ML20212A169

Proposed Final Rept, Integrated Matls Performance Evaluation Program Review of New Mexico Agreement State Program 970714-18

ML20212A169
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Issue date:	10/15/1997
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J INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF NEW M'EXICO AGREEMENT STATE PROGRAM July 14-18,1997 l

PROPOSED FINAL REPORT U.S. Nuclear Regulatory Commission 9710230175 971015 PDR STPRO ESGNM ATTACHMENT 1 PDR

New Mexico Proposed 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 July 14 18,1997, by a review team ,

comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and 2

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 Performance Evaluation Program Pending Final Commission Approval of the '

4 Statement of Principles and Policy for the Agreement State Program and the Policy l t Statement on Adequacy and Compatibility of Agreement State Programs," published in the  !

i Federal Reoister on October 25,1995, and the September 12,1995, NRC Management l Directive 5.6, " integrated Materials Performance Evaluation Program (IMPEP)." Preliminary .!

results of the review, which covered tiie period August 13,1994 to July 13,1997, were discussed with New Mexico management on July 18,1997

[ Paragraph on Results of MRB meeting will be included in final report.]

The New Mexico Environment Department is the agency within the State of New Mexico j that regulates, 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 Materials Bureau (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 poolirradiator, 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 Energy 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) examination 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 accompaniments 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 radiation control program's performance.

Section 2 below discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common performance indicators and Section 5 summarizes the review team'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

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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.

4 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS l The previous routine review concluded on August 12,1994, and the results were

Mnsmitted to Judith M. Espinosa, Secretary, New Mexico Environment Department, on i Abruary 7,1995. The review findings resulted in recommendations in two program l',dicators. The team's review of the current status of these recommendations is as follows:

l (1) At the time of the 1994 review, the New Mexico radiation protection regult.tions had last been amended on March 10,1989. Compatibility was i withheld because the State had f ailed to meet the three year time frame required for adopting regulations equivalent to nine NRC regulations deemed matters of compatibility: (1) bankruptcy notification, (2) quarterly audit of

, the performance of radiographers, (3) well logging requirements, (4) Na+innal Voluntary Laboratory Accreditation Program (NVLAP) certification of dosimetry 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 J

regulations listed above were part of a package of regulations which were adopted on April 3,1995, and which vecame effective on May 3,1995.

. Af ter reviewing $.e drafts of these proposed regulations, in a letter dated January 9,1995, the Office of State Prograr.1s (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 compatible with NRC requirements. This recommendation is closed.

(2) The 1994 review recommended that the State review 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 allegation follow up. The procedures have not been shared with all staff members, however, creating program inconsistencies which are discussed in 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.

3.1 Status of Materials insoection Proara_m_

The team focused on four factors in reviewing this indicator: inspection frequency, overdue inspections, initial inspection of new licenses, and timely dispatch of inspcction findings to licensees. This evaluation is based on the New Mexico questionnaire responses l

relative to this indicator, data gathered independently from the State's licensing and

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New Mexico Proposed Final Report Page 3 inspection data tracking system, the examination of completed licensing and inspection casework, and intervieu with managers and staff.

The team's review of the State's inspection priorities verified that the State's inspection frequencies for various ;ypes or groups of licenses are at least as frecuent 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 review 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 which the State requires more frequent inspections are as follows:

.T_voe of License New Mexico Frecuency (vears) NRC Frecuenev (vears)

Well logging 2 3 Medical institution 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 comparJd 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 iritial inspections were entered into the computerized tracking system together w;th existing licenses. Inspection due dates 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 initialinspections. From interviews, team reviewers found that the inspection staff was generally 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.

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 initialinspections performed late, ranging from 1 to 21 months past the six-month window, and eight licenses were overdue for initialinspections at the time of the review, from 1 to 34 months past the six month window. The review team recommends that initial inspections of licensees be performed within 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 a!!ow initial inspections to be readily identified to staff and management.

In their response to the questionnaire, RLRP reported that 148 reciprocallicenses 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 reciprocal licenses issued,45 were industrial radiographers, 26 were well loggers and four were

New Mexico Proposed Final Report Page 4 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 available for review by inspectors but inspections are rarely performed. Both program management and staff indicated that short lead times and significant travel distances were in pediments to performing reciprocity inspections. The review team recommends that the State increase tM 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 exarnined, 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. Allinvolved cases with deficiencies 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 and 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 Matwials inspection Program, be found satisfactory with recommendations for improvement.

3.2 Technical Staffina and Trainino issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training and ataff turnover. To evaluate these issues, the review team examined the State's questionnaire responses 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 Specialists 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 radioactive materials prog.am, the Naturally Occurring Radioactive Material (NORM) program and the x-ray program. Approximately 55% of each Environmental 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 staffing level appears to be a minimal level for a program of this size.

With the recent departure of a retired staff member, the staffing levelis even lower and raises concems about the general effectiveness of the program.

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The HRMB Chief ind;cated 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 end manage the licensing program move et!ectively. The Santa Fe office staff took full responsibility for 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 oi 'ignificant 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 medicallicensees who utilize 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 this area.

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 personnel will attend any conventional NRC training courses, unless NRC reassumes the cost for such training. Program management was directed to All Agreement States Letter SP 97-040, dated June 9,1997, 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 personnelin the areas of medical brachytherapy and irradiator technology.

The RLRP Manager stated that he provides 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 comparable 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 Trainitig, be found satisfactory with recommendations for improvement.

3.3 Technical Quality of Licensino Actions The review team examined completed licensing casework and interviewed the reviewers for 11 specific licenses. Licensing actions were evaluated for completeness; consistency; proper isotopes and quantities authorized; qualifications of authorized users; adequate

f New Mexico Feoosed Final Report Page 6 f acilities 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 evaluation reports; product certifications or other supporting documents; consideration of enforcement history on renewals; pre-licensing visits; peer or supervisory review as indicated; and proper signature authorities. The files were checked for retention of necessary documents and supporting data.

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 sampling 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 evalusted included three new licenses, two renewals, one pending renewal, three amendments, and two terminations. In discussions with the RLRP Manager, it was noted that there were no major decommissioning efforts underway with regard to agreement material in New Mexico. Also, there were no identified sites with potential decommissioning difficulties equivalent to those sites in NRC's Site Decommissioning 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 hr s 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 renewal is 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 technical assistence from NRC. The State has sought to identify potential contractors to evaluate the proposed waste water system and has queried other Agreement States to determine how the " solubility" criteria are being addressed in those States. INS has not yet submitted complete information to address all conditions of the Secretary's order. The Unse reviewer intends to require the licensee to consolidate the interim submittals into a hnal rer.awal package. A finallicense application review will be performed when the renewal package is complete. Issuance of this renewal is still pending.

With respect to the overalllicensing program, the RLRP Manager stated that licensing quality had suffered when licensing actions wore being handled out of two different offices. The RLRP Manager sought to improve lic3nsing 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 renewals 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

- New Mexico Proposed Final Report Page 7 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 telephor:e 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.

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 ,egnificant peer or supervisory 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 take.1into 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 performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

3.4 Technical Quality of insoections 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 medicalinstitution; 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 b.>oad 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 apparent 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

New Mexico Proposed Final Report Page 8 accompanied during past resiews. During the accompaniments, inspectors demonstrated a range in skills and abilities its the specific types of inspections they were performing, in two of the three accompanirr ants, inspection techniques were observed to be primarily records-review oriented, with missed opportunities when inspectors could have observed licensee operations. The accorepaniments 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 the 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 c.uality 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 licensee 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 industrial licensees and afternoon-inspections of diagnostic medical licensees. 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 inspectors have attended the NRC inspection training course, the principal inspection effort seems focused on records review, which is contrary to the national (NRC and Agreement State) trend in inspecting for licensee performarre. The review team recommends that the State inspectors attempt to observe licensee operations or demonstrations during all inspections.

On three of the inspections 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 condect independent measurements during inspections, and some inspectors even performed confirmatory measurements (i.e., side-by-side readings 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 iodine-131 and on a tagging licensee, inspectors apparently did not review licensee effluent 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 Annual Limits 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 1

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! 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, resolve 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 reviewing 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 suggests that the State inspectors attempt to interview ancillary 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 not conduct exit meetings with senior licensee managers, or did not make substantial efforts to conduct exit meetings with senior licensee managers (i.e., managers 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 manageme,nt 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 inspectcils attempt to conduct formal exit meetings with senior licensee management on all inspections.

The review team examined the State's performance regarding follow 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 cited 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 amend its license to add authorized users). Similar licensing issues were idutified 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 process 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 confirmed this in interviews. The closest that inspectors come to passing along information to the next license reviewer is by telling them verbally about needed licensing actions, in the case noted above involving the unauthorized user, this method apparently did not work or was not used. The review team suggests that the State develop a formal process for inspectors and license follow up. reviewers to document and transmit pertinent information to each other for The review team also examined whether the State's inspection files were complete. On two of the inspection 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 leamed that occasionally the licensee's response is filed in the license file in Santa Fe, without being transmitted to the Albuquerque inspector for review. The review team suggests that the State develop a

r New Mexico Proposed Final Report Page 10 process for ensuring that inspection files are complete, that all appropriate Stato documents 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 pool-type irradiatos. The review team found that 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 poolirradiator, because it is a new operation in New Mexico involving an extremely large inventory of licensed material. The review team recommends that the State begin documenting all trips to licensees' or applicants' f acilit!ss when inspecting licensed activities, performing special inspections, or performing pre-isensing site visits during construction. This documentation should be filed in the State's officialinspection file.

The review team identified a number of problems, covering both content and documentation, in New Mexico's inspection program. The revicw 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 inspection procedures and techniques utilized by New Mexico were evaluated and determined to be generally '

consistent with, albeit in far less detail than, the inspection guidance provided in IMC 2800. Few of the inspectors were aware of the presence of inspection 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 f9und to provide general insoection areau 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 used NRC's field notes. On its own forms, the State already has developed an inspection report format with major subheadings and spaces for narrative responses, a move away from the checklist format, whicn is the approach that NRC is adopting for materials inspections. The State has been revising its inspection re,. 'rt for approximately the past 2 years, according to the inspector with lead responsibility for the <

inspection form revision, and in that interim time period 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 internal requirement or standardization within the S: ate 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 areat for the type of licensee being inspected, and that RLRP inspectors begin using the standardized form (s).

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

New Mexico Proposed F;nal Report Page 11 the review period. Of the files reviewed, the State cites deficiencies on about one third of its inspections, in response to the questionnaire, the State reported that supervisory inepector 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 accon.paniments documented. 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 respo,ise to incidents and

& emergencies. The State also has available the services of the State's Scientific Laboratory 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 satisf actory with recommendations for improvement.

3.5 Resoonse to incidents and Alleaations in evaluating the effectiveness of the State's actions in respr.nding to incidents and allegations, the review team examined the State's response to the questionnaire relative to this indicator and evaluated the incidents reported 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 files from the Albuquerque office which were delivered to the review team.

The team compiled a I;st of 31 incidents that had occurred in the State during the review period, examined the list for possible trends or generic issues, and chose 11 of the more 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 comrnents 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 has no procedures or forms in place to record information obtained 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 manag 2 ment 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 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 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 I

1

New Mexico Proposed Final Report Page 12 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 avaluated the licensee'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 tearn recommends that the State establish a protocol for making independent investigations and evaluations of the licensee's actions.

Fourth, generic deficiencies noted in five cases where the incident should have been followed up at the next inspection, but was not. The review team recommends the State initiate procedures to ensure incidents are followed up at the next inspection to verify that the licensee's corrective actions have 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 items of 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 maintsin a separate incident file, incidents may be reported by the licensee directly to the Albuquerque inspector assigned to their territory, or they mav be reported to the RLRP office 'n 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 recommands that the State (a) set up a separate incident and allegation file system 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 office, ar 1 (b) establish a system to centrally log and track the progress of incidents and allegations.

The New Mexico statewide emergency plan is the responsibility of the Department of Public Safety. If other State agencies encounter incidents or 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 internal procedures for incident response other than a November 1995 mamorandum 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. Tha 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 tracking system recommended above.

The State does have brief written procedures for investigating allegations. It is their policy to thoroughly investigate all allegations, including those made anonymously, to seek out and interview corroborative witnesses, to investigate the reasons 'or confirmed events, and to document all conversations. It is also their policy to raspect anonymity to the highest possible extent. The tum noted, however, that New Mexico law does not protect the identity of individuals making allegations. The review team suggests that the State consider expanding the allegation procedures to include procedures for notifying the person

New Mexico Proposed Final Report Page 13 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 tne 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 the claims. Onsite investigations were conducted promptly in both cases. In one case, there was evidence that the State kept the individuals making the allegations informed of the resolution of their 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.

4 Except for the period between 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 problems may exist. Therefore, based on the IMPEP evaluation criteria, the review team recommends that New Mexico's performance with respect to the indicator, Response to incidents and Allegations, be found unsatisfactory.

4.0 NON 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 Progr6m, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium Recovery Operations. New Mexico's agreement does not cover uranium recovery operations, so only the first three non-cornmon performance indicators were applicable to this review.

4.1 Leoislation and Reaulations 4.1.1 Leaislative and Leoni 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 7&31 through 74-316. 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.

4.1.2 Status and Comoatibility of Reaulations 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:

New Mexicn Proposed Final Report Page 14

• " 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 on January 28,1997. Note, this rule is designated 4s a Division 2 matter of compatibility. Division 2 compatibility allows the Agreement States flexibility to be more stringont (i.e., the Stete could choose not to adopt self guarantee as a method of financial assurance), if a State 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 (;etter of credit or line of credit), insurance or other guarantee method (e.g., a parent company guarantec).

From reviewing the State's promulgation process and from interviewing 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 Recordkueping 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, *iransfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32 and 35 amendments (59 FR 61767,59 FR 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 January 1,1998.

• " Low Level Waste Shipment Manifest in* nation and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,60 Fh .'5983) that will become effective March 1,1998, and which will become due on March 1,1998. The NRC delcyed its effectiveness until the State could adopt compatible requirements so that the national manifest system will go into effect sit one time.

• " Frequency of Medical Examinations for Use of Respirato:y Proteci m uipment,"

10 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 matter of compatibility. Division 2 compatibility allows the Agreement States flexibility to be more stringent (i.e., the State could choose to continue to require annual medical 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 regulations now overdue and those which are due within the next 12 months.

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

New Mexico Proposed Final Report Page 15

• " 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 Augue 14,1998.

• " Medical Administration of fiadiation and Radioactive Materials" 10 CFR Parts 20 and 35 amendments (60 FR 48623) that become effective on October 20,1995, and which 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 un November 24,1998.

• " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 M 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 ',1996, so that the Department of Transportation (DOT) companion rule could be implemented at 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 possib:e.

• 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 ccnducted outside the IMPEP process and the States will be notified of the results.

During the exan'ination 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, 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 incorporated into the final regulations, it is the State's policy to send copies of final regulations to the NRC; iiowever, it could not be verified that copies of the previous 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 <m 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 rewew team did not revi3w the State's sea'ed 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 authority. The State did not perform any SS&D evaluations during the period of the review.

l l

New Mexico Proposed Find Report Page 16 4.3 Low-L(, vel 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 allow a State to seek an amendment for the regulation of LLRW as a separate category. Those States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although New Mexico has LLRW disposal authority, NRC has not required States to have a program for licensing a Lt.RW 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 ar:d 4 above, the review team found the New Mexico performance with respect to the performance indicators, Technical Quality of Licensing Actions and Legislation and Regulations, to be satisfactory. The review team found the State's ,

performance with respect to Status of Material Inspection Program, Technical Staffing and Training, and Technical Quality of Inspection to be satisfactory with recommendations foi P improvement. The team found the State's performance with respect to the common performance indicator, Response to inc idents and Allegations, to be unsatisf actory. The evaluation of inis indicator identified frequent examples of incomplete, inappropriate, poorly documented, or delayed responses to incidents, and as a result, potential health and safety problems may exist. These significant deficiencies, combined with the general weaknesses and problems identified throughout tne radiation control program, are of great concern to the NRC.

The team found that the primary root cause for the deficiencies was directly attributable to the need for management improvement to offectively assess and respond to potential public health and safety issues. Although no specific examples of public health and safety degradation were identified by the review team, the lack of effective programmatic control certainly increases that possibility. Accordingly, the team recommends that the MRB find the New Mexico program adequate to protect public health and safety but needs improvement, and compatible with NRC's program.

Due to the sipificance and number of deficiencies found in the New Mexico program, at the time of review, that included an unsatisfactory finding for one indicator, the team recommends a period of probation for a duration to be established after consultation with New Mexico radiation control program management.

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

1

1. The reviaw team recommends that the nuclear pharmacy inspection frequency be modified from 2 years to 1 year. (Section 3,1)

2. The review team recommends that initial inspections of licensees be performed within 6 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 initiat inspections to be readily identified to staff and management. (Section 3.1)

~

_ _ _ _ = - - - - - - - - - _ - - . _ . _ - -

New Mexico Proposed Final Report Page 17 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 State maintain the RLRP staffing level to at least 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)

7. 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)

10. The review team recommends that the State inspectors conduct independent measurements on allinspections. (Section 3.4)

11. The review team recommends that the State increase the rigor of reviewing technical health physics issues during inspections, and increese the breadth and scope of inspections. (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 meetirigs with the senior licensee management on allinspections. (Section 3.4)

14. The review team recommends that the State develop a formal process for reviewing licensee responses to deficieacy letters and closing open deficiencies. (Section 3.4)

15. The review team suggests that 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 completa, 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 specia! inspections, or performing pre-licensing site visits during construction.

!Section 3.4)

18. The review team recommends that the State management exercise more stringent supervisory review of inspection reports. (Section 3.4)

19. The review team suggests that the State complete its revision of the inspection report forms, insuring that each set of forms coveis all key areas for the type of licensee being inspected, and that RLRP inspectors begin using the standardized form (s). (Section 3.4) l

New Mexico Proposed Final Report Page 18

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 tha 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 reportlag 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 tne 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. (Section 3.5)

22. The review team recommends that the State establish a protocol for making independent investigations and evaluations of the licensee's actions. (Section 3.5)

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 corrective actions have been implemented. (Section 3.5)

24. The review team suggests that when evaluating incidents, the State cite appropriate items of deficiencies when applicable. (Section 3.5)

25. The review team recommends that the State: (a) set up a separate incident and allegation file system 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 office, and (b) establish a system to centcally log and track the progress of incidents and allegations.

(Section 3.5)

26. 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. (Section 3.5)

27. The review team suggests that the State keep expanding the allegation procedures to include procedures 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. (Section 3.5)

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)

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)

LIST OF APPENDICES AND ATTACHMENTS Appendix A IMPEP Review Team Members

- Appendix B - New Mexico Organization Charts Appendix C New Mexico's Questionnaire Response

- Appendix D License File Reviews Appendix E inspection File Reviews

~ Appendix F Incident File Reviews Attachment 1 New Mexico's Response to Review Fir, dings F

=

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

,.--- _ . - . - _ _ - . , _ _ , _ v

__=- _ - = _

-5-.---

9 APPENDIX B

. NEW MEXICO ENVIRONMENT DEPARTMENT HAZARDOUS AND RADIOACTIVE MATERIALS BUREAU ORGANIZATION CHARTS a

E i _____.m_ _ _ . - _ _ . _ . _

HAZARDRESERRADJRACDYE MAIERIALSJRIREAII !

IsUREAU CINEF

- BENITO J. GARCIA (505) 827-1557 CONSERVATION ODNIERVAT30N NATION AMDSPECIAI, IJCENSMGAND ANDRECUYERY REGISTRATION ANDRECOVERY AgeRECqyyElty Pit 03ECIS ACTptCRA)

SECTION ACT(RCRA) ACT0tCitA) TECHfGCAI, INSFECTIONf g ENFORCEMENT COMrtJANCE PROGRAM fit 0 GRAM Fit 0 GRAM BAltBARAHDDITSC'EK RONKIBtN NORMASRXA WEJJAM(BRJ)HDTD COBYMUCKERut0Y (505) 827-1561 (505) 827-1558 (ses)m-1557 (505)827-15H (505) 827-1558 .

~ ~ ~ -

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APPENDIX C NEW MEXICO'S IMPEP QUESTIONNAIRE RESPONSE 1

M

_ _____ _-__m____.__- _ . - _ - - _

IMPEP QUESTIONNAIRE Name: New Mexico Reporting Period: August 13, 1994-July 13, 1997

2. STATUS OF MATERIA 1A INSPECTION PROGRAM:

1. Please prepare table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800 (issued 4/17/95).

1. There are ne licenses with inspections overdue by more than 25% See Attachment $1 for schedule of inspection from:?ncie(s ) .

. 2. Do you aurre..tly 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.

2. N/A

3. Plaase identify individus1 licensees er groups of licensees the state / Region is inspecting less frequently than called for in NRC Inspection Manual Chapter 2800 (issued 4/17/95) and state the reason for the change.

3. Inspections are conducted more frequently +han shown in NRC Inspection Manual Chapter 2800, issued 4/17/95, because staff is adequate to handle the number of inspections in the inspection categories we have.

4. How many licensees filed reciprocity notices in tha reporting period?

148 reciprocal licenses were issued in the reporting period.

4 a. Of these, how many were industrial radiography, well-logging or other users with inspection frequencies of three years or less?

4.a. E n following tabla of reciprocities:

DM TT IR EDR WL BD NORM R&D GA PA 97 11 0 7 1 8 0 1 3

^

4 1 96 13 0 10 1 6 0 3 2 5 95 11 1 16 0 6 1 0 3 4 94 11 0 12 1 6 2 u 1 4 Totalt 148 *See legends next page.

1 e

• NOTE D/M-density / moisture gauge l TT -Teletherapy IR -Industrial Radiographer BDR-Bigh Dose Remote Afterloader WL -Well Lgging/Tacer BD -Bone D6nsity NORM-Naturally Occuring Radioactive Material R&D-Research and Development GA -Gauge (fixed Measuring levels)

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

4.b. Of the 14 8 out-of-state licensees granted reciprocity during the review period, 67 actually came into the state to perform work at temporary job sites. NRC priority one and two licensees that came into the state included 18 industrial radiographers, 8 well loggers, and 6 source exchange services. Three inspections were conducted, consisting of two industrial radiographers and one gauge licensees.

9. 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, 1994-0.

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

6. N/A

7. Please provide a staffing plan, or complete a listing using t re suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement states, the fraction of time spent in the following areas: Mministration, Materials Licensing & compliance, Emergency Response,11W, U-mills, and other. If these regulatory responsibilities are divided bwtween 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.

2

If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts.

The table heading should be 7A. MAME POSITION AREA EFFORT (FTE%)

William M. Floyd Program Manager Administration 75%

Material Licensing

& compliance 15%

Emergency Response 2%

other 84 Margaret M. Lopez Environmental Materials Licensing Specialist & Compliance 55%

EmergencyResponse2%

Other 43%

John A. Msrtines Environmental Materials Licensing Specia31st & Compliance 55%

Emergency Response 2%

Other 43%

. Walter J. Medina Environmental Materials Licensing specialist & compliance 55%

Emergency Response 2%

Other 43%

Ralph Manchego Environmental Materials Licensing specialist & compliance 55%

EmergencyResponse2%

other 43%

Jerrie Moore Environmental Materials Licensing Specialist & Compliance 55%

Emergency Response 2%

Other 43%

8. Please provide a listing of all new professional personnel hited since the last review, indicate the degree (s) they received, if applicable, and additional training and years of.

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

8. See Attachment 42.

9. Please list all prc'essional staff who have not yet met the qualification requa.rements of license reviewer / materials inspection staff (for NRC, Inspection Manual Chapters 1245 and 1246; for Agreement States, please describe your qualifica-tions and requirements for atterials 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.

3

i

9. Radiation Licensing and Registration Section staff have attended most all U. S. NRC courses available to Agreement State licensing and inspection personnel '

(including the 5-weeks health physics course). Training in teletherapy and Brachytherapy are needed for the staff. A minimum of six months experience is required before a newly-hired individual is allowed to attend U.S.

NRC-sponsored courses.

10. Please identify the technical staff who lef t the RCP/ Regional DNHS program during this period.

10. Debra McElroy left the RCP daring this review period.

III TBCENICAL 90&LTTI 0F 3.ICERSING ACTIONS

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. Ths new licenses issued that were complex and unusual included the following:

199'7- 1. The first NORM license was issued under the new Subpart 14 of the 20NMAC 3.1 regulations;

2. A Research & Development laboratory license was issued that authorized the use of in-vitro radioisotopes instead of animals for toxicological research; 1996- 1. A Co-60 Ganma 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 includwd the followingt

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 c,f Santa 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; 9

4

2) A license that authorized 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 facility;

3) All Industrial Radiography licenses were checked and a survey conducted to determine compatibility of equipment and associated parts, with 10CFR, Part 34.20 and 20NMAC 3.1, subpart 5, paragraph 506;

4) The TNA/Eberline license was amended to allow for bench-scale testing of their the segmented Gate system to volume-reduce soils contaminated with radium, transferred to the New Mexico site from a New Jersey site;

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

12. Please identify any new or amended licenses added or removed from the list of licensees requiring emergency plans?

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

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

13. No variances were granted during this reporting period.

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

during the reporting period?

