ML20199D259

Proposed Final Rept: Integrated Matl Performance Evaluation Program Review of New Hampshire Agreement State Program, Dtd 970819-22

ML20199D259
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Issue date:	08/22/1997
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W INTEGRATED MATERIALS PERFORM.ANCE EVALUATION PROGRAM REVIEW OF NEW HAMPSHIRE AGREEMENT STATE PROGRAM v,

AUGUST 19-22,1997 PROPOSED FINAL REPORT U.S. Nuclear Regulatory Commission 9711200294 971106 PDR STPRQ ESQNH PDR

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New Hampehire Proposed Final Report - Page 1 1.0 ~

- INTRODUCTION ~

This report presents the results of the review of the New Hampshire radiation control program.

1The review was conducted during the period August 19-22,1997 by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Florida. Review 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 Statement of Principles and Policy for the Agreement State Program and the Policy Gtatement on Adequacy  ;

and Compatibi!ity'of Agreement State Programs," published in the Federal Register on October 25,1995, and the September 12,1995, NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)," Preliminary results of the review, which covered -  ;

the period August 19,1994 to August 22,1997 wtere discussed with New Hampshire i management on August 22,1997.

' [A paragraph on results of the MRB meeting will be included in the final report.)

The New Hampshire Agreement State program is administered by the Commissioner, Department of Health and Human Services (DHHS), Office of Health Management (OHM), .

Bureau of Radiological Health (BRH). The BRH regulates approximatoly 100 materials licenses.~

The review focused on the regulatory program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, es amended) Agreement between the NRC and the State of New Hampshire, i In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on May 29,1997. The State provided a response to the i: questionnaire on August 11,1997 and August 19,1997. A copy of the response is included in Appendix C to this report.

The review team's general approach for conduct of this review consisted of: (1) examination of the responses to the questionnaire, (2) review of applicable New Hampshire statutes and 1 regulations,-(3) analysis of quantitative information from the BRH licensing and inspection data

- bases, (4) technical review of selected licensing actions and inspections, (5) field

- accompaniments of two materials inspectors, and (6) interviews with staff and management to answer questions or clarify issues. The review team evaluated the information gathered

against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the State's performance.

, Section 2 below discusses the State's actions in response to recommendations made following 4 -

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 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 enhance the State's program. The State is requested to consider suggestions, but no response will be requested. Recommendations relate directly to program performance

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1 New Hampshire Proposed Final Report Page 2: j by the State. A response will be requested from the State to all recommendations in the final

- report.

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2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS The previous routine review concluded on August 19,1994 and the final results of the review were transmitted to Dr. Charles E. Danielson, Director of the New Hampshire Division of Public Health and Services (DPHS), on January 10,1995. In letter dated February 21,1995, from ,

Dr. Danielti,on to Richard L Bangart, Director, Office of State Programs (OSP), and during the Management Review Board Meeting on the 1994 review, the State responded to the 1994 program review findings, comments and recommendations. In letter dated April 24,1995 from-Mr. Bangart to Dr. Danielson, NRC evaluated the State responses and all items except those identified below were closed. ,

2.1 St*= of itemr. Identified Durina the 1994 Routine Review The open 1994 review findings that resulted in recommendations to the State were assessed during this review. The open findings were in the following areas: (1) Status and Compatibility of Regulations; (2) Legal Assistance; (3) Enforcement Procedures; and (4) Inspection Procedures. The status of these recommendations are as follows:

(1) _ Status and Compatibility of Regulations The State had not adopted rules equivalent to the following NRC regulations: " Emergency Planning Rule," which was needed by

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April 7,1993; " Standards for Protection Against Radiation," which was needed by January 1,1994; " Safety Requirements for Radiographic Equipment," which was needed by January 10,1994; and " Notification of incidents," which was needed by October 15,1994. It was recommended that the Division take steps to accelerate the promulgation process and consider proposing legislation to exempt the RCP from the administrative rulemaking procedures.

Current Status: The State's corrective actions are as follows: " Emergency Planning Rule," has not been adopted by the State. Currently, the State has no licensees to which this rule would be applicable. However, the State has indicated that the  ;

requirements of this rule will be used in the review process for new license applications that would be subject to the requirements of the rule. This ruie is scheduled to be adopted in December 1997. " Standards for Protection Against Radiation," was adopted g

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by the State in February 1995, and was reviewed by the NRC. Comments were .

provided to the State in letter dated August 18,1997 to Ms. Diane Tefft, Administrator, BRH, from Mr. Paul Lohaus, Deputy Director, OSP. " Safety Requirements for Radiographic Equipment," is currently being incorporated by industrial radiography i- license conditions and is scheduled for adoption in December 1997. " Notification of s incidents," was adopted in February 1995 for Parts equivalent to 10 CFR Parts 20,31, 40 and 70, and the equivalents for 10 CFR Parts 30,34, and 39 are scheduled for edoption in December 1997. In addition, in August 1995, the New Hampshire Administrative Procedure was amended to exempt BRH regulations from the administrative rulemaking system of numbering and drafting rules. Under the revised Administrative Procedures, these rules are in compliance with the administrative f

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x New Hampshire Proposed Final Report; Page 3 ,,

rulemaking system if the wording is consistent with the language of the corr 6sponding -

federal regulations; This recommendation is closed;  ;

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_(2) Legal Assistance. Legal assistance was difficult to obtain from the Attomey Generars -;

Offloe on routine legal matters. The review team recommended that the DPHS take -

appropriate steps to assure that the radiation control program had prompt legal '

assistance available when needed.

Current Statusf BRH has direct access to legal counsel. As the result of a reorganization of the New Hampshire DHHS, an attomey from the Attomey Generars

< office was assigned to the OHM. BRH is a part of OHM and it has direct access to this attomey. This recommendation is closed.-

(3) Enforcement Procedures. The BRH used the 1990 draft procedures, which are

, modeled after Appendix C of 10 CFR Part 2, to guide the enforcement process.

However, BRH must publish regulations to implement the authority to assess civi; - ,

penalties and establish severity levels for enforcement actions, it was recommended 1 that BRH consider including the revised inspection and enforcement procedures, with the provisions for severity levels and civil penalties, as part of the 1994 rulemaking package.

Current Status: BRH has not adopted the rules or policy necessary to implement

. severity levels and civil penalties. BRH indicated that the current enforcement policy was effective in achieving licensee complianc.e for the period. In addition, BRH

[ indicated that other rules necessary for compatibility had greater priority and that changes as a result of the reorgani::ation of the DHHS have caused them to take a

" waiting" approach in the area of enforcement. This recommendation is closed and is evaluated further in Section 3.4 under the indicator " Technical Quality of Inspections."

(4) Inspection Precedures.

(a) Although exit interviews are not covered in the procedures, the 1994 review team determined that materials inspectors were attempting to hold exit meetings at the conclusion of an inspection with the highest level of licensee management available. The 1994 review team also determined, through interviews with the

inspectors, that oral debriefings are held informally with the section supervisor

after the inspector retums from an inspection. It was recommended that BRH update the general procedures in the compliance manual to include such issues as exit meetings and oral debriefings with the inspection supervisor following non-routine inspections. It was also recommended that BRH review and update, L as necessary, the compliance manual chapters for each major category of

, licensee to conform to the New Hampshire regulations.

Current Status: The BRH revised its procedures to include exit meetings and debriefings with the section supervisor after inspections, in addition, the compliance -

manual chapter was revised to ccnform with State regulations. This recommendation is 4 closed.

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New Hampshire Proposed Final Report _' Page 4' (b). The review team found that several different versions of inspection forms (field

' notes) had been used over the review period t. Although different inspection - a

- forms are appropriately used for different types of licensees, BRH also had several different sets of inspection forms for the same or similar type licensees, it was recommended that BRH review, update, and standardize the inspection forms used for different categories of licensees.

Current Status: This recommendation was not adopted by BRH. BRH Indicated that because the rule update process is currently underway, it would not be feasible to revise inspection forms until the rulemaking process is completed; otherwise, revisions would be based upon draft regulations. However, BRH stated that it is currently using NRC inspection forms as references to supplement its current inspection forms. Moreover, .

during this review, the review team found that the inspection forms provided good, consistent documentation of inspection findings. 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 Action; (4) Technical Quality of Inspections; and (5) Response to incidents and Allegations.

3.1 Status of Materials inspection Program

. The review team focused on four factors in reviewing this indicator: (1) inspection frequency, (2) overdue inspections, (3) initial inspection of new licenses, and (4) timely dispatch of inspection findings to licensees. The review team evaluation is based on the New Hampshire questionnaire responses'regarding this indicator, data gathered independently from the State's licensing and inspection data tracking system, the examination of licensing and inspection

< casework files, and interviews with the Radioactive Material Section (RMS) Supervisor and staff. .

The State revised its inspection priority system in May 1997 to closely match the NRC system.

Prior to that time there were several priority categories which the State inspected more frequently than NRC. The review team's assessment of the current inspection priorities verified that inspection frequencies for various types or groups of licenses are essentially identical to those listed in the NRC Inspection Manual Chapter 2800 (IMC 2800) frequency schedule.i ln

' . reviewing the State's priority schedule, the review team noted that BRH continues to have

- priority categories which are inspected more frequently than those of the NRC. The teletherapy

- category licensees are scheduled to be inspected on a two year frequency while the NRC inspects these licensees at a three year frequency. In addition, all licenses listed as NRC prionty seven are inspected on a five year frequency.

The inspection frequencies of licenses selected for technical quality of inspection review were compared with the frequencies of the State's priority system and verified to be consistent and as frequent as similar license types under the IMC 2800 system.

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I New Hampshire Proposed Final Report Page 5'-

in their response to the questionnaire, New Hampshire indicated that as of August 19,1997, eight licenses identified as core inspections in IMC 2800 were overdue by more than 25 percent of the NRC's frequency. The review tesm identified 24 overdue core material licenses from the BRH database. Thus,33 percent (8 out of 24) of the core licenses are inspected at intervals that exceed the State's and the NRC inspection frequencies by more than 25 percent, which is unsatisfactory based on the criteria in Management Directive 5.6. For the eight overdue core inspections reported in the questionnaire, the RMS Supervisor discussed a proposed schedule to complete inspections at each facility. The' overdue inspections were late by periods of time  ;

ranging from two to six months. .

During the review period, BRH conducted 22 inspections. The team reviewed the RMS, " Goals and Objectives," which was revised July 7,1997 and is used by staff to assist in implementation of program management. The review team noted that the program objective to perform four inspections per month beginning late 1996 (identified as a priority 1 goal) was not met.

For inspection planning, ti s RMS Supervisor reviews and updates inspection data for new and existing licenses every two to three months. During interviews with the review team, the RMS Supervisor explained that a list of initial and routine inspections coming due is generated and offered for sign-up to inspection staff, in lienf making specific inspection assignments, the

. review team found that inspection staff are expected to initiate selection of inspections from the F updated list when made available by the RMS Supervisor. A review of the updated Inspection due list indicated that 23 inspections were due and not scheduled, with 20 unassigned and three assigned to staff. The review team recommends that core and non-core licensees be scheduled, assigned, and inspected at regular intervals in accordance with the State's established inspection priority system. >

With respect to initial inspections of new licenses, the team reviewed the inspection tracking system and found that initial inspections were usually entered into the system together with existing licenses. The review team found that inspection staff was generally able to identify ,

licenses due for initial inspection.

BRH currently has a six month inspection frequency for all initial inspections, which is a change from its previous inspection policy. During the 1994 review, it was recommended that BRH

. revise its inspection priorities for initial inspections of new licenses to be no less frequent than the NRC's, which is within six months of issuance or receipt of matenal in response to this recommendation, BRH indicated that it had always performed initial inspections of new licensees for priorities 1 and 2 at six months and 12 months for other priorities. The 12 month

_initialinspection exceeded the NRC recommended frequency of six months. BRH stated that its rationale for the longer period was that initial inspections should be reflective of complexity / hazard of licensee use and should not merely be assigned to conform with NRC and

all of its new licenses were hand delivered.' The New Hampshire rationale to extend the interval of time for initial inspections of priority 3 and other lower priority licensees was considered

= acceptable during the 1994 MRB review of the pilot Integrated Materials Performance Evaluation Program and this recommendation was closed. However, BRH changed the 12

- months initial inspection frequency policy to within six months of issuance for all initial inspections.

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. From the review of the inspection database,' BRH was not consisteutly implementing its. revised six month initial inspection policy. The database list of 10 new licenses issued during the =

. review period showed that initial inspections wete conducted within six months for two of the licenses, one veterinarian clinic (priority 3) and a portable gauge (priority 5). Initial inspection was performed for three other new linenset at intervals of 11 months _(portable gauge, priority 5),10 months (portable gauge, priority 5), and 12 months (portable gauge, priority 5) after license issuance or material receipt.- Of the remaining five new licenses, one license did not require an initial inspection because it was equivalent to a NRC general license; one medical 2 . license (NH-402R-American Health Centers Mobile Van Service, priority 2) issued on .

November 1,1996 had not received material and did not require an initial inspection, and three

. licenses needed initial inspections and had not received them. These licenses included the following: two issued in January 1997 (NH-417R-Geotechnical Services, Inc., portable gauge,

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priority 5, and research and development (NH-418R Metabol'c Solutions, in vitro kits, priority 5)),'and one in April 1997 (NH-419R Construction Materials Testing, portable gauge, priority 5). ,

The review team considered recommending that initial lospections of licensees be performed within six months of license issuance or within six months of the licensee's receipt of material  ;

and commencement of operations,- consistent with IMC 2800. The review team did not provide a recommendation based upon the previous decision by the MRB. However, the review team suggests that the State clearly establish its policy for initial inspection of priority 3 and above ,

licenses, (6 months or 12 months),'and adhere to the established pc! icy.

The timeliness of the issuance of inspection findings was also evaluated during the inspection

- file review. Of the 12 files examined, the correspondence for eight inspections was sent to the licensee within 30 days of the inspection date. These inspections were clear, with no deviations or violations of license requirements. Correspondence for the other inspections was sent to the licensee more than 30 days past the inspection date, in these cases varying levels of enforcement actions were identified, leading to longer evaluations of inspection results by staff.

