UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

November 14, 2014 

Suzanne K. Condon 

Associate Commissioner and Director 

Bureau of Environmental Health 

Department of Public Health 

250 Washington Street, 7th Floor 

Boston, MA 02108 

Dear Ms. Condon: 

On October 28, 2014, 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 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 that a period of Monitoring be 

initiated for Massachusetts. Monitoring may be used in cases where one or more performance 

indicators are less than fully satisfactory. Monitoring is an informal process that allows the NRC 

to maintain an increased level of communication with an Agreement State program. 

Section 5.0, page 19, of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendation. We request your evaluation and response to the 

recommendation within 30 days from receipt of this letter. Your response to the 

recommendation should be submitted to Laura A. Dudes, Director, Division of Material Safety, 

State, Tribal, and Rulemaking Programs. 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 2015. 

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/

 Roy P. Zimmerman 

 Acting 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: See next page
cc: Lee Cox, NC 

 Organization of Agreement States 

 Liaison to the MRB 

 John M. Priest, Jr., Director 

 Radiation Control Program 

 John Giarrusso, Jr., Chief 

 Emergency Management Agency 

 State Liaison Office 

 
November 14, 2014 

Suzanne K. Condon 

Associate Commissioner and Director 

Bureau of Environmental Health 

Department of Public Health 

250 Washington Street, 7th Floor 

Boston, MA 02108 

Dear Ms. Condon: 

On October 28, 2014, 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 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 that a period of Monitoring be 

initiated for Massachusetts. Monitoring may be used in cases where one or more performance 

indicators are less than fully satisfactory. Monitoring is an informal process that allows the NRC 

to maintain an increased level of communication with an Agreement State program. 

Section 5.0, page 19, of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendation. We request your evaluation and response to the 

recommendation within 30 days from receipt of this letter. Your response to the 

recommendation should be submitted to Laura A. Dudes, Director, Division of Material Safety, 

State, Tribal, and Rulemaking Programs. 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 2015. 

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/ 

 Roy P. Zimmerman 

 Acting 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: See next page 

DISTRIBUTION: See next page 

ADAMS Accession Number: ML14301A012

OFFICE MSTR:TL MSTR MSTR MSTR:D TechEd NMSS:DD EDO:Acting DEDMRT

NAME JKatanic Via 

email w/edits 

LDimmick 

LCD w/edits 

DWhite LCD 

for 

LDudesSA 

w/edits 

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WM 

RZimmerman 

DATE 10/31/14 10/31/14 10/31/14 11/03/14 11/04/14 11/12/14 11/14/14 

OFFICIAL RECORD COPY
Letter to S. Condon from R. Zimmerman dated: November 14, 2014 

SUBJECT: MASSACHUSETTS FY2014 FINAL IMPEP REPORT 

DISTRIBUTION: (SP05) 

RidsEdoMailCenter 

JFoster, OEDO 

RidsOgcMailCenter 

JOlmstead, OGC 

RidsRgn3MailCenter 

DRoberts, RIII 

RidsRgn1MailCenter 

DCollins, RI 

JDwyer, RI 

RidsSecyCorrespondenceMailCenter Chairman Macfarlane 

RidsNmssOd Commissioner Svinicki 

KMcConnell, NMSS Commissioner Ostendorff 

PHenderson, MSTR Commissioner Baran 

DJanda, RI/RSAO SECY 

FGaskins, RI 

MSimmons, RIV 

SPoy, MSTR 

VDanese, TX DSHS 

MAbogunde, MSTR 

OAS Board 

JWeil, OCA (2 copies) 

 
 Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE MASSACHUSETTS AGREEMENT STATE PROGRAM 

July 28–August 1, 2014 

FINAL REPORT
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the Massachusetts Agreement State Program. The review was conducted 

during the period of July 28–August 1, 2014, by a review team composed of technical staff 

members from the U.S. Nuclear Regulatory Commission (NRC) and the State of Texas.

Based on the results of this review, the review team recommended, and the Management 

Review Board (MRB) agreed, that Massachusetts’ performance be found satisfactory, but needs 

improvement, for three of seven indicators: Technical Quality of Inspection Activities, Technical 

Quality of Licensing Actions, and Technical Quality of Incident and Allegation Activities. The 

review team recommended, and the MRB agreed, that Massachusetts’ performance be found 

satisfactory for the other indicators reviewed: Technical Staffing and Training, Status of 

Materials Inspection Program, Sealed Source and Device Evaluation Program, and 

Compatibility Requirements. 

The review team determined that the eight recommendations from previous IMPEP reviews 

were addressed by the Program and should be closed. The review team made one new 

recommendation to strengthen the Commonwealth’s incident response program. The review 

team recommended, and the MRB agreed, that the Commonwealth take measures to ensure 

that the Program’s evaluation of events is thorough, complete, properly documented to facilitate 

future follow-up, and undergoes appropriate management review prior to closeout. 

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 the NRC's program. Based on the results of the current 

IMPEP review, and in accordance with the criteria in NRC Management Directive 5.6, 

“Integrated Materials Performance Evaluation Program,” dated February 26, 2004, the review 

team recommended, and the MRB agreed, that a period of Monitoring be initiated for 

Massachusetts. 

The review team further recommended, and the MRB agreed, that a Periodic meeting be 

conducted in one year from this review to assess the Commonwealth’s progress and efforts 

taken to address the identified performance issues, and that the next IMPEP review take place 

in approximately 4 years. 
Massachusetts Final IMPEP 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 28–August 1, 2014, by a review team 

composed of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and 

the State of Texas. 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 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 from July 17, 2010, to August 1, 2014, were discussed with 

Massachusetts managers on the last day of the review. 

A draft of this report was issued to Massachusetts on September 3, 2014, for factual comment. 

Massachusetts responded to the findings and conclusions of the review by letter dated 

September 29, 2014. A copy of the Commonwealth’s response is included as an attachment to 

this report. The Management Review Board (MRB) met on October 28, 2014, 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 the NRC’s 

program. 

The Massachusetts Agreement State Program is administered by the Radiation Control 

Program (the Program). The Program is part of the Bureau of Environmental Health (the 

Bureau), within the Department of Public Health. An organization chart for the Program is 

included in Appendix B. 

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

444 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 the NRC and the Commonwealth of Massachusetts. 

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to the Program on February 3, 2014. The 

Program provided its response to the questionnaire on July 2, 2014. A copy of the 

questionnaire response may be found in the NRC’s Agencywide Documents Access and 

Management System (ADAMS) using the Accession Number ML14183B604. 

The review team’s general approach for conduct of this review consisted of (1) an examination 

of the Program’s response to the questionnaire, (2) review of applicable Massachusetts statutes 

and regulations, (3) an analysis of quantitative information from the Program’s database, 

(4) technical review of selected regulatory actions, (5) field accompaniments of four of the 

Program’s inspectors, and (6) interviews with Program staff and managers. The review team 

evaluated the information gathered against the established criteria for each common and 

applicable non-common performance indicator and made a preliminary assessment of the 

Massachusetts Agreement State Program’s performance. 
Massachusetts Final IMPEP Report Page 2 

Section 2.0 of this report discusses the Commonwealth’s actions in response to 

recommendations made during previous IMPEP reviews. The results of the current review of 

the common performance indicators are presented in Section 3.0. The results of the current 

review of the applicable non-common performance indicators are presented in Section 4.0. 

The review team’s findings and recommendations are summarized in Section 5.0. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on July 16, 2010, the review team made 

eight recommendations in regard to the Program’s performance. The status and determination, 

which the MRB agreed with, of each recommendation is as follows: 

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 Program is funded by licensing and registration fees. The funds are placed 

into a retained revenue account and the Program is allowed to retain a certain amount of 

the revenue to meet current Program demands as well as the projected increase in 

workload. Since the 2010 IMPEP review, the Program has hired additional technical 

staff to fill the vacancies identified during the previous review. In addition, the Program 

Director position, which was previously filled with an Acting Director, has been 

permanently filled. Several technical staff members were promoted during the review 

period and the vacancies created as a result of those promotions are being addressed 

by the Program in a timely manner. This recommendation is closed. 

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 of the 2010 IMPEP report)” 

Status: The review team examined the Program’s database and found that the Program 

maintains accurate information in its database. Program management demonstrated 

that the database is being utilized as an effective planning and tracking tool. The 

Program has instituted a system to monitor the database to ensure that inspections are 

conducted in a timely manner. The Program generates reports to flag routine, initial and 

Increased Controls (IC) inspections approaching their due dates. Inspection 

assignments are made at least 90 days in advance of the inspection due date and tickler 

reports are provided to inspectors on a weekly basis. This recommendation is closed. 