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.

15. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.

15. W/A ,

s G

0 (

e

h* bd -

e b

b fj IV. TECENICAL QUALITY OF INSPECTIONS:

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

17. Suoervisor Inspector License cat. Rain 1994 Bill Floyd John Martinez AN 09 94 Jerrie Moore Ralph Manchego Ik 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 HI .. 07 95 g Margaret Lopez Walter Medina MI 07 95 E Bill Floyd Margaret Lopez AN 07 95 Margaret Lopez Ralph Manchego BM 08 95 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 Floyd Walter Medina IR 12 95 Bill Floyd Walter Medina DM 12 95 Bill Floyd Walter Medina GA 12 95 Bill Floyd Walter Medina WL 12 95 Bill Floyd Ralph Manchego HI 12 95 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 Martizez RD 02 96 Bill Floyd John Martinez MI 02 96 John Martinez Margaret Lopez MI 02 96 6

l I

a ,

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Bill Floyd Joht Martines iLD 02 96 Sill Floyd John Martiner. IV 02 96 mill Floyd Margaret Lopes MD 01 96 1997 Bill Floyd Jerrie Moore MI 02 97 mill Floyd John Martines RD 03 97 Bill Floyd Margaret Lopez RF 01 97 Margaret Lopes Walter Medina GI 03 97 Walter Medina Margaret Lopes MI 01 97 Walter Medina Mar aret Lopes MI 01 97 Bill Floyd Ral h Manchego MI 01 97 Bill Floyd Ral h Manchego DM 01 97 III TECERICAL QUhLITY OF LICENSING ACTIONS

19. Describe internal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documente. tion for each accompaniment.

18.- The Frogram 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 ' accompany junior 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 03. .

v. RESPONSES TO INCIDENTS AND ALLEGATIONS:

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

medical misadministration, overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc.) that occurred in the Region / State during the review period. For Agreement States, .information included in previous subalttals to WRC need not be repeated. The listi should be in.the following format:

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

21. .During this review period, did any incidents occur that involved equipment or source iallure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified?

7 4

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

On July 22, INC found a small defect in the weld on the source, SN9510. Mr. Filbert Fong of the State of California was notified at the Berkeley Office. Mr Fong later observed the defect.

On July 24, a preliminary notification was sent out by Region IV staff in Arlington, Ts, regarding the defect.

(See Attachment $4).

21.a. For States, was timely notification made to the Office of State Frograns? 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. was For incidents information on involving the incidentfailure of equipment provided to the agency or sources,ible respons for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each 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 to your procedures for handling allegations'that occurred during the period of this review.

24. No substantive changes occurred in the procedures for handling allegations during this re porting period. All allegations, including anonymous a:, 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

_ . . _ _ . . _ _ _ _ . . _ _ _ . . _ _.__._m __

(

IV. GENERAL

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

25. Nine regulations that had not been adopted as matters of compatibility with U.S. NRC regulations at the time of the last review have now been adopted. These include the following:

1. Bankruptcy Notification;

2. Quarterly Audit of the Performance of Radiographers;

3. Nell Logging Requirements;

4. National Voluntary Laboratory Accreditation Program

5. Certification of Dosimetry Processors;

6. Emergency Plans;

7. Safety Requirements for Radiographic Equipment;

8. 10 CFR, Part 2C 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 final word from NRC, 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 staf f members in order to maintain consistency in staff licensing and compliance activities. As a result of this recommendation, procedures covering internal processing of license applications, scheduling and documenting inspections, and enforcement activities, escalated enforcement actions, and other functions have been incorporated by the New Mexico RCP.

B. NON-COMMON PERFORMANCE INDICATORS:

1. REGULATIONS AND LEGAL AUTRORITY

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

9 i

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26. Strenothat

1. The ability to establish new priorities for inspections of RAM licensees by assignment with emphasis on the' most hazardous to the least hazardous. (i.e., each staff member 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 licens:mg procedures. (i.e., inspections are assigned by individuals on rotating basis).

3. Staf f has reviewed all radioactive material licenses to determine which licensees fall under the decomunissioning rule, and all Industrial Radiography

• licensees have been checked for compatibility with 10 CFR, Part 34.31 and NMAC3.2, Subpart 5, Paragraph 506 equipment rule. '

4. All staff have been trained with the exception of training in Brachytherapy.

5. License inspections are up-to-date.

Weaknesses:

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 :baplementation, (e.g. The Medical Human Use Guide).

~

3. There is a need for an additional Environmental Specialist, Option F, for the NORM regulation workload in licensing and inspection.

4. The creation of program databases for all general licensees, reciprocal licensees, and vendor providers of raduation 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- purcha:ed personal computers, not only in the 10

ward perfcet modo, but with the ocpability of gathering and generating data on the same system for reports.

Examples of Successes:

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

Statf participated in all aspects of the five-day conference.

2. Statf kept up with workload in spite of lengthy public hearing process involving the renewal of the Interstate Nuclear Services Radioactive Material License.

27. Please list all currently effective legislation that affects the radia+. ion control program (RCP). ,

27. Sections 74-1-9, 74-3-5 and 74-3-9 NMSA 1978.

28. Are your' regulations subject to a " Sunset" or equivalent law?

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

28. The New Mexico Radiation Protection Reguistions 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 $7.

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

30. 1. Proposed regulations presented to Radiation Technical Advison Council for advise and consent.

2. Proposed regulations presented to Environmental Improvement Board (EIB) for public hearing EIB approves or disapproves based on bearing record.

3. Amended regulations filed at State Records Center.

4. Amended regulations effective 30 days after 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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f . .

The table heading should be:

SS&D Manufacturer, Type of Registry Distributor or Device Egghgg Custom User or Source

31. Note: No SS&D registrations are pending. If any are received, we , will contract for evaluation assistance either with private industry or will pay U.S. NRC for assistance in evaluation.

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

32. M/A

33. Please include information on the following questions in Section A, as they apply to the SS&D Programs 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. IAnf-LEVEL WASTE PROGRAM:

34. Please include information on the following questions in Section A, as they apply to the Low-level Waste Program Status of Materials Inspection Program- A,I.1-3, A.I.6 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.16-19 Responses tr Incidents and Allegations -A.V.20-23

34. N/A IV. UR&BIUM MILL PROGRAM .

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

Status of Materials Inspection Program -A.I.1-3, A.I.6 Technical Staffing and Training -A.II.7-10 Technical Quality of Licensing Actions -A.III.11, A.III.13-14 Technical Quality of Inspections -A.IV.16-19 Responses to Incadents and Allegations -A.V.20-23

35. N/A 12

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4 ,

NRC ICSPECTION PRIORITIES INSPECTION MANUEL 2800,4/17/98 TYPE OF LICENSE NRC PRIORITT NMED PRIORITY PRIORITY Z BM BROAD MEDICAL 1 YEAR 1 YEAR CI GAMMA IRRADIATOR (POOL) 1 YEAR 1 HAR IR INDUSTRIAL RADIOGRAPBY 1 HAR 1 YEAR TA YAGGING 2 YEARS 1 YEAR RP RADIOPEARMACY 1 YEAR 1 YEAR PRIORITY II AC ACADEMIC 2 YEARS 2 YEARS BB BROAD LICENSE, TYPE B 3 YEARS 2 YEARS D/M DENSITY / MOISTURE GAUGE 5 YEARS 2 YEARS GL GENERAL LICENSE 5 YEARS 2 YEARS IA LAUNDRY 2 YEARS ,

2 YEARS MD MEDICAL DOCTOR-PP 3-5 YEARS 2 RARS MI MEDICAL INSTITUTION 3-5 YEARS 2 YEARS-RD RESEARCE & DEVELOPMENT 2 YEARS 2 YEARS VT VETERINARY 5 YEARS 2 YEARS

-WL WELL LOGGING 3 YEARS 2 YEARS PRIORITIT III AN IABORATORY ANALYSIS 3 U ARS 3 YEARS CS CALIBRATION SERVICE 3 YEARS 3 YEARS DU DEPLETED URANIUM 5 YEARS 3 YEARS GA GAUGE 5 YEARS 3 RARS IX ION EXCBANGE 3 YEARS 3 YEARS IV IN-VITRO 5 BARS 3 YEARS PA PAINT ANALYIER 3 YEARS 3 YEARS SO STORAGE ONLY 3 YEARS 3 YEARS TN TRANSPORTATION / WASTE 3 YEARS 3 YEARS G

t 4

'O

-___---.-_.--n__ - _ - - . - - -

NUCA11HN AND RADIATION REIA1TD COURSES ATTENDED BY WALTER J. MEDINA EDIJCATION-BS Depos, New Mexico Highlands Univenity,1974 Maior: Biology Minor. Chandstry and Math Registered Medical Technologist (MT ASCP) nAINING/NMED

1. Safety Aspects ofladustrial Radiography (H 305), June 4 9,1995.

2. MedicalUse ofRadionudidas August 1318,1995,

3. Ilmasing Practices and Procedures Coures (0109), ih r J4s 11 15,1995.

4. Inspection Procedures Course (0-108), September 25-29,1995.

5. Safisty Aspects of WellImaging (H 314), October 30-Nm ser 3,1995.

6. Applied Health Physics (H.109), February 5-March 8,1996. ,

7. DOE Workabop On Risk Assessment, June 11-12,1996. .

8. Troxler Electronic Imboratodos, Inc. Training Course For *Ibe Use of Nuclear Testing Equipment, October r 23,1996.

9. Calculating and Understanding Risk From Radionuclides Released To The Enviraa'a-a'. April 28 -May 2, 1997.

TRAINING /LOS ALAMOSNATIONALLABORATORY

1. PlutoniumMetallurgy, April 23,1981.

2. Nuclear Criticality Safety, June 14-16,1982. . .

3. Introduction to Materials Sdence, November 1517,1982. .

4. Scanning Electron Mimoscopy and X-ray Microsanlysis, September 17-20,1984.

5. Advanced SW Electron Microscopy and X ray Micrsanalysis, March 18-22,1985.

6. Materials Science and Engineering U, January 20 23,1986,

7. X-ray Safety: Analytical, March 20,1987.

8. Physical Metallurgy of UrarJum nd Pletonium, January 18-22,1988. .

9. Resource Conservation and Recovery Act Waste Generator Awareness, August 15,1990. ,

10. Fundamentals of Chemistry, January 11i15,1993. ' ~

ff$CkA4&tI#2-

RADIATION LICENSING AND REGISTRATION INSTRUMENTS JUNE 1997 MODEL TYPE SERIAL USER CALIBRATION / CONDITION / REPAIRS RO-3C ION 133 JAM 12/96 RO-3C 135

- RO-3C 06 97 137 RALPE 06 97 RO-3C 624 JERRIE RO-3C 06 97 646 MNL 06 97 RO-3C 635 JOEN 06 97 E-520 G/M 4602 JORN 12 96 E-520 4605 06 97 E-520 4609

. E-5;t'dP270 4176 06 11/97 POR CALIBRATION RALPB 10 96 E-530 BP270 847 JERRIE E-530 BP270 849 10/96 E-530 BP270 166!

PRM 6 1053 06 97 PRM 6 1055 SP 06 97 PRM 6 1245 SF 06 97 PRM 6 AC-37 1235 SF 10 96 PRN 6 AC-37 1306 ALB 02 97 PRM 7 uR 107 JORN 06 97 PRM 7 164 ALB PRM 7 06 97 167 JORN 06 97 PRM 7 696 PRM 7 RALPE 06 97 697 JERRIE 11 96 URHOD-3 88237 JERRIE PRM 4 ALPEA 107 ALB LUDLUM INSTRUMENT /S.P. 06/$7 06/97 PNR-4/NRD 4331 02/97 PNR-4/NRD 4365 ALB - -

KVP METER 223 JORN OK

• s

TABLE FOR QUESTION 29. 4 OR DATE DATE SG CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION l Any amendment ese peer to test. Idenefy 04/03/95 amergency plan adopted April 3,1995, offactive eacsi seguismen pesar as sie Cemenetegy of May 3, 1995 a-3 .

Deconnesmeneg; 7a741 04/03/95 N Pens 30 M 70 Esmessency Planung; 4743 04/03/95 Pads 30,40,70 Standssds ter Psosecten Agnant Redsdeng inse 04/03/95 Pad 20 -

Sede0y M- der Redepapids 1n044 04/03/95 .

Equentent: Past 34 h ofincidoses; 10t1544 04/03/95 ,

Pases 20. 30, 31,34,30. 40. 70 Quater teenagesment Psesseum and m

147J35 04/03/95 ,

w. p e 35 ,

l Licensing and Redenen Sasser 7nas 04/03/95 t- ^ serissestees: Ped 36 Ph of Land Deposal 7J22dBS 300t adopted WA ,*

and Wesso Sies QA Pseerasn- Past St

% Recaedhoepag- Docu. wwMaa glot adopted 6/98 menemmen Addamas: Pans 30,40,70 SelHiuasanese as an Adamenal Financial 1d2347 Ilot adopted 6/98 mm Pans 30,40. 70 Useness tes Taengs- Confmueste to EPA 7M47 , .

Blot W ad WA h: Past 40 Tsushases h4 8t1547 Ilot adopted 6/98 Pens 30,40. 70 Psepasemen,Tsenederter c h Dis- 2nes plot adopted 6/98 m and Une of Bypseduct temeenalfor

- Una- Pasen 30. 32_35 a

8

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[

IETSTIGATION OF AILEGATIONS OF IMPROPRIETIES %T' INS e

41enation Findina .

Solution

1. Use of larger mesh 1. In'or.e instance 1. Entire new fil-

' on sweco filter than it was noted that tration system the 50 micron mesh larger mesh was has been in-specified in license ordered application, stalled. Only was ordered(and by it3 proper fliter M , who made size will be the allegation). used.

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

) . -

somethmes became malatenance

• clogged, allowing estimate was that program put in spray heads became place..EEPA lint to escape to clogged twice a flitar will

environment. year. repla'ce water scrubber.

3. Tank f1 leaked. 3. It did leak, but 3. Tank repaired.

- it was no lenger used after inak

. was discovered. *

' 4. Wash vatar holding 4. Did happen at

tanks sometimes least once 4. Alarm will sound -

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

out beneath garage door onto ground. ,

LOPEt REBUTTAL EXHIBIT 1 ..

4

e a .

5. Venting of sludge dryer out window.

5. Gas fixed dry:<r 5. All air exhaust apparently used at will go through one time but ceased BEPA filter with being used when it alarm to notify '

didn t work. Some of malfunction.

former esployees remember it being booked r.p to REPA .

111ter. No way exists ,

to calculate what was exhausted out vindow. -

Swipe from window

• sill showed no evi-desee of contamination.

6. Not spot (44mR/hr) 6. Not spot did exist *6. Manways cut on waste water holding tank 41. (identified in in- .into tank; all ternal audit in 1994 sludge and was monitored on cluding(in- hot regular basis since spot) removed that time).

• and barreled

' for burial as '

waste.

7. Overflow of wash 7. One former employee 7. Rdgular water pits in wash confirmed they did room. maintenance overflow at least

• program once due to clogging instigated.

with lint.

s. Leaking of black plastic line feeding 8. Probably did occur, S. Doubly but 2eak repaired edcapsulated water from post- -

as soon as lt was filtration pits into flow lines discovered.

wash water tank Installed. .

building.

9. Workars instructed 9. Not verifiable; 9. Written pro-to allow air samples samples standardly to decay for up to a cedural manuals read at.24 and 72 followed.

month to show lower hours mocording to readings; also, procedural manual.

workers instructed 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/ less of whether .

not running to cause dryers are running.

lower readings.

e 6

10. Idconse application 10. Only one scrubber 10. Drawing sub-schematic shows exists, but it has mitted trater ecrubber to two hesds.

consist of two dif- .

farent systenst in actuality, only one water scrubber wrists.

II, Corkers ti.31d to 11. No proof that work-M.cral sludge out 11. Manways cut of holitiseg taalus, ers instructed to into ends in viole*, ion of shovel sindge since of tanks to confined space rule allow for confined space -

went into effect. No cleaning cf

• rule. evidence that any.me

• tanks.

on corporate level -

instructed workers to sheval sludge as 8

, alleged.

12. Water samples taken 22. Yes, since this .12. Bolding from drip line from allows for a more -

holding pits, not tanks re-homogenous mixture. plumbed so fiom holding tanks.

se*vle can

- be T.aken at

-

• point where wateranters eewer.

13. Washi'ng machines 13. They are run empty, sometimes run empty but only to rinse

13. Procedural to dilute copper and manuals will out machines between be followed.

zine concentrations. loads so cross- -

contamination of laundry from dif-farent sources is ,

less likely to occur. .

14. Liquid waste has 14. Tank drained and been seeping into 14. Tank will be

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

ground storage tank A recent inspection

' by IRMB showed it to .

since the 1960's. contain a few inches of water; no evidence of leakage.

2E6 dpm as per Report 30, ICRP. and Uranium Bionssay action levels, 5 micrograms per liter. <

Appendix D.3.a. " Records", records should be kept at both facilities for the required length of time, not as stated at facility or at the corporate records vault. -

Appendix D-E.2.*tMstewater Sampling:" Compliance reports for City -

of Santa Fe will be sent to ERMB as well as the city on the reporting requirements.

Ceed Portal monitoring spocifications and installation date.

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

Ceed timetable for installation of RFPA unit filtration system.

Bave no contamination levels in our regulations concerning cceeptable contamination levels. We have been using A?pendh F as cubmitted with this application and for other facilit:.es.

4 This completes this evaluation as submitted and as it relates to the final order for renewal of INS.

Margaret M. Lopez, Environmental Specialist, April 16, 1997.

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i CERONOLOGY OF RADIOACTIVE NATERIAL LICENSE RELD BY INS's SANTA FE FACILITY Chronology of INS file data prior to hearing June 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 license by AEC.

January 1, 1970 Amendment 48 to AEC license.

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

March 24, 1975 First license issued by EID to INS as found in ille. .

March 4, 1980 Amendment number NM-IIL-LA-06 extended expiration date in Item 4 to Match 31, 1985.

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

July 25, 1985 Rewritten license number NN-IIL-LA-11, extending expiration date to July 31, 1990, signed by Benito Garcia, Program Manager. .

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

September 26, 1990 Rewritten license number NM-IIL-LA-13, extending expiration date to June 30, 1995, signed by WL'.liam'M. Floyd, Program Manager.

March 15, 1995 ' Press release on INS laundry and the existence

• thereof.

March 15, 1995 Bill and Margaret from NMED attended press conference held at 107 Cienga St by CCNS where Bill was interviewed about INS licensing and stated that records were available for review upon request at the RLRS Office.

CCNS requested a list of RAM licensees in the Santa Fe Area, and reposted the state to provide testing of e*f.uents at the sewage outflow, and compile a history in sludge and water emanating from INS ad waters downstream from the sewage plant.

r 1

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

April 10, 1995 Application for renewal and supplemental documentation including SOP's is received by HMED for review. (Note: This application would have been evaluated for license renewal had not INS voluntarily submitted its September 5, 1995, application to conform with the NMRPR which became effective May 3, 1995).

June 30, 199S INS's specific license for laundry decontamination services expiration date.

July 21, 1995 A letter to IN3 requested INS re include proprietary information in the application and be made available to the public.

July 28, 1995 Public Notice published on July 20, 1995 on renewal for INS.

September 05, 1995 A revised application, signed by Kent Anderson, dated 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 changes.

September 12, 1995 A letter to Mark Weilder, NMED Secret ry, requested a public hearing on the INS license renewal.

Captember 19, 1995 A letter to Thomas Duker, Public Records Officer, requesting NMED to provide the public access to INS file records.

September 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.

2

'4

September 27, 1995 NMED's response to September 19, 1995 request e

• to provide the public access to information 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 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 were not in the file on October 11, 1995, but were copied and provided to CCNE as previously agreed to by Kathleen Sabo and Margaret on October 13, 1995.

October 23, 1995 Deadline of 10 days prior to set hearing tc provide the Secretary with a list of witnesses and a summary of testimony is required.

Reference to Section (307B) The requf.rement for an Environmental Impact Statement because INS is a -

commercial waste facility? INS is not a waste disposal facility. Any waste produced is incidental to decontamination services provided as 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:

August 7, 1995 Letter from Mark Weidler, Secretary NMED, to Mr. Ray Schmidt, informing of the public hearing to be held on INS license renewal.

August 31, 1995 Re submittal application for INS renewal, and request f or withholding proprietary information Sections B-1;C-1;C-2; and Figures B-1;B-2;B-3; end D-2 from public disclosure.

September 22, 1995 Memo from Willia: Floyd to Tracey Hughes, Legal Counsel, requesting attorney assistance in preparation for public bearing. .

3 1

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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 Kathleen Sabo, CCNS, from Tito Madrid, Hearing appointed hearing officer.

October 17, 1995 Letter from CCNS to Tito Madrid in response to '

his letter of October 10, 1996 requesting postponement of Nov. 2 & 3 hearing due to procedural and substantive irregularities by INS and NMED (the re-submittal of INS renewal application, cic,in 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 pr_rty status by interested persons and non-parties with the opportunity to submit oral relevant issues, views 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 I Hay, 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, exhibits, 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 raised for the first time in the past week.

October 24, 1995 Letter to Tito Madrid from Potter, Mills &

Bays, INS attorneys in response to CONS 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.

4 l

?

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

1. INS renewal application was submitted more than 30 days prior to June 30th, 1995 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 licensure issues under RPA.

4. Proprietary issue claims not evaluated.

5. INS 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 zuling, and cause appropriate notation to be placed in the public file.

6, 7, 8, proprietary issue.

9. Significant interest expressed merits 10.

public hearing of the application.

310 A,B & D have been complied with.

11. References to " Parties", " Interested Persons" and "Any Person Who is or maybe Affacted" are confusing.and resolves as followsi

a. INS & BRMB are deemed to be parties;

b. Information presented that relevant and not cumulative is or otherwise objectionable, any interested person shall be permitted to testif to cross yexamination; under oath and is subject

c. No inte sted person will be permitte" :o testify on behalf of an organizats.on unless they have a signed, summary of testimony. profiled ,

November 9, 1995 Letter from CCNS to Tito Madrid, Response to BRMB's motion for Prehearing Order and Response to INS letter, dated October 24, 1995. CCN9 desires a set time on public testimony bu(t no further restrictions other than relevancy);

determination of propr(ietary information 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, from Geoffrey Sloan providing a list of documents withheld 5

e e

, e.

November 15, 1995 by BRMB, not proprietary information claimed.

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, NMED, INS submittal of information for public record of Justification for Withholding Certain Information for Proprietary Reasons.

November 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 providtd in B-31-95 renewal application. No copies of these figures were made by BRMB.

November 28, 1995 Letter to Keith Eye,. INS Plan Manager, from the State of Washin DOH, Division of Radiation Protection, gton, on Sito Use Permit-Point of Origin Inspection conducted ,on November 18, 1995, - on rules governing the use of the commercial low-level waste' dis?osal facility.

After a review of waste handl;.ng operations, no deficiencies pertaining to the program were found.

November 30, 1995 Letter to Tito Madrid from Kathleen Sabo, CCNS, for Party Status.

December 4, 1995 Letter from REAL to Tito Madrid, in response to November 30, 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 ,

Letter from William Floyd to Mike Bovino, INS, Follow-up to December 19,1995, decommissioning plan & separation of proprietary information.

January 11, 1996 Order from Status Eearing 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 form CCNS to Tito Madrid additional petition and affidavits for reconsideration of Party Status.

6 9

February 26, 1996 REAL response to CCNS affidavits.

February 28, 1996 Letter from William Floyd to Mike Bovino, approving INS Decommissioning 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 generalized 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 CCNs amended petition for arty 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 NMED and City of Santa Fe, on March 28 through April 1,1996, (See report dated April 4, 1996).

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

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

" manhole" used to represent this connection point. Decommissioning Plan document expected on April 30, 1996.

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

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

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

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

April 26, 1996 SLD analysis, Sludge from Bolding Tank (2, April 29, 1996 Official copy of April 26 Sampling Analysis.

April 26, 1996 Journal North Article on protestors that

' condemn IANL 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, TheTrust Bank of Boston, and NMED.

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

in 1996. response to violations Notice of April 12, Letter outlined mitigation measures to be completed by June 15, 1996:

May 14, 1996 City Order to INS.

of Santa Fe Administrative Compliance discharge into cityCease 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 Landin PB., Engineer II City of S.F. Water Quality Division from INS to make programmatic and facility modification prevent recurrence to of cited violations, eliminate possible sludge into sewer system and May 22, 1996 new compliance sampling point.

New Mexican Article on waste a,t INS on 8

/

i

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 Fax from City of Santa Fe to Mike Bovino, INS on proposed facility mouifications no written approval granted until review of May 21 plans.