Three letters containing notices of viol:. tion were transmitted within two months of the

, inspection date. A team inspection of one of New Hampshire's major licensees identified

- significant deficiencies in the program operations. The State verbally communicated with the licensee to resolve deficiencies, but the final report dispatch occurred approximately 10 months after the inspection was performed. The review team recommends that the State review and revise its inspection report preparation process for those containing enforcement actions to ensure timely issuance of inspection findings.

New Hampshire reported in their response to the questionnaire that 41 material licensees had submitted requests for reciprocity during the review period. These 41 material licensees included nine industrial radiography,23 portable gauges, five service, one gas chromatography, and three lixiscopes. These licensees made a total of 307 reciprocity requests. Of the 307 .

, reciprocity requests,- 143 were portable gauges and 127 were industrial radiography. Of the

. nine industrial radiography licensees, the State performed three inspections. This effort is below the IMC 1220 guidance to inspect 50 percent of the priority 1 reciprocity licensees. The .

-. review team suggests that the State increase reciprocity inspections to meet the inspection L goals established in IMC 1220.-

p l' - In letter dated October 23,1997 from Mr. Jeffrey E. Schaub, Director, Office of Health  :

Management, Department of Health and Human Services, in response to the draft report, I

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New Hampshire Proposed Final Report . Page 7--

additional information was provided under this indicator. The letter indicated that six of the.-

eight core inspections, which were overdue at the time of review, have been conducted. In .

addition, it was indicated that ties two remaining inspections are to be completed within three .

weeks of the date of the letter.- With the completion of the six inspections, eight percent (2 out. .

F of 24) of the State's core materials inspection would exceed the State's and the NRC's inspection frequency, which is satisfactory based on the criteria in Management Directive 5.6.-

In the draft report, the review team initially n commended that New Hampshire's performance with respect to the indicator, Status of Materials inspection Program, be found unsatisfactory.

However, based on the actions taken by the State subsequent to the review and the IMPEP evaluation criteria, the review team recommends that New Hampshire's performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory with -

recommendation for improvement since the State is still in the process of addressing the team's recommendation with regard to timely issuance of inspection findir,gs.

3.2 Technical staffina and Trainino 4 - lasues central to the evaluation of this indicator include the radiozetive materials program staffing level, technical qualifications of the staff, training, and staff tumover. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed selected BRH managers and staff, and considered any possible workload backlogs.

The New Hampshire organization chart shows that, at the time of the review, BRH was funded for 17 persons or 15.26 FTE's based on 1800 hrs / year /FTE. BRH consists of five sections with

, approximately 2 FTE's in Radon,2.5 FTE's in Emergency Response,2 FTE's in Radiochemistry, 3 FTE's in Radiation Machines and 3 FTE's in RMS. The remainder of the i FTE's are devoted to clerical and general administrative tasks. An FTE for the BRH is considered to be 37.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> per week. The RMS Supervisor and five staff members devote 3.0 L FTE effort to the agreement materials program which includes material licensing, inspection

! event response, and laboratory activities. These staff members also have additional responsibilities in the Radiation Machine Section and to a lessor degree in the other sections.

j in comparison to other Agreement States, it appears there are a sufficient number of FTE's i allocated to the agreement materials program to assure public health and safety. There has been no tumover since the last review and all of the staff have a wide iange of heensing and inspection experience. There are a number of overdue core Scense inspections and a licensing backlog that may be partially due to the difficulty in balancing personnel between the RMS and the radiation machine section since personnel are rotated between the two sections on a .

monthly basis, without regard to whether inefficiencies result from disruption of licensing and inspection casework in progress. At the time of the review, there were 98 pending licensing

_ actions, 8 administrative renewals (fee collection),60 amendments,5 new license applications and 25 renewals.~ Sixty-nine of these actions were overdue by over 1 year. As noted in Section

- 3.1, at the time of the review. 33% of the core inspections were overdue and only 22 inspections had been performed in the last three years. In light of the current backlogs in the

- inspection and licensing proqrams, the review team recommends that the State evaluate the effectiveness of rotating staff on a monthly basis and the necessary number of staff to implement the program.

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4 New Hampshire Proposed Final Report - Page 8 BRH has established qualifications for its tecimal classifications, including Health Physicist 1 )

(HP1) and He ith Physicist 2 (HP2). The Supervisor position is an HP2 with the remaining staff i HP1's.' Applicants at the entry level, HP1, are required to have a baccalaureate degree in a l physical or life science. BRH does not have a formal documented qualification and training l program for the materials staff. However, staff are assigned increasingly complex licensing and u inspection duties under the direction of the RMS Supervisor. Staff are required to demonstrate {

competence curing review and accompaniments by the Supervisor. This information was verified brough discussions with managers and staff. All of the BRH staff have attended NRC courses that include, licensing and inspection procedures, five week applied health physics, industrial radiography and medical uses, as well as courses in emergency response and 4

portable gauges. The review team determined that all staff utilized for the agreement materials program were technically qualified by evidence of their training and experience. However, the ,

State would benefit from a training and qualifications plan in the event of staff tumover. The i review team suggests that the State develop a written training and qualifications plan.

Based on the training that program personnel have received, the State appears supportive of

. continued staff training, and management demonstrated a commitment to staff training during

, , the review, However, the State has concems as to the impact of NRC's change in policy for

funding State training and is looking it'to other training options.

I Based on the IMPEP evaluation criteria, the review team recommends that New Hampshire's performance with resoect to the indicator, Technical Staffing and Training, be found

satisfactory.

! 3.3 Technical Ondtv of Licensina Actions F

The review team examined completed lice.ises and casework for 13 license actions in 13 specific license files, representing the work of five license reviewers. The license reviewers and RMS Supervisor were interviewed when needed to supply additional information regarding f licensing decisions or file contents.

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! Licensing actions were reviewed for completeness, consistency, proper radioisotopes and quantities authorized, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions.

Licenses were reviewed for accuracy, appropriateness of the license and for its conditions and

%-down conditions, and overall technical quality. Casework was reviewed for timeliness, adherence to good health physics practices, reference to appropriate regulations, L documentation of safety evaluation reports, product certifications or other supporting F documents, consideration of enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authorities. The files were checked for retention of necessary documents and supporting data.

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

.w chi h had been completed in the review period and to include work by all reviewers. The sampling included three of the State's major licenses and included the following types:

research and development; manufacturing and distribution; industrial radiography; nuclear medicine; mobile nuclear medicine; academic; portable gauges; and "in vitro" laboratory.

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New Hampshire Proposed Fir.al Report Page 9 ,

l Licensing actions reviewed included 3 new,2 renewals,- 7 amendments and 1 termination. in

- discussions with BRH management, it was noted that there were no major decommissioning ,

efforts underway with regard to agreement material in New Hampshire. 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 13 licenses with case specific comments can be found in Appendix D.

The review team found that the licensing actions were very thorough, complete, consistent, of high quality, and with health and safety issues properly addressed. The licensee's compliance history appeared to be taken into account when reviewing renewal applications as determined from documentation in the license files and/or discussions with the license reviewers. No exemptions were issued by BRH during this review period.

The review team found that terminated licensing actions were well documented, showing ,

appropriate transfer records and survey records. A review of the licensing actions over the period showed that almost all terminations were for licensees possessing sealed sources, These fi% ebowed that documentation of proper disposal or transfer was available, Licenses were renewed on a five year frequency. The State is extending the renewal period for certain licensees on a case-by case basis. Licenses that are under timely renewal are amended as necessary to assure that public health and safety issues are addressed during the period that the license is undergoing the renewal process. Each licensing action receives supervisory chain raview.

The review team found that the current staff is well trained and experienced in a broad range of licensing activities. The casework was reviewed for adequacy and consistency with the New Hampshire procedures. The casework review also indicated that the BRH staff follow their licensing guides during the review process to ensure that licensees submit the information necessary to support the license. The licensing guides were very similar to the NRC guides.

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

3.4 Technical Quality of Inspections The team reviewed the inspection reports, enforcement documentation, and the data base Information for 12 materials inspections conducted during the review period. The casework included the State's three materials inspectors and covered a sampling of different license types as follows: one broad academic; one veterinary clinic; one research and development facility; six portable gauges; nuclear medicine private practice; and two hospitals. Appendix E provides a list of the inspection cases reviewed in-depth with case-specific comments.

- The inspection procedures and techniques utilized by New Hampshire were reviewed and determined to be generally consistent with the inspection guidance provided in IMC 2800. The team reviewed inspection reports and found them to be comparable with the types of t

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New Hampshire Proposed Final Report Page 10 l ~ information and data collected under NRC Inspection Procedure 87100 and New Hampshire >

- proceduresJ Inspections were performed on an unannounced basis. -

The inspection field notes provided good, consistent documentation of inspection findings. _The State uses separate field notes for different types of inspections covering the areas of industrial /research development, industrial radiography, commercial irradiator (draft), medical broad-scope, portable gauges, and medical and teletherapy licenses.

Inspection reports were reviewed to determine if the reports adequately documented the scope of the licensed program, licensee organ!zation, personnel protection, posting and labeling, control of materials, equipment, use of materia 8 transfer, and disposal. The reports were also checked to determine if the reports adequately ocumented operations observed, interview of workers, independent measurements, status of previous noncompliance items, substantiation of all items of noncompliance, and the substance of discussions during exit interviews with management. To assure consistency and quaRy of reports, the RMS Supervisor provided thorough review and comment, and signed all inspection correspondence and field notes.

Overall, the reviaw team found that the inspection reports showed excellent quality and i- attention to detail. From review of casework, reports contained only minor discrepancies from standard practices or established BRH guidance.

Routine enforcement letters were drafted by inspectors and were issued to licensees by the i RMS Supervisor. When the licensee responds to a notice of violation (NOV), the response is

given to the inspector to evaluate the licensee's response, and to draft a reply for the RMS Supervisor's signature. The review team noted a good practice in that the State uses a violation response review checklist to document staff reviews of the licensee response to each

NOV. The review team also identified a concem related to State follow-up of licensee responses to NOVs. During review of two inspection files which resulted in significant problems with the licensee's program, it was noted that a staff follow-up inspection was not conducted to confirm that the commitments made in the licensee's correspondence were implemented. The e

review team recommends that appropriate State follow-up inspection be conducted to confirm implementation of licensee conective actions when significant problems have been identified.

I For the casework reviewed, documented inspection findings led to proper regulatory actions ,

l and appropriate enforcement. The RMS Supervisor stated that inspection results showed a licensee compliance was acceptable during the review period and that escalated enforcement beyond issued NOVs was limited. A finding from the previous NRC review recommended the

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State include rules for enforcement procedures with provisions for severity levels and civil

, penalties. In their response to that recommendation, New Hampshire committed to revising the rules after July 1995. In evaluating the State's response to the NRC recommendation, the review team found that the rules in question were not adopted and the manual which describes the program for determining enforcement actions was not revised. The State indicated because of higher priorities and the reorganization of the DHHS, they took a " waiting" approach in the

area of enforcement. The State continued to base their enforcement program primarily upon

onsite inspections and NOVs. If escalated enforcement is necessary, the State DHHS has authority to issue ordersi The review team suggests that the State reconsiders revising its regu'ations and enforcement procedures to include provisions for severity levels and civil penalties.

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New Hampshire Proposed Final Report Page 11- j Tw9 inspector accompaniments identified in Appendix E were performed by a review team memoor on Ju!y 10,- 1997 (self shielded irradiator) and July 24,1997 (hospital-nuclear medicine program)< Of the remaining two inspectors, one was accompanied during previous assessments and the other was not yet performing independent inspections of high priority licensaes. During the accompaniments, inspectors demonstrated appropriate inspection skills and knowledge of the regulations. The inspectors were well prepared and thorough in the :

review of licensee radiation safety programs. Inspection techniques were observed to be -

. performance oriented, and the technical performance of the inspectors was at a high level. The 1 inspections were adequate to assess radiological health and safety at the licensed facilities, i

New Hampshire has a policy of performing annual supervisory accompaniments of inspectors, in response to the quesil0ralaire, the State reported that supervisory inspector accompaniments wei not performed during the review period.' Instead, the RMS Supervisor explaineo that senior stsff reviewed inspector methods during team inspections, inspectorb

~ debriefed with supervisory staff upon return to the office, ar.d inspection reports received close supervisory review. Since supervisory accompaniments provide program management a better i understanding of both the inspectors' abilities and compete 1ce to perform in the field, the review team suggests that the State adhere to the policy of annual supervisory accompaniments of allinspectors.

The review team noted that New Hampshire has an ample number of portable radiation detection instruments for use during routine inspections and response to incidents and emergencies. For large licensed programs, a laboratory specialist assists inspectors by taking confirmatory measurements and samples. The State uses an outsioe vendor for instrument service and calibration. The portable instruments used during the inspector accompaniments were observed to be operational and calibrated. The instrument storage area is co-located with the radiation counting laboratory and storage area for emergency response kits. A sampling of portable instruments maintained at each location were available and found to be within calibration, e

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

3.5 Roanonse, to incidents and Allean%ns in evaluating the effectiveness of the State's actions in responding to incidents and allegations, the review team examined the State's response to the questionnaire regarding this indicator,  :

4 reviewed the incidents reported for New Hampshire in the " Nuclear Material Events Database" (NMED) against those contained in the New Hampshire files, and reviewed the casework and supporting documentation for 14 material incidents and six allegations.

l The 14 incidents selected for review included two misadministrations, one lost source, seven L_ contamination events, three reported loss of control of radioactive material, and one non-routine L . event and are listed in Appendix F. Of the six allegations reviewed, NRC Region I office i, referred two to the State and the otner four came directly to the State from allegers.

, . ,, ,, -. - - , ~ - - , , -. < . . . --. .. - ~.

