ML20197C772

Forwards Final Rept for 970819-22, Integrated Matls Performance Evaluation Program,Review of New Hampshire Agreement State Program. Next Review Will Be Scheduled in 4 Yrs,Unless Concerns Develop That Require Earlier Evaluation

ML20197C772
Person / Time
Issue date:	11/25/1997
From:	Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Schaub J NEW HAMPSHIRE, STATE OF
References
NUDOCS 9712240268
Download: ML20197C772 (3)

Text

_

v 0 November 25, 1997 Mr. Jeffrey B. Schaub, Director Office of Health Management Department of Health and Human Services 6 Hazen Drive Concord, NH 03301-6527

Dear Mr. Schaub:

On November 13,1997 the Management Review Board (MRB) met to consider the proposed final Integrated Materials Performance Evaluation Program (IMPEP) report on the New Hampshire Agreement State Program. The MRB found the New Hampshire program adequate to protect public health and safety and compatible with NRC's program.

Section 5.0, page 18, of the enclosed final report presents the IMPEP team's suggestions and recommendations. We have received your letter dated October 23,1997, and appreciate the positive actions that you and your staff have taken and are continuing to implement with regard to our comments. No response to this letter is necessary.

Based on the results of the current IMPEP review, the next review will be scheduled in four years, unless program concerns develop that require an earlier evaluation.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your support of the Radiation Control Program. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely, Origma l Signed by Huc Hugh'h L. Thompson, Jr.

L Thompson, Jr.

Deputy Executive Director for Regulator / Programs Enclosurs: C, C "g As stated Eb Ca Diane E. Tefft, Administrator c;) cc: bec: Chairman Jackson w New Hampshire Radiological Health Bureau Commissioner Dieus i Commissioner Diaz fj Woodbury P. Fogg, State Liaison Officer Commissioner McGaff;gan b Distribution: 240081 DIR RF DCD (SP01) g

SDroggitis PDR (YESj,_ NO )

CGordon, RI SMoore, NMSS l

FCameron, OGC KCyr, 0GC kI C DChawaga, RI h DWhite, RI HNewsome, OGC CPaperiello, NMSS h WPassetti, FL GDeegan, NMSS TMartin, AE0D

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DATE 11/18/97* 11/19/97* 11/20/97 11tX /97 9712240268 971125 OSP FILE CODE: AG-18 PDR STPRQ ESGNH PDR

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Mr. Jeffre s B. Schaub, Director-Office of Health Management 4 Department of Health and Human Services -

6 Hazen Drive' Concord, NH -- 03301-6527--

Dear Mr. Schaub:

On November 13,1997 the Managemen view Board MRB) met to consider the proposed -

finst Integrated Materials Performance Evaluation Prog am (IMPEP) report on the New ' ~

Hampshire Agreement State Program. The MRB fou the New Hamsphire program adequate to protect public heaRh and safety and compatible w' NRC's program. -

4 Section 5.0, page 18, of the enclosed final report esents the IMPEP team's suggestions and recommendations, We request your evaluation a d response to those suggestions and recommendations within 30 days from receipt of is letter.

[ I L Based on the results of the current IMPEP revi w, the next review will.be scheduled in four years, unless program concems develop that equire an_ earlier evaluation.

I appreciate the courtesy and cooperation 'xtended to the IMPEP team during the review and

- your support of the Radiation Control Pr ram. _ l _look forward to our agencies continuing to .

work cooperatively in the future.

i-Sincerely.

Hugh'L. Thompson, Jr.

Deputy Executive Director for Regulatory Programs

Enclosure:

As stated

. cc: Diane E. Te Administrator -

New Hampshire h,adiological Health Bureau Distribution:

DIR RF DCD (SP01)

SDroggitis PDR (YES f_ NO )

CGordon, RI- SMoore, NMSS

.DChawaga,RI FCameron, OGC DWhite, RI' HNewsome, OGC -

WPhasetti, FL, GDeegan, NMSS

- KSchneider j' LRakovan '

New Hamps ire File DOCUMENT NAME; G:\KXS\97FINLTR.NH; ~

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OFFICE fRWP

/ l OSP:1 1dJ[ OSP:D DEDR l l NAME (Mn'M PHLohaus J V '

RLBangart HLThompson DATE /M/ 1/97 11/l Y/97 11/ /97 11/ /97 -

OSP FILE CODE: SP-AG-18 J

l pnneog p 1k -- UNITED STATES

,i } NUCLEAR REGULATORY COMMISSION

• # WASHINGTON, D.C. 3086H001

%*****/ November 25, 1997 Mr. Jeffrey B. Schaub, Director -

- Office of Health Management Department of Health and Hur:an Services 6 Hazen Drive-Concord, NH - 033016527

Dear Mr. Schaub:

- On November 13,1997 the Management Review Board (MRB) met to consider the proposed final integrated Materials Performance Evaluation Program (IMPEP) report on the New Hampshire Agreement State Program. The MRB found the New Hampshire program adequate to protect public health and safety and compatible with NRC's program.

S.4 ion 5.0, page 18, of the enclosed final report presents the IMPEP team's suggestions and recommendations. We have received your letter dated October 23,1997, and appreciate the positive actions that you and your staff have taken and are continuing to implement with regard to our comments. No response to this letter is necessary Based on the results of the current IMPEP review, the next review will be scheduled in four

- years, unless program concems develop that require an earlier evaluation.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your support of the Radiation Control Program. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely, ld)

' L. Thomps i, Jr.

D uty Execut! Dir - r for Regulatory Programs

Enclosure:

As stated cc: Diane E. Tefft, Administrator New Hampshire Radiological Health Bureau Woodbury P. Fogg, State Liaison Officer l

T

4 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF NEW HAMPSHIRE AGREEMENT STATE PROGRAM -

AUGUST 19-22,1997 t

FINAL REPORT U.S. Nuclear Regulatory Commission 4

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4 New Hampshire Final Report Page 1

1.0 INTRODUCTION

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

The 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 membero 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 Statement on Adequacy and Compatibility of Agreement State Programs," published in the Eederal RegisicI 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, were discussed with New Hampshire management on August 22,1997.

A draft of this report was issued to New Hampshire for factual comment on September 22, 1997. The State of New Hampshire responded in a letter dated October 23,1997 (Attachment 1). The State's factual comments were incorporated in the final report. The Management Review Board (MRB) met on November 13,1997 to consider the proposed final report. At the time of the review, the review team found the State's performance to be unsatisfactory for the indicator, Status of Materials inspection Program. Based on the unsatisfactory performance for this indicator, the review team had originally recommended a finding of adequacy, but needs improvement and compatible. However, based on actions taken subsequent to the review, the review team found the State's performance to be satisfactory with recommendations for improvement. The MRB found the New Hampshire radiation control pogram was adequate to protect public health and safety and compatible with NRC's program.

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 approximately 100 materials licenses.

The review focusef 1 the regulatory program as it is carried out under the Section 274b. (of the Atomic Energ) of 1954, as amended) Agreement between the NRC and the State of New Hampshire, 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 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 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 l

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L4 New Hampshire Final Report Page 2

- 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 the previous rcview. 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 summarizas the review team's findings, recommendations and suggesGans. 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 by the State. A response will be requested from the State to all recommendations in the final report.

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. Charis E. Danielson, Director of the New Hampshire Division of Public Health and Servic6s (DPHS), on January 10,1995. In letter dated February 21,1995 from

. Dr. Danielson to Mr. Richard L. Bangart, Director, Office of State Programs (OSP), and during the MRB 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 allitems except those identified below were closed.

2.1 Status of items 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 Regulatiorys; (2) Legal Assistance; (3) Enforcement Procedures; and (4) Inspection Procedures. The status of these recommendations is as follows:

(1) Statue and Compatibility of Regulations. The State had not adopted rules equivalent to

the following NRC regulations

" Emergency Planning Rule,"which was needed by 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, h 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. l 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 rule is scheduled to be i adopted in December 1997. " Standards for Protection Against Radiation," was adopted  !

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. , . . . ~.- , _

1 E

4 New Hampshiro Final Report Page 3 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 license conditions and is scheduled for adoption in December 1997. " Notification of 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 adoption in December 1997. In addition, in August 1995, the New Hampshire Administrative Procedure was amended to exempt BRH regulations from the administrative rulemaking system nf numbering and drafting rules. Under the revised Administrative Procedures, these rules are in compliance with the administrative rulemaking syste.n if the wording is consistent with the language of the corresponding Federal regulations. Thi-s recommendation is closed.

(2) Legal Assistance. Legal assistance was difficult to obtain from the Attorney General's Office on routine legal matters. The review team recommended that the Department take appropriate steps to assure that the radiation control program had prompt legal assistance available when needed.

