March 2, 2004

Patricia A. Nolan, M.D.

Director

Rhode Island Department of Health

Three Capitol Hill

Cannon Building, Room 401

Providence, RI 02908

Dear Dr. Nolan:

Enclosed is the final report of the follow-up Integrated Materials Performance Evaluation

Program (IMPEP) review of the Rhode Island radiation control program. The review was

conducted by a review team consisting of technical staff members from the U. S. Nuclear

Regulatory Commission (NRC) on November 17-18, 2003. The team reviewed, in detail, the

performance indicator of concern identified during the 2002 IMPEP review, Status of Materials

Inspection Program. Ms. Patricia Larkins, NRC Office of State and Tribal Programs, was the

team leader for the follow-up review.

The team noted that significant program improvements have been implemented by Rhode

Island, which include reducing the inspection backlog and recruiting and training of two new

technical staff. The review team recommended closure of four of the five recommendations

from the 2002 IMPEP review. These actions have demonstrated a high level of management

support for the Agreement State program and a commitment to operating and maintaining a

fully satisfactory program in the future.

We appreciate receiving Ms. Marie Stoeckel’s e-mail, dated January 16, 2004, supporting the

review team’s findings and draft follow-up report.

Based on the follow-up IMPEP review, the Management Review Board (MRB) agreed that

Rhode Island’s performance with respect to the common performance indicator, Status of

Materials Inspection Program, be changed from the November 2002 IMPEP review finding of

unsatisfactory to satisfactory. The review team recommended and the MRB agreed on

discontinuance of the heightened oversight process; however, the NRC will continue to monitor

State activities through quarterly teleconferences between the Regional State Agreements

Officer and Rhode Island management. The quarterly teleconferences are designed to assess

the progress of the State to maintain program improvements, and to address areas that require

additional progress. 

Section 3.0, on page 4 of the enclosed final report, presents the one open recommendation

from the 2002 IMPEP review. We request your response to the open recommendation within

30 days from receipt of this letter.

Based on the results of the follow-up IMPEP review, the next full IMPEP review will be

scheduled approximately four years from the 2002 IMPEP review, with a periodic meeting

approximately 18 months from the date of the follow-up IMPEP review. This periodic meeting

will consider and address removing the program from monitoring if the State maintains

satisfactory performance over the 18-month period.
Patricia A. Nolan, M.D. -2-

I appreciate the courtesy and cooperation extended to the IMPEP team during the follow-up

review and your support of the radiation control program. I look forward to our agencies

continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director

 for Materials, Research and 

 State Programs

Enclosure:

As stated

cc: Walter S. Combs, Jr., Ph.D.

Executive Director 

Environmental Health

Marie Stoeckel, Chief

Occupational and Radiological Health

Peter Todd, State Liaison Officer

Rhode Island Emergency Management Agency

Mike Broderick, OK

OAS Liaison to the MRB
Patricia A. Nolan, M.D. -2-

I appreciate the courtesy and cooperation extended to the IMPEP team during the follow-up

review and your support of the radiation control program. I look forward to our agencies

continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director

 for Materials, Research and 

 State Programs

Enclosure:

As stated

cc: Walter S. Combs, Jr., Ph.D. Marie Stoeckel, Chief

Executive Director Occupational and Radiological Health

Environmental Health

Peter Todd, State Liaison Officer Mike Broderick, OK

Rhode Island Emergency OAS Liaison to the MRB

Management Agency

bcc: Chairman Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution:

DIR RF DCD (SP01) PDR (YES)

KSchneider, STP CMiller, NMSS

LRakovan, STP MBailey, NMSS

AMcCraw, STP DWhite, R1

RStruckmeyer, NMSS DSollenberger, ASPO

STreby, OGC ISchoenfeld, EDO

JLieberman, OGC TCombs, OCA (2)

Rhode Island File FCameron, OGC

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To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy

OFFICE STP STP:DD STP:D NMSS:D OGC DEDMRS

NAME PMLarkins:kk JMPiccone PHLohaus

(via E-Mail)

MJVirgilio

(via E-Mail from

MBailey)