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 of the 2010 IMPEP report)” 

Status: The Program performed all but one supervisory accompaniment of inspectors in 

2011. The Program performed all supervisory accompaniments of inspectors in 2012 

and 2013. One supervisory accompaniment has been completed in 2014 and the 
Massachusetts Final IMPEP Report Page 3 

Program is on track to complete the remaining accompaniments by the end of the 

calendar year. 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 FSME 

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

Status: The review team examined the Program’s procedures for tracking events and 

found that the procedure stresses the importance of determining whether an event is 

reportable and if so, to make the required notification to NRC in accordance with the 

specified timeframe in Office of Federal and State Materials and Environmental 

Management Programs (FSME) Procedure SA-300. The Program’s procedure also 

establishes that reportable events are to be entered, updated, and closed in the Nuclear 

Materials Events Database (NMED) in a timely manner. The review team examined 

over 50 events that the Program had reported to NRC during the review period and were 

in NMED, and found that reportable events were being reported to NRC in accordance 

with the timeframes noted in FSME Procedure SA-300. Where appropriate, updates 

were made by the Program and events were closed in NMED in a timely manner. The 

review team also reviewed a sample of events that the Program had identified as not 

reportable to NRC. Although one non-reported event may potentially be a medical event 

(see Section 3.5), the other non-reported events reviewed were found to be classified 

correctly. This recommendation is closed. 

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

compatibility with the required 3-year period. (Section 4.1.2 of the 2006 IMPEP report, 

modified in the 2010 IMPEP report)” 

Status: The review team noted that the Commonwealth had made significant progress 

in the promulgation of regulations since the last IMPEP review. Specifically, since the 

2010 IMPEP review, the Program has submitted 12 final regulation amendments to NRC 

for review. The Program currently has no overdue regulation amendments. This 

recommendation is closed. 

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 of the 2010 IMPEP report)” 

Status: The Program has reissued certificate MA-0555-S-102-S with the appropriate 

table indicating radiation levels under maximum loading conditions. This 

recommendation is closed. 

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

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

4.2.2 of the 2006 and 2010 IMPEP reports, incorrectly identified as MA-0116-102-B in 

the 2002 and 2006 IMPEP reports)” 

Status: The Program has reissued certificate MA-0166-D-102-B with the appropriate 

corrections. This recommendation is closed. 
Massachusetts Final IMPEP Report Page 4 

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

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

IMPEP report, modified in the 2010 IMPEP report)” 

Status: The Program has reissued certificate MA-8154-D-803-B, to include a cover 

page of the corrected registration certificate for NR-143-D-103-B and the inactivated 

certificate MA-8154-D-803-B. This recommendation is closed. 

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

Considerations 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 the indicator, interviewed managers and staff, reviewed job descriptions and training records, 

and considered any workload backlogs. 

The Program is currently managed by the Program Director, the Radioactive Materials Unit 

Supervisor (Unit Supervisor), the Licensing Supervisor, and the Inspection Supervisor. The 

Radioactive Materials Unit is responsible for materials licensing, inspection, compliance, 

sealed source and device evaluation, regulation development, and emergency response 

activities. At the time of the review, in addition to the supervisory positions noted, there were 

four technical staff members with varying degrees of involvement in the radioactive materials 

program, to include, as appropriate: materials inspection, materials licensing, and sealed 

source and device evaluations. In addition, the Planning/Monitoring Unit Supervisor and the 

Nonionizing/Industrial X-Ray/Accelerator Unit Supervisor also perform radioactive materials 

licensing and inspections as part of their current duties. The Program devotes approximately 

10.2 full-time equivalents (FTE) to radioactive materials licensing and inspection activities, 

including administrative and supervisory duties. 

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

previous Unit Supervisor retired in May 2011; one technical staff member resigned in April 

2012; the Deputy Director, who was functioning as the Acting Director, resigned in November 

2012 (an Interim Director was then assigned as Program Director until the permanent Director 

was hired); three technical staff members were promoted to supervisory positions within the 

Program, including the Unit Supervisor position (filled in December 2011); two technical staff 

members were hired in January 2011 and May 2013, respectively; and a permanent Program 

Director was hired in March 2014. Three positions were vacant at the time of this review: two 

full-time technical staff positions and a Deputy Director position. The Program is in the 

process of filling the two technical positions, which have been vacant since February 2014 

and June 2014, respectively, due to the promotion of two technical staff members to 

supervisory positions. The Director anticipates filling the Deputy Director position, which has 
Massachusetts Final IMPEP Report Page 5 

been vacant since November 2012, during the third quarter of 2014. The review team did not 

identify any backlogs in licensing or inspections due to the vacancies. The review team 

determined that staffing levels were adequate for the Agreement State program and 

comparable to other programs of similar scope and complexity. 

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 

NRC’s Inspection Manual Chapter (IMC) 1248, “Formal Qualification Programs in the Nuclear 

Material Safety and Safeguards Program Area.” Staff members are assigned increasingly 

complex duties as they progress through the qualification process. Currently, the Program has 

two technical staff members undergoing the qualification process. Based on a review of 

qualification journals, the review team determined that the Program adequately documents each 

staff member’s qualification status. The review team concluded that the Program’s training 

program is adequate to carry out its regulatory duties and noted that Massachusetts 

management supports the Program’s training program. 

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. 

3.2 Status of Materials Inspection Program

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

inspections of Priority 1, 2, and 3 licensees, 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 licensing and inspection database, examination of completed 

inspection casework, and interviews with Program management and staff. 

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

material licenses are at least as frequent as similar license types listed in NRC IMC 2800, 

“Materials Inspection Program.” The Program currently conducts inspections of eight licensees 

more frequently than prescribed in IMC 2800, including four multi-site medical broad scope 

facilities which are inspected annually, rather than the 2 year inspection frequency prescribed by 

IMC 2800. It was noted that the Program is conducting Increased Controls (IC) inspections in 

conjunction with the routine health and safety inspections. 

The review team determined that the Program conducted 162 Priority 1, 2, and 3 inspections 

during the review period, based on the inspection frequencies established in IMC 2800. The 

Program identified in its response to the questionnaire, and the review team verified, that a total 

of five of these inspections were conducted overdue by more than 25 percent of the inspection 

frequency prescribed in IMC 2800. There were no Priority 1, 2, and 3 inspections overdue at 

the time of the review. 

The Program performed 68 initial inspections during the review period, one of which was 

conducted overdue. As described in IMC 2800, initial inspections should be conducted within 

12 months of license issuance. There was one initial inspection which was overdue at the time 

of review due to the fact that the licensed material was on a ship out at sea and not available for 
Massachusetts Final IMPEP Report Page 6 

inspection. The ship had recently returned to shore and the Program was planning to schedule 

and conduct the inspection in the near future. The Program, in its response to the draft report, 

indicated the inspection was completed on August 13, 2014. Overall, the review team 

calculated that the Program performed three percent of its inspections (Priority 1, 2, 3, and 

Initials) overdue during the review period. 

The review team evaluated the Program’s timeliness in providing inspection findings to 

licensees. A review of inspection reports and printouts from the Program’s database 

determined that inspection findings were generally issued within 30 days of inspection 

completion, with very few exceptions. 

During the review period, the Program granted 65 reciprocity requests for Priority 1, 2, and 3 

licensees. The review team determined that during each year of the review period, the Program 

exceeded the NRC’s criteria found in IMC 1220, “Processing of NRC Form 241 and Inspection 

of Agreement State Licensees Operating Under 10 CFR 150.20,” of inspecting 20 percent of 

candidate licensees operating under reciprocity in each of the four years covered by the review 

period. 

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. 

3.3 Technical Quality of Inspections

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

notes, and interviewed inspectors for 23 radioactive materials inspections conducted during the 

review period. The casework reviewed included inspections conducted by six current Program 

staff and one former Program staff member and covered inspections of various license types, 

including: academic broad scope, medical broad scope, research and development, high dose 

rate remote afterloader, industrial radiography, gamma knife, nuclear pharmacy, mobile nuclear 

medicine, reciprocity, and IC. Appendix C lists the inspection casework files reviewed, with 

case-specific comments, as well as the results of the inspector accompaniments. 

Based on the evaluation of casework, the review team found that most inspection reports were 

thorough, complete, and consistent, with sufficient documentation to ensure that a licensee’s 

performance with respect to health and safety was acceptable. The documentation supported 

violations, recommendations made to licensees, the effectiveness of licensee corrective actions 

taken to resolve previous violations, and discussions held with licensees during exit interviews. 