Current Status: BRH has.oirect access to legal counsel. As the result of a reorganization of the New Hampshire DHHS, an attorney from the Attomey General's office was assigned to the OHM. BRH is a part of OHM and it has direct access to this attorney. 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 civil penalties and establish severity levels for enforcement actions. It was recommended that BRH consider inclJding the revised inspection and enforcement procedures, with the provisions for severity levels and civil penalties, as part of the 1994 rulemaking package.

i l 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 compliance for the period. In addition, BRH indicated that other rules necessary for compatibility had greater priority and that changes as a result of the reorganization 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 Procedures.

(

(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 1394 review team also determined, through interviews with the inspectors, that oral debriefings are held informally with the section supervisor

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New Hampshire Final Report - Page 4 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 GRH review and update, as necessary, the compliance manual chapters for each majcr 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 conform with State regulations. This re:ommendation is closed.

(b) The review team found that several different versions of inspection forms (field notes) had been used over tne review period. Although different intection 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 currer.tly 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 recon.mendation 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 Materia,Is 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 insoection Proaram 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 i 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. 1 The State revised its inspection priority system in May 1997 to closely match the NRC system.

Prior to that time tnere were several priority categories which the State inspected mare  !

frequently than NRC. The review team's assessment of the current inspection priorities verified )

i

)

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.d New Hampshire Final Report Page 5 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. In reviewing the Stbte'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 teletberapy category licensees are scheduled to be inspected oa a two year frequency while the NRC inspects these licensees at a three year frequency. In addition, alllicenses listed as NRC priority seven are inspected on a five year frequency.

The inspection frequencies of licenses selected for technicai 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.

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 team identified 24 core materiallicenses from the BRH database. Thus,33 percent (8 out of 24) of the core licenses were inspected at intervals that exceed the State's and the NRC inspection frequencies by more than 25 percent, which is unsailsfactory 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 inspectior:s were late by periods of time ranging from two to six months.

During the review period, BRH conducted 22 inspections. The team reviewea 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 me t.

For inspection planning, the 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 rou'ine inspections coming due is generated and offered for sign-up to inspection staff. In lieu of making specific inspection assignments, the review team found that inspection staff are expected to initiate selection of inspections from the 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 i

revise its inspection priorities for initialinspections of new licenses to be no less frequent than the NRC's, which is within six months of issuance or receipt of material. In response to this

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A New Hampshire Final Report Page 6 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 ilampshire 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 IMPEP and this recommendation was closed. However, BRH changed the 12 months initialinspection frequency policy to within six months of issuance for all initial inspections.

From the review of the inspection database, BRH was not consistently implementing its revised six inonth initial inspection policy. The database list of 10 new licenses issued during the review period showed that initial inspections were conducted within six months for two of the licenses, one veterinarian clinic (priority 3) and a portable gauge (priority 5). Initial inspection was perforr9ed for three other new licenses at intervals cf 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 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 initialinspection, and three licenses needed initialinspections and had not rece ved them. These licenaes included the following: two issued in January 1997 (NH-417R-Geotechnn.,al Services, Inc., portable gauge, priority 5, and research and development (NH-418R-Metabolic 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 inspections 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 policy.

The timeliness of the issuance of hspection 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 violation 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 Ms inspection report preparation process for those containing enforcement actions to ensure timely issuance of inspection findings.

New Hampshire Final Report Page 7 New Hampshire reported in their response to the questionnaire that 41 material licensees had submitted requests for reciprocity during the review period, These 41 materiallicensees included nine industrial radiography,23 portable gauges, five service, one gas chromatography, and three lixiscopes. These licensees made a total of 307 reciprucity requests. Of the 307 reciprocity requests,143 were portable gauges and 127 were induetrial radiography. Of the nine industrial radiography licensees, the State performed three inspections. Thic effort is below the IMC 1220 guidance to inspect 50 percent of the priority 1 reciprocity licensees. The

. review team suggests that the Stato increase reciprocity inspections to reeet the inspection goals established in IMC 1220.

In a 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, additionalinformation was provided regarding this indicator. The letter indicated that six of the eigM core inspections, which vare overdue at the time of review, have been conducted in addition, Mr. Schaub indicated that the two remaining inspections were to be completed within three weeks of the date of the letter, (At the MRB meeting, Ms. Tefft reported that the two inspections were being completed that week.) With the completion of the six inspections, eight percent (2 out of 24) of the State's core materials inspections would exceed tho 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 recommended that New Hampshlre's performance with respect to the indicator, Status of Materials inspection Progi , 7, be found unsatisfactory. However, based on the actions taken by the State subsequent to the review and tue IMPEP evaluation criteria, the review team recommends that New Harapshire's performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory with recommendations for improvement.

3.2 lenhnical Staffino and Trainina Issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training, and staff turnover. To evaluate 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 Raden,2.5 FTE's in Emergency Response,2 FTE's in Radiochemistry, 3 FTE's in Radiation Machines and 3 FTE's ;n RMS. The remainder of the FTE's we devoted to clerical and generai 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 FTE effort to the agreement materials program which includes materials licensing, inspection, event response, and laboratory activities. These staff members also have additional responsibilities in the Radiation Machines Section and to a lesser degree in the other secEns.

In comparison to other Agreement States, it appears there are a sufficient number of FTE's allocated to the agreement materials program to assure public health and safety. Tnere has been no tumover since the last review and all of the staff have a wide range of licensing and inspection experience. There are a number of overdue core license inspections and a licensing

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4 New Hampshire f.r,ai Report Page 8 backlog that may be partiaily due to the difficulty in balancing personnel between the RMS and the Radiation Machines Secton 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 progrtsss. At the time of the review, there were 98 pending licensing actions,8 adT.lnistrctive reruwals (fee collection),60 amendments,5 new license applications and 25 renewals. Sixty nira of these actions were overdue by over 1 year. As noted in Section 3.1, at the time of the reviow,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 programs, the review team recommends that the State evaluate the number of staff needed to imploment the program.

BRH has established qualifications for its technical classifications, including Health Physicist 1 (HP1) and Health Physicist 2 (HP2). The Supervisor position is an HP2 with the remaining staff HP1's. Applicants at the entry level, HP1, are required to have a baccalaureate degree in a physical or life science BRH does not have a formal documented qualification and training program for the materials staff. However, staff are assigned increasingly complex licensing and inspection duties under the direction of the RMS Supervisor, Staff are required to demonstrate competence during review and accompaniments by the Supervisor. This information was verified through 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 portable gauges. The review tecm determined that all staff utilized for the agreement materiMs program were technically qualified by evidence of their training and experience. However, tne State would ben 3 fit from a training and qualifications plan in the event of staff tumover. The review team suggests tnat 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 Stcte has concerns as to the impact of NRC's change in policy for funding State training and is looking into other training options.

Based on the IMPEP evaluation criteria, the review team recomrrends that New Hampshire's performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

3.3 le&hnical Quality of Licensina Actions The review team examined completed licenses and casework for 13 license actions in 13 specific license files, repmsenting the work of five license reviewers. The license reviewers and RMS Supervisor were interviewed when needed to supply additionalinformation regarding licensing decisions or file contents.

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

Licenses were reviewed for accuracy, appropriateness of the license and for its conditions and tie-down conditions, and overall technical quality. Casework was reviewed for timeliness,

4 New Hampshire Final Report Page 9 adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history on renewals, pre licensing visits, peer or supervisory review as indicated, and proper signature authonties. The files were checked for retention of necessary documents and supporting data.

The license casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The 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.

L! censing 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 dforts underway with regard to agreement materialin 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 files showed that documentation of proper disposal or transfer was available.

Licenses were renewed cn a five year frequency. The State is extending the enewal period for l 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 l period that the license is undergoing the renewal process. Each licensing action receives l supervisory chain review.

l 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 ind!cated that the BRH staff fcilow their licensing guides during the review process to ensure that licensees submit the information i necessary to support the license. The licensing guides were very similar to the NRC guides.

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

4 New Hampshire Final Report Page 10 3,4 Technical Quajity of Insoections The team reviewed the inspection reports, enfecement documentation, and the data base information for 12 materials inspections conducted during the review period. The casework included the State's threo materials inspectors and covered a sampling of different license ty, es 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 information and data collected under NRC Inspection Procedure 87100 and New Hamphire procedures. Inspections were performed on an unannounced basis.

The inspection field notes provided good, consistent documentation of inspection findings. The Stato uses separate field notes for different types of inspections covering the areas of industrial /research development, industrial raciography, 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 organization, personnel protection, posting and labeling, control of materials, equipment, use of materials, transfer, and disposal. The reports were also checked to determinf. 7 the reports adequately documented operations observed, interview of workers, independent measurements, status of previous noncompliance items, substantiation of allitems of noncompliance, and the substance of discussions during exit interviews with management. To assure consistency and quality of reports, the RMS Supervisor provided thorough review and comment, and signed all inspection corresporidence and field notes.

Overall, the review team found that the inspection reports showed excellent quality and 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 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 concern 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 tiiat the commitments made in the licensee's correspondence were implemented. The review team recommends that appropriate State follow up inspection be conducted to confirm implementation of licensee corrective actions when significant problems have been identified.