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i a r New Hampshire Proposed Final Report Page 12 ,

- Responsibility for initial response and follow-up actions to material incidents and allegations rests with the BRH staff. When the BRH is notified of an incident during working hours, time  ;

permitting, a staff meethg is held to discuss the approach to be taken regarding the incident.

For incidents during non-work hours, each staff member has a copy of the "DHHS Initiator '

- Handbook." The Handbook is designed to be used for response to incidents involving radioactive materials and nuclear reactors. The radioactive materials section of the Handbook -

is sufficient to provide guidance for responding to incidents involving radioactive materials, -

including transportation inciderts. Copies of the Handt;ook and current calllists, which include:  ;

beeper numbers, are distributed periodically to all appropriate persons or agencies. The State provides a 24-hour emergency number for anyone to use to report emergencies involving hazardous materials. When a radiological incident is suspected, BRH staff is contacted. >

The review of incident casework, licensing casework, and interviews with staff revealed that '

incidents are promptly evaluated for the need for on-site investigations. For those incidents not requiring on-site investigations, copies of letters to licenseet were in the licensing files indicating that the incident would be investigated during the next scheduled inspection, in responding to incidents and allegations, BRH had taken prompt, appropriate action. The review of casework indicated that incident reports were thorough and well-documented. The incident reports were reviewed and signed by the section supervisor.

The review team also found good correlation of the State's response to the questionnaire, the L incident Information in the casework, and the incident information reported on the NMED system printout for New Hampshire. For discrepancies that did exist between the NMED .

Information and the State casework, satisfactory explanations for the discrepancies were available. The reviewer obtained a May C,1997, "All Events - On line Report," of the incidents sent to Idaho National Environmental Engineering Laboratory (INEEL) for inclusion in the NMED system. The Report indicated that 21 incidents had been reported to NMED; however, '

the NMED file only included 11 of these incidents. The 10 incidents were not included for the following reasons. Although a New Hampshire licensee was involved, two incidents occurred in another State (Massachusetts) and would be listed under that State. Three incidents did not include radioactive material, and one involved non-Atomic Energy Act material. Two incidents were considered information and not reportable events, and one event involved a reactor. In b - addition, one incident was received by INEEL and should have been a part of the system but the contractor misunderstood the data. ,

The State has implemented an excellent tracking system for incident files. Wrthin the past few months the State obtained access to the Intemet system and is able to promptly submit information to the NMED system.' The State is also updating its entries into the NMED system

- by submitting data on incidents that occurred in 1995 and 1996 that were not previously reported to the NRC.1The New Hampshire incident tracking system is able to manipulate data

in a number of ways for regulatory use. For example, the State can retrieve data based upon

_ license number, dates of occurrence, or the county in which the event occurred.

l- Based on the IMPEP evaluation criteria, the review team recommends that New Hampshire's j

performance with respect to the indicator, Response to incidents and Allegations, be found

!_  : satisfactory.

1:

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

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. New Hampshire Proposed Final Report - Page 13 -

4.0 ' NON-COMMON PERFORMANCE INDICATORS -

IMPEP identifies four non-common performance indicators to be used h reviewing Agreement State programs: (1) Legislation and Regulations; (2) Sealed Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery 1 -

- Program. New Hampshire's agreement does not oover uranium recovery operations,'so only j the first three non-common performance indicators were applicable to this review. I 4.1 Legislation and Regulations i 4.1.1 Legislative and Legal Authority The Department of Health and Human Services is authorized as the State radiation control agency under New Hampshire Revised Statutes Annotated (RSA) 1990, Chapter 125.

RSA 125-F:1 to F:25 covers radioactive material, RSA 125:77-b covers radioactive waste, and RSA 125-B covers emergency response. The radiation control program is administered by the BRH. No changes have occurred in the legal authority of the BRH since the previous review. ,

As noted earlier in the report under Section 2, " Status of items identified in Previous Reviews," ,

a legislative amendment was made to the New Hampshire Administrative Procedure Act in August 1995 to exempt BRH regulations from the formatting requirements of RSA 541 A:3 of the State's administrative rulemaking system.

4.1.2 Status and Comentibility f Regulations The "New Hampshire Rules for Control of Radiation," apply to all ionizing radiation, whether emitted from radionuclides or devices.

'. The review team discussed the procedures used in the State's regulatory process with the BRH Administration and found that New Hampshire offers the public the opportunity to ecmment on proposed regulations and participate in public hearings following the comment period.

Procedures also require the proposed regulations, proposed hearing date, hearing comments and analysis be well publicized. Draft copies of the proposed regulations are provided to NRC during the rule development process. Final regulations are subject to a " Sunset" law and rules

expire exactly six years after promulgation for rules adopted prior to August 1994, and after

- eight years for rules adopted after August 1994. After expiration, these regulations must be resubmitted in their entirety to remain in effect.-

The review team evaluated New Hampshire's responses to the questionnaire, NRC correspondence pertaining to the review of New Hampshire's regulations subsequent to the August 1994 review and discussed the State's regulations or other legally binding requirements

, ' with the BRH Administrator and the RMS Supervisor to determine the status of the New i

Hampshire program with regard to the implementation of regulatery requirements needed to

' maintain compatibility through December 1997.

1

' The State adopted two NRC regulation amendn ents since the 1994 review and are -

implementing five other NRC rules by other legally binding means or they are not currently .

s applicable to the New Hampshire program:

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. New Hampshire Proposed Final' Report Page 14 l ,

e " Standards for Protection Against Radiation," 10 CFR Part 20 amendment (56 FR

.. 61352) was needed by January 1,1994. As noted earlier in the report, this r6gulation was adopted by the State in February 1995, and was rev'Rved , by the NRC for -

compatibility and health and safety. This revie.v was in accordance with the new Policy Statement on Adequacy and Compatibility of Agreement State Programs approved by.

the Commission by Staff Requirements Memorandum (sRM) dated June 30,1997, j Based upon this review, two comments with compatibility significance were provided to >

the State in letter dated August 18,1997. ,ne review team notes that NRC staff is -

currently reviewing all Agreement State equivalent regulations to Part 20, Standards for _

Protection Agrdnst Radiation. The reviews are being conducted outside th' lMPEP

- process.

e " Notification of Incidents," was adopted in Fubruary 1995 for Parts equivalent ta 10 CFR l

Parts 20, 31,40 and 70, and the equivalents of F' arts 30, 34, and 39 are scheduled for

! - adoption in December 1997. These requirements were reviewed by the NRC as a part of the overall revision of the New Ham.oshire Rules for the Control of Radiation which were published in 1995. In letter dated January 3,1997, these regulations were found to meet the compatibility requirements, at that time. In accordance with the new Policy

. Statement on Adequacy and Competit ility of Agreement State Programs, the review l team's evaluation found these regulations would continue to be compatible.

4

. e- " Emergency Planning Rule," 10 CFR Parts 30,40, and 70, which was needed by April 7,1993. As noted earlier, currently the State has no licensee to which this rule is applicable. However, the State has indicated that the requirements of this rule will be

i. used in the review process for new license applications for facilities that should be

,' subject to these requirements. This rule is a part of the rulemaking package which is i - scheduled for adoption by December 1997.

o " Safety Requirements for Radiographic Equipment," which was needed by -

January 10,1994. The review team verified that these requirements are being

• incorporated by industrial radiography license conditions. This rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

1 e " Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 amendment (58 FR 7715) which became effective on July 1,1993 and was due by July 1,1996. The State currently has no licensee to which this rt.le is applicable.

However, the State has indicated that the requirements of this rule will be used in the

, review process for new irradiator license applications, if any are received.

o " Decommissioning Recordkeeping and Documentation Additions",10 CFR Parts 30,40 and 70 amendments (58 FR 39628) which became effective on October 25,1993 and

~ were due by October 25,1996. The State adopted a portion of this regulation in 1993.

. However, the State has indicated that the requirements of this rule are being used in the review process for licenses. -The remaining portion of this rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

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New Hampshire Proposed Final Report . Page 15 . , ,

'e  ; "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 was due by January 28,1997. Note, this rule was designated as a Division 2 - l

, matter of competitdlityc Division 2 compatibility allows the Agreernent States flexibility to be mera stringent (i.e., the State could choose not to adopt self-guarantee as a method '

' of financial assurancc). If a State chooses not to adopt this regulation, the State's

. regulation, however, must contain provisions for financial assurance that include at least s subbet of those provided in NRC's regulations; e.g., prepayment, surety method (letter of credit cr line of credit), insurance or other guarantee method (e.g., a parent company guarantee). This rule has been redesignated as Category D under the Commission's

- new adequacy and compatibility policy; however, NRC is currently proposing to redesignats it as Categroy D-H&S. [For category D-H&S regulations, States should adopt the essential objectives of the rule in order to maintain an adequate program.)

• The State currently has no licensee to which this rule is applicable, However, the State has indicated that the requirements of this rule are being used in the review process for new license applicctions. This rule is a part of the rulemaking package which is .

scheduled for adoption by December 1997. >

e " 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 was due by August 15,1997. The State currently has no licensee to which this rule is applicable.

However, the Siate has indicated that the requirements of this rule are being incorporated as conditions in licenses issued before rule promulgation. This rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

e " Quality Management Program and Misadministration," 10 CFR Part 35 amendment (56 FR 34104) which became effective on January 27,1992 and was due by January 27, 1995. BRH has not adopted the equivalent to the quality management and 2

misadministration rule. As reported to NRC previously, BRH withheld adoption of this rule pending NRC's revision to 10 CFR Part 35. The NRC is continuing to defer compatibility findings for Agreement States ths Save not yet adopted a compatible Quality Management rule until NRC issues a re, ed 10 CFR Part 35 rule. When the

- revision of 10 CFR Part 35 is completed, compatiteility designations for the new rule will

- be established, and an effective date for Agreement State implementation will be set.

The following rules were not due during the review period but are in the rulemaking process to be adopted by December 1997:

^

• " Preparation, Transfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30, 32 and 35 amendments (53 FR 61767, 59 FR 65243,60 FR 322) that became effective on January 1,1995 and will become

- due on January 1,1998.

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

61 amendments (60 FR 15649,60 FR 25983) that will become effective March 1,1998.

Agreement States are expected to have an offective rule on the same date.

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

New Hampshire Proposed Final Repo.1 Page 16 r e " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 _ _

CFR Part 20 amendments (60 FR 7900) that became effective on March 13,1995, and will become due on March 13,1998. Note, this rule was 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). This rule has been redesignated as Category D-H&S under the -

- Commission's new adequacy and compatibility policy.- [For category D-H&S regulations, States should adopt the essential objectives of the rule in order to maintain an adequate program.)

-o- " Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendments (60 FR 28323) that became effective on June 30,1995, and will become due on June 30,1998.

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

become due on August 14,1998, t

o " Medical Administration of Radiation and Radioactive Materials," 10 CFR Part 20.35 j amendment (60 FR 48623) that became effective on October 20,1995 and 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 wili Decome due on November 24,1998.

While no rulemaking action has been initiated, at the time of the review the following items are on the BRH's regulatory agenda:

e " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71

, amendment (60 FR 50248) that became effective April 1,1996 and will become due on April 1,1999. The State plans to adopt this rule in 1999.

2 e  ? Termination or Transfer of Licensed Activities: Record Keeping Requirements,"

10 CFR Parts 20,30,40,61,70 (61 FR 24669) that became effective on May 16,1996.

F This requirement need not be in effect until May 16,1999. The State plans to adopt this rule in 1999.

r

, e' ' Resolution of Dual Regulation of Airbome Effluents of Radioactive Materials; Clean Air

< Act,* 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,' 1997

- and will become due January 9, 2000. , The State plans to adopt this rule in 1999.

• "Racognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became -

effective on January 13,1997 and will become due January 13,2000. The State plans g to adopt this ruleiri the year 2000.

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

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

New' Hampshire Proposed Final Report Page 17

• . " Criteria for the Reisase of Individuals Administered Radioactive Material," 10 CFR Part

~ 20.35 amendment (62 FR 4120) that became effective on January 29,1997 and will i become due January 29,2000. The State plans to adopt this rule in the year 2000, j m ' Based on the IMPEP evaluation criteria, the review team recommends that New Hampshire's i performance with respect to the indicator, Legislation and Regulations, be found satisfactory. J 4.2 Sealed Source and Device Evaluation Program  ;

- The review team did not evaluate the State's sealed source and device (SS&D) program during this review. Although New Hampshire currently has responsibility for this area, the State did not perform any SS&D evaluations during the period of the review.' The reviaw team verified this information by review of the national SS&D registry and confirmed that the State had not issued

- any SS&D sheets during the review period.

.'4.3 Low-Level Radioactive Waste Disposal Program 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" t-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 Hampshire has LLRW disposal authority, NRC has not required States to have a program for licensing a LLRW

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

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's performance with respect to each of the common performance indicators and the non-common indicators, to be satisfactory with recommendations for improvement for indicators, Technical Staffing and Training, Technical Quality of Licensing Actions, Technical Quality of Inspections, Response to incidents and Allegations, and Legislation and Regulations. The review team found the State's performance to be satisfactory with recommendations for improvement for the indicator, Status

' of Materials inspection Program. Accordingly, the review team recommends that the MRB find

the New Hampshire program to be adequate to protect public health and safety, and compatible with NRC's program.

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

4

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INew Hampshire Proposed Final Report.' Page 18 Recommendations:

1. . The review team recommends that core and non-core licensees be scheduled, assigned, and inspected at regular intervals in accordance with the State's established inspection priority system. (Section 3.1)

2. ' The review team recommends that the State review and revise its inspection report preparation process for those containing enforcement actions to ensure timeiy issuance of inspection findings. (Section 3.1)

3. The review team recommends that'the State evaluate the effectiveness of rotating staff. 1 on a monthly basis and the necessary number of staff to implement the program.