KDCyr

(via E-Mail)

CJPaperiello

DATE 2/04/04

2/24/04

2/25/04 2/6/04* 2/23/04* 2/10/04* 2/12/04*

3/2/04

 ML040560644 Pkg. OFFICIAL RECORD COPY
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF RHODE ISLAND AGREEMENT STATE PROGRAM

NOVEMBER 17-18, 2003

FINAL REPORT

U.S. Nuclear Regulatory Commission
Rhode Island Follow-Up Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the follow-up review of the Rhode Island Agreement State

program conducted November 17-18, 2003. This follow-up review was directed by the

Management Review Board (MRB) based on results of the November 18-22, 2002 IMPEP

review. The MRB directed that a follow-up review of the common performance indicator, Status

of Materials Inspection Program, be conducted approximately one year from the last review due

to a finding of unsatisfactory for this performance indicator. The follow-up review also included

evaluation of the actions taken by the State to address the five recommendations made during

the 2002 review. Other aspects of the program, not fully evaluated as part of the follow-up

review, were discussed at a periodic meeting held in conjunction with the review. The periodic

meeting summary can be found in Appendix D.

The follow-up review was conducted by a review team consisting of technical staff members

from the Nuclear Regulatory Commission (NRC). Review team members are identified in

Appendix A. The follow-up review was conducted in accordance with the November 5, 1999,

NRC Management Directive 5.6, "Integrated Materials Performance Evaluation Program

(IMPEP)." Preliminary results of the follow-up review, which covered the period of 

November 23, 2002 to November 17, 2003, were discussed with Rhode Island management on

November 18, 2003. 

The Rhode Island Agreement State program is administered by the Office of Occupational and

Radiological Health (the Office). The Office Chief reports directly to the Executive Director of

Environmental Health located in the Department of Health (the Department). Organization

charts for the Office and the Rhode Island Department of Health are included as Appendix B. 

At the time of the follow-up review, the Rhode Island Agreement State Program regulated

approximately 53 specific licenses authorizing Agreement materials. The review focused on the

regulatory program as it is carried out under the Section 274b (of the Atomic Energy Act of

1954, as amended) Agreement between the NRC and the State of Rhode Island. 

Prior to the follow-up review, the NRC conducted a period of heightened oversight of the Rhode

Island program, which included the State’s development and implementation of a Program

Improvement Plan (the Plan) in response to the 2002 IMPEP review. Bimonthly conference

calls were conducted between the NRC and Rhode Island to discuss the State’s progress in

implementing the Plan. Conference calls were held April 7, 2003; June 11, 2003; August 13,

2003; and October 1, 2003. The Plan and minutes from the bimonthly calls can be found in

Appendix C.

The review team's general approach for conduct of this follow-up review consisted of: 

(1) examination of the heightened oversight information; (2) analysis of quantitative information

from the Office’s inspection databases; (3) review of the status of applicable Rhode Island

statutes and regulations; (4) interviews with staff and management to answer questions or

clarify issues; and (5) summary review of the Office’s inspection files. The review team

evaluated the information gathered against the IMPEP performance criteria for the single

common performance indicator and made a preliminary assessment of the State’s

performance.

Section 2 below discusses the results of the follow-up review of the Rhode Island program for 

the single common performance indicator, including two recommendations from the previous
Rhode Island Follow-Up Final Report Page 2

review. Section 3 summarizes the follow-up review team’s findings and one open

recommendation. A response is requested from the Program to this one open

recommendation. The general status of the other aspects of the Rhode Island program

addressed during periodic meeting discussions can be found in Appendix D.

2.0 COMMON PERFORMANCE INDICATORS

The follow-up review addressed one of the five common performance indicators used in

reviewing both NRC Regional and Agreement State programs. The team reviewed the one

indicator, Status of Materials Inspection Program. 

2.1 Status of Materials Inspection Program

During the follow-up review, the review team evaluated actions taken by the Office in response

to the finding of unsatisfactory made during the 2002 IMPEP review, the status of the

inspections performed since the 2002 review, and the current status of due and overdue

inspections. 

