ML20211C176

Draft Rept, Integrated Matls Performance Evaluation Program Review of New Hampshire Agreement State Program, Period 970819-22

ML20211C176
Person / Time
Issue date:	09/22/1997
From:	NRC
To:
Shared Package
ML20211B246	List: ML20211B242 ML20211C176
References
NUDOCS 9709260135
Download: ML20211C176 (65)

Text

. .- . _ . - . . . . - . - . - _ . - - _ - . - - . . -

. ,r INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF NEW HAMPSHIRE AGREEMENT STATE PROGRAM AUGUST 19-22,1997 DRAFT REPORT U.S. Nuclear Regulatory Commission e

D S E N

J

New Hampshire Draft Report Page 1

1.0 INTRODUCTION

4 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 members are identified in Appendix A.

The review was conducted in accordance with the " Interim implementation of the integrated Materials Performance Evaluation Program Pending Final Commission Approval of the Statement of Principles and Policy for the Agreement State Program and the Policy Statement on Adequacy and Compatibility of Agreement State Programs," published in the Federal Reaister 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 paragraph on results of the MRB meeting will be included in the final report.)

4 The New Hampshire Agreement State program is administered by the Division of Public Health Services (DPHS), Bureau of Radiological Health (BRH). The BRH regulates l approximately 100 materials licenses.

The review focused on the regulatory program as it is carried out under the Section 274b.

(of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of New Hampshire.

i In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on May 29,1997. The State provided a response to the questionnaire on August 11,1997 and August 19,1997. A copy of the response is

, included in Appendix C to this report.

4 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 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 performence.

Section 2 below discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common.

performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings, recommendations and suggestions. Suggestions made by the review team are comments that the review team believes could enhance the State's program. The State is requested to consider suggestions, but no response will be requested. Recommendations relate

J New Hampshire Draft Report Page 2 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. Charles E. Danielson, Director of the New Hampshirr DPHS, on January 10,1995. In letter dated February 21,1995, from Dr. Danielson to Richard L.

Bangart, Director, Office of State Programs (03P), and during the Management Review Board Meeting on the 1994 review, the State responded to the 1994 program review findings, comments and recommendat ons, in letter dated April 24,1995 frein Mr. Bangart to Dr. Danielson, NRC evaluated the State responses and all items except those identified below were closed.

2.1 Status of items identified Durino the 1994 Routine Review The open 1994 review findings that resulted in recommendations to the State were assessed during this review. The open findings were in the following areas: (1) Status

,~} and Compatibility of Regulations; (2) Legal Assistance; (3) Enforcement Procedures; and (4) Inspection Procedures. The status of these recommendations are as follows:

(1) Status and Compatibility of Regulations. The State had not adopted rules equivaler;t 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. It was recommended that the Division take steps to accelerate the promulgation process and consider proposing legislation to exempt the RCP from the administrative rulemaking procedures.

Current Status: The State's corrective actions are as follows: " Emergency Planning Rule," has not been adopted by the State. Currently, the State has no licensees to which this rule would be applicable. However, the State has indicated that the requirements of this rule will be used in the review process for new license applications that would be subject to the requirements of the rule. This rule is scheduled to be adopted in December 1997. " Standards for Protection Against Radiation," was adopted 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. Diene 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 Part; 20,31,40 rand 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 BhH regulations from the administrative rulemahing systein of numbering and drafting rules. Under the revised Administrative Procedures, these rules are in compliance with the administrative rulemaking system if the wording is consistent

i l

i Naw Hampshire Draft Report i Page 3 with the closed. language of the corresponding federal regulations. This recommendation is (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 DPHS take appropriate steps to assure that the radiation control program had prompt legal assistance available when needed.

Current Status: BRH has direct access to legal counsel. As the result of a reorganization of the New Hampshire Departma v 1 Health and Human Services (DHHS), an attorney from the Attomey General's sice was assigned to the Office of Health Management (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 including the revised inspection and enforcement procedures, with the provi* ions for severity levels and civil penalties, as part of the 1994 rulemaking package.

Current Status:

BRH has not adopted the rules or policy necessary to implement severity levels and civil penalties. BRH indicated that the current enforcement policy was effective in achieving licensee 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 of and is evaluated further in Section 3.4 under the indicator " Technical Quality Inspections.'

(4) Inspection Procedures.

(e)

Although exit interviews are not covered in the procedures, the 1994 review team determined that materials inspectors were attempting to hold exit meetings at the conclusion of an inspection with the highest level of licensee management available. The 1994 review team also determined, through interviews with the inspectors, that oral debriefings are held informally with the section supervisor attor the inspector returns from an inspection. It was recommended that BRH update the general procedures in the compliance manual to include such issues as exit meetings and oral debriefings with the inspection supervisor following non routine inspections. It was also recommended that BRH review and update, as necessary, the compliance manual chapters for each major category of licensee to conform to the New Hampshire regulations.

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

New Hampshire Draft Report Page 4 compliance manual chapter was revised to conform with State regulations. This recommendation is closed.

(b)

The review team found that several different versions of inspection forms (field notes) had been used over the review period. Although different inspection forms are appropriately used for different types of licensees, B also had several different sets of inspection forms for the same or similar type licensees. It was recommended tha; 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 revise inspection forms until the rulemaking process is completed; otherwise, revisions would be based upon draft regulations. However, BRH stated that it is currently using NRC inspection forms as references to supplement its current inspection forms. Moreover, during this review, the review team found that the inspection forms provided good, consistent documentation of inspection fin This recommendation is closed.

3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both Regional and Agreement State programs. These indicators are:

(1) Status of Materials inspection Program; (2) Technical Staffing and Training; (3) Technical Qualit Action; (4) Technical Quality of Inspections; and (5) Response to incidents and .

3.1 Status of Materials insoection Procram 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 dispatch of inspection findings to licensees. The review team evaluation is based on New Hampshire questionnaire responses regarding this indicator, data gathered independently from the State's licensing and inspection data tracking system, the Material Section (RMS) Supervisor and staff. examination of licensing a The State revised its inspection priority system in May 1997 to closely match the NRC system. Prior to that time there were several priority categories which the State inspect more frequently than NRC. The review team's assessment of the current inspection priorities verified that inspection frequencies for various types or groups of licenses are essentially identical to those listed in the NRC Inspection Manual Chapter 2800 (IMC frequency schedule. In reviewing the State's prionty schedule, the review team noted BRH continues to have priority categories which are inspected more frequently than t of the NRC. The teletherapy category licensees are scheduled to be inspected on a two year frequency while the NRC inspects these licensees at a three year frequency. In addition, alllicenses listed as NRC priority seven are inspected on a five year frequen Ne

i t

New Hampshire Draft Reped Page 5 The inspection frequencies of licenses selected for technical quality of inspection review were compared with the frequencies of the State's priority system and verified to be consistent and as frequent as similar license types under the IMC 2800 system.

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 overdue core material ,

licenses from the BRH database. Thus,33 percent (8 out of 24) of the core licenses are inspected at intervals that exceed the State's and the NRC inspection frequencies by more than 25 percent, which is unsatisfactory based on the criteria in Management Directive 5.6. For the eight overdue core inspections reported in the questionnaire, the RMS Supervisor discussed a proposed schedule to complete inspections at each facility. The verdue inspections were late by periods of time ranging from two to six months.

During the review period, BRH conducted 22 inspections. The team reviewed the RMS,

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

For inspection planning, 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 routine 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 initialinspections 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 allinitialinspections, which is a change from its previous inspection policy. During the 1994 review, it was recommended that BRH 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 materla!. In response to this recommendation, BRH indicated that it had always performed initial inspections of new licensees for priorities 1 and 2 at six months and 12 months for other priorities. The 12 month initialinspection exceeded the NRC recommended frequency of six months. BRH stated that its rationale for the longer period was that initialinspections should be reflective of complexity / hazard of licensee use and should not merely be assigned to conform with NRC and all of its new licenses were hand delivered. The New Hampshire rationale to extend the interval of time for initialinspections of priority 3 and other lower priority licensees was considered acceptable during the 1994 MRB review of

t New Hampshire Draft Report Page6 the pilot Integrated Materials Performance Evaluation Program and this recommendation was closed. However, BRH changed the 12 months initialinspection frequency policy to within six months of issuance for allinitialinspections, i From the review of the inspection database, BRH was not consistently implementing its revised six month initialinspection policy. The database list of 10 new licenses issued during the review period showed that initialinspections were conducted within six months for two of the licenses, one veterinarian clinic (priority 3) and a portable gauge (priority 5),

initialinspection was performed for three other new licenses at intervals of 11 months (portable gauge, priority 5),10 months (portable gauge, priority 5), and 24 months

' (portable gauge, priority 5) after license issuance or material receipt. The remaining five new licenses issued by the State had not received initialinspections. These licenses included the following: one license issued in 1995 (as a second license for a medical facility, priority 3); one ilcense (medical-diagnostic, priority 5) issued in November 1996; l '

two issued in January 1997 (portable gauge, priority 5, and rei,earch and development (in vitro kits, priority 5)), and one in April 1997 (portable gauge, priority 5). The review team considered recommending that initialinspections of licensees be performed within six l

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 montSs), and adhere to the established policy.

The timeliness of the issuanco of inspection findings was also evaluated during the inspection file review. Of the 12 files examined, the correspondence for eight inspections was sent to the licensee within 30 days of the inspection date. These inspections were clear, with no deviations or violations of license requirements. Correspondence for the other inspections was sent to the licensee more than 30 days past the inspection date. In these cases varying levels of enforcement actions were identified, leading to longer evaluations of inspection results by staff. Three letters containing notices of 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 its inspection report preparation process for those containing enforcement actions to ensure timely issuance of Inspection findings.

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

New Hampshire Draft Report Page 7 Based on the IMPEP evaluation criteria, the review team recommends that New Hampshire's performance with respect to the indicator, Status of Materials inspection Program, be found unsatisf actory.

