ML20203F517

Draft Rept, Integrated Matls Performance Evaluation Program Review of Ma Agreement State Program 980112-16

ML20203F517
Person / Time
Issue date:	02/10/1998
From:	NRC
To:
Shared Package
ML20203F511	List: ML20203F507 ML20203F517
References
NUDOCS 9802270334
Download: ML20203F517 (44)

Text

{{#Wiki_filter:.. r INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF M ASSACHUSETTS AGREEMENT STATE PROGRAM JANUARY 12 t3,1998 1 DRAFT REPORT J U.S. Nuclear Regulatory Commission PDR T v

• ie-P

y + v j- -Massachusetts Draft Report Page1 n

1.0 INTRODUCTION

4 i This report presents the results of the initial review of the Massachusetts radiation control program. The review was conducted during the period January 1216,1998, by a review team 1 comprised of technical staff members from the Nuclear Hegulatory Commission (NRC) and the-A0reement State of Georgia. Team members are identified !n Appendix A. The review was j conducted in accordance with tha " Implementation of the Integrated Materials Performance Evaluation Program and Rescission of a Final General Statement of Policy," published in the Federal Register on October 16,1997 and the November 25,1997 NRC Managemem Directive 5.6," Integrated Materials Performance Evaluation Program (IMPEP)." Prelir*ary results of - the review, which covered the period March 21,1997 to January 16,1998 sore discussed with Massachusetts management on January 16,1998. i~ - [A paragraph on the results of the MRB meeting will be includad here in the final report.) The Massachusetts Agreement State program is administered by the Radiation Control Program (RCP) located in the Department of Public Health (MDPH). Organization charts are included as Appendix B. The Massachusetts program regulates approximately 435 licenses e authorizing agreement materials, plus an additional 90 licenses authorizing only Naturally ~ Occurring and Accelerator Produced Radioactive Material (NARM). i The review focused on the materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) /.greement between the NRC and the Commonwealth of Massachusetts. l The Massachusetts Regulations for Control of Radiation, found in Chapter 105 of the Code of Massachusetts Regulations, Section 102.000, apply to all ionizing radiation, whether emitted from radionuclides or devices. Massachusetts requires a license for possession, and use, of all j_ radioactive material including naturally occurring materials, such as redium, and accelerator-i; - produced radionuclides. Massachusetts also requires registration of all equipment designed to j. produce x-rays or other ionizing radiations. in oreparation for tiie review, a questionnaire addressing the common and non-common - - indicators was sent to the Commonwealth on October 14,1997. The Commonwealth provided a response to the questionnaire on December 12,1997. A copy of tne response is included in 7 Appendix C to this report.

The review team's general approach for conduct of this review consisted of

(1) examination of Massachusetts' response to the questionnaire; (2) review of applicable Massachusetts statutes and regulations; (3) analysis of quantitative information from the radiation control program-licensing and inspection data base; (4) technical review of selected licensing and inspection actions; (5) field accompaniments of four Massachusetts inspectors; and (6) interviews with staff and management.to answer questions or clarify issues. The team evaluated the

- information that it gatherwd against the IMPEP performance criteria for each common and non- - common indicator and made a preliminary assessment of the radiation control program's performance. o - * = e 2-n- -u--e,--,e-. .--%w-w--m.- v%. . -. - -+ rr-e-,.e-w-w- =r -e -r e s a = - - -i.:- =

r o .e Massachusetts Draft Report Page 2 7 Section 2 below, Status of items identified in Previous Reviews, is not applicable to the - Commonwealth as this was the initial program review, Results of the current review for the IMPEP common performance indicators are presented in Section 3. Se:: tion 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's-a j findings and recommendations. Suggestions made by the review team are comments that the review taam believes could enhance the Commonwealth's program. The Commonwealth is 4 requested to consider suggestions, but no response is requested. Recommendations relate 4 directly to program performance by the Commonwealth.: A response is requested from the Commonwealth to all recommendations in the final report. 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS l The Commonwealth of Massachusetts became an Agreement State on March 21,1997 The agreement includes byproduct material as defined in Section 11(e).1, source and special nucleer materials, low-level radioactive waste disposal and sealed source and device evaluations. It does not include byproduct material as defined in Section 11(e).2. This was the initial program review, A management orientation meeting was held with the Ccmmonwealth on June 18,1997. The purpose of the meeting was to discuss the status of the l-program s'"i the initial program activities following the transfer of authority. No attempt to i evaluate thi performance of the program was made at that meeting. i. [ 3.0 COMMON PERFORMANCE INDICATORS lMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials p Inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.- 3.1 Status of Materials Insoection Program The team focused on four factors in reviewing this indicator; inspection frequency, overdue inspections, initialinspection of new licenses, and timely dispatch of inspection findings to licensees. This evaluation is based on the Massachusetts questionnaire responses relative to this indicator, data gathered independently from the Commonwealth's licensing and inspection data tracking system, the examination of completed licensing and inspection casework, and - interviews with managers and staff,- l The team's review of the Commonwealth's bspection priorities verified that the Commonwealth's inspection frequencies for various types or groups of licenses are at least as . frequent as similar license types or groups listed in the NRC Inspection Manual Chapter 2800 _ (IMC 2800) frequency schedule.-- Four license categories are scheduled for more frequent inspections by the Commonwealth than similar NRC licensees, as follows: n i i _~. _ _,

I J Massachusetts Draft Report Page 3 Tvos of License Massachusetts Freauency(vgata) NRC Freauency (vears) Teletherapy 2 3 Self Shielded Irradiators 3 5 General License Distribution-in vitro kits 3 5 Source Mriterial-Other 3 5 With respect to initial inspections of new licenses, the team evaluated the inspection tracking data system and verified that initial inspections were entered into the computerized tracking system together with existing licenses. A review of the inspection tracking system showed that initial inspections are not always differentiated from routine inspections. Thus, some initial inspections are scheduled at regular inspection frequencies instead of the six month frequency i required by program procedures. A review of the database identified 14 new licenses issued since the Agreement, by the Commonwealth. Four licenses had initialinspections due during the review period. Of these four, one license was insoected within the six month window, one was inspected a month late and two licenses are overdue for inspection (both due in December 1997.) The team did not !dentify any licenses transferred to the Commonwealth by the NRC which were overdue for initialinspections. The review team recommends that initialinspections of licensees be performed within six months of the licensee's receipt of licensed material, within six months after commencement of licensed activities, or within one year of license issuance, whichever comes first, consistent with IMC 2800. In response to the questionnaire, Massachusetts indicated that two core inspections were overdue by more than 25% of the scheduled frequency. Those two inspections have since been performed and thus the only inspections overdue are the initial inspections identified above. Since the effective date of the Agreement, Mass 9chusetts has authorized reciprocity to 31 licenses. Of the 31 reciprocallicenses,3 were teletherapy /irradiator source replacement firms, 7 were industrial rad;ographers,6 were service companies and 15 were gauge or device users. To date, the RCP perforn"d only two inspections of reciprocity licensees, one irradiator source replacement and one industrial radiographer. Reciprocity requests are recorded in the tracking system but inspections have rarely been performed. The Acting Supervisor indicated that short lead times and inefficient internal handling of reciprocity requests were impediments to performing reciprocity inspections. Recently, intemal changes were made to bring all reciprocity requests immediately to the attention of the Acting Supervisor, allowing him to make decisions to divert inspectors for reciprocity inspections. TW improved system was evidenced during the review when a reciprocity request was recs by the program, referred in a timely manner to the Acting Supervisor, and an inspector us dispatched to the site. The review team recommends that the Commonwealth increase the number of reciprocity inspectior,s to better evaluate the health and safety implications of out-of state companies working in Massachusetts I I