The review team noted that a few inspection reports were missing items such as a description of 

licensed activities. Additionally, of the casework files reviewed, five inspection reports from four 

different inspectors had sections that were left blank and did not provide a written description of 

some functional or program areas reviewed or otherwise indicate that these areas were not 

inspected. The Program’s Inspection Procedures describe in the section “Instructions for 

Inspection Reports,” that the inspection report should at least include, but is not limited to, a 

description of licensed activities, scope of the inspection, and the functional or program areas 

inspected. For the casework files reviewed, it appeared that the Program was not consistently 

implementing its procedures for documenting inspection reports. The review team considered 

making a specific recommendation in this area but did not propose one because the Program 
Massachusetts Final IMPEP Report Page 7 

already has procedures in place for both the content and completion of inspection reports and 

for supervisory review of inspection reports. This was discussed with Program management 

who acknowledged that steps would be taken to consistently implement the current inspection 

report documentation procedures. 

The inspection procedures utilized by the Program are consistent with the inspection guidance 

outlined in IMC 2800. Following each inspection, the inspector briefs a supervisor regarding the 

inspection. An inspection report is then completed by the inspector and reviewed and signed by 

a supervisor. The Program issues to the licensee, either a letter indicating a clear inspection or 

a Notice of Violation (NOV), in letter format, which details the results of the inspection. When 

the Program issues a NOV, the licensee is required to provide a written corrective action plan, 

based on the violations cited, within 10 days. The review team determined that the inspection 

findings were appropriate and prompt regulatory actions were taken, as necessary. Inspection 

findings were clearly stated and documented in the reports and sent to the licensees with the 

appropriate letter detailing the results of the inspection. 

The Program has a policy for supervisors to accompany all staff performing radioactive 

materials inspections on an annual basis. All supervisory accompaniments of inspectors were 

performed annually during the review period with the exception of one missed inspector 

accompaniment in 2011. The supervisors performing accompaniments prepare reports that 

document the areas covered during the accompaniments as well as the supervisor’s review of 

the resulting inspection report. 

The review team noted that the Program has an adequate supply of survey instruments to 

support its inspection program, as well as responding to incidents. Appropriate, calibrated 

survey instrumentation, such as Geiger-Mueller (GM) meters, scintillation detectors, ion 

chambers and micro-R meters, was observed to be available. The Program also has neutron 

detectors and other survey and analysis equipment to support the inspection program at the 

State Laboratory. Instruments are calibrated annually by an approved vendor. 

The review team accompanied four Program inspectors during four inspections the week of 

May 12-16, 2014. The Program inspectors were accompanied during inspections of the 

following types of licensees: industrial radiography, production facility (cyclotron), medical 

use with written directives required, self-shielded irradiator, and research and development. 

The inspector accompaniments, with specific comments, are identified in Appendix C. 

Inspectors were found to be well prepared for the inspections. During each of the 

accompaniments, the inspectors utilized appropriate and calibrated radiation survey 

instrumentation. Where appropriate, the inspectors verified the licensee’s inventory with the 

data maintained in the National Source Tracking System (NSTS). However, as noted below, 

the team found that three inspectors did not identify some items important to health and 

safety or security with respect to completeness and thoroughness of the inspection, and 

technical quality. The three inspectors lacked familiarity with or misunderstood some 

requirements related to the health and safety or security of the materials being inspected. 

As an example, an inspector reviewing records related to patient release criteria was not 

familiar with the related regulations or guidance for these activities. During three of the 

inspections, inspectors were noted to have a strong reliance on the previous inspection 

record, and tended to ask leading questions, rather than independently verifying licensee 
Massachusetts Final IMPEP Report Page 8 

compliance with requirements. Inspectors tended to “trust” licensee performance rather 

than interview personnel, ask for demonstrations, or verify information. During one 

inspection of security-related items, the inspector asked a licensee employee if anything had 

changed since the last inspection, and when the licensee noted that it had not, that portion 

of the inspection was concluded without any verification of compliance or interviews with 

other appropriate licensee personnel. When the review team member asked the inspector 

why the items were not verified, the inspector explained that if the items were inspected 

during a previous inspection and found to be in compliance that they did not need to be 

reviewed again during subsequent inspections. 

At the conclusion of each accompaniment, the review team member provided specific 

performance observations to each inspector. Additionally, the review team member briefed 

Program management regarding the specific concerns identified. The review team member 

noted specific concerns related to one inspection that was not adequate to assess the 

security of licensed materials. The review team member discussed the specific areas in 

which potentially important security concerns were not inspected, including potential 

vulnerabilities in the physical security of licensed material as well as access control 

deficiencies. In response, Program management developed a corrective action plan which 

included providing additional guidance to the inspection staff and performing a re-inspection 

of the subject licensee. The additional guidance to the inspection staff outlined Program 

management expectations for certain security-related inspections. All inspectors were also 

reminded by Program management of its inspection guidance to use a performance-based 

approach and to directly observe work activities, conduct interviews with licensee personnel, 

ask for demonstrations, and review selected records. The re-inspection of the subject 

licensee was conducted the next business day and was performed by the inspector, the Unit 

Supervisor, and the Program Director. The inspection identified serious deficiencies in the 

licensee’s security program and resulted in the Program issuing a Confirmatory Action Letter 

to the licensee to correct the identified deficiencies. 

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, but needs improvement. 

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license reviewers for 

29 specific licensing actions. 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, operating and 

emergency procedures, appropriateness of license conditions, and overall technical quality. 

The casework was also reviewed for use of appropriate deficiency letters and cover letters, 

reference to appropriate regulations, supporting documentation, consideration of inspection and 

enforcement history, use of pre-licensing guidance and conduct of pre-licensing visits, and 

peer/supervisory review. 

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

completed during the review period. Licensing actions selected for evaluation included: 6 new 

licenses, 8 renewals, 3 decommissioning or termination actions, and 12 amendments. Files 
Massachusetts Final IMPEP Report Page 9 

reviewed included a cross-section of license types, including: broad scope, medical diagnostic 

and therapy including high dose rate remote afterloader, temporary/permanent implant 

brachytherapy, etc., industrial radiography, research and development, nuclear pharmacy, 

portable gauges, manufacturers and distributors, and self-shielded irradiators. The casework 

sample represented technical reviews performed by nine current and one former Program staff 

member. A list of the licensing casework evaluated, with case-specific comments, is provided in 

Appendix D. 

Overall, the review team found that most licensing actions were thorough, complete, consistent, 

and of high quality with health, safety, and security issues properly addressed. Deficiency 

letters clearly stated regulatory positions, were used properly, and identified substantive 

deficiencies in the licensees’ and applicants’ submittals. With a few exceptions noted below and 

in Appendix D, license reviewers used the Program’s licensing guides and/or NRC 

NUREG-1556 series licensing guidance documents, policies, checklists, and standard license 

conditions specific to the type of licensing actions to ensure consistency in licenses. 

Terminated licensing actions were well documented, showing appropriate transfer and survey 

records. For medical licenses, the Program’s review of preceptor attestations was found to be 

thorough. 

Each licensing action is assigned a primary and secondary reviewer and completed licenses are 

signed by the Program Director. New licensing requests are also reviewed by the Unit 

Supervisor following the primary and secondary review. Licenses are issued for a five-year 

period under a timely renewal system. 

The team noted consistent use of the security and risk significant material check lists 

(pre-licensing guidance) for every licensing action. The Program performs pre-licensing checks 

of all licensing actions, including new applications, amendments, and transfers of control. The 

Program’s pre-licensing review methods incorporate the essential elements of NRC’s revised 

pre-licensing guidance to provide a basis of confidence that the applicant will use requested 

radioactive materials as intended. All new license applicants receive a pre-licensing site visit 

which includes an evaluation of the applicant’s radiation safety and security programs prior to 

license issuance. 

The review team found that some licensing casework reviewed was inconsistent in risk 

significant areas with respect to safety and security of radioactive material. The specific areas 

involved include: maximum possession limits, use of license conditions for certain devices, 

review of enforcement and inspection history during renewals, use of superseded licensing 

guidance, and use of a non-NRC approved legally binding requirement. Specifically, three of 

the casework files reviewed did not specify maximum possession limits for radioactive materials 

as requested by Office of Nuclear Material Safety and Safeguards (NMSS) letter RCPD-10-007, 

“Requesting Implementation of a Policy on Maximum Possession Limits for Radioactive Material 

Licenses,” dated June 21, 2010. During the casework file review, the review team identified that 

two of the Program’s radiography licenses did not specify maximum possession limits for 

radiographic sources and also identified one broad scope license that did not specify a 

maximum possession limit for a sealed source. This was discussed with the Program, and in 

response, the Program reviewed the licenses for its other two industrial radiography licenses 

and determined that these licenses also did not have maximum possession limits. For 

radiography licenses, the Program had been following an older licensing template that had not 
Massachusetts Final IMPEP Report Page 10 

been revised to address maximum possession limits. For the broad scope license, the lack of a 

possession limit for a sealed source appeared to be isolated. The Program informed the review 

team that they would contact the identified licensees to obtain the necessary information 

regarding amounts of radioactive material possessed, and issue corrected copies of the 

licenses with maximum possession limits specified. The Program, during the MRB meeting, 

indicated that it added the possession limits and issued corrected copies to the identified 

licenses. 