3.2 Technical Staffino and Trainina Issues central to the evaluation of this indicator include the radioactive materisis program staffing level, technical qualifications of the staff, training, and staff tumover. To evaluate these issues, the review team examined the State's questiornaire responses relative to this indicator, interviewed selected BRH managers and staff, and considered any possible workload backlogs.

The New Hampshire organization chart shows that BRH was funded for 13 persons at the time of the review. BRH consists of five sections with 2 FTE's in Radon, 2 FTE's in Emergency Response, 3 FTE's in the Radiochemistry Laboratory, 3 FTE's in Radiation Machines and 3 FTE's in RMS. An FTE for 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 materiallicensing, inspection event response, and laboratory activities. These staff members also have responsibilities in the Radiation Machine Section, 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. There has been no turnover since the last review and all of the staff have a wide range of l licensing and inspection experience. There are a number of overduo core license

} inspections and a licensing backlog that may be partially due to the difficulty in balancing personnel between the RMS and the radiation machine section since personnel are rotated between the two sections on a monthly basis, without regard to whether inefficiencies result from disruption of licensing and inspection casework in progress, At the time of the review, there were 98 pending licensing actions, 8 administrative renewals (fee collection),

60 amendments, 5 new license applications and 25 renewals. Sixty-nine of these actions were overdue by over 1 year, As noted in Section 3.1,33% of the core inspections are overdue and only 22 inspections have 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 effectiveness of rotating staff on a monthly basis and the necessary number of staff to implement 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

New Hampshire Draft Report Page 8 gauges. The review team determined that all staff utilized for the agreement materials program were technically qualified by evidence of their training and experience. However, the State would benefit from a training and qualifications plan in the event of staff turnover. The review team suggests that the State develop a written training and qualifications plan.

Based on the training that program p3rsonnel have received, the State appears supportive of continued staff training, and management demonstrated a commitment to staff training during the review. However, the State has 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 recommends that New Hampshire's performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

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

Licensing actions were reviewed for completeness, consistency, proper radioisotopes and j quantities authorized, qualifications of authorized users, adequate f acilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and for its aonditions and tie-down conditions, and overall technical quality. Casework was reviewe' for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authorities. Tne 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 besn 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.

Licensing actions reviewed included 3 new,2 renewals,7 amendments and 1 termination, in discussions with BRH management, it was noted that there were no major decommissioning efforts underway with regard to agreement 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

New Hampshire Draft Report Page 9 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 licensess possessing sealed sources.

These files showed that documentation of proper disposal or transfer was available.

Licenses were renewed on a five year frequency. The State is extending the renewel period for certain licensees on a case-by case basis. Licenses that are under timely renewal are amended as necessary to assure that public health and safety issues are addressed during the period that the license is undergoing the renewal process. Each licensing action receives supervisory chain review.

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

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

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

The inspection procedures and techniques utilized by New Hampshire were reviewec! 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 Hamoshire procedures, inspections were performed on an unannounced basis.

The inspection field notes provided good, consistent documentation of inspection findinas.

The State uses separate field notes for different types of inspections covering the areas of industriel/research development, industrial radiography, commercial irradiator (draft),

medical broad scope, portable gauges, and medical and teletherapy licenses.

Inspection reports were reviewed to determine if the reports adequately documented the scope of the licensed program, licensee organization, personnel protection, posting and

t New Hampshire Draft Report Page 10 labeling, control of materlats, equipment, use of materials, transfer, and disposal. The reports were also checked to determine if the reports adequately documented operations observed, interview of workers, independent measurements, atatus of previous noncompliance items, substantiation of allitems of noncomplianu, 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 correspondence and field notes. Overall, the review team found that the inspection reports showed excellent quality and attention to detail. From ieview 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 e 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 stan follow up inspection was not conducted to confirm that 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 ections and appropriate 6nforcement, The RMS Supervisor stated that inspection results showed licensee compliance was acceptable during the review period and that escalated enforcement beyond issued NOVs was limited. A finding from the previous NRC review recommended the 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 1905, in evaluating the State's response to the NRC recommendation, the review team found that the rules in question

[

were not adopted and the manual which describes the program for determining enforcement actions was not revised. The State indicated because of higher priorities and the reorganization of the DHHS, they took a ' waiting" approach in the area of enforcement. The State continued to base their enforcement program primarily upon onsite inspections and NOVs. If escalated enforcement is necessary, the State DPHS has authority to issue orders. The review team suggests that the State reconsiders revising its regulations and enforcement procedures to include provisions for severity levels and civil penalties.

Two inspector accompaniments 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 techn; ques were

t New Hampshire Draft Report Page 11 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, inspectors debriefed with supervisory staff upon return to the office, and inspection reports received close supervisory review. Since supervisory accompaniments provide program management a better understanding of both the inspectors' abilities and co npetence to perform in the field, the review team suggests that the State adhere to the policy of annual supervisory accompaniments of allinspectors.

The review team noted that New Hampshire has an ample number of portable radiation detection instruments for use during routine inspections and response to incidents and emergencies. For large licensed programs, a laboratory specialist assists inspectors by taking confirmatory measurements and samples. The State uses an 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.

3.5 Resoonse to incidents ano Alleastions 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 the New Hampshire files, and reviewed the casework and supporting documentation for 14 materialincidents and six allegations.

The 14 incidents selected for review included twc misadministrations, one lost source, seven contaminston events, three reported loss of control of radioactive material, and one non-routine event and are listed in Appendix F. Of the six allegations reviewed. NRC Region 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 materialincidents 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 "DPHS Initiator Handbook." The Handbook is designed to be used for response to

{

New Hampshire Draft Report Page 12 i

)

incidents involving radioactive materials and nuclear reactors. The radioactive materials section of the Handbook is sufficient to provide guidance for respond!ng to incidents involving radioactive materials,incluJing transportation incidents. Copies of the Handbook and current calllists, which includes beeper numbers, are distributed periodically to all appropriate persons or agencies. The State provides a 24-hour emergency numbor for anyone to use to report emesgencies involving hazardous materials. When a radictogical incident is ruspected, BRH staff is contacted.

The review of incident casework, licensing casework, and interviews with staff revealed that incidents are promptly evaluated for the need for on-site investigations. For those incidents not requiring on site investigations, copies of letters to licensees were in the licensing files indicating that the incident would be investigated during the next scheduled inspection, in responding to incidents and allegations, BRH had taken prompt, appropriate action. The review of casework indicated that incident reports were thorough and well-docemented.

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, l 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 casework, satifactory 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 NMED system. The Report indicated that 21 incidents had been reported to NMED; however, the NMED file only included 11 of these incidens. The 10 incidents were not included for the following reasons. Although a New Hampshire licensee was involved, two incidents occurred in another State (Massachusetts) and would be listed under that State.

Three incidents did not include radioactive material, and one involved non-Atomic Energy Act material. Two incidents were considered information and not reportable events, and one event involved a reactor. In addition, one incident was received by INEEL and should have been a part of the system but the contractor misunderstood the data.

The State has implemented an excellent tracking system for incident files. Within 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 and 1996 that were not previously reported to the NRC. The Now Hampshire incident tracking system is able to m?nipulate 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 th0 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

i New Hampshire Draft Report Page 13 4.0 NON COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Regulations; (2) Sealed Source and Device Evaluation Program; (3) Low Level Radioactive Waste Disporal 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 Leoislation and Reculations 4.1.1 Leoislative and Leoel Authority The DPHS is authorized as the State radiation control agency under New Hampshire Revised Statutes Annotated (RSA) 1990, Chapter 125. RSA 125 F:1 to F:25 covers radioactive material, RSA 125:77 b covers radioactive waste, and RSA 125 B covers emergency response. The radiation control program is administered by the BRH. No changes have occurred in the legal authority of the BRH since the previous review. As noted earlier in the report under Section 2, " Status of items identified in Previous Reviews," a legislative amendment was made to the New Hamnshire Administrative Procedure Act in August 1995 to exempt BRH regulatfore trom the State's administrative rulemaking system, 4.1.2 Status and Compatibility of Reaulations The "New Hampshire Rules for Control of Radiation," apply to allionizing 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 during the rule development process. Final regulations are subject to a

" Sunset" law and rules expire exactly six years after promulgation for rules adopted prior to August 1994, and after eight years for rules adopted after August 1994. After expiration, these regulations must be resubmitted in their entirety to remain in effect.

The review team evaluated New Hampshire's responses to the questionnaire, NRC correspondence pertaining to the review of New Hampshire's regulations subsequent to the August 1994 review and discussed the State's regulations or other legally binding requirements with the BRH Administrator and the RMS Supervisor to determine the status of the New Hampshire program with regard to the implementation 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 legally binding means or they are not currently applicable to the New Hampshire program:

New Hampshire Draft Report Page 14 I

" Standards for Protection Against Radiation," 10 CFR Part 20 amendment (56 FR f 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 provHed to the State .6 !etter 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 incidents," was adopted in February 1995 for Parts equivalent to 10 CFR Parts 20,31,40 and 70, and the coWvalents of Parts 30,34, and 49 are scheduled for adoption in December 1997. These requirements were reviewed by the NRC as a pmt 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 l accordance with the new Policy Statement on Adequacy and Compatibility of Agreement State Programs, the review team's evaluation found these 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 eerlier, currently the State has no licensee to which this I

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 ic scheduled for adoption by December 1997.

" Safety Requirements for Radiographic Equipment," which was needed by January 10,1994. The review team verified that these requirements are being incorporated by industrial radiography license conditions. This rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

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

However, the State has indicated that the requirements of this . rub v. : ue 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 due by October 25,1996. The State adopted a portion of this regulation in 1993. However, the State has indicated that the requirements of this rule are being used in the review process for licenses. The remaining portion of this rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

New Hampshire Draft Report Page 15 e "Self. Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (58 FR 68726 and 59 FR 1618) that became effective on January 28,1994 and was due by January 28,1997. Note, this rule is designated as a Division 2 matter of compatibility. Division 2 compatibility allows the Agreement States flexibility to be more stringont (i.e., the State could choose not to adopt self guarantee as a method of financial assurance). If a State chooses not to adopt this regulation, the State's i3gulation, however, must contain provisions for financial assurance that include at lost 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., o parent company guarantee). 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 rulema .ag package which is scheduled for adcption by December 1997.

o " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 360261 that became effectivc on August 15,1994 and was l

due by August 15,1997. 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 incorporated as conditions in licenses issued before rule promulgation. This rule is a part of the rulemaking package which is scheduled for adoption by December 1997.