- (Section 3.2)

4. The review team recommends that appropriate State follow up to inspections be conducted to confirm implementation of licensee corrective actions when.significant problems have been identified. (Section 3.4) ,

1 Suggestions:

.1. The review team suggests that the State clearly establish its policy for initial inspection of priority 3 and above licenses, (6 months or 12 months), and adhere to the established 4 policy. (Section 3.1)

2. The review team suggssts that the State increase reciprocity inspections to meet the inspection goals established in IMC 1220. (Section 3.1)

3. The review team suggests that the State develop a written training and qualificaticas plan. (Section 3.2)

4. The review team suggests that the State reconsiders revising its regulations and enforcement proce'dures to include provisions for severity levels and civil penalties. ,

-(Section 3.4) i 5. The review team suggests that the State adhere to the policy of annual supervisory accompaniments of allinspectors. (Section 3.4)L 4

Good Practice:

The State uses a violation response review checklist to document staff reviews of how the - '

licensee addresses their response to each NOV. (Section 3.4)

~

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LIST OF APPENDICES l

Appendix A' IMPEP Review Team Members  !

Appendix B New Hampshire Organization Charts j Appendix C New Hampshire's Questionnaire Response 1

Appendix D License File Reviews Appendix E Inspection File Reviews Appendix F Incident File Reviews -

- Attachment i New Hampshire's Response to Draft Report l

APPENDIX A iMPEP REVIEW TEAM MEMBERS J

Name - Area of Responsibility Cardelia H. Maupin, NRC/OSP Team Leader

. Response to incidents and Allegations Legislation and Regulations Craig Gordon, NRC/RI Status ofInspection Program Technical Quality of Inspections William Passetti, FL Technical Staffing and Training Technical Quality of Licensing Actions e

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Approved by OMB i' No. 3150 0183

. Expires 4/30/98 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 00ESTIONRAIRE Name of State: New Hampshire Reporting Period: August 19, 1994 to August 19,1997 (General conment: We are curious as to the rationale for this program review taking place after only three years of the previous review, whereas at least one of other states that participated in the original " pilot" JWEP is scheduled to be reviend in 1999, five years from their last review.)

A. COMMON PERFORMANCE INDICATORS .

I. Status of Materials Insoection Proaram

1. Please prepare a 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). The list should include initial inspections that are overdue.

ResDonse to item 1.

(Cenment: We have been under the apparently incorrect understanding that the criteria was 50% of the scheduled frequency)

• (Note: the figure w have used in 'Nonth O/D" is months overdue past the date at 25% greater than scheduled due date. Therefore, 5 years + 15 months: 3 years + 9 months: 2 years + 6 months: 1 year + 3 months. Dates are as of August 1,1997.)

The table identifying New Hanpshire licenses witn inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspectton Manual Chapter 2800 appears on the next page.

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

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\ The plan of actton has already been incorporated into the l Radioactive Materials Section's Gotis and Objectives, January 1997 >

(and as revised July 1997), Of the several initiatives taken, the l hesith physics staff has been directed to comlete a mininun of four inspections a month, untti 2005 comletion of overdue i inspections has been achieved, at which time, w will reduce our schedule to a three inspecttons per month anintenance schedule. i (The three per month schedule will cover one priority 1 or 3  :

licensee, one priority 5 licensee, and one reciprocity licensee.)

As for the currently overdue inspecttons spec 1fically identified '

on the above list, the following is offered: although it has been recognized for several months that the th11versity of New Hamshire (LMH) (Acadenic w broadscope) is overdue for inspection, when i plans came to coordinate an inspection, it ws close to swmer l break. As stated in the last inspectton report inspection of i Itcensed activities at WH should not be taken.during the swmer.

.With as few as 30 principal investigators, mos't of them taking the swmer months off, it is a less than ideal situation to carry 1

. out an inspection during the sw mer: it w uld in no way provide an accurate representation of the scope of activities being carried out nor of its radiation protection program. It is likely that that Parkland Hospital, will be inspected prior to NRC's arrival and that Portsmouth

• Regional Hospital and Southern NH Regional Hospital will be inspected the wek following NRC's visit . Lakes Region Hospital, St. Joseph Hospital, Venegas* calibration facility and Radiation Safety and Control Services will be inspected in by the end of October 1997. (NOTE: Venegas' currently provides survey instranent calibration services to only .

t w customers, Process Engineering, Inc. (radiography with sources) and Hitchner Manufacturing (shleided room x ray radiography). A discussion of licensed activities took place over -

the telephone on August 6,1997, with Nanuel Venegas, and a copy i of current leak tests and customer reports wre faxed to the Bureau on that day.)

in order to address the broader issue of ensuring that future inspections of licensees are conducted in a timely manner and as per the inspection Schedule, severs 1 initiatives are underway.

These include imlenenting imrovanents to be more e,ffective in 3

.ew -e. , . ww d , y--r . . . . . , , _ , . ~ , - . . . , , ,.ee ,-,mm, m.,.~,.r..-,.~.-n.--,,. ., ,...,,,-.,m,,,.E.,m.,. ....,...e..-, . . - . - . .,- - .y -

processing 1icense applicattons, (e.g., staff assigrenent to .

\

. licensing cases), cepletely onrhauling Itcense data infonnatton (i.e. MS Access database for anintaining licensee infonnation, inspectton infonnatfon, automated docunentatton. taking advantage of Internet access to infonnation available from MC anJ other state RCPs, etc., now that internet is available to staff (as of mid-My 1997),

3. Please identify individual licensees or 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.-

Resoonse to item 3.

To.our knowledge, there are currently no New Hopshire specific licensees which are prioritized to be inspected less frequently than called for in the NRC Inspectton Manual Chapter 2000. The program fully adopted the MC inspection schedule in April 1997, with the exception being the adninistrative decision not to have a Priorftj 7 category, the 10wst category being a Priority S.

(Note: prior to adopting the inspection Manut! Chapter 2000 priority listing, most radioactiva meterial licensees in New Hanpshire wre scheduled for inspection on a gr.g frequent basis than the NRC listing, (e.g., portable gauges, every 4 years: all medical fact 11 ties, every two years: broadscope acadenic 1nstitutfons, every year)

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

Resoonse to item 4 Approximately 50 Itcensees

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

Resoonse to item in. Of these, 9 wre industrial radiographers, and there wre no wil-logging licensees.

b. For those identified in 4a how many reciprocity inspections were conducted?

4 4

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{ Resconse to item 4b. Of these, 3 industrial radiographers wre inspected. (Other inspections wre carried out for out-of state gauge 1fcensees.)

5. Other than reciprocity licensees, how many field inspections of

. radiographers were performed?

Resoonse to item S.

One field inspection of our sole industrial radiographer authorized to perform field site activities was inspected.

6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed l Resoonse te item 6. Not applicable

!!. Technical Staffino and Trainina ,

7. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, cnd, for Agreement States, the fraction of time spent in the following.

areas: administration, materials licensing & compliance, emergency response, LLW, U mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel.

If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

H&E PQ11IION PRINCIPAL AREA 0F EII EFFORT 5

i .

o ..

Resoonse to Itam 7.

' ^

7. The current total radioactive materials section FTEs is 3.6 which includes clerical time. The total radioactive material section

• professional

• FTEs (which includes administrative / managerial.and dedicated radio analytical laboratory radiochemist times) is 3.06 '

FTEs. (Note als) that radiological health enployees work a 37.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> work week. Therefore, our 1 FTE is based on 1800 hours0.0208 days <br />0.5 hours <br />0.00298 weeks <br />6.849e-4 months <br /> / year). It is not feasible to divide FTEs into further divisions (i.e., the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response LLW, U mills, other) as requested, as.the professional staff is not sub specialized into those areas.)

8 ., Please provide a listing of all new professional personnel hired since the last review indicate the degree (s) they received If

. applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

Resoonse to item 8.

There wre no new professional personnel hirhi since the last I review. ,

9. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials

. ir.spection staff (for NRC, Inspection Manual Chapters 1245 and

1246

for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

Resoonse to item 9.

All health physic staff must have at least a Bachelor's degree in the physical or life sciences. All are expected to attend, at the very least, so-called core" courses in radfoacttve matertal licensing and inspections (80-hou s), applied health physics (200-hours). Industrtal radiography (G-nours), medical uses of 6

- - - . _ , , - - . . - - - - - - -- , - - - - ,- ,-,-,n-., ----. --

. .t radfonuclides (40-hours), . rad 1010gleal emerpency response (40-

{

• hours), portable nuclear gauge training (6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />). All current staff bcVe carpleted these core courses. j

. I gag rDtE CERSES KEDED i l

Diane E. Tefft No additional core courses needed.  !

- Dennis O'Domi No additional core courses needed. l J. Christopher Pirie Mr11 Logging Course (Note: There are currently no wil '

logging licensees in M, and such activities are rarely.

if ever, conducted within the state)., .

Mario fannaccone W Transportation; a short course in RNi transportation i

• 1s expected to be given at this yirar's Annual New England Radiological Nealth Carnittee meeting in l' Massachusetts and evallable for attendance to staff. ,

Deborah Russell RNi Transportatfon: a short course in RNi transportatton is expected to be given at this year's Annual New l England Radiological Nealth Comittee meeting in Nassachusetts and available for attendance to staff.

Kathleen McAllister RNi Transportation; a short course in RNi transportation is expected to be given at this year's Annual New -

England Radiological Health Comittee meeting in Massachusetts and available for attendance to staff.

Twila Kenna -No core courses needed for current duties and I responsibilities in radio-analytical laboratory smport. '

Nowver, in order to expand Ms. Kenna's rasponsibilities, particularly in the area of '

Inspections, she will need to attend a radioactive

meterial inspection course. .

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10. Please identify the technical staff who left the RCP/ Regional DNMS program during this period. I Resoonse to Itam 10. ,

There wre no technical staff who left the Bureau ef Radiological ,

Health during this period. Honver, one individual. Deborah Russell began pursuing a Master's Degree in industrial Hygiene over a year ago and is currently M>rking only on a part-time basis.

III. Technical Quality of Licensina ActigE

11. Please identify any major, unusual, or complex licenses which were issued, received a major amendment., terminated or renewed in this period. ,

Resoonse to item 11.

License Name License License Type Number '

Syncor internatfonal 391R Nuclear Phannecy )

American Health Centers 402R Mobile Nuclear Medicine Service Metabolic Solutions 418R Research, Development, Medical Manufacture Rochester Equine Clinic 397R Veterinary Nuclear Medicine Stocker & Yale 395R Trittun Device Manufacture Seacoast Cardiology 389R Nuclear Cardiology

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

Resoonse to item 12.

To our knowledge, there wre no new or amended licenses added or removed from the list of Itcensees requiring energency plans during this period.

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

l 8

l 4

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4 Resoonse to item 13.

~

To our knowledge, there wre no variances in licensing policies and procedures or exerptions frcrn the regulations granted during this period.

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

during the reporting period?

Resoonse to item 14.

No major changes since last review.

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

Resoonse to item 15. Not applicable ,

IV. Technical Dun 11tv of Insnections ,

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

Resoonse to item 16.

O in January 1997, inspection priorities wre modtfled to reflect the latest changes in NRC Manual Chapter 2800.

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

Resconse to item 17.

Suoervisor Insoector License Cat. Datt None. (Conment: Since the last review, team inspection of major licensees wre carried out, in which our more senior (nona supervisory) staff members acconpanied other staff and reported to 9

l

the section s@ervisor on inspectors' methods. Also, within a day .

or two following each and every inspection conducted, a detailed de brlefing on the findings are conveyed to the sectton sypervisor. in addition to identifying arty significant issues .

requiring proupt actton, inspectton methods and discusston with annagement. RS0's and staff are described. All inspection field note reports are revlemed by the sypervisor.)

18. Describe internal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory acconpaniments were documented, please provide copies of the documentation for each acconpaniment.

ResDonse to 1 tan 18 Internal procedures are that each health physics staff menber should be acconpanied once a year on an inspectfon. ,

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

Resoonse to item 19. . s Equipment is calibrated on a routine basis, depending on type of use. All equipment currently in use has been appropriately calibrated. Typically, survey instrunents used during license inspections are calibrated at a frequency required of the category ~,'

of licensee (e.g., instrunents used by BRH inspectors when inspecting industrial radiography licensees have been calibrated within the last quarter.) Conplete docunentation of instrunent calibration is attached.

V. Resnonses to Incidents and A11ecations

20. Please provide a list of the mastlinnificant 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. For1 Agreement States information included in prev'fous s,ubmittals to i

10 t

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NRC need not be repeated. The list should be in the following format:

Resoonse to item 20.

LICENSEE NAE LICENSE # DATEOF TYPE OF INCIDENT INCIDENT / REPORT A listing of all incidents recorded in the Bureau's incidents database is attached for review.

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

Resoonse to item 21. - -

All such events would be reported to the appropriate agency. Please reference the attached listing of incidents for infonnation on such incidents.

a. For States, was timely notification mnde to the Office of State Programs? For Regions, was an appropriate and timely PN generated?

Resoonse to item 21a.

All such events would be reported to the appropriate agency.

Please reference the attached listing of incidents for infonnatton on such inc1 dents

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

11

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Sesnansetoitem22. .

-I For insidents involving feilure of equipment or sources, '

information on the incident would be provided to the agency .

responsible for evaluation of the device for an assessment of i

, possible generic design defic 1ency ,plesse reference the attached listing of incidents for information on such incidents

23. In the period covered by this review, were there any cases  !

involving possible wrongdoing that were reviewed or are presently j undergoing review? If so', please describe the circumstances for each Case.  !

Roshonse to Itam 23.

In the period covered by this review, there wre a few cases involving possible wrongdoing that wre reviend

• and/or presently undergoing review. Among these are:

Atlantic 7esting latd., a portable nuclear gauge Itcensee, in which the license was suspended for a period of time based on several violations:

Department of Envirornental Services laboratories, in which small amounts of source material (in general licensed or exenpt )

quantitles) w re stored;  ;

An unifcensed MMI source supposedly possessed by an individual:

~ ..

24. Identify any changes to your procedures for handling allegations that  !

occurred during the period of this review.

Bggg.nse to item PL in the period covered by this review, there wre no significant I changes in the Bureau's procedures for handling allegations that occurred during the period of this review, except that a decision was made to record such allegations in the Bureau's incident database, at least at this time.

