETE inMOR LOCALIZAT10N Se 75 PANCREAS IMAGING Ytr1M ' CISTEte0 GRAPHY Ne-133 SLOOD FLOW STLEIES AND PULMONARY FLs!CTION STW IES OTCR ORAIN IMAGING

{

CARDIAC IMAGING TNTR0!D IMAGING '

SALIVART GLAND IMAGING Te-99m SLtXD POOL IMAGING PLACENTA LOCAll2Afl0N LIWR Am SPLEEN IMAGING LUNC IMAGING BONE IMAGlWG OTNER ED 016 ku SUPPLEMENT 3 - PAGE 1 9%

O G G g

y .

  • 2. CLlulCAL TRAINING AND EXPERIEICE OF A80VE NAED PNTSICIAN (Cont {nued)

NLMRER OF IscTOPE CA%ES INVOLVING CONDITIONS DIAGNOSED OR TREATED PEtt0NAL COMMEATS A PARTICIPATION (Additional Inforestion or comments may B

C by subaltted ce separate sheets)

D P 32 TREATMENT OF POLTCTTWEM1A VERA,

($olihle) LEutEMIA, AWD BONE METASTASES P 32 INTRACAvlTART TREATCNT (Colloide')

TREATMENT OF TNTROID CARCINCMA

!*131 TREATMEN10F WTPERTNTR0!DISM Au 198 INTRACAVITART TREATMr.WT Co-60 INTER $i.TIAL TREATMENT or Ca*137 IWIRACAVITART TREATMENT 1+13 er lWTERSTITIAL T&EATMEWT tr M Co 60 or TELETNERAPT TREATE NT Cs 137

$r*90 TREATMENT OF ETE DISEASE RAD 10PNARMACEVTICAL PREPAAATION Mo+99/ GENERATOR Tc-99m sn 113/ GENERATOR In-113e

  • Tc 99m REAGENT KITS

. OTCt l

i

3. DATES AND TOTAL NMER OF Mauts RECEIVED IN CLINICAL RADIols070PE TRAINING 4 -

A. I'3 TRAINING AND EXPERIENCE ltCICATED ABOVE WAS DETAINED UNDER THE SUPERVISIOk of t 6. PRECEPT 0R'S 510NATLatt NAfE 08 SUPERVISOR NAE OF INSTITUTION

7. PRECEPT 0R's RAME (Please type er print)

MAILING ADDRESS CITY 8. DATE

$. MATERIALS LICEN11 NUMBER (5)

ED 016*NU SUPPLEMENT 8 - PAGE 2

.mm e

St:tc of N:w Mexico

, *g ENVIRONMENTDEPARTMENT a

ll l y}

}

Hazardous & Radioactive Materials Bureau 2044 Galisteo g$" \

sw \

\%.a % G P.O. Box 26110 Santa Fe, New Mexico 87502 (505) 8271557 CARYE. JOHNSON oonwon Fax (505)8271544 xaxt. uztpt.tk SECaETAaY EDCAR1.TitoRh70N,m DistirrLtcatrAsy APPLICATION FOR RADIOACTIVE MATERIAL LICENSE INSTRUC110NS:

Cmlete l'=? 1 17 if this is an iniual app 0 cation. If appbcanon is for runessl of a becose, cmplete o.tly i indicate new irkunstion or ehres in the in.gra as iwwad in items 8-17.

14a) Name, street address, and phone number of apphcant (Institution, Tirm, Penon, Departent, etc.)

1.(b) Street aCWes) and pbme number at stich radioneuve matEIaisill be stcred and used (PO Box numbers are not accep.able) 2.

Penon to contact regardmg appbcauon (include phone t) 3.

I+Mous I.,icense Numbers (if this is a renes 31 apphcanon, please so inoicate and give current license number) 4.

Indmdual Usen (name and nue ofin&tr+"a4 sto 301 use5.or Eachaum Safety 05ce(anach resume of trammg and expenence) directly supernse use of ra6oactive material) 6.(a) Eggent Mass No. (b) Form (Chem /Phvs) (c) Mar Acurity (d) h{anufacturer & Model No (ses3ed smutes)

7. Use O be made of each item of raioactive matenal requested above (anach supplemental sheets if twm=7)

B. Indmdual Um:r(s) Trauung (anach resume). Complete the followug informauon on the indmdual user (s) and (A) Nuclev physics, atomic structure, and interaction of radiauts with matter (B) Radisuon detection instrutnentation, calibration, and standardtzation (C) Radiation potection, waste disposal, and survey and dosirnetric procedures (D) Radiobiology, kuluding effects of radiation on the human tody length of academic Name. Title. DeenrQ) Where Trained imgth of on-thedob Trainine in A B C.D Trainine in A B.C D i

l

~

9. Actual E= ience With Radiauon (actual use of radioiaatapes, attach resume)

, Hung Isotope MaximumActivity Place of Extwience Imnth of F=dence

10. Radtation Detection Instruments (attach supplettental ahaa'3 if w =- -y)

Number Radiation Use ofinstrument Twe% del Sensitivity Window thichess sveilable (e.g. monitoring, dessted ranse mrMr 2 me'em _ surveyine me=du)

_T

11. Method, frequency, and Wed uses tn calibrauon i'tstrurnents hsted tn itern 10 (attach supplemental sheets if necessa
12. 7ihn bedges, d ameters, and bionanny procedares used (for fdm bs4 6 and TLDs. speedy toethod of cahtratmg an supplier, specify frequency of mhange, attadi supplemental shnets if necessary) fTEMS 1316 ARE TO BE ANSWERED ON SUPl'NAL SHEE13 D. Facilities 1and Equipm at. Dem. ribe laboratory facilities and runate handhng gM sacrase containers, @w . fume hood (Attach c9 anatory sketch of facility)
14. Radiation Protection Program. Describe the reestion protection progran, including control measures. If application co autalt leak tesung procedures where appliable; name, training, and exponence of persons to perform leak test, and initial radaation survey, servicing, maintenance and repair of the sourte.
15. Weste Disposal. If a commercial waste esposal serva is eenployed, specify name of company. Otherwise, sulenit methods which will be used for disposing of radioacdw westas and estunatas of the type and amount of activity involved.
16. (a) Survey Program. Describe the surven to be made to deserame ifradiation hazards exist in a facihty in which radioactive storei N Racords h8-=ement Program Records keepite and reviewing remrds of surven, matrialinventories, per==-1 exposures, etc.

CERTIFICATE (This item must be completed by the applicant)

The applicant and any official executing this certificate on behalf of the applicent namad in hem I, certify that this apphos conformity with the New Mexico Radiation Pr** Regulanons, Subpart 3-Liormning of Radiaar*ive Materials; and that all information ocatained herein, including any supplements are Ad hereto, is true and correct to the best of our knomiedge and beliet Applicant Name(Please Print) Applicant Signature Date Certifying Official (Please Print) Cerufying Officaal Title "Certifvmg Omeial Signature Date

ATTACHMENT 6A

, GENERALINSPECTION REPORT FORM -

INSTRUCTIONS FOR INSPECTION AND PREPARATION OF GENERALINSPECTION REPORT GENERAL LICENSE INSPECTION REPORT CHECKLIST

M

)- INSTRUCTIONS FOR INSPECTION AND j

PREPARATION OF GENERAL INSPECT 20er REPORT PART 1. INSPECTION BACKGROUND DATA 1.

a Conylete date.

inspection all items; if this is an initial inspection indicate under last 2.- Check announced or unannounced.

3. With the exception of initial inspections all inspections should be

, unannounced.

PART 2. LICENSE DATA

2. Couplete all items. 1 1 ,

f PART 3. PREV 20US INSPECTION CORRECTIONS 1.

Review the corrective action taken for all violations found during the

' last inspection. Either close out as satisf actory or list as a repeat

' linding on the current inspection.

2.

Review acceptance of any reconenent.ations made during the last inspection and elane out if anellemhia.

PART 4. PERSONS CONTACTED

1. List-all individuals contacted and their job titles.
2. For broad licensees, give the principal investigator and use
authorization number or designation.

l PART 5. MANAGDIENT 4

1. Describe the organisation and attach an organisation chart if
applicable.
2. Describe the Radiation Safety officer (RS0) position within the 4

organisation and the ability to carry out responsibilities such as

3. filling vacancies and obtaining equipment and supplies as necessary..

Review minutes of the Committee meetings and verify actions required for safety are addressed. Did the committee perform safety audit responsibilitiest 4.

List name and title of Conunittee members.

PART 6. UNUSUAL OCCURRENCE OR INCIDENTS

1. Review any incidents reported and investigations since the last inspection.

2.

Review issued forcorrective a reportable actions taken Es the result of a Notice of Violation incident.

3.-

In cases where overexposures have occurred, evaluate actions the licensee has taken to prevent recurrence.

l 1

  • 4.

PART 7. INVENTORY 1.

Verify compliance with maximum allowable type and quantities isotopes authorized.. i 2.

3. Verify frequency and accuracy of inventories taken by the licensee.
4. Verify that material is used in accordance with the application.

Uses of material.

PART 8. SEALED SOURCES 1.

2.

Verify that leak test are taken at required frequency.

Verify that records are accurate and complete.

3.

4.

Verify that qualified individual makes leak test swipe.

Verify that leak test samples are analyzed by qualified individual or authorized service.

5. Verify that safety mechanisms are tested (ie shutter) IAW license I

conditions or procedures. i PART 9. USE LOCATIONS l

1. Identify temporary job sites authorized.
2.  !

Identify storage areas.

3. Confirm that fire protection is provided.

PART 10. Training

1. Verify authorized users per license or license condition.

2.

3.

Review training re:ords for users and ancillary personnel.

Discuss radiation safety principles with workers.

4.

Review training provided for special uses such as transportation and waste packaging.

5. Review refresher training.

PART 11. POSTING

1. Verify that all posting requirements are being met.

2.

Examine discarded discarded after use?containers. Are labels defaced when the container is PART 12. EXTERNAL RADIATION MONITORING

1. Review all monitoring records from the last inspector forward.

2.

Verify that all individuals who are required to have monitoring are assigned monitoring.

3. Evaluate type vs needs.

4.

Evaluate the licensee's efforts towards reduction in dose (ALARA).

2

i PART 13. INTERNAL DOSE EVALUATIONS

3. Confirm that bioassays have been done if indicated, and records amintained.
2. Determine equipment sensitAvity and appropriateness of measurements.
3. Review records.
4. Review use of engineering controls.

PART 14. ENVIRONMENTAL 1.

Evaluate all areas where releases to the environment may have occurred.

. Determine adequacy of the licensees monitoring program. Review results.

PART 15. INSTRUMLf7ATION 1.

Verify that the licensee has the proper type of instruments for their needs.

2.

3. Verify that there is adequate instrumentation available for surveys.

Verify that calibrations are adequate and have been done in accordance with written procedures.

PART 16. PROCEDURES

1. Verify the licensee has copies of all procedure manuals and documents that were submitted with the license application. Review procedures for l

' updates or changes not included in licensee file.

2. Review procedures covering receipt of licensed material.

3.

Assure that procedures are followed by reviewing records of receipt and package surveys.

4.

Assure that waste packaging and shipment procedures are followed and procedures are adequate by reviewing records of shipments.

5.

Review transfer procedures and records of licensed naterial transfers 6.

that may have an impact on areas not under control of the licensee.

Verify that radiation protection standard operation pro:edures that were 7

approved by the radiation control program have not been modified.

Verify that approved procedures are being followed.

8. Verify that emergency procedures are adequate for the needs of the licensee.

PART' 17. PADICACTIVE WASTE

1. Review waste storage and packaging procedures.
2. Verify that storage for deca l.' procedures are not causing elevated radiation doses to waste processing workers.
3. Verify that all labels of empty containers and shields are defaced before items are released to sanitary land fills.

PART 18. Shipping and Packaging

1. Verify that all appropriate portions of U.S. Department of
2. Transportation regulations Title 49 CFR 170-199 are complied with.

Verify that correct documentation on file.

3

_, _ _ _._ . _m._. ._ -_- -

PART 19. INSPECTOR'S MEASUREMENTS AND OBSERVATIONS

1. Make measurements in all areas called for, both wipes and direct radiation measurements.
2. Document results.
3. Attach a floor plan when radiation levels may have an impact on personnel exposures.
4. complete the entire observation checklist.
5. Consnent on discussions with radiation and ancillary workers. Are workers knowledgeable of precautions to take for various radiation hazards?

PART 20. INSPECTION FINDINGS

1. hupply a statement of f acts for each item of non-coupliance uncovered.

Answer the questions; who, what, where, when, how, if possible for each item that may be contested. Follow the rules of evidence. Each item of non compliance must be tied to a specific regulator and/or license condition.

The licensee must be informed of all items of noncompliance uncovered either during the exit intervisw or following further consultation with the program management by the inspector in cases where *.he violations are not clear. -

NMED/RLRS.REV. 9/9*/

K-GEN. PRO 4

t c -

, - --r w - - -w - + - + -

GENERAL INSPECTION REPORT FORM License Number I Expiration Date Date orthis Inspection Inspection Priority PreviousInspection Date Type ofInspection_._ Routine Announced Unannounced Initial Special A. LICENSEE & ADDRESS ACTUAL LOCATION ,

TELEPHONE B.

INDIVIDUALS INCLUDED IN MANAGEMENT INTERVIEW (109):

C.

NAME OF RESPONSIBLE PERSON (Organizational chart):

D. SPECIAL LICENSE CONDITIONS (308h E. Letter sent to Licensee on:

Inspector Date ofReport Reviewer Date ofReview-1

r 1.

FOLLOW UP ON PREVIOUS INSPECTION FINDINGS:

2.

SUMMARY

OF LICENSED PROGRAM.(Type ofprogram):

3.

INTERNAL AUDIT (Annual Safety Resiew & ALARA & SOP'S):

4.

AUTHORIZFn USERS: (Training Certi5 cation, Supervision of authorized users):

t'

5. TRAINING / RETRAINING:

RSO Training /Fvmrienne Dmennneihilities & Authnrity Aneillarv Persannel Trainine Refremher Trainine

- Ev whoi.s/Certifiention Written Fram Management Review 2

6.

FACILITIES (Engineered Controls: Access Alarms & Controls, Transport Vehic

~

7.

SECURITY (425):

Access and Exit Controls Fire Protection Visihte and AnAihle Wamino Elenate-Phynie.nl budtv & Manitc --Le Ihv. Erit

8. EQUIPMENT (Survey Meters, See License Condition or Application):

Monitoring Instruments C*A.Gon Procedures _ In.Hane. Vandae Calibration Frequency By Whom/Certi5 cation Posted Electronic Calibration. Frequency Operational Checks Perforned Records

9. PROCEDURES FOR RECEIVING AND OPENING PACKAGES (432):

4 I

/

10. INVENTORY LOG / RATE OF USE(317):
11. LEAK TESTS: -

I

12. PERSONNEL DOSIMETRY:

Film Badge or 'lLD for each Individual.

Fi-:-:==5ed by Frequency Exposure Records Comnliance with reoulatary linha.

Fr eiiw A'. ARA (<10% ofmir.immn nermineihle)

Noti 6 cation Reports Available to Employee High Readng/Overexposures n=_.rm Himarv nrnvia.A to umninveen ..

RE .2 revi=ad by

13. POCKET DOSIMETER:

Pocket Dosimeterprovided by Range 0 200 mR/hr.

Calibration Frequency Rw=e History Reviews

, = =

4 4 . .. .. .. .

O 14.

ENVIRONMENTAL &/OR AIR MONITORING PROGRAM:

(NOTE: ALI Anmyl Limit on Intake Values Table 1, Column 1 & 2, Appendix B; DAC-Derived Air Concentration Values Table 1, Column 3, Appendix B) -

15. .

RESPIRATORY PROGRAM (428): Ye. No N/A Calculations Sampling / Analysis Records

16. SPECIAL PROCEDURES:

AreloCnations pefonned? Yes No N/A.

IF YES, Isotopes / Quantities- I-125 1-131 Xe-133 Number of procedures per month (avg.) I-12.5 1-131 Xe-133 Type ofmonitoring Equipment .--

Perfonned by Due Radu Last charcoal filterchange 17.