• " 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 pending 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 compatible Quality Management rule until NRC issues a revised 10 CFR Part 35 rule. When the revision of 10 CFR Part 35 is completed, compatibility designations for the new rule will be established, and an effective date for Agreement State implementation will be set.

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

• " Preparation, Transfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32 and 35 amendments (59 FR 61767, 59 FR 65243,60 FR 322) that became effective on January 1,1995 and will become dee on January 1,1998.

• " Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,60 FR 25983) that will become effective March 1,1998. Agreement States are expected to have an effective rule on the same date.

i S

New Hampshire Draft Report Page 16 i 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, i 1995, and will become due on March 13,1998. Note, this rule is designated as a J Division 2 matter of compatibility. Division 2 compatibility allows the Agreement States flexibility to be more stringent (i.e., the State could choose to continue to require annual medical examinations).

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

4 4 * " 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.

2

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

While no rulemaking action has been initiated, at the time of the review the following items

are on the BRH's regulatory agenda

e " Compatibility with the international Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996 and will become due on April 1,1999. The State plans to adopt this rule in 1999.

o *' Termination or Transfer of Licensed Activities: Record Keeping Requirements,"

10 CFR Parts 20,30,40,61,70 (61 FR 24669) that became effective on May 16, 1996. This requirement need not be in effect until May 16,1999. The State plans to adopt thi rule in 1999.

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

e " Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective on January 13,1997 and will become due January 13,2000. The State plans to adopt this rule in the year 2000.

o " Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Pa9 20.35 amendment (62 FR 4120) that became effective on January 29,1997

2 New Hampshire Draft Report Page 17 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 Sealed Source and Device Evaluation Prooram 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 information by review of the national SS&D registry and confirmed that the State had not issued any SS&D sheets during the review period.

4.3 Low-level Radioactive Waste Discosal Proorgrn In 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumpt on Thereof by States Through Agreement" to allow a State to seek an amendment for the egulation of LLRW as a separate category. Those States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although New Hampshire has LLRW disposal authority, NRC has not required States to have a l

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

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's performance with respect to each of the common performance indicators and the non-common indicators, to be satisfactory for indicators, Technichi Staffing and Training, Technical Quality of Licensing Actions, Technical Quality of Inspections, Response to incidents and Allegations, and Legislation and Regulations. The review team found the State's performance to be unsatisfactory for the indicator, Status of Materials Inspection Program. Accordingly, the review team recommends that the MRB find the New Hampshire program to be adequate to protect public health and safety, but needs improvement and compatible with NRC's program.

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

t New Hampshire Draft Report Page 18 Recommendations:

l

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 these containing enforcement actions to ensure timely issuance of inspection findings. (Section 3.1)

3. The review team recommends that the State evaluate the effectiveness of rotating staff on a monthly basis and the necessary number of staff to implement the program. (Section 3.2)

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

Suggestions:

} 1. The review team suggests that the State clearly establish its policy for initial l 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 qualifications plan. (Section 3.2)

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

(Section 3.4)

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

Good Practice:

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

f!

LIST OF APPENDICES Appendix A IMPEP Review Team Members l.

Appendix B New Hampshire Organization Charts Appendix C New Hampshire's Questionnaire Response Appendix D _ License File Reviews Appendix E Inspection File Reviews Appendix F Incident File Reviews Attachment 1 New Hampshire's Response to Draft Report

t'  ;

)

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Cardelia H Maupin, NRC/OSP Team Leader Response to incidents and Allegations Legislation and Regulations Craig Gordon, NRC/RI Status of Inspection Program Technical Quality of Inspections William Passetti, FL Technical Staffing and Training Technical Quality of Licensing Actions l

N'

l t

1. PPENDIX B DEPARTMENT OF HEALTH AND HUMAN SERVICES ORGANIZATIONAL CHART f

4

i t

)

APPENDIX B DEPARTMENT OF HEA1.TH AND HUMAN SERVICES CRGANIZATIONAL CHART s.

_a-A.de e..4 .a _.D m-m M le emA .- e. -. .es 4 4 A m M 4 4 42.-_44n. .M,A oa4a 4 _4 a m.e & - k4 w mdz4a A 4 M w h mu.arw me -i==hpe+d.aa.Ga4h4J--A4AMhen.*-d- . . -L--* -myM* sea._ __we_b..u.A ..,A aaa, 4w.g.i._,

l L

, . i

, . I, 2 l .I. I . 1 o

r..j< gg x i  ;

c

... J g j ig ,

II ,

e v v EsgE 37 3I i  ; .

a

.'sl- .

o ,

. ,, a-  !

' \ of N b y l' _ _ _

i J

! i .

l < .

y{ ,

a I

i i .

4 g, L

! L l

[ - - -.- .-

g, _

g

, I .

n,.

. , i , . u. . .. .g . .

h ' '

l - I-

~. ,- ,- ,- 1 3 1

[, Ii j .

'l 1 1-i i s"o 1 1 j ,

1 .

p

, . c , i j ,

m .

I I l

, i. L. . 1. 4 L?

'j .! g!} ",_

2 l i . . i. , . . , , ,

u

,1.

fc j  ; j ..

> ,- ,- 4

~ ~~'

(. .

1 j

i i

n

~

=1 '

3 .

11 n i .

1

, .I. '

l 3

y" 1 s

)

4. g .1 l

4. .

. ,1. , . , . . i. l.

I

• 5 v v

v. ,l o _

h F 4

1 '31 1, ,i<li -

5

p.-----.-.m----.,,.,.,-,-,.-- - - - - - - -,-, -

i l

, i i

1 L

APPENDIX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE - RESPONSE

e l 1

J ,

p Approved by OMB 1( No. 3150 0183

- Expires 4/30/98 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM i

@ESTIONNAIRE Name of State: New Hampshire Reporting Peiiod: August 19,1994 to August 19, 1997 (General cortment; We are curious as to the rationale for this program review taking place after only three years of the previous review, whereas at least

one of other states that participated in the or ^ginal " pilot" IMpEP is scheduled to be reviewed in 1999. five years fra their last review.)

J ,

! A. COMMON PERFORMANCE INDICATORS

1. Status of Materials Insocction Proaram j 1. Please prepare a table identifying the licanses with inspections

• # that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800 (issued 4/17/95). The list should include initial inspections that are overdue.

Resoonse to item 1.

(Ccriment: We have been under the apparently incorrect 1

understanding that the criteria was b0% of the scheduled frequency)

• (Note: the ftgure we have used in " Month O/D" is months overdue past the date at 25% greater than scheduled due date. Therefore.

S years + 15 nonths: 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 Inspection Manual Chapter 2800 appears on the next page.

(

w4

1 g 4

4 l  %

M3R'%E.LL.2UM. M M M i

j l University of New Hampshire 2 08/04/96 6 j (BroadscopeAcademicTypeA)

! HCA PortsmoUtfiReg166al"fl651filP ?":73 J W " 0'4/22/96~ 7"6N I (Limited scope medical:, diagnostic uses 5. - . .

lc '~7l .  ; -

! with outpatient-therapeutic nuclearM.. .<,,F,~ OU..' ..'. ' ' .i .W !

- ',?.

I modieine. only).ss.. s e. . .m, ..e ac;oc. .e.w & . . .

.- 6 i Lakes Region General Hospital 3 06/02/96 5 l (Limited scope medical diagnostic uses

with outpatient therapeutic nuclear j medicine only) '

! SoiithiirnDRegidnalCHidical'! Center.'d EST3.S 7:K 3(f6/17/96't.' WTG'?.'

j '(Limited scokmedicalf diagn6stic' usis G 5:4.1/  % Ni- T'G ' I

kith cutpatient* therapeutic nuc]ean.pg [.'y. ~"2, ,

Mf [.[, ...Lj',jf.,k.iijU.[j. '

^1' W 6 '* u *E' ~

~ w-

~ ~ ^ ~

.'u#-

N- e-medicine HCA'ifealthCe only)lt'er"d[New saihNM ~ 3 0$I1N95~ ~^d~

(Limited scope medical: diagnostic uses with outpatient therapeutic nuclear

, medicine only) ~~

4

.Venegas ,I.ridustr.1aliTdi.,fing IT.a. ... C

. - .e W..T.,,;.. -..". 'M. ,., E06. /29/96.4.. UTC.4. - 9',0, , , ,

i Laborator.ies fInc..(see Note'below) T A. . ;c t . ;b'. 7 6 L.i :,0 qy zl4

! .(suryey'.,Heteni.ca)jbratisservj'ce)JMh,1 Ca.1 WE. . Ed d;.5'M l Radiation Safety and Control Services, 3 08/01/96 3 l Inc.

(Survey Heter Calibration Service)

~

, St'.2JosepfHis;iital'742 'T T.#7 W E ; U E '~"4 ff08'/18/96* ?,3.2Fff

.(Limited scope medicaltdiagnosti.c;usespp ipig c. .K it9;. " .4 $/g'."'-

! with outpatient!therapeut1.c nuclear.pf0' 2- '. % ,7 4 " M i ,'. 'O

. medic 1ne n iyk i! & w M ? 'P R % .suc.f.pt) 1 anw:asa 2 a:- - M hi L.y Y .

I

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

B 1

1 2

a O

Resoonse to item 2.

The pl.an of action has already been incorporated into the Radioactive Materials Section's Goals and Objectives. January 1997 (and as revised July 1997). Of the several initiatives taken, the health physics staff has been directed to cmplete a minitrun of four inspections a month, until 100% cmpletion of overdue inspections has been achieved, at which time, we will reduce our schedule to a three inspections per month maintenance schedule.

(The three per month schedule will cover one priority 1 or 3 licensee, one priority 5 licensee, and one reciprocity licensee.)