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

12 s

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

Fesconse to item 24n.

At the present time, there are two such cases.

One involves ABC Testing, Inc. an industrial radiographer licensed by the NRC working in the New Hanpshire under reciprocity, issues involve the question of whether the Bureau was appropriately nottfled that licensed activities were taking place on that date, and whether the licensee should have reported to the state the circunstances involving an incident which resulted in exposure below regulatory limits while korking in the state.

The second issue involves a newspaper article which references Kearsage Metallurgical in No. Conway (a former industrial radiography licensee) as having been involved in illegal dmping of unsealed radioactive material in a pond  !

adjacent to the facility. This case had uadergone extensive

. review in the past, with unsubstantiated allegations having been made for many years, in spite of the fact that the facility was never licensed to use unsealed radioactive material. This case is considered closed by the Bureau, despite attenpts by the NRC to consider; it open based on the unsubstantfated article.

VI. General

25. Please prepare a sumary of the status of the State's or Region's ections taken in response to the coments and recomendations following the last review.

Resoonse to item 24a.

The last review team provided the following sumary list of recomendations, for action by the State.

1. The review team recomended that BRH revise its inspection priorities for initial inspections of new licenses to be consistent with NRC's Adopted.

13 O O 9

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2. - The rev1w team rocamended that BM tevise its inspection l priorities to confom to their current practice of annual )

, l inspect &on for fixed industrial radiography licenses. ,

Adopted, i i

3. The review team recomended that the inspection procedures be  !

revised to include all essential elements of the inspection and to confom to BM regulations, -

Adopted. l

4. The reviw team recomended that the BM narrative reports used for routine inspections cover each of the essential elements covered in ,

the inspection forms.  :

Adopted. ,

The rev1w team recoactJs that BM reviw, update, and standardize I 5.

the inspection forms.used for different categorie's of licensees. ,

Not adopted. The difffculty here lies in the fact that with the 1

rules update process underway. .it makes little sense revise inspection I foms at this time. What has been done however is for staff to become  ;

familiarized with NRC inspection foms and to use these as references to e supplement our current inspection foms. In addition. some new '

inspection foms have been produced (f.e., the irradiator inspectton fom). .

6.- The reviw team recomended that the model, serial number, and calibration date of survey instruments used during BM inspections be included on each inspection report.

Adopted. In addition, tracking records now exist for each -

instrunent used, so that should this infomation be inadvertently omitted from the fleid notes, it mould be available by referencing the  ;

instrunent sign out sheet and survey instranent database.

7. - The reviw team recomended that BM inspectors perform instrument response checks'against known reference check sources on radiation detect 1_on equipment used on inspections.

w-e-,,--.- -e, e, --- rW-,m., r---s, me m + y e e - rw, - =. e.-w w asrn,==xsw-= v- rwra e -wr-w erU

7 Adopted. In fact, check sources wre bought and attached to certain survey instrunents.

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8. The rev ew team recomended the Division of Public Health take steps to accolerate the promulgation process in order to maintain regulations compatible with the NRC's.

Adopted. An exerption was written into the adninistrative rule statute to allow more flexibility in our rulenaking.

9. The review team recomended that the Division of Public Health take appropriate steps to assure that the radiation control program has prompt legal assistance available when needed.

Adopted to some degree. Although the Division was not able to pursue this, a major re organization of the Department of Health and Hanan Services has, at least in theory, resulted in more .

readily available legal assistance to Bureaus in'cluding Radiological Health. The Bureau has on occa* Jn,_recently sought the assatance of Office of Program Support's legal Ccordinator, John Dabu11ewicz, and also, the legal counsel in the Carmissioner's Office, John Wallace. .

10. The review team recomended that BRH adopt the rule necessary to implement the provisions for severity levels and civil penalties that are now in draft form.

Not adopted, in tenns of priorities in rulemak)'ng, other provisions required for cortpatibility have greater priority at this time. In addition, changes already in place brought on by the department's re-organization, along with potential changes in an ever dynamic area of re-engineering the department, makes it prudent at this time to take a " waiting" approach with regard to the area of enforcement, unt!1 final decisions are reached at the com issioner*s level.

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.

?

15 e

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I i

Bggaga to itam Nn.

StMngths:

Staff Training and Experience in a wide variety of areas of responsibilftles j

@ality of Licensing Actions i

@elity of insHctions

@elity and Timeliness of incident Response Wality and Timeliness of Radiological Emergency Response

@ality, @antity and Availability of field Radtplogical Instrunentatton +

Weaknesses: .

Staff Responsibilities in Several Diverse Areas Unavailability of Radiological Training for Staff I- .

Lock of Strong Support for l'rogram (at least in the past)

Timeliness and Wantity of License Applications Processed Timeliness and Wantity of Inspections Conducted, including those for reciprocity a Reliability of Radio analytical Equipment Capability low Norale of Staff based on ever-increasing responsibilities at reistively inadequate pay  ;

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8. WON. COMMON PERFORMANCE INDICATORS

1. ReaulatioM and Leoal Authority

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

Resr>onse ta ltom 27.

RSA 125 F:1-25 Radiological Health Program RS4 107 B Civ11 Defense Act RSA 12S B:1 New En91and Cnact Radiological Health Protection RSA 125:77-E Redfonctive Wette Prohibition

28. Are your regulations subject to a"* Sunset

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

Resconse to item 28. .

Yes, every six years for rules adopted prior to August 1994, and every etght years for rules adopted after August 1994. NH rules equtvalent to 10 CFR Parts 19, 20, 39, 61, and 71 sere adopted in February 1995,

29. Please complete the enclosed table based on NRC chronology of amendments.

Identify those that have not Deen adopted oy the State, explain hty they were not adopted, and discuss any actions beirp taken to adopt them, Resoonse to item 29.

Reference attached table. -

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

Resoonse to item 30.

Reference Table 29 attached.

4 9

17

II, Sealed Source and Device Procram )

31. Prepare a table listing new an.1 revised SS&D registrations of sealed sources end devices issued during the review period. The table heading should be: -

SS&D Manufacturer. Type of Registry Distriistor or Device Number Custom User or Source Resconse to itam 31.

There have been no new and revised SS&O registrations of sealed sources and devices issued during this review period.

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

Resoonse to item 32.

In the event that such an evaluatton was nece'ssary, all available )

NRC guidance, standards and procedures wuld be used. including

- Regulatory Guides 10.10 and 10.11. ANSI standards, etc. would be used. as required by the agency's and generally accepted 1icensing procedures.

33. Please include infonnation on the following questions in Section A. as they apply tu the Sealed Source and Device Program:

Technical Staffing and Training . A.II.7-10 Technical Quality of Licensing Actions - A.III.11. A.!!!.13 14 Responses to Incidents and Allegations - A.V.20 23 Resoons* to Itam 33.

Unclear as to the references.

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111 Law Level Waste Procram k Pleashinclude information on the folloking questions in Section A. as 34.

' they apply to the Low level Waste Program:

Status of Haterials Inspection Program - A.I.13, A.I 6 Technical Staffing and Training A.!!.7-10 Technical Quality of Licensing Actions - A.!!!.11, A.!!!.1314 Technical Quality of Inspections A.IV.1619 -

Responses to Incidents and Allegations A.V.20-23

. Resnonse to iters 34.

Not applicable. .

IV. Uranium Hill Proaram .

35. Please include information on the folicwing questions in Section A as they apply to the Uranium Hill Program: -

Status of Materials Inspection. Program A.I.J-3. A.I.6 Technical Staffing and Training A.II 7-10 Technical Quality cf Licensing Actions - A.!!!.11 A.!!!.1314 Technical Quality of Inspections - A.IV.1619 Responses to Incidents and Allegations - A.V.20 23 Resoonsts fa item 35.

Not applicable.

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l Evtter e4TE freeveo AmmtAct 32nss peopfeset noendues e Mac neeism I d==e ed =samen ter y=As- tap .im6 % resism RAer. Nace mmend set summe ned sensa = he.ased mood h Mn am.esmosome se. emend a nemmend=eas names ==ser=e ad.ael-- - m.emm penemmes - u-.-w and stessi =am emmemmed ed.wamme =e. pumed , ed.an-- a ctAss m Reported to NRC N Lic 8 ZZZ UTH , NHedese6 Deddr: W Cesar dhessend te teus of =e (2) Cdess-57 spas amenet tach Ihand a 2.9 mG e etnyme duer, seedse deem due emmenaud stemas gin N p===== T=e asunes mese taped esseemr Serini mester $2e9e42 sW g ctAss DEssTs Repe ged se NRC Y Lic # 2SGL tAs 2w96 NIfetet19 He h==== medRed te NRC teendquareus Opassiems Cemeer team a Tasmier N w essemining set (* sumer sus em=h= tem te had ofpidup

                                                             %                            trud im Dush tems. Asumens as licemame.te smee user == seem to te W h ofEse samt asempessag weet an ejue>=ine im                                                                     ;

a-u.-s ummm-en-sen= The sseee sed wer W in te h posaies ame tuded im a secused outammer W to te had of te ph Whms te meer  !

sumussed to his M amer o samy emessesed cast h ed cle :md emmamimer r animmius tems had of seek. Ik meme useIAnd h Cley Psitet med e= psEme i I insmamme te news % f m-=== mens esefied c -ya.e pacisic mas Tsenter Gage and sequessed gauge te mese4 es samenn het

                                                           ,                              tJpDATE:On Fetumy e 1996 at 1240 t E---. aseAed PmC Regium I en w had tamm inismused as sradt of aree m etw n a                                       em tid ear.and provide eanianymetesNac.                                                                                                                                                             ;

ctAss DEssTs Reported to NRC Y Lie # 273R , i W ' y2IM NI9pfeel2 On F2tM Hussie Hoeyled seerleed les aC etbudk Tecomusimme 99m aos Symmer femmamey. Wipe eeser war dame em the tend ple Mas seselps. AGur  !

                                                                                                             , wipes an===d sees d=m per see e,=== an. ship === med pie due===mamense es so ap= pa les egn== cum. symmer pt==.cy eAsd ty immer.

j ctAss e 3,pe,,,g se NRC Y Lic 5 301R y2sm Neepteet3 on y25m thes%: nuspied someked see acl ethat T-a-e--ven tem syneer ptemmer. wipe e== === dame me imme pa 4-ing s semelpt es== semin. eAs a wires es=== $3ee dre per see sgn=e cum. shapenas me pis massessmmmed to see dem per see ,,me an. symmer pnemmer meeAnd by asser.

                                                                               .          ctAss EWRs

• Reported to NRC Y Lic # 30lR aus i

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4 I 4 1 i EVENT DATE ITDIMD AWETRACT I 4 7/2We6 NHegeead Tsus eart s.s etsewer a Ms=ushill. Mas ImadIR. RW sepusase a Ie.See cymt m -d , am , Epssed end aseems en te migteshig NBt emmair

,                               ===== MH DuesemW pumsort sesponded to Matmed TM mal-- y eens ad semesed by hh a 5 '38. Infusumiam in enuh imeumand pusimme                                     '

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                                          - m d sediamme- has =r -m- meerms smassy sus uma a maa heme sammed by emesu musty en enemy mas te,ues se hiessimyseksaae,som tiptiATE te AFIL 97 Decem pumanet seemsund to hese samage men a tethod. Decay paled essesnug 3 hdtthe. See smentes shame P esund.

Farabyepwame gious r to AT=- ethma  ; CLAs3 EVENTS Reperced toNRC7 Y Lic # ZZZ  ! I t^s ,

             ,r:7m   seHeset23 Puhm testg eed pummse W Gd per-se 999973 Cmeande sedag == Emed m emede plundam DS p samus. taptma mighdby ema by

} h Grassel 30suphd. Imme uma senmund se emme ests. DisComal T ^ ^ . t l caAss EVEBffS Reported toNRC7 Y Lie # 138R ,

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90em NHF7eeW3 Dushmuey suyasilmg servise shoes Molded medh ammemspy high espomme (SeEsufinum, huoneen 4We6 ed 90WeEs huestead tegummsy name dumhmmey tage em j l le==rsomeastunderis unisen j

) ctAss Eveens Repened toNRC7 Y Lie # 145R l ERP i

lornam Mnv7 esse T

n=r pudme wese =*=d='-- d 25 atl etDtPA a-=-a teneseemened 25 =O MDP. Tsuur dhessmed ehme pudman seemmed Bem hungbgwie se home aptee j , ehess,et ts.esismse by keephs se== mas sw semee.ed som sW tat d% vt.ause hhuted usung. IAmur OWN Phmedagle esMm3 94ds Wet

                                =ese W mehst                                                                                                                                                   .

class EVE 55Ts Repened asNRC7 Y IJe # 263R 12 nim 3sneest29 Padmainehaupied some==si e 2.smesetThesium.2et wieunivet,edneedsemeemmens ser -d n-a.m. Astheadofdeamend  ; p.m -=sessedtv =en h eing. M a d - i--- *=+y ---a e me same.ame a -i== a- won e= e==r m - are syme en ee amor me i j te esmemM sN meus tiemmed as assusf wt==-a Tmsussed to ammfmeme ases ed esessed ett tend apsume ammisme deemy to P Rear of sammem sense es.esed weh need, pamaic med shamens amend as maned a saamme = esmemmashut As ess,heism erdiese ed seedus stanties s=== =as j i sempeed for ese wth eerw tememM. .

                                '   **m EVENTS                                                       RepenedteNRC7 Y                               IJc 5 30lR nus 12tI3m    NHeset2d   hd==d Pouer Fema Musiend Itur. Rad Messer of a seiner Asel psehesme,smession h he sumuner ==d-m Mhessieser.psmer s mme a   home ads syyr Amt psettom ehest 30% of te simme. Pimmt we esammer es tend med ammment wgIGh4 samed semeng is

• A % per saammt Meer semams 219 emirseOmies er shout i IAS.se0 ofens fyec Emmit.