B10 ASSAYS (408)- N/A Isotopesm.. C-14 1-125 I131- H 3_ P-32 Llw.4e Conditions _._In-House _ Vendor _

Fnquency Equipment /mtmentation Type oftest: Thyroid Urine Other Total Body Countin?

Action Levels--

{

/

18.

POSTING & LABELING:

NhED045-License and Operating Procedures:

Regulations Emergency Procedures Any Notice ofViolation Trainin2 Outline

" CAUTION RADIATION AREA Signs" Labeling on Device /Equiptuent 19.

RADIATION SURVEYS & RECORDS (432):

Frequency ofSurveys Meter Surveve Emergency procedure Wine Smvev Worker Aw_.==

Vehicle Surveys Surveys Daily Weektv Surveys upon transfer ofRAM Other Surveys

  • 20.

TRANSPORTATION (U.S. DOT 49 CFR 170-199):

21. DISPOSAL hETHODS:

Rela === to Sewermee Svrtem Yes No f lemnae (%ndition Daelv.in-Stormae ~

Stormeei u m+ ion e .cgstion Tmnarer pr..rd 4.

6

r

22. INCIDENTS OR OVEREXPOSURES:

Reports and Noti 5 cation

23. OPERATIONS OBSERVED: (NOTE: Every attempt must be made to obseEe operations conducted in association with possession, use, and disposal oflicensed material).

24.

INFORMATION CONTINUATION FROM PREVIOUS PARAORAPHS:

25.

INDEPENDENT MEASUREMENTS (Results Cc,iugard to Licensee, NOTE: attach analysis report sheet):

Bked inetmment used Madel # S/N C21 Baie survev/ wipe mens i

7

e.

26. INSPECTION

SUMMARY

i

27. EXIT INTERVIEW:

Senior Management Date License Reviewer Alert, memo sent?

Ifyes, Date sent NhED/RLRS REV.10/97 8

l l

l l

ATTACHMENT 6B i MEDICALINSPECTION FORM -

INSTRUCTIONS FOR MEDICAL INSPECTION REPORT ,

il 1

o I j

I l

INSTRUCTIONS FOR MEDICAL INSPECTION REPORT l

PART 1: INSPECTION RACKGROUND DATA

1. Check the appropriate box to indicate if the inspection was announced or unannounced.
2. Fill in the License Number, Inspection Agency, Itxpiration Date of the License, and the Inspection Date. )

1

3. Did the licensee submit a timely renewal? N/A is used only with a new application.

4.

Put in the amendment number when the license was last renewed in its entirety to the current amendment number.

5. Circle the priority of the licensee.
6. Put the date of the last amendment. If its been a year or more, you may wish to check with Licensing Section to determine whether subsequent amendments have been issued.
7. Check the appropriate supplement box (es) if the licensee is authorized for the group (s) .
8. The Inspector's signature and the date the UIF was completed.
9. The Supervisor's signature and the date the inspection was approved. This date will depend on the agency's policy: upon completion of the inspection packet or approval of the NOV and cover letter.

PART 2: LICENSEE DATA

1. Fill in the licensee's name and address from the license.
2. If the inspection address is different from the license address.
  • ill in. If it is the same, check the box.
3. Fill in the name and ti':le of individual, administration, who was contacted at the last inspection. If it is a private practice, you may wish to put th9 business manager's name.

PART 3: LAST INSPECTION /COPkECTIVE ACTIONS

1. Fill in the date of the last inspection and the date of the letter which described the corrective action (s) .
2. List the violation (s) noted at the last inspection. If it's too numerous, attach the NOV.- If no items of noncompliance were found, write NONE in violations section.

1

3. List the recommendation (s) from the Isst inspection. If it's too numerous, attached the cover letter.

PART 4: PERSONS CONTACTED 1.

List the names and titles of the persons contacted during the inspections a.

The administrator and/or his assistant who is responsible for the radiology department - This could be the persons you contacted at the beginning of the intpection or the persons contacted by the radiology department.

b. The radiation safety officer and/or the chairman of the radiation safety committee and any other physicians that were contacted daring the inspection.
c. The radiology manager and the chief nuclear medicine technologists.
d. The nursing supervisor if training is required of nurses.

PART 5: MANAGEMENT ORGANIZATION -

1.

If no changes had occurred in management structure, check the box.

List the new management who will receive the inspection findings and the organizational chart of the facility.

2.

Check if the RSO listed in License Condition #14 is still present.

3. If the Radiation Safety Committee is required:

a.

Is the chairman as listed in License Condition #14 and is there a r.aember of the administration on the committee?

b. Is the RSC meeting at their required frequency?

c.

Does theBT Appendix minutes reflect the duties of RSC as described in 4

List the chairman, the radiation safety officer, and the administration member from the last inspection or license application.

inspection. You may wish to make corrections during the 5.

Comments section is for any additional information that is needed

< but could not be entered in PART 4 or 5 because of space limitation.

2

PART 6 UNUSUAL OCCURRENCE & INCIDENTS

1. If nothing was found in the inspection file or through interview of the staff, write the mane of the senior person making that claim. Check the minutes of radiation safety committee to verify as well as exposure reports.
2. It incidents have occurred, has the facility implemented corrective actions to prevent a reoccurrencat PART 7: p0 STING
1. Is the licensee complying with NMRPR, Subpart 4?

PART 8: EMPLOYEE TRAINING

1. Use the remarks section to describe the training program for the technologist and ancillary staff as well as refresher / continuing education from the license applications.

2.

Is the facility complying with commitments made in the license application? If no coemdtments were made, do you wish to wake recommendations?

3. Circle Yes or No, if records were reviewed or if persons were interviewed.

PART 9: EXTERNAL PERSONNEL EXPOSURE

1. Write the name of the vender from the license application or from the last inspection whichever is later. During the review of exposure records write down the account number, especially if it's a private practice.
2. The period reviewed should be from the last date that was reviewed during the last waterials inspection. If the machine program has examined the exposure records after the last materials inspection, you may start from the last date of the machine program. Make a note in the comments section if you are not using the date that was reviewed during the last materials inspection.
3. , Is whole body and axtremity monitoring being provided as required by NMRPR, Subpart 4? List badge type, film or TLD, and exchange frequency, monthly or quarterly, spot check the percentage of late returns. If there is a large number, check the high risk category for complete record.

4.

Are pocket dosineters used? List the types and if they are being calibrated and leakage tested as required.

5. Are there .,y purported cvarexposures?

3

I p 6. Does the facility have a complete and accurate exposure history?

7. Are the exposures ALARA?

4 8.- All overexposure reports made to the Department?

9. Does the f acility maintain records of prior doses?

10, Are reports provided to the eeployeest d

11. Who reviews the exposure records?

PART 10: INTERNAL PERSONNEL EXPOSURE

1. If there is no bioassey requir ent, check Not Applicable box and skip to Part 22.
2. List License Condition (s) which require bioassays. If bioassay is required, is the method, frequency, and instrumentation as described in the License Condition (s)?
3. List the isotope (s) which require bioassay.
4. Was a dose assessment'made on the positive bioassay?
5. Check the bioassay procedure (s) used.
6. Check the engineering controls in place to prevent uptake.
7. Was the negative pressure of the ste ? age and use locations for Xe.

127/133 checked?

PART 11: NOBLE GAS / SANITARY SEWER RELEASES

1. Documentation that air concentration in controlled areas are within regulation limits, NMRPR,_Subpart 4, Section 461, Appendix B.
2. Documentation that air concentration in uncontrolled areas are within regulation limits; NMRPR, Subpart 4, Section 461, Appendix
3. Determination made by calculation or sampling analysis?
3. Documentation that water concentration in the sanitary sewer is within regulation limits: NMRPR, subpart 4, Section 435, Appendix
5. Note patient discharges into the sanitary sewer is exempted.

4.- All accidental releases r3 ported NMRPR, Subpart 4, Section 452?

I 4

PART 12: INSTRUMENT QUALITY ASSURANCS l

1.

List all wedel no and serial no. of dose rate instruments compensated 0 M, ion chambers, etc.

a. Instruments calibrated at required frequeney?
b. Proper calibration procedures being followed and performed by an authorised vendor?
c. Instrument is capable of measuring the dose rate of therapy patient and/or Tc 9pm generator?
d. Is it currently operable?
2. List all model no. and serial no. of contamination survey instruments; end window 0 M or pancake probe.
a. Instruments calibrated at the required frequency?
b. Is check source used to determine if detector is functioning?
c. Is it currently operable?

3.

List all model no. and serial no. of dose calibrator (s) .

a. Is the constancy of the dose calibrator checked each day the dose calibrator is used? .
b. Is the linearity of the dose calibrator checked quarterly?
c. Is the dose calibrator calibrated annually?
d. Was the geometric variation of the dose calibrator performed at installation or after repair?
4. List all model no, and serial no. of gamma camera (s); fixed and mobile, that are used.
a. Is an uniformity flood performed each day the camera is used?
b. Is a spatial resolution performed weekly?
5. List model no. and serial no. of other counting system (s): thyroid uptake probe, well counter, etc.
a. Proper : slibration procedures being followed?
b. 2ne r r" ment (s) ceSibrated at required frequency?

PART 13: SEALED SOURCOS

1. Does the licensee leak cast required sealed sources at six month intervals?
2. Are leak test records complete and accurate; all required sealed sources must be leak tested unless there is a license condition exempting
  • stored sealed sources.

5

-vw.-, ,,..: n,,,-- , - . , -n e n v - - . . m -

i I

l

3. i Is the person taking wipe test of sealed sources authorized by the '

license?

4. Is the vendor, who is analyzing the wipe tests for leakage, authorized by the Departnant?
5. 2s any positive leak test reported to the Department within five days of the test?
6. List all sealed sources located in Nuclear Medicine Department.

PART 14 PROCEDURAL REVIEW

1. All radioactive materials, standing and non-routine, ordered as per license condition?

2.

Written protocols in place for off-duty delivery and security?

3. Package survey and opening per license condition and regulations?

4.

Is licensee authorized for a generator and does it perform Mo 99 breakthrough on each eluate?

5. Did the licensee exceed possession limit?
6. Were all users authorized? In places that has only one authorized user, you must interview the user and the technologist and/or review nuclear medicine reports.
7. If locum tenens were used, does the licensee have documentation per license condition?
8. Is the nuclear medicine technologist certified or does the facility have a waiver?
9. Who determines the appropriateness of nuclear medicine procedures?

Does he/she have written protocols available? ,

10. All use locations authorized?
11. All RAM controlled and secured by the licensee?
12. Use and User (s)
a. List all isotopes utilized by the licensee from the patient log,
b. List all groups authorized by the license with possession limit and if license fees are current.
c. List all authorized user (s) and the groups that they are authorized for in the license,
d. List all locum tenens used during the last three years and the groups that they were authorized for.

6

e.

f.

List all authorised locations in the license.

List all Nuclear Medicine Technologists, certified as well as trainees.

13. Are all necessary caution signs posted?

14.

Was radiation monitoring done on each day isotopes were prepared and injected? List the period of record review.

15.

_ contamination survey performed each day of- Asotope use? List the period-of record review.

16.

Daily wipes for contamination surveys required and performed?

17 Survey of group 5 patients:

a. Survey of patient at bedside, 1 meter, and doorway?
b. Nursing care notification posted on door and in patient's file?

l c. Patient surveyed at discharge?

d. Room surveyed and decontaminated as required before release?

e.

Use the remarks section to describe the training program for the nursing staff as well as refresher / continuing education from the license application.

f.

Is the licensee complying with commitments made in the license application?

g.

Circle Yes or No, if records were reviewed or if nurses were interviewed.

18. Disposal of radioactive materials:.

-a. Does sanitary disposal by the licensee meet requirements of NMRPR, Subpart 4, Section 4357

b. Is the RAM decay storage area posted and does the radiation levels at uncontrolled areas meet NMRPR, Subpart 4?

c.

Now defaced? does the licensee insure that all radioactive labels are

d. Is .the shipping records of generators complete and accurate?
e. Are the shipping records of other materials complete and accurate?

f.

Does the transfer of any RAM meet U.S. - DOT Regulations?

h. Does the f acility dispose of radioactive animal per license commitments?

A.

Does the licensee compact radioactive, waste per license conditions?

PART 15:

INSPECTOR'S MEASUREMENT & OBSERVATIONS

1. List model no., serial no., and calibration date of all instruments used to survey the licensee.

7

2.

If the licensee haa a floor plan, indicate radiation readings on the plan.

3. List the radiation range in the controlled and uncontrolled areas around the Nuclear Medicine Department.

4.

Indicate if contamination evaluation or effluent sampling were performed. i

5. Check those items observed and evaluated by the inspector.

PART 16: INSPECTION FINDINGS

1. List items of noncompliance.

PART 37 RECOMMENDATIONS

1. List all recotamendations to the licensee.

PART 18: LICENSE REVIEWER ALERT

1. If yes, check the box and write a short description.

~

NMED,RLRS, REV. 9/97 K MED. PRO o

8

MEDICAL INSPECTION FORM License Number:- .

Expiration Date:

LastInspection Date:

Irspection Priority:

Inspection Date:

Type ofInspection: _ Routine _ Annnunced Unannounced initial Special A. LICFNEF NAME & ADDRERS ACTUAL LOCATION Telenhnne #

B. MANAGEMENT CONTACTmTI FIORGANf2ATIONAL CH ART (109h C. RADIATION SAFETY OFFICFR-

12. PROPRIFTARY INFORMATION (307.Fh E. SPECIAL LICENRF CONDITIONS (30th Inspector Date ofReport Management Review

, Date of Resiew I

1. LAST INSPECTION-(VIOLATIONS / CORRECTIVE ACTIONS-l l

L SCOPE OF LICENSED PROGRAM!

i 1 ADhENISTRAT&T REQUIREMENTS:

L. RADIATION SAFETY OFFICFR (702Rh L ALARA.STf.TEMENT & ANNUAL RFVIEW (702 Ah

- 6. ALARA/AITTHORITY & RRRPONSIBIITTY/ SUPERVISION (702h

7. MF111 CAL RADIATION SAFETY COMM1 ri EE (702Ch (Noter Membershin/Meetime Freanenev/Miente Chair /RSO/ Admin.)

2

  • l l

L,, EdTHORI7FD IJSERS Imenm Tenens 1,, TRAINING /EXPERIFMCE (712)!

1

  • (NOTE: ANCILLARY STAFF, MAINTENANCE, JANITORIAL, SECURITY)

RSO Trainine Physician Traininc Nuclear Medicine Techn cian Certification Fmnleyee Refresher and/or On Going Training Nurse's Trsinine How Ofien Bv Whom Written Trainine Outline /Framination Certification /Frpiration Date Records reviewed Inteniewed

10. GENERAL TECHNICAL REQUIREMENTS (703)
11. FACILITY
12. POSTINGt Notice to Emnlovees Iicence & Amendments Cu..mt Copy of Reculm* ions Ooerating Procedures Emerger.cy Procedures Nuclear Medicine Tech Certificitae

~3 _

e i

13. CAUTION SIGNS-RmAinnetive Materiale Slan RmAintion Area Ai6arne RmAinnetivity Area Container i mheline Radiannelide i mhelina Viale/Svrinne f.nhelino ,

l

14. SECURITV-
15. SF AT Fn SOURCES (CAT TRRATION SOURCES)(703 D.h Semiad Soure~ S/N Cal. Date DisposalDate Co.51 Cs 137 Ra-133 Co-60 Rm-22
16. T F AK TEST (415h gif)TEr. Person takine wine test anthar!=ad by ==as -dl* tan or a. ^: .ad) 6 ww. nth intervals Date of tank S:^2 h ic. .. a by Certified /Frd dan Date
17. SURVEYS:

(NOTE: Serveys each day of use with survey meter & wipes where prepared or adelaistered and weekly where RAM are stored. & reported in DPM):

Survey Area Map Iniection Area Mat T mh Floor Tr=' mill Aren(s) Actinn level Daily Radiatian Monitorino Stormee Arem(s) Waab1v Wine Survev How are swines annivnd Bv whom Racerds e

(NOTE: Costandmation acb levels-2000 cpm /100 cm sq., or see regulatory guides 8.23).