The team focused on the timeliness of core and initial inspections performed since the last

review period, the current and projected backlog of overdue inspections, reciprocity inspections,

and the timeliness in communication of inspection results to licensees. The evaluation is based

on data provided by the Office from their inspection tracking system, the examination of

completed licensing and inspection casework, and interviews with managers and staff.

Two of the five recommendations from the 2002 IMPEP review primarily relate to the materials

inspection program. The review team’s evaluation of the Office’s actions to these

recommendations is discussed below. Actions in response to the remaining three

recommendations are presented in the periodic meeting summary. 

Recommendation 2

The review team recommends that the Office implement the action plan and perform

inspections of core licenses at their appropriate frequencies.

Current Status

At the time of the 2002 review, the Office had 14 overdue core inspections. Over the last year,

the Office completed 13 of these inspections. The one remaining overdue inspection was not

completed due to the renewal of the license and change in the Radiation Safety Officer. The

renewed license was issued in early November 2003 and the inspection has been scheduled for

January 2004. 

Since the last review, two core inspections became due and were conducted within the

appropriate frequency. One new license was issued in September 2002 and the initial

inspection was conducted in January 2003. A second new license was issued in September

2003 and has been scheduled for inspection in February 2004. 

The team determined that the Office has scheduled all core and non-core licensees at the

appropriate frequency in accordance with Inspection Manual Chapter (IMC) 2800. The review

team recommends that this recommendation be closed.
Rhode Island Follow-Up Final Report Page 3

Recommendation 3

The review team recommends that the Office inspect core licensees granted reciprocity in

accordance with the criteria in IMC 1220.

Current Status

Since the 2002 review, the Office has received and approved reciprocity requests for 11 core

licensees to conduct licensed activities in the State. The Office inspected four of these

licensees. The performance criterion for conducting inspections is 20 percent of core licensees

granted reciprocity as indicated in IMC 1220. The Office’s performance exceeds the criteria in

IMC 1220. The review team recommends that this recommendation be closed.

In addition to the recommendations above, the timeliness of issuance of inspection results was

also reviewed by the review team for this indicator. The review team reviewed 19 inspection

reports and found that 14 were issued within 30 days. The remaining five reports were issued

between 32 and 57 days after the conclusion of the inspection. Three of the five reports were

issued during the first half of the review period when the Section Supervisor was working with

new inspectors to complete the inspection documents and related correspondence.

Inspection reports, enforcement documentation, and inspection field notes for 10 materials

inspections conducted during the review period were evaluated by the review team. The

casework included all three of the Office’s materials inspectors, and covered inspections of

various types as follows: portable gauge, medical broad scope, manufacturing and distribution,

service (source exchange), industrial radiography, and medical institution. Based on the

casework file reviews, the review team found that routine inspections covered all aspects of the

licensee’s radiation protection program. The inspection reports were thorough, complete,

consistent, and of high quality, with sufficient documentation to ensure that licensee’s

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

supported the cited violations. Exit interviews were held with appropriate licensee personnel. 

Team inspections were performed when appropriate and for training purposes. The review

team found that violations are categorized into severity levels which can later be used for

escalated enforcement, if necessary. All inspections are reviewed and approved by the Section

Supervisor. 

In summary, since the last review, the Office completed 13 overdue core inspections, two core

and one initial inspection that became due during the review period, four reciprocity inspections,

and nine non-core inspections. Future inspections have been scheduled in accordance with

IMC 2800. The completion of these inspections and the training of new staff to conduct

inspections independently demonstrates that the Office has improved its performance for this

indicator during the review period.

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

that Rhode Island’s performance with respect to the indicator, Status of Materials Inspection

Program, be changed from unsatisfactory to satisfactory.

3.0 SUMMARY

The team noted that significant program improvements have been implemented by the Office,

which include reducing the inspection backlog and recruiting and training of two new technical

staff. The Office is also working towards transferring responsibility for Sealed Source and
Rhode Island Follow-Up Final Report Page 4

Device Evaluation Program reviews for the State’s sole manufacturing and distribution licensee

to the Commonwealth of Massachusetts. The review team recommends closure of four of the

five recommendations from the 2002 IMPEP review. These actions have demonstrated a high

level of Department management support for the Agreement State program and a commitment

to operating and maintaining a fully satisfactory program in the future.