For the casework reviewed, documented inspection findings led to proper regulatory actions and appropriate enforcement. The RMS Supervisor stated that inspection results showed licensee compliance was acceptable during the review period and that escalated enforcement

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New Hampshire Final Report Page 11 action beyond the issuance of NOVs was limited. A finding from the previous NRC review recommended the 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 Statn's response to the NRC recoomendation, the review team found that the rules in question were not adopted and the manualwhis 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 orders.

Two inspector accompanirnents identified in Appendix E were performed by a review team member on July 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 licensees. 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 inspections were adequate to assess radiological health and safety at the licensed facilities.

New Hampshire has a policy of performing annual supervisory accompaniments of inspectors.

in response to the questionnaire, the State reported that supervisory inspector accompaniments were not performed during the review period. Instead, the RMS Supervisor explained that senior staff reviewed inspector methods during team inspections, ir spectors debriefed with supervisory staff upon return to the office, and inspection reports received close supervisory ceview. Since supervisory accompaniments provide program management a better understanding of both the inspectors' abilities and competence to perform in the field, the review team suggests that the State adhere to the policy of annual supervisory accompaniments uf 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 outside 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.

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.

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'New Hampshire Final Report Page 12 3.5 ' Resoonse to incidents and Alleaations 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, reviewed the incidents reported for New Hampshire in the " Nuclear Material Events Database" '

(NMED) against those contained in tho New Hampshire files, and reviewed the casework and supporting documentation for 14 material incidents and six allegations.

The 14 incidents selected for review included two misadministrations, one lost source, seven -

contamination events, three reported loss of control of radioactive me.terial, and one non-routine event and are listed in Appendix F. Of the six allegations reviewed, NRC Ragion I office referred two to the State and the other four came directly to the State from allegers.

_ 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 meeting 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 incidents. Copies of the Handbook and current calllicts , which include beeper numbers, are distributed periodically to all appropriate persons or agencies. The Statt provides a 24-hour emergency number for anyone to use to report emergencies involving hazardous materials. When a radiologicalincident is suspected, BRH staffis 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 licensees were in the licensing files indicating that the incident would be investigated during the next scheduled inspection.

in responding to incidents and allegations, GRH 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 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 cacework, satisfactory explanations for the discrepancies were available. The reviewer obtained a May 8,1997, "All Events - On line Report," of the incidents sent to Idaho National Environmental Engineering Laboratory (INEEL) for inclusion in the 4

NMED system.-..The Report indicated that 21 incidents had been reported to NMED; however, the NMED file onFf included 11 of these incidents. The 10 incidents were not incluoed for the following reasons. Although a New Hampshire licensee was involved, two ine dents occurred in another State (Massachusotts) and would be listed under that State. Three it idents 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

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New Hampshire Final Report Page 13 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 execlient tracking system for incident files. Wthin the past few months the State obtained access to the internet 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 anr' 1996 that were not previously reported to the NRC. The Neu 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.

Based on the IMPEP evaluation criteria, the review team recommends that New Hampshire's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to b6 used in reviewing Agreement State programs: (1) Legislation and Regulations; (2) Sealed Source and Device Evaluation Program; (3) Low Level Radioactive 'Naste Disposal Program; and (4) Uranium Recovery Program. New Hampshire's agreement does not cover uranium recovery operations, so only the first three non-common performance indicators were applicable to this review.

4.1 Lecislation and Regulations 4.1.1 Legislative and Legal Authority The DHHS 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 125-8 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 Comoatibility of Reaulations 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 comment 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

l New Hampshire Final Report Page 14 during the rule development process. Final regulations are subject to a " Sunset" law and rules expire exactly six years after promulgation for rules adoptd 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 revier of New Hampshire's regulations subsequent to the August 1994 review and discussed the Statt s regulations or other legally binding requirements with the BRH Administrator and the RMS Supervisor to determine the status of the New Hampshire program with regard ;o the imptomentation of regulatory requirements needed to maintain compatibility through December 1997.

The State adopted two NRC regulation amendments since the 1994 review and are implementing five other NRC rules by other lega.ly binding means or they are not currently applicable to the New Hampshire program:

• " 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 regulation was adopted by the State in February 1995, and was reviewed by the NRC for compatibility and health and safety. This review 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.

Based upon this review, two comments with compatibility significance were provided to the State in letter dated August 18,1997. The review team notes that NRC staff is currently reviewing all Agreement State equivalent regulations to Part 20, Standards for Protection Against Radiation. The reviews are being conducted outside the IMPEP process.

• " Notification of incidentt" was adopted in February 1995 for Parts equivalent to 10 CFR Parts 20,31,40 and 70, vid the equivalents of Parts 30,34, and 39 are scheduled for adoption in December 1997. These requirements were reviewed by the NRG as a part of the overall revision of the New Hampshire 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 Compatibility of Agreement State Programs, the review team's evaluation found thes6 regulations would continue to be compatible.

• " 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 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 scheduled for adoption by December 1997.

• " Safety Requirements for Radiographic Equipment," which was needed by l

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

New Hampshire Final Report Page 15 incorporated by industrial radiography license conditions. This rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

• Licensing and Radiation Safety Requhements 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 rule is applicable.

However, tha 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.

• " 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 c'ue 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 , inis rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

• "Self-Guarantee os 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 matter of compatibility. Division 2 compatibility allows the Agreement States flexibility to be more stringent (i.e., the State could choose not to adopt self-guarantee as a method of filmncial assurance). If a State chooses not to adopt tinis regulation, the State's regulation, however, must contain provisions for financial assurar>ce that include at least a subset of those provided in NRC's regulations; e.g., prepayment, surety method (letter of credit or line of credit), insurance or other guarantee method (e.g., a parent company guarantee). This rule has been redesignated as Category D under the Commission's new adequacy and compatibi'ity policy; however, NRC is currently proposing to redes <gnate 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 applications. This rule is a part of the rulemaking packcge which is scheduled for adoption by December 1997.

• " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40. and 70 amendments (59 FR 36026) that becanw effective on August 15,1994 and wac due by August 15,1997. The State currently has no licensee to which this rule is apph able.

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

• " 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 misadministration rule. As reported to NRC previously, BRH withheld adoption of this rule pendirg NRC's revision to 10 CFR Part 35. The NRC is continuing to defer compatibility findings for Agreement States that have not yet adopted a compatiole

New Hampshire Final Report Page 16 Quality Management rule until NRC issues a revised 10 CFR Part 35 rule. When the revision of 10 CFR Part 35 is com91eted, compatibility designations for the new rule will be established, and an effective cate 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:

e " Preparation, Transfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32 and 35 amendments (59 FR 61767, 59 FR 65243,60 FR 322) that became effective on January 1,1995 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 effective rule on the same date.

o " 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 compa'ibility. 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 oojectives of the rule in order to maintain an adequate program.)

e " 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.

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

19 ana 20 amendments (60 FR 36038) that became effective August 14,1995 and will become due on August 14,1998.

• " Medical Administration of Radiation and Radioactive Materials," 10 CFR Part 20.35 amendment (60 FR 48623) that became effective on October 20,1995 and will become due on October 20,1998.

• "Clarificatiori of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995, and will become 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:

New Hampshire Final Repori Page 17 e

• Compatibility with the International Atomic Energy Agoney," 10 CF R Part 71 araendment (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.

e ' Termination or Transfer of Licensed Actis. ties: Record Keeping Requirements,'

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

This requl:ement need not be in effect un'il May 16,1999. The State plans to adopt this rule in 1999.

• Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act,' 10 CFR Part 20 amendment (61 FR 65119) that became effectivo January 9,1997 and will become due January 9,2000. The State plans to adopt this rule in 1999.

• ' Recognition of A0reement 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 to adopt this rule in the year 2000, e 'Critoria for ik B 9 ease of Individuals Admininted Radioactive Material,' 10 CFR Part 20.35 amendment (62 FR 4120) that became effective on January 29,1997 and will become due January 29,2000. The State plans to adopt this rule in the year 2000.

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

4.2 Scaled Somce and Device Evaluation Procram 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 review team verified this in'ormation 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 LoytLeyemadioactive WAtte Disposal Procram in 1981, the NRC amended its Policy Statement,"Cr".eria for Gu! dance of 3tates and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to allew 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 Lt.RW disposal authority, NRC has not required States to have a program for licensing a LLRW disposal facility untWch time as the State has been designated as a host State for a LLRW disposal facility. hn a1 Agreement State has been notified or becomes aware of the need to regulate a LLRW dispoent 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.

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New Hampshire Final Report Page 18 ,

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's performance to be satisfactory with respect to each of the indicators, Technical Staffing and Training, Technical Quality of Licensing Actions, Technica! 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 inspec'!cn Program. Accordingly, the review team recommended and the MRB concurred, in finding the New Hampshire program to be adequate to protect public health and safety, and compatible with NRC's program.