4

4

18. EQUIPMENT OUAI ITY ASSURANCE (703h DOSE CALTRRATOR (703 A.h ,

Constanev Da n; Accuracy-ImT4.g.,$;,Artually Linearity-Installdson & Onuterly Jometrical Variation-Installation .

CiO.17a For Procedures See Regulatory Guide 10.8. Appendix E).

Dose calibrator measurements (703C):

19. SURVEY INSTRUMFNTS (703B):

INOTE:. Range-0.5 mR/hr-100 mR/hr & 1 mR/hr-1000 mR/hr):

Bacbm Onerationa' Check Source Performed Calibration Dates Calibration Freauenev Certified Vendor Calibration Procedures:

T met Calihimilon dates __

20. G AMMA CAMQt Flood Fields Daily Bar Phantoms (Resolutionni Weeklv
21. OTHFR COUNTING SYSTEMS:

Calibration Procedures Calibration Frecuenev

22. PROCEDURES PEVIEW:
23. MOLYBDENUM o9 GENERATOR:

(NOTE: Mo 99 detection. activity level 0.015 aci/ml Mo-99 per mci of Tc-99m before administered)

Manufacturer Possession Limit / Activity Shieldine S

I

- Evehanee Freauenev MolvW.nm Braak hroneh t test Alumina Braakthroneh tae+

Dir .:al/Sanrenation? Darav.In-Stormee

24. SUPPI TFR RECFTVING(7021n; Inventnev los Acanired Ec.r..-

Rinole d.= l Multinle d.=

- No....m1 Deliverv Tima/mi '

Nr.r.-Routine Ordern Raeurity A=u.ted hv

@ 12vels! Parkmee survev-rnatar r.-l. e:

Park..e Ooenine Pracantes

- 25. EXTERNAL / INTERNAL PERSONNEL EXPCSURE: -

l - PERSONNEL DOSIMETRY (415h f

NVLAP Vendor Evehanoe Frean=m Period Framined &cm to WB- Rine En. ...ity Any ernomure(s) excaadine limits EDQCET DOSIMETERt j

l

- Maka/maAa1 #

c=ht..e:nn Freauenev Rvnaenre ALARA (10% o.M Daeard of Prior Dana Det_...inatian Manarta reviewed by

26. INTERNAL PERSONNEL EXPOSURE:

27.B10 ASSAY PROCEDURES:

Equipment orInstrumentation License Condition Freauency ._.

1motone(s) 1-123 I-131 Xe127/133

]fgghed In-house vandar +

Thvmid Urine Whole Body Couni;ne 6

Dose Assessment (Action Levels)

28. ENVIRONMENTAL CONTROLS:

Air Concentration. Controlled Area Air Concentration. Uncontrolled Area -

Enrineered Contri Hood (s)

Charcoal Trans(NOTE: filter change dnTite should be blue not pink or white.)

Shielded Container Negative Pressure:

Area Monitorino/Calenlations

29. DISPOS AL:

Disposallog Decay-In-Storage Sanitary Sewer Disposal Disposal of sources since last inspection Deface RAM Labels Shipping papers and package labels proper Shipping Records Any Shipment incidents

30. INCIDENTS / REPORTS:

Thefts or Losses Oveiexnosures Excessive contaminntion levels loss of timelfacility Eouinment failure ,, miendministration Notification Reoorts Ceri&tive Actions 7

31. INSPECTOR'S OBSERVATIONS / COMMENTS:

Observation Checklist!

1. Gamma Camera Tests 6. Svringe Shields 11. Package Caenino-Surveys
2. Dose Calibrator Tests 7. Hoittakeenina 12. Storage Shields
3. Generators 8. Hoods 13. Refrieerator
4. Protective Clothes 9. Waste Containers 14. Employee Actions
5. KamplelDose 10. Patient Bathroom 15. Area Monitorino
16. Other (NOTE: KEY NUMBERS TO COMMENTS):

31 INSPECTORS COMMENTS:

32. INDEPENDENT INSPECTION SURVEYS:

Instrumetc Used:

Model No. S/N Calibration.Date

33. INSPECTION FINDINGS:

8

31 RECOMMENDATIONS:

36 LICTNSE REVIEWER AIRRT YES NO IF YES. d*** mant NMFn/RLRS.REV. 9/97 9

l ATTACHMENT 6C DENSITY / MOISTURE GAUGE INSPECTION FORM INSTRUCTIONS FOR PORTABLE GAUGE INSPECTION CHECKLIST l PORTABLE GAUGE INSPECTION CHECKLIST PORTABLE GAUGE INSPECTION BY MAIL

c PORTABLE GAUGE INSPECTION CHECKLIST

1. INSPECTION SACKGROUND DATA ( ) announced ( ) unannounced License Amendment No.

l Inspection Date Expires Renewal ( )

2. LICENSEE DATA

. Licensee Address ( ) same as Lic. Item 2.

Insp. Locatn. [ ] same as above Contact Title Phone No.

3 3NSPEC70R Date Supervisor Approval-4.LAST INSPECTION - RESULTS AND CORRECTIVE ACTION (Date of last inspectioL)

a. Noncompliance ! ) None Current Status
b. Recomenda tion ! ) None j

)

5. PERSONS CONTACTED DURING INSPECTION Mgt. a Ent Exit other

[] {) []

RSO b

() [] []

-Operator c

() () []

Ancillary d

[] [] []

6.MMEhGDIENT/ SAFETY ORGANIZATION [ ) same Es last in!p.- .

i a.-RSO's apr' Title same as 5.a-[ ]

IC ' No RC

b. 330 as per License- NA NC

[} () ()  !]  ! l ---

c. Aks0 as per License

[ 1- []- [] [ 1- []

7. IIfUSUAL OCCURRENCES & INCIDENTS
a. None since last insp. per
b. Thef t or losa reported. -[ ] [}  !) () []
c. Notifications' 1 ). [] [} l) [.)
d. Reports

() [] [] [} []

-e. Presumptive Overexposure

[ ):yes  ! ) no see 11.f.

8. NOTICES. INSTRUCTIONS, & REPORTS a.-Informational Posting (1) Copy of Regulation . [} () []' [ ). [}

(2) License and Amendments [] [] [-) [] [ ')

(3) Operating (includ ' emergency predrs) [] [] [] [] []-

-(4)- Notice to Employees [] [.) [] [']  !)

' b. Info. Posting Notice Used

[ ] yes ( ) no

'S. POSTING SIGNS AND' LABELING

a. -Area Posting (1) Radiation Area () [] [] [] [}

(1) Radioactive Material [ ]- -[] [] [] []

i b. Container / Gauge Labeling [] [] [] [] [}

. Mfrs Label on Transport Case () yes [ ] no
10. TRAINING (Lic. Doc.)
a. ' operators (obtain list or annotate in notes)

(1) Records of training (certs.) - [] [] [] [! [}

(2) RSO statements of auth. [] [] [] [] []

[ ] List [ l'Indiv. statements A

b.. Rso procedural Knowlede)

(1) _ Operating /2nergency procedures [] [] [} -() ()

(2)- Shutter Cleaning () [] () () ()

(3) Leak test collection [] [] [] [] [}

c. . Ancillary personnel [;

[] [] [] []

'11.

EXTERNAL RADIATION EXPOSURE MOWITORING a.- Vendor name Ac:t. #

b. Type of monitoring frequency

- c. Period examined:- From to

. (l'2 Range of-annual exposure for year, from _ arem to arem

! d. Number of workers in program

} e. In Accordance with Lic. Condition [] [] [] [] []

(1) Dosimetry used ( ) yes [ ] no (2) Compliance with reg. limit [ ] yes [ L-(3) Records maintained properly ( ) yes [ ] ao

-(4) Timely return to vender

[ ] yes ( ) no

f. Report of Presumptive overexposure 12.- 10 CATIONS OF STORAGE AND USE IC NO RC NA NC
a. Permanent Storage Locations (1) Security
1) available/ maintained ii) adequate while recharging

() () () () { }-

[] [] [] [] []

(2) Fire Related Safety (3). License Condition

1) loca. tion per item #10 [] [] []

ii) comply with drawing [] []

[] [] [] [] [ ).

iii) storage capacity for Possession limit [] [] [] [] []

b. Temporary Jobsites Documents (Lic. Cond.)
1) RSO auth, statement () () [] [] []
11) license (') () [] [] []

111) manufac. instrue.

manual /emerg. procedures

() () [] [] []

c. In/out Log () () () () [}

d.

~

Storag3 At Tempor:ry Jobsit:s [] '[ ] [] [] []

(1) security i) availab*.e/ maintained [] [] I1 [] []

11). adequate while recharging () [] [ -) [] []

(2). Posting [] [] [] [] []

(3) Duration [ ). [] [] [] []

Minimum _ , days Maximum _- _ days

13. . INVENTORY

.a. Within possession limit # [).

{] []  !) []

b. Records of receipt, transfer, and' disposal. [] [] [l'  !) ()
c. Physical inventory (obtain serial numbers or  !] [] [] [} []

attach list)

.m-l l

14. LEAK TESTS IC NO RC NA NC -
a. Leak / wipe test collected per required freq. (Lic. Cond.)

[] [] [] [] [}

b. Records maintadned (Lic. Cond.) I] [] [] [] [ 1-Gauge. Date of Test- Vendor

(

c.. Persons collecting wipe tests, authorized [)~ [} ). [] []

d. Reports of positive results/ corrective actions [-) []- [] [] []
15. .

COMPLIANCE WITH OTHER/SPECIAL LICENSE CONDITION

a. Maintenance' [ 3- [] [] I) ()
b. Storage only [1 () [] []  !)

C.

16. TRANSPORTATION, PACKAGING & SHIPPING
a. Method of Transport to Jobsites-
b. Security during Transport (49 CFR 177.842d) IC NO RC NA NC

.(1) Open vehicle () Closed vehicle []

(2) Package braced, blocked or otherwise [] [} [] [] []

. adequately secured in vehicle

c. 'Pxkaging during Transport (DOT 7A, Type A 49 CFR 173.415)-

() () () () ()

(1) Uses afr's case / package' [] ye2 I

[ ] no

_( 2) Uses other case / package [ ] yes [ ] no

d. Package Marking and Labeling (1) Package legibly marked (49 CFR 172.300 thru ( ) ()

310) (' -[] ()

i (2) Package legibly labeled (49 CFR 172.403) I] []  !) () []

(RAD Yellow II, 2 sides of package)

e. Shipping Papers Used (49 CFR 177.817e) [] [] [] [} l) f.

Certifications (49 CFR 173.476 & 173.415a)

(1) RAM Test-Certification available [] [] [] []  !]

g2) DOT *JA Packaging, Test Certification available () () () []  !)

g. Enroute Storage-(describe)

-17 INSPECTORS MEASUREMENTS & OBSERr e..' IONS

a. Measurements Taken ( ) Not required [ ]

Make Model. Serial Number til Instruments used (2)- Calibration date Vender (3) Radiation levels in controlled areas (4) Rac . ton levels in uncontrolled areas

b. Inspector Coaunents
18. DISCUSSION WITH OPERATOR IC NO RC NA NC
a. Adequacy of Operator Knowledge. [] () () [] [}

i) Operating / emergency procedures [] [] [ ]- [] []

ii) Transportation / security () [] [] [] []

iii) Shutter cleaning

() {] []  !) []

iv) Leak / wipe test collection () [] [] [] []

v) Other [ ).  !) [] [] I)

b. Operator Conenents ,

4

19. -

EXIT CONFERENCE WITH MANAGEMENT l

I l

20. TRJVEL DIRECTION TO LICENSEE 2C o In compliance RC = Recommendation No e Not observed NC = Non-compliance NC = Not Applicable mannus.nav wet feeEA. PRM l-O 6

e INSTRUCTIONS FOR PORTABLE GAUGE INSPECTION CHECKLIST I.

LICENSEE AND PREVIOUS INSPECTOR ETATUS

.. Complete all items.

B. Verify that previous violations have been corrected. Have the last inspectors recommendations been adopted?

2 PERSONS CONTACTED A.

List the names and titles of individuals contacted.

3. MANAGENINT/ ORGANIZATION A. Attach an organization chart if available.

B.

C.

Identify the RSO's positions within the company.

If the company has various field locations list the managers of each.

4.

UNUSUAL OCCURRENCES OR INCIDENTS A. Review any accidents that have been reported.

B. Has there been a theft of a gauge reported?

5. POSTING OF INSTRUCTIONS I A. Are all required documents posted?
6. AREA POSTING A.

Observe all required posting of warning signs and labels.

7. TRAINING A. Review training records and complete certificates.

B.

Interview personnel to determine extent of knowledge of radiation survey.

8. IITEND PERSONNEL MONITORING A.

Review all monitoring records if monitoring is required by license conditions.

B. Review storage location of badges when not in use.

9. STORAGE LOCATIONS A.

B.

Review all permanent storage locations authorized under the license.

Are temporary storage locations used? If so, under what circunistances and for how lor.g?

bD

10. INVENTORY A.

List the make and model of all gauges possessed. Are all authorized by the License?

2.

Deter 1nine the frequency inventories are taken by the RSO.

11. LEAK TEST A.

B. Verify that all gauges are tested at the required frequency.

Has the gauge been returned to the manufacturer for maintenance?

Verify that a leak test is collected prior to placing it back in use.

12. TRANSPORTATION, PACKAGING AND SECURITY A. Verify all transportation requirements are met.

B.

Observe the security devices provided to prevent theft gauges while en-route to job sites.

C. Review shipping paper work that - the operator mu . carry while transporting the gauge to job sites.

13. INSPECTORS MEASURENINTS A.

Measure radiation levels at storage location to verify permissible dose rates to personnel adjacent to storage locker.

B.

Measure radiation levels at cab of the transport vehicle if the gauge is placed near the cab while in transport.

NMED/RLRS. REV. 9/97 K-PG. PRO

DENSITY MOISTURE GAUGE INSPECTION REPORT FORM License Number Expiration Date Date of this Inspection Inspection Pdority PreviousInspection Date -

Type ofinspection__ Routine Announced Unannounced Initial Special A. LICENSEE & ADDRESS ACTUAL LOCATION TELEPHONE B.

INDIVIDUALS INCLUDED IN MANAGEMENT INTERVIEW (109):

C.

NAME OF RESPONSIBLE PERSON (Ora +2donal chart):

D. SPECIAL LICFNSE CONDITIONS (30Rh 4

E. uwer sent to Licensee on:

Inspector Date ofReport Reviewer Date ofReview I

1 1 l

e 1.

FOLLOW-UP ON PREVIOUS INSPECTION FINDINGS:

2.

SUMMARY

OF LICENSED PROGRAM.(Type ofprogram):

3.

INTERNAL AUDIT (Annual Safety Review & ALARA & SOP'S):

4. '

AUTHORIZED USERS: (Training Certification, Supervision of authorized users):

5. TRAINING / RETRAINING:

RKO Traininemrnerienes R :r=.dhilities & Anth. hv -

' Anci11mev L-.. . 21 Trainine Ra'.J.ar Tr h.:..e By whom/Cartifiention -

Written Frnm Manneement Review 2

6.

FACILITIES (Engineered Controls: Access Alarms & Controls, Transport Vehicles,

=

7.

SECURITY (425):

Access and Exit Controls Fire Protection Visible and Audible Wamino Sionnie Physical Secur;iv & Monitorino L%n Frit 8.

INVENTORY LOGS / RATE OF USE(317):

9

9. - LEAK TESTS:

9 1 10.

PERSONNEL DOSIMETRY:

Fihn Badge or 7LD for eachIndividual Pic-:==-i by Frequency Exposure Records Comnliance with reculatorv limits-

'3 .

o

Erwwwe ALARA (<10% ofminimtim rm,,,,immible)

Notification Reports Available to Employee .