As for the currently overdue inspections specifically identified on the above list, the following is 01fered; although it has been recognized for several months that the University of New Hangshire (UNH) (Academic - broadscope) is overdue for inspection, when plans came to coordinate an inspection. It was close to swmer break. As stated in the last inspection report. Inspection of licensed activities at UNH should not be taken.during the smmer.

With as few as 30 principal investigators, most of them taking the swmer months off. It is a less than ideal situation to carry out an inspection during the swmer: it would in no way provide an -

accurate representation of the scope of activities being carried out nor of its radiation protection program. It is likely that that Parkland Hospital, will be inspecte ' prior to NRC's arrival and that Portsmouth Regional Hospital and Southern NH Regional Hospital will be inspected the week following NRC's visit . Lakes Region Hospital. St. Joseph Hospital, Venegas' calibration facility and Radiation Safety and Control Services will be inspected in by the end of October 1997. (NOTE: Venegas '

currently provides survey instrument calibration services to only two customers. Process Engineering. Inc. (radiography with sources) and Hitchner Manufacturing (shielded room x-ray radiography). A discussion of licensed activities took place over the telephone on August 6.1997. with Manuel Venegas, and a copy of current leak tests and customer reports were faxed to the Bureau on that day.)

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

These include inplementing itiprovements to be more e,ffective in 3

s processing license applications (e.g., staff assigment to licensing cases), cortpletely overhauling license data information \

(i.e. MS Access database for maintaining licensee information, inspectton informatfon, automated docunentatton, taking advantage of Inter::e* access to information available fra 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 Hanpshire specific licensees which are prioritized to be 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 Priority 7 category, the lowst category being a Priority S.

(Note: prfor to adopting the inspection Manual Chapter 2800 priority listing, most radioactive material licensees in New Hampshire were scheduled for inspectton on a gLg frequent basis than the NRC listing. (e.g., portable gauges, every 4 years; all

. medical facilities, every two years; bro 3dscope academic institutions, every year)

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

Resoonse to item 4 Approximately 50 licensees

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

Resoonse to item Aa. Of these, 9 were industrial radiographers, and there wre no well-logging licensees.

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

4

- _ - _ - .- . _. . ~ = _ - - - - .- _. -__.-_ - -

1 i

4 l

( Resoonse to item Ab. Of these. 3 industrial radiographers were inspected. (Other inspections wre carried out for out of state >

gauge licensees.)

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

! radiographers were performed?

1 .

Resoonse to item S.

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

6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so.

please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed l Resoonse to item 6. Not applicable II. Technical Staffino and Trainina ,

, 7. Please provide a staffing plan, or complete a listing using the j suggested format below, of the professional (technical) person-j years of effort appliea to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response. LLW. U mills, other. If these regulatory responsibilities are divided between offices, the table should oe

, consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel.

If consultants were used to carry out the program's radioactive

materials responsibilities, include their efforts, The table heading should be

G gg POSITION PRINCIPAL AREA 0F 5 EFFORT i

5

_. ,y - --,-

u g ram g m Aw a r, ,

6 b

Resoonse to item 7.

)

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

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

, health physics, or other disciplines, if appropriate, ,

k Resoonse to item 8.

There were no new professional personnel hired 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 r 1246: for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

Resoonse to item 9.

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

I

t radionuclides (40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />), radiological emergency response (40-

. I, 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 have cmpleted these core courses.

I lisE CDRE CQuaSES_ HEEDED Diane E. Tefft No additional core courses needed.

Dennis O'Domi No additional core courses needed.

J. Christopher Pirie Well Logging Course (Note: There are currently no well logging licensees in NH and such activities are rarely, if ever, conducted within the state).,

Mario fannaccone RAM Transportation; a short course in RAM transportation is expected to be given at this year's Annual New England Radiological Health Conmittee meeting in Massachusetts and available for attendance to staff.

Deborah Russell RAM Transportation; a short course in RAM transportation is expected to be given at this year's Annual New England Radiological Health Conrnittee meeting in Massachusetts and available for attendance to staff.

Kathleen McAllister RAM Transportation; a short course in RAM transportation is expected to be given at this year's Annual New England Radiological Health Cmmittee meeting in Massachusetts and available for attendance to staff.

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

Howver, in order to expand Ms. Kenna's responsibilities, particularly in the area of inspections, she will need to attend a radioactive material inspection course.

7 1

u

10. Please identify the technical staff who left the RCP/ Regional DNMS program during this period. ) l

. i Resoonse to item 10.

There were no technical staff who left the Bureau of Radiological Health during this period. However, one individual, Deborah Russell began pursuing a Master's Degree in Industrial Hygiene over a year ago and is currently working only on a part-time

, basis.

}

111. Technical Quality of Licensina Actions

11. Please identify any major, unusual, or complex licenses which were

issued received a major amendment, terminated or renewed in this period.

j Resoonse to Iten 11.

~

License Name License License Type i

! Number ,

Syncor international 391R Nuclear Pharmacy ) l American Health Centers 402R Mobile Nuclear Medicine Service Metabolic Solutions 418R Research, Development, Medical Manufacture l

- Rochester Equine Clinic 397R Veterinary Nuclear Medicine 1

Stocker & Yale 395R Tritium Device Manufacture i

Seacoast Cardiology 389R Nuclear Cardiology l

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

Resoonse to ! tem 12.

1 To our knowledge. there wre no new or amended licenses added or removed from the list of licensees requiring emergency plans during this period.

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

. 8 9

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

t

( Resoonse to It m 13.

To our knowledge, there here no variances in licensing policies and procedures or exenptions frorn the regulations granted during this period.

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

during the reporting period?

Resoonse to It m 14.

l No major changes since last review,

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

• Resoonse to it a 15. Not applicable IV. Technical Ouality of Insoections

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

Resoonse to it m 16.

In January 1997, inspection priorities were modified to reflect the latest changes in NRC Manual Chapter 2800.

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

Resoonse to Itm 17.

Suoerviser Insoector License Cat. Ditt None. (Ccnnent: Since the last review, team inspection of major licensees here carried out, in which our more senior (non-supervisory) staff members acccmpanied other staff and reported to

(

9

the section supervisor on inspectors

• methods. Also, within a day or two following each and every inspection conducted, a detailed de briefing on the findings are conveyed to the section supervisor. In addition to identifying any significant issues.

requiring promt action. inspectton methods and discusston wIth management. RSO's and staff are described. All inspectton field note reports are reviewd by the supervisor.)

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

ResDonse to item 18.

Internal procedures are that each health physics staff member should be accom anied once a year on an inspectfon.

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

~

ResDonse to item 19. s Equipment is calibrated on a routine basis, depending on type of use. All equipment currently in use has been appropriately calibrated. Typically, survey instrwnents used during license inspections are calibrated at a frequency required of the category of licensee (e.g., instranents used by BRH inspectors when inspecting industrial radiography licensees have been calibrated within the last quarter.) Com1ete docunentatton of instrunent calibration is attached.

V. Resoonses to Incidents and A11eaations 1

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

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

that occurred in the Region / State during the review period. For Agreement States information included in previous s,ubmittals to I

10 1

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

Resoonse to item 20.

1 LICENSEE NAME LICENSE # DAILQE TYPE OF INCIDENT INCIDENT / REPORT A listing of al1 incidents recorded in the Bureau's incidents database is attached for review.

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

Resoonse to item 21. .

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

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

Resoonse to item Pla.

All such events wuld be reported to the appropriate agency.

Please reference the attached listing of incidents for information 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 provide details for each case.

(

11

\

t Resoonse to item 22.

1 For insidents involving failure of equipment or sources, information on the incident would be provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency. , Please reference the attached Ifsting of incidents for information on such incidents

23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

Resoonse to item 23.

In the period covered by this review, there were a few cases involving possible wrongdoing that were reviewed and/or presently undergoing review. Among these are:

Atlantic Testing Lmtd., a portable nuclear gauge licensee, in which the license was suspended for a period of time based on several violations:

1 Department of Environmental Services Laboratories, in which small amounts of source material (in general licensed or exeipt I quantities) wre stored:

An unlicensed NAWI source supposedly possessed by an individual:

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

In the period covered by this 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 allegations in the Bureau's incident database, at least at this time,

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

12

, -r y ,_. - - _,- m-.-- - - - , - . . , , , - , # _ .-.- ..-,. - ,.,.- -

o Resoonse to item 24a.

At the present time. there are tw such cases.

One involves ABC Testing. Inc. an industrial radiographer Itcensed by the NRC working in the New Haapshire under reciprocity. Issues involve the question of whether the  !

Bureau was approprlately notified that licensed acttvitles '

wre taking place on that date, and whether the licensee should have reported to the state the circtnstances involving an incident which resulted in exposure below regulatory liulits while working in the state.

The second issue involves a newspaper article which references Kearsage Metallurgical in No. Conway (a former industrial radiography 11censee) as having been involved in illegal dwping of unsealed radioactive wterial in a pond adjacent to the facility. This case had undergone extensive

. review in the past, with unsubstarattated allegations having been made for many years, in spite of the fact that the facility was never licensed to use unsealed radioactive material. This case is considered closed by the Bureau.

despite attenpts by the NRC to consider it open based on the unsubstantiated article.

VI. General

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.

Resoonse to item 24a.

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

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

13

. . . x - - . -

2. The review team recommended that BRH revise its inspection priorities to conform to their current practice of annual I inspect &on for fixed industrial radiography licenses.

Adopted. l

3. The review team recommended that the inspection procedures be revised to include all essential elements of the inspection and to conform to BRH regulations, Adopted.

4. The review team recomended that the SRH narrative reports used for routine inspections cover each of the essential elements covered in the inspection forms.

Adopted.

5. The review team recomends that BRH review, update, and standardize

, the inspection forms used for different categories of licensees.

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

forms at this time. What has been done however is for staff to betwe familiarized with NRC inspection forms and to use these as references to l supplement our current inspection forms. In addition, see new inspection forms have been produced (i.e., the Irradiator inspection form). .