The team also noted that a license authorizing possession and use of a certain model of 

irradiator did not contain the license condition addressing safe use of the irradiator. The 

additional safety considerations for the specific model of irradiator are found in Standard 

License Condition 75, from NUREG-1556, Volume 20, “Consolidated Guidance About Materials 

Licenses: Guidance About Administrative Licensing Procedures,” and were developed in 

accordance with the Order issued by NRC on July 3, 1984. This was discussed with the 

Program, who was able to show the review team that the license conditions were alternately 

described in an earlier tie-down condition to the license. In an effort to determine whether this 

was an isolated occurrence, the team identified that the Program had nine licensees that 

authorized possession and use of the certain model of irradiator. The team reviewed the other 

eight licenses for the specific license condition. Although the other eight licenses are not 

addressed in the casework in Appendix D, the review team identified that two of the eight 

licenses did not contain the license condition or alternately did not clearly describe the safety 

considerations in tie-down conditions to the license. The Unit Supervisor stated that the 

identified licensees had the additional safety considerations in place for the irradiator. It 

appeared to be an oversight that the license conditions were not listed on the licenses or 

otherwise clearly specified in the tie-downs to the licenses. The Program stated that they would 

add the standard license condition to all three of the identified licenses that did not contain the 

condition and issue corrected copies of the licenses. The Program, in its response to the draft 

report, indicated that it added the standard license condition and issued corrected copies to all 

three of the identified licenses. 

Additionally, the Program was inconsistently reviewing inspection and enforcement history 

during the license renewal process. Some license reviewers indicated that they reviewed the 

inspection and enforcement history during license renewals but do not maintain the 

documentation of the review. Other license reviewers indicated that they do not review the 

inspection and enforcement history during license renewals. The Program’s licensing 

procedures do not describe the need to perform a review of the inspection and enforcement 

history during license renewals. The Program agreed to review its current licensing procedures 

and develop and implement a plan to ensure that license reviewers are reviewing inspection 

and enforcement history during license renewals. 

The Program encouraged licensees and applicants to utilize the licensing guidance in the NRC 

NUREG-1556 series, “Consolidated Guidance about Materials Licenses,” for their submittals. 

For almost all types of licensing actions reviewed, the NUREG-1556 series was being utilized. 

However, the review team found that for medical licensees, there were some cases where 

licensees were still submitting licensing information to the Program utilizing the guidance in 

NRC Regulatory Guide 10.8, “Guide for the Preparation of Applications for Medical Use 

Programs.” The licensing guidance in NRC Regulatory Guide 10.8 is outdated and was 

superseded with the publication of NUREG-1556, Volume 9, “Consolidated Guidance about 
Massachusetts Final IMPEP Report Page 11 

Materials Licenses: Program-Specific Guidance about Medical Use Licenses,” dated January 

2003. The Program’s licensing procedures allow license reviewers to review and accept 

licensing actions using the guidance in NRC Regulatory Guide 10.8 although it does not contain 

current regulatory references or updated risk-informed licensing approaches. The Program 

agreed to review its licensing procedures and revisit its practice of accepting medical licensing 

actions based on superseded licensing guidance. 

The review team examined the Program’s licensing practices regarding the IC and 

Fingerprinting Orders. The Program had previously submitted to the NRC for review and 

compatibility determination, two legally binding requirements (license conditions) for 

implementing: (1) the IC, and (2) Fingerprinting requirements. The review team noted that 

some of the subject licenses contained the two NRC reviewed and approved license conditions. 

However, three licenses contained a different, single license condition that had not been 

submitted to the NRC for compatibility review and approval. The Program had developed this 

single license condition in an effort to consolidate the two previously used and approved license 

conditions. This consolidated license condition had not been submitted to NRC for review. 

Review of this license condition (legally binding requirement) for compatibility to NRC 

regulations was outside the scope of the team’s review. The review team identified three 

licenses that contained the unapproved license condition but did not review all 42 of the 

Program’s IC licenses. The Program committed to review all 42 IC licenses, identify the 

licenses that contain the license condition that had not been submitted to NRC for review and 

compatibility determination, replace it with the license conditions that have been approved by 

the NRC, and issue corrected copies of the licenses. 

The review team strongly considered making specific performance recommendations regarding 

the areas of maximum possession limits, use of license conditions for certain devices, review of 

enforcement and inspection history during renewals, use of superseded licensing guidance, and 

use of a non-NRC approved legally binding requirement. However, because of the strong 

Program management commitments made during the review, and actions taken to begin to 

address these identified performance concerns, the review team determined that specific 

performance recommendations were not necessary. 

The review team examined the Program’s implementation of its procedure for the control of 

security-related sensitive information. Prior to July 25, 2014, the Program did not have a written 

procedure in place for handling security-related documents; however, certain security-related 

files were being maintained in locked file cabinets. Prior to the review, the Program identified 

that they did not have a written policy for the control of sensitive information and on July 25, 

2014, issued a written policy. This policy addresses a more comprehensive approach to the 

identification, marking, transmission, control, and handling of documents that contain sensitive 

information related to licensees subject to the IC. 

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, but needs improvement. 
Massachusetts Final IMPEP Report Page 12 

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 Program’s response to the questionnaire relative to 

this indicator, evaluated selected incidents reported for Massachusetts in NMED against those 

contained in the Program’s files, and evaluated the casework for nine radioactive materials 

incidents. A listing of the casework examined, with case-specific comments, can be found in 

Appendix E. The review team also evaluated the Program’s response to six allegations 

involving radioactive materials, including two that the NRC referred to the Commonwealth 

during the review period. Note that this section addresses the Program’s response to routine 

materials incidents and allegations; the Program’s response to incidents and allegations related 

to the Sealed Source & Device (SS&D) evaluation program are discussed in Section 4.2.3. 

The incidents/events selected for review included the following categories: medical event, lost 

radioactive material, contamination, dose to embryo/fetus, and exceeded effluent constraint. 

The review team compared the Program’s reporting of events to the NRC with those established 

in the NMSS Procedure SA-300 “Reporting Material Events.” The program has procedures in 

place for reporting events to the NRC and for entering events into NMED. The review team 

examined the Program’s procedures for tracking events and found that the procedure stresses 

the importance of determining whether an event is reportable and, if so, to make the required 

notification to the NRC in accordance with the timeframe specified in NMSS Procedure SA-300. 

The Program’s procedure also establishes that reportable events are to be entered, updated, 

and closed in NMED in a timely manner. The review team examined over 50 events that the 

Program had reported to the NRC during the review period and were in NMED, and found that 

reportable events were being reported to the NRC in accordance with the timeframes noted in 

NMSS Procedure SA-300. Where appropriate, updates were made by the Program and events 

were closed in NMED in a timely manner. The review team also reviewed a sample of events 

that the Program had identified as not reportable to the NRC. With one potential exception 

described below, the other non-reported events reviewed were found to be classified correctly 

and did not meet the reportability thresholds. 

The review team’s evaluation of selected incident case files found that the Program’s responses 

to reported incidents were not well coordinated, not consistent, and in some cases, not 

thorough. When the Program was notified of an event, there was a prompt response to 

determine whether the event is reportable, and if so, to make the report to the NRC in a timely 

manner. The event was then assigned to a reviewer; however, there was no systematic 

approach to determine the scope and level of effort of the Program’s response. There was no 

process to systematically evaluate reported events and make a determination as to whether an 

onsite response was warranted regarding the safety or security significance of an event, and if 

so, the time frame and scope of the response. As a result, the Program’s response to events 

was often not commensurate with the potential health and safety significance of the event. As 

an example, the Program performed an onsite inspection for a low health and safety 

significance issue related to a lost generally licensed static eliminator that contained radioactive 

material below the reporting thresholds. On the other hand, for a medical event that resulted in 

an Abnormal Occurrence, a potentially high health and safety significant event, an onsite 

inspection was not performed until almost a month after the event. The Program’s lack of a 

systematic approach to determine what type of response was warranted for reported events 

was discussed with Program management. To address the review team’s observation, an event 
Massachusetts Final IMPEP Report Page 13 

report evaluation policy was drafted by the Program. The draft policy is intended to provide 

guidance to the Program in providing a timely evaluation of reported events to help determine 

the appropriate scope and time frame of the Program’s response. The Program Director 

planned to obtain additional feedback from the Program staff prior to finalizing and implementing 

the policy. 