High Reading /Overexposures Er. .=.* Himenrv providad to Emnin ;=

Rr-.m reviewed by

11. POSTING & LABELING:

NMED045 License and Operding Procedures:,,

Regulations -

EmergencyProcedures AnyNotice ofViolation Training Outline

" CAUTION RADIATION AREA Signs" Labeling on Device / Equipment

- 12.

l TRANSPORTATION (U.S. DOT 49 CFR 170-199):

1

13. DISPOSAL METHODS:

Stoman i em+ ion Trr.A Rm..rds ,_

14.

INCIDENTS OROVEREXPOSURES:

Reports and Noti 5 cation 4

15.

OPERATIONS OBSERVED: (NOTE: Every attempt must be made to observe operations conducted in association with possession, use, and disposal oflicensed material).

16.

INFORMATION CONTINUATION FROM PREVIOUS PARAGRAPHS:

17.

INDEPENDENT MEASUREMENTS (Results C+4=M to Licensee, NOTE: Attach analysis report sheet):

Bked Tr.r.ument naad Madel # _. S/N ('m1 nate Survev/ wine mann

18. INSPECTION

SUMMARY

19. EXIT INTERVIEW-Senior Management Date License Reviewer Alert, memo sent?

Ifyes, Date sent NMED/RLRS REV.10/97 6

\.. . . . . . ..

2 r

PORTABLE GAUGE INSEECTION BY MAIL

4. Licensee Name Address City. State. ZIP
2. Radiation Safety Officer

- Authority; who appoints and contact with management.

3.

Describe by this agency, any corporate or organizational changes in your company since the last inspection i

4, List below the PORTABLE RADI0 ACTIVE GAUGES you store and/or use:

Manufacturer Model Nteher Radioactive Materials and

$/3 amounts in millicuries (Use supplemental pages if necessary to list additional units.)

5. Describe use of-gauge:

- 6.

Describe storage location of gauge (s). Submit drawings of storage area as Attachment ~6.

1

7.

List all the individuals who are authorized to use the portable gauges and who provided training. (D0 NOT SUBMIT COPIES OF THEIR TRAINING

  • CERTIFICATES)

Authorized User -Trained by Authorized User Trained by (Use supplemental pages if necessary to list additional users.)

8. Radiation safety program management. ~

[]

The and radiation Radiation Safety safety tasks Officer (RS0) takes care of radiation safety records, training

' [ -] RSO is the owner, a partner or manager

[]

RSO was. officially appointed by the owner, a partner or facility manager i 9.

Portable gauges must be stored in a secure area. Pleast L eck all that apply:

[] Portable gauges are stored and not being used I'

Portable gauges not being used

[-] will be returned to manufacturer

[] -

() are stored and used at the address' listed in Question-1 of this form are stored at another pennanent storage site listed on license

[]

Portable gauges are used in the field and stored at temporary sites 10.

.. Regulations.

Portable gauges must be transported according to U.S. Department of Transportation Please confinn:

[]

During transportation on public roads, the portable gauge is blocked _and braced that it cannot change position during conditions nonnally incident to transportation (49 CFR Part 177.842(d)..

-[]

Shipping papers accompany every shipment of radioactive material (49 CFR Part

-177.817).

Sutait a copy of the shipping paper used to transport your gauge.

[]

Emergency response information is included with shipping documents (M CFR Part 172.602).

[]

The emergency response telephone numer is a 24-hour monitored, live line, not a beeper or other mechanical answering device (49 CFR Part 172.604).

[]

. A copy of the shipping haant, the emergency procedures and the 24-hour emergency telephone numer are kept in the driver's conpartment within reach of the driver at all times during transport. [49 CFR Part 177.817 (e))

2

IIT Persons who use portable gauges should wear personnel dosimetry devices. Please check the type of dosimetry you wear and the exchange frequency: ,

() Film badge

[] TLD badge

[:)_ Finger badge.

() Exchange monthly '

[] Exchange' quarterly

-[ J' Don't kncw*

[] Other*

  • Submit explanation. '

12.

Please check all the boxes that apply to maintenance you perfonn on your gauge,

() Routine device cleaning nnly; no source rod or shield block cleaning

() No maintenance, return to manufacturer for all maintenance

() Authorized for source rod or shield block cleaning by license condition

() During cleaning, put source rod in a " pig" to shield radiation

() Do source rod cleaning as described in manual

( )- Wear " fir.ger badges" when doing do source rod cleaning i

[ -) Have special training to de source rod cleaning

13. Check the doctsnents that are posted:

[] Notice to Egloyees-NMED045.

[] Vendor Certificate.

[ 3- Copy of the Radioactive Materials License, including attachments.

-( ) . Copy of HMRPR.

[] Alternate Notice (this takes the place of the Radioactive Materials License including the application and any attachments. operating procedures and NMRPR),

14.

Current copies of the following documents are transported with each gauge:

-[ ] The Radioactive Materials License

() . Operating procedures

[-] The Validation Certificate

() Leak Test-

15. Please confirm the following regarding leak testing:

.(). The RSO=or designee does the leak test wipe

[] Leak tests are done every 6 months in acconiance with license condition  ;

[-)

Leak tests done on each sealed source for the past 3 years.

Isotope Model # S/N Date of wipe Analyzed by Results List below the vendor who does leak test analyses.

NAME ADDRESS CITY STATE. ZIP LICENSE'NO.

CONTACT 3

-- d

: . :. . ;, : . : :. :. : : . . :. :. . . . :. :. :. . : : : 2. 2 . : : : :. :. :. : :. :. . . . : ; ;. : . . . . . . : . : . . . . : . : . : : :. +,s CERTIFICATION
16. I certify that all items on this fona are accurate and true.

SIGNATURE PRINT-NAME TITLE OF CERTIFYING PERSON

,DATE NMED/RLRS.REV. 9/97 K PGMail.FM I

4

4 ATTACHMENT 6D INDUSTRIAL RADIOGRAPHY INSPECTION FORM INSTRULTIONS IN PREPARATION FOR INDUSTRIAL RADIOGRAPHYINSPECTION REPORT INDUSTRIAL RADIOGRAPHY FIELD S7 TE INSPECTION REPORT I

I i

INSTRUCTIONS IN PREPARATION FOR INDUSTRIAL RADIOGRAPHY INSPECTION

1. Inspection Background Data a

complete all items at the conclusion of the inspection.

Type of inspection - check all appropriate boxes.

Indicate all persons contacted during the inspection, g

2. Organization Describe the organization and comment on its radiation safety effectiveness.

List all radiography and assis Act radiography personnel.

Indicate date of employment and eachnical certification if any, ie. level 3, etc.

3. Inspection History Provide a brief description of the licensees recent complianco history. Include incidents investigated.

Explain remaining items of noncompliance and why they have not been corrected.

4. Training Complete all items - review training provided for radiographers and their assistants. See NMRPR Subpart 5, Sections 515 & 527, Appendix A.
5. Internal Audits Verify audits done and by whom.

Type of record - log / checklist, etc.

6. Maintenance of equipment Verify that all equipment has been maintained. Examine for flaws that should have been repaired such as labels, etc. Source crank mechanisms should be tested for smooth operation and ware of connector tip.
7. Posting Verify th* licensee has supplied all necessary documents to field operating crews. Determine documents are posted for in-house operations.

1

O

e. Utilization Log Review questions.

an adequate number of utilization logs to complete all Items should be checked if they are done - if not check N/A.

9. Inventories Are all sources accounted for quarterly?  ?

Indicate make authorized and by the medel of sources if different from those license.

Identify a select number of projectors and sources contained in them. 4 10 Facilities Describe only temporary storage locations (less than 30 days) .

Attach a plot plan if fixed facilities.

Describe safety systems and their maintenance.

Review ctorage areas including en route storage on vehicles, j

  • Field sites:

NOTE:

A field site audit must be included in all radiography license r

inspections. At least one site should be visited to verify all operations are conducted according to the license and regulations.

The field site' inspection may be conducted prior to the complete inspection of the license and attached to the entire package when closed.

  • Survey meters:

A. Verify records covering items 1-5.

B. Observe use and accuracy of meters during field site audits.

Compare readings obtained with the inspector's meter's reading.

C.

Determine if numbers of meters on hand are adequate for the size of the operation.

11. Personnel Monitoring.

Complete review of all records.

Supply the licensee with a statement that all records up to the latest reviewed had been looked at by the inspector.

Verify monitoring equipment is worn during fiald site audits.

12. Leak Tests.

Verify all sources have been leak tested at proper intervals and records are maintained.

13. Survey Records.

2

Review and verify all survey records.

14. Posting & Lhbeling.

e observe all mecessary posting and labeling. signs must clearly i indicate radioactive material or radiation area at barricades of field sites.

15. surveys.

Measurements of dose rates at the surface of projectors should be made and if possible a conparison between the licensees readings ehould be made.  !

+

ne survey meter used by the inspector for measurements during any radiography inspection should be calibrated within 3 months.

16. Shipping / Receiving Procedures.

Verify that all package 3 received have besn surveyed.

Review shipping records to show that all spent sources had been properly packaged and surveyed. *-

17. Transportation.

Verify all transportation requirements are met.

St. Incidents Procedures.

Review any reports or incidents the licensee may have been involved with since the last inspection.

cernanan tt f rema rk a i Add any items not identified on the inspection form but may be pertinent to the licensee's ability to maintain a good radiation safety program.

clemina h erane.e/ trit interview:

officer.

D: scribe the inspection findings to management and the Radiation Safety All violations must be explained to the licensee in advance prior to issuance of the Notice of Violation.

items being actual violations, then the entreet inforination can beIf the inspector is uncertain ab coasnunicated to the licensee af ter consultation with the supervisor.

Reconenendations should be made whenever an item of noncoupliance is identified but there still needs to be innprovement made in the safety program. ,

- b22.r'o-NMED/RLRS. fMV.9/97 3

t

~_._.__ _._ _ _ _ _.

RAM COMPLIANCE Industrial Radiography Field Site Inspection Report

( ) Announced ( ) Unannounted Date Licenset ,

License No.

Inspector (s)

= ,

Inspectionlocatinn Phdiography Personnel Radiographer Date Hired Radiographer An4stant Date Hired Dther(s) Employer if not Licensee Monitoring Equipment Badge Supplier Wear Period /Date Issued Px ket Dosimeter S/N's Calibration Date .

Survey Meter Make, Model & S/N Calibration Date Calibration Date Dther Niitoring Device Calibration Date l

RadiographyProjector/Eauipment Projector Make. Model. Serial f Source / Activity. Serial i trank Assenbly Condition Good [ ] Fair [] Bad []

Source Tube Condition Good [] Fair [ ] Bad []

Pigtail & Connector Tip Condition Good [ ] Fair [ ] Bad []

I

2 ecnailpmoc. . 10 smeti sanidniF

] [ oN ) ( seY dedracalP elciheV

) ( oN ][seY .stnemucoD rehtO

)(oN ) ( seY tseT kaeL/trahC yaceD

][oN ) ( seY srepaP gnippihS ecruoS

) ( oN ) ( seY seeyolpnE ot ecitoN

) ( oN ] [ seY RPtM

) ( oN ] [ seY serudecorP ycnegremE & gnitarepO

)(oN ][seY esneciL no demaN rehpargoidaR 1

etaD tnemdnemA tsetaL

][oN ] [ seY esneciL eht fo ypoC noitatnamcab .

)rh/Rm ees eciL(

)rh/Rm rotcepsnI( nosirapmoC reteM yevruS eesneciL/rotcepsnI

) ( oN )(seY yevruS erusopxE tsoP tcerroC j_ .

) ( oN ) ( seY tcennocsiD/tcennoC reporP

) i oN ][seY deniatniaM ecnallievruS 4

snoitavresbO

) ( oN ) ( seY reniatnoC B epyT

][seY

) ( oN reniatnoC ytiruceS rotcejorP

)(oN )(seY etiS ta moor kraD * *

'Findinas

. Items of Noncompliante .-

)

. l Corrective Action Taken Job Allowed to Continue Yes [ ] No [ ]

Inspectors Inpression 3 ,

7

Inspection Plan Check

() Office Audit Within 30 Days

. ( ) Second Field Audit Planned ,

() Hold for Next License Inspection

() Other - Explain

Supervisors Review / Approval Yes[] No ( )

I Inspector Signature OEWht.WV. MM l'IRh.D i

S

=

4

0 INDUSTRIAL RADIOGRAPHY INSPECTION FORM I License Nurnber: 1 Expiration Date:

Last inspection Date:-

Inspection Priority:

Inspection Date:

Type ofInspection: Routine Announced - Unannounced Initial Special A L!CFNSE NAhE & ADDRERS ACTUAL LOCATION Telenhone B. MANAGFMENT CONTACT /ITTLF (ORGANIZATIONAI_ CHART (109h C. NAhG OF RADIATION SAFETY OFFICER.

D. PROPRIETARYINFORMATION(307-Fh E. SPECIA1 L? CENSE CONDITION (30th L i mttar ment to lie # nema on' Inspector Date ofReport .

Reviewer Date ofReview I

r

L FIEI n SITE INSPECTION:

L LAST INSPECTION: (VIOLATIONS / CORRECTIVE ACnONS); -

.L ALARA Program *

4. RECETVING & SHIPPING : -

i

' Procedures for Shineinc/Receivinc

~

l "

Survevs When ReEeived l

i Surveys When Shinped Jhinpers Panerwork:

Records

5. SURVEY INSTRUhEhTTS (Range 21000 mR/hrV509):

, Manufacturer-

, Adeunte Number Available

, , Instruments Calibrated & Onerable:

3 Month Interval Calibration

, Wher e Calibrated Records of Calibration' Safety Fouipment (Collimators. chielde Etc.h UEAR TEST (510h Wines T erformed by:

Method:

2

j i

I Riv (6) Manth intervala-n y,_3 y _ ,_ _ r _ _ ;,

7. OUARTERIN 'l?NENTORfRC/ INTERNAL AUDITE(Sith i met Invent,wv t' '-1 t/ht t=*=.act -

3 UTff 17 ATION LOO (312h Device and RmAle.n_.h-- TA=.:: Mad.

1_=2:1.r.dDates 15r.il Mad? _

En * ..du R==Alana R - ' ' hally hn:!r.d= RaehnE ' at the start of Neh thia.

Phveieal Eu asva R--- ' '

9 INRPECTION/MAINTENANrF OF DFVIPRC/CONTAINRRR/CHAN6mC511b  ;

hulnment Chark Prie.r to Une Week Day; hi:!r.mmnt check at 3.Mr. ^!. fatarvals' ,

ME.-E-a of Rannite t t

i 10 FAr'11 TTfFR AND CWrDRITY(31dh FiwaA faellity as daaaiihad in man!!r=Han '

ti sd112 - or lackad to L1 J-..; ===:hnr!**A an**va

- Vielkie & anAihle alennie ta =-... af- = ofreAia*ian

_ n! :.: Ri-veill- af Hieh DmAin*lan Aeam th ---- Area DmAlmeinn k;& -

F-- _ _de; .: ". . ; Ph . 2 n11v h=.x ',-

Eeva Eneitmiled hv*

3

11. POSTING ($20h NMFn045 Lleente and amendments Written Ooerating and Emeroenev Procedures Current Emereenev Procedures Cunmut Cony of Reculations i Conien of Procedures fumichad to all Radio 2ranhers and A.anistance:

Instruction Appendix A, Subpart 5 --

Notification Procedures in case of accident

._ _ Procedures to minimin exposure during accidents Any notice of violations orders issued Postmg of Vehicles; Storrge Room or area; Desicos & Storage Containers with " CAUTION RADIATION AREA signs.-

12. RADIATION SURVEYS / RECORDS (521):

Frequency ofSurveys Temporary Field Surveys Surveys aAer each exposure Surveys prior to securing source container Other surveys 1

Methods of survey (Radiation levels in unrestricted areas?)

11 PERSONAL MONITORING (517 52't FilmfTLD SunnHer (NVLAP)

Frecuenev Raeh Individual meeiened RmAme/ Pocket Danimatar/R atameter-Annum 1 Emlibration Pocket Danimatain?