The Office has completed the majority of the Plan activities and has almost eliminated the

inspection backlog. Therefore, the follow-up review team recommends that Rhode Island’s

performance for the indicator, Status of the Materials Inspection Program, be changed to

satisfactory. The team found that although the status of Legislation and Program Elements

Required for Compatibility was found satisfactory during the 2002 IMPEP review, based on an

anticipated adoption date of the first half of 2003, little progress has occurred since the 2002

IMPEP review. The amendments remain under review by the State’s Radiation Advisory

Commission. 

Based on the overall findings, the review team recommended and the MRB agreed on

discontinuance of heightened oversight. The team recommended and the MRB agreed that the

NRC will continue to monitor State activities through quarterly teleconferences between the

Regional State Agreements Officer and Rhode Island management. The quarterly

teleconferences are designed to assess the progress of the State to maintain program

improvements, and to address areas that require additional progress, such as the adoption of

overdue regulations, identified in the Plan, which addressed the recommendations in the final

2002 IMPEP report. Finally, the review team recommended and the MRB agreed that the NRC

conduct a periodic meeting approximately 18 months from the follow-up review, in April 2005. 

This periodic meeting will consider and address removing the program from monitoring if the

State maintains satisfactory performance over the 18-month period. The next full review should

be conducted approximately four years from the November 2002 IMPEP review.

Below is the one open recommendation from the 2002 IMPEP report. No new

recommendations were identified during the current review. 

1. The review team recommends that the Office adopt overdue regulations required for

compatibility. (Section 4.1.2) (Recommendation 4 from the 2002 report)
LIST OF APPENDICES

Appendix A IMPEP Review Team Members

Appendix B Rhode Island Organization Charts

Appendix C Heightened Oversight Program Correspondence

Appendix D Periodic Meeting Summary

Attachment January 16, 2004, E-mail from Marie Stoeckel, Chief,

Office of Occupational and Radiological Health
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Patricia M. Larkins, NRC/STP Team Leader

Periodic Meeting

Duncan White, NRC Region I Status of Materials Inspection Program

Periodic Meeting 
APPENDIX B

RHODE ISLAND

DEPARTMENT OF HEALTH

ORGANIZATION CHARTS

ML040290369
APPENDIX C

HEIGHTENED OVERSIGHT PROGRAM CORRESPONDENCE

Minutes of Bimonthly Conference Calls:

1. April 7, 2003 Minutes (ML031190582)

2. June 11, 2003 Minutes (ML031700324)

3. August 13, 2003 Minutes (ML032471541)

4. October 1, 2003 Minutes and Rhode Island October 2003 Bimonthly Report as of

September 17, 2003 (ML032890108); ML032800882)

Letters from/to Rhode Island:

1. March 31, 2002 Letter from P. A. Nolan to C. J. Paperiello submitting Program

Improvement Plan (ML031000330 )
APPENDIX D

PERIODIC MEETING SUMMARY

INCLUDING STATUS OF OTHER RECOMMENDATIONS

FROM THE PREVIOUS REVIEW

A periodic meeting was held with Rhode Island management by Patricia Larkins, Team Leader,

and Duncan White, Regional State Agreements Officer (RSAO), during the follow-up review

pursuant to STP Procedure SA-116, “Periodic Meeting with Agreement States Between IMPEP

Reviews.” Those topics normally documented during the periodic meeting that received full

evaluation as part of the follow-up review will not be discussed in this Appendix. The following

topics were discussed:

Status of Recommendations from 2002 Report

See Sections 2.1 for details on recommendation numbers 2 and 3. The status of the remaining

recommendations from the 2002 IMPEP report are described below.