May 28, 1996 INS l'atter outlining Engineering controls taken for man-way installation & sludge removal from tanks.

May 28, 1996 Radiation Survey of areas surrounding INS by John Martinez and Walter Medina.

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

May 30, 1996 From INS attorney's to Jeff Sloan, NMED attorney Drkft 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 INS RAM license. Attorney Privilege.

May NMED 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 5 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 Standards Set for Nuclear Laundry by City."

May 31, 1996 CCNS to Jeff Sloan concerning information on proposed expansion areas and contamination clean-up.

June 3, 1996 Letter to Mike Bovino, INS to notify the State before sludge removal from tanks or any processing of sludge and protective measures taken. .

June 5, 1996 Representative from Yellow Freight concerned r

( 9

. , 1 1

about possible exposure by INS to employees.

Recommended he contact INS from WB counting.

Provided him with information of surveys at INS.

June 6, 1996 INS to Bill Landin, City Water Quality, response to supply requested information on TSS treshold limits.

June 7, 1996 Letter from INS keeping NMED informed of documents from City of SF to INS and meeting scheduled on Tuesday June 11, 9 'A.M. for " final inspection" to release cease & desist order.

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 radionucliie 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 Or< der. 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 North Article on Radionuclide Tests being required by City Council and affacts on private residences.

July 17, 1996 Unopposed motion for Issuance of Deposition Subpoena to Leroy Romero and CCNS before hearing.

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 deposition subpoena to grant motion and issue subpoenas.

July 17, 1996 Joint motion INS and NMED to amend order denying City of SF Party Status.

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

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 subpoena Romero before Tito Madrid to squash for 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, s

G 4

g.

11 4

APPENDIX D LICENSE FILE REVIEWS File No.: = 1 - .

Licensee: Espanola Hospital License No.:: MlO73 Location: ' Espanola . Amendment No.: 20 License Type: Medical Institution - 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 wat 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 mnewal was in the file. The renewal (amendment 5) was found on a corr v .md printed out for the file but the licensee's letter requesting renewal wr ;ound.

File No.: .

Licensee: Ethicon Endo-Surgery License No.: Gl316 Location: Albuquerque Amendment No.: O License. Type: Pool Irradiator Type of Action: New Date Amendment issued: 01/19/96 License Reviewer: ML Comments:

a) Cocuments ( 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.

File No.: 4

- Licensee: Continental Testing and Inspection License No.: IR323 Location: Signal Hill, CA/ Aztec, NM Amendment No.: 0 License Type:- Industrial Radiography Type of Action: New Date Amendment issued: 07/11/96 License Reviewers: ML/WJM Comments:

a) RSO qualification and facility diagram submittals were not tied to license.

b) No training and experience was documented for one of the named radiographers.

New Mexico Proposed Final Report Page D.2 License File Reviews File No.: 5 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. Romero, 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 reccrds 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).

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-down condition and that recent operating and emergency procedures that were included in the file were not referenced in the license.)

New Mexico Proposed Final Report Page D.3 License File Reviews File No.: 9 Licensee: Atomic Inspection Lab License No.: IR022 Location: Albuquerque Amendment No.: 14 License Type: Industrial Radiography Type of Action: Renewal Date Amendment Issued: 04/04/97 Lic3nse Reviewer: WMF Comment:

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 L; cense Reviewer: ML Comments:

a) No indication that all items identified as deficiencies in the undated Licanse Application Evaluation "The New Mexico Environment Departirent 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.

File No: 11 Licensee: Rotary Wire Line Service, Inc. License No. WL300 Location: Hobbs Amendment No. O License Type: Well Logging Type of Action: New Date 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 documentation in his personal notes.

C

APPENDIX E INSPECTION FILE REVIEWS File No.: 1 Licensee: Kleinfelder, Inc. License No.: DM318 Location: Albuquerque Inspection Type: Unannounced, initial License Type: Moisture /Donsity 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 Service, Inc. License No.: IR138

• 4 Location: Farmington inspection Type: Unannounced, Routine License Type: Industrial Radiography Priority: 1

i. 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 4

Licensee: Petro Wireline Service License 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 i

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 i the license.

i b) Deficiency letter sent to licensee late - 3 months after the inspection, which exceeds the 30 day post exit cr'terion, c)- Operations not observed, d) Exit meeting held with a non-authorized user, not senior licensee management, e) Acknowledgment letter (respo iding to licensee's reply to deficiencies) not in file, f) Key areas not inspected / addressed (training, inventory, and shipments not inspected; condition of equipment not reviewed; licensee conducting tracer studies, i but bioassays not inspected).

l g) Licensee's response to repeat deficiency on survey meter calibration does not

. address how future violations will be prevented.

a

New Mexico Proposed Final Report Page E.2 Inspection File Reviews File No.: 4 Licensee: Northeastern Regional Hospital License No.: Ml153 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 / addressed (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.

Fite No.: 5

) Licensee: Science Applications international Corp. License No.: RD249 Location: Albuquerque Inspection Type: Unannounced, Routine License Type: Research and Development Priority: 2 Inspection Date: 05/15/96 Inspector: JAM Comments:

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

L) No supervisory review of inspection report indicated.

c) Exit meeting with RSO, not senior licensee management, d) Key areas not inspected / 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 appropriate, since cobalt-60 has a half-life longer than appropriate for decay-in-storage).

File No.: 6 Licensee: Ethicon Endo Surgery License No.: Gl316 Location: Albuquerque inspection Type: Unannounced, Initial License Type: Pool Irradiator Priority: 1 Inspection Date: 07/01/97 Inspector: JLM Comments:

a) Independent measurements were made (but actual dose leveis 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 demineralizer 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.

~

New Mexico Proposed Final Report Page E.3 Inspection File Reviews File No.: 7 Licensee: Biotech Pharmac) 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 waste disposal; inspector does not recall whether inspection included wipe tests for removable contamination),

c) Inspection report form in draf t.

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 Alternate RSO, instead of changing the RSO, not documented e) Nuclear pharmacy used 1131 during review period, but no bioassays performed. No estimates of worker internal 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.

File No.: 8 Licensee: New Mexico Institute of Mining 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) Inspection dates inconsistent: inspector reports 2/18/97, inspection form shows 2/20/97, letter to licensee states 2/19/97, b) Operations not observed; independent measarements not made, c) Key areas not inspected / addressed (surveys, security, mceipt/ inventory, transfers / shipping, and internal audits not addressed in inspection report; inspector does not recall whether hc looked at licensee surveys; insufficient detail on worker doses; process for waste disposal described, but no information regarding whether waste was being disposed).

d) No interviews of students in authorized user's laboratory, e) Exit meeting with RSO and authorized user, not senior ur.sersity 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 license distributes; examination of annual audits not addressed; insufficient detail on bioassays, extremity doses, emergency response, and gaseous effluent levels).

C New Mexico Proposed Final Report . Page E.4 Inspection File Reviews 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 resea (n. Inspector reports that licensee is performing radiation experiments on people, inspector did not ask what the licensee was doing.

b) Alls 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.

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 facili.", dosimetry results not provided).

c) Students not interviewed regarding training. One significant authorized use under this license is to train students in the use of portable gauges.

4 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) Ir,spector 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 Laundry 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.

New Mexico Proposed Final Report Page E.5 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 International .

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. Jo'eph Hospital License No.: Ml210 Location: Albue serque Inspection Type: Unannounced, Routine License Type: 3rachytherapy Priority: 2 Inspection Da'a: 06/17/97 Inspectu: ML Comments:

a) Inspe : tor was not sufficiently trained in brachytherapy.

b) Therapies in progress were not observed (LDR, eye plaque, tr 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: Atomic Inspection 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 of incident and Final Disposition: Approximately 20 mci tr 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 evaluation, in interview with review team, inspector stated he thought he remembered conducting onsite investigation the next' day. Licensee sent State report with medical and >

radiological evaluations and changes in 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 calculations, and confirmatory measurements of cleanup. Memorandum or report of results of onsite investigation never located; no record of inspector visit on licensee sign-in log for 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.

File No.: 2 Licensee: NOL X NDT Services License No.: IR152 incident ID No: NM 9610 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 returned to manufacturer, industrial Nuclear Corporation (INC), a California licensee. INC reported leaking source to California Radiation Control Program, who reported it to NRC RIV (PNO-IV 96-040). Cause apparently pin-hole leak in source, considered to be one-time failure.

Comments:

a) No documentation of State's response actions; information taken from reports furnished to the State by NOL-X NDT Services, and California 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, i

New Mexico Proposed Final Report Page F.2 incident File Reviews File No.: 3 Licensee: H&G Inspection Co, Inc.

License No.: IR268 incident ID No: NM 9011 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 Dispo:lition: When licensee returned dosimetry to vendor, they were advised of an exposure reading of 198 rem for a radiographer. Licensee reported 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 radiographer's work schedule, compatison 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 evaluatic; af licensee's response, d) No close-out information or signature; is record of management involvement or review.

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

File No.: 4 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 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 following procedures and promised improvement.

Comments:

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

b) No documentation in file to identity person taking report from licensee; no close out 4

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

c) 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.

I a

" New Mexico Proposed Final Report Page F.3 Incident File Reviews File No.: 5 *

. Licensee:- Syncor, Inc.

License No.:- RP261 incident ID No.: NM 9611 Location: Albuquerque 4{

- 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 but

- wrong tagging agent (phermccoutical). Hospital advised Syncor that patient was injected with incorrect radiopharmaceutical. Syncor reported error caused by net following procedures and prom! sed improvement.

Comments: -

a) No documentation of State's investigativa er 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 hiose-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 of State's evaluation of licensee's response, f)' No evidence incident reviewed at next inspection.

File No.: '6 .

Licensee: Halliburton -

License No.: WLO87 incident ID No.: NM 95-09 Location: . Russell well sits,- 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 f allowed appropriate capping procedures; copy of plaque was included in report.

Comments: . - - --

al No record of Sta:e's response. Only documentat!on of incident was licensse report to State.

= b) ; L No documentation in file to identify _ person taking report from licensee; no close-out .

- information or signature; no record of management involvement or review. - i 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 Location: Gas pipeline near Colorado border Date of Event: 1/22/95 Type of Event: IR Source Disconnect

' investigation Date: 2/27/95 Summary of Incident and Final Dispocition: Radiographer failed to connect 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.

,i..,,,

New Mexico Proposed Final Report Page F.4 incident File Reviews Comments:

a) Although incident wat significant enough to require immediate onsite response with in depth review of circumstances, including reenactment, verification of dose t calculatione, 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 infonaation along with licensee's response, but no evidence of investigation as to cause (training, inadequate procedures, etc.)

and no evidence of evaluation of licensee's response.

c) Licensee not cited fcr event nor for late report, d) No close-out information or signsture; no tecnrd of management involvement or review.

e) Incident not followed up during next inspection, f) included in NMED.

File No.: 8 Licensee: University of New Mexico

• License No.: BM233 Incident ID No.: NM 97 01 Location: Albuquerque Campus Date of Event: 2/24/97 Type of Event: Lost RAM 1.

Investigation Date: Unknown Summary of incident and Finst Disposition: Two vials of 250 uCi each of P-32 was taken from the radiat'on safety office. Only one vial was found in the box on receipt. Vial presumed disposed of in ordinary waste. Licensee report dated 3/12/97 states they investigated, estimated probable dose, and changed procedures as corrective action.

Comments: "

a) No evidence cf investigative actions taken by State althuugh 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 material.

b) No record of any contact between State and licensee other than letter report from licensee to State dated 3/12/97.

c) Inspector's report for next inspection states that problem was discusced with RSO, who attributed problems to new computer system, but no citation was issued and discussion of incident was not included in enforcement letter to licensee, d) No documentation in file to identify person handling report from licensee; no close-4 out information or signature; no record of management involvement or review, e) Reported to NRC in qurterly report.

B F

N

O New Mexico Proposed Final Report Page F.5 incident File Reviews File No.: 9 Licensee: AGRA Earth and Environmental License No.: DM201 incident ID No.: NM 97 e; Location: Las Cruces c Date of Event: 3/28/97 Type of Event: Transportation Investigation Date: 3/28/97 Summary of Incident and Final Disposition: Vehicle carrying boxed and secured portable moisture density gauge was involved in serious accident in which driver was killed. Police arrived soon after, contacted State, and were told to secure area. State contacted licensee's assistant 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.

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 perran taking report from licensee; no close-out information or signature; no record cf 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: 8/3/94 Type of Event: Contamination Investigation Date: 8/3/94 Summary of incident and Final Disposition: Radioactive contamination found on bed of Tri 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-hot se memorandum dated 8/4/94 does t not identify person taking report or who mada 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 thic period.

. 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

New Mexico Proposed Final Report Page F.6 incident File Reviews 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 onsite 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.

b) Only documentation of incident is memo to file after telephone call which does not contain names and shows spill as 100 uCi, contrary to licensee's report of 100 mci.

c) No evidence State reviewed licensee's response for adequacy, d) Licensee not cited for events causing incident nor for late reporting.

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

f) Not reponed to NRC.

~

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s j )

State ofNew Mexico ENVIRONMENTDEPARTMENT QO HaroldRunnels Building

'** 1190 St. Francis Drive, P.O. Drawer 26110 Seata Fe, New Mexico 875024110 MARK E. WEIDLER (605) 827 28S5 ucatrar .

CARYLJOHNSON Fax:(605)8272836 -

oavsanon October 10,1997 Mr. Richard Bangart, Director 8

- Office of State Programs 8 U.S. Nuclear Regulatory Commission Washington, D.C. 20555 0 a

• to

, o Re:

s On-Site IMPEP Review - New Mexico, July 14-18,1997 s State Program Response to Draft Report Oen s

Dear Mr.Bangart:

'Ibe New Mexico Radiation Control Program (RCP) tnanks the IMPEP team for their preliminary findings 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 response keyed to the review team's findings, suggestions, and recommendations. Our focus is on nadinga requiring action by the State. We submit that we w&end_ the new emphasis the review team believes our efforts should have. We can show that we are deliberately on that path. Probation is not warranted, especially in comparison to issues arising in cases of other state programs.

1. Ihe review team mmends that the nuclear pharmacy iaWon frequency be modified from 2 years to 1 year. (Section 3.1) -

Response: -As Attachment 1 indicates, the RCP has increased the inspection frequency for nuclear pharmacies to annually. 'Ihe two-year ia== + ion frequency being used previously was based on a Oequescy recommended in an out-dated copy ofIMC 2800 which we believed to be current.

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

2. The review team :==nmends that initial inaa~+ ions of new licensees be performed within 6 months after license issuance or within six months after 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, first-time licenses, now has a hard copy

. file for new licenses in his office and will track new license i_aar= + ions on a six month basis. Also, th:: RCP Program Manager has established a tickler Sie and will prompt inspectors to inspections coming due during a two-month block at least a month in advance. The computer database used by ATTACHMENT 1

' 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. The review team recommerds 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 oflicensees showing inspections coming due will be generated by an assignal technical staffperson during the last week of every month and a copy will be delivered to the Piogram Manager, the Bureau Chief, and all inspection staff. -The Program Manager shall insure that the staff person responsible for the-appropriate geographical area of the state completes any due or overdue inspection.' The Bureau Chief will be responsible for notifying the Program Manager in writing of any initial inspections due fcr first time licensees still held on file at the end of the first six month period.

4.1 The review team recommends the numbx of reciprocity inspections be incre eed to better evaluate the health and. safety implications of out-of-state companies working in New Mexico.

(Section 3.1)

Response: When the 3-day notification is received of an out-of-state licensee's .:= Sag entry into the state, the RCP Program Manager will make a duplicate copy of the notification 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 1 and Priority 2 recipW licensees.- If unannounced inspections are not possible Wm directions for locating the licensee's activity are -

needed, documented phone calls will be made to obtain directions or to coordinate meeting up and accompany visits to the 6 eld site. If RCP staff workload, staffunavailability or other considerations do not allow for inspections ofreciprocal licensees in fic!d locations, the RCP Program Manager will write onto the notification form why an inspection was not conducted. A new master reciprocity inspection file has been created and will be maintained by the Fig.ru Manager in Santa Fe.

- RMymcel license iaWons will be coordinatad with almady pending routine inspections of state g licensees tc maximim use ofin-state travel funding. ' Since the IMPEP review, three Priority 1 and 2 idymcel licensees have been inspected at their temporary field sites in southeast New Mexim

5. The review team reconunends that the state maintain the RCP staffing level to at least the level which existed throughout the review period. (Section 3.2)

Response: As verbally conunitted by Secretary Weidler at the IMPEP team outbrief on July 18,

- 1997, the two Envimr. mental Specialist positions _ vacated since the IMPEP review have been approved for hire and nave been advertised for applicant interviews. 'Ibe positions will be filled i

Mr. Bangart October 10,1997 Page 3 .

following the interview process. Based on past experience, tl.e new personnel will require extensive specialized training to be able to function independently as fully proficient 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 staffon October 14,1997, with refresher training thereafter annually (Attachment 3). There are currently brachytherapy programs at four hospitals in the state.

Paul Ripley, RSO at Ethicoa EndoSurgery's 5 million curie Co-60 irradiator in Albuquerque, has approved RCP staff atterdance at pool irradiator training to be offered by Nordion sometime in -

November,1997. This training will be updated on an annual basis (Attschment 4). There are currently two pool irradiators in the state: the one at EtNeon and a 20,000 curie Co-60 raodel used for instructional and research purposes at the University of New Mexico School of Medicine.

7. The review tearn recommends that the RCP develop a formalized training program comparable to IMC 1246, "Formr.1 Qualification Programs in the Nuclear Material Safety and Safeguard Program Area."(Section 3.2) -

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

.Tustification for this assistance will be forhming in an ofHeial request to NRC. Regardless of the availability of formali=d training ~%, the RCP will continue to expand in-house and on-the-job training and obtain training from the private sector and other state institutions.

- 8. De review team suggests that complete documentation oflicense reviewer's actions be entered and maintained in license Bles. (Section 3.2)

Response: The RCP Program Manager is developing standard operational procedures to assure that all calls, letters, and supplemental information generated during 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.- Sinc- the iMPEP review, all files have been returned to the centralized Santa Fe RCP of6ce. The importance of documentation for every action taken by staff W

c __ - _-

i Mr. Bangart October 10,1997. [

Page 4 l in response to licensees' requests has been discussed at RCP staff meetings. A telephone log sheet l(Attachment.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 writing The

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

9. - The review team recommends that the state inspectors make observations of licensee operations or demonstrations during all inspections. (Section 3.4)_

Response: . New inspection forms incorporate routine review of operations or observation of demonstrations (Attachment 6). The Program Manager and Bureau Chief have begun more frequent accompaniments ofinspection staff and will continue to do so. One such accompaniment has been conducted by the Bureau Chief and one RCP inspector as a training exercise which included a radiographer field site operational inspection. The Program Manager has accompanied an inspector 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 Inspections" has been revised (Attachment 7),

and a copy has been delivered to each staff member. The importance of performance-based inspections has been discussed at RCP staff meetings and inspection forms have been finalized reflecting performance-based inspections. The importance ofinterviews with workers, independent measurements, status of previous violations, and the substance of discussions 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. 'Ibe one non-central inspector will personally bring all inspection forms to the central office and discuss finding = with the Program Manager as inspections are accomplished. The New Mexico RCP submits it abould be noted that with the exception of one inspector, all inspection staff attended the U.S. NRC sponsored "In=a~4 ion Procedures Course" prior to the advent ofperformah inspection guidelines and not since. Before our first IMPF.P review this July, RCP inWars have never in the past been criticized for the type ofinspections they were conducting.

10. 'lhe review team recommends that the state inspectors conduct independent measurements at allinspections. (Section 3.4)

Response: The importance of taking independent measuiements on all inspections has been

. discussed at staff meetings since the IMPEP review. Inspection SOP documents have been changed

.. to reflect the procedures for conducting independent measurements with portable survey instruments and for obtaining laboratory samples when it is deemed necessary as part of the inspection.

. MriBangart October 10,1997 Page5 '.

I1. The review team recommends that the state increase the rigor of reviewing technical health physics issues during inspections, and increase the breadth and scope ofinspections. (Section 3.4)

- Response: Inspection forms and Inspection Guidance Documents (Attachments 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 will, by written memo, report to the Burcau Chief after each training session which forms and topics have been covered during the training sessions.

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

Response: The Program Manager has emphasized the irr.portance of ancillary worker interviews

- during inspection as per the SOP on General Provisions for Inspecuon Procedures (Attachment 7).

The provisions of Subpart 10, Section 1005, of the New Mexico Radiation Protection Regulaticas, pertaining to consultation with workers during inspections have been discussed during staff meetings and includci as an item for the monthly staff training meetings.

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)

Response: Ivlon forms and inspection guidance documents have been changed to indicate that "the closeout conference should be held with the licensee's highest level of management available," and that " inspectors should always contact upper management upon entering a facility."

he importance of following-up with upper management, even if unsvailable at time ofinspection,

- has been stressed at staff meetings.

- 14. The review team recommends that the state develop a formal process for reviewing and closing out for scheduled follow-up, all licensee responses to deficiency letters. (Section 3.4)

Response: The Pmgram Manager has implemented a response tracking system using a period timed ticklet file to be maintainad by the Program Manager. De RCP Program Manager (initially) and the Bureau Chief will sign off on the adequacy oflicensee msponse. Requests for additional information are always in writing, with copies of all correspondence to be placed in each licensee's

. folder. ' Failure to respond to letters of deficiency within the response period, is pursued by enforcement action as per the " Guidance and Policy for Escalated Enforcement Action" (Attachment 8). A form (Attachment 8-B) has been developed to track inspection follow-up activities.

15. The review team suggests that 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 staffmeetings 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 satisfied in writing, and the Program Manager will reiterate what is needed by E Mail to the '

inspector.

16. The review team suggests that the state develop a process for ensuring that inspection files are coniplete, that all appropriate state documents are prepared and filed, and that licensee responses 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 respecases to letterr of violation are received. The adequacy of responses le reviewed sud approved by both the Program Manager in writing. Letters in reply to licensee responses are signed by the Program Manager. The 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 !icensees' and applicants' facilities when inspecting licensed activities, performing special inspections, and performing pre-licensing site visits dunng constniction. (Section 3.4)

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

18. The review team recommends that management exercise more stringent supervisory review ofinspection reports. (Section 3.4)

Response: By relocating all but one of the RCP inspectors to the central office in Santa Fe, inspection reports will not accumulate in field offices without management review. The RCP Program Manager now reviews inspector field notes and inspection reports, and the Program Man.:ger reviews licensee responses to violation notices. The Program Manager's written review and approval are entered into the licensee's file.

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Mr. Bangart October 10,1997 Page 7

19. The review team suggests that the state complete its revision of the inspection report fonns, 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 naff 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 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 I 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 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. (Section 3.5)

Response: 'Ihis 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 MRB. We believe that the state program 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 our last NRC program review) 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 implementation will realize by adjusting our approach. We are dedicated to it. We shall do it without probation. New incident and allegation report fonns are in Attachment 11. Guidance document procedures have been developed for incident and for allegation investigations (Attachments 9 & 10). Copies have been distributed to staff and are in use. Finally, on September 16,1997, Mr. Sam Pettijohn of the NRC trained New Mexico, Colorado, and Arizona Radiation Control Program Staffin use of new NMED software to track data intemally and forward data to the NRC.

1

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Mr. Bangart October 10,1997 Page 8 .

22. De review team recommends that the state establish a protocol for making independent investigations and evaluations of the licensee's actions. (Section 3.5)

Response: Attachment 7 contains the protocol to be followed for makkng independent investigations and evaluating the licensee's actions. The protocol has been distributed to staff and is in use.

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 corrective actions have been implemented. (Section 3.5)

Response: A separate section entitled " Incidents / Reports" has been incorporated into inspection forms which provides for listing information on types ofincidents that occur aAer the last inspection, including notification mports and conective actions, ne importance of completing this section has been emphasized in staff meetings and inspection reviews by management. This will also be an agenda item at monthly staff training sessions.

24. The review team suggests that when evaluating incidents, the state include citations to appropriate regulatory authority (when applicable). (Section 3.5)

Response: In the past, the RCP has handled some deficiency notices verbally. De routine now requires Notice of Deficiency letters in all casos where a breakdown of procedures occurred or may h:.ve occurred to cause a reportable incident. Interviews with licensee management are conducted to discuss csuse ofincident, consequences and corrective actions taken.

25. De review team recomtr. ends that the state: (a) set up a separate incident and allegation file system in the Santa Fe office so that all documents and records pertaining to an incident are available in one location, with the data c mes-referenced to license and inspection files centrally and in the Albuquerque olSce, and (b) establish a system to centrally los and track the progress ofincidents and allegations. (Section 3.5)

Response: The incident and allegation Ales have been moved 6om the Albuquerque office to the Santa Fe office. A new facident/ Allegation theHst has been developed, as well as a new Incident / Allegation Report Form (Attachment 11). The NMED database is now utilized to track all incidents and allegations and to forward the data to the NRC. A chronology file (hard copy) is also kept in the Santa Fe office, and a tickler file has been established to track the progress of incidents and allegations and prorrrpt follow-up. The Program Manager is responsible for this tracking system.