R m Recania Reviewed for the Period to Average Ouarteriv Ernneure

. Egunts Available for Review by Emninvaaet High Readings /Ovwuporuivs Personnel provided exposure history 4

POCKET CMAhmERS Chamber (Range 0 200 mR/hr):

Pocket dosimeter provided by Calibration Frequency Dosimeter readings recorded _

{

15. TRAINING / RETRAINING ($15 & $27. Ann =dir Ah Radiographers named on license:

RSO Training Experience Responsibilities & Authority Refresher Training Approved Training Program:

Wrinen Test: .

Results Reviewed by Management:

16. TRANSPORTATION:

Tyne B Container Vehicle P1meerded Reeintered User of Parkmee Rhinnino Panerwork ,,,,,,

Annroved NRC Emmera Procram Tid..r.ortation Inder mR/hr 12 vein orR.Aintion emomure from Devhn a ennemir.=c Exterior of device to source 10 Cm or less - 50mR/hr, or less Exterior less of device to source 20 Cm or more and all outer source container - 200 mR/hr.

'S ,

17. DISPOSAI - '

Disposal of sources since last inspection Authorized containers Shipping papers and package labels proper? -

Transferrecords Any Shipment incidents 12 INCinENTS/NOTIFICATIONI452h Overernomres inee of C'c r.noVDiaconnaet-Erraneive 12velat Then-Di ge to EnuirTent?

Incident Renott/Invaatiention

19. INSPECTORS SURVEYS 20.

INSPEGOR'S OBSERVATIONS / COMMENTS:

6

- .. J

- __. .- - - - . - - _ _ . . . - - - _ _ - - . .=. _-. _ . . - -- - .-

0

21. INSPECTION FINDINGS!

l l

22. EXIT INTERVIEW!

~

SeniorManagement Signature '

Date

23. LirFNSF REVIEWER Af FRT. MEMO RFVI*/

If vet date ment NMFn/RI RS. REV. 9/97 7

RAM COMPLIANCE Industrial Radiography Field Site Inspection Report

[ ] Announced [ ] Unannounced Date Licensee License No.

Inspector (s)

InspectionLocation Radiography Personnel Radiographer Date Hired Radiographer Assistant Date Hired l Other(s)

Employer if not Licensee Monitoring Equipment Badge Supplier Wear Period /Date Issued Pocket Dosimeter S/N's Calibration Date Survey Meter Make, Model & S/N Calibration Date Calibration Date Other Monitoring Device Calibration Date RadiographyProjector/ Equipment Projector Make, Model Serial i Source / Activity, Serial i Crank Assembly Condition Gocd[3 Fair [] Bad []

Source Tube Conditior. Good [] Fair [ ] Bad [-)

Pigtail & Connector Tip Condition Good [] Fair [ ] Bad ()

1

%x

Dark Room at Site Yes ( ) No()

Projector Security Container Yes ( ) No [ ]

Type B Container yes[3 g3 [ )

Observations Surveillance Maintained Yes [ ] No[]

Proper Connect / Disconnect Yes ( ) No ( ) .

l Correct Post Exposure Survey Yes [ ] No [ ]

Inspector / Licensee Survey Heter Comparison (Inspector mR/hr)

(Licensee mR/hr)

Documedatd20 Copy of the License _ Yes[] No [ ]

Latest .t dient Date Radiographer Named on License Yes[] No [ ]

Operating & Emergency Procedures Yes ( ) 'No [ ]

MtPR Yes[] No ( )

Notice to Employees Yes [ ] No [ ]

Source Shipping Papers Yes[] No [ ]

Decay Chart / Leak Test Yes [ ] No [ ]

Other Doctments Yes [ ] No ( )

Vehicle Placarded Yes ( ) No [ ]

Findings item of Noncompliance 2

Findines Items of Noncompliance '

i i

Corrective Action Taken l .

Job Allowed to Continue Yes [ ] No [ ]

Inspectors Intression 3

Inspection Plan Check

() Office Audit Within 30 Days

() Second Field Audit Planned ,

[] Hold for Next License Inspection

[] Other Explain Supervisors Review / Approval Yes() No()

Inspector Signature eswan.m. wp 8.WL8.m -

4 ,

ATTACHMENT 7 INSPECTION PROCEDURES

- . . - _ . . . . - . . . . - - - - ..ge '

O INSPECTION PROCEDURES M MPECTION PROCEDtJREE - GEtJERAL ETATEMENT - INTRODUCTION Inspection procedures stress above all observation of licensed operations, review of authorizations, record review, identification of findings, recommendations, and management review (audit) by (

agency of inspectors / inspection results.

l i

M PURPOSE AND MIESION State Radioactive Materials Inspection Programs inrure the health and safety of the public and the environment from radiation hatards. To accomplish this mission, states conduct on-site reviews of licensed activities. Inspections o

identify the factors needed to protect public health and safety; o

use standardized, industry-wide methods and techniques to evaluate the uses of radioactive materials; o report regulatory findings to the publics o provide the licensee with a status reports o define necessary remedial actions; and o

encourage the licensee to remediate p..oblems promptly arid ef ficient '.y.

Inspectors. are to conduct on-site reviews of radioactive material operations;users to measure the radiation hazard from the licensed estimate personnel exposure from future use of radioactive material; assess compliance with regulations; and assure that licensees use good radiation protection practices throughout their operations.

The procedures discussed in this document can provide inter-state and NRC compatibility and nationwide enforcement uniformity.

Licensees who do not follow rules and requirements while operating in one state cannot move to another state and re-establish the 1

same unsafe pattern of handling of licensed radioactive material.

M DEFINITIONE AtJJtAt An operating philosophy for keeping radiation exposures and effluent releases as low as reasonable achievable within acceptable cost.

Closeout or Termination T.nspection: 1) verification that all RAM used or possessed by the licensee has bee: properly disposed of; 2) the facility is free from contamination; 3) records of all tranWers or disposals are complete.

Dead File Records which have been reviewed during an inspection which may be discarded or put in permanent storage. Such records include surveys, receipt, disposal, leak test, QC and QA, etc. Personnel dosimetry records should never be discarded.

Field Inspection: An inspection at a licensee's temporary job site.

Follow-up Inspection: An escalated enforcement action to verify the licensee's corrective actions have been taken and are effective.

Initial Inspection: The first inspection performed after a new license is issued. This inspection asust be performed within 6 months af ter RAM is received. Phone contact should be made prior to scheduling the licensee's initial inspection to verify that licensed material has been received, but inspection itself must be

! unannounced. Do not inspect until radioactive materials are being used by the licensee.

Include standard condition in newly issued licenses that license will be terminated in one year from date of issue if no licensable material has been received.

Interim compliance Actions: A form completed by the licensee and returned to the Agency to verify compliance with rules and '

l license conditions.

2

Notice of Violation: The formal written document issued to the licensee describing the inspection findings and citing violations of the State's Regulations or License Conditions, overdue Inspection: Any inspection date that exceeds the license priority due date. Exaupla, a priority one licensee must be inspected once each year. - If they _ are not inspected within 12 months of the last inspection they become overdue.

l Prelicensing Inspection: Inspection at an applicant 's facility to verify qualifications for license. Conducted only when the situation warrants a site visit.

' Priority: The frequency of inspection for a given type of license.

RAM: Radioactive Material.

Reciprocity Inspection: A complete inspection of an out-of-state or NRC licensee's activities. Reciprocity inspections should be by their very nature field inspections.

Routine Inspection: A complete review of a licensee's activities for regulatory purposes.

Telephone contact: The person who may be contacted prior to an inspection.

L.2 METHODE AND CRITERIA Review of radiation safety inspection data results in proper evaluation of program adequacy. Inspectors should o be thoroughly familiar with regulatory requirements of the licensee; o have a complete knowledge of the particular license.and all conditions placed on it by licensing staffs o plan to inspect each of the various requirements; o

identify problem areas examined during the inspection; i

4 3

o determine which confirmatory measurements are necessary and the appropriate instrumentation to be used o

prepare an equipment list for everything that will be used during the inspection; and  ;

o be able to answers who, what, when, where and why, when documenting items of noncompliance.

i Preparation and planning are essential to an effective and efficient inspection. Review the license and referenced documents that results describe the organization's radiation safety program. Review

!, of previous inspections and investigations. Prepare an vatline that emphasizes possible problem areas such as reSonses to prior findings. Identify if promised corrective actions have been done.

i The radiation safety survey may involve deterTnination of radiation fields and concentrations both within and outside the radiation facility. The licensee should maintain records that will provide enough information about radiation levels to permit an adequate evaluation of their operations. The inspector must make his own measurements to confirm licensee records.

Review licensee records from several days that the licensee used dates radioactive material.

selected which may Ask the licensee for all records for the include area surveys, leak tests, personnel monitoring results, .eter calibration records, etc. Spot checking all required items for 20 dates since the last inspection presents with requirements. a valid statistical picture of a licensee's compliance The inspector may require the licensee to get a complete set of radiation measurements resulting from uses under review.

also include: These measurements will include radiation fields but may o

Wipe sampling for nuclide concentrations on surfaces in controlled and uncontrolled areas; o

Air sampling in the breathing zone of operators to assess internal exposure to workers; o

Bioassay and whole body counting to assess internal dose; 4

o Process air satqpling to measure nuclide concentrations to test engineering controls; and o

Air sampling at discharge points to assess internal exposure of individuals in the surrounding community; (isokinetic sampling techniques must be used if discharges involve particulate radipactive materials.

The licensee's program for use of radioactive material should include provisions for collection, recording and evaluation of all environmental and process data described above. Review records to insure that the frequency and extent of observations are adagaate within the scope of the licensed program.

A radioactive materials program review involves more t.han examination includei of licensee radiation records. Other records to review o

Personnel radiat.%: exposure records ( film badge or TLD records for doses from external sources; bioassay records

- urinalysis, thyroid counting and whole body counting -

for doses from internal-sources of radiation);

o Investigation of incidents and near misses. These incidents include overexposures, excessive concentrations or material losses which must be reported. Note if the licensee adequately investigated unusual occurrences to determine the cause.and prescribed remedial actions to prevent recurrences o Hazard evaluation and radiation safety surveys of proposed and ongoing uses; o Tests for leakage and contamination of sealed radioactive sources; o

Proper radioactive material accounting methods, including records of receipt, transfer and disposal. The inspector should review records to show compliance with possession limits imposed by the license, and evaluate limits and conditions affecting disposal of radioactive waste imposed by radiation _ control regulations. Records of transfer should, in addition, be reviewed for license 5

b.

authorization, not only with respect to the recipient's license but with respect to the license under review, as well; and o Records of medical procedures performed and administered. Review of these records bears ondoses the l

j question of efficacy as well as patient safety. Kinds of procedures performed and the doses administered to human subjects must be consistent with the authorizations specified in the license to procedures performed pursuant a Non-Routine authorization should conform with acceptable medical practices, although occasional use of an above-or below-usual range dose is permissible by request for exemption.

Assure that management procedures establish safe and effective use of radiation while furthering the goals of the organization.

Agency reviews of programs should identify scientific merit. The question of merit most frequently arises in human use or field tracer studies.

Evaluation of the potential for environmental radioactive material addition releases arising from uses under review involves, in to review of past and present performance already discussed, determinations of the followings o

The Radiation Safety Officer. Are he and his staff adequately trained and experienced? Is there provision for use of a health physics consultant where training or experience is lacking? In more than a few cases the radiation safety officer will be entirely competent to administer sound a prsgram but will lack the ability to make judgement on some more complicated technical problems. In these cases, the input of a consultant will be essential in making the difference between adequacy and unacceptability of office staff.

o Users. Is prior training and experience, as determined by performance ud questioning, adequate to enable users to safely undertake activities authorized by the license? Is there adequate provision for on-the-job training .f new users? Is there adequate -provision- for retraining existing users in order to convey radiation safety 6

~

0 program and/or regulation changes as they affect the program? Are ancillary workers informed as to basic radiation safety criteria (such as janitorial or clerical staff) for the type of material used by the licensee?

o In cases where users are specified by licenso conditions, does the program staffing conform to these conditions? l o Engineering controls, ventilated enclosures, shielding, remote handling tools. Are ventilated enclosures adequate to prevent internal exposure? Are shielding and remote handling tools adequate to reduce external exposure to the lowest practicable levels within regulatory limits?

Arc exhausts from ventilated enclosures adequately treated to reduce emissions to the out-of-plant environs to the lowest practicable leveh within regulatory limits?

o Security Devices. Are interlocks and warning signals adequate to ensure sce;ictly controlled and safe entry to high radiation or high airborne areas within the facility?

o Do f acilities conform to user commitments incorporated by refeience in license conditions?

o Posting. Are individuals adequately warned as to the

f. presence of radioactive material, radiation fields and airborne concentrations? Are workers informed of their rights and obligations (Notice to Employees)? Does posting conform to . license conditions and radiation control regulations?

o Administrative procedures. Are these procedures adequate to define the duties and responsibilities of the Radiation Safety Officer with respect to such matters as records, surveys, leak tests, personnel monitoring including bioassay, investigation and reporting of incidents, and disposal of radioactive waste?

o General radiation safety procedures. Are these procedures adequately developed for the instruction of users and other staff personnel?

7

o Detailed operating and radiation safety procedures. Are these procedures adequate considering the uses which they describe and regulate?

o Do-existing procedures conform to procedures incorporated by reference as licensing conditions?

5.0 INSPECTION PRIORTTIES INSPECTION PRIORITY, from the definitions, means the interval between compliance inspections. Priority 1 means there is only one year between inspections; priority 2, two years, etc. The priority system addresses relative risk associated with a license. For example, a licensee with an inspection priority 1 has the greatest potential for hazards in health and safety. This priority requires the most frequent inspections because of the nature of the operations. On the other hand, an inspection priority 7 involves little potential hazard to health and safety and requires less frequent inripections.

  • Examples of priorities by license type Mela, this schedule is subject to change by programs based on safety emphasis.

Attachment I- See NMED INSPECTION PRIORITY TABLET 6.0 INSPECTION PROTOCOLS The word protocol means amenities, decorum, etiquette, conventions or customs contingent upon a subject. In the case of inspections of radioactive material licensees, protocols refer to the specific steps or procedures which are used to complete an inspection.

6.1 TYPES OF INSPECTIONS

1. Initial Inspections Inspections of all specific licensees shall be conducted within six months af ter material is received and operations under the license have begun. Initial inspections of new licensees should be unannounced, but a phone call prior to a visit.should be made to

--confirm that licensee has begun operations with material.

licensable 8

2. Routine, Periodic Inspections Inspections of licensees shall be conducted at intervals corresponding to their inspection priority. Priority 1 = each year; Priority 2 = each two years; Priority 3 = each three years These should be unannounced unless prior notification of no more than 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> would enable more complex facilities to assemble documents to be reviewed by inspectors or to ascertain that licensees located in remote areas will have someoae prese c to grant access to premises.
3. Follow-up Inspections Follow-up inspections shall be conducted for cases involving willful or flagrant violations, repeated poor performance in an area of concern, or serious breakdown in management controls.

Program compliance management shall determine whether a follow-up inspection should be conducted, based on the compliance score of the closed inspection code sheet. Each follow-up inspection shall be conducted within six months of the most recent inspection and should be unt.nnounced.

4. Close-out Surveys Upon notification that a license has expired or is being processed for termination, a close-out survey may be performed to ensure that licensed material has been properly disposed of .ind that af fected areas of the licensed facility may be safely releastd for unrestricted use. Each survey, if supervisory personnel deems it necessary, shall be conducted as soon as possible af ter the notification is receive S. Reciprocity Inspections When a licensee that is licensed by another Agreement State or the NRC requests permission to work within the State permission may be granted provided: (1) the licensee does not work continuously for more than 180 days in a calend.sr year, and (2) the licensee notifies the State at least three days prior to entering so that an inspection may be conducted. An inspection of an out-of-state licensee is called a reciprocity inspection. The inspection report and correspondence to the licensee are handled the same as any other licensee inspection.

9 k J L/ "

g.2 EEMRNULYNG INEDEETTONE

1. Obtain inspection due list.
2. Identify licenses within a geographical area to optimize travel.-
3. Identify licenses most- -in need of inspection (prioritize).

l

4. Plan travel itinerary allowing for substitutions and have Program Manager, Bureau Chief and Financial Specialist approve overnight travel.

l .

