October 14, 2010 

Suzanne Condon, Director 

Bureau of Environmental Health 

Massachusetts Dept. of Public Health 

Schrafft Center, Suite 1M2A 

529 Main Street 

Charlestown, MA 02129 

Dear Ms. Condon: 

On September 20, 2010, the Management Review Board (MRB) met to consider the proposed 

final Integrated Materials Performance Evaluation Program (IMPEP) report on the 

Massachusetts Agreement State Program. The MRB found the Massachusetts Agreement 

State Program adequate to protect public health and safety, but needs improvement, and 

compatible with the U.S. Nuclear Regulatory Commission=s (NRC) program. The MRB directed 

NRC staff to initiate a period of monitoring of the Massachusetts Agreement State Program. 

Monitoring is an informal process that allows NRC to maintain an increased level of 

communication with an Agreement State program. As part of the monitoring process, NRC will 

conduct quarterly calls with the appropriate representatives from the Massachusetts Agreement 

State Program. 

Section 5.0, page 15, of the enclosed final report contains a summary of the IMPEP review 

team=s findings and recommendations. Mr. Robert Gallaghar’s letter dated September 9, 2010, 

adequately discusses the Commonwealth’s proposed actions for resolving the review team’s 

recommendations. No further response is requested at this time. 

Based on the results of the current IMPEP review, the next full review of the Massachusetts 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for July 2011. During the periodic meeting and at the next IMPEP review, 

NRC will evaluate the effectiveness of the Commonwealth’s response to the review team’s 

recommendations, as well as the overall implementation of your Agreement State program. 
S. Condon -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA Michael F. Weber/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

Massachusetts Final IMPEP Report 

cc w/encl.: Robert Gallaghar, Acting Director 

 Radiation Control Program 
S. Condon -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA Michael F. Weber/

 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

Massachusetts Final IMPEP Report 

cc w/encl.: Robert Gallaghar, Acting Director 

 Radiation Control Program 

DISTRIBUTION: See next page.

ML02710451 EDATS: FSME-2010-0275 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME MOrendi DWhite TReis RLewis TReis for 

DATE 10/1/10 10/4/10 10/5/10 10/6/10 

OFFICE Tech Editor FSME DEDMRT 

NAME PTressler for CPoland CCarpenter for CMiller MFWeber 

DATE 10/07/10 10/07/10 10/14/10 

OFFICIAL RECORD COPY
Letter to S. Condon from Michael F. Weber dated: 

Distribution: EDATS: FSME-2010-0275 

MSSA RF DCD (SP01) 

EDO RF 

RidsEdoMailCenter 

RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

MBeardsley, FSME/MSSA Commissioner Svinicki 

DJanda, RI/RSAO Commissioner Apostolakis 

LCuadrado, FSME/MSSA Commissioner Magwood 

JMullauer, RIII Commissioner Ostendorff 

Karl Von Ahn, OH SECY 

JKinneman, RI 

KBrock, OEDO 

CMiller, FSME 

BJones, OGC 

PLouden, RIII 

Dennis O’Dowd, NH 

JOlmstead, OGC 

APowell, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE MASSACHUSETTS AGREEMENT STATE PROGRAM 

JULY 12-16, 2010 

FINAL REPORT
Massachusetts Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Massachusetts Agreement State Program. 

The review was conducted during the period of July 12-16, 2010, by a review team composed of 

technical staff members from the Nuclear Regulatory Commission (NRC) and the State of Ohio. 

Team members are identified in Appendix A. The review was conducted in accordance with the 

"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 NRC Management Directive 5.6, "Integrated Materials Performance Evaluation Program 

(IMPEP)," dated February 26, 2004. Preliminary results of the review, which covered the period 

of May 20, 2006, to July 16, 2010, were discussed with Massachusetts managers on the last 

day of the review. 

A draft of this report was issued to Massachusetts for factual comment on August 16, 2010. 

The Commonwealth responded by letter dated September 9, 2010, from Robert Gallaghar, 

Acting Director, Radiation Control Program (the Program). A copy of the Commonwealth’s 

response is included as the Attachment to this report. The Management Review Board (MRB) 

met on September 20, 2010, to consider the proposed final report. The MRB found the 

Massachusetts Agreement State Program adequate to protect public health and safety, but 

needs improvement, and compatible with NRC’s program. The MRB directed NRC staff to 

initiate a period of monitoring of the Massachusetts Agreement State Program. Monitoring is an 

informal process that allows NRC to maintain an increased level of communication with an 

Agreement State program. As part of the monitoring process, NRC will conduct quarterly calls 

with the appropriate representatives from the Massachusetts Agreement State Program. 

The Massachusetts Agreement State Program is administered by the Program, which is located 

within the Bureau of Environmental Health (the Bureau). The Bureau is located within the 

Department of Public Health (the Department). Organization charts for the Commonwealth and 

the Program are included in Appendix B. 

At the time of the review, the Massachusetts Agreement State Program regulated approximately 

503 specific licenses authorizing byproduct, source, and certain special nuclear materials 

(radioactive materials). The review focused on the radioactive materials program as it is carried 

out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement 

between NRC and the Commonwealth of Massachusetts. 

In preparation for the review, a questionnaire addressing the common and non-common 

performance indicators was sent to the Program on February 12, 2010. The Program provided 

a response to the questionnaire on June 25, 2010, and a revised response on July 23, 2010. A 

copy of the revised questionnaire response can be found in NRC’s Agencywide Documents 

Access and Management System (ADAMS) using the Accession Number ML102140206. 

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 Program=s licensing and 

inspection database, (4) technical review of selected regulatory actions, (5) field 

accompaniments of three of the Program’s inspectors, and (6) interviews with staff and 

managers. The review team evaluated the information gathered against the established criteria 
Massachusetts Final Report Page 2 

for each common and applicable non-common performance indicator and made a preliminary 

assessment of the Massachusetts Agreement State Program=s performance. 

Section 2.0 of this report covers the Commonwealth=s actions in response to recommendations 

made during previous reviews. Results of the current review of the common performance 

indicators are presented in Section 3.0. Section 4.0 details the results of the review of the 

applicable non-common performance indicators, and Section 5.0 summarizes the review team's 

findings and recommendations. Recommendations made by the review team are comments 

that relate directly to performance by the Commonwealth. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on May 19, 2006, the review team made 

eight recommendations regarding the Massachusetts Agreement State Program’s performance. 

Two recommendations carried over from the 2002 IMPEP review. 

1. The review team recommends that the Commonwealth pursue adequate funding to 

support and implement the staffing plan which is needed to meet current program 

demands as well as the projected increase in workload. (Section 3.1 of the 2006 IMPEP 

report) 

Status: The review team found that the two vacancies identified during the 2006 IMPEP 

review have not been filled due to budget constraints. In addition, there have been 

further decreases in funding for staffing despite increased work duties creating additional 

demands on existing staff. This issue is discussed in more detail in Section 3.1 of this 

report. This recommendation remains open. 

2. The review team recommends that the Commonwealth address each of the licensing 

cases where Increased Controls are needed by either issuing license amendments to 

decrease possession limits or issuing license amendments to include Increased 

Controls. (Section 3.4 of the 2006 IMPEP report) 

Status: The review team found that the Program has identified and taken appropriate 

action on those licenses requiring Increased Controls. Furthermore, the Program has a 

policy in place to use an equivalent version of NRC’s Risk-Significant Radioactive 

Materials Checklist, which aids a license review in determining the applicability of the 

Increased Controls or other security measures. This recommendation is closed. 