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. s Mr. Bangart October 10,1997 Page 9

26. De review team recommends that the state develop and implement written procedures for responding 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 been instructed in their use. The 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 11" exercise in May 1997. Additional emergency response

- training is being sought.

27. De review team suggests that the state keep expanding 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. ' nc RCP requested a meeting of the Radiation Technical Advisory Couisil (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 mystibility standpoint, nc RTAC took action on the two most critical compatibility regulations _

and withheld action on the others until a fbture meeting, no RCP will request a hearing from 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 sheady contains 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 compatibility tanguage from the Federal Register (61 FR 24669) was approved by the RTAC fot inclusion unds Subpart 3 Section 311.G (page 3 32) 20 NMAC 3.1 by the Environmental Improvement Board.

C Mr. Bangart October 10,1997 Page 10 ,

B. "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 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.

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 submittal to the Environmental Improvement Board. (These will be proposed for adoption no later than May 1998): .

(1) " Timeliness in D-mlasioning 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 Pans 30,32, and 35 amendments; (3) " Low Invel Waste Shipment Manifest Information and Reporting," 10 CFR parts 20 and 61 amendments; (4) " Frequency ofMedical Evaminations for Use of Respiratory Protection Equipment," 10 CFR Par;20 amendments; (5) " Radiation Protection Requimments: Amended De6nitions and Criteria," 10 CFR Parts 19 and 20 amendments; (6)- " Medical Administration ofRadiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments;

-(7) " Clarification for Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments;

-(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)

t' Mr. Bangart October 10,1997 Page11 ,

Response: All regulation promulgation and NRC approval correspondence is now kept in discrete files for easy access.

In closing, we ask that the MRB take account of our struggles, recognize our improvements, and overrule the review team's recommendation for a period ofprobation. New Mexico's RCP will work

. diligently and in concert with the NRC to make any beneficial changes needed to improve the RCP.

Resp u ,

E. er, Secte New Mexico Environment Department oc: Maul H. Lohaus, Office of State Programs, U.S. NRC Jim Lynch, State Agreements Program, U.S. NRC, Region III

LIST OF ATTACHMENTS Attachment 1: -Schedule ofinspections Attachment 2: Vacancy Advertisement-18ersonnel Announcements Not Available As OF October 10,1997 Attachment 3: Brachytherapy Course Outline' Attachment 4: Irradiator Safety Training Attachment 5: Procedurn For Licensing Actions /New Licenses

-Evaluation Form Attachment 6A: -GeneralInspection Report Form Instructions For Inspection And Preparation Of General Inspection Report Attachment 6B: -MedicalInspection Form

-Instructions For Medical Inspection Report Attachrr.snt 6C: Density / Moisture Gauge Inspection Form

-Instructions For Portable Gauge Inspection Checklist Portable Gauge Inspection Checklist Portable Gauge Inspection By Mail Apachmant 6D: -Industrial Radiography inspection Form Instructions in Preparation For Industrial Radiography inspection Report

-Industrial Radiography Field Site Inspection Report Attachment 7: -Inspection Procedures Attachment 8A: Enforcement Procedures Attachment 8B: -Follow-up On Inspection Letter Attachment 9: Standard Operating Procedure For Response To incidents involving Radioactive Materials

-Incident Investigation Procedures

-Incident Reporting System / Abnormal Occurrence Criteria Attachment 10: -Allegation Response C=#*ve Document (being developed, to be presented to MRB on October 23,1997)

Atachman* I1: -Incident Report For Radioactive Material Licensees Atachmant 12: -Telephone Log

---

.--_---------L., ---

4

['2 ATI'ACHhENT 1 SCHEDULE OF INSPECTIONS P

SCHEDULE OFINSPECTIONS Priority Type ofLicense Substquent inspection

1. Broad License, Type B Field Industrial Radiographers,Inplant 1 Year Industrial Radiographers, Radio-pharmacies, Gamma liradiators.

Well Logging Tagging Operations.

(BM,IR, RP, GI, TA).

2. Broad License, Type B or C, Industrial with Multicurie Sources or Unsealed, except Gauge Licenses. 2 Years Medical Institutional with Therapy, Generator or Ai6orne Sources.

(BB, MI, GL, WL).

2. Academic Specific, Industrial Gauge .

Licenses, Industrial, Curie or Less Scaled Sources, Medical Institution, Medical 2 Years Private Practice. Medical In-Vitro Only, Research & Development.

(AC, DM, MD PP, RD)

3. Industrial Calibration Senices, Gas Chromatograph, Laboratory Analysis with Microcurie Sources. Storage Oniy. 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 Gamma Irradiator 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 Laundry VT Veterinarian Gauge MA Bone M Analyzer WL Well Logging DU Depleted Uranium MD Medical Doctor-PP GA Gauge MI MedicalInstitution GC Gas Chromatography PA Paint Analyzer

Ri r14 ATTACHMENT 2 VACANCY ADVERTISEMENT-PERSONNEL ANNOUNCEMENTS NOT AVAILABLE AS OF OCTOBER 10,1997

"i?

4

, S .y ATTACHMENT 3 BRACHYTHERAPY COURSE OUTLINE 9

1

u% m u ckvc e-, F v is m mes v m m== ,> = w e a =~ im - % e ee=e m.s=' exo =

FAX Date: Friday, September 26,1997 TirN: 8:24:17 AM 3 Pages To: Mr. Bill Floyd From: Thomas H. Kirby, Ph.D.

Hazardous / Radioactive Materials Bureau UNM CRTC Medical Physics Fax: ,1,5058271544 Fax: (505)272-4973 Voice: Volos: (505) 272-4986 Commerits:

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 different than what you forwarded, the material is about the same. We can adapt it as needed. I will fax my resume in a few minutes.

Tom Kirby Pager: 768-9422

~

Brachytherapy CMn4ewfor State Nudear Materlad Irmpactors October 14,1997 Course Droctor:

Thornas Krby, Ph.D., CNW Physicist and Associde Prcfesect Cancer Research and Treatnuwit Center The Uniwruity d New Madco Hesith Sdences Center

1. Scheile a 09.00 09.30 Fadtrtytour

b. 09.30- 1000 Introduction

c. 10.00- 10 30 Applicade regtdations d 'l0:30- 11:00 Radoactive sources used in brachytherapy

e. 11:00- 11:30 Handing and safety

f. 11:30- 1230 Lunch and docussion g 1230- 13:30 Loudose rate procedures

h. 13,30 - 14:30 Hgh dose rate procedures

1. 14:30 - 15:00 Records and reporting procedures J. 15:00- 15:30 Wrap and dscussion 2 Introduction a Def.nitions

b. Physical leas appicable to brachytherapy

c. Uses d brachytherapy in cancer treatments d Typical procedures

3. Applicade regtdations and training a Federd: 10CFR Parts 20 and 35

b. State d NewMadco

c. Udversity d NewMadoo d Certiflevilon and trairing d Meded Physidsts

4. Radoactive sources used in brachAherapy a Suppilers

b. Calibration and source strength speedcation

c. Types d nources endisotopes used

5. Handing and sdety d sources a Source handing dstance, sNeldng and time

b. Shipdng and receiving sources

c. Leaktesting

d. Storage d pennanent and temporary irrantory

e. Record keepng

f. Transport from storage area to patient rooms

6. Loudose rate procedures a Gyn treatmerfs "'Cs tubes, n2lr treatments

b. Vdumeimplants

c. Endol roncNd procedures A\ Brachy course outline.wpd September 26,1997 4

~

e m e.Am m e=>m i."J .eo % ,

M a g G ,6 G hTGLd 7 j

d Pwsonnel pdeedon

e. Pdent surveys andinventory contrd

f. Restrided -

.i

g. Ernergency pc*. dres i

7. Hgh dose rate pocockres a QAfor source re#acement

. b. MontN/ QA

c. Treatment QA '

d Procedures

e. Emergency pocodres

8. Records and Repcdng a QeatertyIrwentory and survey

b. Radosotive mderials transfer reocrd

c. Irwentory contrd fcr p4ent i t e i44

, d Source strength records

e. Calibtstion and survey instrumor,tstion rooords i-1 i

r i

J l

i

! 6 1

i 4

A\ Brachy course outline.wpd September 26,1997 4

4

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_ -e o.,=emea SUMN%RY OF QUAUF1CA110NS Thomas H. Nrty, PitD.

December,1994 Acaderde oosidons-i Research Assodde Prdessor at Udversity d New Mexico Health Sdence Center Assistant Prdessor at University d New Madco Moded Schod (6 yeare)

Assistant Prdensor W Lodelana State Udvestty Medcad Schod (2 years)

Instructor at Udv. Texas Houston Graduate Schod d Somedcad Sdences (6 years)

Education:

Ph D. In 1980 (Bomeded Sdences) Udversity d Tees W Houer on M.S.1975 (Physics) MempNs StWe Udversity B.A 1973 (Phpics and Mathematics) Southern Illinois Udversity TeacNno / educabond oroductivity.

Instructor for 3 courses W UNM (RTT 350, 300, 370) i to 3 semester hours 11 fdi acadenic courseo at various lawels from RTT schod to graduate level (most d them multiple pers) at dfferent universites, indudrg Astronomy lab and lecture, General phyelcs lectures and labs, RTT physics, Sdid stde physics, Doolmetry, Electromagnetic theory, Radobidog/, I developed the course cunieda for most d these courses. Al were regdarly schecued courses for arweamic credt, mostly 2 to 4 semester hours. The number d students varied from 4 to 30.

SchdarsNo / Research / Crestiveverk

1) Author or co-author d 10 refereed published sdentific artides

2) Irwlted speaker twice for nadoned review coursee

3) Author or co author for 18 nationd presentations and abstracte

4) Author or co-author for 5 refereed techdcol reports

5) Two papers subnytted for putilcation

6) Numerous other presentations and lectures for state or local organizations

7) Co#es d severad papers are Induded in the rocket which are representative d my renearch intereats irt Imadng, n-dui. used to reden dosimetry d nationsi didcad triads, and basic physici measurements related to radation therapy.

8) Member d, or consultant for 4 national sdentific task groups (1 current)

9) Member d 7 cc wettees for nationed radetherapy diNesi trial groups

10) Prindpd or co4rwestigator for 3 rosearch grants

11) Chairman d 1 nationsi sdentific task group (current)

12) American Boerd of Raddog/ catified in Therapeutic Raddedcal Physics

13) ReAewer for Medcad Physics (peer redewed sdentific joumal d AAPM)

14) Member of nationed sdentific comrdttee (currently in 2nd three year term)

$ 1 of 2 pag s

_______.m.____ m__m ___---_ ----_-

e , . .u., WCm . av .J e m men v mm i. . e,.r. o m  % s .,u ea.,. -c.*=, e = ,i es Thomas H Nrby, Ph.D.

Service and Administration

1) CNet physidst, UNM Cancer Research and Treatment Certer (6 years).

Responsiblities indude demop nent and impementWion d new radotherap/ technicpes, dosimetry and treatment #anring, adrinistration d physics section (8 em#cyees),

teacNng engneering, quWrty assurance, etc. The phpics section has the general responsitAty for treatment pandng and qudity assurance d radstion therap/ tredrnents, inacNne mintenance, teacHng RTT students, qudity assurance and research and development, etc.

2) Physidst at M.D. Anderson Cancer Center, Houston (8 years). Duties included development and im#aTientWion d reMews for nationsi didcol triais, teacNng in g/aduate and RTT schods, supervision d g aduWe students

3) CNef Physidst, Charity Hospite in NewOrieans. RougNy the same duties as at UNM, but induded supervision d RTT personnel.

4) Judge for New Mendco Hgh Schod Supercomputing Challenge (last 5 years).

5) CQI coordnator for Radation Onedogy

6) Lecturer for Nudear Engneering Departmenth Ngh schod teacher sdence symposta

7) Partidpated in seversi radstion treatments d arimals for cano:ar in cor)l unction Wth ares veterinarians.

8) Assisted in organtdng national AAPM mewing (1982).

9) Served as sdentific session chair at several national meetings.

10) Organized two national / Intemational workshops.

11) UNM HSC RTT currictium comrdttee member

12) AdAsor or member d 8 graduate student superdsory committees.

13) Assisted severd cther graduate / g tdcdtord students frorn UNM and Los Alamos National Labvhle at UNM.

14) Graduate student liaison for Univ. Teocas Houston Department d Physics for several years TNs facd:/ position kirved as initial contact for r.tospective graduate students

15) Partial list d dinicW radotherapy techdcpes der.Jgsed andimpemented tctd body photon irraddion fcr bone marrovvtrans# ants; t:Lal skn doctrcn treatments for mycosis fungddes; stereotactic brain impants using radonctive seeds; l-125 eye paque impants for octdar melanomas; Ngh dose rate afterioeder brachAberapf, deterrWnetion d neutron comr.ru h d Ngh energ/ photon beams, calibration d neutron therap/ beams, many other routine techdques and dosimetry procedurce for radation therapy.

16) Executed bWa site tests for Computer, zed Medcal Systems, Inc. radstion therap/

trma sft #anning system.

17) Supervisor for Health Careers Opportunity Prograrn Ngh schad students for the past 5 years Average 2 Ngh schod s idents each summer who Wsh some exposure to the hesith carefield

18) ReAomd well o/er 100 radctherapy depertments for the NCI vdle W MDACC.

19) President, Computerized Meded Systems, Inc. use s group.

2 d 2 pages

w o.m 52c w ee o v.-,% = %..,u ,% m., . . .

Thomas H. Nrb/, Ph.D.

CURRICULUM VITAE April,1995 Name Thomas H. Mrb/, PttD.

Present Ti1[g: CNW Ph#det UNversity d NewMedeo Cancer Research and Trestment Center 13QCD: Nwomoer 10,1951 St.Latis,MO Cnizenshig U.S.A Sodel Securttv. 350 46-3740 Home Address: 5015 Larchmont, NE Abuquercpe, NewMedco 87111 (505) 171-0156 OfficeAc2iress Radation Oncology D.p-in vent University d NewMedeo Cancer Research and Treatment Center 900 Camino de Salud, NE Abuquerque, No.y Medco 87131-5331 (505) 277-6141 Educagon Ph.D. (1980) BiomedrJ Sdences lhe UNversity d Tocas at Houston MS (1975) Physics Memphis Stde UNversity B.A (1973) Physics and Mathematics Southern Illinds Unherstty at Carbondale Soccialty Boetde and Ucensos Certified in Therapeutic Raddodcal PhWes, American Board d Raddogy (198R).

C;ts d f6 Medco Ucense in Radation SWety and Radation 1 d 9 pages

6N Mehr @ WLuiCC #es getmMWNWesidhiMmemese geese pop 6 g14 Paeuy,sesnumeeD 9erf 904# .

Thames H. Kitty, PrtD, Timap/ MacNrw Cditrabon t

k 2 of 9 pages

- i- - -

[

CccaNLDCDGICD QCDGDC30. DCW o a emN CCOCO CC'J,CQC e se Oc Thomas H. Nrty, Ph.D.

We wxf Professiond Acadttrnents.

1989- presert Chef, Physics Section, Redstion Onod.gy Department Udversity d NewModco Cancer Research and Treatment Center Assistant Prdensor Ur dversity of New Miedco Schod d Meddne 1986 1989. Assistant Pitysidst, instructor 1983- 1996: Asejstantin Phyeks Departmert d Radation Physics University of Tivu M.D. Anderson Cancer Center at Houston '

1996 1989. Assoolate Faedty Member University of Texas Hesith Sdence Center at Houston 1981 1983: Staff Clirical Pitysidst & Consutant Physidst West Jefferson General Hospital, Morrero, l.A CNef Clincal Physidst Chartty Hos#tal of Louisiana, NewOrleans, LA Assistant Prdessor Louisiana State University Medcal Schod, New Orleans, LA 1980- 1961: Assistant In Phyolos Department d Radation Physics Uriwrsity of Texas M.D. Anderson Cancer Center at Houston 3

3 of 9 pages

, c:a e.givsi , wa ,.n.uv Thomas H. Nity, Ph.D.

[4stional Sdentito Commrttees 1990- present American Aesodation of Phyeks in Meddne (AAPM)

Radation Therapy Committee (RTC) 1993- present AAPM RTC Task Group 54 (Unear Acoeierstor Primary / Scatter Radation), Chairman ,

1989- 94: AAPM RTC Task Group 46 (Unear Accelerator Data) 1988- 89. AAPM RTC Task Group 18 (Fast Neutron Doolmetry) 1983- 88: AAPM RTC Task Group 29 (Total Body Irradation Techniques),

Constitar1t 1983- 8&. AAPM RTC Task Grcup 31 (Quaitty Assurance)

National dirical trial aroues:

1983- 1986: Radation Therapy and Physics Committee, Brain Tumor Cooperative Groupf 1980- 1986: Radetherapy Queirty Contrd Subcu m.iii=

Southeastern Cancer Study Group

• 1987-1989. Radation Therapf Onodogy Group

• c 1986- 1989: Member or attemate: Executr ') Committee, Radation Therap/ and Ph#cs Committee, Data Sm .ty and Monitoring Comrnttee Cdleborathe Octdar Melanoma Study, National Eye Institute 1964- 198&. Radation Therapy Committee, Radation Therapy Quality Contrd Sh.. . Hee, Southwest Onedogy Grourf

• Funded by the National Cancer Institute for nationsi dinical trials 1988-1989. South-North Center for Hesith Studes s

4 of 9 pages l

. . . __ -__m..___---_ - - - - . - - - - - -

m i. .mrer m , ,mor,v. ,m u . . - .... a,,..,a=

Thomas H Mity, Ph.D.

.Norkhcm Coordndor.

Labordory Diredor, "Prac4os; Counn d Physical Decimetry in Radotherapy for Latin American Physidsts (in Spanish)" San Antorio, Tass, August 34,1988.

"Radatic.1 Therapy and Physics W Ocdar Melanomer, Cdiaborative Ocdar Melanoma Study Annual ha:mtin9. Sun Vatley, Idaho,1987.

f.@N Boerdr Reuemer, Medcal f4waim Honors and Awards-Rosalie B. Hte Scholar, University d Texas GSBS,1978 - 1980 ~

Freeldunt's Schdar, Sou hern Illinds Unhersity, *W- 1973 Soosty Membershics:

1977- present. American Assodaben d Physidsts in Meddne American Institute d Physico 1989- present American Sodety for Therapeutic Radstion Onodog/

1994- present. President, Computertzea Modent Systems, Inc, Users Group 1988- present /enerican Nnebrewers' Assodation 1W8- 1981: Sodety d Phattvaphic Sdenbsts and Erdneers Grant Succort 1987- 1989; CA10953, Co Irmstinder, Raddo#esi Physics Center ($3M) 1992 UNM Research Allocation Committe, Project #C-1041 Dwelcpment d a Pameive h n er. der Implant ($1500) 5 d 9 pages k,

9

NiEBemenmCici:F@c7w omer.Mc o e e is a Thames H Nrty,rw D.

1992 US Wat Foundscrt Heat Monitoring Prcioet ($2100) -

6 cf 9 pages

eu ,e em  % e. m., v wm= n = = e ,. a e =. - n -%WE.-. =-n.=r e = a e Thomas H. Nrby, Ph.D.

Courses Taudit 1989- preserit. Physics I & II, OudMy Assurance Radation TherapyTechndog/ Program Uriversity d nan Modco Schod d AJlied Hedth Sdences 1984 1988 Introduction to Rad.dico Ptlysics, Ph#cs for Residents in Radotherapy Department d RedWien Therapy UriversMy d Texas M.D. Anderson Cancer Center 1984- 1988: Radation Therapy Physics for Technolopsts Radation Therapy Techndogy Prograrn 1982 Physics for Raddogy Techridaris Radabidogy for Nuc. Med. Techndopsts La.istma StWe Ureversity Medcal Schod 1980- 1987: Atomic and Sdid State Physics UniversMy d Teams Graduate Schod d Biomedcal Sdences 1W6- 1989: Extemd Beam Desimetry- Prindpas and Calibrations Extemal Beam, interstitid and IntraceMtary Desimetry. ManuW and Computer Methods d Calculation Dosimetry d Hgh Energy Sectron and X-ray Therapy MacNnes Department d Radstion Phpics Uriversity d Texas M.D. Anderson Cancer Center 1973- 75; General Astronomy Lat: oratory, introWetory Physics Department d Physics, Memphis State University 1972- 73: General Physics %nuy Department d Physics, Southem lilinois Uriversity Student Sucervisory Committees and Other Rdes RancWI Salyer, M.S., University d Now Medco, Nudear Eng M S. CuinWiiue,1995 Cynttia MWmer, M.S., University d New Medco, Nudear Engneering Summer Practicum in Meded Phpi:s,1994.

R. Cde Rodrson, M.S., Uriversity d Tees GSBS, 1987 - 1989, Chairman. Energy 7 d 9 pages t

.a

u.ocmon e m , % oau. :2.....sn Thomas H. Nrby, Ph.D.

Response d UF TLD 100 to Hgh Emw Photons" Student Suoervisorv cut.i.e es and Other Rdes icont'ch Pei Fong Wong, M.S., Udv. W Tees GSBS, 1986 87," Comparison of Boctron Bamm Depth dose and ON-ads Prdiles Wth Various Detoders in Water and Plastic" Richard Umoh, M.S.,1986, University d Toms GSBS, "Deterministion d X-ray Beam Quality Ch.nges d Unser Accelerdor From lonization Measurements in Phantonf' Charles Able, M.S., UniversNy d Team GSBS,1985 - 1987," Evaluation d the MCWH Total Sesip Bectron irraddon Techdquef' Dewid Voehringer, Surnmer Student, 1988,"l-125 Dosimetry Wth Thin T1.D Chips" Ann M. Mnter, Summer Student,1985, "Hgh Enerw Photon Bedecstter Factors" Doudas A Cates, Summer Student,1984,"Totti Body Phdon irraddon DusimetrV' BBUOGRAPHY A Published RdereedMias:

1. Zermano A Nrby TH, Comet R, Marsh L: Laser Readout d Boctrostatic Images, SPIE Acol .d Oct Inst in Med Vil, 173:81-87,1979, 2 Zermeno A Marsh L, CoMurt R, Ong P, Nrby TH: Ught Beam Raurh it of Bactrostdic Images, Xll Irt Cort on Madcal and Bd. Em, Jerusalem, Israel, 1979.

3. Nrby TH, Zermano A Residusi Potential in ATu p;,cus Selenium Photore$ ors, SPIE Aml. d Oct Inst in Med B:61 64,1980.

4. Gastorf RJ, Hanson WF, BerWey LW, Nrby TH, Chu C, Shalek RJ: A Comprison d Hgh Energy Amelerator Depth Dose Dea MedM_Mos,10 881-885,1983.

5. Nrby TH, Gastorf RJ, Hanson WF, BerWey LW, Gagnon WF, Hade JD, Shsdek RJ: Bectron Beam Central AWs Depth-Dose Measurements, Moded Physics.

12 357-361, 1985.

6. Nrby TH, Hanson WF, Gastorf RJ, Connel C, Shalek RJ: MaiteleTLD System 8 d 9 pages

. 66 -

.b= cm ,

mm en w m~ n-m 5. ,.o m ,m % aou ea= nin, e *u s--

1 Thomas M. Nrty, Ph.D.

for Photon and Bectron Beams, kl.1 'ad One. Bo. Phys. 12261 265,1985.

A Published Refereed Artides (cont'd): l

7. Nrb/ TH, Hanson WF, Cates DA Verification d Tote Body Phcton irradation Dosimetry Techniques. Moded Phvsics 15:364:360,1988, 1

l 8.

Nrty TH, Hanson WF, Johnston D. Uncertdrdy Andysis d Absorbed Dose '

' Caledations from Thermduminescence Desirnsters, Medcal Phvolts 12.1427-1434,1992.

9. Hazie J, Nrby TH and Hanson WF: Results d absorbed dose rnessurements for \

TG 21 pretood, Med Ptwsics (acceped for publication),1994.

2

10. Karlssen U, Nrby TH, Orrison W and Uonberger M Oee f ar Gobe Topographyin i

Radetherapy, Int.1 Rad One. Bo Phvs. (acmpted for publication),1994.

B. Irwited Talks:

'Thermduminescence Dosimetry ', Physics Department, Steven F. Austin Univ.,1968.

t "Radotherapy Beem Cailbration Techniques" Meded Phples RedewCourse, AAPM i Annual Meeting, Detrdt,1987.

"Medcal Uses of Radatiorf', Worishopfor Hgh Schod SdenceTeachers, Uriversity of New Medeo Nudear Erdneering Department, Albtmerque, NM, 1992-94.

e C. Almti-di, andTalle Presented.