Massachusetts Draft Report Page 4 The timeliness of the issuance of inspection findings was also evaluated during the inspection file review. Of 23 inspection findings examined, the corraspondence for 14 inspections was sent to the licensee within 30 days of the inspection date. For the other nine inspections, the correspondence was sent to the licensee from 33 to 81 days after the inspection. Three of the cases involved escalated enforcement or were delayed while waiting for further information from a licensee, and six cases were late because of inspector workloads and lack of urgency by inspectors. The Acting Supervisor indicated that this was an area in which he sees room for improvement and is emphasizing timeliness to staff during training meetings. Another factor which contributes to delays in the issuance of inspection findings is that some inspection staff office locations are in a temporary trailer. Consolidation of staff into one area in a single building (planned for March 1998) should help improve timeliness. The review team suggests that the Commonwealth issue inspection findings in a more timely manner to meet the 30-day program goal. Based on the IMPEP evaluation criteria, the review team recommends that Massachusetts' performance with respect to the indicator, Status of the Materials Inspection Program, be found satisfactory. 3.2 Technical Quality of Insoections 4 The team reviewed the inspection reports, enforcement documentation, and inspection field notes and interviewed inspectors for 18 out of 49 materials inspections conducted during the review period. Of the 18 inspections evaluated all were unannounced. The casework included six of the Commonwealth's materials license inspectors, and covered inspections of various types including: research and development, broad scope medical, broad scope academic, nuclear laundry, veterinary, medical institution, industrial radiography, decontamination, calibration, in vitro laboratory, broad scope manufacturer, portable gauge, nuclear pharmacy, and manufacturing and distribution licensees. Appendix C lists the inspection files evaluated 1 in-depth with case specific comments. Numerous interviews and discussions were held with the Commonwealth inspectors during the week of the review. The inspectors demonstrated a good working knowledge of radiological health and safety. The Acting Supervisor actively communicates with his staff and discusses each inspection with the inspectors and he signs off on allinspection reports, inspection records and field notes indicate that each inspector is competent and experienced in the area (s) that he/she has inspected. Inspection field notes and written narratives were of good quality and the files were generally complete. The appropriate inspection forms were used for the type of inspection conducted. Violations were identified and adequately documented in the inspection reports. In six cases, apparent violations noted in the field notes were subsequently not cited as violations in correspondence to the licensee and there was no explanation or i documentation provided in the file as to why the apparent violations were not cited after supervisory review. During the week of Decamber 8,1997, a review team member performed accompaniments of four Commonwealth inspectors on separate inspections of licensed far ilities (See Appendix D). The inspections included puclear gauge manufacturer, an academic institution, a research and development company and a hospital nuclear medicine program. During the

Massachusetts Draft Report Page5 accompaniments, inspectors demonstrated appropriate inspection skills and knowledge of the regulations. The inspectors were well prepared and thorough in the review of licensee programs, inspection techniques were observed to be performance-oriented and the technical performarice of all four inspectors was excellent. The inspections were acequate to assess radiological health and safety at the licensed facilities. The team evaluated the Commonwealth's laboratory support process. The Department of Public Health's environmental radiation laboratory is responsible for the calibration and maintenance of radiation monitoring equipment. This laboratory operates under the RCP. Survey instruments are sent out for calibration on an annual basis to an approved calibration laboratory. Each inspector is assigned a kit with a calibrated survey instrument and several types of radiation detection probes. The instruments are capable of detecting alpha, beta, gamma and neutron radiation. Instrumentation available includes: GM meters, rate meters, pocket dosimeters, sodium iodide scintillation probes, end window GM tubes, alpha scintillators, alpha / beta scintillators and pancake probes. The lab is also equipped with germanium detectors (gamma spectroscopy), gas flow proportional counters, and liquid scintillation counters for sample counting and analysis. The team also reviewed activities with respect to supervisor accompaniments of inspectors. Thus far, in the 10-month nistory of the program, m nagement has accompanied only three of eight inspectors on field inspections. The importance of supervisory accompaniments of inspectors was discussed with the Acting Supervisor and RCP Director, The accompaniments allow first hand assessment of performance and assure appropriate and consistent application of policies and guides. The review team recommends that program managers conduct annual field accompar.ments of each inspector to assess performance. Based on the IMPEP evaluation criteria, Me review team recommends that Massachusetts' performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory. 3.3 Igchnical Staffing and Training issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training and staff tumover. To evaluate these issues, the review team examined the Commonwealth's questionnaire responses relative to this indicator, interviewed program management and staff, and considered any possible workload backlogs. The Acting Supervisor stated that all technical staff positions require the equivalent of a bachelor's degree in the sciences. Positions are classified as either Environmental Engineers or as Environmental Analysts. The RCP, with approximately 525 licenses, has a planned staffing level of one supervisor,11 Environmental Engineers, one Environmental Analyst and two administrative personnel responsible for the radioactive materials program, including the NARM Licensing program. The current technical staffing level is 9.0 FTE with three technical positions (Environmental Engineers) vacant. Technical staff parform both inspection and licensing functions. The

I Massachusetts Draft Report Page 6 Supervisor position is filled in an acting capacity. Based on review results, this staffing levelis adequate for a program of this size. Strains identified in other areas of the program (reciprocity inspections, inspection report timeliness, etc.) and anticipated significant increases in the Sealed Source and Device program workload indicate that the RCP would greatly benefit from the filling of the vacant positions. The RCP Director stated that filling of the vacant Environmental Engineer positions is in process and two of the three positions are currently posted. The review team recommends that, due to current program demands and the projected increase in workload, program rnanagement closely monitor the filling of the RCP vacancies. The RCP has a documented training and quahfication program m place for the staff which is taken directly from the NRC's IMC 1246, " Formal Qualification Programs in the Nucir,, Material Safety and Safeguards Program Area." The technical staff is well qualified from an eNeation and experience standpoint. Staff has attended many core training courses but have been inhibited by the decreased slots available in NRC-sponsored courses. For example, three staff have not attended the Transportation of Radioactive Materials course, no one has attended the Root Cause/ Incident Investigation Workshop and only one staff member has completed the Health Physics Technology course. All of these courses are core training courses in the RCP qualification program. One new staff member (hired in August 1997) has not yet attended any of the required training courses but is scheduled to attend courses as they become available. Training funds are available from the licensee fee base and no training travel roadblocks exist, according to the RCP Director. Alternate training efforts are being initiated by the Commonwealth, both alone and in conjunction with other New England states, to bring training courses to the area. The RCP does not have a formal mechanism by which management certifies that an inspector or license reviewer has met qualifications in a particular area of responsibility. The Acting Supervisor, however,is aware of each staff member's training and experience and assigns licensing actions and inspecticris to those with appropriate training in the specific modality, as verified by the team during file reviews and discussions with staff members. The review team recommends that the Commonwealth manage the training program to ensure that staff receive required training courses to fulfill RCP qualification requirements for inspectors and license reviewers. Based on the IMPEP evaluation criteria, the review team recommends that Massachusetts' performance with respect to this indicator, Technical Staffing and Training, be found satisfactory. 3.4 Technical Quahtv of Licensina Actions The review team examined completed licensing casework and interviewed the reviewers for 12 specific licenses. Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities authorized, qualifications of authorized users, adequacy of facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the license and of its conditions and tie-down conditions, and overa!! technical quality Casework was evaluated

Massachusetts Draft Report Page 7 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 _ supervisor / review as indicated, and proper signature authorities. The files were checked for retention of necessary documents and supporting data. _ The licensing casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The cross-secuon sampling included the following types: radiopharmaceutical manufacturer; manufacturer of generally licensed products: industrial radiography; pool irradiator, self shielded irradiator; research and development; medical teletherapy; and high dose remote afterloader. Licensing actions included 3 new licenses,11 amendments, and 1 termination. A list of these licenses may be found in Appendix E. The licenses transferred from NRC to the Commonwealth are being reissued as Massachusetts licenses when amendments to these licenses are issued. Where a Commonwealth license for naturally occurring or accelerator produced materials exists in addition to a transferred NRC license, the Massachusetts licenses are being combined with the reissued agreement materials - licenses.. This action is consistent with the plan expressed in the request for the Agreement. For the pomose of this review, the team classified the reissueu sicenses as " amendments" rather than "new licenses.' It was noted that in nearly all of the licensing actions reviewed, a pre-existing NRC licenu was available for use as the basis for the Commonwealth license, in the few actions which did not involve a transferred NRC license, appropriate Commonwealth review procedures were followed and checklists wt -used, in discussions with program management, it was noted that Massachusetts was continuing the major decommissioning efforts NRC had underway at the time of the Agreement. There were no new identified sites with potential decommissioning difficulties equivalent to those sites in NRC's Site Decommissioning Management Plan. Based on the IMPEP evaluation criteria, the review team recommends that Massachusetts' performance with respect to the indicator, Technical Quality of i.icensing Actions, be found satisfactory. 3.5 - Roanonne to incidents and Allegations

In evaluating the effectiveness of the Commonwealth's actions in responding to incidents and allegations, the review team examined the Commonwealth's response to the questionnaire

relative to this indicator and reviewed the incidents reported for Massachusetts in the " Nuclear