3. The review team recommends that the Commonwealth take appropriate and timely 

follow-up actions commensurate with the potential health and safety significance for all 

events. (Section 3.5 of the 2006 IMPEP report) 

Status: The review team found that the Program has taken appropriate and timely 

follow-up actions in its response to radioactive material incidents where a potential 

health and safety issue exists. This recommendation is closed. 

4. The review team recommends that the Commonwealth take necessary steps to ensure 

that all reportable events are submitted and updated to NRC in accordance with Office of 
Massachusetts Final Report Page 3 

State and Tribal Programs (STP) Procedure SA-300, “Reporting Materials Events.” 

(Section 3.5 of the 2006 IMPEP report) 

Status: The review team found that, although the Program has made progress in 

reporting events to NRC in accordance with Office of Federal and State Materials and 

Environmental Management Programs (FSME) Procedure SA-300 (formerly STP 

Procedure SA-300), there has not been a period of sustained performance by the 

Program with respect to the timeliness of reporting and updating events. This 

recommendation remains open. 

5. The review team recommends that the Commonwealth adopt regulations necessary for 

compatibility within the required three year time frame and submit alternate forms of 

legally binding requirements for NRC review following the guidance in FSME Procedure 

SA-201. (Section 4.1.2 of the 2002 IMPEP report) 

Status: The review team found that the Program submitted legally binding requirements, 

such as license conditions, for several of the regulation amendments during the review 

period; however, the Program still has regulation amendments that have not been 

finalized in the required 3-year period. This recommendation remains open, but has 

been modified to reflect the Program’s efforts in addressing part of this recommendation. 

The review team recommends that the Commonwealth adopt regulations necessary for 

compatibility within the required 3-year period. 

6. The team recommends that the Commonwealth make corrections to registration 

certificate MA-0166-D-102-B (this was incorrectly listed as MA-0116-102-B in the 2002 

and 2006 reports). (Section 4.2.1 of the 2002 IMPEP report) 

Status: The review team found that the Program has gathered the information 

necessary to make the corrections but has not issued the corrected registration 

certificate. This recommendation remains open. 

7. The review team recommends that the Commonwealth develop and document a set of 

formal qualification requirements for sealed source and device (SS&D) reviewers. 

(Section 4.2.1 of the 2006 IMPEP report) 

Status: The review team found that the reviewer qualification requirements were 

incorporated into the Program’s Licensing Procedures document. The Program’s 

qualification procedures for SS&D reviews are consistent with the qualification 

requirements for SS&D reviewers in NRC’s Inspection Manual Chapter (IMC) 1246, 

“Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program 

Area.” This recommendation is closed. 

8. The review team recommends that the Commonwealth issue inactivated registration 

certificates in the future with full text and reissue the shortened certificates with full text, 

if practicable. If the Commonwealth wishes to continue the practice of short forms, then 

the review team recommends that the registration certificate, which is referenced in the 

short text, be attached to the inactivated registration. (Section 4.2.2 of the 2006 IMPEP 

report) 
Massachusetts Final Report Page 4 

Status: The review team found that newly issued inactivation certificates were found to 

be complete with the full text. One of the two 2006 SS&D casework certificates (MA1059-S-905-S) was for a duplicate model number registration and was not reissued as 

there is a current registration. The second case work certificate (MA-8154-D-803-B) has 

not been reissued. This recommendation remains open with respect to the reissuance 

of registration certificate MA-8154-D-803-B with the complete text and has been 

modified accordingly. The review team recommends that the Commonwealth reissue 

registration certificate MA-8154-D-803-B with the complete text or equivalent form. 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review NRC Regional and Agreement State 

radioactive materials programs. These indicators are: (1) Technical Staffing and Training, 

(2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical 

Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities. 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Program’s staffing level and staff 

turnover, as well as the technical qualifications and training histories of the staff. To evaluate 

these issues, the review team examined the Program’s questionnaire response relative to this 

indicator; interviewed managers and staff; reviewed job descriptions and training records; and 

considered any workload backlogs. 

When fully staffed, the Massachusetts Agreement State Program is composed of the 

Radioactive Materials Program Director and technical and administrative staff in the Radioactive 

Materials Unit (Unit). A supervisor heads the Unit. Technical staff members perform both 

inspection and licensing duties, and respond to incidents and allegations. Based on information 

provided by the Program, the review team estimated that the Program currently expends 

approximately 12.5 full-time equivalents (FTE) to administer the Agreement State program. 

During the review period the Program experienced the following personnel changes: the 

Program Director retired from the Agreement State program, a clerical staffer was reassigned 

outside of the Unit and a technical staffer who performed part-time licensing/inspection duties 

was transferred to the Environmental Laboratory within the Massachusetts Radiation Control 

Program. One technical staff member was hired into the Unit during the review period. At the 

time of the review, the Bureau still had two full-time technical vacancies that existed at the 2006 

IMPEP review, a part-time technical vacancy, and a clerical vacancy. The Program Director 

position became vacant in October 2009 and a technical staffer was promoted to the Acting 

Program Director position. The vacancies in the Program have forced staff to take on additional 

duties to try to maintain the Program’s increasing workload. The review team identified the 

vacancies as an underlying cause of the Program’s performance weaknesses, such as overdue 

inspections and inconsistencies/inadequacies in the files and databases, discussed in later 

sections of this report. 

As stated in Section 2.0, the Program still has not been able to fill the two vacant technical 

positions that existed during the 2006 IMPEP review due to budget constraints. The Program is 
Massachusetts Final Report Page 5 

allowed to retain a certain percentage of the revenue from its annual licensing fees and is 

capped at that point. Excess revenue is deposited in the Commonwealth’s general fund. 

Without an increase in this cap the Program does not have the funding to fill the vacant 

positions. In addition, the Acting Director expressed concern that the current staff will be tasked 

with additional duties resulting from the transfers of the personnel mentioned above. The review 

team is concerned that this increased workload demand will adversely affect performance under 

the Agreement with NRC; therefore, the review team kept open the recommendation from the 

2006 IMPEP review on pursuing adequate funding in order to fill the technical vacancies, 

because the Program’s current staffing level is not sufficient to carry out all of its regulatory 

duties in a timely manner. 

The Program has a documented training plan for technical staff that is consistent with the 

requirements in the NRC/Organization of Agreement States Training Working Group Report and 

IMC 1246. The Program uses on-the-job training, such as inspector accompaniments, to 

supplement formal coursework. Staff members are typically assigned increasingly complex 

duties as they progress through the qualification process. Staff members are authorized to 

perform regulatory duties independently after demonstrating competency. The Unit Supervisor 

signs off on all staff qualifications at the recommendation of the appropriate senior advisor. The 

review team noted that the Acting Program Director encourages and supports training 

opportunities based on program needs. The Unit Supervisor has instituted better tracking and 

documentation of staff training history and experience. The review team noted that the most 

recently hired technical staff member was progressing through the Program’s qualification 

process. The review team concluded that the Program’s training is adequate to carry out its 

regulatory duties. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance with respect to the indicator, Technical Staffing and Training, 

be found satisfactory, but needs improvement. 