1. The review team recommends that the Office use a fully documented interim

qualification program for inspectors. (Section 3.1 of 2002 report)

Current Status: The Office developed and implemented an interim qualification program

form for inspectors through a Personnel File Memo and a Matrix Training History Form,

which were reviewed by the team. The Personnel File Memo identifies the specific

inspection categories for which the staff member has been deemed qualified with

references to general training categories and accomplishments, i.e. selective NRC

training courses, on-the-job-training, mentored accompaniments, and previous

experience. The Matrix Training History Form is used to monitor the status of training

and is similar to the training form included in the NRC/OAS Training Working Group

Report. This form includes the year for completion of core, supplemental, and other

training courses, as well as courses waived and courses needed but not completed. 

Due to the significant staff effort directed towards reducing the inspection backlog and

training new staff, the Office was unable to develop training qualification criteria, which

has been defined as a long-term goal for the program. The review team recommends

that this recommendation be closed.

4. The review team recommends that the State adopt overdue regulations required for

compatibility. (Section 4.1.2)

Current Status: As of the 2002 IMPEP review, all due and overdue amendments had

been drafted and were under review by the State’s Radiation Advisory Commission. 

Little progress has occurred since the 2002 IMPEP. The amendments are currently

under review by a subcommittee of the State’s Radiation Advisory Commission. This

recommendation remains open. 

5. The review team recommends that the Office train and qualify a sufficient number of

reviewers to conduct and sign safety evaluations of sealed source and device (SS&D)

application in accordance with NRC/OAS Training Working Group Recommendations. 

(Section 4.2.2)
Rhode Island Follow-up Final Report Page D.2

Current Status: The Office determined that it could not justify the amount of resources

necessary to maintain at least two qualified individuals to review SS&D applications for

the State’s one manufacturer and distributor licensee with two registration sheets. The

Office discussed this matter with the licensee and they agreed to formally request

transference of the Rhode Island registration sheets to the Commonwealth of

Massachusetts. The licensee has a research and development facility in the

Commonwealth and has an active registration sheet issued by the Commonwealth for a

similar device. The Massachusetts Radiological Health Program maintains several

qualified SS&D reviewers due to the significant number of manufacturers and

distributors in their jurisdiction. A written request has not been received by the Office

from the licensee to transfer the sheets due to a change in the licensee’s Radiation

Safety Officer. At this time, the Office maintains the registration sheets.

The Office indicated that if an application for an SS&D review was received in the near

future, the Office would solicit assistance from the New England Radiological Health

Compact to review these sheets. The SS&D sheets would be issued and maintained by

the State of Rhode Island. In the long term, Office management would like to train at

least two staff members to complete SS&D reviews. At this time, however, core training

is of higher priority. The review team recommends that this recommendation be closed.

Current Program Status

A detailed discussion of the Office’s inspection program can be found in Section 2.1.

The Office indicated that they plan to revise their inspection field notes next year due to the

revision of Part 35 and the State’s anticipated adoption of this revision. 

The Office currently has 53 specific licenses. The staff discussed the current status of the

licensing program. There are currently 19 licensees in timely renewal. All of these actions

have been reviewed by Office staff at least once and are currently in various stages of the

review process. The Office is currently reviewing two amendments that present some

challenges. One action involves the approval of Zevalin at a medical Broad scope and the

second involves possession limit increases of xenon and iodine-131 at the State’s only nuclear

pharmacy. Office staff expects all issues to be satisfactorily resolved and the amendments

issued in a timely manner.

The status of the Office’s proposed changes to their regulations is discussed in detail under the

recommendations status of this appendix.

Program Strengths and/or Weaknesses

In general, the Office Chief related that the program has adequate administrative support, good

legal support, stable funding levels and satisfactory laboratory support. The Office has access

to the services of a staff member, from another office, to support rulemaking efforts. The

Department has hired a new bioterrorism staff member who will provide emergency operations

support. The new staff member will also provide support to the Office through management of

technical equipment, including maintaining calibration schedules for radiation survey

instruments.