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

Adopted. In addition tracking records now exist for each instraent used, so that should this informatton be inadvertently omitted from the field notes, it would be available by referencing the instraent sign out sheet and survey instraent database.

7, The review team recomended that BRH inspectors perform instrument response checks against known reference check sources on radiation detection equipment used on inspections.

14

a Adopted. In fact, check sources wre bought and attached to

( certain survey instrunents.

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

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

9. The review team recomended that the Division of Public Health take appropriate steps to assure that the radiation control program has  ;

prompt legal assistance available when needed.

Adopted to some degree. Although the Division was not able to pursue this, a major re-organization of the Department of Health and Human Services has, at least in theory, resulted in more readily available legal assistance to Bureaus including Radiological Health. The Bureau has on occasion recently sought the assistance of Office of Program Support's Legal Coordinator.

John Dabu11ewicz, and also, the legal counsel in the Ccnmissioner's Office, John Wallace. .

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

Not adopted. In terms of priorities in rulemaking, other provisions required for cometibility have greater priority at this time. In addition, changes already in place brought on by the department's re organizatfon, along with potenttal changes in an ever dynamic area of re-engineering the department, makes it prudent at this time to take a waiting" approach with regard to the area of enforcement. untti final decisions are reached at the comissioner's level.

26. Provide a brief description of your program's strengths and weaknesses.

These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

(

15

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

't f

e i

ResDonse to itm 24a.

Strengths:

Staff Training and Experience in a wide-variety of areas of responsibilities .

Wality of Licensing Actions

@ality of Inspections Wality and Timeliness of incident Response

@ality and Timeliness of Radiological Emergency Response

, @ality, Quantity and Availability of Field Radiological Instrunentation Weaknesses:

l Staff Responsibilities in Several Diverse Areas Unavailability of Radiological Training for Staff 1 Lack of Strong Support for Program (at least in the past)

Timeliness and Wantity of License Applications Processed Timeliness and @antity of Inspections Conducted. Including those for reciprocity Reliability of Radio-analytical Equipment Capability Low Morale of Staff based on ever-increasing responsibilities at relattvely inadequate pay

• 9 16

_~ _

, _ _ - , - _ . c,,__ ._ . . , - - . _ . . -~.,.-4,- . -

G). 2

> t I

, l B. NON. COMMON PERFORNANCE INDICATORS

1. Raoulations and leaal Authority

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

Resoonse to item 27.

RSA 125 F:12S Radiological Health Program RSA 107-8 Civil Defense Act ,

RSA 125 B:1 New England Camact Radiological Health Protection \

RSA 125:77 8 Radioactive Waste Prohlbstion

28. Are your regulations subject to a"* Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

Resoonse to item 28. <

Yes, every 5ix 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 were adopted in February 199S.

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

Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them.

Resoonse to item 29 Reference attached table.

30. If you have not adopted all amend.nents within three years from the date of ^

NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC.

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

Resoonse to item 30.

Reference Table *29 attached.

17

~

t

11. Sealed source and Device Proaram )

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

SS&D Manufacturer. Type of Registry Distributor or Device Number Custom User gt.igytt,g Resconse to It m 31.

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

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

Resoonse to It m 32.

In 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 1tcensing procedures.

33. Please include information on the following 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.Ill.11. A.Ill.1314 Responses to Incidents and Allegations - A.V.20 23 Resoonse to It m 33.

Unclear as to the references.

. I 18 ,

l

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

. _ _ _ _ . . _ _ . . _ . .. - - _ __ __ . __ _ _ . _ . _ __ _ m . _ _ __ __. . _ .

TABLE FOR OVESTION 29.

OR

. DATE DATE 10 CFR rte.E DUE ADOPTED CuRRENr EXPECTED STATUS ADOPTION Any amendmerd due prior to 1991. Idardfy each regidoton (refer to Wie Chronology of Arnendments)

Deammessomng; 7/27191 1253 Adopted as He P 2030 whicin is being reused b become hep 4030 14fA Park 30,40,70  !

Emergency P'enning; 4/7/93 NRC rule used as beeis for reviour of new appares==* Rule adoption

. 12/97 g Parts 30,40,70 in proa!ss Standards for Protecton Agamet P=s mari; 1/1/94 2/95 Part 20 Saidy R vi.. .;. for Radiographe 1/1054 H@ 2034 in revieson. Cuneney Wiis rule God doom into Verweges 12/97 Equipment; Part 34 _

Econee by conditon. WE do same for at Notricettriofinodents; 10f15/94 2/95 He-P 4C213 Considerparts to 10CFR 30,34 & 39 are in process 12/97 i Parts 20,30.31,38,39,40,70 -

l Quality Managemord Program and 1T27/95 Not yet adopted. Waigng for Snel nale. NH does have Misadmnetratons; Part 35 nessenwustamon reportng sequwement 4

Licensing and Radston Safety Requwements 711/9 6 Used proposed rulesps guidance in Econee reweeur. ham - none for Irradoents; Part 35

• l Definihon of Land Deposal 7/22/96 Land disposal delnition as per 10 CFR. Weste site QA program?  :

and Weste Sien QA Isogram; Part 61 -

NH - Never a weste site. t t

Decommmasorung Remrtsteeping- Docar 10f2'W96 in part Rememmg rule in' process 12/97 mentaten Addisons; Parts 30,40,70 12/93 SeEGuarantee as an Addibonel FIM . 1728/97 in prdass 12/97 Mechanenc Parts 30,40.70 .  !

Oransarn M5 TaEings- Conforming to EPA 711/9 7 N/A

- eart 40 ,

Timeli6ess in Demmmisesorung 8/15797 in process 12/97 Parts 30,40,70 -

l 20

'< f l . Low Level Waste Procram k Pleassinclude information on the following questions in Section A, as 34.

they apply to the low level Waste Program:

Status of Haterials Inspectior. Program A.I.13, A.I.6 Technical Staffing and Training A.!!.710 Technical Ouality of Licensing Actions A.III.11, A.!!!.1314 Techn!cet Quality of Inspections A.IV.16 19 i

Reventes to Incidents and Allegations A.V.20 23

. 8ggpnsetoitem34.

Not applicable.

IV. kririum Mill Procram

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

Status of Materials Inspection Program - A.I.,13. A.I.6 Technical Staffing and Training - A.ll.710 4 Technical Quality of Licensing Actions - A.!!!.11 A.III.13-14 Technical Quality of Inspections - A.!V.16 19 Responses to Incidents and Allegations - A.V.20-23 Resoonse to item 35.

Not applicable.

(

19 l

il l li1, ll IiI Il 11 N

o DN EO T

CD m

• E PO XD F 7 g

f 7

9

/

7 9

/

y g

f 7

9

/

7 9

/

g g

7 9

/

9 9

g g 0 0

0 0

2 2 g s A E

1 1 {2 2 1

2 1

2 1 g 2

1 9

1 9

1 0

2 0

2 R s s

O e T c G t

NS p m r a

EU n P RT i s

R TA n s R a

US C eg 4 R C n

3 C R 0 R S 2 S S M P S t r

r =

e e =

H p a p

s s

s s

s s s e s m

_ c ec e

c p

o o o o r r r r r e p

p p p p n n n n s a

i i i i s

_ n n n n e t p

_ o o o n m i h h h e

• p p p o o o o t n r p

• d d d o A A A M I n T

_ D EET T

A P DOD A

1 E E 8 6 2 T 8 S 8 9 I M 9 O 0 AU 8 9

9

/

8 9

I M 9

/

4 9 O 9 0 D 0 '

DD / 3 / 0 4 2 9

/

G

/

6 0 d 3 9 1

/

1

/

1

/ 0 1

/

/

1 1 f 0 /

1 W 1

1

/ 2

/

1 3 3 6 8 1 4 1 5 1 1 1 f

o d -

s e y e e r r

s hp d h i

in n

- o n g e An isf U a e in m so e

Dis i r

o r

g m d g

. d n d ma oe od l

ae r f t io A n a A nd i

s at s s e d -

s u gg cy t d bl ae c s l

a r e nt a gn r

o e Am C. ir u

eM f t on in R n F. r h s f ls Lu g eg i

t e e n e J dl md sm a r s

e s. oa l ia mu5 i mp M o m 4-syA i

d nr i t aa ivn at e e ct de

f. a Uen

- t r od3 ma t w ay Sede na l Co r 2 ag i n egn  ;

. u h g R i8 e i om d=M f

q d r f t

n eta f M r

oyp3 ExEn mt e d

=e o r e yew eft o e o._Ra pn ew f

r B 0, pr e o - n . m ev nen l

mE a ae .

f u e e Rsce eeS sd ef 3 h p els sq t a

fs o s c Se oc sn n t a e n ee net asa r

id d e et t eR sd J.

g s

oe ir dc [

Cm;o a

erel e Tg aR r

l ao ud i

r gs m Ar u e e l ei o Rda E

r UP Mro an R cd 1 t na r Da fF o ds 7A oi n f

o rge r t

L T,d r. fo P Wan e ena eM p fo R heR U nn es yr y c r P s nr tl r a dem ne neA

- R bo a. U co leio ntn nn o e Poan An o e no f

od t d r

ore R anl nt vt ae oe hm ae d h k o s mnn F r o a a

e u ar e a mm ie t Rt a i

l ae od nr tt un nUa f t ses pudnc ic r q sp lmr a g r

m C e wo op fr = in dn d u r q F

Cme io dd c uo mce l

o sem ue o c eh s in nen dem 0 ebe r r e of n e- ae a e ea e eit TeR PiM n FR l 0t n r r d

- 1 Li PF RD CR 1 I MR RE RAW CA

,' tlll

M

.o ..