3.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely dispatch of inspection findings to 

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 

on the Program’s questionnaire response relative to this indicator, data gathered from the 

Program’s database, examination of completed inspection casework, and interviews with 

managers and staff members. 

The review team verified that the Program’s inspection frequencies for all types of radioactive 

materials licenses are at least the same frequency as those listed in NRC’s IMC 2800, 

“Materials Inspection Program.” The Program conducts inspections of four multi-site medical 

broadscope facilities more frequently than it is prescribed in IMC 2800. These four medical 

broadscope facilities are inspected annually, whereas IMC 2800 prescribes a 2-year inspection 

frequency. In addition, the Program is conducting Increased Controls inspections in conjunction 

with the routine health and safety inspections. 
Massachusetts Final Report Page 6 

The Program conducted a total of 164 Priority 1, 2, and 3 (high priority) inspections during the 

review period. The Program identified in its response to the questionnaire, and the review team 

verified, that a total of 24 high priority inspections were conducted overdue by more than 25 

percent of the inspection frequency prescribed by IMC 2800. The review team verified that no 

high priority inspections were overdue at the time of the review. The review team also 

evaluated the Program’s timeliness for conducting initial inspections. The Program conducted 

73 initial inspections, of which 23 were conducted overdue. Initial inspections are to be 

conducted within 12 months after license issuance, as prescribed by IMC 2800. The overdue 

inspections ranged from a few days to 24 months overdue. The review team verified that no 

initial inspections were overdue at the time of the review. Overall, the review team calculated 

that the Program performed 19 percent of its Priority 1, 2, 3, and initial inspections overdue 

during the review period. In addition, the team found that many of the entries into the database 

were inaccurate thereby providing flawed results. 

In investigating the underlying causes of the number of overdue inspections, the review team 

found that inspections were assigned in a timely manner using the inspection and licensing 

database, which generates printouts of upcoming inspection due dates; however, the Program 

managers did not follow up on the performance of these inspections. 

 

The review team evaluated the Program’s timeliness of issuance of inspection reports. The 

Program has a policy of issuing the inspection findings to licensees within 30 days from the date 

of the inspection. The review team examined the Program’s database printouts and inspection 

files and determined that inspection findings were usually issued within 30 days of inspection 

completion. 

In reviewing the Program’s performance of reciprocity inspections, the review team found that 

the Program granted 54 reciprocity requests for Priority 1, 2, and 3 licensees during the review 

period. The review team determined that the Program inspected 20 percent of the candidate 

reciprocity licensees in accordance with IMC 1220, “Processing of NRC Form 241 and 

Inspection of Agreement State Licensees Operating Under 10 CFR 150.20,” in each year of the 

review period, except 2008. In 2008, the Program inspected only 2 of the 13 candidates for that 

year. The Program self-identified an incorrect priority code that was assigned to several 

reciprocity licensees during that year. The Program corrected the priority code assigned to 

each of the reciprocity licensees and was able to meet the 20 percent criterion in subsequent 

years of the review period. 

The review team recommends that the Commonwealth monitor and maintain accurate 

information in its inspection database so it can be used by Program management and staff as a 

reliable planning and tracking tool to ensure that inspections are completed within the required 

timeframe. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance with respect to the indicator, Status of Materials Inspection 

Program, be found satisfactory, but needs improvement. 

 
Massachusetts Final Report Page 7 

3.3 Technical Quality of Inspections

The review team evaluated inspection reports, enforcement documentation, and inspection field 

notes and interviewed the responsible inspectors for 17 radioactive materials inspections 

conducted during the review period. The casework examined included a cross-section of 

inspections conducted by eight inspectors and covered a wide variety of inspection types. 

These included medical broadscope, diagnostic nuclear medicine, gamma knife, industrial 

radiography, waste disposal/processing, academic broadscope, research and development 

broadscope, and self-shielded irradiator. The casework included initial, routine, follow-up, 

reciprocity, and Increased Controls inspections. Appendix C lists the inspection casework files 

reviewed, with case-specific comments. 

Based on the evaluation of casework, the review team determined that inspections covered all 

aspects of the licensees’ radiation safety and security programs. The review team noted that 

the inspections covered the Increased Controls, fingerprinting, and the National Source 

Tracking System requirements, when appropriate. The review team found that inspection 

reports were thorough, complete, consistent, and of high quality with sufficient documentation to 

ensure that licensees’ performances with respect to health, safety, and security were 

acceptable. Inspection report documentation supported violations, recommendations made to 

licensees, and unresolved safety issues. 

While on site, the review team evaluated the Program’s handling and storing of sensitive 

documents. According to the Acting Program Director, the Program has statutory authority to 

withhold certain documents related to security matters, such as Increased Controls issues. For 

example, letters and/or tie-down documents containing security-related information are 

maintained in a locked cabinet and are not released to the public. The Program cannot mark 

documents, such as materials licenses, as sensitive information based only on the maximum 

possession limits listed on the license. Information related to physical security must also be 

present on the document in order to withhold it from public release. An exception to this policy 

is that the Program withholds all documents with Increased Controls-related issues. These 

documents have a security header to notify the reader of the presence of security-related 

information. In addition, the Program has the authority to redact security-related information 

from Freedom of Information Act requests. The review team concluded that the Program’s 

policies and practices for sensitive information are adequate. 

The Acting Program Director and senior inspection staff perform supervisory inspection 

accompaniments. The review team noted that, during the review period, supervisory 

accompaniments were not performed for any inspector on an annual basis. Several inspectors 

were not accompanied by a supervisor over a period of 3 consecutive years. The Unit 

Supervisor noted that there were several reasons for the inconsistency in annual 

accompaniments, including not maintaining a list or tracking system for completion of the 

accompaniments, staffing shortages which led to prioritization of other duties, and Program 

management changes. The review team recommends that the Commonwealth routinely 

perform accompaniments of each inspector, at least annually, to ensure quality and consistency 

in the inspection program. 

The review team accompanied three of the Program’s inspectors during the period of June 8-10, 

2010. The facilities inspected included an industrial radiography licensee and diagnostic 
Massachusetts Final Report Page 8 

nuclear medicine licensees. The inspector accompaniments are listed in Appendix C. The 

inspectors demonstrated performance-based inspection techniques and knowledge of the 

regulations. The inspectors were well trained, prepared for the inspections, and thorough in 

their audits of the licensees’ radiation safety and security programs. The inspectors conducted 

interviews with appropriate personnel, observed licensed operations, conducted confirmatory 

measurements, and utilized good health physics practices. The inspectors held entrance and 

exit meetings with the appropriate level of licensee management. The review team determined 

that the inspections were adequate to assess radiological health, safety, and security at the 

licensed facilities. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance with respect to the indicator, Technical Quality of Inspections, 

be found satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team examined 25 completed licensing casework files and interviewed 5 of 6 license 

reviewers as well as the Coordinator for Materials Licensing. Licensing actions were reviewed 

for completeness, consistency, proper radioisotopes and quantities, qualifications of authorized 

users, adequacy of facilities and equipment, adherence to good health physics practices, 

financial assurance, security requirements, operating and emergency procedures, 

appropriateness of license conditions, and overall technical quality. The casework was also 

reviewed for timeliness, use of appropriate correspondence, reference to appropriate 

regulations, supporting documentation, consideration of enforcement history, pre-licensing 

visits, peer or supervisory review, and proper signatures. 