The Program’s inspection procedure describes that special inspections involving medical events 

will be performed using the guidance in NRC Management Directive 8.10, “NRC Medical Event 

Assessment Program,” (now titled “NRC Assessment Program for a Medical Event or an 

Incident Occurring at a Medical Facility”) and that other special inspections will be performed 

using the guidance in NRC Inspection Procedure 87103, “Inspection of Material Licensees 

Involved in an Incident or Bankruptcy Filing.” Both of these documents provide procedures and 

guidance for responding to and documenting events involving materials licensees. The review 

team found that the Program staff did not routinely refer to either of these documents for 

guidance regarding the conduct of event response activities. These guidelines do not require 

that onsite inspections be performed for events but rather provide guidance to be used in 

determining whether an onsite inspection is warranted or whether the event can be followed up 

during the next routine inspection, by a review of a licensee event report, or other appropriate 

actions. For the events reported to the Program that were reviewed by the team, these 

guidelines were not reviewed by the Program. As a result, the Program did not follow the 

inspection activation guidelines or otherwise document a rationale for its event response 

decisions, whether that be to conduct an onsite inspection or to review a licensee report. 

For those events where the Program did not perform an onsite response, the Program 

responded to events by reviewing licensee written reports which are required by regulation to be 

submitted to the Program. For two of the events reviewed, the Program did not identify that the 

licensee written reports did not contain all of the information required by regulation. If the 

information required to be provided in licensee written reports is not contained in the reports, the 

Program’s evaluation of the event may be based on incomplete or inadequate information. This 

was discussed with Program management, and in response, a policy was developed and issued 

regarding event report closeout expectations. The policy describes the Program Director’s 

expectations that Program staff should review licensee written event reports against the 

associated regulatory reporting requirements. In addition, the Program was preparing an 

Information Notice to be sent to all medical licensees reminding them of the need to include all 

necessary and required information when submitting written reports related to medical events. 

A review of the selected incident files indicated that, especially concerning medical events, the 

Program’s review and analysis of the event was not thorough and relied on the licensee’s 

conclusions rather than performing an independent evaluation of the event that included a 

determination of the contributing factors and root causes. Medical event files did not 

consistently contain adequate information needed for the Program to evaluate the effectiveness 

of the licensee’s corrective actions to prevent recurrence, identify any generic issues, or 

determine whether events were isolated or programmatic. Completed and closed event files 

were reviewed by the Program’s event coordinator but did not routinely undergo Program 

management review. The review team found that event files often contained the initial event 

information and email correspondence between the Program and the licensee regarding the 

event, but did not often contain the Program’s documented analysis or evaluation of the event. 

For potential or actual medical events, the circumstances of such events are often sufficiently 
Massachusetts Final IMPEP Report Page 14 

complex to render email communication regarding technical questions and details of the event 

to be ineffective. As noted earlier, one of the non-reported events reviewed involved a high 

dose remote afterloader brachytherapy procedure where the applicator was not fully inserted for 

the first two fractions. Based on the written information provided by the licensee, the Program 

concluded that the event was not a reportable medical event. However, the information 

provided by the licensee in the event file did not contain complete information regarding the 

procedure and the final treatment record that would have been necessary to make a 

determination as to whether or not a medical event occurred. It is unclear from the specific 

incident file whether the individual received the prescribed dose to the intended treatment site 

and/or whether there was dose to unintended tissue. The lack of information in the particular 

case file was discussed with Program management, who indicated that a plan would be 

developed to obtain additional information regarding the case, and a report would be made to 

the NRC if it was determined to be a medical event. During the MRB meeting, the Program 

reported that it had completed its review of the case and determined that it was not a medical 

event. 

As noted, Program management was responsive in commencing efforts to address issues 

related to event response coordination and licensee written report review. The review team 

believes that these efforts will enhance the Program’s event response but determined that 

additional efforts are necessary to strengthen and enhance the quality of event response. The 

review team recommends that the Commonwealth strengthen its incident response program 

and take measures to ensure that the Program’s evaluation of events is thorough, complete, 

properly documented to facilitate future follow-up, and undergoes appropriate management 

review prior to closeout. 

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

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

Commonwealth during the review period. The Program responds to allegations in accordance 

with its procedure for the management of allegations. The procedures describe the receipt, 

processing, and completion of reviews of allegations. The review team concluded that the 

Program consistently took prompt and appropriate action in response to the 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 

concerned individuals of the conclusion of its investigation. The review team determined that 

the Program adequately protected the identity of the concerned individuals. 

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, but needs improvement. 

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) Low-level Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. All 

four non-common performance indicators applied to this review. 
Massachusetts Final IMPEP Report Page 15 

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 NMSS, and 

conducted interviews with managers 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 located 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 was passed during the review period 

which would affect the Agreement State program or its authority. Massachusetts regulations 

are not subject to sunset review. 

4.1.2 Program Elements Required for Compatibility

The Commonwealth’s 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 material. 

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

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

review. After addressing any compatibility comments, 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 regulations 

are then presented to the Commonwealth’s Public Health Council (PHC), which meets monthly 

and approves the proposed regulations for public comment. Once comments are addressed, 

the revised regulations are submitted to the PHC for promulgation. After PHC approval, the 

final regulations are submitted 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 the 

NRC for a compatibility review as final regulations. The rulemaking process takes 

approximately nine months to complete. The Program Director noted that additional support for 

rulemaking activities has been identified for future regulation development. 

During the review period, the Program submitted 12 final regulation amendments to the NRC for 

review: 1 final regulation amendment to replace a previously approved license condition; 1 final 

regulation amendment which is due in 2015; and 10 final amendments that were overdue for 

State adoption at the time of submission. Current NRC policy requires that Agreement States 

adopt certain equivalent regulations or legally-binding requirements no later than three years 

after they become effective. The NRC’s compatibility review resulted in three comments, which 

will need to be addressed by the State in upcoming rulemaking activities. The following 10 

amendments were overdue when submitted to the NRC: 
Massachusetts Final IMPEP Report Page 16 

• “Financial Assurance for Materials Licensees,” 10 CFR Parts 30, 40 and 70 amendment 

(68 FR 57327), that was due for Agreement State adoption on December 3, 2006. 

(RATS ID 2003-1) 

• “Compatibility with IAEA Transportation Safety Standards and Other Transportation 

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

Agreement State adoption on October 1, 2007. (RATS ID 2004-1) 

• “Security Requirements for Portable Gauges Containing Byproduct Material,” 10 CFR 

Part 30 amendment (70 FR 2001), that was due for Agreement State adoption on July 

11, 2008. (RATS ID 2005-1) 

• “Medical Use of Byproduct Material – Recognition of Specialty Boards,” 10 CFR Part 35 

amendment (70 FR 16336; 71 FR 1926), that was due for Agreement State adoption on 

April 29, 2008. (RATS ID 2005-2) 

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

15005), that was due for Agreement State adoption on March 27, 2009. 

(RATS ID 2006-1) 

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

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

adoption on October 29, 2010. (RATS ID 2007-1) 

• “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 was due for Agreement State adoption on December 17, 2010. 

(RATS ID 2007-2) 

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

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

adoption on November 30, 2010. (RATS ID 2007-3) 

• “Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent,” 

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

adoption on February 15, 2011. (RATS ID 2008-1) 

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

amendment (74 FR 33901), that was due for Agreement State adoption on September 

28, 2012. (RATS ID 2009-1) 

The review team noted that the Commonwealth had made significant process in the 

promulgation of regulations since the last IMPEP review and currently has no overdue 

regulation amendments. A complete list of regulation amendments can be found on the NRC 

website at the following address: http://nrc-stp.ornl.gov/rss_regamendents.html. 
Massachusetts Final IMPEP Report Page 17 

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. 

4.2 Sealed Source and Device Evaluation Program

In reviewing this indicator, the review team used three sub-elements to evaluate the Program’s 

performance regarding the SS&D evaluation program. These sub-elements 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 reviewed 

certain reported incidents involving products authorized in Massachusetts SS&D sheets, the use 

of guidance and procedures, and interviewed the staff currently conducting SS&D evaluations. 

4.2.1. Technical Staffing and Training

At the time of the review, the Program had four reviewers who were qualified to perform safety 

evaluations of SS&D applications. However, the Program’s SS&D evaluation responsibilities 

were distributed between three active reviewers with the fourth individual not currently involved 

in SS&D reviews. All have science degrees and have attended the 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 Program sent one individual to the NRC SS&D Workshop 

held in 2014. The Program plans to fill an open staff vacancy in the near future and indicated 

that this individual may be trained to perform SS&D safety evaluations. The review team 

determined that the Program’s staffing and training with respect to SS&D evaluations is 

adequate, based on the Program’s current SS&D workload. 