1. Nrby TH, Hanson WF: Comparison of Graphite and N%on Thimble Farmer Chambers in the Supervdtage Region, AAPM meetiru Temple, TX,1974.

2. Zermano A Marsh L, Cowert R, Ong P, Nrby TH. Ught Beam Rameh t of Bectrostatic Images, >01 IntematiuW Conference on Medcal and Bdogical

. ErWneeriro Jerusciem, Israd,1979.

3. Nrby TH, Zermeno A Properties of the Dondelectric Image Receptor, SPIE Applications of Optical Instrumentation in Meddne Vlli Conference, Las Vegas, Ne/ada,1980.

9 of 9 pages

>.umec:5 simi, , ,4oeu r. ,anoncas Thcmas H. Nrt" Ph.D.

4. Nrty TH, Gastorf RJ, Hanson WF, Shdek RJ, Hazie JD: Bectron Beam CerfaW AMs DephDone Monsurements, Moded Phssics 11:399,1984.

C. 6tadtg;ts andTalks Preswited(oont'd):

5. Nrty TH, Chu CH, Gastorf RJ, Hanson WF, Shafek RJ: Mailed TLD System for Monitoring Output of Bectrcn Prodadng MacNnes, Med Ptwsics 11:405,1984.

6. Reddoded Ph#cs Center: Researen ActMties of the Raddegical Physics Center, Sdentific ExHtit. Proceedngs d the Inter-American Meeting d Medcal Physics, CNeaget, IL,1984.

7. Task Group 29, Radstion Therap/ Commntee of the American Assodation d Physidsts in Meddne Physical Aspects of Total and HWf Body Photon irradation.

8. Wrth TH, HansonWF, Cates DA: Tote Body irradation Dosimetry. Medcal Phvsics 12523,1985.

9. Grruth SA Hdmigo Sdvatierta 0, Mrb/ TM Energ/ Response and Fadng Characteristics of Different Batches of UF-T1.D. Moded Plwelcs 12543,1985.

10. Hade JD, Hanson WF, NrtyTH, Gastorf RJ, Shdek RJ: Reedts d Absorbed Dose Measurements for Phcton Bearns Using the AAPM TG-21 Calibration Pratoed. Medcal Physics 12518,1985.

11. Nrby TH, Hanson WF, Gastorf RJ, Hade JD, Agdrre JF, Kenned / PM, Wright E%:

Experience of the Reddodcal Physics Center Wth the New AAPM Cadibration Protocd. Medcal Physics 13:597,1988.

12. Hanson V.F, Nrb/ TH, Kenned /PM, Hade JD, Aguirre JF, Wright 3A Techniced Reports frorn the Raddogical Ph#cs Center. Medcal Prwsics 13:596,1986,

13. Kalend AM, Reinstein 2, Nrty TM Dependence of Wedge Factor Upon Measurement Depth. Medcal Ptwsics 14:490,1987,

14. Robinson RC, Nrty TH. Energy d Response of UF T1.D-100 to Hgh Energy Photon Beams. Phys. Med Bid. 33 Suppement 1:7.1988,

15. Hanson WF, Kannedy PM, Krefft GB, Agdrre JF, Nrby TH ImprcNement in Dosimetry Practices Over 20 Years: A Hotoricad Account From the RPC,1989, g ASTRO Meeting.

10 of 9 pages

m% occ %e.mmesv:mm v.T.me,r.e wn =,e ueru,=.r. u.=,e==#

Thomas H. Nrty, Ph.D.

16. Nrtsy TH, Hanson WF, Mr,.twi CW Uncertainty Analysis of Absortmed Dose CalcJdons From Thermduminescent Doelmsters,1989 AAPM Mestire

17. Karleson UL, NrtyTH, Orrison W and Uanberger NL Laceitzstion Fx:*alon of the Oodar Lans for Radetherspoutic Simdation, Raddedcal Scdety of North America,19g3 Annusi meeting

18. Orcutt FV, Karleson UL, Nrby TH, Fircabsidsn KK The Srialdng Effect d Spinsi implants During Thorspoutic Reddon of the Spine, North Anotican S#ne Godsty Annual Mosting, San Dego CA,1993.

D. Books and Chacters- .

1. Nrty TH: The Effect of Neutron Radation in Tiesue, Theels, MSU,1975.

2. Nrb/ TH: Orldn of ResidLad Pderfsf in ATup;icus Selerium Photoreceptors, Ph.D. Desertation, Uriversity of Toms at Houston,1980. -

E Techniced Reoarts (oser redeMed)

1. Hanson WF, Sheisk RJ, Nrby TH, Kanned/ PM: Information That Shodd be included in Every Patient's Radcthersp/ Record (Extemal Beam). RaddoWest Pn#cs Center Techniesi Repert 18,1985.

2 Nrty TH, Mnter AM, Hanson WF: Peelocatter Facters for Hgh Energ/ Photon Beams. RaddoWesi Physics Center Techniced Report 19,1986.

3. Nrb/ TH, Hanson WF, Wong PF; Estimate of the Mnimum Radation Dame Delivered to the Maringos From 10 MVX-Rays. Raddodosi Ptrysics Center Techriesi Report 20,1986.

4. Wright 1%, Nrby TH, Hanson WF: Partidpation of the RaddoWcal Phyelcs Center in the NBS Ferrous SJfate Cosimeter Bactron Beam Monitoring Proyarn RaddoWesi Physics Center Techniced Report 21,1986.

5. Nrby TH, Hanson WF, Gastorf RJ, Hsde JD, Aguirre JF, Kennedy PM, Wright 1%:

, Experience cf the RaddoWest Ph#cs Center Wth the NeuAAPM Calibration Protocci RaddoWest Physics Center Technical Report 22,1986.

, 11 of 9 pages

m

, m.

ATTACHMENT 4  %)

IRRADIATOR SAFETY TRAINING

)

, fop-25-97 O2:26P p,og ETHICON ENDO SURGERY a

fe 00mP897 p.o. An isto Atwouereve .4ew Mence 87t26 25 September 1997 To:

William Floyd New Mexico Environment Department Hazardous & Radioactive Materials Bureau Radiation Licensing and Registrulon Section FAX (505) B27-1544 From:

Paul Ripley Radiation Safety Officer License Gl316 01

Subject:

Summarv of Training Subiects and Period of Training Attached is one sheet lis*.ing the initial and periodic training requirements per 20 NMAC3.1 Section 1517.

This is what I am using for guidance on annual retraining.

Let me know if yot* ters , ca e.

5

" DOR.b

-? ei 'h/

Paul A. R.piay # /

Ocp-25-97 02:27P P.02 Training Requirernents 9/25/97 ETHICON ENDO-SURGERY A m querg w 2:10 PM License G1316-01 1

e 20 NMAC 3.1 Period Section 1517 Subject (Weeks)

A1 Fundamentais To Operate A.2 Reguisbons tSA 0401) To Operate A.3 Operation of irradetor To Operate A.4 Procedures To Operate A5 Accident Reports To Operate B Operations Test To Operate C On The Job Tramrng To Operate D.1 Procedure Review 52

~'

D.2 Regulabon Review (SA 0401, 5.1.3) 52 D.3 Anomaty Revew 52 DA Safety Performance Revew 52 D.5 Eoulpment Performance Review 52 0.6 Emergency Onli 52 E Performance Review 52 TRAIN.XLS Page 1 of 1

• m

A'ITACHMENT 5 i

PROCEDURES FOR LICENSING ACTIONS /NEW LICENSES - E#.

EVALUATION FORM

PROCEDURES FOR LICENSING ACTIONS NEW 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 information as to where copy of New Mexico Radiation Protection Regulations may be obtained).

3. Identify the LICENSE TYPE from application information (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

1. 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 #. rawer.

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. When the NEW APPLICATION review is complete, staff processes the license in draft using a DRAFT LICENSE as designated by technical staff.

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).

6. 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.

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 STAFF during the license review, support staff should process them within 5 dayc 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 the 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 .l icense in draft using a DRAFT LICENSE as designated by Program Manager.

4. Staff returns DRAFT LICENSE to Program Manager for final review.

5. Staff completes processing, signs 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 3

PART I: ADMINISTRATIVE AMINDMENTS NOTE: ADMINISTRATIVE AMENDMENTS are used for corrections to licenses or to make administrative changes to licenses, e.g.,

y 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

I

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 SHEE1 in

. TEMPORARY FILE FOLDER.

3.

Forward TEMPORARY FILE with AMENDMENT REQUEST LETTER to Program Manager or reviewer.

4. If DEFICIENCY LETTERS are written by TECHNICAL STAFF during the AMENDMENT REQUEST review, support staf f 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

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 provides training to use the word processing program.

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 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

~.

LICENSE APPLICATION EVALUATION FORM 1.. Applicant Name:

License Number:

Expiration Date:

' 2. Address: Actual Location:

Telephone #:

3.

Contact:

Contact:

4. Is the location listed identifiable from the description ofrered? (P.O. Box alone not acceptable) Yes No

5. is the applicant a corporation? Yes No 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 review.

6. If applicant 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 period and possible hearing? - Yes No.

Name oflocalpaper:

Publication Date:

Application Date:

1

REVIEWERS EVALUATION COMMENTS:

(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 must be evaluated for proper radioactive material use and storage requested (design, shielding, etc.). Evaluation must include a consideration of health and environment impact from exposure and probable release of material to restricted and unrestricted areas: (See 20NMAC 3.1 - Subpan 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).

9.

Evaluate the application and assume sufficient description is outlined for the isotopes and quantities to be used: (See Scaled Source and Device Catolog er Specific Regulatory Guidance for specific license type).

Radioisotopes Mass No. Form (Chem / Phys 3 Model # Ouantitv/Actisity 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. Training documentation must include a Prece; tor

Statement, proof ofNM licensure, and any Board Certification. (Reference appropriate 20NMAC 3.1 regulations and applicable licensing guides), (See Subpart 7, Section 712 A-M):

12. Evaluate the duties of the Medical Isotope Committee. Members shall meet quarterly and keep minutes. (For Broad Scope and Medical licensing, se' '04MAC 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).

a 3

14. - ' Evaluate procedures for ordering and receiving radioactive material and procedures for safely opening packages containing radioactive materials, (See 20NMAC 3.1, Subpart 4 Secdon 432, or Subpart 7, Section 703 H),

c

15. - Evaluate instrumentation used and survey procedures and frequencies by area, designated with action levels, and calibration frequencies by an NVLAP certified provider and cufied 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 utilized. (NVLAP provider and frequency) and type of bioassay if required by license condition or application commitment. (See 20NMAC3.1, Subpart 4 or, Section 707, Control of Aeroscis and

. Gases).

4

17. -

Evaluate the possibility of radioactive wate production by the applicant and the ability to

- adequately store and dispose of such waste. (General Disposal requirements 20 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 -

Menual. (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.

/11 placardmg and labeling according to U.S. DOT regulations.

.- Good housekeeping committments.

Effluent concentration limits in accordance with 20NMAC 3.1, Subpart 4:

A. Section 406, " Compliance with Requirements For Use Summation of Extemal & Intemal Doses.", or may be more restrictive; B. Bionssay Program Yes No; C. Section 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 Requirements";

E. Section 432, " Procedures for Receiving & Opening Packages,"in accordance with U.S. DOT regulations,. In accordance with Section 325, "Preparetion of RAM for Tran. port," exposure rate levels. See applicant's procedures.

Subpart 1, Section 108 & 441, " Records for Radiation Protection Provisions of Program," shall be kept until terminatica oflicense. Records of audits and reviews ofprogram content and implementation maintain for 3 years after record is made. Other reporting procedures in specific areas were records and reports are required.

5

Training as described for specific license types. (See 20NMAC3.1 anxi Applicant's SOPS for type oflicense requested),

t

19. Fct purposes of cornplying with the requirements of 20NMAC 3.1, Subpart 3. Section 311 F.,"Decornmissioning and Surety Plan for the Facility", is docurnentation requested attached.- Send applicable letter of deficiency upon finit waluation 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. Yss - No; IfYes, License number assigned  ;

If No, Indicate what actions were taken:

Reviewed by Date: .

NMED/RLRS.REV.10/97.

6

• I 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,

l l APPLICATION FOR RADI0 ACTIVE MATERIAL LICENSE HUMAN USE New Mexics Enviroment 0:partment, Nnardous aM Radioactive Materlat sureau 525 Camino de los Marquet

• P.O. Box 26110, Santa fe, NM 87502 6110 * (505)E27 4300 A13) Montgomery btvd. NE AlbuquercNe, NM 87109 * (505)S41 9465 lxsTRUCTIONS:

Coglete items 1 through 26 If this is an Initlet application of supplemental sheets where necessary. Item 26 aust be completed and signed.an application for renewal of a license. Use Retain one copy. Submit original to one of the above addresses. Upon approval of this application, the applicant wit t receive a Radioactive Meterlet L 1.4. NAME AND MAILING ADDREES OF APPLICANT (Institution, fire, clinic, physician, etc.) INCLLDE ZIPCODE 1.b. STREET ADDRES$(ES) AT WNICN RADIDACTIVE MATERIAL WILL BE (if different from 1.a.) INCLUDE ZIPCODE TELEPHONE No. ( ) *

2. PERSON 10 CONIACT REGARDING b18 APPLICATION

3. THIS IS AN APPLICAfl0N FOR: (Circle appropriate itee)

a. NEW LICENSE TELEPHONE N0.3 ( )

• b. AMENDMENT 70 LICENSE No.

c. RENEWAL 0F LICENSE No.

4. INDIVIDUAL USERS (Name individants who will use or directly supervise use of radioactive esteriet. 5. RADIATION PROTECTION OFFICER (RPO) (Name of person designated Caglete septements A and 8 for each indivichael.) as a redletion protection officer. If other than individual user, complete resume of training and experience as in Swplement A) 6.a. RAD 10 ACTIVE MATERIAL FOR MEDICAL USE MAXIMUM ,

CWCK POSSESSION MAxlMUM RADIDACTIVE MATERIAL ITEMS CHECK POSSES $10N LIMITS ADDn 9.AL ITEMS:

LISTED IN: DESIRED (altlicuries) ITEMS LIMITS DESIRED (millicurles) 3 220 F FOR IN VITRO STLDIES As Required 10 DINE 131 As tw[w, wit TREATMENT PART 3, SCHEDULE C, GROUP 1 OF NTPERTNYR01DISM As Required PART 3, SCNEDULE C, group 11 PHOSPMORUS 32 AS SOLUOLE PHOSPNATE As Required FOR TREATMENT OF POLYC1TNEMIA VERA, LEUKEMIA A 2 BONE METASTASES j PN0$PNORUS-32 AS COLLOIDAL CNROMIC PNOSPNATE FOR INTRACAVITART TREAT

• MENT OF MALIGNANT EFFUSIONS 90LD 196 AS COLLOID FOR INTRA-CAVITART TREATMENT OF MALIGNANT EFFUSIONS 10 DINE 131 AS ICBIDE FOR TREATMENT OF TNYR0!D CARCINOMA XENON *133 As GAS OR GAS IN SALINE FOR BLOOD FLOW STWlES AND PULMONARY FUNCT10N STW lES 6.b. RADIDsCTIVE MATERIAL FOR UIES NOT LISTED IN ITEM 6.a.

For mested sources include annufacturer and modet or drawing maber.

CNEMICAL MAXII6JM NupeER ELEMENT AND MASS NUMBER AND/OR OF MILLICURIES DESCR18E PURPOSE OF USE PHYSICAL FORM OF EACM FORM 4

ED 016 NU PAGE 1 ee *e.,

Ftr flee Itens 7 through on a seperate' 23, check the propriate bon (es) and stAnit s detailed de6cription of att the requested information sheet. . Segin each Identify the item tuuber and the date of the application in the tower right corner of each pege,if you Indicate that an appendia to the medical licensint guide WILL be followed, do not subalt the popes, but specify the ,

g

7. MEDICAL ISOTOPES COMMIT 1EE

15. rENERAL RULES FOR THE SAFE USE OF Names and Speclettles Attached; and RADIDACTIVE MTERIAL (Check one)

Duties as in Apymdia 8; or ' " " ""I " I *  ! **

Equivalent Duties Attached " "I "" 'A"***

8. TRAlklNG AND EXPERl[NCE ES @ eck one)

Sqlements A & B Attached for Each IndivichJet User;and M N n AMac M S e tement A Attached for RSO

9. INSTRUMENTAfl0N (Check one) 17. AMA SURVET PROCEDURES (Check one)

Appendix C Fore Attached; or 18 PNeckares followed; or List by Name and Model Number EWivelent Procochares Attached

1. $ ( heck one)

10. CAllSRATION OF INSTRUMENTS Appendia J Fors Attached; or Appendia D PrecedJres Followed for W Inst a ts; or Equivalent Inforention Attached E9Jivelent Prece&res Attached; and

19. fMERAPEUTIC USE OF RAD 10PNARMACEUTICALS (Check one)

D Procedsres Followed for Dose Ap;widia K Procockares Followed; or Equivalent Procockarn Attached E In e J es Meched

. THERAPEUTIC USE OF SEALED SOJRCES

11. FACILITIES Asc EQUIPMENT Description and Diagram Attached n im AMac ; and

12. PERSONNEL TRAINING PtocRAM la L P N W es Followed; or (Check one)

Equivalent Procochares Attached Description and Diagram Attached SE OF u ==g=,gti= = =CEma 21.RAD PROC.EDURES CTiVE .A. S <e...AND PRECAUTIONS

,enon. FOR U, m Detailed Information Attached Detailed Information Attached

14. PROCEDURES FOR SAFELY CPENING PACKAGES RAD OA VE MT AL CONTAINING RADICACTIVE MTERIALS ANI $

Appendix F Procochares Followed; or "

Equivalent Procedures Attached

. S IONS M USE OF RADIDACTIVE MTERIAL SPECIFIED IN ITEM 6.b.

Detailed Inforestion Attached ED 016 HU PAGE 2 s

I

-_____ 1

,e *

24. PERSONNEL 0051METRT --

(Check appecpriate box) SUPPLIER

-ACMANCE FREQUENCY FILM

e. WHOLE SCOT TLD OTHER (Specify)

FILM

b. flNGER TLD OTHER ($petify)

FILM

c. WRIST TLD OTHER (Specify)

d. OTHER (Specify)

25. FOR PRIVATs PRACTICE APT.lCANTS ONLY

a. HOSPITAL AGROING TO ACCEPT PATIENTS CONTAlWING RADIDACTIVEb.MATERIAL ATTACN A COPY OF THE AGRECMEMT LETTER Name of Hospital SIGNED ST THE NO$PITAL ADMINISTRATOR Malting Address c. WHEN REQUESTING THERAPT PROCEDURES, ATTACN A COPY OF RADIAfl0N SAFETT PRECAUTIONS TO BE TAKEN AND Lisi AVAILABLE RADIATION City state Zip DETECTION INSTRLMENTS

26. CERTIFICATE (This item sust be completed ty the applicant)

e. The applicant and any officist saecutine this certificate on behalf of tt.e applicant named in Itan 1.a. certify that this application is wepared in conformity with Part 3, New Mexico Radletion Protection Regulations and that all inferination con.alned herein, including any setements attacW Nreto, is true and correct to the best of our knoielodge and belief.

b. APPLICANT OR CERTIFTING OFFICIAL (Sigsture)

WAM (Type or print) liTLE DATE ED 016 HU PAGE 3 e .

TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIAT10N SAFETT OFFICER

- 1. h4% OF AJ7Fal2ED USER OR RADI ATION SAFETT OFFICER 2.

3. CERTIFICATION SPECIALTT 30Mt0 CATEGORT A MONTN AND TEAR CERTIFIED B

C

4. TRAINING RECEl%1D IN SASIC RADICISOTOPE K4NDLING TECHNIQUES TYPE AND LENGTN OF TRAlulNG FIELD OF TRAINING LOCATION AND DATE(S) 0F TRAINING LECTURE / SUPERVISED A

8 LABOPRTORT LABORATORT COURSES EXPERIENCE (Nours) (Nours)

C D E

a. RADIATION PNTSICS AND '

INSTRLMENTATION

b. RADIATION PROTECTION

c. MATHEMATICS PERTAINING TO THE USE AND MEASURE 8ENT OF RAD 104CTIVITT

d. R2 10PNARMACEUTICAL CNENISTRT

$. EXPERIENCE WITN RADIATION (Actuel use of Radiolectges of Egalvalent Empettence)

ISOTOPE MAXIfRM AMOUNT WNERE EXPERIENCE WAS GAINED DURATION OF EXPERIENCE TYPE OF USE- ,

ED 016 NU SUPPLEMENT A

• e e e

PRICEPTOR STATEMENT ,

e Supplementobtain experience, a aust be conpleted a seperate by the statement from applicant each. physician's preceptor. If more then one p eceptor is necestery to doeunent

1. APMICANT PHYSIC 1/N'S NAME AND @ DRESS KET TO COLLMN C FULL NAME Personal participation should consist of

1. Swervised examinetton of patients to deteraire the suitability for radiolsotope diagnosis and/or treatment and reconnendation for prescribed dosage.

STREET ADDRESS

2. Collaboration in dose calibretton and actual administration of dose to the patient including calculation of the redletion dose, related measurements and plotting of date.

CITT STATE IIP 3. Adegaste period of training to enable physician to manese radioective pottents and follow patients through diagnosis

( - en#or course of treatment.

2. CLle..*" TRAINING AND EXPERIENCE OF A40VE NAMED PNTSICIAN 6

NUMBER OF CASES INVOLVING C094ENTS 550 TOPE Coelil0NS DIAGNOSED OR TRuTED PER$0NAL (Aeditional information or comments may PARTICIPATION tLe sdimitted on separate sheets.)

A B C D DIAGNOS!$ OF TNTR0!D FUNCil w l 131 OETERMINAtl0N OF BLOOD AND or IL'J00 PLASMA VOLUME l 125 -

LIVER FUNCTION Sit 21ES FAT ASSMPfl0N STUDIES E!DNET FukCTION Sit 2IES IN VITRO Sita! M

~

OTHER l 125 DET;CTION OF TNRAWS0$l$

1 131 TNTROID IMAGING P ?2 ETE TUMOR LOCAll1AT!W Se 75 PANCREAS IMAGING

, Tb-169 CISTEkNOGRAPNT Xo 133 Bloco FLOW STUDIES AND PULMONART FUNCT10N STt21ES OTHER BRAIN IMAG!NG r CARDIAC IMAGING TNTR0!D INAGlka

• SALIVART GLAND IMAGING Te< sm SLOOD POOL IMAGING PLACENTA LOCALIZAfl0N LIVER AND SPLEEN IMAGING LUNG IMAGING SONE IMAGING OTHEL ED 016-NU SUPPLEMENT B = PAGE 1

=

e 4 e e

e 2. CLINICAL TRA1NING AND EXPERIENtt 0F ABOVE NAMED PUSICIAN (Continued)

NtM8ER OF CASES INVOLVING ISOT0et CONDITIONS DIAGNOSED OR TREATED COMMEG S PERSONAL PARTICIPA110N (Additional inforestion or ch.vnents may A B C by sMitted on separate sheets)

D P 32 TREA1 MENT OF POLICYTNEMI A VERA,

($;ldd e) LEUKEMIA, AND SONE METASTASES P 32 INTRACAv! TART TREATMENT (Cittolde )

TREATMENT OF TNYROID CARCINOMA l*131 TREATMENT OF NYPERTHYR010!$M Au 196 INTRACAVITART TREATMENT Co 60 INTEtSTITIAL TREATMENT t or Cs 137 'NTRACAVITART TRE/' MENT l 125 or INTERSTITIAL TREATMENT tr 192 Co-60 or TELETNERAPY TREATMENT Cs 137 Sr 90 TREATMENT OF EYE DISEASE RADIOPMARMACEUTICAL PREPARAfl0N Mo 99/ GENERATOR Tc 99m Sn 113/ CENERATOR In 113e Tc 99e REAGENT KITS OTNER

3. DATES As TOTAL IWMBER OF NOURS RECEIVED IN CLINICAL RADIDISOTOPE TRAINING

4. TNE TRAINING AND EXPERIENCE IWICATED A30VE 6. PRECEPT 0R'S SIGNATURE WAS OSTAINED UNDER THE SPERVISION OF NAME OF SUPERVISOR NAME OF INSTITUTION

7. PRECEPT 0R'S NAME (Please type or print)

MILING ADDRESS

8. DATE CITT

5. MATERIALS LICENSE NUMBER ($)

< ED 016 NU SUPPLEMENT S - PACE 2

[

l 1

e State of New Mexico

, q ENVIRONMENTDEPARTMENT a 1

,\ \

Hazardous & Radioactive Materials Bureau r 4x yx V 2044 Galisteo i {[-- 5 P.O. Box 26110

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%A.V Santa Fe, New Mexico 87502 (505)~8:71557 GARYE. JOHNSON Fax (505)8271544 covzwon xARxt.wtwita sscarrar EDGAR T. THORA 70N,m worrsecarrar APPLICATION FOR RADIOACTIVE MATERIAL LICENSE INSTRUCDONS:

CWete Itaans 1 17 if this is an initial appbcation. If appbcation is for renewal of a heense, complete only items I-7 and indicate new information or chaa_= in the program as requested in Items 817.