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

completed during the review period. Licensing actions selected for evaluation included 2 new 

licenses, 8 renewals, 8 amendments, 3 license terminations, and 4 reciprocity requests. 

Casework reviewed included a cross-section of license types including: a service provider, 

industrial radiography, broadscope and limited medical, decommissioning, storage only, 

research and development and gamma knife. A listing of the licensing casework reviewed, with 

case-specific comments, can be found in Appendix D. 

The review team found that the licensing actions were complete, consistent, and of high quality 

with health, safety, and security issues properly addressed. License tie-down conditions were 

stated clearly, and were generally backed by information contained in the file. 

The Program renews licenses every 5 years. The review team noted that most licensing actions 

were promptly acted upon, usually within 30 days of receipt. During the 2006 IMPEP, the 

review team noted that eight renewals were pending for more than 1 year; however, at the time 

of this review, the review team noted that of the 15 renewals currently in house only one had 

been pending for 11 months. This review of this action was active, and the team did not find 

any safety-significant impact on this licensee's program due to the length of time of this pending 

renewal. 

All licensing actions are peer reviewed by a primary and secondary license reviewer and the 

Licensing Supervisor. The Acting Director or designee signs all licensing documents. The 
Massachusetts Final Report Page 9 

program uses a variety of licensing guidance, which includes the NRC NUREG-1556 Series, 

“Consolidated Guide About Materials Licenses,” and the NUREG-1757 Series, “Consolidated 

Decommissioning Guidance,” as well as Program guidance and information on the internet. 

The review team evaluated financial assurance and decommissioning activities conducted in the 

Program. The review team found that decommissioning actions were well documented from the 

initiating action to final surveys, materials disposition, and termination of the license. No 

potentially significant health and safety issues were identified. The review team found that 

actions terminating licenses were well documented, included the appropriate material survey 

records, and contained documentation of proper disposal or transfer or radioactive material, as 

appropriate. 

The review team determined through interviews with Program managers and staff that the 

Program does not routinely verify that licensees conducting business in Massachusetts under 

reciprocity have the proper security conditions on their license. The Program had a number of 

radiographers enter the Commonwealth under reciprocity during the review period. 

Radiographers typically possess materials in quantities of concern that meet the criteria for 

implementation of the Increased Controls. The review team determined that the Program’s 

reciprocity reviewer only verifies that the out-of-State license has not expired. The review team 

discussed with Program managers and staff the importance of examining the reciprocity 

licensees’ licenses for the presence of the appropriate security conditions. 

The review team assessed the Programs' implementation of the pre-licensing guidance. The 

Program has implemented the essential elements of NRC’s pre-licensing guidance issued on 

September 22, 2008, and transmitted to the Agreement States via Office of Federal and State 

Materials and Environmental Management Programs (FSME) Letter RCPD-08-020, “Requesting 

Implementation of the Checklist to Provide a Basis for Confidence That Radioactive Material 

Will Be Used as Specified on a License and the Checklist for Risk-significant Radioactive 

Material.” 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance with respect to the indicator, Technical Quality of Licensing 

Actions, be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Program’s actions in responding to incidents and 

allegations, the review team examined the response to the questionnaire relative to this 

indicator, evaluated selected incidents reported for Massachusetts in the Nuclear Material 

Events Database (NMED) against those contained in the Program’s files, and evaluated the 

casework for 10 of the 60 reported radioactive materials incidents. A listing of the casework 

examined can be found in Appendix E. The review team also evaluated the Program’s 

response to five allegations involving radioactive materials received during the review period, 

including two allegations that NRC referred to the Commonwealth. 

The Event Coordinator has primary responsibility for oversight of all incidents and allegations. 

The initial response and followup to incidents and allegations involving radioactive materials are 

coordinated with the Program Director, Unit Supervisor, and Coordinator for Materials Licensing. 
Massachusetts Final Report Page 10 

A combined written procedure exists for handling all incidents and allegations. If an inspection 

is warranted, Program management is notified and an inspector is assigned to handle the event. 

The Program conducts on-site investigations for all incidents that present a potential or actual 

hazard to public health and safety. Prior to dispatching responders to the site, Program 

management is advised of the planned response. The Program assigns each incident and 

allegation an individual docket number and maintains a local database for tracking the status of 

all incidents and allegations. If an incident meets the reporting requirements established in 

FSME Procedure SA-300, the Program notifies the NRC Headquarters Operations Center. If 

the investigation is complex and extends over a period of time, the Program updates the 

respective NMED record, using the NMED software. 

The incidents selected for review included the following categories: possible overexposure, lost 

or stolen radioactive material, medical, transportation, and contamination. The review team 

determined that the Program’s responses to incidents were thorough, complete, and 

comprehensive. Initial responses were prompt and well coordinated, and the level of effort was 

commensurate with the health and safety significance of the incident. The Program dispatched 

inspectors for on-site investigations when appropriate and took suitable enforcement and followup actions. When no immediate threat was present and the Program determined that the 

licensee had qualified, competent individuals investigating the incident, the Program generally 

responded by telephone with subsequent review of the licensee’s written report or an on-site 

follow up at a later date. 

The 2006 IMPEP review team identified that the Program was not reporting significant or routine 

events in a timely manner as requested in FSME (formerly STP) Procedure SA-300 and kept 

open a recommendation from the 2002 IMPEP review that the Commonwealth take necessary 

steps to ensure that all reportable events are submitted and updated to NRC in accordance with 

SA-300. Prior to the on-site portion of this review, the review team queried NMED and identified 

51 NRC reportable events for Massachusetts over the review period. During the on-site review, 

the review team evaluated the timeliness of reporting these events to the NRC Headquarters 

Operations Center and determined that five events were not reported to NRC in a timely 

manner. In addition, the review team identified that timely followup information was not 

provided for nine events that are still open in NMED. The review team discussed the issue of 

reporting events and providing updates in a timely manner with Program managers and the 

Event Coordinator. Program managers indicated that several of the events involved loss/theft of 

radioactive material and were left open in NMED because there is no new information regarding 

these events and the Program staff has not determined the events to be closed. Although the 

review team found that progress has been made in reporting events to the NRC in accordance 

with FSME Procedure SA-300, there has not been a period of sustained Program performance 

regarding timeliness of reporting and updating events to warrant closing the recommendation 

from the 2006 IMPEP review. Therefore, the recommendation from the 2006 IMPEP report 

remains open. 

In evaluating the effectiveness of the Program’s response to allegations, the review team 

evaluated the completed casework for five allegations, including two that NRC referred to the 

Commonwealth. The review team concluded that the Program consistently took prompt and 

appropriate action in response to concerns raised. The review team noted that the Program 

thoroughly documented the investigations and retained all necessary documentation to 

appropriately close the allegations. The Program notified the allegers of the conclusion of their 
Massachusetts Final Report Page 11 

investigation. The review team determined that the Program adequately protected the identity 

of allegers. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State programs: 

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) LowLevel Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. NRC’s 

Agreement with Massachusetts does not relinquish regulatory authority for a uranium recovery 

program; therefore, only the first three non-common performance indicators applied to this 

review. 