4.2.2 Technical Quality of the Product Evaluation Program

The Program completed 61 SS&D evaluation actions during the review period, including 

amendments, inactivations, new registrations, and corrections. The review team evaluated 17 

of the 61 SS&D evaluation actions. 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 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 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 

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

and were used appropriately in performing SS&D reviews. 
Massachusetts Final IMPEP Report Page 18 

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

conservative assumptions to ensure that 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

During the review period, there were six reported incidents related to SS&D defects involving 

sources or devices registered by the Commonwealth of Massachusetts. All six reported 

incidents were reviewed by the review team. The review team found that the Program’s 

response to the reported incidents was prompt, taking into consideration the health and safety 

or security significance of the incident. Program staff was aware of the need to evaluate such 

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

The Program received one allegation during the review period related to an unregistered 

sealed source in use in Massachusetts. The allegation was provided to the Program by 

another Agreement State. The review team determined that the response by the Program 

to the allegation was prompt and that the Program took appropriate action in response to 

the concerns raised. The review team noted that the Program thoroughly documented the 

investigation and retained all necessary documentation to close the allegation. 

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. 

4.3 Low-level Radioactive Waste Disposal Program

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

Discontinuance of NRC Authority and Assumption Thereof by states Through Agreement,” 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, the 

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. 

The Program’s questionnaire response indicated that a Program Coordinator performs low-level 

radioactive waste fee and survey collection activities. The review team discussed the 

referenced fees and activities with the Program. The Program collects fees from the 

Commonwealth’s Class A low-level waste generators, and these fees are deposited into a 

Massachusetts low-level waste fund. This money is used by the Commonwealth to monitor the 

low-level waste activities of the generators licensed by the Program. The generators work with 
Massachusetts Final IMPEP Report Page 19 

a low-level waste processor to dispose of their material. Although the review team followed up 

on the information provided in the questionnaire, a review of this indicator was not performed. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, the review team recommended, and the MRB agreed, 

that Massachusetts’ performance be found satisfactory, but needs improvement, for the 

indicators Technical Quality of Inspection Activities, Technical Quality of Licensing Actions, and 

Technical Quality of Incident and Allegation Activities. The review team found Massachusetts’ 

performance to be satisfactory for the other indicators reviewed. The review team made one 

recommendation regarding the performance of the Commonwealth. As noted in Section 2.0, 

the review team determined that the eight recommendations from previous IMPEP reports were 

addressed by the Program and should be closed. 

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 the NRC's program. Based on the results of the current 

IMPEP review, and in accordance with the criteria in NRC Management Directive 5.6, the 

review team recommended, and the MRB agreed, that a period of Monitoring be initiated for 

Massachusetts. Monitoring may be used in cases where one or more performance indicators 

are less than fully satisfactory. Monitoring is an informal process that allows the NRC to 

maintain an increased level of communication with an Agreement State program. 

The review team further recommended, and the MRB agreed, that a Periodic Meeting be 

conducted in 1 year from this review to assess the Commonwealth’s progress and efforts taken 

to address the identified performance issues, and that the next IMPEP review take place in 

approximately 4 years. 

Below is the review team’s recommendation, as mentioned in the report, for evaluation and 

implementation by the Commonwealth: 

The review team recommends that the Commonwealth strengthen its incident response 

program and take measures to ensure that the Program’s evaluation of events is 

thorough, complete, properly documented to facilitate future follow-up, and undergoes 

appropriate management review prior to closeout. (Section 3.5) 
LIST OF APPENDICES 

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

Janine F. Katanic, NMSS Team Leader 

 Technical Quality of Incident and Allegation 

 Activities 

 Inspector Accompaniments 

Stephen Poy, NMSS Sealed Source and Device Evaluation Program 

 Technical Quality of Incident and Allegation 

 Activities 

Donna Janda, Region I Technical Staffing and Training 

Compatibility Requirements 

Technical Quality of Inspections 

Farrah Gaskins, Region I Technical Quality of Licensing Actions 

Michelle Simmons, Region IV Technical Quality of Licensing Actions 

Vanessa Danese, Texas Technical Quality of Inspections 

Status of Materials Inspection Program 
APPENDIX B 

MASSACHUSETTS ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML14183B586 
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/17/11 and 5/19/11 Inspector: AC 

File No.: 2 

Licensee: Applus RTD USA, Inc. License No.: 48-0426 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 1/29/14 and 2/20/14 Inspector: BP 

File No.: 3 

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

Inspection Type: Special, Unannounced Priority: 2 

Inspection Date: 9/19/12 Inspector: JS 

Comment: The inspection report did not address certain functional or program areas or 

otherwise identify them as “not inspected.” 

File No.: 4 

Licensee: PETNET Solutions, Inc. License No.: 42-0650 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/2/13 Inspector: AC 

File No.: 5 

Licensee: Steward Saint Anne’s Hospital Corp. License No.: 44-0009 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/10/12 Inspector: JS 

File No.: 6 

Licensee: Medi-Physics, Inc. dba GE Healthcare License No.: 58-0001 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/14/12 Inspectors: MI 

Comment: Inspector’s observations of licensee activities were not described in the inspection 

report. 

 
Massachusetts Final IMPEP Report Page C. 2 

Inspection Casework Reviews 

File No.: 7 

Licensee: Lahey Clinic Foundation License No.: 44-0015 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/6/12 Inspectors: MI, MR 

File No.: 8 

Licensee: Woods Hole Oceanographic Institution License No.: 00-0643 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 11/1/13 Inspector: BP 

Comment: The inspection report did not include a description of licensed activities and did not 

address certain functional or program areas or otherwise identify them as “not 

inspected.” Inspector’s observations of licensee activities were not described in the 

inspection report. 

File No.: 9 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/19/11 and 7/21/11 Inspector: JD 

File No.: 10 

Licensee: Acuren Inspection License No.: 66-0128 

Inspection Type: Reciprocity, Unannounced Priority: 1 

Inspection Date: 5/7/13 Inspector: AC 

Comment: Inspector’s observations of licensee activities were not described in the inspection 

report. 

File No.: 11 

Licensee: North Shore Medical Center License No.: 44-0161 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/14/14 Inspector: MI 

File No.: 12 

Licensee: UMass Memorial Health Care License No.: 60-0096 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/8-11/11 Inspector: MW 

File No.: 13 

Licensee: Hallmark Health System, Inc. License No.: 44-0035 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/18/11 and 2/22/11 Inspector: MI 

File No.: 14 

Licensee: Hallmark Health System, Inc. License No.: 44-0035 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/2-3/14 Inspector: AC 
Massachusetts Final IMPEP Report Page C. 3 

Inspection Casework Reviews 

File No.: 15 

Licensee: Eastern Massachusetts Surgery Center License No.: 70-0594 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/23/12 Inspector: AC 

File No.: 16 

Licensee: Sturdy Memorial Hospital License No.: 44-0043 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/20/12 Inspector: AC 

File No.: 17 

Licensee: Brandeis University License No.: 60-0110 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 11/30/12 Inspector: MW 

File No.: 18 

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

 Environmental Services, LLC 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 1/18/13 Inspector: JS 

File No.: 19 

Licensee: Mistras Group, Inc. License No.: 16-5591 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 10/22/13 Inspector: MI 

Comment: The inspection report did not contain information on licensee’s scope of work and 

did not address certain functional or program areas or otherwise identify them as 

“not inspected.” Inspector’s observations of licensee activities were not described in 

the inspection report. 

File No.: 20 

Licensee: Mistras Group, Inc. License No.: 16-5591 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 10/22/13 Inspector: MI 

File No.: 21 

Licensee: Massachusetts Moblie PET, P.C. License No.: 44-0373 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/07/14 Inspector: MI 

File No.: 22 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/19/12 Inspector: JS 

 
Massachusetts Final IMPEP Report Page C. 4 

Inspection Casework Reviews 

File No.: 23 

Licensee: North Shore Medical Center License No.: 44-0161 

Inspection Type: Special, Unannounced Priority: 3 

Inspection Date: 5/14/14 and 5/19/14 Inspector: MI 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Mistras Group, Inc. License No.: 16-5591 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 5/12/14 Inspectors: AC 

Comments: 

1) The inspector misunderstood some requirements related to health and safety and 

security of the licensed activities being inspected. 

2) The inspector did not clearly state regulatory requirements to the licensee regarding 

non-compliances. 