1.(a) . N=~. street a&% and % E number of applicant 1.(b) Street a&Wes) and phone number at stich tadiactive matenal will Cutitutioc, Firm. Pcrson, Department, etc.)

be stored and used (PO Box numbers are not acceptable)

~2. Person to contact regardios application (include phone #) 3, Previous License Numbers (if this is a renews! application, please so indicate and give current license number)

4. Individual Users (name and title ofindividuals who will use or 5. Radiation Safety ofBeer (attach resume of trammg and expenence) directly supcmse use of radaoactive material) 6.(a) Ekaggt Mass No. (b) Form fr'h=/ Phys) (c) Max. Activit: (d) Manufactmer & M! No. (nealed sources)

7. Use to be m* i>f each item of radioactive material requested above (attach supplementet sheets if necessary)

8. Individual User (s)Trk.ning (attach resurne). Complete the following information on the individual user (s) and their training in-(A) Nuclear physics, atomic structure, and interaction of r.diation with matter (B) Radiation detection instrumentation, calibration, and standardization (C) Radiation protection, waste disposal, and survey and dosimetric procedures (D) Radiobiology, including efTects of radiation on the human body length of academic Length ofon-the-job Name. Title. Dearee(s) Where Trainad iramme in A. B. C. D Trainine in A. B. C. D i

9 A*=1 E-;+'~~ With Radiation (actual use of radiotsotopes, attach resume)

Hams Isotope Mmvi== Activity Place ofEe Length of Experience

10. Radiation Deion Ins uments u (attach supplemental sheets if ===7)

Use ofinstrument Number Radiation Sensitivity Wm' dowthickness Twe/Model (e.g. monitoring, available detected ranne mr/hr mr/cm2,___ surveyinc. measunne) 4

I 1. Method, f.equency, and standard uses in calibration instruments listed in item 10 (attach supplemental sheets if necessary)

12. Film badges, dosimeters, and bionssay procedures used (for film beiges and TU7s, specify method of cahbrating and pecessing, or name of supplier; specify frequency of ercharige; attach supplemental sheets if nerea<ary)

TIEMS 13-16 ARE TO BE ANSWERED ON SUPPLEMENTAL SHEEIS

13. Facilities and Equipnent. Describe laboratory facilities and innate handimg G  % W stwage containers, shielding, fume hoods, etc.

(Attach explanatery sketch of facility)

14. Radiation Protection Program. Describe the radiation protection pogram, including control measures, if application covers sealed sources, submit leek testmg pin = where applicable; name, traming, and expenence. of persons to perform leak test, and arrangernente for performmg initial radiation survey, sememg, maintenance and repair of the source.

15. Waste Disposal. If a commercial waste disposal service is employed, spectfy name cf company. Otherwise, submit detailed description of methods which will be used for disposmg of radioactive wastes and estunates of the type and amount of activity involved.

16. (0) Survey Program. Describe *.he surveys to be made to M=n'n- if radiation I tzards exist in a facility in which radioactive matenal is used or stored.

(b) Records M%st Program. Records kW_af and reviewmg records of surveys, material inventories, el conures, etc.

CERTIFICATE (This item must be earnplanad by the apphcant) 1he applicant and any of5cial executag this certificate on behalf of the opphcant named in Isam 1, certify that this apphcstion is pepared in conformity with the New Mexi:o Radiation Protection Regulatres, Subprt 3-I leansing of P=AMve Materials; and that all informataco contained herem, including any supplements *= chad hereto, is true and correct to the best of ow knowledge and belief.

Applicant Name (Please Print) Applicant Signature Date Certifymg OfIicial(Please Print) Certtfymg Of5ctalTitle Certifving Oflicial Signature Date

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4 ATTACHMENT 6A

- GENERALINSPECTION REPORT FORM m M

M INSTRUCTIONS FOR INSPECTION AND PREPARATION OF GENERAL INSPECTION REPORT .

1 GENERAL LICENSE INSPECTION REPORT CHECKLIST 4

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INSTRUCTIONS FOR INSPECTION AND PREPARATION OF GENERAL INSPECTION REPORT PART 1. INSPECTION BACKGROUND DATA

1. Complete all items; if this is an initial inspection indicate under last inspection date.

2. Check announced or unannounced.

J. With the exception of initial inspections all inspections should be unannounced.

PART 2. LICENSE DATA

1. r mplete all items.

PART 3. PREVIOUS INSPECTION CORRECTIONS

1. Review the corrective action taken for all violations found during the last inspection. Either close out as satisfactory or list as a reneat findino on the current inspection.

2. Review arceptance of any recommendations made during the last inspection an6 close out if annliemble.

PART 4. PERSONS CONTACTED

1. List all individuals contacted and their job titles.

2. For brord licensees, give the principal investigator and use authorization number or designation.

PART 5. MANAGEMENT

2. Describe the organization and attach an organization chart if applicable.

2. Describe the Radiation Saf ety Officer (RSO) position within the organization and the ability to carry out responsibilities such as filling vacancies and obtaining equipment and supplies as necessary.

3. Review minutes of the Committee meetings and verify actions rt.;uired for safety are addressed. Did the committee perform safety audit responsibilities?

4. List name and title of Committee members.

PART 6. UNUSUAL OCCURRENCE OR INCIDENTS

1. Review any incidents reported and investigations since the last inspection.

2.

Review corrective actions taken as the result of a Notice of Violation issued for a reportable incident.

3. In cases where overexposures have occurred, evaluate actions the licensee har taken to prevent recurrence.

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4 PART 7. INVENTORY

1. Verify compliance with maximum allowable type and quantities isotopes authorized.

2.

Verify frequency and accuracy of inventories taken by the licensee.

3. Verify that material is used in accordance with the application.

4.. Uses of material.

PART 8. SEALED SOURCES

1. Verify that leak test are taken at required frequency.

2. Verify that records are :.ccurate and complete.

3. Verify that qualified individual makes leak test swipe.

4. Verify that leak test samples are analyzed by qualified individual or authorized service.

5. Verify that safety mechanisms are tested (ie shutter) IAW license conditions or procedures.

PART 9. USE LOCATIONS

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. Review training records for users and ancillary personnel.

3. Discuss 2.diation 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 containers. Are labels defaced when the container is  ?

discarded after use?

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 monitesing are assigned monitoring.

3. Evaluate type vs needs.

4.

Evaluate the licensee's efforts towards reduction in dose (ALARA).

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i FART 13. INTERNAL DOSE EVALUATIONS

1. Confirm that bioassays have been done if indicated, and records maintained.

2. Determine equipment sensitivity and appropriateness of measurements.

3. Review records.

4. Review use of engineering controls.

PART 14. ENVIRONMENTAL

1. Evaluate all areas where rele,w a to the environment may have occurred.

Determire adequacy of the licensees monitoring program. Review results.

PART 15. NSNUMENTATION

1. Verify that the licensee has the proper type of inctruments for their needs.

r 2. Verify that there is adequate instrumentation available for surveys.

3. Verify that calibrations are adequate and have been done in accordance with written procedures.

l FAR'r 16, PROCEDURES

1. Verify the licensee has copies of all procedure manuals and documents that were submitted with the license application. Review procedures for 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 procedries are followed and procedures are adequate by reviewing records of shipments.

5. Review transfer procedures and records of licensed material transfers that may have an impact on areas not under control of the licensee.

6. Verify that radiation protection standard operation procedures that were approved by the radiation control program have not been modified.

'4 . Verify that approved procedures are being followed.

8. Verify that emergency procedures are adequate for the needs of the '

licensee.

PART 17. RADIOACTIVE WASTE '

1. Review waste storage and packaging procedures.

2. Verify that storage for decay 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.

P1RT 18. Shipping and Packaging

1. Verify that all appropriate portions of U.S. Department of Transportation regulations Title 49 CFR 170-199 are complied with.

2. Verify that correct documentation on file.

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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 ma/ have an impact on personnel exposures.

4. Complete the entire observation checklist.

5. Coment on 41scussions with radiation and ancillary workers. Are workers knowledgeable of precautions to take for various radiation hasards?

9 ART 20. INSPECTION FINDINGS

1. Supply a statement of facts for each item of non compliance uncovered.

Answer the questions; who, what,-where, when, how, if possible for each item that may be contested. Follow the tvles 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 interview or following further consultation with the program management by the inspector in cases where the violations are not clear.

NMED/RLRS.REV. 9/97 K-GEN. PRO 2

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i GENERAL INSPECTION REPORT FORM License Number Expiration Date Date of this Inspection Inspection Priority Previous inspection 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 chan):

D. SPECIAL UCRNRR CONDmONS G08h E. Letter sent to Licensee on-Inspector Date ofReport Reviewer Date of Review I

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FOLLOW-UP ON PREVIOUS INSPECTION FINDINGS:

2.

SUMMARY

OF LICENSED PROGRAM.(Type of program):

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3. INTERNAL AUDIT (Annual Safety Review & ALARA & SOP'S):

4. AUTHORIZED USERS:(Training Certification, Supervision of authorized users):

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5. TRAINING / RETRAINING:

REO Tralning/Frnerinnee Ramnnneihilities & Authnrity Ancillary Perennnel Training Refremher Training By whom/ Certification Written Eram Management Review 2

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FACILITIES (Engineered Controls: Access Alarms & Controls, Transport Vehicles, etc):

7. SECURITY (425):

Access and Exit Controls Fire Protection Visible and Audible Warning Sienals Physical Security & Monitoring Unon Frit

8. EQUIPMENT (Survey Meters, See License Condition or Application):

Monitoring Instruments Calibration Procedures In. House Vendor Calibration Frequency By Whom/ Certification Posted Electronic Calibration. Frequency Operational Checks Performed Records

9. PROCEDURES FOR RECEIVING AND OPENING PACKAGES (432):

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10. INVENTORY LOG / RATE OF USE (317):

11. LEAK TESTS: .

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12. PERSONNEL DOSIhETRY:

Film Badge or TLD for eachIndividual Processed by-Frequency .

Exposure Reccads Comnlinnee with reunistorv limits-Ernosure ALARA (<10% of minimum permincible)

Notification Reports Available to Employee High Reading /Overexposures Frnosure History providad to Fmninyees Renorts reviewed by

13. POCKET DOSIMETER:

Pocket Dosimeter provided by Range 0-200 mR/hr Calibration Frequency Exposure History Reviews 4

14.

ENVIRONMENTAL &/OR AIR MONITORING PROGRAM:

(NOTE: ALI Annual Limit on Intake Values Table 1, Column I & 2, Appendix B; DAC.

Derived Air Concentration Values Table 1, Column 3, Appendix B) -

15. Yes No RESPIRATORY PROGRAM (428): N/A Calculations Sampling / Analysis Records _

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16. SPECIAL PROCEDURES:

Are lodinations performed? Yes No N/A.

IF YES, Isotopes / Quantities: 1-125 I131 Xe-133 Number of procedures per month (avg.) I 125 I-131 .Xe-133 Type ofmonitoring Equipment Perfonned by Date Results Last charcoal filter change

17. BIOASSAYS (408)- N/A Isotopes: C-14 I125 I-131 H3 P-32 License Conditions _In-House._ yendor Frequency Equipment / Instrumentation Type oftest: Thyroid Urine TotalBody Counting Other Action Levels

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18. POSTING & LABELING:

NMED045 License and Operating Procedures:-

Regulations Emergency Procedures _

Any Notice of Violation Training Outline -

" CAUTION RADIATION AREA Signs" Labeling on DeviceEquipment 19.

RADIATION SURVEYS & RECORDS (432):

Frequency of Surveys Meter Surveys Wine Survey Emergency procedure Worker Awareness Vehicle Surveys Surveys Daily Weekly Surveys upon transfer ofRAM Other Surveys 20.

TRANSPORTATION (U.S. DOT 49 CFR 170-199):

21. DISPOSAL METHODS:

Release to Sewerage Systern Yes No License Condition Decav.in-Storage Storage Location Secregation Trantfer Records 6

22. INCIDENTS OR OVER2XPOSURES:

Reports and Notification

23. OPERATIONS OBSERVED: (NOTE: Every attempt must be made to observe operations conducted in association with possession, use, and disposal oflicensed material).

24. INFORMATION CONTINUATION FROM PREVIOUS PARAGRAPHS:

25. INDEPENDENT MEASUREMENTS (Results Compared to Licensee, NOTE: Attach analysis report sheet):

Bkgd Instmment used Model # S/N Cal.Date Survev/ wipe maps 7

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26. INSPECTION

SUMMARY

27. EXIT INTERVIEW:

Senior Management Date License Reviewer Alert, memo sent?

Ifyes, Date sent NhED/RLRS REV.10/97 8

ATTACHMENT 6B MEDICAL INSPECTION FORM -

INSTRUCTIONS FOR MEDICAL INSPECTION REPORT 3 a

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INSTRUCTIONS FOR MEDICAL INSPECTION REPORT PART 1: INSPECTION BACKGROUND DATA

1. Check the appropriate box to indicate if the inspection was announced or unannounced.

2. Fill in the License Number, Inspection Agency, Expiration Date of the License, and the Inspection Date.

3. Did the licensee submit a timely renewal? N/A is used only with a new application.

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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 an.endments 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 inspectio:. was approved. This date will depend on the agency's policy: upon i

completion of the inspection packet or approval of the NOV and cover letter.

PART 2: LICENSEE DAT1.

1. Fill in the licensee's name and address from the license.

2. If the inspection address is different from the license address, fill in. If it is the same, check the box.

3. Fi31 in the nope and title of individual, administration, who was contacted at the last inspection. If it is a private practice, you may wish to put the business manager's name.

PART 3: LAST INSPECTION / CORRECTIVE 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.

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l j 3. List the recommendation (s) from the last 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

' inspection l a. The administrator and/or his assistant who is responsible i

for the radiology department - This could be the persons you contacted at the beginning of the inspection or the persons contacted by the radiology department.

l b. The radiation safety officer and/or the chairman of the  !

l radiation safety committee and any other physicians that j were contacted during the inspection.

c. The radiology manager and the chief nuclear medicine technologists.

d. The nursing supervisor if training is required of nurses.

! PART 5: MANActMFFT ORGANIZATION -

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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 requireds

a. Is the chairman as listed in License Condition #14 and is there a member of the administration on the committee?

b. Is the RSC meeting at their required frequency?

c. Does the minutes reflect the duties of RSC as described in Appendix B7 ,

4. Lir.t the chairman, the radiation safety officer, and the administration member from the last inspection or license application. You may wish to make corrections during the inspection.

5. Comments section is for any additional information that is needed l but could not be entered in PART 4 or 5 because of space i

limitation.

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PART 6: UNUSUAL OCCURRENCE & INCIDENTS

1. If nothing was found in the inspection file or through interview of the staff, write the name of the senior person making that claim. Check the minutes of radiation safety committee to verify as well as exposure reports.

2. If incidents have occurred, has the facility typlemented corrective actions to prevent a reoccurrence?

PART 7: p0 STING

1. Is the licensee complying with NMRPA, Subpart 47 PART 8: EMPLOYEE TRAINING

1. Use the remarks section to describe the training program for the technologist and ancillary s*.aff as well as refresher / continuing -

education from the license appifcations.

2. Is the facility complying with commitments made in the license application? If no commitments were made, do you wish to make recommendations?

2. Circle Yes or No, if records were reviewed or if persons were interviewed.

PART 9: EXTERNAL PERSONNEL EXPOSURE

1. Write the name of the vendor 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 materials 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 extremity monitoring being provided as required by NMRPR, St part 47 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 dosimeters used? List the types and if they are being calibrated and leakage tested as required.

5. Are there any purported overexposures?

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6. Does the facility have a complete and accurate exposure history?

7. Are the exposures ALARA?

6. All overexposure reports made to the Department?

9. Does the facility maintain records of prior doses? '

10. Are reports provided to the employees?

11. Who reviews the exposure records?

PART los INTERNAL PERSONNEL EXPOSURE

1. If there is no bioassay requirement, check Not Applicabli box and skip to Part II.

2. List License condition (s) which require bionssays. If bioassay is required, is the method, frequency, and instrumentation as described in the License Condition (s)?

3. Litt 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 storage and use locations for Xe-127/133 checked?

PART 11: NOBLE GAS / SANITARY SEWER REL1 ,ES

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 B. Determination made by calculation o'. sampling analysis?

3. Documentation that water concentration in the sanitary sewer is within regulation limits; NMRPR, Subpart 4, Section 435, Appendix B. Note patient discharges into the sanitary sewer is exempted.

4. All accidental releases reported NMRPR, Subpart 4, Section 4527 I

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PART 12: INSTRUMENT QUALITY ASSURANCE

1. List all model no. and serial no. of dose rate instruments compensated 0 M, ion chambers, etc.

a. Instruments calibrated at required frequency?

b. Proper calibration procedures being followed and performed by an authorized vendor?

c. Instrument is capable of measuring the dose rate of therapy patient and/or Tc 99m generator?

d. Is it currently operable?

2. List all model no. and serial no. of centamination survey instruments: end-window 0 M or pancake probe.

a. Instruments calibrated at the required frequeney?

b. Is check sotree 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 calibration pre t *es being followed?

b. Instrunent (s) calibra'

• required frequency?

PART 13: SEALED SOURCES

1. Does the licensee leak test required sealed sources at six month intervals?

2. Are leak test records complete and accurates all required sealed sources must be leak tested unless there is a license condition exempting stored sealed sources.

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3. Is the person taking wipe test of sealed sources authorized by the license?

4. Is the vendor, who is analyzing the wipe tests for .1 4akage, authorized by the Department?

5. Is any positive leak test reported to the Department within five days of the test?

6. List all sealed sources located in Nuclear t e licine 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 tocations authorized?

11. All RAM controlled and secuted 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.

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e. List all authorized locations in the license,

f. 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 isotope 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 ratient at bedside, 1 meter, and doorway?

b. Nursing care notification posted on door and in patient's file?

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 rocords 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 47

c. How does the licensee insure that all radioactive labels are defaced?

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 facility dispose of radioactive animal per license commitments?

1. Does the licensee compact radioactive waste per license conditions?

FART 15: INSPECTOR'S MEASUREMENT & OBSERVATIONS

1. List model no., serial no., and calibration date of all instruments used to survey the licensee.

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i p 2. If the licensee has a floor plan, indicate radiation readings on r i the plan.

3. List the radiation range in the controlled and uncontrolled areas I

around the Nuclear Medicine Department.

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Indicate if contamination evaluation or effluent sampling were performed.

5. Check those items observed and evaluated by the inspector.

PART 16

INSPECTION FINDINGS

• j 1. List items of noncompliance.

PART 17: RECOMMENDATIONS

1. List all recommendations to the licensee.

j PART 18: LICENSE REVIEWER ALERT f

j 1. If yes, check the box and write a short description.

NMED,RLRS, REV. 9/97

. .K MED. PRO i

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MEDICAL INSPECTION FORM License Number: -

Expiration Date:

Last Inspection Date:

Inspection Priority:

Inspection Date:

TypeofInspection: Routine AnnnuneM Unannounced Initial Special A. LICEblSE NAME & ADDRFRS ACTUAL LOCATION Telephone #

B. MANAGEMENT CONTACTmTI FlORGANIIATIONAL CHART (109h C, RADIATION SAFETY OFFICERt D. PROPRIFTARYINFORMATION(307 Fh E. SPECIAL LICENSE CONDITIONS (308h inspector Date ofReport Management Review Date of Review I

1. L AST INSPECTION: (VIOL ATIONS/ CORRECTIVE ACTIONS L_ SCOPE OF LICENSED PROGRAM:

1 ADMINISTRATIVE REQUIREMENTS:

L RADIATION SAFETY OFFICER (702B):

L ALARA. STATEMENT & ANNUAL REVIEW (702Ah

6. ALARA/ AUTHORITY & RPRPONSIBTI ITY/ SUPERVISION (702h

7. MFISICAL RADIATION SAFETY COMhEITEE (702Ch (Noter Memhershin/Meetino Frecuenev/ Minutest Chair /RSO/Arimin.)

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L AUTHOR 17Fn USERS:

Imeum Tenens ..

L TRAINING /EXPERIFNCE (712h

• (NOTE: ANCILLARY STAFF, MAINTENANCE, JANITORIAL, SECURITY)

RSO Trainino Physician Training Nuclear Medicine Technician Certification Emnloyee Refre.nher and/or On Going Training Nurse's Trainina _

How Often By Whorn Written Training Outline /Framination Certification /Fyniration Dnie Records reviewed interviewed

10. GENERAL TECHNICAL REQUIREhENTS (703)

11. FACII TTY

12. POSTING:

Notice to Emnlovees Licence & Amandments Cunent Cony of Reentations Ooeratine Procadures Fmaroency Procedures Nuclear Medicine Tach certifiestae _ , _ _ , , . , .

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13. CAUTION SIGNS:

Radioactive Materials Sicn .

Radiation Area Airbome Radioactivity Area Container Labeling Radionuclide Labeling Vials / Syringe Labeling

14. SECURITY:

15. SE Al FD SOURCES (CALIBRATION SOURCES 1(703 D.h Scaled Sources S/N Cal. Date Disposal Date Co.57 Cs-137

_ Ba-133 Co-60 Rn-22

16. I F AK TEST (415h (NOTER. Person taking wipe test authorized by lleente condition or certified) 6 month intervals Date ofleik tests Performed by Certified /Frnirstion Date

17. SURVEYS:

(NOTE: Surveys each day of use with survey meter & wipes where prepared or administered and weekly where RAM are stored. & reported in DPM):

Survey Area Map Inlection Area Hot T mh Floor Trend mill Area (s) Action level Daily Radiation Monitorino Storage Area (s) Weekly Wipe Survev How are swipes analyzed By whom Records (NOTE: Contamination action levels-2000 cpm /100 cm sq., or see regulatory guides 8.23).

4 l

0

18. EOUIPMENT OUALITY ASSURANCE (703h DOSE CAI IRRATOR (703A h .

Constanev-Daily Accuracy-Installation & Annually I inearity. Installation & Ouarterly Geometrical Variation-Installation .

(NOTE: For Procedures See Regulatory Guide 10.8. Appendix E).

Dose calibrator measurements (703C):

19. SURVEY INSTRUMFNTS (703Bh (NOTE:. Range-0.5 mR/hr-100 mR/hr & 1 mR/hr-1000 mR/hr):

Backun Onerational Checkjogce Performed Calibration Dates Calibration Frecuency Certified Vendor Calibration Procedures:

imet Calibration dates

20. GAMMA CAMFRA:

Flood Fields Daily Bar Phantnms(Resolutions) Weekiv

21. OTHFR COUNTING SYSTEMS:

Calibration Procedures Calibration Freauenev

22. PROCEDURES REVIEW:

23. MOLYBDENUM 99 GENERATOR:

(NOTE: Mo 99 detection activity level 0.015 uCi/ml Mo-99 per mci of Tc-99m before administered)

Manufacturer Possencion Limit / Activity

, Shieldina

Exchange Frequency Molybdenum Breakthrouch test ~

Aluminn Breakthrough test .

, Disposal / Segregation: Decav.In-Storace

24. SUPPLIFR RECEIVING (702Hk Inventorv log Acauired from

Single dose Multiple doses Normal Deliverv Time (s)

Non-Routine Orders Security Accented bs ?

Action Levels: Packnoe survev meter twipes a

Package Ooenino Procedures

25. EXTERNAL / INTERNAL PERSONNEL EXPOSURE: -

PERSONNEL DOSIMETRY (415h NVLAP Vendor Exchange Frequency Period Examined from to WB Rino Extremity Any ernosure(s) exceeding limits POCKET DOSIMETER:

Make/mndel #

Calibration Freonenev Ernosure ALARA (10% of MPL)

Record of Prior Dose Determination Renorts reviewed by

26. INTERNAL PERSONNEL EXPOSURE:

27. BIOASSAY PROCEDURES:

Equipment or Instrumentnion License Condition Frequenev

~

Isotooe(s) I123 I-131 Xe127/133 Method In-house vendor Thyroid Urine Whole Body Coumine 6

_ Dose Assessment (Action Levels) l

28. ENVIRONMENTAL CONTROLS:

- Air Concentration. Controlled Area J Concentration. Uncontrolled Area -

_ Engineered Controls:

Hood (s)

Charcoal TransfNOTE: fUter change dryrite should be blue not pink or white.)

4 Shielded Container Negative Pressure:

_ Area Monitorine/Calenistinne

29. DISPOS Att Disposallog Decay In Storage Sanitary Sewer Disposal Disposal of sources since last inspection Deface RAM Labels .