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

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 timely issuance of inspection findings. (Section 3.1)

3. The review team recommends that the State evaluate the number of staff needed 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 oroblems have been identified. (SecSon 3.4)

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 policy. (Section 3.1)

2. The review team suggests 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 qualificatie.ns plan. (Section 3.2)

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

I New Hampshire Final Report Page 19 Good Practice:

The State uses a violation response review checklist to document staff reviews of how the licensee addresses thair response to each NOV. (Section 3.4)

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LIST OF APPENDICES Appendix A IMPEP Review Team Members l Appendix B New Hampshire Organization Charts i Appendix C New Hampshire's Questionnaire Response {

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

Attachment 1 New Hampshire's Response to Draft Report ,

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iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility >

Cardella H. Maupin, NRC/OSP Team Leader l Response to incidents and Allegations  !

] Legislation and Regulations  ;

Craig Gordon, NRC/RI Status of Inspedion Program Technical Quality of Inspections William Passetti, FL Technical Staffing and Trainlag I Technical Quality of Licensing Actions l

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. DEPARTMENT OF HEALTH AND HUMAN SERVICES ,

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Approved by OM8 i No. 3150 0183  :

. . Expires 4/30/98- l INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 00ESTIONNAIRE i Name of State: New Hagshire .

i Reporting Period: August 19,1994 to August 19. 1997 l

(General coment: Ma are curious as to.the ratfonale for this progr6m review taking piece after only three years of the preyfous review, whereas at least one of other states that participated in the orIginst " pilot" MEP is scheduled to be reviand 1n 1999, ffve years fra their last revied.) .

. A. COMMON PERFORMANCE INDICATORS .

I. Status of Haterials Insnection Proaram .

1. Please prepare a table identifying the licenses with inspections .

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• .* 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.

Resoonse to item 1. .

(Coment: 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 0/D" is months overdue '

past the date at 25% greater than scheduled due date. Therefore, ,

5 pars + 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 with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspectton Manual Chapter 2000 appears on the next page.

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~

medicine only) '

1. rBuitWafs[ijffog $?i.wi e'riegis Laborator ';I,j es ?Inc.2 (seeJot g te7below)j:$

f J,{:,,, /.- j $129/96$ j 4 3%,/,v%e.g

"/ c. 4.4 r

. (sutypy.'Heten.filjbratimist Radiation Safety and Control Services.

F disilidA 4%gg..ccdd.704 MpCOMd - " 4.'u u{jdl1 3 08/01/96 3 Inc. -

(Survey Heter ~

Calibration Service)

Stit)os'ep{i iEsMtalM.';F;).y3377.!!.ti:T-3'GTp. .T05/1'8' /9s51 33.2M55

.( Limited s. cope laedt' c alfdiagnysti p,%f

[g.gp P*

with mutpatientitherspeytic m c medi.c.smo3 y)#t.M>r::WlrF},e@. ar

,c;hsest!.

y piLe

12'p yy,p/

w1J21iE3 397 deM,1 ~qg?

p.e'  ; q y i '(g ' ~ %gf.M 2 :qac $3.@

1 u%e, f

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, 2

w,---- -- - _ - - - - -v

F' l l

• Rese nse to item L i

\ The plan of actton has alreaQ been incorporated into the  !

l RedfonctIVe Materials Sectlon's Goals and Objectives, January 1997 \

(and as revised My 1997). Of the seversi initiatives taten, the  ;

health physits staff has been directed to ceplete a mininun of I i

four inspecttons a conth, untt! 2001 cmpletion of overdue l

. Inspections has beon achieved, at which time, w will reduce our  ;

y schedule to a three inspections per nonth mofntenance schedule. .

(The three per month schedule will cover one priority 1 or 3  ?

l licensee, one prforf ty 5 licensee, and one reciprocity licensee.) l As for the currently overdue inspecttons spectfically identified l

~

- on the above Itst, the following is offered: although it has been i recognized for several months that the University of New Hanpshire l (UNH) (Acadenic - broadscape) is overdue for inspect 10n, when '

plans came H t.00rdinate an inspectfon, it was.close to stoner

. break. As stated in the last inspectton report, inspection of r

Itcensed acttvities at WH should not be taken during the swmer.  ;

With as few as 30 principal investigators, mos't of then taking h

! the swmer months off. It is a less than ident situation to carry  ;

out an inspection during the swmer it wuld in no way provide an '

accurate representation of the scops of activities being carried .

V 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 L 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 i inspected in by the end of October 1997. (NOTE: Venegas' currently provides survey instranent calibration services to only .

e tw customers, process Engineering, Inc. (radiography with sources) ani Hitchner Manufacturing (shleided room x ray  ;

radlography). A discusston of licensed act1y1 ties took place over .

the telephone on August 6,1997, with Manuel Venegas, and a copy ';

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 i

inspections of ifcensees are conducted in a timely manner and as per the inspection Schedule, several initiatives are underway. 1

, These include inplementing inprovenents to be inore e,ffective in  ;

1 3

4 -

, --m..-- . , - , , , ,-,.,.y-- q.-%mv ,-,,,%,.c,,rm , r-e n - evve e w w -rw ,- e t-au-me ,-- -o- w eari-,re-, -v*--m--w +e---i.-eem-in- +e'm -vww-in-e- - ----e-=- m-ww-*-www-w we-a-+=-wei-r-wr--+- a-,-

processing license applications, (e.g., staff assigrenent to .

Itcensing cases), conpletely overhauling Itcense data information  :

(f.e. JtS Access database for maintaining licensee information, inspectton informatfon, outanated docunentatfon, taking advantage of Internet access to information available fran NRC and other state RCPs, etc.. now that internet is available to staff (as of  ;

mid July 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 Hamshire specific licensees which are prioritized to br inspected less frequently

. than called for in the NRC Inspection Manual Chapter 2800. The program fully adopted the NRC inspection schedule in April 1997 with the exception being the adninistrative decision not to have a Prioritj 7 category, the lowest category being a Friority S.

(Note: prfor to adopting the inspectton Manual Chapter 2800 priority listing, most radioactive material Itcensees in New Hamshire wre scheduled for inspection on a cut frequent basis than the NRC listing. (e.g., portable gauges, every 4 years; all medical facilities, every two years: broadscope acadenic institutions, every year)

4. How many licensees filed reciprocity notices in the reporting '

period? ,

Etsoonsetoitem4 Approximately 50 licensees

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

Etsponse to item 4a. 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

. c .

Rosbonne to itm etL Of these, 3 industris1 redtographers wre inspersed. (Other inspections wre carried out for out-of state gauge 1icensees.)

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

. radiographers were performed?

i f Resnonse to it m E.

One ffeld fnspection of our sols industrisi rodtographer suthorited to perform ffeld site activitles was inspected. -

2 l 6. For NRC Regions, did you establish numerical goals for the number '

i of inspections to be performed during this review period? If so, please describe your goals, the numher of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed ResDonse to item 6. Not app 11 Cable

[ 11. Technical Staffino and Trainino ,

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 i

program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following ,

areas: administration, materials licensing & compliance, emergency response, LLW, U mills, other. If these regulatory responsibilities are divided between offices. the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor wrk of ,1unior personnel.

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

gg FOSITION PRINCIPALAREA0F III Eff2I L .

5 I ~- [

ResDonse to It m 7. .

7. Thi 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 also 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 18.00 hours0 days <br />0 hours <br />0 weeks <br />0 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, eme gency response. LLW, U mills, other) as requested, as.the professional staff 1: 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) tb / received, if

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

ResDonse to it m B.

There wre no new'professwv personnel hir$i since the last I review. .

9. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC Inspection Manual Chapters 1245 and 1246: for Agreement States, please describe your 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. .

ResDonse to It m 9.

All hesith physic staff avst have at least a Bachilor's degree in the physical or life sciences. All are expected to attend, at the very least, so called ' core" courses in radioactive snattrial 11 censing and inspections (80-hou s), app 1ied health physics (200-hours), industrial radiography (G-hours), nedical uses of 6

t

r i

>. l radionuclides (40. hours), radiological earrgency 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 beve copleted these core courses, j j

gg c0RE c0URSES MEDED

{

p Diane E. Tefft No additional core courses needed. l Dennis O'Dowd No additional core c rses needed. .

J. Christopher pirie Well Logging Course (Note: There are currently no kell

- logging licensees in AN, sM such activities are rarely.

If ever, conducted within the state)., .  ;

i

- Mario fannaccone RN1 Transportation; a short course in N transportation  ;

.is expected to be given at this yirst's Annus! New .

England Radiological Hesith Cmittee meeting in  ?

Massachusetts and sysflable for attendancc to staff.

p .