D,+T AN Events-One Line Report

/47 ff' la m ar Z'r 2 = W A' l' C'*S

• C' ETVYY5KU b I**" f _

EVENT DATE TFEM NO ABSTRACT NHM0006 IASt 3 )$ ggCI midgl43 spuste Emed wie PEdmW-Umur gen /-- ^ " ,sent (Or SEyggel $3pEgb suspiW pumpgMy, When 3 &Eigget 3/23/94 ch of ,0 ps yeny me almednit ===- No s sce so-d. Rasmit tassant see es c ass EVENTS Reported so NRC N Lic# IISR g LAs 9rl6/94 NH940007 Tsush euck wiesesed misms at espuest sier in Mass med was esdued es noen to Sedseek tush temAr facility by Mams Drft NH Ret Heste paressmel aus suck and tossed 8-13 tin pasient weste. Tramiened to lined casemmer med sessed in seSe bcule musil decer to P in Dec 94.

ctASS EVENTS Repenged go NRC N Lic# ZZZ tAs larI494 NH960091 Ii=====t Event @ Vamma Yustee Nuclear Pweer Plass - Service maner rame is nucest W med te tudmy symme she value will est cisse. Pweer plant is as Unusef Event by tech spec med had 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to fin pouMese er h No poss45isy of setemme as a sesudt of tis puuttama Peutlene Emed by sussung.

ctAs3 EVENTS Reponged so NRC N Lic# ZZVY OTH ler1994 NH940003 rass--sammi== famed en die inside of a singyiseg essammer ofNat.13 69 suCI,securved Dame $yener Imammusammi rasy===== in Wetuun, Ma Pet of ayumie W = seemit of par r=*s0=s-ctAs3 EVENTS Reported to NRC N Lie # 256K RLAd 30'28/94 NH964015 Reyest ofhigh cupsome en persammel flism badge. Badge ryost sessed one indendent secaeved 3.9 adt dusing thisd gemeer efe year. W seweeled persommet desammary sad seer tudSes ofeder personed in esp. pies mis imendeds duties esing Pesind is r--=.-- remise desees of sendus.

class EVENTS Reported toNRC N Lic# 129R W ,

3/2995 NH960074 Pusiese given 242 ssCI ofbene scanTc-99sm MDP Nasend of the M carencTc-99m nGet_ Puniens med Decess moeded. TW mesenhe in seleceng vist.

et att EVENTS Reported to NRC Y Lic# 13SR

""* b 5/3095 NH960010 r- femme em the imide of a simppus comesser during seatine secessing W ofTc Team tesm Syncer. about 154.2004me. Seemus h k k

ctAs3 EVENTS Reported to NRC Y Lic # 30lR RLAG ,

,2>

f N

o l __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

EVENT DATE FTEM NO ASBTRACT F3095 ' NH90 eses Fased esemenmaise em inside of sigyms comammar of tak Tc49m a sees Rommme wipe east a====d 154,20e 4mm en wipes af+=====r, syvage ad vid secarved

=r ==ad Shayyer.Syecer of H==resseer.NH moeded. l In sigymmut ctAss WENTS geporged to NRC Y Lic # 30lR RLM i enumm.or m g und im .0,es sr.ed emo se. imedesim- NH w m5. n.s,. send emse != m..d.m d

uia5 NH en5 semic % wac admed. Invesmemmen se, eses less during a , - -

m i

l r = -==  ;

ctAss stusts Reported to NRC Y Lic# ZZZ I  !

iAs i est$ NH960stI Doing synsamly invenesry of seated samnes ese eshek 57 seestea NEN 003, said ammter SeeJit2 Sees duaed 2f95 was asessmed ====Imr tant use en hear 23,1992. BeiWing med mes .4==&=d but me sensee fount Acesseyless thus les %

class WEBffs gepg,ged go ygg y yeg 3g3g j l i 1As r

NHeteoso Peniset impassend wkh 25.4 agRa Eg syylicment en imme 27.1995. White spending migha of 26-27 June in she Y ye teemme esudhsed ad let ned meet I l w29f95

! inun temens ed n men ser same seasse imma==ed samme cap. whine in tems.am psamma need s nne as eue and osmanese duey emer Duey emne.s.emesgespy ,

emmed, sees.aed somme and passed in pig ammmmmed in penums wneestody dose m enu cas-hses a me esse eum se esem ctAss DEBITS Reported to NRC Y Lic# 130R Mo2 i

amp 5 NHoteses c pa =orp esmeeasegg er seesessised use ofXFR gauges. Resuk endheded. f Er= is=* meme ofmsnimmens en use ofImus tem eder emayammes. Om esy of esmytmut inum we h W Alphe tand P.tist verify by tuseum push t

1. ' *** DENTS Reponed to NRC N Lie # 392K 1

3/1995 PsHesel13 Femme Isaktig houses ofblood-Ite masend mehed seesmesse. Scame med ymeios insetoed essdemed airand dashed for . AR sesshs magsave.

l s -pa-e shtesResne-e n dtN.saamme.asosa med rg id.asese meset l

j ctAss newts .

Reponed to NRC N Lie # ZZZ orn S/3I35 lef960893 Semage spos.tig sedt spuged as cause HsW Disease Result Net a Retama youbless ctAss nENTs Reported to NRC N Lie # ZZZ om i i

i 2  ;

I 1 [

! i i  :

~

I

~ =. i EVENT DATE ITEM NO ABSTRACT 9/14/95 NHH0096 Asegensa d illegal peadwes velshag to ingsopw per====,a peeecesse during X-Ray assene ame. Comepless im weisen siwan dernwed to Buseau em Wl495.

Unmensumced supecs== d5 pace Age Teming <=aducted 9n 585. hwesngmien sevessed esenerspe=rs woe not tems meansed ser espeemses se dism.m semne j

wemms wie *=esw sosse " _ m , devices. Notice dVietsmen issued, CLASS EVENM Reported to NRC N Lie # ZZZ j oM 1 i

NH M0092 8% seeds wese Isand implanned in a psaient and sexueved Dese paiens by Y Inwer==== sewesis seeds wee impimmed July 2.1953 m Mesty Hespent l 9/2965 n

in sense ess,Mm===remens we== paiess ses 5 mismos aid. onguies 6 comes de.d mas he ped secases dem,eyet raies was e seeds wese sang in sgeme.

B e iset m ofseeds som hosped rosene id drama rswe commenes nee possese sairasamed se-ch.

CLASS EVENTS Reported to NRC Y Lie # 357R LAS a

lef2395 NNp60116 NH leases: Red Hemide ==Pwed a NItC E ===* im W tud sueved a emusemy of Wisium (I C3 in visis)to a NH tocamou odeus w =, Netc iw humased slang wie NH. L . sevealed allegenen czesect. Osmemmy was appW Isr a NH r=m===rewe mesmans tir==== but was Joe Imeensed to have ved ma maisheNH. rm missed seemsf back to lir===J facility in h deossumssmeed NH facsiley med W psoper li====r team Mt CLASS EM geponed go NRC Y Lic# 395R om NH960122 The Cineens Wienis le Miles (C.19) youg ,W redumecarve deseeine __ _

• spiked" as a sesult of a selease of redisecame useamel tema Sestseek Nuclear lin095 s

Pweer ummi== en 29 New 95. Forund, full scan 6 NItC invesnesasse useelvses Muus DPHS and NH Bw Red Hemsei seps=====mwes. Elesuhs en C.10 meters same s sesult et5estseek "lesk*. Elessit Not a Radimman Prehi's CtAs3 EVENTS Reported to NRC N Lic# M om 11/2135 NH96ee87 Tensh such seeing edtromance stessus at wheelehrseer es* to energy Encility. Facilier cmIL NH Red. HesidL Busens pe=====a famed Nery Gummer wesen suck was

==a==ded. Traces es privsee household being eksed out. hem pieced in mush wish no buentedge dmemnan hamed.

poemmene Need shyyad eyeed a seseech Nery seekings and aske casesdy ofimmu. Seus tuned een to Nery. Meksuss h Met V Med 8 AEMe sustar Leekeus device smede in l943. Radian simAmiss used CLASS EVENTS Reported to NRC Y Lie # ZZZ LAS 11/2285 NH960675 heissensusersaien o'aurdical radioecarve dose in est a rai== was i=r-ed wie 24 6 esci /IV Tc-99 MDr (bene f. css) isueemd ef the i====M Tc-99a4IBI(carest).

. Docser send pairm adessed. No ill effects to peias e=pwed ,

CLASS EVEBITS Reported to NRC Y Lic# 138R esD2 3

p  ; i 1 lj  !!!!1l p8i

[i sv i*8l ili 1 ij n a

!gn ~1:

3 l 3 i !!i l

!!isli[1ll1 i I i!

!! li il li"-

1l a 1-l I dl 9 118lalt f} $ ! $ 118ha"!!alilill i ili!li lai 101i lil'!

I,I 11 l ir . 11 e a 11 ji 41! l ] il li

!! .} i i

')

li ']l i- b ci ! I is 11 p is 11 1i e

lI!! l  !! I Pi f,

I l}llifils!li18ilhh{l li ii I I I i i i l 3 i 8 i I

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

w  %

EVENT DATE ITEM seO AW5 TRACT 4/19f96 P49900114 A =ca ,=t sodiums somer (amaguayI was samt by US mail tem lose to a psivene ==m-d deceur im NIL Decour,soomgoleing puumMe named,huesgte lamm es newy l sa=+--* Hespent nesy N=6ert Hespemi,a NH hoemsee.eset possesmen dee inum med useded NH m.m.a.y e Heath "_- . . sevested U2 doen  ;

peopac p--e omfy one penen, pesans es,asyee, was,d, a--a :n ing e---ad the dose peuunned to the yddic. US Pesed 5erwise, bee and NBC magium I {

minonnie name d sad --m- -d wie denug + n== ps.pesey sena e e.le.e. i i

CtAss EWITS Reported to NRC Y Lie # ZZZ l EXP LAS  !

t  !