! ctAs3 EVEffft Repened toNRC7 N IJe# ZZSS otM s ,

                 ~

e e *

                                          .    .      m                                                                                                          *-                                                                                                                                        m.
                                                                                                                                                                                                                                                                                                              -s
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{ i i EVDff 9ATF. ITD8 MO A35 TRACT  ; 12fl3/96 WH986127 Immendens in stage of womme summesi for te NH PuM6e HesNb h6e W mahammedadelse hr a putspe of Rydd Som es sheeney hb muted smesamtes.

                                                                        -      .- se,eske me k,sas shuse -                      _ _ p-*.e oss in facs engesny in.assed by siyan twi.a omme=r er sewahe %.

CLASS EVEBM3 Reported toNRC7 N Lie t 323R l OTH I2n7pp6 MHeset28 A sammesmed cresem (mand a pedage ormediest suppeles em te side of a higtsesy he h havided hasups es pastage to his tumme in h NH ad we, w partage in his sesheesser esse might. Chisem esmascaed the e=ner.CI5415 inwand mysed to ousspost se pastage past usy task to esame. I P+g <ms ,, ,20 gel esys ef 313i. y j ! i h Aer *.se Essed es tsee tema last team a Fed-Es neck utom a dust lock hoste as the sesudt eta e='We endose otha esamund in EsNasd, teams. C11b Nff8 Repened toNRC. Y Lie # ZZZ i p-32nti,6 NHeset3e n ons=d mad mes.mer add for user ,= efdevises semps esd de=meninha mesmesme summeda. sesened less,whoses ad Mac e cues,in ac or i=rs=ess ude. class EverS Repened toNRC7 Y Lie # own I/2 ssp 7 NHFf0005 NH Dept Eswisessmamand $srvisse esmesened am insamery of their headses sessage bander in tw 3CL Fause wese sessed smedI vide of wha h thought en he sheten med ===a== DES .a a=d wisi sacalermed usesse and Aemd e 75 smMr. anses erm M Besset posessmus samst sused 5 sten,sume aussa 3_95 usume h esamms wisi tese etviss admaines = se te3 kun amuses, emaakke seset .es ime bish h,d atser p.eder. sense need nessed *nt sce. Appse s te eares essfesmekass essa, sed een aisemanha . DEsemmenesmedprea== CLASS EVEMS Repaged goNRC7 Y Lie # MER 1 own 3r3pp7 Pety7 gell Ampost of a asisetuimisemism. esse ANehg tesa psenested dose by sus e een 199L A dose ofSD mei efluene 130 mes admed by te physide 6 Dess messahamed oss 8.4 sucL Esser seedied essi te Smiums 133 sc8 peace suuste seedue smises *.9% est day. Testmatsght ad met etserse devielen team masse poter to dose behg =a=nd*=d Psalamt med phyuldam esse lidsomed med as 15 ensens as pasi =s asse meesd. i To the te pestium Russimhg of W be Imyssammes of deviadues toss mese to seesser sessnes. t ' CLASS EVEffrS Reponed toNRC7 Y Lie # 368R tan . 1 i l I 4

I

                                                                            -. .+

EVENT DATE ITDINO ABSTRACT 4/24M NH9'9994 Symeer de#sey veldde womspeselug ' .' ' " aus immaesed in a single car meinem in h tet. Thadelser,en amey pseuwsim te vehicle e sur emme,susessmed spiser imperses. Escal fise med police -_ , " " --4 asked for Some police brey % ee humsdoms cego payess sur legsmsy emey. Ne damage  ! e,sms,p e . . mas me has ~ et =s-- e se seese much tody essayy es W Caos ===mse es sysser pas,any in wet-a, Muss by t museer Symeer whide. a cases sus S *smemo cans". Insee mese emysy preums, t essassmed R$ smCl Tc99mm sud T1291, med I esmemiming 730 suCI Tc9 tut On seems to Symmm s guemmy in wehe a wipe est me perferend nesuhsmemeside surssies et*ammme bones" o.weged e.s apu per ens W ctASS EVENTS Reporged to NRC Y Lie # 04-26507 01 5 ms , i stjim t# m es25 Iw Event a Vesume ye te po.erm . An ensegmee ammher h an essegmee in payens la lessMindh & Atene set pois is e et G. Ta h=arna W vesyssed dechession etUnusual Event. Admet esegude ammiser sendissa sum 0.124 0 in Muse semah yiene he aseng im wuncai er auss-j west passe. This uns +===d W esser and amesmal ewest tesummased by paun at e905 tes SGIM. MRC ptsumer ping rhminh==* essa 32428. 1

CLASS EVENTS Reported to NRC N Lie # ZZVY OTH  ;

i uim No m ee27 en =ia. tes.sen Sestseek p e, pine.Sune med NRC dem Auf sods wie pin late hds and pommie v Shut version.Doing seAuf emesse I Sestemsk Amund 5 Aset seds in eligesent 4 Asel assauMies had yin hate leds. Whese senser:A etsees aus % 8 tsuke M in emmeur of sed sud muscher huske I jaggespy sine meer eeuner. Seekseek wished en vesnese " geer Emet sees in summe asse for ensamimmense but was h wee M Pif a*gmursed tsehe med added 6 to syneens (12 ding sees miseedy m II pomete a essammmunism as syn -p ch by NItC shoued esas itgood sods tsabe One musihuma esmemndmeise en synaeus named sem N andy tne and ar=risi,==a== seemeMe. Sasse and MitC gese pasmindse es y==s==d D.TefR saysesuming same. ctASS EVENTS Reported soNRC N Lie # 77M . Om t i ul0M t#497MI6 Roseised imidst seemst of W wester essempesme tems Spase Age TW Tlueer desinney suppner, KN W Ser%sayesh a W sement 34,9N  :

;                                                  seems wheie nedy. fun sepest due by mid July.                                                                                                                            !

CLASS EVENTS Repeated to NRC N Lic # ZZZ  ; Exp ' i v24M NH97eO29 Higginslesspind W sippuest ctASS EVENTS

• l Reported to NRC Y Lie # 30lR  !

4 nus - l

                                                                                                                                                                                                                          = l j

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APPENDIX D - LICENSE FILE REVIEWS-File No.: 1 Licensee: American Health CenNrs, Inc. License No.: 402R Location: Bedford, NH _ Amendrnent No.: New

            - License Type: Mobl3 Nuclear Medicine                                         Type of Action: New Dete issued: 11/1/96                                                       License Reviewer: CP Camment:

a)- Pre-license visit File No.: 2 Licensee: Metabolic Solutions, Inc. License No.: 418R Location: Merrimack, NH Amendment No.: New License Type: Research and Development, Type of Action: New Manufacturing / Distribution Date issued: 1/10/97 License Reviewer: CP File No.: 3. Licensee: Venegs.s industrial Testing, Lab. License No.: 217R Location: Nashua, NH Amendment No.: 32 License Type: Industrial Radiography Type of Action: New Date issued: 3/25/97 License Reviewer: CP Comments: a) Change in license condition to allow out of specifications source changers to be used as storage containers. b) Well researched and documented. File No.: 4 Licensee: Atlantic Testing Laboratories, Limited License No.: 296R Location: Manchester, NH , Amendment No.: 29 License Type: Portable Gauge - Type of Acuan: Amendment Date lasued:- 7/11/97 License Reviewer KM File No.: 5 Licensee: University of New Hampshire License No.: 190R

           - Location: Durham, NH                                                          Amendment No.: 29 License: Type:- Broad Scope - Academic                                 Type of Action: Amendment Date lasued: 12/19/95                                                       License Reviewer. CP Comments:

a) Decommissioning of a building containing 30 or more laboratories.

           - b)         Excellent cooperation with licensee in overseeing and confirming proper close-out.

l

      .+                                                                                   -
                       't,i J. .
               ;                                                                                   ;,                         1
                                                                                                                               )

J New Hampshire Proposed Final Report : Page D.2 License File Reviews  : File No.: 6- -

                   ' Licensee: Catholic Medical Center -                 .

License No.: 109R'

                   - Location: Manchester, NH -                                                      Amendment No.: 41-        .
                   , License: Type:' Diagnostic / Limited Therapy _                          Type of Action:- Amendment -

j

                   ' Date lasued.12/16/95                                                         License Reviewer: DO -

File No.:- 7 , Licensee: Distide',Inc. License No.: 377R i

                   ~ Location: Londonderry, NH         _

Amendment No.: 9

                   - License:-Type: Research/ Development  "

Type of Action: Amendment

                   !Dateissued: 3/27/97                                                           License Reviewer: KM         -
                   ' File No.: 8
                 -- Licensee: Mary Hitchcock Memorial Hospital                                        License No.: 139R Location: Lebanon, NH         _

Amendment No.: 57 , License Type: Diagnostic / Therapy Type of Action: Amendment Dateissued: 2/24/97 License Roviewer. MI File No.: 9 ~

                   ' Licensee: LeadTech, Inc.                                                         License No.: ~ 396R Location: Moultonboro, NH                                                    Amendment No.' New License Type: Fluor. x ray                                                      Type of Action: New Date issued: 3/19/96                                                          License Reviewer: MI File No.: 10              ,

Licensee: Heynen Teale Engineers, Inc. License No.: 353R Location: Bedford, NH Amendment No.: 13 License Type:- Portable Gauge - Type of Action: Renewalin entirety . Date Issued: 6/3/96 License Reviewer: DR Comment: a) Missing March 22,1996 letter referenced in tie-down condition. 5 F! e No.: 11 Licensee: Elliot Hospital License No.: 182R _ Location: Manchester, NH - Amendment No.: 41 License Type: Diagnostic / Therapy Type of Action: Amendment-Date issued: 7/17/97- License Revimver: DR File No.: 12-Licensee:' Jawors'el Geotech, Inc. LI:ar,r No.: 345R

                   ~ Location: Manchester, NH                                                         Amenchnent No.: 9
                   ; License Type: Portable Gauge                                            Type of Action: Amendment
                   . Date issued:- 8/5/96 _                                                       Ll cense Reviewer. DR

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

      ' New Hampshire Proposed Final Report                                          Page D.3 License File Reviews File No.: 13 Licensee: Ear, Nose & Throat Phys. & Surgeons, P.A.                 License No.: 333R Location: Manchester, NH.                                            Amendment No.:

License Tyre: In vitro lab Type of Action: Termination Date lasued: 4/20/95 License Reviewer: DR f 4

.o APPENDIX E INSPECTION FILE REVIEWS File No.: 1 Licensee: Rochester Equine Clinic License No.: 397R Location: Rochester Inspection Type: Unannounced, initial License Type: Veterinary Clinic Priority: 3 Inspection Date: 11/7-8/96 Inspector. KM Comments: a) Range of exposures indicated in dosimetry reports not identified. b) Licensee's response did not address requested information related to prior doses of individuals new to facility. File No.: 2 Licensee: Dames & Moore, Inc. License No.: 392R Location: Salem Inspection Type: Unannounced, Routine, Field License Type: Portable Gauge Priority: 5 Inspection Date: 11/13/96 Inspector CP Comment: a) Two months to issue NOVs. b) Good documentation in inspection field notes. File No.: 3 Licensee: Wentworth Douglas Hospital License No.: 206R Location: Dover Inspection Type: Unannounced, Routine, Field License Type: Hospital Priority: 3 Inspection Date: 6/30/97 Inspector: CP Comments: a) Inspection overduo. b) Report does not k.entify whether worker interviews conducted. File No.: 4 Licensee: M&W Soils Engineering, Inc. License No.: 264R Location: Charlestown Inspection Type: Unanncunced, Routine, Field License Type: Portable G auge Priority: 5 Inspection Date: 12/12/96 Inspectar KM Comment: b) Timely NRC referral of failure to file reciprocity for work in Vermont. File No.: 5 licensee: M&W Soils Engineering, Inc. License No.: 264R Loc ition: Charlestown Inspection Type: Unannounced, Follow-up, Partial License Type: Portable Gauge Priority: 5 Inspection Date: 6/04/97 Inspector DO

a.  !

    .;                                                             ~

New Hampshire Proposed Final Report Page E.2 Inspection File Reviews ' Comments: a)- Telephone conversation used as inspection but phone record not in file.

         - b)           No documsntation in file to support NOV for gauge possession.