~ Material Events Database (NMED)" against those contained in the Massachusetts casework and license files, and supporting documentation, as appropriate for nine incidents. The team reviewed the Commonwealth's response to the two allegations received during the reiic..- period. A list of the incident casework with comments is included in Appendix F.

l y .e l c [ Massachusetts Draft Report Page 8' The nine incidents selected for evaluation included three misedministrations, four lost sources, one reported loss of control of radioactive material, and one equipment failure. Of the two allegations evaluated, the NRC Region I office referred one to the Commonwealth and the other one came directly to Massachusetts. Responsibility for initial response and follow-up actions to materia l incidents and allegations rests with the RCP staff. When the Commonwealth is notified of an incident during working hours, the anigned

• Officer of the Day takes the incoming notification and briefs the Acting

- Supervisor or the RCP Director to determine the approach to be taken regarding the incident. The Commonwealth provides a 24-hour emergency number for anyone to use to report _ emergencies involving hazardous materials. When a rr ologicalincident is reported after work 4 - hours, RCP staff is contacted at home. 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 4 requiring on-site investigations, copies of letters to licensees were in the incident and licensing files indicating that the incident would be investigated during the next scheduled inspection. In response la incidents, the RCP had taken prompt, appropriate action. The evaluation of casework indicated that incident reports were thorough and well-documented. The incident reports were reviewed and signed by the Acting Supervisor. The evaluation of the two allegation cases indicated that the RCP had taken prompt and L appropriate action in response to the anegers' concems. Further review of the casework and a staff interview determined that the RCP did not provide periodic feedback. An acknowledgment of one allegation was not sent back to the alleger and a follow up communication was not completed discussing the findings of the RCP's investigation into the allegation in accordance with the Commonwealth's written procedures. The review team reccmmends that the RCP - 3: provide written periodic feedback on the disposition of allegations to allegers in accordance with Commonwealth procedures. 4 The review team found good correlation of the Commonwealth's response to the questionnaire - and the incident information in the casework. The review team also queried the incident information reported on the NMED system for Massachusetts which identified only two reported 4 incidents. The team interviewed the staff person responsible for incident coordination and i . determined that the additional incidents had been forwarded for inclusion in the NMED system, . but were not yet loaded on the system at the time of the review. ( Based on the IMPEP evaluation criteria, the review team recommends that Massachusetts' performance with respect to the indicator, Response to Inciderts and Allegations, be found satisfactory. - 4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement L State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed f Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; - and (4) Uranium Recovery Program. Massachusetts' agreement does not cover uranium d v y -w W-t - er m--- -i-w-,--- --%m-,, - -

1. -sw.-

v. w + -, -, - --mm- ~ w

e - Massachusetts Draft Report . Page_ g - recovery operations, so only the first three non-common performance indicators were applicable to this review. ' 4.1 : Legislation and Program Elements Required for Comnatibihty 4.1.1 Legislation Along with their response to the questionnaire, the Commonwealth provided the review team ' with the opportunity to review copies of legislation that affect the radiation control program. - Legislative authority to create an agency and enter into an agreement with the NRC is granted in Massachusetts General Law Chapter 111. The Department of Public Health !s designated as the Commonwealth's radiation control agency. The review team noted that the legislation had previously been found adequate during the review of the Commonwealth's request for an Agreernent, and there had been no changes. '4.1.2 Program Elements Raouired for Compatibikty The review team examined the procedures used in the Commonwealth's regulatory process and found that they are unchanged from the descriptions provided in the application for the Agreement. Proposed regulations are presented to the Public Health Council with a proposal to seek public comment. After a schedule of public hearings is completed and comments received - c - are addressed, final regulations are presented to the Public Health Council for adoption. The-adopted regulations are filed with the Secretary of State for publication. The team evaluated Massachusetts' responses to the questionnaire and noted that there have been no regulations adopted by the Commonwealth since the March 21,1997, signing of the Agreement. The Commonwealth had adopted, before the Agreement was signed, all regulationc identified as due prior to June 30,1998. The team found that the Commonwealth is addressing the following NRC regulation amendment;

e

" Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996. In order to avoid a " whip-saw" effect on licensees transferred from NRC to the Commonwealth, Massachusetts was required to adopt regulations or altemate legally binding requirements equivalent to ali NRC regulations in effect on the effed;e date of the Agreement. The Commonwealth was unable to promulgate regulations equivalent to the new Itart 71 in time, and agreed to issue an of der to all licensees to comply with the requirements of new Part 71 pending their adoption of equivalent rulesc The team confirmed that the order was issued, and that draft rules equivalent to new Part 71 are being prepared for public comment. ~ ?L The Commonwealth has not yet adopted the following regulations, but intends to address them in rulemakings or by adopting altemate generic legally binding requirements: L... _.,...

s' Massachusetts Draft Report Page 10 " Radiation Protection Requirements: Amended Definitior,s and Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995.

• Medical Administration of Radiation and Radioactive Materials,' 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective on October 20,1995.

" Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995. ' Termination or Transfer of Licensed Activities: Record Keeping Requirements,' 10 CFR Parts 20,30,40,61,70 (61 FR 24669) that became effective on June 17,1996. ' Resolution of Dual Regulation of Airbome Effluents of Radioactive Materials Clean Air Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997. ' 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 February 27,1997.

• Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Parts 20 and 35 amendments (62 FR 4120) that became effective on May 29,1997.

' Licenses for Industrial Radiography and Radiation Safety - Requirements for Industnal Radiography Operations,' 10 CFR Parts 30,34,71,150 amendment (62 FR 28947) that became effective on June 27,1997. ' Radiological Criteria for License Termination," 10 CFR Parts 20,30,40,70 amendment i (62 FR 39057) that became effective on August 20,1997. It is noted that Management Directive 5.9, Handbook, Part V, paragraph (1)(c)(iii), provides that the above regulations should be adopted by the Commonwealth as expeditiously as possible, i but not later than three years after the effective date of the new Commission Policy Statement on Adequacy and Compatibility, i.e., September 3,2000. Based on the IMPEP evaluation criteria, the review team recommends that Massachusetts' performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory. 4.2 Sealed Source and Device (SS&D) Evaluation Proaram in assessing the Commonwealth's Sealed Source & Device (SS&D) evaluation program, the review team examined information provided by the Commonwealth in response to the IMPEP questionnaire on this indicator. A review of all completed SSt D evaluations and supporting documents covering the review period was conducted. The review team interviewed the staff and Acting Supervisor responsible for SS&D evaluations ano examined the staff's use of - guidance documents and procedures. I

l l '6 n' ] Page 11 Massachusetts Draft Report The Commonwealth has adopted the use of the NRC's NUREG-1550,? Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations," Regulatory i Guide 6.g, " Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material," and Policy & Guidance Directive 64 22, Revision 1, "What Source and Device Designs Require an Evaluation," as standard - reviewer guidancei Staff uses the template registration certificates and checklist from NUREG-1550 to assist in the review of SSADs and to help to ensure that all pertinent issues are F addressed. The Commonwealth also uses a tracking sheet to track correspondence and staff I work regarding SS&D actions. The Acting Supervisor responsible for SS&D evaluations must audit the SS&D package and sign off on the tracking sheet before any action can be slosed and 3 the registration certificate issued. 4.2.1 Technical Quakty of the Product Evaluation Program L The review team examined all four of the SS&D registration certificate actions for the review period. -The registration certificates reviewed covered the period since the Commonwealth r became an Agreement State and represented cases corr.:.leted by three of the four staff. l members authorized to sign registration certificates. The SS&D registration certificates issued by the Commonwealth and evaluated by the review team are listed with case-specific F - comments in Appendix G. The review team suggests that the Commonwealth consider the SS&D commenta identified in Apper dix G and take action as the Commonwealth deems appropriate. interviews with staff.%dicated that not all staff were aware of the current SS&D policies and ~ proceduresi The ter believes that in order to have a sound program and ensure that reviews are performed consis,ently, it is important that all reviewers are working from a standard policy and that the policy remains in place until a change is approved by management. - The team noted one item in particular. Interviews with staff indicated that not all staff were L aware that there was an established policy on what constitutes a concurrence review. Some staff had individually determined that concurrence reviews should be performed as independent reviews. Discussions with management indicate that the current policy is to require that all l-aspects of the SS&D review will be addressed, but to allow an interdepenoency between the i reviewers." For example, in any particular evaluation, each reviewer does not have to be able to perform all aspects of the SS&D review, provided that at least one of the reviewers can adequately evaluate each issue. Under the Massachusetts program, full signature authority is [ granted to all reviewers, even though each reviewer may not be qualified to perform all areas of an evaluation, ~ p Although this policy was compatible with the guidelines in the previous version of Management Directive 5.6, it is not compatible with the current guidelines in Management Directive 5.6, which specifically states: "An independent technical review of the application and proposed certificate of registration is performed by a second individual and supports the finding that the product is acceptable for licensing purposes. (It is important to keep in mind that - the independent technical reviewer must concur with the initial review.), and ~