4.1 Compatibility Requirements

To assess Massachusetts’ status with respect to this performance indicator, the review team 

examined the Program’s response to the questionnaire relative to this indicator; reviewed 

Massachusetts’ State Regulation Status Data Sheet (SRS), as maintained by FSME; and 

conducted interviews with managers and staff responsible for this program area. 

4.1.1 Legislation

Massachusetts became an Agreement State on March 19, 1997. The authority under which the 

Program administers the Agreement is in Massachusetts General Law Chapter 111H and 

Chapter 111. The statute authorizing the Governor to enter into the Agreement is contained in 

Chapter 111H, and the statute under which the Program operates is in Chapter 111. The 

Department of Public Health is designated as the Commonwealth's radiation control agency. 

The review team noted that no new legislation, which would affect the Agreement State program 

or its authority, was passed since the last review. 

4.1.2 Program Elements Required for Compatibility

The Commonwealth regulations for the Program are located in Title 105 of the Code of 

Massachusetts Regulations Section 120, and apply to ionizing radiation, whether emitted from 

radionuclides or devices. Massachusetts requires a license for possession and use of 

radioactive materials. 

The review team examined the Program’s rulemaking process. Regulations are drafted by the 

Program, reviewed by Program managers and staff, and are then sent to NRC for a 

compatibility review. The Program evaluates any NRC compatibility comments and revises the 

regulations, as necessary. The regulations are then reviewed by the Program’s legal counsel. 

A memorandum containing the regulations, revised to reflect legal counsel comments, is 

presented to the Department Commissioner for review. The time required for the Department 

Commissioner to review and, if necessary, edit this memorandum can take several months. 

The regulations are then presented to the Commonwealth’s Department of Public Health 
Massachusetts Final Report Page 12 

Council (PHC) who approves the publication of regulations for public comments. A notice that 

regulations are available for public comments is published in two newspapers and in the 

Massachusetts Register for public review and comment. If requested, the public comment 

period may be extended, which consequently, extends the time for promulgation. Any 

comments received by the public are evaluated through comment analysis by the Program staff, 

and the regulations are revised, as necessary. The amount of time to complete the comment 

analysis varies, but usually takes several months. The revised regulations are reviewed by 

Program managers and are submitted to PHC for promulgation. Once PHC approves the 

regulations for promulgation, the Program’s legal counsel submits regulations to the Secretary 

of the Commonwealth, who establishes an effective date for the regulations. A copy of the final 

promulgated regulations is then sent to NRC for a compatibility review as final regulations. 

The review team noted the Program preferred to present PHC a regulation package with 

significant changes and include in those packages any minor amendments NRC had issued. 

The review team explained that this practice may compromise the ability of the Commonwealth 

to adopt regulations within the required 3-year period in accordance with current NRC policy. 

At the time of this review, four amendments were reviewed as proposed regulations, but were 

considered overdue, because they were not adopted and effective by the required 

implementation date. NRC reviewed these proposed regulations and submitted comments on 

three of the four regulations. The Commonwealth has promulgated these regulations and will 

submit them to NRC for final review. The four amendments identified overdue at the time of the 

review are the following: 

• ACompatibility with IAEA Transportation Safety Standards and Other Transportation 

Safety Amendments,@ 10 CFR Part 71 amendment (69 FR 3697), that was required for 

Agreement State adoption by October 1, 2007. 

• ASecurity Requirements for Portable Gauges Containing Byproduct Material,@ 10 CFR 

Part 30 amendment (70 FR 2001), that was required for Agreement State adoption by 

July 11, 2008. 

• AMedical Use of Byproduct Material - Recognition of Specialty Boards,” 10 CFR Part 35 

amendment (70 FR 16336, 71 FR 1926), that was required for Agreement State 

adoption by April 29, 2008. 

• “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40 and 70 amendment (71 FR 

15005), that was required for Agreement State adoption by March 27, 2009. 

The review team identified the following regulation amendments that the Program will need to 

address in upcoming rulemakings or by adopting alternate legally binding requirements: 

• “Medical Use of Byproduct Material – Minor Corrections and Clarifications,” 10 CFR 

Parts 32 and 35 amendment (72 FR 45147, 54207), that is due for Agreement State 

adoption by October 29, 2010. 
Massachusetts Final Report Page 13 

• “Exemptions from Licensing, General Licenses, and Distribution of Byproduct Material; 

Licensing and Reporting Requirements,” 10 CFR Parts 30, 31, 32, and 150 amendment 

(72 FR 58473), that is due for Agreement State adoption by December 17, 2010. 

• “Requirements for Expanded Definition of Byproduct Material,” 10 CFR Parts 20, 30, 31, 

32, 33, 35, 61, and 150 amendment (72 FR 55864), that is due for Agreement State 

adoption by November 30, 2010. 

• AOccupational Dose Records, Labeling Containers and Total Effective Dose Equivalent,” 

10 CFR Parts 19 and 20 amendment (72 FR 68043), that is due for Agreement State 

adoption by February 15, 2011. 

• “Medical Use of Byproduct Material – Authorized User Clarification,” 10 CFR Part 35 

amendment (74 FR 33901), that is due for Agreement State adoption by September 28, 

2012. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance with respect to the indicator, Compatibility Requirements, be 

found satisfactory, but needs improvement. 

4.2 Sealed Source and Device Evaluation Program

In reviewing this indicator, the review team used three subelements to evaluate the Program’s 

performance regarding the sealed source and device (SS&D) evaluation program. These 

subelements were: (1) Technical Staffing and Training, (2) Technical Quality of the Product 

Evaluation Program, and (3) Evaluation of Defects and Incidents Regarding SS&Ds. 

In assessing the Massachusetts SS&D evaluation activities, the review team examined the 

information provided in response to the IMPEP questionnaire and evaluated the SS&D registry 

sheets and supporting documents processed during the review period. The team also 

evaluated SS&D staff training records, certain reported incidents involving products authorized 

in Massachusetts SS&D sheets, the use of guidance documents and procedures, and 

interviewed the staff currently conducting SS&D evaluations. 

4.2.1 Technical Staffing and Training

SS&D evaluation responsibilities are distributed between two reviewers. They were the only 

active SS&D reviewers during the review period. 

The Program has four reviewers who are qualified to perform safety evaluations of SS&D 

applications. No new reviewers were added during the review period. All have science degrees 

and have attended NRC’s SS&D Workshop. The review team interviewed staff members 

involved in the reviews and determined that they were familiar with the procedures used in the 

evaluation of a source/device and had access to applicable reference documents. The review 

team determined that the SS&D staffing level and technical qualifications for the current staff 

were adequate. 
Massachusetts Final Report Page 14 

4.2.2 Technical Quality of the Product Evaluation Program

The review team evaluated 18 of the 112 SS&D evaluation amendments, inactivations, new 

registrations, and reactivations. The reviewers alternate between being the initial reviewer, with 

the other as the concurrence reviewer. The cases selected for review were representative of 

the Program’s licensees and types of sources and devices evaluated. A list of SS&D casework 

examined, with the case-specific comments, can be found in Appendix F. 

In assessing the Program’s SS&D evaluation activities, the review team examined information 

contained in the Program’s response to the IMPEP questionnaire for this indicator and 

interviewed Program staff and managers. The review team confirmed that the Program follows 

the recommended guidance from NRC’s SS&D Workshop, NUREG-1556 Series guidance, 

applicable and pertinent American National Standards Institute standards, ISO-9001, and 

Massachusetts rules. The review team verified that these documents were available and used 

appropriately in performing SS&D reviews. 