Sfl5/96 Peletet26 A tag ofesmemsummand muser was sesmoved Some a puhunt's seems 6m te h==ried Wasse was esagaceed wie oder"hussmal" muser med samt es Im for tumist penissa [

was undagssag tesammes wie 155 ssCI of I.138. Invessammen eeuM anwe er shing shove ladyumund at the lesdHE,but aus immed a sensus poises  ;

in ymmeses suunn. i i

MeteamtoFah,=f f

% class Em Reposted to NRC Y Lic # 130R [

LAS i I

5/23/96 NHBeef9p beise6memmunies ofsmo6 cal sedesselve ease Punient scfedeled for teme stat was impucand wie 21JuCIofTc99 w iseaume d 25msCIofTc9 ems tWP. Ne E [

e5cas amend and rums =r h was =ama=d . To anect the pseNems a h desage will te used ter Tc99mm DEF. Tc99ms her emesse wel be 24 suCI ismased d i

, 25smCL I class N Reported to NRC Y Lie # I47K j

9g32

[

r e

t [

l 6/6#96 NH900006 NH Sense PoEse smede a tellic soup of a _ _ _f _' _ ===a.y ashgsment* st a esEFImant Felicerump a,s.,

5-.--a -- m , ef te NH Busene etmy l l Heath. Mesmet of tsvesagmasse: Net am m.m.== Po=*= Tsusk was casryess eseessed passaic tags. [

, CLAs3 EWITE geyerged go NRC N Lie # ZZE [

own 6f25#96 NHet0005 A pedage impsspely amated as esseammug s=m===se mesenal was secewed med spened by semiboom asyleyues of Pm-==== Ibestag Casame. Pedage was assed by m-- during a want enough ==p====

P essmussed due Buseus of a.a.a.y e Huset for numammae. Isoesmemmen seweeled me se6mmumve j massensis. Sea was assed wids an old su6secarve maksug which 6d met assad shippnag tag. Appues KeSy Air Fesee base im Temas used inappoeyssee comemmer l DODf my===agencyaselfledtoemneetpntienes NoPenommel mp-ad CLASS Em Repor$dto' N RC Y Lic# ZZZ OTH t

i k

i r

l EvuwTm4TE rroereo AssTanct 7/26N 160060004 Tses med set of simum at HoetsE. Mass t==aEm Reading suponed a 18,880 cymt h amesNules immed med as seems es er asissamme Pet e

====== let DeseemmW pew sesponded to haddssd Temusfer ammi== W edsam and idemmeed by tub es 5-131. tagsseness im emh h pummut smees sus muece smemmes summmme hun v==* smedical feedsy =us ese - summs samed by namader Emaimsy sur dismy amas ar.ees me indammymmese sum UppATE le Arst 97 Ihmeme persammet seemmed to isen seg men sa N Decay peind *=mmeur 38 kmsf 5 sus. les smendum showa 6-ag-a inmid.

Ferdisyspensaeisen esee%

class EWNTS Repersed to NRC Y Lic # ZZZ LAS g 9fi7/96 NHetet23 Fusient IW sid M =pA==d Old M (fB8975 Causasume versume was found es emmemum WW poner somen. Imamame esqssumsy emme by W n====uf ge==past huss uns sessmed as dentmaar . sh=rd TW class EVEsem Reported to NRC Y Lie # 13st s oTH 90eN NHptesel % supesengsweise does imesidual wie ummausNy Ingh eguame 00Emmamit hemmemm 4W96 and 900N Inesedumf tospsume soms r demummy budge en le=er pass adL Undeinoesmesums class aussa Reported to NRC Y Lic # I45R Exp w whom psalmuns summond hem imumyng wie as home igenhe tertsN 789910e00 Tisse pameses mese admimmened 25 asCI of UTPA immated of te puescribed 25 smCI bel #. Esser steereed lowesagemoi by hespasi sesents sysseu suceived tem W Lad of Wassese, Vt. uust Imbeimd usung. tener oms. W esmans vials suma mese W mesine i class N Reponed to NRC Y Lic # 263R une l I2/3 t/96 78f960829 Fugiust in a lumsysemi tesamset sessa uns given 2.6 saci ch2GI wie en lY driy sud asked as use somemmiN imr I minuer wesent. As er end of er aushaus puissa emmeed IV eus leaking. nee 6 cal pen === a W secused pm and seen,eum h W Wie te emosymum efe syse en she Boer med te h1 mR meus tiemmed to manuel hadysund TW unseed as ass 9mblic ses med esemed wie land sysess emmmmg escay as P Fluer of eseansena soon essesed wie lead, pdessic and desshest manerset and smeded a smesmsmee e At osmghese of desse and amens essvenes sessa uns sesymmed for sme wie aera aumemE.

class HEssTS Reported toNRC7 Y Lic # 3OIR nud NH969f24 hahm=4 Peuer plut -Menned Bur. Red Hunte of a maimer Aset pusheems,se6same saaeme in secour assima. Mmemnump ,ypower pimmes hose eis sype feet postless I2/I3/96 shout 39%of te aimac. Flame win

• as tend and smemaer. WAGB4 mesmini semens is ISS encsusases per saamid New semdug 216 suussCmmes er shoes ille.800 of asch spec Ilmmt.

class Eve!5sTS Repersed to NRC7 N Li8 77'tt OTH 6

- ~ ,,

g .. m - -.

EVDfT SATE ITERE NO AMETRACT 12fl3/96 NH980127 Imevident is chage of wome semusval for te NH PuMic Neale Imbs seguessed ====a- =4merier sur e ymdage eflhymid tous te vuotagy Imre ammhed h is.esmansin rewessed me levels she.c % - rmdase esin faaorigmeny usadised bysi, maw r =-,==y es seemise essammer.

class nefm Reported toNRC N Lie # 325R OTH 12/17/96 NH980128 A h ela3=== found a Pedage ofW ===rina se te side efe higbumy in h Im6vedmmi tusept the puuhage to his homme in pa==== NH med sessed me ymdage in his 4-._ ever mig >L Cieisen h he emner.CIS-US ba and speed to mesmyost te yndsge past may had to auser.

Pedage was _ ", 20 ses a,s ofI-83 . g red.me s f md e huse seem i.m hun a rdEs sud when a deer led made a te susuk of e seAlc h whist ocemmed im medged, ades, i

ctAss nesis Repenedtr,NR C Y Lie 8 ZZZ i LAS t

i, 12/17/96 NDagget30 D 0Dowd aseleed neuysper add for asesium ofdevhes suspeceed ofcasemmag

• Joe examists. MmeAnd h med E Opuusiums Cemeer im DC of t IsmPend'E edt-class nelT3 Reponed to NRC Y Lic #

oTu 1128/97 NH970005 NH Dept W Seevices h an insemeery of sheir hansdoms samsuge W in Comosed NH. F= sed wee se,mui sendt vials of utut is ensight se he esdme and summmm. DES rh= 6=awie N anser med famed 8.75 mEUhr. Busens ermW Ituale par =====8 cend famed 5 visds,mma esamt 3.95 asuhrinessenetwintemeofvimiidsmusesn** te3i=&emuseuremmmmmmagshout.e6inehhighIs esofyeyps-eur. assethada n=ama Tu soc. Aspear i to he eds the shuff e6=-ar=e= emasyend hom % & DES asseges Supeed r=ha=-

class nerfs Reponed teNRC Y Lic# IIBK

' OTH 3/3/97 NH9780ll Reyest of a essadamammesse -dame ditiming team psescribed dose by smose ems 195 A dose of t 9 nacierledme 138 was esdesed by er pisynare== Dese adr====n-ed aus SA escL Ecurw tema se beimme 133 sesmusee sousee sending muinas 7.9%eum M. TW did met ehusroe devismen issue amam psier to dose being W Palent sad physsenen mese imissumed med no B effaces as puniset ease usand.

To lh te ph Reemining af'-*==a.ga= in W ofdevismusa Esse mesma in h souseum.

class pert 3 Reported toNRC Y Lic 5 368"t moz l

i 9

I 7

1 I

1

,___m ..

-m _ .. . . _ . . . . _ _ . _ . . . - . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ._ _ _ . _

l EVENT DATE ITERG MO ABSTRACT NH970014 Symeer dehveryvehide emmpostug ~ ." ' A was inwelved in a sisgele car esNic accadest im W Mt. 7% emeer,the only passem in the scenicle at 4/2487 the tune, samensmed miimer injuries. IAcal fine and police responded and asked fe. Sisee pelece help W the haemsesus curso papen for legsf2y only. No alemage to simpp-g cemesmers med me huown setesse of r an= ara v e masensis shhough euck hady camepy was damaged. Cage seemmed to Symant payeny im Wobuse, homas by amedia synoor widcie. <

Cage was 5 ammmo esus". Thsee war empey seemas, I h 85 smCl Tc99m med T1291, sad I esmemaeus 730 msCi Tc99me. On sesem to $=m ses ancehy in webwe wipe tese wac perfesmies. Reades indicane emanade sursums of amme boas avanged o.I dpm per csm ag -edt CtAss EVENTS gepargedgo WR C Y Lie # 04-26507 01 N t ,

3r3 n7 NH,70o25 Ummunal Event at Venment Yadme M=ri=r Power Semaion - As casthqmde ====a- h an easdhqude in pseyess im Needs-Seudi piame. Alana set poH is 0.01 sei, .med dedeusena of Unusual Event Acomal carthqude aanmeer sending was 0.124 G in Nesch soush pisme but madmag in werecaier esse- l O.T.,hmarna g _

w:st pasme. This was deamed , ener and amusmal event tensmased by plant at 9935 hrs 5/3137. NRC Power pImmt thad=== ewet 32420. {

class EVENTS Reported to NRC N Lic # ZZVY

• otu

+

&lM7 NH970027 h between Sesimock Power pIme, Sesse and MtC shnet Emet sods wish pin hele leaks med pessMe ===g-== Shast wwuse - Desing sefuel cumge Sestsook Lwee $ imel sods in dinesent 4 fuei a--hare had pin hele leaks. When semmoval of sees aus W I heehe caessly se causer of sed med amedier heehe  ;

jaggesby adeo meer cemeer. tenh===k wished to sanove " good" fuel seds in semic seen Eur e.amanman== het was ==r==med widi radiologpcal--=9==~* if a "psed" sed heehe and added h to syneem Geding seds aheady added sN poemble e==ns,= n-. se sygnes4 c.e,.ama==ms by NRC simmed even if good sods beehe die l meamiummum h-- to synet: would segl he only 1/16 sech specsficassem allowable. Somer med NItC gave remusemen to ps==a D.TefR seysenemenug samme.

class EVEISTs Reported to NRC N Lic# TI M OTH i

1. 1097 NH970026 Received initisi sepan of positie wester ovaempomme ime Space Age Teneing. Their a====y supplier. IOS n a wy Services.npests e hedge r==d== 34,908 mmen whose body. Full seport due by mid July, e etAss EVENTS Rcported so NRC N Lic # ZZZ  !

i EXP

&2487 NH970029 Huggins Hospient h sqsyment class EVENTS

• Reported to NRC7 Y Lic # 291K 8E8 i i

I

)

46 Records ,

[

i 1

J. . .*

i APPENDlX D LICENSE FILE REVIEWS i

File No.: 1 Licensee: American Health Centert., 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 condition to allow out of specifications source changers to be used as storage containers, b) Well researched and documented.