l Massachusetts Draft Report Page 12 'A concunence review includes an independent technical review of the materia!s submitted by the applicant and the documents generated by the initial reviewer. The concurrence review includes evaluation of each area addressed during the initial review (e.g., construction of the product, labeling, and prototype testing), but the concurrence review is not to the same level of detail as the initial review (i.e., it is not necessary to review every page of the applicant's submittal). The concurrence review must be focused on ensuring that the product meets all applicable regulations, that the product would not pose any health or safety concems, and that the registration certification provides an adequate basis for licensing. This concurrence review by a second qualified reviewer is necessary in view of the potential health and safety implication resdting from the widespread distribution of sealed sources and devices.' The purpose of these guidelines is to ensure that each area of the evaluation is addressed by two qualified individuals. Full signature authority should be given only to those r3 viewers that are qualified to perform all areas of the evaluation. Limited signature authority to perform specific areas of the evaluation f could be granted to reviewers not having qualifications in all areas. Each evaluation should be performed by two individual reviewers with full signature authority, that each perform complete evaluations. As an alternative, one of these individual reviewers may be replaced by a team, where two or more reviewers combine to cover the areas in the evaluation. It should be stressed that the team must perform a complete evaluation and that their review is independent of the individual reviewer. rhe designated leader for the team will sign the registration certificate. The review team recommends that the Commonwealth review cu, Tent policy and procedures, and update or establish policy and procedures as necessary, including definition of concurrence reviews consistent with the current Management Directive S.6. 4.2.2 Techt ical Staffino and Trainino The Commonwealth reported that three staff members and the Acting Supervisor currently have authority to sign SS&D evaluations, with a combined staff effort equaling approximately one FTE dedicated to performing safety evaluations. The balance of staff time is spent in licensing actions and inspections. The Commonwealth reported that four actions were completed during the review period. It was noted during the review that the Commonwealth is expecting, in the next several months, a large influx in the number of registration certificates (an estimated 200) that it will be responsible for when Amersham transfers a major product line to its Massachusetts office. This could result in a significant increase in the staff time necessary to address SS&D issues and should be considered in future staffing plans. The Acting Supervisor has a B.S. in Physics, a Masters in Radiation Physico, a Ph.D. in Physics Dosimetry and has some experience in source manufacture. The first staff member has an Associates Degree in Radiological Sciences, is a Registered Radiologic and Nuclear Medicine Technologist, and had done NARM SS&Ds previous to doing byproduct SS&Ds. The

l l.- L.. Massachusetts Draft Report . Page 13 J second staff member has a B.S. In Mechanical Engineering and has experience in areas providing knowledge of the radiological aspects. The third staff member has a B.S. in Nuclear i . Engineering and e Masters in Radiological Science The staff member stated that this Nuclear Engineering degree did not contain significant study in the areas of mechanics and design + engineering He has been to one of the NRC's SS&D Workshops. At the time of the review, l this staff member had been assigned cases, but had not yet signed any. l In general, SS&D staff are well trained in Health Physics principles. Due to the fact that only four actions were processed by the Commonwealth since becoming an Agreement State, the basis for assessing the adequacy of the engineering design analysis skills of the j Commonwealth staff was limited. However, based on the interviews with the staff, it appears i that three of the staff may not have a strong background, through formal training and prior-i experience, in the area of engineering design analysis. In addition, it does not appear that the l cases involving NARM are numerous enough or complex enough to provide significant experience in the engineering design analysis area. To address this issue, program managers i stated that qualified engineering contractors are readily available for consultation, if needed. [ The review identified that the Commonwealth does not have a clear policy on how signature authority will be granted. The current Management Directive 5.6 states: l- _ "All initial and concurrence reviews are performed by persons having adequate training, and I Newly hired employees need to be technically qualified. Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences.- Both initial and concurrence reviewers should be able to: e Understand and interpret, if necessary, appropriate prototype tests that ensure i the integrity of the products under normal and likely accidental conditions of use, Understand and interpret test results, t Road and understand blueprints and drawings, i Understand how the device works and how safety features operate, Understand and apply appropriate regulations, Understand the conditions of use, Understand extemal dose rates, source activities, and nuclide chemical form, and Understand and utilize basic knowledge of engineering materials and their -i i properties." The team discussed the importance of a qualification program in the SS&D area. Such a program would assure that for reviewers to be given SS&D signature authority, they would first be evaluated to ensure that the reviewer meets established minimum standards through

experience, training, and/or formal education to enable the reviewer to fully address all issues in i.

the areas for which they are being granted signature authority. The qualification program would also assure that reviewers complete a sufficient number of cases which are critiqued by a qualified SS&D reviewer to determine whether the reviewer adequately identifed and ,s ..,... _ _.. ~,, -,.

Massachusetts Draft Report Page 14 addressed all pertinent issues. The review team recommends that the Commonwealth establish a signature authority qualification program for all, including current, SS&D reviewers. 4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds The Commonwealth reported one incident involving product failure. This incident involved an Amersham industrial radiography guide tube end stop. A user of the ena stops reported that on two occasions the source broke through the tip of the end stop during use. The manufacturer was made aware of the incident and investigated it. A determination was made by the manufacturer that it was not a generic issue, that thc cause of the failure was due to wear on the outside of the end stop due to excessive use, and that use of collimators over the end stop contributed to the wear. The Commonwealth agreed with the determination. The incident file indicated that, at one point, there were discussions that Amersham would issue a notice to its users reminding them that they should be alert for, and inspect for, significant wear on the end stops, and should t.ot use end stops which show signs of excessive use or significant wear. Since there was no positive commitment by Amersham for this, there was no follow-up in the incident file on this issue to determine whether the notice was issued. The review team examined the Commonwealth's evaluation of this incident and determined that relevant issues were addressed. Based on the IMPEP evaluation criteria, the review team recommends that Massachusetts' performance with respect to the indica'nt, Sealed Source and Device Evaluation Program, be found satisfactory with recommendations for improvement. 4.3 Low-Level Radioactive Waste (LLRW) Discosal Proaram Massschusetts requested and received LLRW disposal authority in the March 21,1997 Agreement. NRC does not require States to have a program for licensing a LLRW disposal facility until such time as the State has been designated as a host State for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. The Commonwealth does have appropriate legislation and regulations compatible with 10 CFR Part 61. The legislation and regulations are unchanged since the Agreement became effective. There are no plans for a LLRW disposal facility in Massachusetts. Accordingly, the review team did not review this indicator. S.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found the Commonwealth of Massachusetts' performance to be satisfactory for the indicators, Status of Materials Inspection Program, Technical Quality of Inspections, Technical Staffing and Training, Technical Quality of Licensing Actions, Response to incidents and Allegations, and Legislation and Program Elements Required for Compatibility. The review team found the Commonwealth of Massachusetts' performance to be satisfactory with recommendations for improvement for the indicator, Sealed Source and Device Evaluation Program. Accordingly, the team recommends 1

Massachusetts Draft Report Page 15 the Management Review Board find the Massachusetts program to be adequate to protect public health and safety and compatible with NRC's program. Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of the report, for evaluation and implementation, as appropriate, by the Commonwealth. RECOMMENDATIONS: 1. The review team recommends that initial inspections of licensees be performed within six months of the licensee's receipt of licensed material, within six months after commencement of licensed activities, or within one year of license issuance, whichever comes first, consistent with IMC 2800. (Section 3.1) 2. The review team recommends that the Commonwealth increase the number of reciprocity inspections to better evaluate the health and safety implications of out-of-state companies working in Massachusetts. (Section 3.1) 3. The review team recommends that program managers conduct annual field accompaniments of each inspector to assess performance. (Section 3.2) 4. The review team recommends that, due to current program demands and the projected increase in workicad, progrs.m management closely monitor the filling of the RCP vacancies. (Section 3.3) 5. The review team recon. mends that the Corr,monwealth manage the training program to ensure that staff receive required training.:ourses to fulfill RCP qualification requirements for inspectors and license.eviewers. (Section 3.3) 6. The review team recommends that the RCP provide written periodic feedback on the disposition of allegations to allegers in accordance with Commonwealth procedures. (Section 3.5) 7. The review team recommends that the Commonwealth review current policy and procedures, and update or establish policy and procedures as necessary, including definition of concurrence reviews consistent with the current Management Directive 5.6. (Section 4.2.1) 8. The review team recommends that the Commonwealth establish a signature authority qualification program for all, including current, SS&D reviewers. (Section 4.2.2) SUGGESTIONS: 1. The review team suggests that the Commonwealth issue inspection findings in a more timely manner to meet the 30-day program goal. (Section 3.1) 2. The review team suggests that the Commonwealth consider the SS&D comments identified in Appendix G, and take actic, as the Commonwealth deems appropriate. (Section 4.2.1)