5. Announce visit in advance only if necessary.

6.

Review licensed materials and prepare field notes (copy all necessary documents; do not take primary file into field).

7. Review previous inspections thoroughly and any incidents which may have occurred within the inspection interval.
8. Obtain necessary equipment.
9. Provide inspection schedule to management for u emergencies.

6.3 INEPECTION TEEMNIOUE 1.

The inspector should have a complete knowledge of the license, and the State's Rules, Policies and Regulations.

2.-

Always contact upper managesment upon entering a facility.

3.

The ' inspector should comunicate effectively avoiding the use of leading questions or statements.

4.

The inspector's appearance should reflect the Agency's idiom. Dress appropriately for the type of inspection.

5. When requesting records during an inspection, the 10 u

inspector should not assist with their location or procurement.

6. %e inspector should be aware of licensee stalling tacties and maintain control of the inspection.

7.

At the conclusion of the inspection, the inspector (s) should take time to themselvea to evaluate all findings and identify possible areas of noncompliance.

inspector The should feel confident that items of noncompliance are truly violations of regulations or conditions of the license. If in doubt, never call an item of noncompliance until certe.in. This should eliminate the possibility of rescinding a violation later, following a successful challenge by the licensee.

8. Inspection findings must be revealed and discussed with l-l the licensee's management during the exit interview. Any other findings not identifie'd during the exit should be 4

communicated to the licensee by telephone prior to issuance of the Notice of Violation.

conference whould be* held with the licensee's The closeout highest level of management available.

7.0 GUIDANCE 7.1 ALARA (AS LOW A9 REASONABLY ACHIEVAELE)

A licensee engaged in license activities should, in addition to complying with regulatory requirements and license conditions, make reasonable efforts to maintain radiation exposures and releases areas as of lowradioactive materials

. as reasonably in effluente to unrestricted achievable. Even though current occupational exposure limits provide a very low risk of injury, it is prudent to avoid unnecessary exposure to radiation. This can be accomplished by the implementation of good radiation planning,.

practice and commitment to policies that prevent departure frem these practices.

The inspector can verify ALARA commitments by reviewing:

o A written commitment by high level management to minimize worker exposure via the-implementation of clearly defined 11

procedures and policies; o That licensea personnel are made aware of managements' commitment to keep occupational exposures AIARA; o

That the radiation protection staff have been given authority to assure ALARA procedures and policies are carried out; o

That workers are adequately trained, not only in the radiation safety procedures, but riso in the ALARA philosophy; .

o That management and its designees perform periodic audits to find out how exposures and effluents releases might be lowered; o That modifications to procedures, equipment and

' facilities have been made to reduce exposures at reasonable cost where possible; and

o The Quality Assurance (QA) and Quality control (QC)

' programs where applicable (i.e. manuf acturing, R and D, radiopharmacy, etc.).

  • 1.2 GENEPAL GUIDANCE FOR ALL INSPECTIONS All inspections should include a mix of records and procedures review, observations, confirmatory measurements, and discussions with personnel involved in the " hands on" work.

Inspection of licensees should be done by observation of operation, interviewing of licensee personnel, and review of records. The record review should asrve to verify both the observed operation and the information collected during the interviews.

General review of the licensee rect.a with special attention paid to proble.a identification, may be useful to identify areas deserving special attention during the inspection. The inspector should pay particular attention to evidence of trends that may lead to a breakdown in the licensee's safety program.

12 r

. c W INTERVIEWS Jersonnel interviews are extremely ingportant.

1. All interviews with authorized users and ancillary workers must be documented, including job titles.
2. It's acceptable to asx workers to take a short examination to test their knowledge of radiction safety i as it pertains to the type of operation being inspected.
3. Interviews can and should be held in private, away iu m the licensee's management and other workers that may intimidate the responses given.

4.

Be certain to question janitorial staf f regarding the labeling of radioactive material waste containers and areas to avoid during cleanup of labs.

5.

l Verify that receptionists understand the proper storage location for packages that contain radioactive materials that are either received or sent out by the facility.

6. Determine that supervision is provided for all license operations where unsupervised work is prohibited.

7.

Personnel interviews are important! Ask the employees if they received the required training. Ask them questions about their training, job duties, and problems encountered to determine whether they are properly trained and capable of performing their duties safely and according to the operating procedures. Take the malcontent employee to coffee and listen to the problems of the radiation protection program as they perceive them.

7.2.2 RECORDS REVIEW When reviewing records, the inspector should start with the last previous inspection and come forward in time, occasionally records that go back beyond the last inspection must be reviewed to 13

verify that corrective action has been taken.

7.2.3 RECORDS RETENTION

{

The licensee is allowed to dead file all records that have been reviewed by-the inspector. However, there may be legal time requirements for such records as personnel monitoring and bioausay exam reports.

?.2.4 OBSERVATIONS The inspector can learn from direct observation whether the licensee is complying with regulations and licensing conditions, following his own written procedures and whether good ' radiation safety practices are utilized in the process. In some cases it may be necessary to stand back and assume you're a " fly on the walla, in order to adequately observe operations.

7.2.5 INDEPENDENT MEASUREMENTS During mest inspections, performing independent measurements is required. The need for radiat$on surveys, wipe surveys and tests of air, water, or soil will vary with the type of licensee. There are general rules concerning independent surveys by the inspector that must be follew ' such as:

o Usc of a survey meter of a type and range similar to the licensee's.

o Use of a survey meter that is calibrated at the same time period as the licensee's. Example:

For radiography inspections, always use a meter that has been calibrated within three months.

o Meter calibrated against NIST standards and at two points per range.

o Wipes of areas for contamination should. cover 100 square centimeters.

14

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o. Wipes should be evaluated by instruments that are sensitive to the isotopes in question. Differentiate between dose rate measurements and contamination measurements (mr/hr or dpm).
o. Verify survey instrument response with an appropriate l check source.

M INSTRUCTIONS FOR EPECIFIC LIr*NSE TYPES RADIOGRAPHY

1. Should be unannounced.

2.

A field inspection shall be made for 25% of the routine inspections of this type.

3.

Observe operations incognito; use binoculars or observe without being observed during field site inspections.

4.

Evaluate condition of radiography equipment, however, repair and replacement of old worn out equipment is the responsibility of the licensee.

, 5. Evaluate training and testing program.

6.

Look for proper use of monitoring equipment.

7. Verify receipt and-shipping procedures.
8. Assure adequate security of RAM.

9.

Audits time).

may need to be conducted during off hours (night MANUFACTURING & DISTRIBUTION 1.

Verify current client license authorization (make sure the licensee has all necessary client information to comply with transfer rules).

15

2.

Review shipping procedures and records (make sure all shipping is in compliance with 49 CFR). Appendix Z has USDOT Limited Quantity form which may be useful.

3. Review processing / quality assurance methods (make sure all requirements for Sealed Source and Device registration or F~ Tave been completed).

4.

Verify the final General Lic3nsee in accordance with General shipment" License rules. Confirm if there will be a " drop to a middleman who must be specifically licensed.

BROAD LICENSES 1.

Confirm RSC authorizations for users.

2. Assess risk potential among principal investigators based on type and quantity of RAM.

3.

Depending on previous compliance history and recent risk assessment, observe a sample of Principal Investigators.

(This may range from 15% to 100%, depending on licensee's status.

NUCLEAR PHARMACY

1. Begin inspection at 3 am (doses are prepared for distribution before 7 am).

l l 2. Verify drivers' qualifications and proper training regarding USDOT regulations.

3. Verify supervision of ancillary workers using RAM.

4.

Confirm that client information is accurate and current (make sure RAM is transferred only to authorized licensees).

WASTE BROKERS 1.

Confirm that the resident time of waste does not exceed the licensed allowable time limit.

16

2. Verify the type of waste authorized (does licensee address mixed waste?). I MFnICAL INCLUDING DIAGNOSTIC, BRACMYTHERAPY AND rrnETHERAPY 1.

Confirm that doses are within well established limits. ,

2. Verify patient release criteria.

i 3.

Verify that adequate personnel dosimetry and training is provided to nursing staff.

4. Verify physician and authorized user qualifications.
5. Confirm that scans are being read by an authorized user.
6. Confirm terhinologist licensure.
7. Verify camera OA in accordance.with RDA recommendations.
8. Verify dose calibrator QA (cf. NCRP No. 95).

gEILE MEnICAL VANS 1.

If dose calibrator is transported, verify that accuracy and constancy are performed before each use.

2. Perform 25% site of use inspections.

3.

Confirm that doses are verified prior to injee. tion.

4.

Confirm that f acility surveys are performed upon exit from facility; confirm also that no residual contamination remains.

5.

Confirm that there is 11 cense authorization for transport

-of dose calibrator and/or sealed sources.

SERVICE LICENSES (T 7AX TEST. INSTRUMENT CALIBRATION. ETC.)

1. Verify that distribution and temporary job sites are authorized.

17 k

2. Confirm that leak test kit conforms to postal regulations.

3.

Confirm that there is adequate instrument sensitivity regarding leak test analyses and NIST traceability of standards.

WELL LOGGING

1. Observe fishing operations if possible.

2.

Verify requirement for casing of potable water zones.

3.

Verify that tracer studies are performed in accordance with license conditions.

4.

Site visitation permits may limit accessibility to well logging operations.

PORTABLE GAUGES (MOISTURE DENSITY GAUGES)

1. Verify authorized storage locations (check for home storage and veMeles) .
2. Verify transportation and security procedures.

3.

Verify that operator maintains security at all times.

4.

I Personnel monitoring; verify that authorized user list is current.

VETERINARY MEDICINE AND THEPAPY

1. Verify patient release criteria and home instructions.

2.

Verify technician qualifications and training.

3.

Verify that there is license authorization (i.e. a license condition) to dispose of wastes down the sewer.

4.

Veterinary medicine does not follow human use rules.

18

[ .. .

0 RESEARCH AND DEVETOP6 1.

Verify that license status is only R & D and that there is no distribution.

2. Verify that -animal use safeguards.

is conducted with adequate INDUSTRIAL LIXISCOPE 1.

Verify that source exchange is authorized by license.

FIYFn GAUGER 1.

Verify location and labt. ling of gauges.

2.

Perform inventory of all gauges including any Generally Licensed gauges.

3. Make sure the licensee has lockout procedures for l maintenance.

GAE CHROMATOGRAPMS 1.

If portable, verify that licensee uses proper shipping-procedures.

t 2. Check venting of H-3 sources (Sc tritide) .

M INSTRUCTIONS FOR INSPECTION REPORTS The basic intent of inspection reports is to provide a written record of inspections. The. primary purposes of the written record are to: (1) provide a basis for compliance action and record the results of the inspection of the licensee; and, (2) provide information for management of the inspection program within uhe agency.

The minimum objectives of an inspection report are:

1.

To eliminate unnecessary detail in inspection reports by 19

requiring documentation of only those facts necessary to form the basis for enforcement actions and to describe the scope and findings of inspections.

2. To achieve uniformity in inspection reports.-

The minimum content of the report requires detailed summarized information gathered during the inspection limited to subjects which are applicable and have safety significance, plus those subjects for which non-compliance items were found. Where a subject was not inspected or was found to be not applicable, the inspector need only indicate this finding in the report.

For subjects of lesser significance, the inspector need provide only a summary of information and gathered including no more than that which may be necessary to support a conclusion of adequacy. It is not necessary to record all information obtained during the - inspection. The inspector should use judgement and record essential facts that will give an overall view of the l

licensed program.

A reasonable effort should be made to attribute information to the proper source, such as statements by named individuals, l

excerpts or summaries from specific records, and observations by.

the inspector. If the source information is obvious, it need not be -

specified. References to inspection requirements in written inspection procedures should be made as necessary to f acilitate reviewing the results of the inspection.

L,1 CONTENTS The report is a concise record of factual, accurate information~which is used to form the basis for compliance action, and describe the scope and findings of the inspection. At least it should include:

1.

A description of licensed activities, including name, address, license number. priority, license type, inspection date, inspectors, instrumentation, and scope of inspection.

20 I l

2.

List licensee representatives and other individuals not employed by the licensee, who furnished information for the inspection. Limit the list to those at the technical and supervisory level and include the name and title of each individual. If convenient, indicate by an asterisk or other suitable note those individuals who participated in the exit interview.

3.

Description of the organization to show responsible line of authority from operational level and radiation safety officer to management.

4.

State actions on previous inspection findings. (Omit if not applicable or not inspected). To the ex'ent t that licensee action on the previously noted compliance items and unresolved items was examined, it should be described. Appropriate reference to the items is made followed by a description of the findings and a statement as to whether each item included remains open or is closed.

5. Functional or program areas inspected. This is the main body of-the report containing paragraphs describing the inspection of functional or program areas It is divided, whera possible, into paragraphs with titles of the inspection procedures under which the inspection was performed. The titles of procedures may be shortened or expanded to provide an adegaate description of the information reported.

Where the inspection was perforTned under one or two lengthy inspection procedures, the details should be divided into paragraphs by lina items or groups of line items within the inspection procedures.

6.

Exit interview, List the names and position titles of persons present at the exit interview with licensee management. The inspector should identify each subject discussed at the interview. It is not necessary to de: scribe in detail the specific items discussed, a brief summarizing statement can be used. If the licensee's management has a position (agrees, disagrees, or comment) on compliance matters and unresolved items, this position 21

~ - _ _ _ .

should be f actually documented. Any contact after the exit interview regarding changes in management's position on an item should also be reported.

The depth of reporting for subjects inspected is related to the inspection findings as follows:

  • 7 .

Noncompliance items and recommendations. It is necessary to provide full substantiating information for cited items of noncompliance and recommendations. For noncompliance items, the information required is a clear statement of the requirement - referenced, paraphrased or quoted - and a detailed description of the manner in

, which the licensee did not follow or meet the requirement. This description should be in sufficient detail to permit a knowledgeable reader to come to the same conclusion. The description of the item of noncompliance should include, as appropriate, the date(s) of the noncompliance, the means of identification (i.e. ,

inspector observation, discussion, recordr, reports from licensee, etc.), the specific procedurer, operation, or location involved, and the event or circumstances that occurred. If the requirement is conditional, the supporting information should describe the way in which the conditions are satisfied to make it clear that the requirement applies.

8. Acceptable areas. For subjects examined and found to be acceptable, the inspector should report, as a minimum:

(1) what is inspected; (2) dates covered by the I

ev. amination or review; (3 ) the acceptance criteria if other than regulations, license conditions or technical specifications; and, (4) the findings or conclusions of the inspector.

It is not necessary to reprt all information gathered to support a conclusion of adequacy. Normally, the depth of reporting should be related directly to the significance of the subject examined and the information obtained. For example, examination of licensee logs and operating records for a specified period of time can be reported as a listing of the records examined and the dates covered. Similarly, the result of a tour of the licensee's facility can be reported es a brief series of observations or highlights of 22

such observations. At the other end of the spectrum, follow-up of licensee reported events (e.g. , incidents and overexposures) should be reported more fully, although it is not necessary to report all inforuation obtained. Rather, the inspector should lindt his reporting to the basis for concluding adequacy or keeping the item {

open.

The objective is to report substantive information and {

i minimize interest.

the reporting of information of lesser importance or M REPORT GUIDANCE Specific guidance regarding handling of reports is as follows:

1.

Any fd.2 ding leading :o a conclusion that a noncompliance occurred shall alyp2s be handled as a noncompliance item except for ma sc:

licensee-identifism noncompliances.

Recommendations are made when deviations from acceptable or nornal practice are noted and there is no regulatory basis for citation of noncompliance.

2.

The following types of information should not be included in inspection reports:

(a) Opinions of a personal nature by the inspector; (b) Identity of persons giving confidential information to the inspector and any part of the confidential information that would reveal the identify of such persons; (c) Proprietary information.

3.

Use of sketches (floor plans, equipment) and copies of licensee's forms and report should be used as attachments to the inspection report to provide clarity and to reduce the narrative portion of the report.

4.

Inspection reports should be drafted as soon as nossible following the inspection, typed and reviewed by area supervisor, reviewed by the supervisor and entered into the data tracking system.