One issue was identified in registration number MA-0555-S-102-S in that the certificate 

registration section “External Radiation Levels” identified the radiation levels per microgram of 

californium-252 instead of the maximum loading of 116.9 micrograms (64.11 mCi) as indicated 

in the current version of NUREG 1556, Volume 3. The safety significance is that a license 

reviewer or inspector could misread the table of radiation levels and significantly underestimate 

the radiation levels. The review team recommends that the Commonwealth reissue the 

certificate MA-0555-S-102-S to contain a table indicating radiation levels under maximum 

loading conditions. 

The review team determined that the Program performed evaluations based on sound 

conservative assumptions to ensure public health and safety was adequately protected. 

Deficiency letters clearly stated regulatory positions and all health and safety issues were 

addressed. The review team determined that product evaluations were thorough, complete, 

consistent, and adequately addressed the integrity of the products during use and in the event 

of accidents. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Seven incidents related to SS&D defects involving sources or devices registered by the 

Commonwealth of Massachusetts were reported during the review period. (Six of the incidents 

were related to a specific component assembly manufacturing lot.) The review team found that 

the Program’s response to incidents was prompt, taking into consideration the health and safety 

or security significance of the event. Program staff was aware of the need to look at such 

incidents as potentially generic in nature with possible wide-ranging effects. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance with respect to the indicator, Sealed Source and Device 

Evaluation Program, be found satisfactory. 
Massachusetts Final Report Page 15 

4.3 Low-Level Radioactive Waste Disposal Program

In 1981, NRC amended its Policy Statement, “Criteria for Guidance of States and NRC in 

Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement,” to 

allow a State to seek an amendment for the regulation of low-level radioactive waste (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 the 

Massachusetts Agreement State Program has authority to regulate a LLRW disposal facility, 

NRC has not required States to have a program for licensing a 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, it is expected to put in place a regulatory program that will meet the criteria for an 

adequate and compatible LLRW program. There are no plans for a commercial LLRW disposal 

facility in Massachusetts. Accordingly, the review team did not review this indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, the review team found Massachusetts’ performance to 

be satisfactory for four of the seven performance indicators reviewed, and satisfactory, but 

needs improvement for the following three performance indicators: Technical Staffing and 

Training, Status of Materials Inspection Program, and Compatibility Requirements. The review 

team made three recommendations regarding program performance by the Commonwealth and 

kept open five recommendations from previous reviews. Overall, the review team 

recommended, and the MRB agreed, that the Massachusetts Agreement State Program be 

found adequate to protect public health and safety, but needs improvement, and compatible 

with NRC's program. Based on the results of the current IMPEP review, the review team 

recommended, and the MRB agreed, that the Massachusetts Agreement State Program be 

placed on Monitoring, with a periodic meeting held in approximately 1 year to assess the 

Program’s progress in addressing the open recommendations. The review team recommended, 

and the MRB agreed, that the next full IMPEP review take place in approximately 4 years. 

Below are the recommendations, as mentioned earlier in this report, for evaluation and 

implementation, as appropriate, by the Commonwealth: 

1. The review team recommends that the Commonwealth pursue adequate funding to 

support and implement the staffing plan which is needed to meet current program 

demands as well as the projected increase in workload. (Section 3.1 of the 2006 IMPEP 

report) 

2. The review team recommends that the Commonwealth monitor and maintain accurate 

information in its database so it can be used by Program management and staff as a 

reliable planning and tracking tool to ensure that inspections are completed within the 

required timeframe. (Section 3.2) 

3. The review team recommends that the Commonwealth routinely perform 

accompaniments of each inspector, at least annually, to ensure quality and consistency 

in the inspection program. (Section 3.3) 
Massachusetts Final Report Page 16 

4. The review team recommends that the Commonwealth take necessary steps to ensure 

that all reportable events are submitted and updated to NRC in accordance with FSME 

Procedure SA-300. (Section 3.5 of the 2002 IMPEP report) 

5. The review team recommends that the Commonwealth adopt regulations necessary for 

compatibility within the required 3-year period. (Section 4.1.2 of the 2006 IMPEP report) 

(Modified in 2010) 

6. The review team recommends that the Commonwealth reissue the certificate MA-0555-

S-102-S to contain a table indicating radiation levels under maximum loading conditions. 

(Section 4.2.2) 

7. The team recommends that the Commonwealth make corrections to registration 

certificate MA-0166-D-102-B. (Section 4.2.1 of the 2002 IMPEP report) (Section 4.2.2 of 

subsequent reports) (Incorrectly identified as MA-0116-102-B in the 2002 and 2006 

reports) 

8. The review team recommends that the Commonwealth reissue registration certificate 

MA-8154-D-803-B with the complete text or equivalent form. (Section 4.2.2 of the 2006 

IMPEP Report) (Modified in 2010) 
LIST OF APPENDIXES 

Appendix A IMPEP Review Team Members 

Appendix B Massachusetts Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source & Device Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Michelle Beardsley, FSME Team Leader 

 Technical Staffing and Training 

Leira Cuadrado, FSME Status of Materials Inspection Program 

 Compatibility Requirements 

Donna Janda, Region I Technical Quality of Inspections 

 Technical Quality of Incident and Allegation 

 Activities 

 Inspector Accompaniments 

James Mullauer, Region III Technical Quality of Licensing Actions 

Karl Von Ahn, Ohio Sealed Source and Device Evaluation Program 
APPENDIX B 

MASSACHUSETTS ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML102170078
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Massachusetts Institute of Technology License No.: 60-0094 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 10/4-6/06 Inspector: AC 

File No.: 2 

Licensee: Massachusetts General Hospital License No.: 60-0055 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 3/3-6/09 Inspector: AC 

File No.: 3 

Licensee: Tufts New England Medical Center License No.: 68-0263 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/3/08 Inspector: AC 

File No.: 4 

Licensee: UMass Memorial Health Alliance License No.: 44-0191 

 Leominster Campus 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/6/07 Inspector: RG 

Comment: 

The Program conducted the inspection 4 months overdue. 

File No.: 5 

Licensee: Philotechnics License No.: 56-0543 

Inspection Type: Initial, Announced Priority: 2 

Inspection Date: 4/7/08 Inspector: BP 

Comment: 

The Program conducted the inspection 18 months overdue. 