LIST OF APPENDICES AND ATTACHMENTS Appendix A IMPEP Review Team Members Appendix B Massachusetts Organization Charts Appendix C Massachusetts' Questionnaire Response Appendix D inspection File Reviews Appendix E License File Reviews Appendix F Incident File Reviews Appendix G Sealed Source and Device Reviews Massachusetts' Response to Review Findings l

APPENDIX A IMPEP REVIEW TEAM MEMBERS i Name Area of Responalbility i James Lynch, Rlli Team Leader Status of Materials inspection Program Technical Staffing and Training Richard Blanton, OSP Technical Quality of Licensing Actions Legislation and Program Elements Required for Compatibility Cynthia Sanders, Georgia Technical Quality of Inspect;ons i Respones to incidents end Allegations Duncan White, RI Technical Qua lty of Inspections Response to incidents and Allegations Michele Bergess, NMSS Sealed Source and Device Evaluation Program

r t I ~ I I i I I i i t i I I k r 1 APPENDIX B COMMONWEALTH OF MASSACHUSETTS EXECUTIVE OFFICES AND DEPARTMENTS i AND 1 r l RADIATION CONTROL PROGRAM e ORGANIZATION CHARTS 1 1, I l _sey-Ma-rp**-r+r ais e 77 4=9-yew +,+v, c-w w e ,*t-Islw-+'s-w = --m<<g w-, e*-e en m M'----

_mw._2m..-2.,-- 4 a. 33 ....-.--.__-,_,.A.a ,e e _.--A-m.%e-e e_. w,4Je ..+#-. -.a2--a _4.h..a.-b+-=4.m Ja .-..a in.- A._. 1 f]e ammemune f,.k ( i $f

p p

~ 'h 71s j 4 3 E

jk.

f.; g r n,: 4 u.. I ?! Eg

• k E ja$ lla!

k i

l m

E 25 53

!p[))

=

d e

e35 b h 3< y W~ ~" f !,;;" 3 D ~A '6 i"J w g y.e 0 g O .r.v; ga gg

1,g 3

s e *""'" *"" U' e,gt L'I ~m -e.w w + 4 Q gg.,7 r dY o.. O 'y, o L ,5u p.;g.p.3 0 g g'g a p. .a e Z -o- "" E e W l @;2.. 2hj 2 ,, ' '"Y.. ,o D;;, es H ss $. I a ${ I4%* e

• W- ;

o3 W E"E 3($ h A s j c O .Q pE -m . O

2 T

2 c a s D ,k E 1 ] 5 $, j.3 H = 2 5 jt s = I i 1 c ml E e i 2 g b h 0 9 w 5 1 h

M_ A _ m AA4 __._A-4._-___e. -.A _.__ma+ _w.,Aa. +_ -m. c.,.A. La _A__._ 2 a_.,uw_A --~_,_._Je.m a Lum -i... - .m __,..~m. na A. .i._..__.a 9 _..o. 3 } f ' ll l 0 l'Brto ~ [ l 1 I I l '9 C I r l tj1 i oi! L og F ag l 1, -{ f ' El -l !v ' l..f g ' h ,b N, I R ! i .l i 8: f o im I e l. .c ......u... e, "- ".7 , ! ', g ! 's r... j, ...) - r-i. ',a [g ->[R:i I[ nL su - [ I !l - [, >[ o 0ll 0 1, tI',0y ni i i t h 0 l

g. ':

.....r* ' - [ - r - l r. l o 5' J e o e i T'~'-r-L. ... 1._.. . L. ... L., .. a... l, " !",,,;j[,6 j[" [,', s La,i"J.; J: I 's ': II:l [ ig i [I - [t [ f~.[

n..m.

i o I I ef ,1 1 .d g. la i 1 f' 'jI 6 f 3.- J; e lle i t i I,,.. i. l 4 a j i, ls i el,3,i .e .,L. .. s lcL 4 ~ ").d n i ,8 l -i [ ,8 i; jj: l U) l,. i i g t H m, J, L L, p,, 3 11 I fj,!j . )":j,. j,. : 1 c r r L II l ilj r ,i -[, gla ..r e . l... .s q g j& 1 7 t. 1j' L 0 E .s E

APPENDIX C COMMONWEALTH OF MASSACHUSETTS IMPEP QUESTIONNAIRE RESPONSE

Approved by OMB' i No. 3150 0183 Expires 4/30/98 4 r INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTJONNAIRE i Name of State: Commonwealth of Massachusetts Reporting Period: March 21,1997, to December 06,1997 A. COMMON PERFORMANCE INDICATORS 1. Status of Materials insoection Prooram 1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out la NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue. Licensee Name insp. Frequency. Due Date, Months O/D (Years) l UNIV. OF MASS. 1 8/31/97 3 -MED. CENTER NEW ENGLAND 1 8/31/91 3 MEDICAL CENTER 2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire. 1 Estimated burden per response to comply with this voluntary collection requesti 60 hours. Forward comments regarding burden est.,nate to the information and Records Management BrarYh (T 6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0052), Office of Management and Budget, Washington, DC 20503. NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

\\ Inspections have been assigned and scheduled to be conducted before the end of December,1997. 3. Please identify individual licensees or groups of ficensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change. None 4. Please complete the following table for licensees granted reciprocity during the reportin0 period. Number of Licensees Granted Reciprocity Number of Licensees Priority Permits Each Year inspected Each Year Service Licensees performing 1997 4 0 teletherapy and irrediator source installations or changes 1 1997 6 1 2 1997 3 1997 4 M Other 1997 20 5. Other than reciprocity I!censees, how many field inspections of radiographers were performed? .None 6. For NRC Regions, did you estt.,lish 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 tne goals and the actual number of inspections performed. 2

i 0 1 .N/A l II. Techniemi cuality of ineadhns 7. What, if any, changes were made to your written inspection proosdures during the reporting nigriod? None 8. Prepare a t$ble showing the number and types of supervisory accompaniments made during the review period, include: Inspector Supervisor License Cat. Dale Robert Gallaghar Salifu Dakubu Nuclear Pharmacy 9/10/97 Agostino Savastano Salifu Dakubu in V/tro Lab 9/19/97 Kenath Traegde Salifu Dakubu Academic 12/3/97 Research 9. Describe internal procedures for conducting supervisory accompaniments of inspectors in the field. If aupervisory accompaniments were documented, please provide copies of the documentation for each accompaniment. A check list is used to assist the evaluation of the conduct of the inspection. All inspectors have been provided copies of the lists used to assist them to pay attention to issues considerd important to management, See Attachment i for copies of check lists used. 10. Describe or provide an update on your instrumentation and methods of calibration. Are allInstruments properly calibrated at the present time? ? See Attachment 2 for types of instrumentation. Calibrations of field - Instrumentation are done by a licensed service which uses NIST traceable ) . >urces and are up to-date, Laboratory instruments are calibrated internally using NIST traceable standards.

Ill, Technical Staffing and Training 11.

Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person years of effort applied to the agreement or radioactive material program by individual. Include the name,- position, and, for Agreement States, the fraction of time spent in the following 3

areas: administration, materials licensing & compliance, emergency response, LLW, U mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program, include all vacancias 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 r Arts. The table herding should be: NAME POSITlQU AREA OF EFFORT EIE Thomas Coulombe Environmental Licensing Inspection / 80/20 Analyst ll Laboratory Christine A. Dahrooge Env. Eng, lil Licensing inspection / 100 Allegations Coordinator Richard Fairfull Env. Eng, il Licenting Inspection / 100 SS&D Robert Gallaghar Env. Eng, lli Licensing Inspection / 100 Financial Surety Coordr. Thomas O'Connell Env. Eng. IV Licensing inspectiol,- 50 Decommissioning / Lab. Agostino Savastano Env. Eng. lil Licensing-inspection / 100 SS&D Kenath Traegde Env. Eng, lil Licensing inspection / 100 SS&D Milan Shah Env. Eng. lll Licensing inspection / 100 Events Coordinator Michael Whelan Jr. Env. Eng. lll Licensing-Inspection / 100 Database Management Robert Hallisoy Manager Vil Administration and 50 Compliance Salifu Dakubu Env. Eng. til All areas of Materials 100 Acting Supervisor Program Larry Harrington Env. Eng. lil inspections / Environmental 25/75 Monitoring Robert Watkins Env.Eng.V Inspections / Other 50/50 Program Areas 4

i I 12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate. See Richard Fairfull's resume as Attachment 3. 13. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection 4 Manual Chapters 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. Richard Fairful, who joined the Program in August,1997, is currently undergoing on the job training and will be taking NRC sponsored training as vacancies become availabe. Attachment 4 presents the qualification requirements used by Massachusetts Radiation Control Program (MRCP). 14. Please identify the technical staff who left the RCP/ Regional DNMS program during this period. None 15. List the vacant positions in each program, the f*ngth of time each position has been vacant, and a brief summary of efforts to fill the vacancy. Three Env. Eng. lll and one Manager position,4 months, positions will be filled when budget office authorizes it. IV. Technical Quality of Licensino Actions 16. Please identify any major, unusual, or complex litanses which v>ere issued, received a major amendment, terminated, decommissioned, bankruptcy notification or renewed in this period. "to identify any new or amended licenses that now require emergency plans. -NEN Life Sciences MA license # 00 3200 (previous NRC license # 20-00320-

01) spun away and sold by Dupont. The two companies continue the same previous emergecy plan by understanding. They have separate financial surety instruments.

17. Discuss any variances in licensing policies and procedures or exemptions from ' the regulations granted during the review period. 5

.New England Baptist Hospital granted an amendment to receive prostate brachytherapy services from Beth Israel Deaconess West Campus by amendment to the license of Beth Israel Deaconess West Campus to provide this specific limited

• mobile" service.

18. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memorande, etc.) during the reporting period? None i 19. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more. V. Resoonges to incidents and Alleaations 20. Please provide a list of the reportable incidents (i.e., medical misadministration, overexposures, lost and abandoned sources, incidents requiring 24 hour or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB 3150-0178). The list should be in the following format: TYPE OF LICENSE # LICENSEE DATE OF TYPE OF INCIDENT INCIDENT NAME lblGlDENT/ REPORT RPTBLEVT DESCRIP EQP 02 8483 Polar : Corp 16 Jul 97 U LAS 60 0005 Berkshire Medical 16 Apr 97 N LAS 00 3205 Dupont NEN 18 A;r 97 U LAS 44 0015 Lahey Clinic 18 Jun 97 N LAS 44 0164 Cape Cod 20 Jun 97 N llospital LAS 30 1800 Summit,Inc 21 Apr 97 N SAFETY CONTROlJSYSTEM DEGRADATION MD2 44 0062 Boston University 04 Apr 97 N Medical Center MD2 60-0055 Massachusetts ll Jun 97 U Generalliospital MD2 11 9730 Winchester 09 Sep 97 N 11ospital 6

6 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? For States, was timely notification made to NRC7 For Regions, was an appropriate and timely PN generated? No incident. 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 possiblo generic design deficiency? Please provide details for each case. N/A 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. No cases 24. Identify any changes to your procedures for handling allegations that occurred during the period of this review, a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed. None VI. General

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

N/A 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. Good database management is a major asset in keeping the entire Program in good running ' order. B. NON COMMON PERFORMANCE INDICATORS 1. Lecislation and Prooram Elements Reauired for Comoatibility 7

- =

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

Massachusetts Department of Public Health Radiation Control Statutes: M.G.L. c.111662, 3,4F, 5K, SL, 5M,50, SP,50. Administrative Procedures Act: M.G.L. c. 30A. Conflict of Interest Law: M.G L. c. 268A. Low Level Radioactive Waste Law: M.G.L. c.111H. Labor and 4 Industry Statutes: M.G.L. c.149.

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

No.

29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

Done.

30. If you have not adopted all amendments whhin 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 he normal length of time anticipated to complete each step.

N/A ll. Sealed Sourcg 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 Date Numhet Custom User or Source llautd MA 399-D 105-G ION TRACK INC. DEVICE 71797 MA 330 D 102 G HNU SYSTEMS DEVICE 10-6 97 MA 1030-D 101 G THERMO DEVICE 62697 ENVIRONMENTAL MA 555-S 101 S CIS-US, INC. SOURCE 11397 8

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

-NUREG 1550

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

Technical Staffing and Tralning A.lli.11 15 Technical Quality of Licensing Actions A.lV 16-18 i Responses to Incidents and Allegations A.V.20 23 -Same as in section A. Ill. Low-Level Waste Proaram 34. Please include information on the following questions in Section A, as they apply to the Low level Waste Program: Status of Materials inspection Program-A.I.13, A.I.6 Technical Quality of inspections A.ll.7-10 Technical Staffing and Training - A.lll.11 15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations A.V.20 23 -N/A IV Uranium Mill Procram 35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program: Status of Materials inspection Program A.I.1-3, A.I.6 Technical Quality of Inspections A.ll.710 Technical Staffing and Training A.lli.11 15 Technical Quality of Licensing Actions - A.IV.16-18 i Responses to incidents and Allegations - A.V.20-23 N/A 9

TABLE FOR QUESTION 29. OR DATE DATE 10 CFR RUI.E DUE ADOPTED CURRENT EXPECTED STATUS ADOF7 TON Any & =.4...c6; due prior to 1991. Identsfy each regulaton (refer to the C wegy of Amendmerfs) Decommissonsng' 7/27/91 2/9G6 Parts 30. 40, 70 Eirmigw.cy Planning. 4/7/93 2/9/96 Parts 30,40. 70 Standards for Protecbon Against Radiaton; 1/1/94 2/24S5 Part 20 Safety Requirements for Radographic 1/10S4 2 S/96 Equipment Part 34 Nuth Lwi of l. cW,.b. 10/15 S4 2/9/96 Farts 20. 30. 31. 34. 39. 40, 70 Quality Management Program and 1/27/95 2/9/96 Misa;...;,.;a.aions: Part 35 bcensing and Radiabon Safety Requwements 7/1/96 2/9/96 for Irradiators: Part 36 Definition of Land Drsposal 7/22/96 and Waste Site GA Pnxyam; Part 61 Dm.v. ..ssioning Recordkeeping Docu-10/7';,96 2/9/96 mentaten Additons: Parts 30,40. 70 Self-Guarantee as an Addebonal Fmancial 1/28/97 2/9/96 W-d.o.Jw, Parts 30. 40, 70 Uranium Mill Tailings: Cui4v...a.y to EPA 7/1/97 Standards; Part 40 Timeltness in Decommissioning 8/15/97 2/9/96 Parts 30,40. 70 10 s

~; :, OR DATE DATE 10 CFR PULE DUE ACDPTED CURRENT EXPECTED STATUS ADOPTION Preparahon. Transfer for C6u.eM Dis-1/1/98 2!9/96 tnbuton, and Use of Byproduct Material for Medcal Use: Parts 30. 32. 35 Frequency of Medical Examsnahons for Use of 3/13/98 Resparatory Protecton Equement Low-Level Waste Shgment Mansfest 3/1/98 2J9/96 liJv,n &,n and Reportng Fwivu,w Requwements for Radography 6/30/96 2/9/96 Equipment Radiaton Protechon Requwements Amended 8/14/96 Defirwhons and Crilena Clarificaton of Decommesserung Funding 11/24/98 Requwements 10 CFR Part 71:Compshtsty with the 4/1/99 Draft regutahons ready for pubhc comment in January or February, internatonal Atorme Energy Agency 1996 Medical Adrrunestraten of Radiabon and 10/20/98 Radcactrve Malenals. Termwrahon or Transfer of Licensed Actnrfbes. 5/16/99 Recordkeeping Requwements. Resolubon of Dual Regulabon of Arbome 1/9/00 Effluents of Radooctrve Malenals; Clean Air Ad Recogrubon of Agreement State Licenses in 1/13.90 Areas Under Exduseve Federal Junsdichon Withire an Agreement State Cntena for the Release of Ind' nduals 1/29/00 n Adtrumstered Radcachve Malenal Licenses for Industnal Radiography and S/28/00 Radiaton Safety Requwements for Industnal Radiuy4,y Operahons: Final Rule Radological Cntena for Lcense Termrtahon 7/2* C 11