File No.: 4 Licensce: 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 Date 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.

l l

)

New Hampshire Draft Report Page D.2 License File Reviews File No.: 6 Licensee: Catholic Medical Center License No.: 109R Location: Manchester, NH Amendment No.: 41 License: Type: Diagnostic / Limited Therapy Type of Action: Amendment

, Date issued: 12/16/95 License Reviewer: DO File No.: 7 Licensee: Distide, Inc. License No.: 377R Location: Londonderry, NH Amendment No.: 9 License: Type: Research/ Development Type of Action: Amendment Date issued: 3/27/97 License Reviewer: KM d

File No.: 8 Licensee: Mary Hitchcock Memorial Hospital License No.: 139R Location: Labanon, NH Amendment No.: 57 License Type: Diagnostic / Therapy Type of Action: Amendment Date issued: 2/24/97 License Reviewer: MI File No.: 9 Licensee: LeadTech, Inc. License No.: 396R Location: Moultonboro, NH Amendment No.: New License Type: Fluor. x-ray Type of Action: New Date issued: 3/19/96 License Reviewer: MI File No.: 10 Licensee: Heynen Teale Engineers, Inc. License No.: 353R Location: Bedford, NH Amendment No.: 13 License Type: Portable Gauge Type of Action: Renewal in entirety Date issued: 6/3/96 License Reviewer: DR Comment:

a) . Missing March 22,1996 letter referenced in tie-down condition.

File No.: 11 Licensee: Elliot Hospital License No.: 182R Location: Manchester, NH Amendment No.: 41 License Type: Diagnostic / Therapy Type of Action: Amendment Date issued: 7/17/97 License Reviewer: DR File No.: 12 Licensee: Jaworski Geotech, Inc. License No.: 345R Location: Manchester, NH Amendment No.: 9 License Type: Portable Gauge Type of Action: Amendment Date issued: 8/5/96 License Reviewer: DR

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

i New Hampshire Draft Report Page D.3

- License File Reviews File No.: 13 Licensee: Ear, Nose & Throat Phys. & Surgeons, P.A. License No.: '333R

, Location: Manchester, NH ' Amendment No.:

License Type: In vitro lab Type of Action: Termination Date issued: 4/20/95 License Reviewer: DR c

l i

t d

4 i

e t

-_a_____. - - -

t

)

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 4

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 f acility.

File No.: 2

. Licensee: Dames & Moore, Inc. License No.: 392R Location: Salem inspection Type: Unannounced, Routine, Field 1

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

,t j

4 New Hampshire Draft Report Page E.2 inspection File Reviews Comments:

a) Telephone conversation used as inspection but phone record not in file, 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: Unannounced, Routine, Field

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

a) Report does not indicate whether preliminary findings discussed with management.

b) NOV for failure to provide training not identified as a recurring item.

File No.: 7 Licensee: Diatech, Inc.

License No.: 377R

Location

Londonderry inspection Type: Announced, Routine, Follow-up, Field License Type: . Research and Development Priority: 3 Inspection Date: 11/15/94 Inspectors: KM/MI Comments:

a) NOVs not timely, b) No follow up to confirm licensee corrective actions to various cited program deficiencies.

File No.: 8 i

Licensee: Haley & Aldrich License No.: 399R Location: Bedford inspection Type: Unannounced, initial, Office License Type: Portable Gauge Priority: 5 Inspection Date: 6/24/97 Inspector: MI Comment:

+

a) Inspection performed over one year from new license issuance (5/96).

. File No.: 9 i Licensee: Professional Service Industries, Inc. License No.: 400R Location: Portsmouth inspection Type: Unannounced, Routine, initial, Field License Type: Portable 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

'\'

New Hampshire Draft 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.

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

1 I

New Hampshire Draft Report Page E,4 Inspection File Reviews Accompaniment No. 2 Licensee: 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 4

body and ring badge dosimetry report resolved.

b). Goed interviewing techniques.

1

• e, 4

f 0~

4 l

4 4

1

. p-

, .1

! APPENDlX F INCIDENT FILE REVIEWS File No.: 1 Licensee: Huggins Hospital License No.: NH-301 R Location: Wolfeboro, NH Date of Event: 6/16/97 F

Type of Event: Contamination Summary: Licensee received a contaminated shipment of bulk Technetium 99m from Syncor. Shipment arrived at 7:10 a.m. and was wipe tests at 7:30 a.m. Decontamination of materials was unsuccessful. Syncor was notified and the shipment was returned to them on 6\17\97.

File No.: 2 Licensee: Huggins Hospital License No.: NH 301R Location: Wolfeboro, NH Date of Event: 6/20/97 Type of Event: Contamination Summary: Licensee reported minor spill from IV in patient on treadmill. Approximately four droplets of thallium 201 fell on the treadmill. The area was secured from the public.

The area was surveyed and decontamination procedures were conducted. After decontaminstion efforts were completed, the treadmill was the only area which continued to show measurable activity. The treadmill was moved to the nuclear medicine laboratory and was draped with lead aprons.

File No.: 3 Licensee: Huggins Hospital License No.: NH 301R Location: Wolfeboro, NH Date of Event: 12/11/96 Type of Event: Contamination Summary: Patient was given Thallium 201 and was asked to use the treadmill for a 1 minute workout. At the end of the workout, the patient noticed that the IV was leaking.

Medical personnel immediately secured the patient and room an initiated decontamination procedures. After decontamination efforts were completed, the areas were cleaned to background with the exception of the treadmill and a spot on the floor.- The treadmill was removed from room and was draped with lead aprons. The spot on the floor was covered with lead, plastic and absorbent material and marked as radioactive contamination.

File 14o.: 4 Licensee: Huggins Hospital License No.: NH 301R Location: Wolfeboro, NH Date cf Event: 3/25/96 Type of Event: Contamination 1

I i 2

4 New Hampshire Draft Report Page F.2 l= Incident Files Reviews Summary: On March 25,1996, the licensee received a contaminated shipment of bulk Technetium 99m from Syncor.. Wipe tests were performed on the lead pig upon receipt.

Decontamination of materials was successful. Syncor was notified by letter.

File No.: 5 Licensee: Huggins Hospital 4

License No.: NH 301R Location: Wolfeboro, NH

Date of Event: 3/21/96 Type of Event: Contamination Summary: On March 21,1996, the licensee received a contaminated shipment of bulk Technetium 99m from Syncor. Wipe tests were performed on the lead pig upon receipt.

Decontamination of materials was successful. Syncor was notified by letter, i

File No.: 6 Licensee: Duggins 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 iristead of the intended cardiac Tc-99m MIBl. Patient and Doctor notified. Technologist selected wrong vial.

d w

I, 2

s' New Hampshire Draft Report Page F.3 Incident Files Reviews File No.: 9 Licensee: Exeter Hospital, Inc. '

License No.: NH 138R Location: Exeter, NH Date of Event: 9/23/96 Type of Event: Non routine Summary: Patient having old pacemaker replaced. Old pacemaker,1975 Corotomic version, was found to contain plutonium 238 power source. implant was originally performed by Massachusetts General Hospital. The old pacemaker was returned to distributor.

File No.: 10 Licensee: Cheshire Medical Center Location: Keene, NH License No.: NH 265R l Date of Event: 1/11/96 Type of Event: Lost source l Summary: Licensee discovered that two cobalt 57 spot makers were lost. Each source was listed as containing 2.9 mci as of the date of the' report. The two sources were taped together.

Commem:

A copy of the incident report needs to be placed in the licensing file.

File No.: 11 Licensee: Cheshire Medical Center Location: Keene, NH License No.: NH 265R Date of Event: 10/19/94 Type of Event: Contamination Event Summary: Contamination found on the inside of a shipping container of Nal,13.69 mCl, received from Syncor 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 implanted on July 2,1953 at Mercy Hospital in Springfield, Massachusetts when the patient was 5 months old. The doctors who implanted the seeds are now deceased and the hospital records were destroyed. The patient was unaware that the seeds were stillin pit 0e. BRH took possession of the seeds

It o.

W New Hampshire Draft Report Page F.4 Incident Files Reviews from the hospital. A positive identification of the radioactive contents of seeds were not possible after a national search; however, it is believed that the seeds are radium.

File No.: 13 I Licensee: Miller Engineering & Testing License No.: 278R Location: Manchester, NH Date of Event: 2/6/96 Type of Event Loss of Control Summary: The licensee notified NRC headquarters Operations Center that a Troxler moisture density gauge containing radioactive sources had been stolen from the back of a pickup truck in Dorchester, Massachusetts. According to the licensee, the gauge t.ser was returning to the Northborough, Massachusetts, office after completing work at a job site in Rockland, Massachusetts. The source rod was locked in the shielded position and locked in a secured contained chained to the bed of the pickup. When the user returned to his truck after a stop, he discovered the cab unlocked and the chained container was missing.

The licensee 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 8,1993, the licensee notified NRC Region I that the gauge had been recovered.

File No.: 14 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 conte 6ated waste was removed from a patient's room in the hospital. Waste was ce,mpacted with other " normal" waste and sent to landfill for burial.

Patient was undergoing treatment with 155 mci of I 131. Investigation could detect nothing above background at the landfill, but contamination was found at various locations in patient's room.

,