File No.: 6 

Licensee: ABC Testing, Inc. License No.: 19-7781 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 6/25/08 Inspector: AC 

File No.: 7 

Licensee: Children’s Hospital Boston License No.: 60-0137 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 12/15-17/08 Inspector: TC 

 
Massachusetts Final Report Page C.2 

Inspection Casework Reviews 

File No.: 8 

Licensee: University of Massachusetts/Lowell License No.: 60-0049 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 2/10-11/09 Inspector: AC 

File No.: 9 

Licensee: Thermo EGS Gauging, Inc. License No.: 20-6751 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Dates: 1/26/10, 2/2/10 Inspectors: JD, JS 

File No.: 10 

Licensee: Caritas Good Samaritan Medical Center License No.: 44-0023 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/28/07 Inspector: JS 

File No.: 11 

Licensee: Tufts Medical Center License No.: 68-0263 

Inspection Type: Special, Announced Priority: 2 

Inspection Dates: 4/3/08, 5/2/08, 12/30/08 Inspector: TC 

File No.: 12 

Licensee: Tufts Medical Center License No.: 68-0263 

Inspection Type: Followup, Unannounced Priority: 2 

Inspection Date: 6/29/10 Inspector: JS 

File No.: 13 

Licensee: Quality Assurance Lab License No.: 48-0426 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 6/9/09 Inspector: BP 

File No.: 14 

Licensee: Northshore Medical Center License No.: 44-0161 

Inspection Type: Followup, Unannounced Priority: 3 

Inspection Dates: 1/28/09, 7/21/09, 1/22/10 Inspector: MW 

File No.: 15 

Licensee: Baystate Health License No.: 01-4127 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 5/12/09 Inspector: BP 

File No.: 16 

Licensee: Caritas St. Elizabeth’s Medical Center License No.: 00-6345 

Inspection Type: Followup/Special, Announced Priority: 5 

Inspection Date: 7/30/08 Inspector: MW 

 
Massachusetts Final Report Page C.3 

Inspection Casework Reviews 

File No.: 17 

Licensee: MDS Nordion License No.: 66-0021 

Inspection Type: Reciprocity, Unannounced Priority: 2 

Inspection Dates: 3/2-3/10 Inspectors: AC, MI 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: ABC Testing, Inc. License No.: 19-7781 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 6/8/10 Inspector: TC 

Accompaniment No.: 2 

Licensee: Beverly Hospital License No.: 60-0052 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/9/10 Inspector: MW 

Accompaniment No.: 3 

Licensee: Joslin Diabetes Center, Inc. License No.: 15-2661 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 6/10/10 Inspector: AC 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Quality Inspection Services, Inc. NRC License No.: 31-30187-01 

Type of Action: Reciprocity Amendment No.: 12 

Date Issued: 6/3/10 License Reviewer: MI 

File No.: 2 

Licensee: Eyegate Pharmaceuticals, Inc. License No.: 33-0549 

Type of Action: New Amendment No.: N/A 

Dates Issued: 2/12/07 License Reviewer: BP 

File No.: 3 

Licensee: Eyegate Pharmaceuticals, Inc. License No.: 33-0549 

Type of Action: Termination Amendment No.: 01 

Dates Issued: 6/11/08 License Reviewer: BP 

File No.: 4 

Licensee: Nobel Hospital License No.: 16-1811 

Type of Action: Renewal Amendment No.: 20 

Date Issued: 7/9/07 License Reviewer: AC 

File No.: 5 

Licensee: University of Massachusetts Memorial Hospital License No.: 44-0063 

Type of Action: Renewal Amendment No.: 15 

Date Issued: 7/24/09 License Reviewers: AC, BP 

File No.: 6 

Licensee: Milton Hospital License No.: 44-0050 

Type of Action: Amendment Amendment No.: 11 

Date Issued: 11/30/09 License Reviewers: BP, AC 

File No.: 7 

Licensee: Smith College License No.: 01-4621 

Type of Action: Renewal Amendment No.: 24 

Date Issued: 2/1/10 License Reviewers: AC, MI 

File No.: 8 

Licensee: Spaulding Rehabilitation Hospital License No.: 44-0064 

Type of Action: Termination Amendment No.: 5 

Date Issued: 10/22/07 License Reviewers: BP, AC 
Massachusetts Final Report Page D.2 

License Casework Reviews 

File No.: 9 

Licensee: Norfolk County Cardiology Associates License No.: 67-0285 

Type of Action: New Amendment No.: 3 

Date Issued: 3/31/10 License Reviewers: AC, MI 

File No.: 10 

Licensee: Tufts New England Medical Center License No.: 68-0263 

Type of Action: Amendment Amendment No.: 4 

Date Issued: 5/5/08 License Reviewers: AC, KI 

File No.: 11 

Licensee: Williams College License No.: 04-0284 

Types of Action: Renewal Amendment No.: 9 

Dates Issued: 4/16/08 License Reviewers: JS, MI 

File No.: 12 

Licensee: Boston College License No.: 00-6427 

Types of Action: Renewal Amendment No.: 13 

Dates Issued: 5/19/09 License Reviewers: AC, MI 

File No.: 13 

Licensee: Beth Israel Deaconess Medical Center License No.: 60-0432 

Type of Action: Amendment Amendment No.: 10 

Date Issued: 9/11/08 License Reviewers: MI, AC, KD 

File No.: 14 

Licensee: M/A - Com License No.: 48-0405 

Type of Action: Termination Amendment No.: 4 

Date Issued: 10/22/07 License Reviewer: JD 

File No.: 15 

Licensee: Entergy Nuclear Op., Inc. License No.: 07-6262 

Type of Action: Renewal Amendment No.: 15 

Date Issued: 3/6/09 License Reviewer: AC, MI 

File No.: 16 

Licensee: Beth Israel Deaconess Medical Center License No.: 60-0432 

Type of Action: Amendment Amendment No.: 9 

Date Issued: 6/11/08 License Reviewer: MI, AC 

File No.: 17 

Licensee: MDS Nordion NRC License No.: 54-28275-01 

Type of Action: Reciprocity Amendment No.: N/A 

Date Issued: 12/1/09 License Reviewer: MI 
Massachusetts Final Report Page D.3 

License Casework Reviews 

File No.: 18 

Licensee: H & H X-ray Services, Inc. NRC License No.: 17-19236-01 

Type of Action: Reciprocity Amendment No.: 26 

Date Issued: 11/12/09 License Reviewer: MI 

File No.: 19 

Licensee: Conam Inspection License No.: 16-5591 

Type of Action: Amendment Amendment No.: 15 

Date Issued: 8/18/09 License Reviewer: JD 

File No.: 20 

Licensee: Easter Massachusetts Surgery Center, LLC License No.: 70-0594 

Type of Action: Amendment Amendment No.: 2 

Date Issued: 1/12/10 License Reviewers: TC, JD 

File No.: 21 

Licensee: Varian Medical Systems NRC License No.: 45-30957-01 

Type of Action: Reciprocity Amendment No.: N/A 

Date Issued: 12/22/09 License Reviewer: MI 

File No.: 22 

Licensee: ABC Testing License No.: 19-7781 

Type of Action: Amendment Amendment No.: 10 

Date Issued: 10/28/07 License Reviewer: AC 

File No.: 23 

Licensee: Neutron Products, Inc. Maryland License No.: 31-025-03 

Type of Action: Reciprocity Amendment No.: N/A 

Date Issued: 4/18/07 License Reviewer: MI 

File No.: 24 

Licensee: Decontamination, Decommissioning & License No.: 56-0623 

 Environmental Services, Inc. 