APPENDlX D INSPECTION FILE REVIFWS File No.: 1 Licensee: Diacton, Inc. License No.: 28 6881 Location: Charleston, MA Inspec+ ion Type: Routine License Type: Research and Development Priority: 5 Insp6ction Date: 5/23/97,5/27/97 Inspector: MW a) Apparent vioiations noted in field notes not cited in letter to licensee. File No.: 2 Licensee: Deaconess MedicalCenter License No.: 60-0011 Location: Boston, MA Inspection Type: Routine License Type: Broad scope Medical Priority: 1 Inspection Date: 11/12 14/97 Inspectors: MW and AS File No.: 3 Licensee: Northeastern University License Nos.: 06-4327,60-0137 Location: Boston, MA inspection Type: Routine License Type: Type A Broad scope Academic Priority: 1 Inspection Date: 9/4 5/97 Inspector: AS File No.: 4 Licensee: Good Samaritan Medical Center License Nos.: 44 0023,12 8281 Location: Brockton, MA Inspection Type: Routine License Type: MedicalInstitution Priority 3 Inspection Date: 8/28/97 Inspector: TC File No.: 5 Licensee: Interstate Nuclear Services License No.: 03 5291 Location: Springfield, MA Inspection Type: Routine License Type: Nuclear Laundry Prionty: 2 Inspection Date: 9/10/97 Inspector: RG Comment: a) Clear inspection letter issued 74 days after the conclusion of the inspection. File No.: 6 Licensee: Angell Memorial Animal Hospita; License No.: 48-0133 Location: Boston, MA Inspection Type: Routine License Type: Veterinary Priority: 5 Inspection Date: 10/22/97 Inspector: TC Comment: a) Clear it ection letter issued 60 days after the conclusion of the inspection.

Massachusetts Draft Report Pa9e D.2 Inspection File Reviews File No.: 7 Licensee: Thielsch Enpineering, Inc. License No.: 66 0018 Location: Taunton, MA Inspection Type: Reciprocity License Type: Radiography Priority: 1 Inspection Date: 5/7/97 Inspector: TC l Comments: a) Inspection letter with violations issued 53 days after the conclusion of the inspection. b) Apparent violations noted in field notes not cited in letter to licensee. File No.: 8 Licensee: Bartlett Nuclear. License No.: 20 6331 Location: Plymouth, MA Inspection Type: Routine License Type: Decontamination Priority: 3 Inspction Date: 10/24/97 Inspector: AS File No.: 9 Licensee: University of Massachusetts Amherst License Nos,: 60-0107, 00 8823,00-8824 i Location: Amherst, MA Inspection Type: Routine License Type: Type B Broad scope Academic Priority: 2 Inspection Date: 7/15 16/97 Inspectors: CA and KT i File No.: 10 Licensee: Biovest,Inc. License No.: 28 2222 Location: Milford, MA Inspection Type: Routine License Type: In vitro Laboratory Priority: 5 Inspection Date: 9/19/97 Inspector: AS Comment: a) Apparent violatioris noted in field notes not cited in letter to licensee, File No.: 11 Licensee: Dositec, Inc. License Noc 21 3261 Location: Hopkinton, MA Inspection Type: Routine License Type: Calibration Priority: 3 Inspection Date: 12/22/97 Inspector: RG File No.: 12 Licensee: Amersham Corporation License No.: 12 8361 Location: Burlington, MA Inspection Type: Speciai License Type: Type A Broad scope Manufacturer Priority: 1 Inspection Date: 5/30/97 Inspectors: AS, KT

I

l-Massachusetts Draft Report Page D.3 Inspection File Reviews Comments: a) Speclat inspection requested by NRC to investigate licensee's quality assurance procedures regarding end stops on guide tubes. b) Clear inspection letter issued 46 days after the conclusion of the inspection. File No.: 13 Licensee: E.l. DuPont NEN Products License Nos.: 00 3200,00 3205 Location: Boston, MA Inspection Type: Routine License Type: Type A Broad scope Manufacturing Priority: 1 Inspection Date: 6/19 20/97 Inspectors: KT, CA Comments: a) Apparent violations regarding quantity of effluents released not cited based on dose to nearest member of the public. b) Clear inspection letter issued 45 days after the conclusion of the inspection. . File No.: 14 Licensee: Cushing, Goins and Kirschner, Inc. License No.: 30 3721 Location: Middleboro, MA Inspection Type: Routine License Type: Portable Gauge Priority: 5 Inspection Date: 7/17/97 Inspector: AS a) Apparent violations noted in field notes not cited in letter to licensee. File No.: 15 Licensee: Granger Lynch Corp. License No.: 30 3491 Location: Millbury, W Inspection Type: Routine License Type: Portable Gauge Priority: 5 Inspection Date: 8/28/97 Inspector: MW File No.: 16 Licensee: Medi Physics License Nos.: 58-0001,30 1761 Location: Woburn, MA Inspection Type: Routine License Type: Nuclear Pharmacy Priority: 1 Inspection Date: g/11/97 Inspector: RG Comment: c) Clear inspection letter issued 81 days after the conclusion of the inspection. File No.: 17 Licensee: North Shore Medical Center License Nos.: 00-0083,44-0161 Location: Salem, MA inspection Type: Routine License Type: MedicalInstitution Priority: 3 Inspection Date: 5/29 30/97 Inspector: MW

Mass 6chusetts Draft Report Page D. 4 Inspection File.% views File No.: 18 Licensee: Children's Hospital License Nos.: 60-0137,09 5687 Location: Boston, MA Inspection Tyr e: Routine License Type: Broad scope Medical Priority: 1 Inspection Date: 7/23 24/97 Inspectors: RG and TC Comments: a) Security violations identified during inspection, Severity Level Ill violation issued. b) Licensee was not provided with choice letter to discuss security violation. c) Apparent violations noted in field notes not cited in letter to licensee, in addition, a review team member made the following inspection ac ompaniments as part of the on site IMPEP review: Accompaniment No.: 1 Licensee: Anna Jaques Hospital License No.: 13 3911 Location: Newburyport, MA Inspection Type: Routine License Type: Hospital Priority: 3 inspection Date: 12/09/97 Inspector: AS Accompaniment No.: 2 Licensee: College of the Holy Cross License Nos.: 19 7481 end SN 0526 Location: Worcester, MA Inspection Type: Routine License Types: Academic and SNM Priority: 5 inspection Date: 12/10/97 Inspector: RG Comment: a) Administration official not present at exit meeting. Accompaniment No.: 3 Licensee: Eurotherm Gauging Systems License Nos.: 20-6751 and 20-6752 Location: Billerica, MA Inspection Type: Routine License Types: Manufacturing and Disiribution Priority: 3 inspection Dato: 12/11/97 Inspector: KT Accompaniment No.: 4 Licensee: Therion Biologics Corporation License No.: 28-6931 Location: Cambridge, MA Inspection Type: Routine License Type: Research and Development Priority: 5 Inspection Date: 12/12/97 Inspector: MW Comment: a) Independent measurements were not performed. .m,. e ..m_.. u

APPENDlX E LICENSE FILE REVIEWS File No.: 1 Licensee: Autolmmune,Inc License No.: 30 A172 Location: Lsxington, MA Amendment No.: 2 License Type: Self Shielded irradiator Type of Action: Amendment Date issued: 12/3/97 License Reviewer: CA File No.: 2 Licensee: NEN Life Sciences License No.: 00 3200 Location: Boston, MA Amendment No.: 7 Licen::e Type: Radiopharmaceutical Mfr. Type of Action: Amendment Date issued: 6/25/97 License Reviewer: BG File No.: 3 Licensee: NEN Life Science Products, Inc License No.: 00 3205 Location: Boston, MA Amendment No.: 7 License Type: GL Distribution Type of Action: Amendment Dateissued: 6/25/97 License Reviewer: BG File No.: 4 Licensee: New England Health Consultants License No.: 44 0128 Location: Concord, MA Amendment No.: 1 License Type: Mobile Nuclear Medicine Type of Action: Amendment Date issued: 12/22/97 License Reviewer: TC File No.: 5 Licensee: Isomedix, Inc License No.: 28 7911 Location: Northborough, MA Amendment No.: N/A License Type: Poollrradiator Type of Action: Financial Assurance Review Date issued: 8/15/97 License deviewer: BG File No.: 6 Licensee: Lahey Clinic Foundation License No.: 44 0015 Location: Burlington, MA Amendment Nos.: 1,2,3,4 License Type: Medical Broad scope; HDR Type of Action: Amendments Date issued: 5/9/97; 6/30/97; 7/24/97; 8/13/97 License Reviewers: CA, KT File No.: 7 Licensee: Genetics Institute,Inc License No.: 60-0086 Location: Cambridge, MA Amendment No.: 2 License Type: R&D, Type A Broad scope Type of Action: Amendment Date issued: 11/25/97 License Reviewer: MW