.3 N

5.

The inspection report is an agency document and will ordinarily not be utilized elsewhere..It is acceptable to enter handwritten notations on the: final typed report.

Q REPORT DISTRIBUTION Following final review of the inspection report by the supervisor, the original is placed in the central-license file in-the licensing office and a copy is placed in the-area office file.

M REPORT FORMAT AND EXAMPLES.

In order to' present a consistent and effective inspection report, the report outlines and' examples- presented should be-reasonably adhered-to. The report package should be filed in the following order, bottom to top -

g c Inspection report notes and check list on bottom.

o Licensee's documents (plans, procedures, personnel monitoring reports, etc.).-

o Inspector's letter of inspection findings and Notice of L

p Violation (NOV)- [ Notice of Noncompliance], if issued.

o Licensee's response letter to inspection findings of NOV.-

o Final closing letter _[close loop letter] to licensee from supervisor, o- Inspection package tracking system.

M INSPECTOR'S EOUIPMENT M RADIATION MONITORING EQUIPMENT

1. Survey Meter (cpm and mR/hr) .

2.- Detect. ors .

a. Energy compensat d GM
b. Pancake probe,
c. Low energy NaI(T1) probe (thin) and check source to 24

confirm probe efficiency.

d. High energy Nal(T1) probe (1x1) and check source to confirm probe efficiency.
e. Alpha scintillation probe and check source to confirm probe afficiency (optional) .
f. Beta scintillation probe and check source to confirm probe efficiency (optional) .

3.

Check source.NIST traceable (Cs 137)

-4. Audible alarm meter (optional).

5.

Personnel . dosimetry (personal film badge or TLD NVLAP traceable for Categories I-VI) 9.2 SAFETY EOUTPMENT

1. Dieposable gloves 2.

Ha;a hat, safety shoes, earplugs, safety glasses

3. Disposable shoe coverk M INSPECTION SUPPLIES
1. Inspection forms 2.

Personnel dosimetry guide, prenatal guide, Notice to Workers, medical, portable gauge, IR, etc., guides

3. Consultant list, vendor list, etc.

M )QEC,"T.T ANEOUS HP SUPPLIES

1. CRM signs
2. Transportation labels (WI, YII, YIII)
3. Tape rule
4. CRM barrier tape
5. Burlap bags which can be tilled with dirt for shiciding 25 I

1

6. Indelible pens in black, red 7 Notepaper
i. Wipe _ test materials

.9. Writing pens & pencils

10. Calculator

-11. Tape recorder & tapes

12. Cellular phone ISED/ ALRS.REV. 10/97 2NSP.PRC 26 H

ATTACHMENT 8A ENFORCEMENT PROCEDURES 7

[di a

l

ENFORCEMENT PROCEDtJRES J ROITffME ENFORCEMBrT 1.1 Inspector prepares noncompliance letter. Bureau chief reviews nonoceplianoes response time. and signs letter. Letter requires a 20-day 1.2 short form letter (no items of noncompliance) may.be 9 mt to licensee after the inspection indicating no items of noncompliance. These letters are to be signed by the RLRS Program Manager.

1.3 Each itenlevel severity of noncompliance 1, 2, or 3. is categorized according to

. Severity level 3 noncompliances have a high probability of causing a health and safety problem; severity level 2 cculd cause a health and safety problem; and severity level 1 indicates an administrative noncompliance which has minor safety significance.

Repeat items of asaoomplianoe must be stated in the acacompliance letter.

1.4 Notice of Noncompliance must be sent within 20 calendar days of the date of inspection closing.

l 1.5 l

Licensee response to noncompliance letter is required in 30 days.

1.6 Inspector follows

-intervene if up on licensee licensen response. Supervisor may response is unsatisfactory or inadequate.

If rannonne is adaeuata. thant o

Inspection is closed out with "close loop" letter after all items of noncompliance have satisfactorily been addressed, o

An inspection report is ocapleted as soon after the inspection as possible, and usually not longer than 30 days. Complicated or involved inspections may require a longer period to prepare and assemble all documents for the report.

If rammense is un=atinfmetorv. thamt e

Management level of this program becomes involved, and all correspondence should be signed by ogram Manager and countersigned by the inspector, o

Second lettar with shortar required response time.

I

o Phone calls are made as frequently as necessary to get the licensee's attention.

ROUTINE ENFORCEMENT (continued) o Follow-up visit may be made to spot check progress within 6 months of inspection.

o Enforcement conference with licensee management at RLRS office to shouldenforcement, escalated' be offered as a last solution before going o shorten inspection frequency temporarily). (raise priority o Require periodic reporting by licens(weekly, monthly, quarterly) written ee.

o Administratively write additional restrictive license conditions into that specific license, o

Administrative possessed, 1y limit amount of isotopes that may be o

Require licensee -specialized to be presented training - programs and audits by to State.

2,d ESCALATED ENFORCEMENT / ADMINISTRATIVE PENALTIES.

2.1 74-3-11. Civil-penalty; injunction. ,

A.

If the violating director has good cause to believe that any person is a condition of a license issued by the agency, or administered nuclear by the regulatory agency- pursuant to an agreement with the commission person shall be given an opp,ortunity to be heard ator any regulation-of the board, the before the director. The director shall notify the person by a hearing certified mail of the date, time, place and subject of the hearing.

If the director finds that the person is violating or threatens to violate a condition of the license or a regulation of the board, the director license heldshall issue by the an order person, to cease whichever and desist or revoke the is appropriate.

B.

The - director may issue a cease and desist order, on an emergency basis, pending tho hearing provided in subsection A of this section, protect huar.ifhealth he deteunines or safety.that Ifimmediate action is required to issued on an emergency basis, the a cease hearing andthe before desist order director is shall be held as soon as possible. The person who is the subject of a cease and desist order issued on an emergency basis may waive in writing the requirement of written notice of the hearing before the director in the interest of expediting that herring.

A qo *m

\

N

- - __-_A

c.

The agency may sa-Jr. injunctive relief against any violation or threatend violation of regulations, rules or orders adopted pursuant to the provisions of the Radiation Protection Act (74-3-1 to 74-3-16 NMSA 1978), and such relief shall be subject to the continuing the jurisdiction court's powers and supervision of the district court and of contempt.

district court for the county in which The action shall beoccurred the violation filed in the or will occur.

The attorney general shall represent the agency.

D.

impose a civil penalty not to exceed five thousand dollars ($

for each day during which violation occurs.

E.

courtAny underperson this aggrieved bf a final judgement of the district other civil actions.section may appeal to the supreme court as in

l ATTACHMENT 8B

. FOLLOW-UP ON INSPECTION LEIIER 4-

^

FOLLOW-UPINSPECTON LETTER Licensee License Number inspector issuing letter ofinspection:

Date 1= Won letter was issued-

'Date response due from licensee:

Response received by due date: Yes No if yes, iaWe should initial this form and "X" out the rest of the page.

- IfNo, proceed to next step:

1" follow-up contact by inMM by telephone. '

Summary:

2" follow-up by registered letter. (Cite date and to whom letter was sent copy to NMEDlegal) 3 follow-up Site visit by inspector to determine circumstances. (Cite date and =-=y of activities).

4* follow-up-Cease and Desist Order from the Secretary's office and subsequent asentatmA enforcement actions. (Cite actions taken.)

Swf:

m eo -

Inspector:

Date:

Program Manager- Date:

NMFn/RLRS REV.10/97 j l

ATTACHMENT 9 STANDARD OPERATING PROCEDURES FOR RESPONSE TO INCIDENTS INVOLVING RADIOACTIVE MATERIALS s

INCIDENTINVESTIGATION PROCEDURES INCIDENT REPORTING SYSTEM / ABNORMAL OCCURRENCE CRITERIA

IncIDanT mapomTImo sYsTsu laMORMat OCCURRENCE cRTTERTa The following criteria shall be used for the determination of an abnormal occurrence.

Events public health involving or safety. a major reduction in the degree of protection of the Such an event would involve a moderate or more severe impact on the public health or safety and could include but need not be limited to:

1.

Moderate exposure to, or release of, radioactive material licensed by or otherwise regulated by the Agency; 2.

Major degradation of essential safety-related equipments or 3.

Major deficiencies in design, construction, use of, or management controls for licensed facilities or material.

Examples criteria are: of the types of events that are evaluated in detail using these For A31 Licensees 1.

Exposure -of the whole body of any individual to 25 rems or more of radiationi exposure of the skin of the whole body of any individual to 150 rems or more of radiations or exposure of the feet, ankles, hands or forearms of any individual to 375 rems or more of radiation or equivalent from internal sources.

l 2.

An exposure to an individual in an unrestricted area such that the whole-body does received exceeds 0.5 rem in one calendar year.

3. The release t

of. radioactive material to an unrestricted area in concentrations which, if averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 500 times the regulatory limit of subpart 3, schedule A, New Mexico Radiation Protection Regulations.

4.

Radiation or contamination levels in excess of design values on packages, or loss of confitement of radioactive material such as (a) a radiation dose rate of 1,000 mrem per hour three feet from the surface of a package containing the radioactive material, or (b) release of radioactive material from a package in amounts greater than regulatory limits (Reference 10 CTR, Part 71.36 (a)) .

5.

Any loss of licensed material in such quantitles and under such circumstances that substantial hazard may result to persons in unrestricted areas.

6.

A substantiated case of actual or attempted theft or diversion of licensed material or sabotage of a facility.

1

_ _____u

  • 1.

Any substantiated loss of special nuclear material or any substantiated inventory discrepancy which is judged to be significant relative to normally expected performance and which is judged to a caused by thef t or diversion or by substantial breakdown of the accountability system.

s.

Any substantial breakdown of physical security or teate.'ial control (i.e.,

access control, containment or accountability systems) that significantly weakened the protection against thef t, diversion or sabotage.

9.

A major deficiency in design, implications requiring insnedi' ate remedial action. construction or operation having safety 10.

EJrious deficiency in management or procedural controls in major areas.

11. Series of events recurring incidents,(where individual events are not of major importance),

facilities and incidents with implications for similar (generic incidents), which create major aafety concern.

2

INCIDENT reports PURPOSE '

An incident report provides documentation of an event which may or may not involve radioactive materials or radiation from any source. It provides a method to later evaluate an event and its associated consequences.

DISCUSSION The radioactive NRC has developed guidelines for the reporting of incidents involving materials. The infomation gathered is used in a national data base criteria into three categories: generic problems. They have divided reporting to evaluate trends and identify 1.

Abnnmal occurrencem--The most significant events. They require a written report for inclusion into the quarterly report submitted by the NRC to Congress.

These events must be reported to the URC by telephone as early as practicable.

2. Telmehene Reeerts--These are incidents that require 24-hour notification of the state by a licensee or an event which rec'eives significant media attention.

3.

Other Renortable Incidents--Events that require reporting by a licensee to the Regulations.

state are covered in Subpart 4, Section 452, New Mexico Radiation Protection For Radiation Control, all incidents and potential incidents will be documented and entered into the record system. Hard copies of all reports will be kept by the Radiation Licensing and Registration Section in Santa Fe.

3

ZMCIDENT INVESTIGATION PROCEDURES

1. Upon receiving notification of a potential incident, complete the Incident Report, Attachment 11.
2. Document actions. taken, people contacted, arrival and departure of emergency response personnel, and any other pertinent information.

3.

andRecord phone number. any notifications made, being sure to include name, agency, date/ time, in Attachment 11. Verify reportability to WRC by checking requirements listed

4. If a press release is required a any news media personnel are at the scene, notify Public Af f airs.

interviews, to the report.Attach copy of all releases, including summaries of  !

~

5. When other emergency response agencies respond or are called to respond, list all names, addresses, phone numbers and dates notified.
6. For transportation incidents, complete the transportation section.

For truck-related incidents, all of the required information should be on the manifest. In some cases, only an EPA No. will be listed for the carrier and the address, phone number, and contact person will not be available.

Record the EPA number and the driver's name. Complete the remaining portion of the transportation section.

  • 1 Give Incident /A31egation Report Forms to the Program Manager no later than the next working day.

B. The Program Manager will review the Incident / Allegation forms for comoleteness I

and reporting requirements.

G. The forms number and data willentry. be given to the designated person for assignment of a tracking

10. When the incident is closed, complete the close-out summary.
11. Date and sign forns and indicate if copies are required for the Incident chronological file.
12. The complete incident packagt is then given to the Program Manager for review and signature.
13. The package is returned to the designated person to complete data entry and filing.
14. Completed incident packages will be kept in a 3-ring binder for each particular licensee behind incident's tab. At the end of the year, the reports are then filed in the filing cabinet in the RLRS office in Santa Fe.

4

STANDARD OPERATING PRoCIDURE (sop)

Pon Anspousa To INCIDawTs InvoLVImo RADIoACTIva taTamIALs I. SENERAL A.

This sop provides general guidance for rerponding to any incident, accident, or emergency in which radioactive materials or a machine source are involved, except for an accident involving reactors.

B.

The Radiation Licensing & Registration Section Program Manager has the primary responses. responsibility for the coordination of all emergency This central point of contact has been established to ensure a smoother, more unified response mechanism.

C.

The Director, and the HRMB Bureau Chief, will be advised of all incidents reported and response contemplated.

II. Rasponsa GUIDE A. General 1.

Whenever the Agency is apprised of an incident, accident or emergency, a response is required. This response may be in the nature of soliciting and providing information over the phone, scheduling an inspection at a later time, or it may involve an immediate on-site response. The RLRS Program Manager or tLe HRMB Bureau Chief wi7, advise as to when an on-site response is necessary.

2.  !

As guidance, an on-site response may be required in the following situations:

a. The Agency is requested to do so and the request does not entail a response beyound the equipment and training capabilities of program and staffi
b. If there is a source disconnect, lost source, overexposure or possibility of contamination.

C.

If radioactive material other than gas, e.g., "a source," i. lost, including a well-logging tool down-hole, or involved in an accident;

d. If there is an actual or potential hazard to public health and safety;
e. If the media should notify the Agency of any real or suspected incident; f.

If the Program Manager or Bureuu Chief deem it necessary.

1

~

3.

When receiving a notification of an incident, the person notified Report should complete an Radiological Incident / Allegation (Attachsmant 11) to obtain pertinent background information.

4.

The Person notified of the incidenty should then verify telephone reports of incidents. This may be done by dialing the number given on the Radiological Incident Report, or in the case of a licensee, by checking the file to validate the informantion given.

5.

During the response, normal office and inspection routines will be maintained unless the Program Manager orders otherwise.

6.

If an on-site response is required, upon arrival at tl.o scene, responders wills a.

Identify both the local / county official in charge and representatives of state agencies that may have responded. Most likely, at least for transportation incidents, a designated officer of the Department of Tranisportation will be on scene and will have assumed the role of Incident commander,

b. Evaluate the situation.
c. offer advice as necessary to protect public health and safety,
d. Advise the Program Manager of the evaluation as soon as possible.

Contact with the RLRS office will be maintained throughout the response and the on-scene responders shall periodically up-date the RLRS regarding event developments.

e.

Attempt to determine whether or not items of non-compliance led or contributed to the incident or accident after control has been established.

f.

Maintain a record of actions taken.

  • 1.

Licensees are responsible for corrective actions. The licensee Radiation Safety Officer should remain with the responders until the situation is resolved.

III. VEHICLE USE A.

The Agency designated emergency response vehicle shotid be used to respond to incidents for which use of a vehicle is deemed appropriate.

2

IV. REPOPTING REQUIREMENTS A. 1.

Reporting requirements for any incidents responded to are found in 20NMAC 3.1, Subpart 4, sectiou 452.

22 The Bmergency Response Program Manager will publish periodiedly a roster of Smergency Response Duty officers and 4 will maintain an up to date amergency Assistance Telephone Can List (anciosure 3). Enclosure 3 will not be provided to anyone outside the Agency.

R. Press

1. The following guidelines apply
a. Press releases will be provided by the Agency's PIO as deemed necessary by the Director. The completed 2ncident/ Allegation Report form will provide the PIO with the basic information with which to prepare a preliminary release. Purther information for media will be followed by subsequent releases as needed.
b. If a source is lost or unaccounted for, all appropriate media and local television stations, if necessary, will be accessed for the purpose of public safety as well as assistance in locating the lost source. Integrated media alert may also be used.