Deborah Russell RMI Transportation; a short course in RM1 transportation is expected to be given at this year's Annus! New  ;

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

l Kathleen McAllister RM1 Trensportation; a short course in RM1 transportation '

is expected to be given at this year's Annus! New England Radiological Health Cmittet meeting in l Massachusetts and sysilable for attendance to staff.

Twils Kenns No core courses needed for current duties and responsib111ttes in radio-analytical laboratory sypport.

However, in order to expand Ms. Kenna's responsibf11ttes, particularly in the sres of >

inspections, she will need to attend a radioactive anterial inspection course.  :

L 4 4

[ .

-..,-,-#- - . .-...-er--.,-,,--y, ..,.r- e,-- - , , ---r-----m,.. .-%.---c<---- e..ww,- - , - - - . - . - ~<w-,.nw. .-er ~-ww- s,.--em+ . - --m._-A--- - - - - --~- _ - - -<

4

,j t

10. Please identify the technical staff who left the RCP/ Regional DW5  !

program during this period. I i Rosconse to itm 10.

[

There wre no technical staff kho left the Bureau of Radiological i Health during th1s period. Honver, one indfvidual, Deborah  ;

Russell began pursuing a Master's Degree. In Industrfel &gtene l l over a year ago and is currently wrking only on a part ttnie i basis.

i

!!!. Technical Duality of Licentina Actient  !

! I

11. Please identify any major, unusual, or coglex licenses which wre 1ssued, received a major amendment.,teminated or renewed in this period. ,  :

I ~

i Rosconse to item 11. .,

?

License Name License

• License Type Number

) '

Syncor internatfonal 391R Nucle'ar Phannacy

) '

American Health Centers 402R Mob 1le Naclent Medfcfne Service Metabolic Solutfons 418R Research, Development, Medt. cal Manufacture -

Rochester Equ1ne C11nic 397R Veterinary Nuclear Ned1cfne  ;

Stocker & Yale 395R Tritfun Device Manufacture t Seaconst Cardiology 389R Nuclear Cardiology l

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

~

i Resoonse to item 12.

\

To our knowledge, there wie no new or amended 11 censes added or  ?

removed from the list of ifcensees requiring energency plans  :

. during this period.

)

13. Discuss any variances in licensing policies and procedures or ,

exegtions from the regulations granted during the review period. -

I 8

i

2

ggggggg, to 1tm 1.1.

To our knowledge, there wre no variances in Itcensing policies \

and procedures or exmptions .from the regulations granted during this period.

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

during the reporting period? l Res00nse to it m 14.

No mejor changes since last review.

15. for NRC Regions, identify by licensee name. license number and l type, any renewal applications that have ben pending for one year  !

or pore. - -

ResnoksetoItm15. Not applicable

]V. Technical Duality of Insoections i

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

Res00nse to itn 16.

In January 1997, inspection priorities wre exif fled to reflect the latest changes in NRC Manual Chapter 2000.

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

Res00nse to itm 17.

Suoervisor Insoector License Cat. Dgig None. (Conment: Since the inst review, team inspection of major Iftensees wre carried out. In which our moie senior (non-supervisory) staff nunbers accmpenied other. staff and reported to 9

O l - ~ .. . . - . . - _ . ~ . - , . . . -- _ , , . - - - - - - , . . . . .

.,l

\

the sectto .Mrvisor on inspectors

• methods. Also, within a day Or tuo following each ad every inspection conducted, a detsfled c\e brinffng on the ffMinos are convejed ta the settion i

~

smervisor, in addition to identifying ery signifIcent issues.

requfring promt action, inspection nethods aM discussion with '

annagement. R50's aM staff are described. All inspection field

} note reports are reviewed by the smervisor.)

1

18. Describe internal procedures for conducting supervisory  !

secompaniments of inspectors in the field. If supervisory  !

accompaniments were documented, please provide copies of the documentation for each acco m animent, i

l Resoonse to item 18 Internal procedures are that each hfpith physics staff nuber should be accmpanied once a year on en inspection. . i

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

-present time? -

ResDonse to item 10 s Equipment is calibrated on a routine basis, depending on type of use. All equipment currently in use has been appropriately calibrated. Typicallf, survey instranents used during ifcense inspecttons are calibrated at a frequency required of the category of ifcensee (e.g.. Instranents used by BRH inspectors when  ;

inspecting iMustrici redtography Itcensees have been enlfbrated e

within the last quarter.) Conplete docwnentation of instrunent calibration is attached.

V. Resoonses to incidents and A11eantions

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

medical misadministration, overexposures lost and abandoned i sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc.)

' that occurred in the Region / State during the review period. For '

Agreement States information included in previous s.ubmittals to

, i 10 s

.e h

. .. , , . - _ _ - , a_.- .- - . . ..

l ..

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

- format: -

i

+ nosbonse to itm 20. -

s i

LICENSEE IME LICENSE # DATE OF 7YK OF INCIDM -

l EUEEIl.BEB1 ,

A listing of all incidents recorded in the Buresu's incidents database is l sttached for review.

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

Resbonse to it m 21. .

All such events wu1d be reported to the oppt'opriate agency. Please reference the attached listing of incidents for information oro such incidents. _

r

a. For States, was timely notification made to the Office of State  :

Programs? For Regions, was an appropriate and timely PN generated? ,

ResDonse to ita 21a.

All such events wvid be reported to the appropriate agency.

Please reference the attached Ifsting of incidents for informatton on such incidents

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 4 provide details for each case. ,

4 11

/ .

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

e ,

i Resoonse to Itm 22.  ;

.3 l

%r Irwidents involving failure of equipment or sources.

Information on the . incident would be provided to the agency .

respon!!ble for evaluation of the device for an assessment of .

Possible generic design deficienqv. ,Please reference the attached ilsting of incidents for infonnation on such incidents

23. In the period covered by thic review, wre there any cases  !

1'1volving possible wroogdoing that wre reviewed or are presently undergoir.g review? If so' please describe the ciretastances for each case.

9,.yDonse to item 23, ,

In the period coverm'by this review, there wre a few cases invalet'g pasibic wrongdoing that wre revieset and/or presently unaGrgving rN iaw. knong these are:

Atlantic Teuing Lmtd., a portable r.uclear gau;< licensee. In .

kbich the license ws: cuspended for a period of time based on several violations: .

Department of Enyt."orrnental Services laboratories, in which small awunts nf source materisi (in general Itcensed or exerpt )

quantitles) wre stored:

An unlicensed NWI source supposedly possessed by an !ndividual:

24. Identify any changes to your procedures for handling allegations that occurred during the period of this review.

Resconse to itemfi,

, in the period ccvered by th1J review, there wre no significant 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 allegattons 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. '

e 12

e "

A' .Roseanno to item 24n.

et the present time, there are tw such cases.  ;

Che involves ABC Testing. Inc. an industrisi rediographer '

1icensed by the ARC wrking in the New HamshIre under i recfprocfty, issues 1nyolve the question of dether the Bureau was appropristely notified that ifcensed act1yities ,

wre taking place on that date and whether the licensee ,

should have reported to the state the circastances '

1nvolving an incident 41ch resulted in exposure below  ;

i reguistory limits Alle wrking in the state.

The second issue involves a newspaper artic1e which references Kearsage Metallurgical in No. Conway (a former l industr101 radiography licensee) as having been involved in filegs! dwptng of unsealed radioacttve matertal in a pond adjacent to the fac11Ity. Th1s esse had undergone extensin review in the past, with unsubstantiated allegations hoeing r been made for many years. In spf te of the fact that the  ;

factlity was never Itcensed to use unsealed rodfoncttre  ;

meterfal. This case is consfdered closed by the Bureau.

despite atterpts by the NRC to considec it open based on the unsubstontiated art 1cle.

VI. General l 25. Please prepare a sumary of the status of the State's or Region's actions

taken in response to the coments and recomendations following the last review.

ResDonse to item 24n. -

! The last review team provided the following sumary list of ,

recomendations, for action by the Stato.

4

1. The review team recomended that BRH revise its inspection

, priorities for initial inspections of new itcenses to be consistent with'RC's.

d Adoptec.

a 13 g 4 g

. .' i

. i

. l

2. The reviw team recomended that BM revise its inspection  !

priorities to conform to their current practice of annual l

. l inspect 6cn for fixed industrial radiography licenses. , l l .,

Adopted. ,

l 3. The reviw team recomended that the inspection procedures be j revised to include all essential elements of the inspection and to j j conform to BM regulations.

Adopted. I

4. The reviw team recomended that the SM narrative reports used for .

routine inspections cover each of the essential elements covered in l 4

the inspection forms. .

r l . t Adopted. ,

+ ..

5. . The rev1w team recomends that BM reviw, update, and standardize  !

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

l i  !