Massachusetts Draft Report Page E.2 License File Reviews File No.: 8 Licensee: Charles River PharmServices License No.: 55 0176 Location: Southbridge, MA Amendment No.: O License Type: Research and Development. Other Type of Action: New Date issued: 5/9/97 License Reviewer: MW File No.: 9 Licensee: Venegas industrial Testing Lab, Inc License No.: 56 0184 Location: North Chelmsford, MA Amendment No.: O License Type: Industrial Radiography Type of Action: New Date issued: 7/14/97 License Reviewer: MW File No.: 10 Licensee: Pentose Pharmaceuticals, Inc License No.: 43 0201 Location: Cambridge, MA Amendment No.: O License Type:- Research and Development Type of Action: New Date issued: 10/10/97 License Reviewer: KT File No.: 11 Licensee: Massachusetts General Hospital License No.: 03 8141 Location: Boston, MA Amendment No.: 27 License Type: Teletherapy Type of Action: Termination Date issued: 7/24/97 License Reviewer: MW File No.: 12 Licensee: Beth Israel Deaconess Medical Center West Campus License No.: 60-0011 Location: Boston, MA Amendment No.: 2 License Type: Brachytherapy Type of Action: Amendment Date issued: 12/11/97 License Reviewer: AS

APPENDIX F INCIDENT FILES REVIEWED File No.: 1 Licensee: Berkshire Medical Center License No.: 60-0005 Incident ID No: MA970001 Location: Pittsfield, MA Date of Event: 3/31/97 Type of Event: Lost Radioactive Material Investigation Date: 8/25-27/97 investigation Type: Site Inspection Summary of Incident and Final Disposition: Source used for marking during bone scans was found missing. Inspector Investigated incident at next inspection to determine cause. Source never found. Comment: a) Administrative closeout of incident file not completed. File No.: 2 Licensee: Summit, Inc. License No.: 30 1800 Incident ID No: MA970003 Location. Saugus, MA Date of Event: 4/21/97 Type of Event: Stolen Portable Gauge investigation Date: 4/22/97 investigation Type: Telephone and Site Inspection Summary of incident and Final Disposition: Troxler g 09e stolen from construction site. Gauge never found. File No.: 3 Licensee: Massachusetts General Hospital License No.: 60-0055 incident ID No: MA970004 Location: Boston, MA Date of Event: 6/09/97 Type of Event: Misadministration investigation Date: 6/11/97 investigation Type: Telephone and Medical Review Board Summary of incident and Final Disposition: Incorrect therapeutic dose of iodine 131 given to patient based on residual activity left in vial, Commonwealth's Medical Review Board determined that incident was not a misadministration. Commento: a) Closeout of incident file not completed,

Massachusetts Draft Repon Page F.2 Incident File Reviews File No.: 4 Licensee: Lahey Clinic License No.: 44 0015 incident ID No: MA970005 Location: Burlington, MA Date of Event: 6/17/97 Type of Event: Lost Radioactive Material investigation Date: 6/18/97 investigation Type: Telephone Summary of incident and Final Disposition: Lost of one lodine 125 seed in hospital. Seed found two days later by licensee in the drain of the treatment room. File No.: 5 Licensee: Winchester Hospital License No.: 44 0006 Incident ID No: MA070010 Location: Winchester, MA Date of Event: 9/09/97 Typ0 of Event: Misadministration Investigation Date: 9/23 25/97 Investigation Type: Inspection Summary of incident and Final Disposition: Patient received wrong radiopharmaceutical as part of a diagnostic treatment resulting in high dosn to the patient's bone surface. Special inspection determined root cause of incident, resulting in violations against licensee and numerous corrective actions by the licensee. File No.: 6 Licensee: Polaroid Corporation License No.: 02 8483 Incident ID No: MA970008 Location: New Bedford, MA Date of Evant: Week of 7/14/97 Type of E { t: Equipment Failure Investigation Date: 8/15/97 ' invest:gation Type: Telephone Summary of incident and Final Disposition: Fixed gauge containing 100 millicuries of americium 241 had a shutter that failed to close properly. Licensee contacted manufacturer who corrected the problem. RCP to follow up at next inspection.

) Massachusetts Draft Report Page F.3 Incident File Reviews File No.: 7 Licensee: DuPont NEN License No.: 00 3205 incident ID No: MA970002 Location: Boston, MA Date of Event: 3/20/97 Type of Event: Lost Radioactive Material investigation Date: 4/18/97 Investigation Type: Telephone Summary of incident and Final Disposition: A package containing 500 microcuries of phosphorus 32 lost during shipment to a New York facility. Package never found. File No.: 8 i Licensee: Cape Cod Hospital License No.: 44 0164 incident ID No: MA970006 Location: Hyannis, MA Date of Event: 6/20/97 Type of Event: Lost Radioactive Material i investigation Date: 6/20/97 Investigation Type: Telephone Summary of Incident and Final Disposition: Shipment of lodine 125 seeds from manufacturer was found to be short one seed (out of 98) upon delivery to hospital. File No.: 9 Licensee: Boston University Medical Center License No.: 44-0062 Incident ID No: MA970007 Location: Boston, MA Data of Event: 4/04 and 18/97 Type of Event: Misadministration investigation Date: 7/10/97 Investigation Type: Telephone Summary of Incident and Final Disposition: Two patients received diagnostic doses of 3.5 millicuries of lodint,-131 instead of 2 millicuries. State's Medical Review Board will be reviewing action to determine if incident is a misadministration.

/ APPENDIX G f 't SEALED SOURCE AND DEVICE REVIEWS File No.: 1 Registry No.: MA 555 S 101 S Manufacture: CIS US,Inc. i SS&D Type: Industrial Radiography Source l Date issued: 11/3/g7 Comments: a) Not all changes were bolded on registration certificate, per national standard format. b) Reviewers accepted licensee statements regarding changes to another manufacturer's products without independent verification. - c) Reviewers did not verify that the modification to add a lock to the Model 650 source changer would not impact the source integrity through reduced r" imeter of the lockinD - mechanism. The IMPEP team identified this to the Commonwa.ith. During the IMPEP review, the Commonwealth performed the verification and reported to the team that the source and modified changer were compatible, d) Reviewers reviewed operational history provided by the licensee. The only details provided by the licensee regarding the operation history was that it has been used overseas for about two years. Where operational history is being used to support a determination, the reviewer should obtain sufficient details about the operational history to make an independent determination that the operational history was sufficient to substitute for prototype history. File No.: 2 Registry No.: MA 3gg D 105-G Manufacture: lon Track, Inc. SS&D Type: lon Mobility Spectrometer Dateissued: 7/17/g7 Comments: a). Not all changes to registration certificate in bold text, b) Information used as part of the basis for approval of the design was not incorporated in the references on the registration certificate, u .{ .e ..., ~,. ,..,~ + n

.. - ~.. __ =. - - _. _ _ - 4 Massachusetts Draft Report Page G.2 Sealed Source & Device Reviews File No.: 3 Registry No.: MA 330 0102 G Manufacture: HNU Systems SS&D Type: Electron Capture Detector Date issued: 10/6/97 Comments: a) Not all changes to registration certificate in bold text. b) 10/25/93 letter referenced in the 9/13/94 registration certificate was not listed on the current registration certificate. Letter should be addeo M next amendment. File No.: 4 Registry No.: MA 1030-D 101 G Manufacture: Thermo Environmental SS&D Type Ceta Gauge and Source Date issued: 6/26/97 f Comment: a) The Commonwealth policy is to honor the source / device design evaluations and approvals issued by another Agreement State or the NRC. The design is not required to be re-evaluated in its entirety at any time. Action in this case was performed according to this policy. However, the review team noted that significant portions of information were not in the file. For example, the deWee was not labeled with device model number and name of the manufacturer or initial transferor, there were no drawings in the file for the device, some drawings for the source needed additional clarification, and there was no documentation in the file for prototype testing for the device. The Commonwealth indicated that this file was currently open for amendment. Given this, the Commonwealth should take this opportunity to ensure that all relevant information is placed in the file. .}}