Accompaniment No.: 2 

Licensee: Semprus Biosciences Corporation License No.: 55-0591 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/13/14 Inspector: DC 

Comments: 

1) The inspector lacked familiarity with some requirements related to the health and 

safety of the licensed activities being inspected. 

2) The inspector did not verify compliance or adequately inspect some programmatic 

areas related to the health and safety of the licensed activities being inspected. 

 

Accompaniment No.: 3 

Licensee: North Shore Medical Center License No.: 44-0161 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/14/14 Inspector: MI 

Comments: 

1) The inspector lacked familiarity or misunderstood some requirements related to the 

health and safety and security of the licensed activities being inspected. 

2) The inspector did not verify compliance with certain security related requirements. 

Accompaniment No.: 4 

Licensee: Massachusetts General Hospital License No.: 62-0656 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/16/14 Inspector: JS 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Massachusetts General Hospital License No.: 42-0343 

Type of Action: Termination Amendment No.: 04 

Date Issued: 10/17/12 License Reviewer: JS 

File No.: 2 

Licensee: IBA Molecular North America License No: 42-0473 

Type of Action: Amendment Amendment No.: 09 

Date Issued: 6/20/14 License Reviewer: ES 

File No.: 3 

Licensee: Boston College License No.: 00-6427 

Type of Action: Amendment Amendment No.: 15 

Date Issued: 8/27/13 License Reviewer: BP 

File No.: 4 

Licensee: Brandeis University License No.: 60-0110 

Type of Action: Renewal Amendment No.: 09 

Date Issued: 4/10/14 License Reviewer: DC 

Comments: 

1) The additional safety considerations for a specific model of irradiator (Standard 

License Condition 75, from NUREG-1556, Volume 20, “Consolidated Guidance 

About Materials Licenses: Guidance About Administrative Licensing Procedures”) 

were not included in the license conditions but were alternately addressed in a 

tie-down letter on the license. 

2) The license did not have a maximum possession limit for a sealed source listed on 

the license. 

3) Inspection and enforcement history review was not performed during the license 

renewal process. 

File No.: 5 

Licensee: PETNET Solutions License No.: 42-0650 

Type of Action: Amendment Amendment No.: 01 

Date Issued: 4/11/13 License Reviewer: MI 

 
Massachusetts Final IMPEP Report Page D. 2 

License Casework Reviews 

File No.: 6 

Licensee: Massachusetts General Hospital License No.: 62-0656 

Type of Action: New Amendment No.: 00 

Date Issued: 9/3/11 License Reviewer: JD 

Comment: The Program did not obtain financial assurance for this license although required. 

This licensee has three separate licenses with the Program and financial assurance 

has recently been submitted to the Program during the renewal of another license. 

The financial assurance documents were still under review by the Program but 

appeared to address and include the financial assurance requirements for this 

license. 

File No.: 7 

Licensee: Lantheus Medical Imaging License No.: 60-0088 

Type of Action: Amendment Amendment No.: 21 

Date Issued: 1/20/11 License Reviewer: AC 

File No.: 8 

Licensee: Boston Medical Research License No.: 13-7482 

Type of Action: Termination Amendment No.: 05 

Date Issued: 6/18/13 License Reviewer: BP 

File No.: 9 

Licensee: PETNET Solutions, Inc. License No.: 41-0296 

Type of Action: Renewal Amendment No.: 15 

Date Issued: 5/4/11 License Reviewer: AC 

File No.: 10 

Licensee: MikRon License No.: 56-0673 

Type of Action: New Amendment No.: 00 

Date Issued: 10/31/12 License Reviewer: AC 

File No.: 11 

Licensee: Si-REL, LLC License No.: 48-0668 

Type of Action: New Amendment No.: 00 

Date Issued: 5/1/2012 License Reviewer: JS 

Comment: The license utilized a legally binding requirement (license condition) that had not 

been submitted to the NRC for review and compatibility determination. 

File No.: 12 

Licensee: Si-REL, LLC License No.: 48-0668 

Type of Action: Amendment Amendment No.: 01 

Date Issued: 3/7/13 License Reviewer: JS 

Comment: 

See File No. 11
Massachusetts Final IMPEP Report Page D. 3 

License Casework Reviews 

File No.: 13 

Licensee: PerkinElmer Health Sciences License No.: 00-3200 

Type of Action: Amendment Amendment No.: 33 

Date Issued: 11/10/10 License Reviewer: JD 

File No.: 14 

Licensee: OSI Electronics License No.: 55-0663 

Type of Action: New Amendment No.: 00 

Date Issued: 2/10/12 License Reviewer: JS 

File No.: 15 

Licensee: GSR Environmental License No.: 48-0659 

Type of Action: New Amendment No.: 00 

Date Issued: 11/17/10 License Reviewer: MR 

File No.: 16 

Licensee: Tran, Vendy License No.: 49-0665 

Type of Action: New Amendment No.: 00 

Date Issued: 2/21/12 License Reviewer: BP 

File No.: 17 

Licensee: Geotechnical Consultants, Inc. License No.: 48-0334 

Type of Action: Amendment Amendment No.: 04 

Date Issued: 8/11/10 License Reviewer: MR 

File No.: 18 

Licensee: Mistras Group, Inc. License No.: 16-5591 

Type of Action: Renewal Amendment No.: 16 

Date Issued: 8/11/11 License Reviewer: MI 

Comments: 

1) The license did not have a maximum possession limit for sealed sources listed on 

the license. 

2) Inspection and enforcement history review was not documented during the license 

renewal process. 

File No.: 19 

Licensee: Prima Care, P.C. License No.: 67-0452 

Type of Action: Amendment Amendment No.: 06 

Date Issued: 9/14/11 License Reviewer: MI 

 
Massachusetts Final IMPEP Report Page D. 4 

License Casework Reviews 

File No.: 20 

Licensee: Prima Care, P.C. License No.: 67-0452 

Type of Action: Renewal Amendment No.: 08 

Date Issued: 12/11/13 License Reviewer: MI 

Comments: 

1) The licensee committed to follow medical licensing guidance that has been 

superseded. 

2) Inspection and enforcement history review was not documented during the license 

renewal process. 

File No.: 21 

Licensee: Anderson, Craig License No.: 49-0577 

Type of Action: Amendment Amendment No.: 02 

Date Issued: 12/20/13 License Reviewer: MW 

File No.: 22 

Licensee: Steward Holy Family Hospital, Inc. dba Holy Family License No.: 44-0032 

Type of Action: Amendment Amendment No.: 23 

Date Issued: 2/19/14 License Reviewer: ES 

File No.: 23 

Licensee: UMass/Memorial Health Care License No.: 60-0096 

Type of Action: Renewal Amendment No.: 29 

Date Issued: 12/6/12 License Reviewer: AC 

Comment: Inspection and enforcement history review was not documented during the license 

renewal process. 

File No.: 24 

Licensee: Geleota Associates, Inc. License No.: 49-0084 

Type of Action: Termination Amendment No.: 05 

Date Issued: 8/1/13 License Reviewer: AC 

File No.: 25 

Licensee: Milford Regional Medical Center License No.: 44-0009 

Type of Action: Renewal Amendment No.: 15 

Date Issued: 1/10/13 License Reviewer: AC 

Comments: 

1) The licensee committed to follow medical licensing guidance that has been 

superseded. 

2) Inspection and enforcement history review was not documented during the license 

renewal process. 

 
Massachusetts Final IMPEP Report Page D. 5 

License Casework Reviews 

File No.: 26 

Licensee: Dana-Farber Cancer Institute License No.: 60-0037 

Type of Action: Renewal Amendment No.: 16 

Date Issued: 3/4/14 License Reviewer: DC 

Comments: 

1) The licensee committed to follow medical licensing guidance that has been 

superseded. 

2) Inspection and enforcement history was not performed review during the license 

renewal process. 

File No.: 27 

Licensee: Microsemi Corporation License No.: 48-0574 

Type of Action: Renewal Amendment No.: 03 

Date Issued: 8/13/13 License Reviewer: AC 

Comment: The license utilized a legally binding requirement (license condition) that had not 

been submitted to the NRC for review and compatibility determination. 

File No.: 28 

Licensee: Boston University Medical Center License No.: 44-0062 

Type of Action: Amendment Amendment No.: 24 

Date Issued: 2/24/14 License Reviewer: KT 

Comment: The license utilized a legally binding requirement (license condition) that had not 

been submitted to the NRC for review and compatibility determination. 

File No.: 29 

Licensee: Applus RTD dba Quality Assurance Laboratory License No.: 48-0426 

Type of Action: Amendment Amendment No.: 07 

Date Issued: 1/24/14 License Reviewer: DC 

Comment: The license did not have a maximum possession limit for sealed sources listed on 

the license. 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: UMass Memorial Health Care License No.: 60-0096 

Date of Incident: 3/5/14 NMED No.: 140127 

Investigation Date: 3/17/14 Type of Incident: Medical Event 

 Type of Investigation: Review licensee report 

Comments: 

1) The Program did not follow its inspection activation guidelines or otherwise 

document a rationale for not conducting an onsite inspection. 