File No.: 6-Licensee:- Monadnock Community Hospital License No.: 368R Location: Peterborough inspection Type: Unannounced Routine Field , ,

License Type: Hospital Priority: 3 Inspection Date: 1/25/95 Inspector: MI Comments: ,

a). Report does not indicate whether preliminary findings discussed with management. b) NOV for failure to provide training not identified as a recurring item. > File No.: 7 Licensee: Diatech, Inc. License No.: 377R Location: Londonderry inspection Type: Announced Routine Follow-up Field License Type: Research and Development Priority: 3 Inspection Date: 11/15/94 Inspectors: KM/MI Comments: a) NOVs not timely. . . b) No follow-up to confirm licensee corrective actions to various cited program deficiencies. File No.: 8 Licensee: Haley & Aldrich License No.: 399R Location: Bedford inspection Type: Unannounced, Initial, Office - License Type: Portable Gauge Priority: 5 Inspection Date: 6/24/97 inspector. MI Comment: a) Inspection performed over one year from new license issuance (5/96). File No.: 9 Licensee: Professional Service Industries, Inc. License No.: 400R Location: Portsmouth inspection Type: Unannounced, Routine, initial, Field License .ype: Portable Gauge Priority: 5 Inspection Date: 6/11/97 Inspector, CP Comments: a) Inspection not performed within 6 months of new license issuance. i b)= Findings discussed with management not identified. t

                          +--n       v s- - - - , - -,   -- -   -w     e,     .        --   -- ~ - - - - - - - - - - - - - - - -                       - - - - - - - - - -

L 1.c , New Hampshire Proposed Final Report Page E.3

             ; Inspection File Reviews

. t IFile No.: 101 ,

             - Licensee? Public Service Company of NH -              '

License No.: 313R Location: Newington Inspection Type: Unannounced, Follow-up, Field -

            ; License Type:- Fixed Gauges                                                                                                                  - Prionty: 5 Inspection Date:- 12/29/94 -                                                                                                             Inspector: CP-File No.: 11
            ' Licensee: Seacoast Cardiology Associates, P.A. _                                                                                     License No.: 389R Location: Newington                         .           _

Inspection Type: Unannounced, Initial, Follow-up, Field i License Type: Private practice - diagnostic __ Priority: 3

             -Inspection Date: 3/22/95                                                                                                                  Inspector: CP             .;

l

             ' Comments:

a) Initial inspection exceeded 6-month interval after license issuanca, 4/94. b)- Question about labeling of containers adequately resolved with supervisor. c) NOV issued 2 months after inspection. File No.: 12 i Licensee: Trustees of Dartmouth College- License No.: 276R , Location: Hanover . Inspection Type: Unannounced, Routine, Office License Type:- Broad Academic Priority: 1 Inspection Date: 1/24/96 and 2/06/96 Inspector: Team Comment: a) Cannot tell how licensee commitments / corrective actions followed up. b) No commitment dates in confirmatory action letter for licensee to confirm corrective actions, e in addition, a team member made the following inspection accompaniments as part of the onsite IMPEP review: Accompaniment No.1 i Licensee: Trustees of Dartmouth College License No.: 382R Location: Letnnon . . Inspection Type: unannounced, routine , License Type: Self-shielded irradiator ~ Priority: 5 Inspection Date: 7/10/97 - Inspector: MI Comments:

r. _ a) Survey of area below facility for radiation exposure not evaluated by inspector, b)- The inspector did not discuss that leak tests were not perfo#med by individual. named on license.

c). The inspector did not survey teletherapy area identified on a different licensee, but adjacent to the self shield irradiator.~ Note: material was no longer being used in that . , room and it is scheduled for termination. t b

                   ,-;,      7--,7-,     ,,,m-     , , - -     ,3y.,     .,     .,,~_w              , . , . +     _m     ._ . ,w   ,_-.-__----.=~1                  .______i__a

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

94 i New Hampshire Proposed Final Report Page E.4 - Inspection File Reviews Accompaniment No. 2 Licensee: Cheshire Medical Center License No.: 256R Location: Keene. Inspection Type: cnannounced, routine License Type: Medical Priority: 3 Inspection Date: 7/24/97 . Inspector: KM Comments: a) Unable to determine how inspector identified issue regarding discrepancy in whole body and ring badge dosimetry report resolved. b) Good interviewing techniques. I t l

I

                                                                                                                                        ~
   #4'                                                                                                                                  .]

e APPENDIX F ' l o lNCIDENT FILE REVIEWS L

              , File No.: -          .
               .Licensoof Huggins Hos'pital License No~.:- NH 301R Location: Wolfeboro, NH Date of Event: 6/16/972 Type of Event: Contamination           _.

Summary: Licensee received a contaminated shipment of bulk Technetium 99m from Syncor. Shipment arrived at 7:10 a.m. and was wipe tests at 7:30 a.m. Decontamination of materials  ; was unsuccessful. Syncor was notified and the shipment was returned to them on 6\17\97. File No.: 2  : Licensee: Huggins Hospital-

              - License No.: NH-301R Location: Wolfeboro, NH Date of Event: 6/20/97                                                                                                     ,

Typ) of Event: Contamination Summary: Licensee reported minor spill from IV in patient on treadmill. Approximately four

              ' droplets of thallium 201 fell on the treadmill. The area was secured from the public. The area                             <

was surveyed and decontamination procedures were conducted. After decontamination efforts were completed, the treadmill was the only area which continued to show measurable activity.- The treadmill was moved to the nuclear medicine laboratory and was draped with lead aprons. I File No.: 3 Licensee: Huggins Hospital License No.: NH-301R Location:- Wolfeboro, NH Date of Event: 12/11/96 Type of Event: Contamination

              . Summary: Patient was given Thallium 201 and was asked to use the treadmill for a 1 minute workout. At the end of the workout, the patient noticed that the IV was leaking. Medical personnel immediately secured the patient and room an initiated decontamination procedures.

After decontamination efforts were completed, the areas were cleaned to background with the exception of the treadmill and a spot on the floor. The treadmill was removed from room and was draped with lead aprons. The spot on the floor was covered with lead, plastic and absorbent material and marked as radioactive contamination. File No.: 4 Licensee: Huggins Hospital License No.:- NH-301R , Location:' Wolfeboro, NH Date of Event:- 3/25/96

              . Type of Event: Contamination 4-
   -     - .a,__.__....,--._         ,.   ---       ..          . _ _ _ - . _          ,.,._ , _ _ ___ _, ._ _             _   -...u...

L.. o .. New Hampshire Proposed Final Report Page F.2 incident Files Reviews Summary: On March 25,1996, the licensee received a contaminated shipment of bu!k Technetium 99m from Syncor. Wipe tests were performed on the lead pig upon receipt. Decontamination of materials was successful. Syncor was notified by letter. File No.: 5 Licensee: Huggins Hospital License No.: NH 301R Location: Wolfeboro, NH Date of Event: 3/21/96 Type of Event: Contamination Summary: On March 21,1996, the licensee received a contaminated shipment of bulk Technetium 99m from Syncor. Wipe tests were performed on the lead pig upon receipt. Decontamination of materials was successful. Syncor was notified by letter. File No.: 6 Licensee: Huggins Hospital License No.: NH-301R Location: Wolfeboro, NH Date of Event: 5/30/95 Type of Event: Contamination Summary: On May 30,1995, the licensee rece;vr.d a contaminated shipment of bulk Technetium 99m from Syncor. Wipe tests were performed on the lead pig upon receipt. Decontamination of materials was successful. Syncor was notified. File No.: 7 Licensee: Exetsr Hospital, Inc. License No.: NH-138R Location: Exeter, NH Date of Event: 3/20/95 Type of Event: Misadministration Summary: Patient given 24.2 mci of bone scan Tc 99m MDP instead of the intene ed cardiac Tc-99m MIBl. Patient and Doctor notified. Technologist selected wrong vial. File No.: 8 Licensee: Exeter Hospital,Inc. License No.: NH-138R Location: Exeter, NH Date of Event: 11/22/95 Type of Event: Misadministration Summary: Patient given 24.6 mci of bone scan Tc-99m MDP instead of the intended cardiac Tc-99m MIBl. Patient and Doctor notified. Technologist selected wrong vial.

4 4 .

   .d New Hampshire Proposed Final Report                                                       Page F.3
            - Incident Files Reviews File No.: 9                                                ,

Licensee: Exeter Hospital, Inc. License No.: NH-138R Location: Exeter, NH Date of Event: 9/23/96 Type of Event: Non-routine Summary: Patient having old pacemaker replaced. Old pacemaker,1975 Corotomic version, was found to contain plutonium-238 pomr source. Implant was originally performed by Massachusetts General Hospital. The old pacemaker was retumed te distributor. File No.: 10 Licensee: Cheshire Medical Center . Location: Keene, NH License No.: NH-265R Date of Event: 1/11/96 Type of Event: Lost source Summary: Licensee discovered that two cobalt 57 spot makers were lost. Each source was listed as containing 2.9 mci as of the date of the report. .The two sources were taped together. CommenL A copy of the inc; dent report needs to be placed in the licensing file. File No.: 11 Licensee: Cheshire Medical Center Location: Keene, NH License No.: NH-265R Date of Event: 10/19/94 Type of Event: Contamination Event Summary: Contamination found on the inside of a shipping container of Nal,13.69 mCl, received from Syncor Intemational Corporation in Wobum, Ma. Part of capsule fragmented as a result of poor packaging. File No.: 12 Licensee: Frisbie Memorial Hospital License No.: NH-357R Location: Rochester, NH Date of Event: 9/29/95 Type of Event: Loss of Control Summary: Radioactive seeds were found implanted in a patient and were removed by the hospital. Investigation reveals seeds were implanted on July 2,1953 ct Mercy Hospital in Springfield, Massachusetts when the patient was 5 months old. The doctors who implanted the seeds are now deceased and the hospital records were destroyed. The patient was unaware that the seeds were stillin place. BRH took possession of the seeds from the hospital. A positive identification of the radioactive contents of seeds were not possible aa.er a national search; however, it is believed that the seeds are radium.

4

 - .c                                               %

New Hampshire Proposed Final Report Page F.4 , incident Files Reviews File No.: 13 Licensee: Miller Engineering & Test'ng License No.: 278R Location: Manchester, NH Date of Event: 2/6/96 Type of Ever t: Loss of Control Summary: The licensee notified NRC headquarters Operations Center that a Troxler moisture density gaugc containing radioactive sources had been stolen from the back of a pickup truck in Dorchester, Massachusetts. According to the licensee, the gauge user was returning to the

      - Northborough, Massachusetts, office after completing work at a job site in Rockland, Massachusetts. The source rod was locked in the shielded position and locked in a secured contained chained to the bad of the pickup. When the user retumed to his truck after a stop, he dis,. overed the cab unlocked and the chained container was missing. The licensee riotified the Boston Chy Police and the police informed the news media. The licensee also notified Campbell Pacific and Troxler and requested that the gauge be added to the stolen list. On February 8,1996, the licensee notified NRC Region I that the gauge had been recovered.

File No.: 14 Licensee: Mary Hitchcock Memorial Hospital LI:ense No.: NH 130R Location: Hanover, NH Dato of Event: 5/15/96 Type of Event: Loss of Control Summary: A bag of contaminated waste was removed from a patient's room in the hospital. Waste was compacted with other " normal" waste and sent to landfill for burial. Patient was undergoing treatment with 155 mCl of I-131. Investigation could detect nothing above background at the landfill, but contamination was found at various locations in patient's room.

l

    )                                                  STATE OF NEW HAMPSHIRE
   +d i

DEPARTMENT OF HEALTH AND HUMAN SERVICES

    ,                                            OFFICE OF HEALTH MANAGEMENT                                                   .

PUBUCHE4LTHSERVICES T*"7 Ia M** 6 NAZF.N DRIVL CONCCRD.NH 033014527 Commissisest 643 271 4s08 TDD Acesse: 1 800 736 2964 - JeGrey B.Schaeb Dinner October 23,1997 Richard L. Bangart, Director Office of State Programs U.S. Nuclear Regulatory Commission Washington, D.C. 20555 0001

Dear Mr. Bangart:

his is to achowledge receipt of the U.S. Nuclear Regulatory Commission's (NRC)," Integrated Material Performance Evaluation Program (IMPEP) Review of New Hampshire Agreement State Program, August 19-22,1997, Draft Report." Please be informed that I have reviewed this report for factua! correctness and have di: cussed the recommendations and suggestions made within with my staff. I offer the following suggested changes and comments for your review: Sunnested Factual Channes Ref. Pane 1. Sec 1.0 Introduction

                        - Paragraph 1: The last sentence should be corrected to read:" Preliminary results of the review, which covered the period August 19,1992 to August 22,1997, were discussed with New Hampshire management on August 22,*1997."
                        - Paragraph 2: De New Hampsliire Department of Health and Human Services has undergone recent re-organization and the New Hampshire Agreement State Program is now administered (statutorily) by the Commissioner, Department of Health and Human Services, through the Office of Health Management / Bureau of Radiological Health (BRH).

Ref. Pane 6. See. 3.1 Status of Materials Insoection Pronram

 ,                      - Paragraph 1: He sentence begincing " Initial inspection was performed for three other new licenses at. " contains a reference to an initial inspection performed at an interval of "24 months (portable gauge, priority 5) after license issuance or material receipt." A careful check of the referenced file in question indicates that this license was initially inspected on September 21,1995. Due to a mis-filing of the report which also resulted in the inspection not being entered into the database tracking as having been completed, another staff member under the impression that inspection had yet to be completed conducted a second inspection a year later. (A copy of the cover and f* mal pages of the Sept:mber 21,1995 initial inspection field report is attached). Derefore, since the date of issuance of the license was November 29, 1994, we request that "24 months" be deleted and "12 months" substituted.

I / m

 '.$ Richard L Bangart, Director.

Office of State Programs October 23,1997 Page 2 ,

              - Paragraph 1: ne sectence beginning "nese licenses included the following: one license issued in 1995 (as a second license for a medical facility)..." he referenced license is for use of source material (depleted uranium) encased in steel for shielding in an industrial device (i.e., linear accelerator).

In must jurisdictions, these sources in devices are subject to a general license granted under the provisions of, or equivalent to, Section 10 CFR 40.25 " General License for use of certain industrial products or devices." New Hampshire rules do not contain an equivalent provision, and therefore the BRH issues specific licenses for these devices. Nevertheless, because these devices are not typically inspected by NRC or state radiation control programs, the BRH assigns a special category to these licenses. ney are not assigned as Priority 3 as stated, but are inspected only during x ray machine inspections; they are also not subject to the initial inspection requirements. We request that you delete this reference from toe list. De next item in that same listing, "one license (medical-diagnostic, priority

5) issued in November 1996;" likely refers to the mobile nuclear van service license (priority 2) issued November I,1996, ne BRH had obtained both telephonic and written confirmation that this licensee has not yet possessed radioactive material, based on our attempt within six months of license issuance to conduct the initial inspection. In conformance with the NRC's IMC 2800 procedures (specifically, 2800-04.03.a.), we have already completed an inspection (as was previously scheduled) in order to verify that the licensee has not received radioactive material. We request that this reference also be deleted from the listing of" late"inspectic.ns.

Ref. Pane 7. Sec. 3.1 Status of Materia!s Insocetion Program

              - Paragraph 1: With regard to the recommendation of the review team that New Hampshire's performance with respect to the indicator, Status of Materials inspection Propam, be found unsatisfactory, we request that this recommendation to the Management Review Board be revised to reflect the current status in which only two scheduled inspections await completion (see Response to Recommendation #1 below).