Shipping papers and ps4Sge labels proper Shipping Records Any Shiptnent incidents 4

30. INCIDENTS / REPORTS:

Thefis or Imecae Overernosures Erraecive enntamination levels loss of time > facility Equinment failure mienAminietration Notification Reoorts Corrective Actionn 7

31. INSPECTOR'S OBSERVATIONS / COMMENTS:

Observation Checklist ,

1. Gamma Camera Tests 6. Svringe Shicids 11. Packnoe Onening Surveys

2. Dose Calibrator Tests 7. Housekeening 12. Sterage Shields

3. Generators S. Hoods 13. Refdgerator

4. Protective Clothes 9. Waste Containers 14. Emnlovec Actions

5. SamnlelDome 10. Patient Bathroom 15. Area Monitorin_c

16. Other (NOTE: KEY NUMBERS TO COMMENTS):

31. INSPECTORS COMMENTS:

32. INDEPENDENT INSPECTION SURVEYS:

Instrument Used:

Model No. S/N Calibration.Date

33. INSPECTION FINDINGS:

s

31 RECOMMENDATIONS:

35. LICENSF REVIEWER AT FRT YES NO F m. ami, me NMFD/RLRS.REV. 9/97

- -9 _

ATTACHMENT 6C DENSITY / MOISTURE GAUGE INSPECTION FORM INSTRUCTIONS FOR PORTABLE GAUGE INSPECTION CHECKLIST 9

PORTABLE GAUGE INSPECTION CHECKLIST 60 PORTABLE GAUGE INSPECTION BY MAIL l

PORTABLE GAUGE INSPECTION CHECKLIST 1 1XSPECTION BACKGkOUND DATA ( ) announced ( ) unanncent ed License Amendment No.

Inspection Date Expires Renewal ( )

2. LICENSEE DATA

. Licenses Address [ ] same as Lic. Item 2.

Insp. Locatn. ( ) same as above Contact Title Phone No.

3. INSPECTOR Date Supervisor Approval 4.LAST INSPECTION - RESULTS AND CORRECTIVE ACTION (Date of last inspection)

a. Noncompliance ( ) None Current Status

b. -Recommendation ( ) None S. PERSONS CONTACTED DURING INSPECTION Ent Exit Other Ngt a () () []

RSO b () () ()

Operator c [] [] []

Ancillary d [] [] []

6. MANAGEMENT / SAFETY ORGANIZATION [] same as inst insp.

a. RSO's mgr Title '

Same as 5.a [ ]

IC NO RC NA NC

b. RSO as per License [] [] [] [] [}

c. ARSO as per License [] [] [] [] []

7. UNUSUAL OCCURRENCES & INCILENTS

a. None since last insp. per

b. Theft or loss reported () [] [] [] []

c. Notifications () [] [} [] ()

d. Reports [} [] [] [] [}

e. Presumptive Overexposure

[ ] yes [ ] no Set 21.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

9. POSTING SIGNS AND LABELING

a. Area Posting (1) Radiation Area [] [] [] [] []

(1) Radioactive Material [] [] [] [] []

b. Container / Gauge Labeling () [] [] [] []

c. Mfrs Label on Transport Case [ ] yes [] no

10. TRAINING (Lic. Doc.)

a. Operators (obtcin list or annotate in notes)

(1) Records of training (certs.) [] [] [] [] []

(2) RSO statements of auth. [] [] [] [] []

[ ] List [} Indiv. statements

b. RSO Procsdural Anow1cdg3

-(1) Operating /Emerg:ncy procsduros [] [} () () ()

(2) Shutter Cleaning -( ) () () () ()

(3) Leak test collection () () () () ()

c.- Ancillary personnel () () () () []

11. EXTERNAL RADIATION EXPOSURE MONITORING

a. Vendor name Acet. #

b. , Type of monitoring frequency

c. Period-examined: From to (1) Range of annual exposure for year, f rom mrem to mrom

d. Number of workers in program _

e. In Accordance with Lic Condition () () () () (.)

(1) Dosimetry used ( ) yes ( ) no .

(2) Compliance with reg. limit ( ) yes [ ] no (3) Records maintained properly ( ) yes [ ] no (4) Timely return to vendor ( ) yes ( ) no

f. Report of Presumptive Overexposure

12. LOCATIONS 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) location per item #10 () () () () ()

11) comply with drawing () (- ) () [] []

iii) scorage capacity for Possession limit [] [] [] [] []

b. - Temporary Jobsites Documents (Lic. Cond.)

i) RSO auth, statement [] [] [] [] []

ii) license () () (.) () []

lii) manufac instrue.

manual /emerg.-procedures

[] [] []  !) ()

c. In/Out Log () () () () ()

d. Storage at Temporary Jobsites [} [] [] [] [}

(1) Security

1) available/ maintained [] [] [] [] []

ii) adequate while recharging [] [] [] [] []

(2) Posting [] [] [] [] []

(3) Duration () [] [] [] []

Minimum days Maximum days

13. INV3NTORY

a. Within possession limit # [] [] [] [] []

b. Records of receipt, transfer, and disposal [] [] [] [] []

c. Physical inventory (obtain serial numbers or attach list)

() [] [] [] []

14. LEAK TESTS IC NO RC NA NC

a. Leak / wipe test collected per required [] [] [] [] []

freq. (Lic. Cond. )

b. Records maintained (Lic. Cond.) [] [] [] [] []

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 [] [] [] [] []

b. Storage Only [] [] [] [] []

C.

16. TRANSPGRTATION, 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. Pack ging during Tr:nsport (DOT-7A, Typ3 A () () () f) ()

49 CFR 173.415) ..

(1) Uses mir's case / package ( ) yes ( ) no (2) Uses other case / package ( ) yes ( ) no

d. Package Marking and Labeling (1) Package legibly marked (49 CFR 172.300 thru ( )

310)

() () () ()

(2) Package legibly labeled (49 CFR 172.403) () () () () ()

(RAD Yellow II, 2 sides of package)

e. Shipping Papers Used (49 CFR 177.817e) () () () () []

f. Certifications (49 CFR 173.476 & 173.415a)

(1) RAM Test Certification available [] [] [} [] []

(2) DOT-7A Packaging, Test Certification available [] []  !] [] [}

g. Enroute Storage (describe) 17 INSPECTORS MEASUREMENTS & OBSERVATIONS

a. Measurements Taken [ ] Not required [ ]

Make Model Serial Number (1) Instruments used (2) Calibration date Vendor (3) Radiation levels in controlled areas (4) Radiation levels in uncontrolled areas

b. Inspector Comments

18. DISCUSSION WITH OPERATOR IC NO RC NA NC

a. Adequacy of Operator Knowledge () () () ()  !)

i) Operating / emergency procedures () () () () ()

11) Transportation / security () () [] [] []

iii) Shutter cleaning () [] [] [] []

iv) Leak / wipe test collection () () [] []  !)

v) Other (1 [] [] [] []

b. Operator Cotanents ,

~

_ _ _ _ _ _ _____m _ _ . _ - _ - . - - - - . . - -

19. EXIT CONFERENCE NITH MANAGEMENT

20. TRAVEL DIRECTION TO LICENSEE IC = In Compliance RC = Recommendation NC = Non-compliance NO = Not observed NC = Not Applicable mws arv. som 6

O INSTRUCTIONS FOR PORTABLE GAUGE INSPECTION CHECKLIST

1. LICENSEE AND PREVIOUS INSPECTOR STATUS A. 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. NANAGENENT/ ORGANIZATION A. Attach an organization chart if available.

B. Identify the RSO's positions within the company.

C. 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 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. EXTEND PERSONNEL NONITORING 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. Review all permanent storage locations authorized under the license.

B. Are temporary storage locations used? If so, under what circumstances and for how long?

10. INVENTORY A. List the make and model of all gauges possessed. Are all authorized by the License?

2. Determine the frequency inventories are taken by the RSO.

11. LEAK TEST A. Verl / that all gauges are tested at the required frequency.

B. 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 must carry while transporting the gauge to job sites.

13. INSPECTORS MEASUREMENTS A. Measure reiiation levels at storage location o verify permissible dose rates ?^ ' rsonnel adjacent to storage locker.

B. Measure . on levels at cab of the transport vehicle if the gauge is pAaced near the cab while in transport.

NMED/RLRS. REV. 9/97 K-PG. PRO A

DENSITY MOISTURE GAUGE INSPECTION REPORT FORM License Number Expiration Date Date of this Inspection Inspection Priority Previous Inspection 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 of Review 1

1.

' FOLLOW-UP ON PREVIOUS INSPECTION FINDINGS:

2.

SUMMARY

OF LIQ ISED PROGRAM.(Type of program):

3. INTERNAL AUDIT (Annual Safety Review & ALARA & SOP'S):

4. ~ AUTHORIZED USERS: (Training Certification, Supervision of authorized users):

5. TRAINING / RETRAINING:

RRO Trainino/Fvnerience Dannemeihilitien & Antharity Ancillerv Permannel Trainine Refremher Trainine By whom/ Certification

' Written Fynm Manneement Review 2

6.

FACILITIES (Engineered Controls: Access Alanns & Controls, Transpcrt Vehicles, etc): #

7. SECURITY (425):

Access and Exit Controls Fire Protection Visible end Audible Waming Siennie Physical Security & Monitoring Upon Erit 8.

INVENTORY LOGS / RATE OF USE(317):

9. LEAK TESTS: .

10. - PERSONNEL DOSIMETRY:

Film Badge orTLD foreachIndividuni

. Prm ==M by Frequency Exposure Records Compliance with regulatory limits-

~3 .

Exnosure ALARA (<10% of minimum nermissible)

Notification Reports Available to Employee .

High Reading /Overexposures Ernosure History provided to Emnloyees Renorts reviewed by I1. POSTING ALABELING:

_NMED045 License and Operating Procedures:

Regulations Emergency Procedures Any Notice of Violation Training Outline

" CAUTION RADIATION AREA Signs" Labeling on Device / Equipment ._,

12.

TRANSPORTATION (U.S. DOT 49 CFR 170-199):

13. DISPOSAT., METHODS:

Storage Location Tran=fer Records

14. INCIDENTS OR OVEREXPOSURES:

Reports and Notification 4

15. _ OPERATIONS OBSERVED:(NOTE: Every attempt must be made to observe

- operations conducted in association with possession, use, and disposal oflicensed material).

4 16.

INFOkMATION CONTINUATION FROM PREVIOUS PARAGRAPHS:

17. INDEPENDENT MEASUREMENTS (Results O +gwM to Licensee, NOTE: Attach analysis report sheet):

Rked inetmment nW Model # R/N Cal Date Survev/ wine mane I8. INSPECTION

SUMMARY

t

19. EXIT INTERVIEW!

Senior Management - Date -

License Reviewer Alert, memo sent?

Ifyes, Date sent NMED/RLRS REV.10/97 s

e.

6

t PORTABLE GAUGE-INSPECTION BY MAIL

1. Licensee Name Add.* ass City Stete.' ZIP

2. Radiation Safety Officer Authority; who appoints and contact with management.

- 3. Describe any corporate or organizational changes-in your company since the last inspection by this agency,

4. List below the PORTAB: c RADIDACTIVE GAUGES you store and/or use:

. Radioactive Materials and

-Manufacturer Model Number .Sig anmnts in millicuries (Use supplemental pages if necessary to list additional units.)

5. Describe use of gauge':

6. Describe storage location of gauge (s). Submit draw 1 gs of storage area as Attachment'6.

1

= ..

7.

List all the individuals who are authorized to use the portable gauges and who provided the' 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 Radiation Safety Officer (RS0) takes care of radiation safety records, training and radiation safety tasks

[] RSO is the owner, a partner or manager

[] RSO was officially appointed by the owner, a partner or facility manager 9.

Portable gauges must be stored in a secure area. Please check all that apply:

[] Portable gauges are stored and not being used Portable gauges not being used

[] will be returned to manufacturer

[]

are stored and used at the address listed in Question 1 of this fonn

[] are stored at another pennanent storage site listed on license

[] Portable gauges ire used in the field and stored at temporary sites 10.

Portable gauges must be transported according to U.S. Department of Transportation Regulations. Please confirm:

[] 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). Submit a copy of the shipping paper used to transport your gauge.

[] Emergency response infonnation is included with shipping documents (49 CFR Part 172.602).

[] The emergency response telephone number 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 document, the emergency procedures and the 24-hour emergency telephone number are kept in the driver's compartment within reach of the driver at all times during transport. [49 CFR Part 177 817 (e))

2

~.

61. 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

[] Don't know*

[] Other*

• Submit explanation. ~

12, Please check all the boxes that apply to maintenance you perform on your gauge.

[] Routine device cleaning only: 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 de:cribed in manual

[] Wear " finger badges" when doing do source rod cleaning

[] Have special-training to do source rod cleaning

13. Check the documents that are posted:

[7 Notice to Employees NMED045, '

[] Vendor Certificate.

[] Copy of the Radioactive Materials License. including attachments.

[] Copy of NMRPR.

[] 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 accordance with license condition

[] Leak tests done on each sealed source for the past 3 years.

Isotope Model i 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 ~.

' CERTIFICATION

16. I certify that all items on this form are accurate and true.

SIGNATURE-PRINT NAME TITLE OF CERTIFYING PERSON ,DATE NMED/RLRS.REV. 9/97 K PGMail.FM

.- M 4

ATTACHMENT 6D

[ INDUSTRIAL RADIOGRAPHY INSPECTION FORM INSTRUCTIONS IN PREPARATION FOR INDUSTRIAL ,

RADIOGRAPHY INSPECTION REPORT ,U u.

INDUSTRIAL RADIOGRAPHY FIELD SITE INSPECTION REPORT

INSTRUCTIONS IN PREPARATION FOR INDUSTRIAL RADIOGRAPHY INSPECTION

1. Inspection Background Data 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 assistant radiography personnel.

Indicate date of employment and technical certification if any, ie. level 3, etc.

3. Inspection History Provide a brief description of the licensees recent compliance 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 the licensee has supplied all necessary documents to field operating crews. Determine documents-are posted for in-house operations.

I

_ _ . , , ________m------- - - - ' -

8. Utilization Log Review an adequate number of utilization logs to complete all questions.

Items should be checked if they are done - if not check N/A.

9. Inventories-

+

Are all sources accounted for quarterly?

Indicate make and model of sources if different from those authorized by the license.

Identify a select nuniber of projectors Lnd sources contained in them.

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 storage areas including en route storage on vehicles.

• Field sites:

NOTE: A field site audit must be included in all radiography license inspections. At least one site should be visited to verify all operatioas 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 rield site audits.

12. Leak Tests.

Verify all sources have been leak tested at proper intervals and records are maintained.

13. Survey Records.

2

r Review and verify all survey records.

14. Posting & Labeling.

observe all necessary posting and labeling. Signs must clearly 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 comparison between the licensees readings should be made.

The 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 packages received have been surveyed.

Review shipping records to show that all spent sources had been properly packaged and surveyed. '

17. Transportation.

• Verify all transportation requirements are met.

18. Incidents Procedures.

Review any reports or incidents the licensee may have been involved with since the last inspection.

comments / remarks:

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, closino conference / Exit Interview:

Describe the inspection findings to management and the Radiation Safety officer. All violations must be explained to the licensee in advance prior to insuance of the Notice of Violation. If the inspector is uncertain about any items being actual violations, then the correct information can be communicated to the licensee after consultation with the supervisor.

Recommendations should be made whenever an item of noncompliance is identified but there still needs to be improvement made in the safety program.

K-IR. PRO NMED/RLRS. REV 9/97 3

RAM COMPLIANCE Industrial Radiography Field Site Inspection Report

[-] Announced [ ] Unannounced Date ___

Licensee License No.

.- Inspector (s)

Inspection Location Radiography Personnel Radiographer Date Hired Radiographer Assistant- Date Hired Other(s) Employer if not Licensee Monitoring Equipment

- Badge Supplier Wear Period /Date Issued rocket-Dosimeter S/N's Calibration Date _

Survey Meter Make, Model i S/N Calibration Date Calibration Date Other Monitoring Device Calibration Date

- Radiography Projector / Equipment Projector Make, Model Serial f Source / Activity Serial i Crank Assembly Condition Good [*] Fair [ ] Bad [ ]

- Sourre Tube Condition Good [ ] Fair [ ] Bad [ ]

Pigtail & Connector Tip Condition Good [ ] Fair [ ] Bad [ ]

1 4

' ' Dark Room at Site Yes ( ) _No [-)

Projector Security Container'- Yes-[.)_ No [ ]

Type B Container Yes [ ] No [ 3 _

Observations

-Surveillance Maintained -Yes [_) No [ ]-

' Proper Connect / Disconnect- Yes [-) = No [ ] .

Correct Post Exposure Survey Yes(). No ( -]

Inspector / Licensee Survey Meter Comparison - (Inspector mR/hr)

-(Licensee imR/hr) '

Documentation Copy of the License Yes [ ] No [ ]

Latest Amendnent Date Radiographer Named on License Yes ( ) No [ ]

Operating & Emergency Procedures Yes [ ] No [ ]

MtPR- Yes [ ] No ( )

-Notice to Engloyees Yes [ ]- No [ ]

-Source Shipping Papers Yes [ ] No ( )

Decay Chart / Leak Test Yes [ ] No ( ) -

Other Documents Yes [ ] No [ ] ,

-Vehicle Placarded Yes [ ] No [ ]

Findinas

.' Items of Noncompliance 2

'  ?

Findinas

.. Items of Noncompliance'

[

J Corrective Action Taken

}

Job Allowed to Continue Yes [ ] No [ ]

Inspectors Impression

< .3 _

v "

- t -- -+ P'

l 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-namn.no. we

. E.leFLS.PN '

4

INDUSTRIAL RADIOGRAPHY INSPECTION FORM License Number:

Expiration Date:

Last Inspection Date:

Inspection P:iority:

Inspection Date:

Type ofInspection: Routine Announced Unannounced Initial ___.Special A. LICENSE NAME & ADDRESS ACTUAL LOCATION Telenhone B. MANAGEMENT CONTACTfrITLE (ORGANIZATIONAL CHART (109h C. NAME OF RADIATION SAFETY OFFICER:

D. PROPRIETARY INFORMATION (307-Fh E. SPECIAL LICENSE CONDITION (308h L Letter tent to licenmee on:

Inspector Date ofReport Reviewer Date ofResiew 1

L. FIELD SITE INSPECTION:

2 . LAST INSPECTION: (VIOLATIONS / CORRECTIVE ACTIONSh -

L ALARA Procram:

A 'CEIVING & SHIPPINO : .

nocedures Sr Shipping / Receiving:

Surveys When Received Surveys When Shipped Shippers Papenvork:

Records:

~

5. SURVEY INSTRUMENTS (Range 2-1000 mR/hrVSO9h

. Manufacturer:

. Adeounte Number Available

. Instnnr:ents Calibrated & Onerable 3 Month Interval Calibration:

Where Calibrated:

Records of Calibration ,

Safety Eouipment (Collimators. Shields. E;O:

6. I FAK TEST (510h Wipes Performed by:

Method:

2

Six (6) Month Intervals:

Records Maintained:

7. OUARTEP1Y INVENTORIES / INTERNAL AUDITS (511h Last inventerv Model S/N lsotope/Cl E. UTILIZATION I OG(512h Device and Radiocranher Identified Locations / Dates Identified; Dosimeter Readings Recorded Daily Dosimeter Recharged at the Start of Feb Shift:

Physical Survevs Recorded *

9. INSPECT *ON/ MAINTENANCE OF DEVICES / CONTAINERS / CHANGER (513h Eauipment Check Prior to Use Each Dav:

Eouipment Check at 3 Month Intervals:

Records of Results

10. FACILITIES AND SECURITY (514h 3 Fixed facility as described in annlication A*eillance or locked to prevcat unauthorized entrv:

Visible & audible siennis to warn ofpresence ofradiation Direct Surveillance of High Radiation Area Storage Aren Radiation Levels Cameras / Containers Physiently Secured:

_._ Keys Controlled hv:

3

11. POSTING (520h NMFn045 .

Licente and amendments Written Ooerating and Emergency Procedures Current Emergency Procedures Current Copy of Reculations Copies of Procedures fumithed to all Radlontanhers and Assistunee: -

Instruction Appendix A, Subpart 5 Notification Procedures in case of accident Procedures to minimize exposure dtuing accidents Any no: ice of violations orders issued Posting of Vehicles; Storage Room or area; Devices & Storage Containers with " CAUTION RADIATION AREA signs.

12. RADIATION SURVEYS / RECORDS (521h Frequency ofSurveys

._ Temporary Field Serveys Surveys after each exposure Surveys prior to securing source container -

Other surveys Methods of survey (Radiation levels in unrestricted areas?)

13. PERSONAL MONITORING (517 523h

, FilmfrLD Supplien s y AP)

Frecuenev

, Rach Individual analened Badge / Pocket Donimater/Ratemeter-Annum 1 Calibration Pocket Domimeterst Fvnneure Records Reviewed for the Period to Average Ouarteriv Frnosure

, Renorts Available for Review by Emnloyees:

High Readings /Overexposures Personnel provided exposure history 4

P_.QCi]lT C11 AMBERS Chamber (Range 0 200 mR/hr):

4 Pocket dosimeter provided by Calibration Frequency Dosimeter readings recorded

15. TRAINING / RETRAINING (515 & 527 Annendir Ah /

_._Radiographers named on license:

RSO _ _ .

Training Experirace Responsibilities & Authority Refresher Training Approved Training Program:

Written Test:

Results Reviewed by Management:

16. TRANSPORTATION:

Tyne B Container Vehlete PimenedeA Reaintared User of Pact nge Rhinning Panerwork Anoroved NRC Camera Program Trananortation inder mR/hr 12vels of Radiation ernomure from Devices & Cantainers:

Exterior of device to source 10 Cm or less - 50mR/hr. or less Exterior of device to source 20 Cm or more and all outer source container - 200 mR/hr. or less 5 ...

17. DISPOSAL!

Disposal of sources since last inspection Authorized containers Shipping papers and package labels proper? -

Transfer records Any Shipment incidents 1R. INCinENTS/ NOTIFICATION (452h Overernosures i nen of Cnntrol/Diaconnact?

Ercaeeive 12veln?

Theat Dammoe to Enuinment?

-Incident Rannet/Inventimatian

19. INSPECTORS SURVEYS

20. INSPECTOR'S OBSERVATIONS / COMMENTS:

?

6

2,L INSPECTION FINDINGS:

22. EXIT INTERVIEW:

Senior Management Signature Date 23, LIr'FNSE REVIEWER AT FRT. MEMO RFhm If vez, date sent NMFn/RLRS. REV. 9/97 7

RAM COMPLIANCE Industrial Radiography Field Site Inspection Report

[] Announced [ ] Unannounced Date Licensee License No.

Inspector (s)

Inspection Location Radiography Personnel

-Radiographer Date Hired Radiographer Assistant Date Hired Other(s) Employer if not Licensee Monitoring Equipment Badge Supplier Wear Period /Date issued Pocket Dosimeter S/N's Calibration Date Survey Heter 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 Good () Fair [ ] Bad []

Source Tube Condition Good ( ) Fair [ ] Bad [ ]

Pigtail & Connector Tip Condition Good [] Fair [] Bad [ ]

1

____u_._..u. - - - - - . - - - - - - - - - - - - - - "

Dark Room at Site Yes [ ] No [ ]

Projector Security Container Yes ( ) No [ ]

Type B Container Yes() No ( )

Observations Surveillance Maintained Yes [ ] No [ ] ,

Proper Connect / Disconnect Yes [ ] No ( ) ,

Correct Post Exposure Survey Yes() No ( )

Inspector / Licensee Survey Meter Comparison (Inspector mR/hr)

(Licensee mR/hr)

Documentetion Copy of the License Yes [ ] No ( )

Latest Amendment Date Radiographer Named on License Yes [ ] No ( )

Operating & Emergency Procedures Yes() No()

NMRPR Yes() No [ ]

Notice to Employees- Yes ( ) No ( )

Source Shipping Papers Yes[] No [ ]

Decay Chart / Leak Test Yes ( ) No ( )

Other Documents Yes ( ) No()

Vehicle Placarded Yes[] No()

Findinas items of Noncompliance 2

Findinas Items of Noncompliance 9

Corrective Action Tak>n Job Allowed to Continue Yes [ ] No [ ]

Inspectors Impression

, 3

4 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 oosn.m. ww E lWLt. fit h

[ ..

I ATTACHMENT 7 INSPECTION PROCEDURES I

Mt kd

q INSPECTION PROCEDURES L_Q INSPECTION PROCEDURES - GENERAL STATEMENT - 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.

LQ PURPOSE AND MISSION State Radioactive Materials Inspection Programs inscre the health and safety of the public and the environment from radiation hazards. 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 public; o provide the licensee with a status reports o define necessary remedial actions; and o encourage the licensee to remediate problems promptly and efficiently.

Inspectors are to conduct on-site reviews of radioactive material users to measure the radiation hazard fro:n the licensed operations; estimate personnel exposure from future use of radioactive material; assess compliance with regulations; and assure that licenseen 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 DEFINITIONS ALARA: An operating philosophy for keeping radiation exposures and effluent releases as low as reasonable achievable within acceptable cost.