C.

Responders on the scenw may provide a short synopsis of what they found but shoald not engage in long discussions or speculation with media representatives.

There will be one spokesperson (as previously designated) for the responders. Any information provided to the media should be provided in coordination with local, county and state officials at the scene. The State PIO should also be apprised of that informations press releases may then be issued by the RLRS.

Any questions, please do not hesitate to ask supervisors.

NMED/RLRS.REV. 10/97 N INCID. PRO 3

1 ATTACHMENT 10 ALLEGATION RESPONSE GUIDANCE DOCUMENT (BEING DEVELOPED, TO BE PRESENTED TO MRB ON OCTOBER 23,1997) l 4

a

i l

I ATTACHMENT 11 INCIDENT REPOR. )R RADIOACTIVE MATERIAL LICENSEES E

w 4 - _

  • "' State of New M xico s ENVIRONMENTDEPARTMENT

\

\\ Hazardous & Radioactive Materials Bureau g$

.') 2044 Galisteo 1 # 1 P.O. Box 26110 Santa Fe, New Mexico 87502 (505) 827 1557 CARYE. JOHNSON eovaanos fax (505)6271644 MBEE WEBLER ucartar KDaAs r. rpotA70N,m overysscurrar INCIDENT REPORT FOR RADIOACTIVE MATERIAL LICENSEES LICENSEE NAME:

LICWSE NO.:

CID':

PHONE NO.:

l TYPE OF EVENT (check all that pertainJ:

( ) Loss of Package Effectiveness or Contanunation

( ) Theft or Loss of Radioactive Material l

( ) Overexposure ofIndividual to Radiation

( ) Overexposure ofIndividual to Radicactive Material

( ) Excessive Levels of Radiation or Concentrations of Radioactive Material

( ) Device Safety Failure

( ) s.cau source s

( ) Mtsadministration: Diagnostic Therapeutic

( ) Transportation lucident

! ( ) Other EVEhT DATE:

DATE REPORTED TO STATE:

REPOR1T.D EY:

REPORT RECEI\T.D BY:

OTTIER LICENSEE INVOLVED (Name/ License No.):

RECIPROCITY LICENSEE? Y/N AGREEMENT STATE: .

LOCAT10N OF EVEhT:

ISOTOPE:

AMOUh7:

1

UCENSEE NAME:

LICENSE NO.:

DESCTdPDON OF EVENT (include cause of event and conective actions taken):

i PERSON ASSIGNED TO: _ , DATE ACHON TAKEN BY RLRS.

m 2

m. :..o..--- '

LICENSEE NAME:

LICENSE NO.: --

FOLLOW UP ACDON NEEDED?Y/N DATE OF FOLLOW.UP:

FOLLOW.ti TNDUCIIDBY: CRDENAL VIOLATION?

FOLLOW UP CONa:

M-CLOSE OUT

SUMMARY

DATIREPORT CLOSED:

REPO?.T CLOSED BY: TITLE-REPORT REVIEWED BY 1TTLE:

FILE COPY OF THIS REPORT UNDER INCIDENT TAB IN LICENSEE FILE AhIMAKE O COPIES AS HECESSARY FOR CHRONO FILE SEND COPY TO DESIGNATED NRC REPORTER 3

0 l

a ATTACHMENT 12 TELEPHONE LOG E

l lllI'1 1I i 111 L

FL FA AC T

SG N

SI RC LA RL P

F OO T N

EE K N

OO P H

PS

&N O ES

_ MR E A P N

N .

O I

T A

S R

E V

N O

C F

O T

C E

J B

U S

E M

AR NE 7 B 9 EM /

SU 0 NN 1 E

C G I

L O L.

N O

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E E T L A E D T

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D E

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12/22/97 l

1 NRCINEW MEXICO MANAGEMENT MEETING MINUTES On Thursday, December 4,1997, Hugh L. Thompson, Deputy Executive Director for Regulatory Programs, NRC, and other NRC managers met with Secretary Mark Weidler, New Mexico Environment Department, and his manegement and supervisory staff to discuss performance concems associated with the New M3xico Agreement State program. These concerns were identified as findings from the New Mexico Integrated Materials Performance Evaluation Program review, conducted July 1418,1997. The specific purpose of the meeting was to ensure that Secretary Weldier supported necessary actions by New Mexico to address program weaknesses and implement program improvements. Attachment 1 contains the agenda for the meeting. Attendees are shown by the Attachment 2 sign up sheet.

Mr. Thompson explained the reason for the meeting and the NRC role to asrure consistency among all Agreement State programs to achieve a

  • national' Atomic Energy Act materials regulatory program that is collectively implemented by NRC and the Agreement States to assure adequate protect:on of public health and safety. The " national" program features less -

dependency on the NRC by Agreement States. S 9eretary Weidler stated that probation for the New Mexico Agreement State program was not warranted based on initiatives already completed, as described in his October 10,1997, letter to Richard L Bangart; as described in William M. Floyd's December 3,1997, letter to Members of the Managemei.t Re.iew Board; and as described in discussions at the December 4,1997, meeting. Secretary Weidler further l noted that New Mexico's objective is to continue their Agreement State program, that he endorses the New Mexico program staff actions to implement necessary improvements, that he supports more active management oversight of the program by Mr. Garcia and Dr Kelley, and that he will seek adequate funding for Agreement State program support (see below). A summary of the major discussion points and associated commitments follow.

Adequate Radiation Control Program (RCP) Funding The FY 2000 budget submittalis the first opportunity to request additional RCP funding for training, travel, and other program needs. Planning for thtt budget request will begin in the summer of 1998. Secretary Weidler plans to obtain information from Mr. Garcia and Mr. Floyd about projected training costs and to either request those funds through the budgeting process (if in the amount of a itw 10,000 dollars) or seek legislation to establish a fee base with at least some of the fees going directly to the Environment Department (if $100,000 or greater).

Currently, Now Mexico has authority to establish fees, but the funds collected from fees would go the State general fund, not to the Environment Department. Secretary Weidler explained that to pass any new legislation, both support from Republican Governor Johnson and the Democratic legislature would be required. Secretary Weidler aise explained the Govemor's direction to minimize the costs of State of New Mexico government.

ATTACHMENT 2

2 Commitment Summary: For FY 2000, Secretary Weidler will seek additional Agreement State program funding that is acequate to support necessary training and other program needs. A decision will be made in mid-year 1998 as to whether to seek additional funding through the Lodgeting process or seek iegislation to establish licensee fees that could be used to directly fund the training neeos of the Agreement State program.

Training Options Even if funds are available, out of State travelis often difficult because of established State policy that discourages such travel. New Mexico will continue to explore training opportunities l at Los Alamos National Laboratory and discussed whether it was possible that some NRC 1 training courses could be presented within New Mexico, if the number of New Mexico and or regional students were sufficient to justify presentation in New Mexico. It also may be cost <

effective for New Mexico to contract with NRC to havo courses presented in that State. NRC commented that some train!ng courses are conducted in NRC Regional offices and at Agreement State office locations, when justified. New M axico was advised to contact NRC's Office of State Programs if they were planning to develop such a request.

Commitment Summary: Secretary Weldier endorsed the commitment by Dr. Kelley and Mr. Garcia to identify and pursue options for training of New Mexico staff, including the use of training provided for Los Alamos National Laboratory staff, as appropriate.

. Mr. Thompson endorsed the commitment by Mr. Bangart to provide Mr. Garcia an NRC contact to discuss NRC training and qualifications criteria used for Agreement State and NRC materials program staff.

On The Job Training Mr. Garcia explained that in addition to formal classroom training and procedure rev!sions, on-the job training was important to assure staff were using and implementing the additional knowledge and revised program procedures and to modify the regulatory

  • culture' of the New Mexico staff, He cited a recent example of an inspector accompaniment that he converted to an on the job training session for the staff member. Ms. Howell noted that New Mexico inspectors have the opportunity to accompany NRC inspectors when inspections of Federal NRC licensees are conducted in New Mexico, such as at VA hospitals. Two week's notice by NRC to New Mexico will allow sufficient time for New Mexico planning. Mr. Garcia noted that he and Dr. Kelley would be involved in RCP program management oversight in the future.

Ms. Howell encouraged New Mexico to contact Region IV for guidance on any RCP issue that NRC could provide useful information, t

3 Commitment Summary: Secretary Weidler endorsed the commitments by Dr. Kelley and Mr. Garcia to more actively involve themsc'ves in man gement oversight and involvement in the New Mexico Agreement State program to ensure its success.

Mr. Thompson endorsed Ms. Howell's commitment to notify New Mexico two weeks in advance of planned NRC inspections to be '

conducted at NRC Federal facility licensees in New Mexico.

Region IV will attempt to provide notification to New Mexico 's soon as possible in the event that a special, unplanned, inspection occurs.

Staffing Vacancy announcements for the two vecant RCP positions have been posted and 19 applications were received. Based on the review of resumes of 6 applicants,it appears that at least one candidate with a strong background has applied. Mr. Floyd will obtain and review resumes of tne other candidater The New Mexico RCP will have to work further with State Office of Personnel to resolve discrepancies in the initial qualification ratings of the applicants.

Mr. Floyd further indicated that staff members normally assigned to the x-ray orogram were being used in the materials program because of the current staffing shortfall. Secretary Weidler indicated his support for continued staffing of the New Mexico RCP at its current level.

Commitment Summary: Secretary Weidler, together with Dr. Kelley, Mr. Garcia, and Mr. Floyd, committed to proceed with the hiring of two new staff members to fill existing vacancies.

Response to Events Mr. Floyd indicated that the State had responded to three events since the MRB meeting on October 23,1997. The written description of two events was included as part of his December 3,1997, submittal to the Management Review Board. A third event response was being documented at the time of the meeting and will be sent to NRC when the document is final. Mr. Floyd indicated he is currently developing criteria that will be used by the RCP to aid in the determination of when a response to an event is appropriate. Once those criteria are developed, NRC willlikely be requested to conduct a review.

4 Commitment Summary: Secretary Weidler endorsed the commitment by Mr. Floyd to provide NRC a copy of the third event response report discussed during the meeting and a copy of the criteria being developed to 1 provide guidance for determining when a response to an event is necessary.

Mr. Thompson committed the'. NRC'u Office of State ?rograms will review the event respoNe repor 4 prepared by the New Mexico staff and provide comments to New Mexico about the  ;

adequacy of the reports. '

Next Steps NRC indicated that the MRB would be reccnvened in the near future to make the final decision on whether to recommend to the Commission that the New Mexico program be placed on probation. The schedule foi *the upcoming meeting will be coordinated with Mr. Garcia and he and his staff were invited to participate via conference call. Mr. Garcia stated that realistic feedback from NRC was useful to the New Mexico RCP, NRC representatives stated it was j likely that an IMPEP follow up review would likely be scheduled next summer.

The meeting adjourned at approximately 10:30 a.m., Rocky Mountain Standard Time.

Attachments:

As stated

NRC/NEW MEXICO MEETING AGENDA DECEMBER 4,1997

1. NRC AND NEW MEXICO AGREEMENT STATE PROGRAM RESPONSIBILITIES PURSUANT TO ATOMIC ENERGY ACT OF 1964, AS AMENDED NRC discontinues regulatory authority upon assumption by New Mexico.

New Mexico's radiation control program must be adequate to protect i public health and safety and compatible with NRC's regulatory program NRC must pulodically review Agreements and actions taken by the State under the Agreements to assure odoquacy and compatibility.

- New Mexico committed in tha 1974 Agreement to use best efforts to cooperate with the Commission and other Agreement States for protection against hazards of radiation and to assure the State's program will continue to be compatible.

The Commision may suspend or terminate all or part of the Agreement if required to protect public health and safety, l

I i ll. OVERVIEW OF INTEGRATED MATER!ALS PERFORMANCE EVALUATION l PROGRAM (IMPEP) i -

Required periodic program review conducted using a performance-j oriented, team approach.

IMPEP developed jointly by NRC and Agreement States, Agreement State representatives are members of the IMPEP rwiew team and liaisons to the Management Review Board.

- Team report subinitted to Management Review Board for approval on Individual performance indicators, overall determination of the adequacy and compatibility of the Agreement State program, and the timing for the next IMPEP review.

- Except for emergency suspension necessary to protect public health and safety, Commission approval required for Agreement State program

probation, suspension, or terminetion.

Strong IMPEP program direction from NRC Headquarters assures cons! stent IMPEP implementation in NRC Regions and Agreement States.

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SUMMARY

OF NEW MEXICO IMPEP REVIEW FINDINGS AND THE SIGNIFICANCE OF PROBATION FOR AN AGREEMENT STATE PROGRAM Team recommended overall finding of

  • adequate to protect public public health and safety but needs improvement
  • and ' compatible with NRC's prograt.).*

Non common indic.stor Legislation and Regulations found satisfactory. Sealed source and Device Evaluation Prognam responsibility being returned to NRC by Govemor of New Mexico.

Of five common indicators, Technical Quality of Lloonsing found satisfactory; Status of Materials inspection Program and Technical Staffing and Training found satisfactory with recommendations for improvement; Technical Quality of inspections found satisfactory with recommendations for improvement after significant discussion about the possibility for a finding of unsatisfactory; Response to common indicator, Response to incidents and Allegations found unsatisfcetory by team, but MRB eknowledged that revised procedures appeared satisfactory, if property implemented, a finding of satisfactory with recommendatiens for improvement is appropriate. No incidents at time of MRB to demonstrate imp 4 mentation.

Twenty one recommendations and eight suggestions made by IMPEP team.

NRC examined the need for program suspension before New Mexico committed to respond to significant events.

MRB identified need for discussions with New Mexico before acting on team's probation recommendation.

Probation la a consideration when deficiencies in IMPEP performance indicators are of such safety significance that assurance of the program's ability to protect public health and safety may be degraded and NRC heightened oversight is required.

Govemor notified; State develops corrective action management plan; timeframe for implementation of improvements agreed upon; heightened oversight through reports, meetings, and/or conference calls.

Notice in Federal Register; letter to all States; press release; notifcation to appropriate Congressional committees and members of the State's Congresional delegation.-

NRC considers need for program suspension or termination if program improvements not realized.

IV. KEY ISSUES REl.ATED TO A PROBATION DECISION A. LEVEL OF PROGRAM STAFFING AND AMOUNT OF RESOURCE SUPPORT Two current vacancies.  ;

Commitments to respond to significant events and conduct reciprocity inspections place futher demands on sta#,

Apparent funding shortfall for necessary training and travel that could benefit the New Mexico Agreement State program, such as training for current and new employees and attendance at the Annual All A0reet.eent States meeting.

is lack of licensea fees a contributor to resource limitations?

B. STAFF TECHNICAL EXPERTISE AND TRAINING NEEDS l

Training needs identified for irradiator technology, brachytherapy, dose modeling, inspection procedures, and inspection techniques.

Written training and qualifications plan recommended to assure adequate training of staM.

New procedure training.

Improved eWoctiveness of supervisory inspector accompanimants.

C. LEVEL OF MANAGEMENT SUPPORT, INVOLVEMENT, AND OVERSIGHT OF AGREEMENT STATE PROGRAM ACTIVITIES Likely most critical determining factor on probation decision.

Higher standards for program performance necessary.

Commitment and plan to strengthen prc71 nMded from management above first supervisory level.

Idemincation of program operational issues for which upper management should be informed / consulted, such as safety significant events, licensing / inspection backlog status, and status of sta#

training / qualifications.

Needs: P.esource Support, Prograrn Goals and Corresponding Performance Measuras, Assessment and Feedback.

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4 Legislation need for adequate program funding?

V. FUTURE ACTIONS MRD will reconvene tc 9 stablish final MRB decision on finding for indicator, Response to incidents and Allegations, and the question of program probation.

New Mexico representatives will be requested to participate by conference call.

i if probation recommended, the Commission must approve.

l Periodic progress reports, periodic conference calls, and a followup review within six months to one year likely.

VI. )MMARY ANu CLOSING 1

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