Not adopted. The difficulty here lies in the. fact that with the l tules update process underway..it makes little sense revise inspection )  :

forms at this time. What has been done homever is for staff to become l familiarized with NRC inspection forms and to use these as references to i supplanent our current inspection forms. In addition, some new

• inspection forms have been produced (i.e.. the Irradiator inspection  :

form). -

l l 6. The reviw team recomended that the model, serial n . ..r. and  :

L calibration date of survey instruments used during BM inspections .

be included on each inspection report. -

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

instranent used, so that should this information be inadvertently omitted from the fleid notes, it wuld be available by referencing the  :

i instrunent sign out sheet and survey instrument database, r i

7. The review team recomended that BM inspectors perform instrument

-response checks against known reference check sources on radiation detection equipment used on inspections.

i 14 p .,

t

. i Adopted. In fact, check Jources sere bought and attached to l certain surny instrunents.

l

8. The rev1w team recomended the Division of Public Health take steps to accelerate the promulgation process in order to maintain regulations conpatible with the NRC's.

Adopted. An exerption was written into the adninistratin Me statute to allow more flexibility in our rulenaking. ,

9. The reviw 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-organizotton 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 occasion recently sought the assistance of Office of Program Support's legal Coordinator. .

John Debu11ewicz, and also. the legal counsel in the Caisstoner'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, i

Not adopted. In tenns of priorities in rulenaking. Other provisions required for conpatibility have greater priority at this 1 time. In addition, enanges already in place brought on by the department's rc. organization siong with potential changes in an ever dynamic area of re-enginetring the department makes it 1 prudent at this time to take s waiting" approach with regard to l the area of enforcenent, untti final decisions see reached at the .

caissioner'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. .

i 15 c

l

, 4

--...# , , . . . . . , _ . - - ,m r_ . . . .- ,.._._,-,,_,,+mm.,a....,,__. .- .~., ._4_. _ . , _ , _ - . , _-,%~ ~_-- - ...

. . i

- i i

ResDonse to It m 242.

Strengths: -

Staff Training and Expe" fence in a wide variety of areas of responsibtiitles i Waltty of Lteensing Acttons Quality of Inspections Quality and Timeliness of incident Response Ovality and Timeliness of Radiological Emergency Response kality, @sntity and Availability of Field Radiological .

Instrunentat100 Weaknestes: ., .

Staff Responsibilities in Several Diverse Areas Unavailability of Radiological Training for Staff I Lack of Strong Support for Program (at least in the past)

Timsliness and @antity of License Applicattons Processed Timeliness and Quantity of Inspections Conducted, including those for reciprocity Reliability of Radio-analytical Equipment Capabf11ty low Morale of Staff based on ever-increasing responsibilities at relatively inadequate pay 9

4 9 e

. 16

, -o,

-_ +- - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . . ___ ___ m.____._..._.-m. _________- _.._____ _ . .-__.

e i P . NON. COMMON PERFORMANCE INDICATORS i

t I, Aeoulations and teaal Authority  !

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

Resbonse to item 27. i l

RSA 125 F:1 2S Radiological Neolth Program RSA 107 B Civil Defense Act RSA 12S B:1 New En91snd Cmpstt Radiolo9fcal Health Protection RSA 125:77 B Radioactive Weste Prohibitton

. 28. Are your regulations subject to a Sunset

• or equivalent law 7 jf so, explain and include the next expiration date for your regulations.

Resconse to item 29.

• Yes, ever'y 2ix years for rules adopted prior to' August 1994, and every e1ght years for rules adopted after August 1994. NH rules equivalent to 10 CFR Parts 19, 20, 39, 61, and 71 e.ere adopted in february 1995.

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

Identify those that have not been adopted by the State explain why they were not ado,nted, and discuss any actions being 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 n.aintain conpatibility with the NRC.

shcwing the normal length of time anticipated to complete each step.

Restonse to item 30.

Reference Table ~29 attached.

17

/

II. Sealed tot ece and Device Prooram I

~

31, Prepare a table listing new and revised SS&D registrations of sealed .

sources and devices issued during the review period. The table heading should be: ,

SS&D Manufacturer. Type of Registry Distributor or Device Number Cuttom User er Source

. Resconse to iten 31.

There have been no new and revised SSku registrattons of sealed sources and devices issued during this review period.

37'. What guides, standards and procedures are usedio evaluate reg'istry applications?

ResDonse to item 32. ~

Jn the event that such an evaluation was nece'ssary, all available )

NRC guidance, standards and procedures wuld be used, including ,

v Regulatory Guides 10.10 and 10.11 ANSI standards, etc. wuld be used, as required by the agency's and generally accepted .

1icensing procedures.

33. Please include information on the folle ag questions in Section A, as they apply to the Sealed Source and Device Program:

Technical Staffing and Training - A.II.710 Technical Quality of Licensing Actions - A.III.11. A.!!!.1314 Responses to Incidents and Allegations - A.V.20 23 -

Resoonse to item 33. .

thcitar SS to the references.

g.

1 18 4

9 e ek e

+ ' -

5.11. Law. Level Waste Procran

34. Pleashinclude infonnation on the folloking questions in Section A. as

' they apply to the Low level Weste Program:

Status of :taterials Inspection Program - A.I.13. A.I.6 '

Technical Staffing and Training A.II.7-10 Technical Quality of Licensir:g Actions - A.!!!.11. A.III.1314 i Technical Quality of Inspections - A.IV.1619 *

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

. Resnonse to item 34.

Not appilcable. .

V i IV. Uranium Mill Procram .

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

Status of Materials Inspection Program - A.I.)-3 A.I.6 Technical Staffing and Training - A.II.710 Technical Quality of Licen31ng Actions - A.III.11. A.!!!.1314 Technical Quality of Inspections - A.IV.1619 Responses to Incidents and Allegations - A.V.20 23 Resconse to item 35.

Not appilcable.

3

' 9 4 19 e

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UPDATE: IS APR 97 Seese penumet nemmed to hem senege see a MEEnd. Deesy peded emessehe 3I hdfSees. 30. sensdum shoes ladysume Summt reennyeye unnsehem- is dhysse ermean. . ' ctAss Em Reported toNRC Y tAs IJc# ZZZ g  ; 9fl7M6 )Sf900123 Psfleet heelst old M sel d===f Old pamamew Mt973 W servism) was Esmed to esmhim pinesdum230 ponersemes. bgAma estWadydust by ta-==m===== Generst Humpled. Inan was seammed to emetbeest.Bl commet T " " . _ _ , ctASS E" JETS Reported te NRC Y IJef 13sR  ! OTH ~ 90ew MHypees) Deshmer sapenho sudse shows hdMessi eth amamdy high esgoume ($85mdhal tesween 4W96 ari 90W96. ludidend Seymmsy some deshusey hedge se i p =eastundeh=mm e nha , ctAss Evtuts Reportedto NRC7 Y E3r IJe # 145R -

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APPENDIX D LICENSE FILE REVIEWS File No.: 1 Licensee: American Health Centers,Inc. ' License No.: 402R

        ~ Location: Bedford, NH                                                      Amendment No.: New License Type: Mobile Nuclear Medicine                                         Type of Action: New
        . Date issued: 11/1/96                                                       License Reviewer: CP Comment:

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: Venegas 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 wndition 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 Action: Amendment Date issued: 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 Da:e issued: 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.

 )*:

New Hampshire Final Report . Page D.2 License File Reviews : File No.r 6 - Licensee: Catholic Medical Center _ License No.: 109R: : Location: Manchester, NH Amendment No.: 41 License: Type: Diagnostic / Limited Therapy Type of Action: Amendment Date issued: 12/16/95 License Reviewer: DO-File No.: 7 Licensee: Dlatide, Inc. License No.: 377R Location: Londonderry, NH Amendment No.: 9 License: Type: Research/ Development Type of Action: Amendment Date lasued:- 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 E Date issued: 2/24/97 License Reviewer: Ml File No.: 9 Licensee: LeadTech, Inc. License No.: 396R Location: Moultonboro, NH - . Amendment No.: New License Type: Fluor x-ray Type of Action: New Dateissued: 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. File No.:' 11 Ucensee: Elliot Hospital License No.: 182R Location: Manchester, NH Amendment No.: 41 License Type: Diagnostic / Therapy Type of Action: Amendment Date 'ssued: 7/17/97 License Reviewer: DR File No. 12 Licensee: JaworskiGeotech,Inc. License No.: 345R Location: Manchester, NH - Amendment No.: 9 License Type: Portable Gauge- Type of Action: Amendment , - Date issued: 8/5/9A Ucense Reviewer: DR

     - New Hempshire Final Report ' '

Page D.3 License File Rev'ews File No.: 13 . . Licensee; Ear, Nose & Throat Phys. & Surgeons, P.A. . License No.: 333R Location: Manchester, NH - Amendment No.:

     . License Type: !n vitro lab                          - Type of Action: Termination Date issued: 4/20/95                                      . License Reviewer: DR 6

4 i e

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 overdue, b) Report does not identify whether worker interviews conducted.