The Office experienced significant staffing turnovers that notably impacted the program. The

staffing issues impacted the Offices ability to satisfactorily conduct timely inspections, which
Rhode Island Follow-up Final Report Page D.3

resulted in an inspection backlog. As a result of the inspection backlog the Office was placed

under heightened oversight during the 2002 IMPEP review. The Office implemented a Program

Improvement Plan and has made progress with most of the programmatic issues identified

during the 2002 IMPEP review. 

The Office has made improvements through the hiring and training of two new staff. The Office 

is working towards transferring the Sealed Sources and Device Evaluation Program (SS&D)

reviews to the Commonwealth of Massachusetts. Considerable efforts were expanded in

meeting with staff of the Commonwealth to cooperatively find a solution to staffing concerns for

SS&D reviews for the one licensee that manufactures devices and distributes under a general

license. Although the Office hired two new staff, unforeseen absences occurred that resulted in

delays in planned training efforts to fully qualify new staff. The two new staff members have

been successfully interim qualified to conduct inspections. While continuing to train new staff,

the Office redirected primary staff efforts towards reducing the inspection backlog. The major

effort put forth by the inspection supervisor and his staff to reduce the inspection backlog has

resulted in only one remaining overdue inspection. 

The Office has experienced little progress in the adoption of regulations since the 2002 IMPEP

review. Although the Office has significantly reduced the inspection backlog, seven of the ten

regulations identified during the 2002 IMPEP review are overdue for adoption and under

continued review by the Radiation Advisory Commission. The program will need additional time

to maintain operation at a satisfactory level; therefore, the 2003 follow-up IMPEP review team is

recommending that NRC monitor program activities through quarterly teleconferences.

Feedback on NRC’s Program

The Office Chief and program staff expressed their appreciation for NRC staff’s assistance with

regard to a number of issues raised over the past year.

Status of Program and/or Policy Changes

There have been no changes to the Office’s enabling legislation, its responsibilities, or staff

since the last review. Funding levels are anticipated to remain to unchanged.

Impact of NRC Program Changes

The NRC staff discussed recent developments regarding the nominations for the two vacant

Commission positions. Also discussed was the consolidation of the Region I and Region II

materials programs, the status of National Materials Program pilot projects, and the potential

impact of NRC’s aging workforce (i.e., succession planning). NRC staff also highlighted the

proposed changes to two documents that directly affect the IMPEP process: Management

Directive 5.6 and STP Procedure SA-116. There was also a discussion on materials licensee 

security and the proposed 274i Agreements. The Office staff inquired about the status of the

final 274i Agreement. The NRC staff indicated that a final 274i Agreement is undergoing staff

review. NRC staff also clarified that the proposed Agreement currently covers large irradiators

and will encompass additional license types in the future, as necessary.

Office staff inquired about the status of the revisions to the training and education requirements

to Part 35. NRC staff indicated that a proposed rule was currently out for comment. The Office

indicated that they plan to use the current Subpart J of Part 35 in their proposed changes to

their regulations.

The Office also asked about the status of the revised NRC Inspection Manual 2800. NRC staff

stated that a revision to IMC 2800 incorporating the Temporary Instruction and experience

gained during its implementation had been adopted on October 21, 2003 and would be posted
Rhode Island Follow-up Final Report Page D.4

on the NRC web site shortly. The final version was published November 25, 2003, and is

available at the NRC web site at: http://www.nrc.gov/reading-rm/doc-collections/inspmanual/manual-chapter/mc2800.pdf

Internal Program Audits and Self-Assessments

With the exception of the bimonthly status reports to the NRC in preparation for the conference

calls, the Office managers reported that no self-assessments were being performed.

Status of Allegations Previously Referred

No allegations were referred to the Office by Region I since the last review. 

Event Reporting and the Nuclear Material Events Database (NMED) 

Since the 2002 review, the Office had no reportable materials events. A general discussion

was held with Office representatives concerning the NMED database program, including recent

modifications. The review team indicated that a new field was recently added to the software

program to indicate if an event has been closed by the State.
ATTACHMENT

January 16, 2004, E-mail from Marie Stoeckel, Chief, 

Office of Occupational and Radiological Health

Rhode Island’s Response to Draft Follow-up IMPEP Report

ML040290379