Ref. Pace 7. See. 3.2 Technical Staffinn and Trainina

              - Paragraph 2: The New Hampshire organization chart shows that the BRH was funded for 17 persons at the time of the revie v or 15.26 FTE's, based on 1800 hrs / year /FTE. Further, we recommend changes be made to the remainder of the paragraph to read as follows:

The BRH consists of five sections with approximately 2 FTE's in Radon, 2.5 FTE's in Emergency Response,2 FTE's in Radiochemistry,3 FTE's in Radiation Machines, and 3 FTE's in Radioactive Material. The remsinder of the FTE's being devoted to clerical and general administration tasks.. An FTE for the BRH is considered to be 37.5 hours per week. The RMS Supervisor and five staff members devote 3.0 FTE effort to the agreement materials program which includes material licensing, inspection, event response, and laboratory activities. Dese staff members also have additional responsibilities in the Radiation Machine Section and to a lessor degree in the other Sections.

  ,.s;            -

Richard L. Bangart, Director Omos of State Prograriu i October 23,1997  : t Page 3 ~- Raf. Pass 13. Sec. 4.1 Iagislation and Regulations y a Paragraph 4.1.1: ne legislative amendment was indeed made to the New Hampshire - Administrative Procedure Act in August,1995 but it did not exempt the BRH rules from ti.e State's  ;

                      ' administrative rulemaking system. Instead, the legislation has exempted these rules "from the formatting                :

requirements of RSA 541 A:3." His has been interpreted to mean that the BRH does not hsve to follow the Rulemaking Manual's requirements per se, but instead to use this document as a guide. His exemption should accelerate the rulemaking process and allow for some rules to be adopted by reference. Respomans to Recommendations: Recommendation #1 .! Although as of the date of completion of the onsite review, the information described in Sec. 3.1 of the report relative to the number of overdue inspections was factually correct, at this time, only two of those eight overdue license inspections remain (one small hospital and one calibration service facility). Dese two remaining inspections are scheduled to be completed within the next three weeks. In addition, we have implemented additional measures to put the materials inspection program back on schedule. An inspection plan was put into effect which clarifies the inspection schedule his should assist in short and long range planning for the materials inspection program. (A copy of this directive is attached). Also implemented since the time of the IMPEP review is closer supervisory management oversight of scheduling and assigning materials inspections, ne " inspections due" list are now to be presented , monthly at one of the regularly scheduled bi-weekly staff meetings. At that time, assignments to .

individual

;taff members are to be made and the dates for completion of the due inspections are to be scheduled. Based on the actions 16en to date, we request your consideration for removing this recommendation, and therefore, changing the finding for the indicator, Status of Materials inspection i Program, to satisfactory.

Recommendation #2 5 . De BRH is currently revising and improving its inspection report preparation process for those containing enforcement actions to ensure timely issusace ofinspection findings. One change is simply

                     -ensuring that routine scheduled inspections tre carried out early enough in the month to allow                      -

completion of reports prior to the principal inspector taking the next month's assignment !n the rullation

_ machine section. In addition, discussion betweca the radiation machine section supervisor and the i radioactive material section supervisor have led to an understanding that health physicist will use time while in the other section to complete necessary reports for the other section, as necessary.

RecommendghgLG - De BRH has addressed this issue on immerous occasions regarding both the rotation process and the time span for rotation. In all cases we have concluded that the rotation process as it currently stands is best for the Bureau for the following reasons: r

                    -       .         .                               .  .             .-    ..    -. -.       .   .                        .I

   ...s
      ..                                                                                                                                                   t
   * '                          Richard L Ban'gart, Director Office of State Programs Oetober 23,1997 -                                                                                                          -
    .-                      -Page 4

1. Sidcovergge -_ no BRH with its limited' staff resources must insure against unplanned f events such as vacancies, lay offs, hiring freezes, position removal and budget cuts. if the BRH decided ,

to permanently assign two of its four Health Physicist I positions to each of its regulatory sections (e.g., ' radioactive material and radiation machines) this insurance would be lost over time. Staff who were once trained in radioactive material licensing etc., would no longer keep current in this field if working , in x-ray and visa versa. 4

2. Access to training- De BRH has limited resources for the now costly training requirements imposed by NRC. Should a vacancy occur, and the BRH be authorized to hire, it is unlikely that at the current HPI salary level, the BRH would attract an already trained person. Hence, a new person would most likely be "in training" for a minimum of two years before becoming fully qualified for either the Radioactive Material or Rae. tion Machine Program. If the BRH could not draw on the expertise of all of its Health Physie staff during this time, the affected program's capabilities would be greatly

diminished.

3. Most siglike the rotation process. - De majority of the Heahh Physics staff seem to like ,

the rotation process and the frequency of rotation. His allows individuals to broaden their areas of , expertise, to have more flexibility in their day and makes the overall job mbre interesting. Deficiency letters can be wntten in one month with responses awaiting the person's return a month later. Consequently, it is felt that the system allows for better continuity of licensing / registration actions and inspection follow up. Regarding the number of staff to implement the program, the BRH notes that it is fortunate to have retained its present staff during recent Department lay-offs. Although creation of additional positions would be welcome, it appears unlikely wA the current biennial budget and Department position cap. He BRH feels that as long as the prese ; d is retained, the Agreement State Program can be effective. Recommendation #4 He BRH agrees with the recommendation that appropriate follow up to inspections be conducted to a confirm implementation of licensee corrective actions when significant problems have been identified. The staff has been made aware of this, and this practice has already been implemented into the inspection Program. Responses is Supestions: 5 . Supestion #1 As stated in Sec. 3 of the report, the BRH has maintained that the 12 month initial inspection for i Iow priority licensees was defensible, and that MRB found this policy to be acceptable. However, new licensees of all priorities continued to be entered into the system as requiring initial inspection within 6

                           - months. - De rationale for this was that it was believed that it was a reasonable " goal" for the BRH to
                           ' still attempt to conduct the initial inspections of low priority licensees within a shorter timeframe of 12 months, regardien of our practice of hand-delivering all new licenses and explaining the regulatory 4

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     **-      Richard L Bangart, Director
      "       Office of State Programs October 23,1997

• Page 5 - ,

requirements with the liceimes. However, for the purposes of clarifying the inue, th: BkN will clarify . Its inspection policy in this matter, and licenses of priority 1,2 and 3 will be inspected within 6 months,- and those lower than priority 3 will be inspected initially within 12 months. Sungestion #2 . In light of the fact that the calendar year has yet to be completed, we do wish to make you awar-that an additional inspection of an out-of state industrial radiography ' licenses was completed earlier th. . month, one inspection short of that necessary to meet the 50% for priority I licensees. < Sumnestion #3 nis point is being considered. Sungestion #4 . His point was considered in the past, but was determined not to be appropriate as the Division at

that time was considering implementing these procedures at a higher Division level. His policy has been changed. Now the Department's policy is to incorporate such items as enforcement procedures, severity levels and civil penalties into rulemaking.

Suggestion #5 nl policy has already been re implemented, with one supervisory accompaniment conducted in August, and two more scheduled before the end of this year.

!                           On behalf of the Department of Health and Human Services, I want to thank you for the professionalism demonstrated by the review team during their week here. I or my designee plan on attending the Management Feview Board meeting tentatively scheduled for November,1997. Should you wish to discuss any further particulars relative to New Hampshire's review prior to this meeting date, I suggest that you contact Ms. Tem at 1-603-271-4588.

Merely. Jefirey E. Schaub, Director Office of Health Management Depurnent of Health and Human Services

             .cc: Diane E. Tem
                    - Dennis P. O'Dowd e u                       -                   -w         *, -w-, m-m m,-. - - -,,     .       - . - - -      gr- w, apryry ,- g           -w,. 1-. g -w

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   .e n r.r.o t h u ,my var l    ,   7d. hs 6. ju. 3, /                  COMPLIANCE INSPECTION REPORT l ,. .         Pe .....g  i PORTABLE CAUGING l y SPECTION BACKGROUND DATA                   (     announced          ( ) unannounced            I       ,.,

'* N T:Pd%I 9 e + Inspection Agency License No. Mk Inspection Date NE Last Amend No. ~ Dateh [6 W Expires __ Renewal 'g ) g.-

                                                                                                   'j?u w *)

(,5fLICENSEE DATA MN,. b . Licensee - Address [ same as Lic. Item 2. Insp. Locatn. [d sa.no as above , contact Title Phone No. $(I 081$ idEk kUAF.- ff!NSPECTOR M l$Mkk M Date. /2) I Supervieor Approval (see item 21) , M T INSPECTION - RESULTS AND ,:ORRICTIVE ACTION INEN M . (Date of last inspection)

a. Noncompliance [ ] None Current Status

                                                        /
                                                    ,/

b. Recommendation [ ] None bd kM Ohmmir VQ I 486'l % lkYM 3 YM% NhC(, It4Mb lQV s&v thessd< u oA of sMe.se M ly.1 NttC. hm sum 4e N9 libus : D00 9 gedu/t Suppledl M

Ahkat f L 11,91 ~ RADIOACTIVE MATERIAL LICENSE INSPECTIONS FIVE-YEAR INSPECTION PLAN Assumptions: Three full-time health physicists assigned approximately half of their time (0.5 FE's each) to the radioactive material section; one part-tiane hemish physicist (approximately 0.25 FE's.) Assumes all health physics staff members have attended 200-hour applied health physics course orequivalent; 40-hours each of the following courses: Licensing ihn:ures, Radioactive Material Inspectum necu"-s, Medical Uses of Radionuclides, aml Industrial Radiography Procedures , as well as periodic refresher courses in basic radiation protection and health physics, and specialty courses, as =aaM Key: Priority 1 inspected every year; includes industrial radiography, irradiator, mobile nuclear medicine; anticipased inspection time for each is I to 1.5 days. l Priority 2 inspected every other year; currently only two broadscope academic type A; anticipated in pection time for each is 2 to 3 days. j Priority 3 inspected every three years; almost exclusively medical t!mycmic uses; anticipated inspection time for each is I day. l Priority 4 inspected every four years; one licensee; anticipated inspection time is I day.

  > Priority 5 inspected every five years; principally portable and fixed gauges, XRFs and G-Cs; anticipated inspection time for each is 0.5 to 1 day.

Our routine inspections schedule based on the current radioactive material licensees (approx. 95) is as follows: Year Year Naasbers of Numbers of Numebers of Numebers of Naashers of Total Neusbers of Reciprocity Est. Number Priority 1 Priority 2 Priority 3 Priority 4 Priority 5 Neunberof Inspectises

                                                                                                                                                                   , M ---       'n "
     .,                         licensees to        licensees to       licensees to    licensees to      licensees to           Roetime            tobe             to be           to be be inspected         be inspected      be inspected     be inspected      be inspected          Scheduled        conducted        conducted        condected Inspectices        by each          by each       by each HPI I                                                                                                                              to be           besith           benIth        permese @

coeducted physicistI physicist per for year per yeart year 2 1998 1 4 1 8 1 12 26 9 2 2 1999 2 4 1 7 0 12 24 8 2 2 2000 3 4 1 7 0 12 24 8 2 2 2001 4 4 1 8 0 12 25 9 2 2 2002 5 4 1 7 1 12 25 8 2 2 Total Number of 4 in 2 in 22 in 1 in 60 in licensees by Priority 1 Priority 2 Priority 3 Priority 4 Priority 5 Priority , NOTE: There are 4 licensees currently categonud as Pnonty 6 (source material as shielding, typically in accelerators) which may be inspected dunng an x-ray or radsoective material inspection, and should Mke no more than a few minutes of time to complete.

     ' Exclude Deborah Russell who is on a part-time schedule most of the year; anticipated that she will co.wfuct only 3 to 4 inspections dunng 1998.
                             ~

2

• Based approximat y on 50% ofot.t-of-state pnonty I licensees (probelly 3); and 25% of out-of-state pnonty 5 licensees (probably 3).

     ' Flexibility is allowed. That is, if one of the staff wishes to conduct more than two inspections in that month, either for another staff member, or to inspect ahead of schedule, this would be allowed. Note also that at the end ofone year (six months total), at two inspe aons per month, the total nu uber ofinspection' conducted would be twelve, winch exceeds the sum of scheduled and recipmcity la=-*ia== The is to take ir.to considerstran an assumed three (3) to six (e) for5i;-sp and'or reactive i==p=<*=a== dunng alm. year.

__ ._ ___ .___-_____-_--___-__---____________-__-_1

p V*$ g , Agenda for Mannt nment Revien Bos,rd Meeting Thursdav. November 13.1997. 9:30 a.m.. TWFN. 2-B ' 1.- Convention. MRB Chair convenos meeting (Richard L. Bangart)

             - 2.      New Business . Consideration of New Hampshire IMPEP Report -                                                                                              - -

A. Introduction of New Hampshire IMPEP Team Members (C. Maupin) B. - Introduction of New Hampshire representatives and other State representative participating through teleconference. (K. Schneider) C. Findings regarding New Hampshire Program (IMPEP Toam) 1

                                         -                          Status of Inspection Program
                                         -                          Technical Staffing / Training                                                                                   ,
                                         -                          Technical Quality of Licensing
                                         -                          Techn'. cal Quality of Inspections
                                         -                          Responss to incidents / Allegations
                                         -                          Legislation and Regulations D.                Questions. (MRB Members)

E, Comments from State of New Hampshire 1 F. MRB Consultation / Comments on issuance of Report (R. Bangart) Recommendation for next IMPEP review

3. Old Business - New Mexico MRB Minutes. (K. Schneider)

4. Status of Upcoming Reviews (K. Schneider) >

- 5. Adjoumment l

l Invitees: Richard Bangart, MRB Acting Chair - Karen Cyr, MRB Member, OGC Carl Papariello, MRB Member, NMSS Thomas Martin, MRB Member, AEOD

Robert Quillin, Colorado L Diane Tofft, New Hampshire .

Cardelia Maupin, Team Leader, OSP William Passetti, Team Member, Florida Craig Gordon, IMPEP Team Member, RI Robert Quillin, Agreement State Liaison to MRB Paul Lohaus, OSP Don Cool, NMSS Kathleen Schneider, OSP Lance Rakovan, OSP L ATTACHMENT 2

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