  . File No.: 4 Licensee: M&W Soils Engineering, Inc.                                              License No.: 264R Location: Charlestown                                 Inspection Type: Unannounced, Routine, Field License Type: Portable Gauge                                                                 Priority: 5 Inspection Date: 12/12/96                                                               Inspector: 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 Location: Charlestown Inspection Type: Unannounced, Follow-up, Partial License Type: Portable Gauge Priority: 5 Inspection Date: 6/04/97 Inspector: DO Comments: a) Telephone conversation used as inspection but phone record not in file.

New Hampshire Final Report Page E.2 - Inspection File Reviews b) No documentation in file to support NOV for gauge possession. File No.: 6 Licensee: Monadnock Community Hospital License No.: 368R Location: Peterborough inspection Type: Unannov. iced, Routino, Field License Type: Hospital Priority: 3 Inspection Date: 1/25/95 Inspector. MI Coniments: a) Report does not indicate wherner 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 Inspectic.1 Type: Unannounced, initial, Office Ucense 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). Filo No.: 9 Licensee: Professional Service Industries, Inc. License No.: 400R Location: Portsmerth Inspection Type: Unannounced, Routine, initial, Field License Tvoo: Ponable Gauge Priority: 5 Inspection Date: 6/11/97 Inspector: CP Comments: a) Inspection not performed within 6 months of new license issuance. b) Findings discussed with management not identified. i

3 l l New Hampshire Final Report Page E.3 Inspection File Reviews File No.: 10 Licensee: Public Service Company of NH License No.: 313R Location: Newington inspection Type: Unannounced, Follow-up, Field License Type: Fixed Gauges Priority: 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 License Type: Private practice - diagnostic Priority: 3 Inspection Date: 3/22/95 Inspector: CP Comments: a) Initial inspection exceeded 6-month interval after license issuance,4/94. b) Question about labeling of containers adequately resolved with supervisor, c) NOV issued 2 months after inspection. File No.: 12 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. In addition, a team member made the following inspection accompaniments as part of the onsite IMPEP review: Accompaniment No.1 Licensee: Trustees of Dartmouth College License No.: 382R

                                       ' Location: Lebanon                                            Inspection Type: unannounced, routine License Type: Self-shielded irradiator                                                           Priority: 5 Inspection Date: 7/10/97                                                                Inspector: MI Comments:

a) Survey of area below facility for radiation exposure not evaluated by inspector, b) The inspector did not discuss that leak tests were not performed 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.

i New Hampshire Final Report - Page E.4 - Inspection File Reviews

                                                                                                                                ~!

Accompaniment No. 2  : Licenses.~ Cheshire Medical Center License No.: 256R  !

               ' Location: Keene                                                  Inspection Type: unannounced, 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. 1 9 U d t

                                                                                                                                  +

e ts-

l APPENDIX F INCIDENT FILE REVIEWS File No.: 1 Licensoo: Huggins Hospita) License No.: NH 301ct Location: Wolfoboro, NH Date of Event: 6/16/97 Type of Event: Contamination Summary: Licensee tocolved 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 retumed to them on 6\17\97. File No.: 2 Licensee: Huggins Hospital Licenso No.: NH 301R Location: Wolfoboro, NH Dato of Event: 6/20/97 Type of Event: Contamination Summary: Licensoo reported minor spill from IV in patient on toadmill. Approximately four droplets of thallium-201 fell on the treadmill. The area was se ured from the public. The area was surveyed and decontamination procedures were conducted. After decontamination efforts woro completod, the treadmill was the only area which continued to show rneasurable activity. The troadmill was moved to the nuclear medicino laboratory and was draped with lead aprons. Fiie No.: 3 Licensoo: Huggins Hospital License No.: NH 301R Location: Wolfoboro, NH Date of Event: 12/11/96 Type of Event: Contamination Summary: Patient was niven 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 personnelimmediately st.?ured the patient and room an initiated decontamination proceduros. Af ter 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 f;oor was covered with lead, plastic and absorbent material and marked as radioactive contamination. File No.: 4 Licensee: Huggins Hospital Licenso No.: NH 301R Location: Wolfeboro, NH Date of Event: 3/25/96 Type of Event: Contamination Summary: On March 25,1996, the licensee received a contaminated shipment of bulk Technetium 99m from Syncor Wipo tests were performed on the lead pig upon receipt. Decontamination of materials was successful. Syncor was notified by letter.

New Hampshire Final Report Page F.2 Incident Files Roviews File No.: 5 Licensoa: Huggins Hospital License i4o.: NH 301R Location: Wolfeboro, NH Date of Event: 3/21/96 Type of Event: Contamination Summe>y: On March 21,1996, the licensee received a contaminated shipment of bulk Technet!um 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 LIconsee: 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 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. File No.: 7 Licensee: Exeter 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 intended 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. I

r New Hampshire Final Report Page F.3

     -Incident Files Reviews File No.: 9-Licensee: Exeter Hospital,Inc.

License No.: NH 138R Location: Exeter, NH Fate 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 power source. Implant was originally perforned by-Massachusetts General Hospital. The old pacemaker was returned to distributor. File No.: 10 Licensee: Chestdre Medical Center Location: Keen 9, 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 mCl as of the date of the report. The two sources were taped together.

Comment: A copy of the Incident report needs to be placed in the licensing file. File No.: 11 Licensee: Cheshire MedicalCenter Location: Keene, NH License No.: NH-205R 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 International Corporation in Woburn, 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 Imp! anted on July 2,1953 at Mercy Hospital in Springfield, Massachusetts when the patient was 5 mor.ths old. The doc; ors 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 possess an of the seeds from the hospital. A positive identification of the radioactive contents of soeds were not possible after a national search; however, it is believed that the seeds are radium.

   - 4 w
     .4
 ,         New Hampshire Final Report                                                               . Page F.4
         - Incident Files Reviews-
                                                                                                                 ~

Filo_No.: 13) .

         - Licensee: Miiler Engineering & Testing                                                                :

License No.: 278R . Location: . Manchester, NH .- Date of Event: 2/6/96 . Type of Event: Loss of Control. Sumrnary: The licenses notified NRC headquarters Operations Center that a Troxler moisture , density gauge containing radioactive secrees had been stolen from the back of a pickup truck in Dorchester, Massachusetts According to the licensee, the gauge user waJ retuming 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 bed of the pickup. When the user retumed to his truck after a stop, he discovered the cab unlocked and the chained container was missing. The ilcensee notified the Boston City 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 . e Licensee: Mary Hitchcock Memorial Hospital License No.: NH 130R Location: Hanover, NH Date 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. O i.

l l *. , b I ATTACHMENT 1 RESPONSE FROM STATE OF NEW HAMSPHIRE TO THE DRAFT IMPEP REVEIW

_. . . _ . _ .___ ___ __ _ _ _ .. ___ _ . ~ . . _ . _ . . _ _ _ . . . _ _ _ _ - . _ ! .: , - STATE CF NEW HAMPSHIRE .

             .                                          DEPARDfENT CF BLtLTH AND HUMAN SERVICES j.p
                                                            . OFFICE OFHEALTH MANAGEMENT                                                           .

a PUBLICREAL1HSEM1CM Tavy t Mwho 4 NAEEN DRrYE. CONCORD,MI S33:16 27 Ceeh - ass 278.esss - TDD Asesses losss 73s 3964 g asser s.sease6 I; neweer - October 23,1997 l Richard L. Bangart, Director > Office of State Programs U.S. Nuclear Regulatory Commission i - Washington, D.C. 20555-0001

Dear Mr. Bangart:

i_ His !s to acknowledge 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 factual correctness and have discossed the recommendations and suggestions made within with my staff.

I offer the following suggested changes and comments for your review: , l Sunested Factual Channest Ref. Pane 1. Sec.1.0 IntrnAetion

                                  - Paragraph 1: ne 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 aanagement on August 22,*1997."
                                  - Paragraph 2: The New Hampshire 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. Sec. 3.1 Status of Materials Innnection Pron am I

                                  - Paragraph 1: The sentence beginning " Initial inspection was performed for three other new licenses at. " contains a reference to an initial inspection performed at an interval of "24 months                               l (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 2

mis-filing of the report which also resulted in the intpection not being entered into the database tracking , i as having been completed, another staff member under the impression that inspection had yet to be a completed conducted a second inspection a year later. (A copy of the cover ara final pages of the 4

September 21,1995 initial inspection field report is attached). Therefore, since the date ofissuance of 1

the lic mse was November 29, 1994, we request that *24 months" be deleted _ and "12 months" substituted.

p g

l Richard L. Bangart, E.setor

   -       Office of State Programs October 23,1997 lj          Page 2 Paragraph 1: De sentence beginning "Dese licenses included the following: one license issued in 1995 (as a second license for a medical facility). " De referenced license is for use of source material (depleted uranium) encased in steel for shielding in an industrial device (i.e., linear accelerator).

In most 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 equlvalent 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 the list. He 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 1,1996. The BRH had obtained both telephonic and written confirmation that this licensee has not yet possessed radioactive material, based on our attempt within six months oflicense 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" inspections.