Closeout or Termination Inspection: 1) verification that all RAM used or possessed by the licensee has been properly disposed of; 2) the facility is free from contamination; 3) records of all transfers or disposals are complete.

Dead Files 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 affective.

Initial Inspection: The first inspection performed after a new license is issued. This inspection must 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 license conditions.

2

Notice of Violation: The formal written document issued to the licenbee 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. Example, 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.

Prelicensing Inspection: Inspection at an applicant 's f acility 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 imC 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.

M METHODS 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 staff; s

o plan to inspect each of the various requirements; o identify problem areas examined during the inspection; 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.

Preparation and planning are essential to an effective and efficient inspection. Review the license and referenced documents that describe the organization's radiation safety program. Review results of previous inspections and investigations. Prepare an outline that emphasizes possible prcblam areas such as_ responses to prior findings. Identify if promised corrective actions have been done.

The radiation safety survey may _ __ involve determination 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 radioactive material. Ask the licensee for all records for the dates selected which may include area surveys, leak tests, personnel monitoring results, meter calibration records,_etc. Spot checking all required items for 20 dates since the last inspection presents a valid statistical picture of a licensee's compliance with requirements. The inspector _may require the licensee to get a complete set of radiation measurements resulting from uses under-review. These measurements will include radiation fields but may also includes 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 sampling 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 adequate within the scope of the licensed program.

A radioactive materials program review involves more than examination of licensee radiation recorde other records to review includes o Personnel radiation 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 recurrence; 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 ar.G conditions affecting disposal of radioactive waste imposed by - radiation control regulations. Records of transfer should, in addition, be reviewed for license 5

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 doses administered. Review of these records bears on the 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. Procedures performed pursuant to 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 releases arising from uses under review involves, in addition 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 a program but will lack the ability to make sound 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 and questioning, adequate to enable users to safely undertake activities authorized by the license? Is there adequate provision for on-the-job training of 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 license conditions, I

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?

Are exhausts from ventilated enclosures adequately ,

treated to reduce emissions to the out-of-rlant environs l to the lowest practicable levels withs.n regulatory limits?

o security Devices. Are interlocks and warning signals j adequate to ensure strictly controlled and safe entry to ,

high radiation or high airborne areas within the '

facility?

o Do facilities confoun to user commitments incorporated by reference in license conditions?

t o Posting. Are individuals adequately warned as to the presence of radioactive material, radiation fields and airborne concentrations? Are workers informed of their rights and obligations (Notice to Employees) ? Does i 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 bionssay, 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 st'aff personnel?

j, 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 PRIORITIES 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 requirer 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 inspections.

Examples of priorities by license type Mais, this schedule is subject to change by programs based on safety emphanis.

-Attachment I- See NMED INSPECTION PRIORITY TABLE!

6.O 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 after 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 licensable material.

8

2. Routine, Periodic Inspections Inspections of licensees shall be conducted at intervals -

corresponding to their inspectic n priority. Prioricy 1 each years Priority 2 = each two years; Priority 3 = each three years; These should be unannounced unless prior notification of no more t%n 48 *y hours would enable more complex facilities to assemble documents to j be reviewed by inspectors or to ascertain that licensees located in ..

4 remote areas will have someone present to grant access to premises, t

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 unannounced.

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 and that affected areas of the licensed facility may be safely released for unrestricted use. Each survey, if supervisory personnel deems it necessary, shall be conducted as soon as possible after the notification is receive

5. 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 calendar 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

f l_E ZR STMG INSPECTIONS

.. Obtain inspection due list.

oc 2. Identify licenses within a geographical area to optimize 7 travel.

3. Identify licenses most in need of inspection (prioritize) .

U 4. Plan travel itinerary allowing for substitutions and have Program Manager, Bureau Chief and Financial Specialist approve overnight travel.

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 tnoroughly and any incidents which may have occurred within the inspection interval.

8. Obtain necessary equipment.

9. Provide inspection schedule to management for emergencies.

6.3 INSPECTION TECHNIOUE

1. The inspector should have a complete knowledge of t )

license, and the State's Rules, Policies and Regulations.

2. Always contact upper 2nanagement upon entering a f acility.

3. The inspector should communicate 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

l inspector should not assist with their location or procurement.

6. The inspector should be aware of licensee stalling >

tactics and maintain control of the inspection.

7. At the conclusion of the inspection, the inspector (s) should take time to themselves to evaluate all findings and identify possible areas of noncompliance. The inspector 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 certain. TF is 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 the licensee's management during the exit interview. Any other findings not identified during the exit should be communicated to the licensee by _ telephone prior- to issuance of the Notice of Violation. The closeout conference should be held with the licensee's hiabest level of management available.

7.0 GUIDANCE 7.1 ALARA (AS LOW AS REASONABLY ACHIEVABLE)

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 releaser of radioactive materials in effluents to unrestricted areas as low as reasonably 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 from 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 licensee personnel are made aware of managements' commitment to keep occupational exposures ALARA; o That the radiation protection staff have been given authority to assure ALARA procedures and policies are carried outs o That workers are adequately trained, not only in the radiation safety procedures, but also 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 possibles and o The Quality Assurance (QA) and Quality control (QC) programs where applicable (i.e. manufacturing, R and D, radiopharmacy, etc.).

7.2 GENERAL GUIDANCE FOR AT.T. INSPECTIONS All inspections should include a mix of records and procedures review, observations, confirmatory measurements, and discussionr with personnel involved in the " hands on a work.

Inspection of licensees should be done by observation of operation, interviewing of licensee personnel, and review of records. The record review should serve to verify both the observed operation and the information collected during the interviews.

General review of the licensee records, with special attention paid to problem 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

O 7.2.1 INTERVIEWS Personnel interviews are extremely important.

1. All interviews with authorized users and ancillary workers must be documented, including job titles.

2. It's acceptable to ask workers to take a short examination to test their knowledge of radiation safety as it pertains to the type of operation being inspected. .

3. Interviews can and should be held in private, away from 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. Verify that receptionists understand the proper storage location for packages that conta:Ln radioactive materials that are either received or sent out by the facility.

6. Determine that supervision is provided for all licence operations where unsupervised work is prohibited.

7. Personnel interviews are important! Ask the employees if they received the o quared training. Ask them questions about their trb aing, 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 cd 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 bioassay exam reports.

7.2.4 ODEERVATIONS 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 afly on the walla, in order to adequately observe operations.

7.2.5 INDEPENDENT MEASUREMENTS ,

During most inspections, performing ind3 pendent measurements is required. The need for radiation 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 followed such as:

o Use 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 abould. cover 100 square centimeters.

-14 I

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 check source.

,Lj. INSTRUCTIONS FOR SPECIFIC LICENSE 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 recoipt and shipping procedures.

8. Assure adequate security of RAM.

i 9. Audits may need to be conducted during off hours (night time).

MANUFACTURING & DISTRIBUTION

1. Verify current client license authorization (make sure the licensee has all necessary client information to comply with transfer rules).

15 1

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 FDA have been completed).

4. Verify the final General Licensee in accordance with General License rules. Confirm if there will be a " drop shipment" to a middleman who must be specifically

< licensed.

ERDAD 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.

NUCirAR PHARMACY

1. Begin inspection at 3 am (doses are prepared for distribution before 7 am).

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 dces not exceed the licensed allowable time limit.

16

2. Verify - the type of waste authorized (does licensee address mixed waste?).

MFnICAL INCLUDING DIAGNOSTIC. BRACMYTHERAPY AND TELETMERAPY

1. Confirm that doses are within well established limits.

2. Verify patient release criteria.

3. . Verify that adequate personnel dosimetry and training is provided to nursing staff.

4. Verify physician and authorized user Tualifications.

5. Confirm that scans are being read by an authorized user.

6. Confirm technologist licensure.

7. Verify camera QA in accordance,with RDA recommendations.

8. _ Verify dose calibrator QA (cf. NCRP No. 95).

MOBILE MFnICAL 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 injection.

4. Confirm that f acility surveys are performed upon exit from facility; confirm also that no residual contamination remains.

5. Confirm that there is license authorization for transport of dose calibrator and/or sealed sources.

SERVICE LICENSES (T72LK TEST. INSTRUMENT CALIBRATION. ETC.)

1. Verify that distribution and temporary job sites are authorized.

17

2. Confirm t. hat leak test kit conforms to postal regulations.

3. Confirm that th-re is adequate instrument sensitivity regarding leak test analyses and NIST traceability or standards.

WELL LOGGING

1. Observe fishing operations if possib13.

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 vehicles).

2. Verify transportation and security procedures.

3. Verify that operator maintains security at all times.

4. Personnel manitoring; verify that authorized user list is current.

VETERINARY MEDICINE AND THERAPY

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 Mispose of wastes down the sewer.

4. Veterinary medicine doce not follow human use rules.

18 1

d

RESEARCH AND DEVELOPMENT

1. Verify that license status is only R & D and that there is no distribution.

_ 2. Verify that animal use is conducted with adequate safeguards.

INDUSTRIAL LIXISCOPE

1. Verify that source exchange is authorized by license.

FIXED GAUCQ

1. Verify location and labeling of gauges.

2. Perform inventory of all gauges including any Generally Licensed gauges.

3. Make sure the licensee has lockout procedures for maintenance.

GAS CHROMATOGRAPHS

1. If portable, verify that licensee uses proper shipping procedures.

2. Check venting of H-3 sources (Sc tritide).

L.A 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 the agency.

The minimum objectives of an inspection report are:

1. To eliminate unnecessary detail in inspection reports by 19 l

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 ir.1 ormation 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 licensed program.

A reasonable effort c aould be made to attribute information to the proper source, such as statements by named individuals, 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 facilitate reviewing the results of the inspection.

El 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

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' tent 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, where 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 adequate description of the information reported.

Where the inspection was performed under one or two lengthy inspection procedures, the details should be <

divided into paragraphs by line 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 describe 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 factually 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, records, reports from licensee, etc.), the specific procedures, 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 examination 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 report 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 as 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 information obtained. Rather, the inspector should limit his reporting to the basis for concluding adequacy or keeping the item open. The objective is to report substantive information and minimize the reporting of information of lesser importance or interest.

M REPORT GUIDANCE Specific guidance regarding handling of reports is as follows:

1. Any finding leading to a conclusion that a noncompliance occurred shall alwavs be handled as a noncompliance item except for minor licensee-identified noncompliances.

Recommendations are made when deviations from acceptable ,

or normal 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 s ystem.

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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.

8.3 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 EXAf4PLES.

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 tops o 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 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 2.1 RADIATION MONITORING EOUIPMENT

1. Survey Meter (cpm and mR/hr).

2. Detectors.

a. Energy compensated GM

b. Pancake probe.

c. Low energy NaI(T1) probe (thin) and check source to 24

confirm probe efficiency.

d.- High energy NaI(T1)- probe (1x1) . and check source to confirm probe efficiency.

e. Alpha scintillation probe and check source to-confirm probe - ef ficiency - (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 EQUIPMENT

1. Disposable gloves

-2. Hard hat, safety shoes, earplugs, safety glasses

3. Disposable shoe covers Mr 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 MISCET 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 filled with dirt for shielding 25

6. Indelible pens in black, red

7. Notepaper

8. Wipe test materials

9. Writing pens & pencils

10. Calculator

11. Tape recorder & tapes

12. Cellular phone WMED/RLRs.try. 10/91 INSP.PRC 26

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ii wayim-ATTACHMENT 8A ENFORCEMENT PROCEDURES p

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ENFORCEMENT PROCEDURES M. ROUTINE ENFORCEMENT 1.1 Inspector prepares noncompliance letter. Bureau Chief reviews noncompliances and signs letter. Letter requires a 20-day response time.

1.2 Short form letter (no items of noncompliance) may.be sent to licensee after the inspection indicating no items of noncompliance. These letters are to be signed by the RLRS Program Manager.

1.3 Each item of noncompliance is categorized according to severity level 1, 2, or 3. Severity-level 3 noncompliances have a high probability of causing a health and safety problem; severity level 2 could cause a health and safety ,

problem; and severity level 1 indicates an administrative f

noncompliance which has minor safety significance.

Repeat items of noncompliance must be stated in the noncompliance letter.

1.4 Notice of Noncompliance must be sent within 20 calendar days of the date of inspection closing.

1.5 Licensee response to noncompliance letter is required in 30 days.

1.6 Inspector follows up on licensee response. Supervisor may intervene if licensee response is unsatisfactory or inadequate.

If resnonse is adeaunte, theni o Inspection is closed out with "close loop" letter after all items of noncompliance have satisfactorily been addressed.

o An inspection report is completed 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 resnonse is unsatisfactory, thent o Management level of this program becomes involved, and all correspondence should be signed by Program Manager and countersigned by the inspector, o Second letter with shorter required response time.

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 should be offered as a last solution before going to escalated enforcement.

o shorten inspection temporarily).

frequency (raise priority o Require periodic (weekly, monthly, quarterly) written reporting by licensee, o Administratively write additional restrictive license conditions into that specific license, o Administratively 2.imit amount of isotopes that may be possessed.

o Require specialized . training programs and audits by licensee to be presented to State.

2.d ESCALATED ENFORCEMENT / ADMINISTRATIVE PENALTIES.

2.1 74-3-11. . Civil penalty; injunction.

A. If the director has good cause to believe that any person is violating a conaition of a license issued by the agency, or administered by the agency pursuant to an agreement with the nuclear regulatory commission or any regulation of the board, the person _ shall be given an opp,ortunity to be heard at a hearing before the director. The director shall notify the person by 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 shall issue an order to cease and desist or revoke the 13 cense held by the person, whichever is appropriate.

B. The director may issue a - cease and desist order, on an emergency basis, pending the hearing provided in Subsection A of this section, if he determines that immediate action is required to protect huan health or safety. If a cease and desist order is issued on an emergency basis, the hearing before the director 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 hearing.

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c. The agency may seek 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 jurisdiction and supervision of the district court and the court's powers of contempt. The action shall be filed in the district court for the county in which the violation occurred or will occur. The attorney general shall represer.t the agency.

D. In addition to the remedy provided above, the tria'l court may impose a civil penalty not to exceed five thousand dollars ($5,000) for each day during which violation occurs.

E. Any person aggrieved by a final judgement of the district court under this section may appeal to the supreme court as in other civil actions.

> ga ATTACHMENT 8B FOLLOW-UP ON INSPECTION LETTER vw

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FOLLOW-UP INSPECTON LETTER Licensee License Number Inspector issuing letter ofinspection-Date Inspection letter was issued:

Date response due from licensee:

Response received by due date: Yes No .

If yes, inspector should initial this form and 'T' out the rest of the page.

If No, proceed to next step:

1" follow-up contact by inspector by telephone.

Summary:

d 2 follow-up by registered letter. (Cite date and to whom letter was sent; copy to NMED legal) 3dfollow-up Site visit by inspector to determine circumstances. (Cite date and summary of activities).

4* follow-up--Cease and Desist Order from the Secretary's office and subsequent escalated enforcement actions. (Cite actions taken.)

Summary:

Inspector: Date:

Program Manager: Date:

NMFD/RLRS.REV 10/97

ATTACHMENT 9 STANDARD OPERATING PROCEDURES FOR RESPONSE TO INCIDENTS INVOLVING RADIOACTIVE MATERIALS INCIDENTINVESTIGATION PROCEDURES 07 E!

INCIDENT REPORTING SYSTEM / ABNORMAL OCCURRENCE CRITERIA w-

.-_m__ - . . _ _ _ _ _ _ - _

INCIDENT REPORTING SYSTBt smuoamit occomarwca cartrara

-The following criteria shall be used for the determination of an abnormal occurrence.

Events involving a' major reduction in the degree of protection of the public health or safety. Such an event would involve a moderate or more severe inpact 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 ot' the types of events that are evaluated in detail using these criteria aret For 111 Licenmaan

1. Exposure of the whole body of any individual ' to 25 rems or more of radiation; 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.

3. 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 -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 confinement of radioactive material such as (a) a radiation dose rate of 1,000 mrom per hour three feet from the s- ' ace of a package containing - the radioactive- material, or (b) release of radioactive material froa a package in amounts greater than regulatory limits (Reference 10 CFR, Part 71.36(a)).

5. -Any loss of. licensed material in such quantities- 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.

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'7. 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 be caused by theft or diversion or by substantial breakdown of the accountability system.

8.

Any substantial breakdown of physical security or material control (i.e.,

access control, containment or accountability systems) that significantly weakened the protection against theft, diversion or cabotage.

9.

A major deficiency in design, construction or operation having safety implications requiring immedi' ate remedial action.

10. serious deficiency in management or procedural controls in major areas.

11. Series of events (where individual events are not of major importance),

recurring incidents, and incidents with implicatfors for similar facilities (generic incidents), which create major safety concern.

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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 NRC has developed guidelines for the reporting of incidents involving radioactive materials. The information gathered is used in a national data base to evaluate trends and identify generic problems. They have divided reporting criteria into three categories:

1. Abnnrmal occurrences--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 NRC by telephone as early as practicable.

2. Telenhene Renorts--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 reportf.ng by a licensee to the State are covered in Subpart 4, Section 452, New Mexico Radiation Protection Regulations.

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.

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INCIDENT INVESTIGATION PROCEDtntBS

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. Record any noti *ications made, being sure to include name, agency, date/ time, and phone number. . Verify reportability to NRC by checking requirements listed in Attachment 11.

4. If a press release is required 93 any news media personnel are at the scene, notify Public Af f airs. Attach copy of all releases, including summaries of interviews, to the report.

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. R%ord the EPA number and the driver's name. Complete the remaining portion of the transportation section.

7. Give Incident / Allegation Report Forms to the Program Manager no later than the next working day.

8. The Program Manager will review the Incident / Allegation forms for completeness and reporting requirements.

9. The forms will be given to the designated person for assignment of a tracking number and data entry.

10. When the incident is closed, complete the close-out summary,

11. Date and sign foms and indicate if copies are required for the Incident chronological file.

12. The complete incident package 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 flied in the filing cabinet in the RLRS office in Santa Fe.

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STANDARD OPERATING PROCEDURE (SOP)

FOR RESPOIISE TO INCIDENTS INVOLVING RADIOACTIVE MATERIALS I. GENERAL A. This SOP provides general guidance for responding 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 responsibility for the coordination of all emergency responses. Thic central point of contact has been established to ensure a smoother, more unified response mechanism.

C. The Director, and the HRMP Bureau Chief, will be advised of all incidents reported and response contemplated.

II. RESPONSE GUIDE A. General

1. Whenever the Agency is apprised of an incident, accident or emergency, a rGeponse 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 Prograra Manager or the HRMB Bureau Chief will 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 cf program and staff;

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," is lost, including a well-logging tool down-hale, or involved in an accident;

d. If there is an actual or potential hazard to public haalth and safety;

e. If the media should notify the Agency of any real or suspected incident;

f. If the Program Manager or Bureau Chief deem it necessary.

1

3. When receiving a notification of an incident, the person notified should complete an Radiological Incident / Allegation Report (Attachment 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 giver..

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 the scene, responders wills

a. Identify both the local / county official in charge and representativet of state agencies that may have responded. Most likely, at least for transportation incidents, a designated officer of the Department of Transportation 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.

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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.

7. 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 should be used to respond to incidents for which use of a vehicle is deemed appropriate.

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0 IV. REPORTING REQUIREMENTS A. 1. Reporting requirements for any incidents responded to are found in 20NMAC 3.1, Subpart 4, Section 452,

2. The Emergency Response Program Manager will publish periodically a roster of Emergency Response Duty Officers and will maintain an up-to date Emergency Assistance Telephone Call List (anclosure 3). . Enclosure 3 will not be provided to anyone outside the Agency.

B. 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 Incident / Allegation Report form will provide the PIO with the basic information with which to prepare a preliminary release. Further 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 scene may provide a short synopsis of what they found but should not engage in long discussions or speculation with media representativea.

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 information; 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

e ATTACHMENT 10 ALLEGATION RESPONSE GUIDANCE DOCUMENT (BEING DEVELOPED, TO BE PRESENTED TO MRB ON OCTOBER 23,1997)

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ATTACHMENT 11 INCIDENT REPORT FOR RADIOACTIVE MATERIAL LICENSEES S

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State of N:w Mexico g q ENVIRONMENTDEPARTMENT a

Hazardous & Radioactive Materials Bureau g$

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2044 Galisteo 1 y 1

.?.O. Box 26110 en. Santa Fe, New Mexico 87502 (505) 827 1557 GARYE JOHNSON Fax (505)8271544 unxt wtmuut covnaxon sscastrar EDGM T. THOMTON,5 Du urysscatrAsv INCIDENT REPORT FOR RADIOACTIVE MATERIAL LICENSEES t LICENSEE NAME: LICENSE NO.:

CITY: PHONE NO.:

TYPE OF EVENT (check all that pertain):

( ) Loss of Package Effectiveness or Contanunation

( ) Theft or Loss of Radioactive Material

( ) Overexposure ofIndividual to Radiation

( ) Overexposure ofIndividual to Radioactive Material

( ) Excessive Levels of Radiation or Concentrations of Radioactive Material

( ) Device Safety Failure

( ) Leaking Source

( ) Misadrninistration: Diagnostic Therapeutic

( ) Tr.nsportation incident

( ) Other EVENT DATE: DATE REPORTED TO STATE:

REPORTED BY: REPORT RECEIVED BY:

OTHER LICENSEE INVOLVED (Name/ License No.):

RECIPROCITY LICENSEE? Y/N AGREEMENT STATE:

LOCATION OF EVEhT:

ISOTOPE: AMOUNT:

1 1

LICENSEE NAME: LICENSE NO :

DESCRIPTION OF EVENT (include cause of event and corrective actions taken):_

PERSON ASSIGNED TO: DATE ACTION TAKEN BY RLRS 2

,__-_________m___..___

LICENSEE NAME: LICENSE NO.:

FOLLOW UP ACTION NEEDED? Y/N DATE OF FOLLOW-UP:

FOLLOW UP CONDUCTED BY: CRIMINAL VIOLA 110N?

FOLLOW-UP COMMENTS.

CLOSE-OUT

SUMMARY

t DATE REPORT CLOSED:

REPORT CLOSED BY: 11TLE-REPORT REVIEWED BY: 11TLE FILE COPY OF THIS REPORT UNDER INCIDENT TAB IN LICENSEE FILE Ah3 MAKE OTHER COPIES AS NECESSARY FOR CHRONO FILE SEND COPY TO DESIGNATED NRC REPORTER l

m ATTACHMENT 12 TELEPHONE LOG

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Aaenda for Manaoement Review Board Meetina Thursday. October 23.1997,2:00 o.m.. OWFN. 4 B-B

1. Convention. MnB Chair convenes meeting. (H. Thompson)

2. New Business Consideration of New Mexico IMPEP Report.

A. Introduction of New Mexico IMPEP Team Members. (J. Lynch)

B. Introduction of New Mexico representatives and other State representatives participating through telephone bridge. (K. Schneider)

C. Findings regatoing New Mexico Program. (IMPEP Team)

- Status of Inspection Program

- Technical Staffing / Training Technical Quality of Licensing

- Technical Quality of Inspections Response to incidents / Allegations

- Legislation and Regulations D. Questions. (MRB Members)

E. Comments from State of New Mexico.

F. MRB Consultation / Comments on Issuance of Report. (H. Thompson)

Recommendation for next IMPEP review.

3, Maryland Good Practice issue (Attachment 3)

4. Old Business - Texas MRB Minutes. (K. Schneider)

5. Status of Upcoming Reviews. (K. Schneider)

6. Adjournment. (H. Thompson)

Invitees: Hugh Thompson, MRB Chair, DEDR Richard Bangart, MRB Member, OSP Karen Cyr, MRB Member, OGC Carl Paperiello, MRB Member, NMSS Richard Barrett, MRB Member, AEOD Ray Paris, Agreement State Liaison to MRB, Oregon William Floyd, New Mexico Geoff Sloan, New Mexico Paul Lohaus, OSP Don Cool, NMSS James Lynch, IMPEP Team Leader, Rlli Terry Frazee, IMPEP Member, Washington Jack Homor, IMPEP Member, RIV/WC Scott Moore, IMPEP Member, NMSS Kathleen Schneider, OSP L6nce Rakovan, OSP ATTACHMENT 2

TECHNICAL QUAllTY OF LICENSING GCOD PRACTICES Maryland conducts pre license-issue visits in lieu of initial inspections within 6 months of license issuance. These visits enable the license reviewer to ascertain the status of licensed facilities and proposed uses, as applied for by the applicant. It also allows an explanation of the licens5g and inspection process prior to the start of licensed activities, thus helping licensees to achieve early success in complying with the requirements of the license and Maryland regulations. This approach was determined to be equally as effective as NRC's initial inspection program.

Maryland contact: Roland Fletcher ATTACHMENT 3

_ _ _ _ _ _ - _ _ _ _ _ - _ . _ .