2) The inspector did not identify that the license’s 15-day written report did not contain 

all of the information required by regulation. 

3) The inspector did not identify incorrect information in the licensee’s report regarding 

the amount of yttrium-90 drawn up into the system. 

4) The Program’s investigation was not sufficient to identify if the incident was the result 

of a generic issue. 

File No.: 2 

Licensee: LTI Smart Glass License No.: G0350 

Date of Incident: unknown NMED No.: 130506 

Investigation Date: 10/15/13 Type of Incident: Lost RAM 

 Type of Investigation: Review licensee report 

Comments: 

1) The inspector did not identify that the license’s 30-day written report did not contain 

all of the information required by regulation. 

2) On 11/5/13, the Unit Supervisor requested that an on-site inspection be performed, 

but the inspection had not been performed as of the date of the review. 

File No.: 3 

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

Date of Incident: 2/1/12 NMED No.: 120136 

Investigation Date: 2/2/12 Type of Incident: Contamination 

 Type of Investigation: Review licensee report/Site 

File No.: 4 

Licensee: Metan Marine, USA License No.: G0673 

Date of Incident: unknown NMED No.: N/A 

Investigation Date: 3/19/14 Type of Incident: Lost RAM 

 Type of Investigation: Site 
Massachusetts Final IMPEP Report Page E. 2 

Incident Casework Reviews 

File No.: 5 

Licensee: PETNET Solutions, Inc. License No.: 42-0650 

Date of Incident: 4/29/13 NMED No.: 130237 

Investigation Date: 4/30/13 Type of Incident: Exceed effluent constraint 

 Type of Investigation: Review licensee report 

File No.: 6 

Licensee: St. Anne’s Hospital License No.: 44-0009 

Date of Incident: 7/28/10 NMED No.: N/A 

Investigation Date: 8/6/10 Type of Incident: Medical event 

 Type of Investigation: Review licensee report 

Comments: 

1) The Program did not follow its inspection activation guidelines or otherwise 

document a rationale for not conducting an onsite inspection. 

2) The Program concluded that the event was not a medical event; however, the 

information contained in the incident file was not sufficient to draw that conclusion, 

and was based, in part, on incomplete information regarding all of the fractional 

treatments delivered. 

3) The Program’s investigation was not sufficient to identify if the prescribed dose was 

delivered to the intended treatment site or if there was dose to unintended tissue. 

File No.: 7 

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

Date of Incident: 5/17/13 NMED No.: 140313 

Investigation Date: 6/12/13 Type of Incident: Medical Event 

 Type of Investigation: Review licensee report/Site 

Comments: 

1) The Program did not follow its inspection activation guidelines or otherwise 

document a rationale for conducting an onsite inspection 26 days after the event, 

which was an Abnormal Occurrence. 

2) The special inspection did not review licensee corrective actions to determine if they 

were effective in preventing a recurrence of the incident, and did not verify whether 

the incident was isolated or programmatic. 

 

 
Massachusetts Final IMPEP Report Page E. 3 

Incident Casework Reviews 

File No.: 8 

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

Date of Incident: 5/3/11 NMED No.: 110348 

Investigation Date: 7/22/11 Type of Incident: Medical Event 

 Type of Investigation: Review licensee report 

 

Comments: 

1) The Program did not follow its inspection activation guidelines or otherwise 

document a rationale for not conducting an onsite inspection. 

2) The Program’s investigation did not verify that only certain treatment sites were 

planned incorrectly although several other sites were treated with the same type of 

applicator. 

3) The Program’s investigation did not evaluate the licensee’s procedures for 

administrations requiring a written directive. 

File No.: 9 

Licensee: Lowell General Hospital License No.: 44-0060 

Date of Incident: 2/16/11 NMED No.: N/A 

Investigation Date: 5/26/11 Type of Incident: Dose to embryo/fetus 

 Type of Investigation: Review licensee report/Site 
APPENDIX F 

SEALED SOURCE & DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: MA-1101-D-103-B SS&D Type: (N) Ion Generators 

Applicant Name: Bruker Detection Corp. Type of Action: Amendment 

Date issued: 3/7/11 SS&D Reviewers: JS, JD 

File No.: 2 

Registry No.: MA-1059-D-334-S SS&D Type: (A) Industrial Radiography 

Applicant Name: QSA Global, Inc. Type of Action: Amendment 

Date issued: 10/5/12 SS&D Reviewers: JS, JD 

File No.: 3 

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

Applicant Name: Radiation Monitoring Device, Inc. Type of Action: Amendment 

Date issued: 6/20/14 SS&D Reviewers: JS, KT 

File No.: 4 

Registry No.: MA-1287-D-103-B SS&D Type: (E) Beta Gauges 

Applicant Name: Thermo EGS Gauging, Inc. Type of Action: Correction 

Date issued: 7/22/10 SS&D Reviewers: JS, JD 

File No.: 5 

Registry No.: MA-1229-D-101-S SS&D Type: (AF) Other Medical Uses 

Applicant Name: Sirtex Wilmington, LLC Type of Action: Correction 

Date issued: 12/10/12 SS&D Reviewers: JS, JD 

File No.: 6 

Registry No.: MA-1340-D-101-G SS&D Type: (N) Ion Generators 

Applicant Name: Charles Stark Draper Lab, Inc. Type of Action: New 

Date issued: 4/14/11 SS&D Reviewers: JS, JD 

File No.: 7 

Registry No.: MA-1059-D-377-S SS&D Type: (A) Industrial Radiography 

Applicant Name: QSA Global, Inc. Type of Action: New 

Date issued: 4/17/14 SS&D Reviewers: JS, KT 

File No.: 8 

Registry No.: MA-1287-D-802-B SS&D Type: (D) Gamma Gauges 

Applicant Name: Thermo EGS Gauging, Inc. Type of Action: Inactivation 

Date issued: 9/2/10 SS&D Reviewers: JS, JD 
Massachusetts Final IMPEP Report Page F. 2 

SS&D Casework Reviews 

File No.: 9 

Registry No.: MA-1287-D-103-B SS&D Type: (E) Beta Gauges 

Applicant Name: Thermo EGS Gauging, Inc. Type of Action: New 

Date issued: 7/22/10 SS&D Reviewers: JS, JD 

File No.: 10 

Registry No.: MA-8232-D-801-G SS&D Type: (N) Ion Generators 

Applicant Name: Sionex Corp. Type of Action: Inactivation 

Date issued: 6/20/11 SS&D Reviewers: JS, JD 

File No.: 11 

Registry No.: MA-0555-S-807-S SS&D Type: (H) General Neutron Source App 

Applicant Name: Industrial Nuclear Company, Inc. Type of Action: Inactivation 

Date issued: 4/8/11 SS&D Reviewers: JS, JD 

File No.: 12 

Registry No.: MA-1059-D-946-S SS&D Type: (H) General Neutron Source App 

Applicant Name: QSA Global, Inc. Type of Action: Inactivation 

Date issued: 9/11/12 SS&D Reviewers: JS, JD 

File No.: 13 

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

Applicant Name: Radiation Monitoring Device, Inc. Type of Action: Amendment 

Date issued: 6/20/14 SS&D Reviewers: JS, KT 

File No.: 14 

Registry No.: MA-1383-D-101-B SS&D Type: (U) X-Ray Fluorescence 

Applicant Name: Protec Instrument Corp. Type of Action: New 

Date issued: 6/23/14 SS&D Reviewers: JS, KT 

File No.: 15 

Registry No.: MA-1059-D-370-S SS&D Type: (A) Industrial Radiography 

Applicant Name: QSA Global, Inc. Type of Action: Amendment 

Date issued: 1/31/14 SS&D Reviewers: JS, KD 

File No.: 16 

Registry No.: MA-1059-D-369-S SS&D Type: (A) Industrial Radiography 

Applicant Name: QSA Global, Inc. Type of Action: Amendment 

Date issued: 12/6/13 SS&D Reviewers: JS, KT 

File No.: 17 

Registry No.: MA-1287-D-801-B SS&D Type: (E) Beta Gauges 

Applicant Name: Thermo EGS Gauging, Inc. Type of Action: New 

Date issued: 9/2/10 SS&D Reviewers: JS, JD 
ATTACHMENT 

September 29, 2014 Letter from John M. Priest, Jr. 

Massachusetts Response to the Draft Report 

ADAMS Accession No.: ML14275A005