Ref. Pace 7. Sec. 3.1 Status of Materials Insoeetion Procram

                    - 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 Program, 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).

Br.f. Pace 7. Sec. 3.2 Technical Staffine and Trainine

                    - Paragraph 2: De New Hampshire organization chart shows that the BRH was funded for 17 persons at the time of the review or 15.26 FTE's, based on !800 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 apprettmately 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 remainder 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. De 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. Rese staff members also have additional responsibilities in the Radiation Machine Section and to a lessor degree in the other Sections.

                                                  .                                                 e

       *-        . RichardL.Bangart, Director                                                                                          l t..a           Of5os'of State Programs                                                                                           i
       -             October 23,1997 M;             Page 3                                                                                                           l r

Ref. Pane 13. Sec. 4.1 Impialation and Reaulations

                              - Paragraph 4.1.1: %e legislative amendment was indeed made to the New Hamphire -                       l I

Administrative Procedure Act in August,1995 but h did not exempt the BRH rules imm the State's administrative rulemaking system. Instead, the legislation has exempted these rules "from the formatting

                  ' requirements of RSA 541 A:3." His has been i, c j to mean that the BRH does not have to follow                    ,

the Rulernaking 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.          .

Responses to Recommendations: -, q Recommendation #1 i Although as of the date of completion of the onsite review, the information described in Sec. 3.1 4

,                   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).

i Dese two remaining inspections are scheduled to be completed within the'next three weeks. In addition, - L - we have implemented additional measures to put the materials inspection program back on schedule. An L linspection plan was put into effect whic'n clarifies the inspection schedule His should assist in short and I - ' 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. He " inspections due" list are now to be presented

j. menthly at one of the regularly scheduled bi weekly staff meetings. - At that time, assignments to

, individual staff members are to be made and the dates for completion of the due inspections are to be scheduled. . Based on the actions taken to date, we request your consideration for removing this recommer.dation, and therefore, changing the fmding for the indicator, Status of Materials Inspection Program,to satisfactory. Recommendation #2 L " De BRH is currently revising and improving its inspection report preparation process for those contain'ng enforcement actions to ensure timely issuance ofinspection findings. One change is simply , ensuring that routine scheduled inspections are carried out early enough in the month to allow . i completion of reports prior to the principal inspector taking the next month's assignment in the radiation machine section. In addition, discussion between the radiation machine section supervisor and the radioactive material section supervisor have led to an understanding that health physicia will use time while in the other section to complete necessary reports for the other section, as necessary. i Recommendation #3 De BRH has addressed this issue'on numerous 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: L l t

• Risard L.Bangart, Director

. ' Office of State Programs

  -         C+tober 23,1997
'.          Page 4

h. -

1. Stagcoverage . The BRH with its limited staff resources must insure against unplanned events such as vacancies, lay-offs, hiring freezes, positior, removal and budget cuts. If the BRH decided to permanently assign two ofits 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 cunent in this field if working in x ray and visa versa.

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 DRH 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 Rar:loactive Material or Radiation Machine Program. If the BRH could not draw on the expertise of all of its Health Physics staff during this time, the affected program's capabilities would be greatly diminished.

3. Most staflike the rotation process. - De majority of the Health 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 overalljob mbre interesting. Deficiency letters um be written in, one month with responses awaiting the persen's retum 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 with the current biennial budget and Department position cap. He BRH feels that as long as the present staffis retained, the Agreement State Program can be effective. Recommer.dation #4 De BRH agrees with the accommendation that appropriate follow up to inspections be conducted to confirm implementation of licensee corrective actions when significant problems have been identified. He staff has been made aware of this, and this practice has already been implemented into the inspection program. Resnonses to Succestions:

      -       Sunnestion #1 As stated in Sec. 3 of the report, the BRH has maintained that the 12 month initial inspection for low 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, ne 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,'regardless of our practice of hand-delivering all new licenses and explaining the regulatory
                                                                                                                                       <                                1
                                                                                                                                         ~~

Richard L.Bangart, Director

• Omce of State Programs

    ~

October 23,1997 * ,' Page5 , requirements with the licensee. Howevar, for the purposes of clarifying the issue, the BRH 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 !aW initially v>ithin 12 months.

Sunes119aB In light of the fact that the calendar year has yet to be completed, we do wish to make you aware that an additional inspection of an out-of state industrial radiography licensee was completed earlier this

.            month, one inspection short of that necessary to meet the 50% for priority I licensees.

Sumnestion #3 4 His point is being considered. Sunnestion #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.- Els policy has been changed. Now the Department's policy is to incorporate such items as enforcement procedures, severity levels and civil penalties into rulemaking. . Sunnestion #5 nis policy has already been re implemented, with one supervisory accompealment 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 f>r the professionalism demonstrated by the review team during their week here. I or my designee plan on attending the Management Review 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. [erely,

                                                                                      's Jeffrey E. Schaub, Director Office ofHealth Management Department of Health and Human Services 4

cc: Diane E. Tem Dennis P. O'Dowd

A h L'.,.d 4. L ./.1: a1 ' RADIOACTIVE MATERIAL LICENSE I SPECTIONS FIVE-YEAR INSPECTION PLAN . Assumptions: Three full-time health physicists assigned app oximately halfof their time (0.5 FTE's each) to the rad *mactive material section; one part-time heeld physicist (approximately 0.25 FTE's.) Assumes all health phyucs staff members have attended 200-hour applied health physics course or equivalent; 40-hours each of the following courses: Licensing Procedures, Radioactive Material Inspection Piece 4 Medical Uses of Radionuclides, and Industrial Radiography Procedures , as well as periodic refresher coorses in basic radiation protection and health physics, and specialty courses, as needed. Key: . Priority 1 inspected every year; includes industrial radiography, irradiator, mobile nuclear medicine, anticipated inspection time for each'is I to 1.5 days. Priority 2 inspected every other vear, currently only two broadscope academic type A; anticipated ir.gection time for each is 2 to 3 days. Priority 3 inspected every three years; almost exclusively medical t!wicycmic uses; anticipated inspection time for each is I day. Priority 4 inspected every four years; one licensee; anticipated inspection time is i day. Priority 5 inspected every five years; principally portable ami 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 Numbers of Numbers of Numbers of Numbers of Nusabers of Total Neunbers of Reciprocity Est. Number Priority 1 Priority 2 Priority 3 Priority 4 Priority 5 Number of I m i Inspecthms laspectio g licensees to licensees to licensees to PKea to licensees to Routine to be to be to be be inspected be inspected beinspected be inspected be inspected Scheduled conducted coeducted coed 8 Inspections by each by each by each I to be me ith he.nen m conducted physicistI physicist per foryear peryeart year 2 1998 1 4 I 8 1 12 26 9 2 2 1999 2 4 1 7 0 12 24 8 2 2 2 2000 _ 3 4 1 7 0 12 24 8 2 2 2001 4 4 I 8 0 12 25 9 2 2 lim 2 5 4 1 7 i . 12 25 8 2 2

       ~ Total Numberof                   4 in               2 in                 22 in          I in              60 in licensees by             Priority 1          Priority 2         Priority 3      Priority 4         Priority 5 Priority                                                                                                                                                                        -

NOTE: There are 4 licensees u maly categorized as Priority 6 (source material as shielding, typically in accelerators) which may be impected during an x-ray or radioactive material inspection, and should take 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 conduct only 3 to 4 inspections during 1998.
          ' Based approximdely on 50% of out-of-state priority I licensees (probably 3); and 25% of out-of-state priority 5 licensees (pmbably 3).
          ' Flexibility is allowed. That is, if one of the staff wishes to conduct more Jian two inspections in that month, either for another staffinember, or to inspect ahead of schedule, thid would be allowed. Note also that at the end of cr.a year (six rronths total), at two inspections per month, the total number ofinspections conducted would be twelve, which e'xceeds the sum of scheduled and recipmcity inspections. The is to in; e into consideration an assumed three (3) to six (6) follow-up and/or reactive 'mispections during the year.
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g4p SPECTIoM SACKGROUND DATA ( announted ( ) trannounced I 1 tr4fet+ Y " T 2nspection Agency License No. M.E 2nspection Date kNM Last Amend No. - Date r-hb/M 4 -- q Empires Renewal ( ) y 12s***O g LICENSEE DATA Dchat./Maadt,k. Lic. . . , Address [ oane as Lic. Item 2. 2nsp. Locatn. (d same as above Contact Title Phone No. GII O$l$ #d 3 N kd$AF s p WSrsCToR M1AH40ME Date.A /11 M W W Supervisor Approval'(see item 21) , gfffAST INSPECTION - RESULTS AND CORRECT!YE ACTION INEMW. (Date of last inspection)

a. Woncompliance ( ) None current Sta'cus

                                                                                                                                                                                  ,/

b. Recommendation [ ] Mone .

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