Type of Action: New Amendment No: N/A 

Date Issued: 6/4/10 License Reviewer: BP 

File No.: 25 

Licensee: ABC Testing License No.: 19-7781 

Type of Action: Renewal Amendment No. : 11 

Date issued: 7/2/10 License Reviewer: JS 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Cardinal Health License No.: 42-0146 

Date of Incident: 3/18/09 NMED No.: 090394 

Investigation Dates: 3/18 – 7/13/09 Type of Incident: Transportation 

 Types of Investigation: Telephone, Licensee Report 

File No.: 2 

Licensee: Cambridge Isotopes Lab/Ontario Power License No.: N/A 

Date of Incident: 6/28/07 NMED No.: 070401 

Investigation Dates: 6/29 – 8/22/07 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Telephone 

File No.: 3 

Licensee: Solo Cup Company General License No.: G0285 

Date of Incident: 10/29/07 NMED No.: 070683 

Investigation Dates: 10/29/07, 11/29/07 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 

File No.: 4 

Licensee: Geotechnical Consultants License No.: 48-0334 

Date of Incident: 11/6/08 NMED No.: 080777 

Investigation Date: 11/7/08 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Telephone 

File No.: 5 

Licensee: Thyro-Cat License No.: 44-0550 

Date of Incident: 6/13/07 NMED No.: 070376 

Investigation Date: 6/20/07 Type of Incident: Contamination 

 Type of Investigation: Site 

File No.: 6 

Licensee: Brigham & Women’s Hospital License No.: 44-0004 

Date of Incident: 6/30/09 NMED No.: 090575 

Investigation Date: 8/27/09 Type of Incident: Possible Overexposure 

 Type of Investigation: Telephone, Licensee Report 

File No.: 7 

Licensee: Massachusetts General Hospital License No.: 60-0055 

Date of Incident: 2/10/10 NMED No.: 100071 

Investigation Date: 2/25/10 Type of Incident: Medical 

 Type of Investigation: Telephone, Licensee Report 

 
Massachusetts Final Report Page E.2 

Incident Casework Reviews 

File No.: 8 

Licensee: QSA Global, Inc. License No.: 12-8361 

Date of Incident: 8/20/08 NMED No.: 080492 

Investigation Date: 8/22/08 Type of Incident: Possible Overexposure 

 Type of Investigation: Site 

File No.: 9 

Licensee: QSA Global, Inc. License No.: 12-8361 

Date of Incident: 12/18/07 NMED No.: 080005 

Investigation Date: 12/21/07 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 

File No.: 10 

Licensee: Quaker Fabric Corp. General License No.: G0122 

Date of Incident: 5/19/09 NMED No.: 090505 

Investigation Date: 5/21 – 6/24/09 Type of Incident: Lost/Stolen/Abandoned RAM 

 Type of Investigation: Site 
APPENDIX F 

SEALED SOURCE AND DEVICE (SS&D) CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Registry No.: MA-1233-D-101-G SS&D Type: (N) Ion Generators, Chromatography 

Manufacturer: Sionex Corporation Model Nos.: SVAC Series micro Analyzer, micro 

 Analyzer-1, micro Analyzer-2, micro Analyzer V2.0 

Date Issued: 4/26/10 Type of Action: Amendment 

 SS&D Reviewers: JD, JS 

File No.: 2 

Registry No.: MA-1059-S-191-S SS&D Type: (F) Well Logging Source 

Manufacturer: QSA Global, Inc Model No.: CDC.CYn series 

Date Issued: 4/1/10 Type of Action: Amendment 

 SS&D Reviewers: JS, JD 

File No.: 3 

Registry No.: MA-1287-D-105-B SS&D Type: (E) Beta Gauge 

Manufacturer: Thermo EGS Gauging Model Nos.: SCL-77A, SCL-1C 

Date Issued: 2/17/10 Type of Action: Amendment 

 SS&D Reviewers: JD, JS 

File No.: 4 

Registry No.: MA-1059-D-114-S SS&D Type: (Y) Calibrators 

Manufacturer: QSA Global, Inc Model No.: 773 

Date Issued: 9/17/09 Type of Action: Amendment 

 SS&D Reviewers: JD, JS 

File No.: 5 

Registry No.: MA-1059-D-930-S SS&D Type: (A) Industrial Radiography 

Manufacturer: QSA Global, Inc Model No.: 650L source changer 

Date Issued: 5/19/09 Type of Action: Inactivation 

 SS&D Reviewers: JS, JD 

File No.: 6 

Registry No.: MA-1059-D-365-S SS&D Type: (A) Industrial Radiography 

Manufacturer: QSA Global, Inc Model No.: 989 

Date Issued: 1/28/09 Type of Action: New 

 SS&D Reviewers: JD, JS 

File No.: 7 

Registry No.: MA-1101-D-801-G SS&D Type: (N) Ion Generator, Chromatography 

Manufacturer: Bruker Detection Corp. Model No.: RAID System Series 

Date Issued: 3/6/09 Type of Action: Inactivation 

SS&D Reviewers: JS, JD
Massachusetts Final Report Page F.2 

SS&D Casework Reviews 

File No.: 8 

Registry No.: MA-1159-D-102-B SS&D Type: (U) X-ray Fluorescence 

Manufacturer: Thermo Niton Analyzers Model No.: XL3p series 

Date Issued: 8/30/07 Type of Action: New 

 SS&D Reviewers: JS, JD 

File No.: 9 

Registry No.: MA-0555-S-102-S SS&D Type: (H) General Neuron Source 

Manufacturer: Industrial Nuclear Corp Model No.: HK252M41 Series 

Date Issued: 8/3/07 Type of Action: New 

 SS&D Reviewers: JS, JD 

Comments: 

a) In the registration certificate section “External Radiation Levels”, the table listed radiation 

profiles on a per microgram (0.536 mCi) basis instead of the customary maximum 

activity. 

b) The maximum loading of the sealed source is 116.9 micrograms (64.11 mCi). 

c) Since a user of the registration certificate could potentially misread the radiation levels, 

the review team recommends that the program reissue this registration certificate to 

include a dose profile from the maximum source loading. 

File No.: 10 

Registry No.: MA-1059-D-364-S SS&D Type: (AA) Manual Brachytherapy 

Manufacturer: QSA Global, Inc Model No.: R2.3 (Sr-90 eye applicator) 

Date Issued: 9/21/06 Type of Action: New 

 SS&D Reviewers: JS, JD 

File No.: 11 

Registry No.: MA-1059-S-215-S SS&D Type: (Y) Calibrator 

Manufacturer: QSA Global, Inc Model No.: SIC.L9 

Date Issued: 1/22/07 Type of Action: Reactivation 

 SS&D Reviewers: JS, JD 

File No.: 12 

Registry No.: MA-0573-D-103-B SS&D Type: (U) X-ray Fluorescence 

Manufacturer: RMD Instruments Model Nos.: LPA-1, LPA-1B, LTR1000 

Date Issued: 7/2/07 Type of Action: Amendment 

 SS&D Reviewers: JS, JD 

File No.: 13 

Registry No.: MA-1059-S-359-S SS&D Type: (X) Medical Reference Source 

Manufacturer: QSA Global, Inc Model Nos.: 1000C series, 1000R series 

Date Issued: 8/1/07 Type of Action: Amendment 

 SS&D Reviewers: JS, JD 

 
Massachusetts Final Report Page F.3 

SS&D Casework Reviews 

File No.: 14 

Registry No.: MA-219-D-813-S SS&D Type: (J) Gamma Irradiator, Category 1 

Manufacturer: Pharmalucence, Inc Model No.: IBL-437C 

Date Issued: 8/1/08 Type of Action: Inactivation 

 SS&D Reviewers: JD, JS 
ATTACHMENT 

September 9, 2010 Letter from Robert Gallaghar 

Massachusetts Response to the Draft Report 

and 

 NRC’s comment resolution document 

ADAMS Accession No.: ML102580885