ML21279A319: Difference between revisions

From kanterella
Jump to navigation Jump to search
(StriderTol Bot change)
(StriderTol Bot change)
 
Line 15: Line 15:


=Text=
=Text=
{{#Wiki_filter:}}
{{#Wiki_filter:ML21279A319 Approved by OMB1 Control No.: 3150-0183 Expires: 02/28/2023 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Rhode Island Agreement State Program Reporting Period: March 11, 2016 through October 22, 2021.
Note:    If there has been no change in the response to a specific question since the last IMPEP questionnaire, the State or Region may copy the previous answer, if appropriate.
A.        GENERAL
: 1. Please prepare a summary of the status of the State's or Region's actions taken in response to each of the open recommendations from previous IMPEP reviews.
B.        COMMON PERFORMANCE INDICATORS I.        Technical Staffing and Training
: 2. Please provide the following organization charts, including names and positions:
(a) A chart showing positions from the Governor down to the Radiation Control Program Director.
See Appendix A: Radiation Control Program Hierarchy Chart (b) A chart showing positions of the radiation control program, including management; and See Appendix B: RI Department of Health Organizational Structure Chart (c) Equivalent charts for sealed source and device evaluation, low-level radioactive waste, and uranium recovery programs, if applicable.
Not applicable for Rhode Island
: 3. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) full-time equivalents (FTE) applied to the radioactive materials program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, low-level radioactive waste, uranium recovery, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program.
If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts.
1 Estimated burden per response to comply with this voluntary collection request: 53 hours. Forward comments regarding burden estimate to the Records Management Branch (T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
Page 1 of 17
 
ML21279A319 NAME              POSITION              AREA OF EFFORT                FTE2 Alexander Hamm        Supervising        Program Management & Policy    0.66 Radiological      Review Health Spec.
Dennis                Senior            Inspection                      0.44 Klaczynski            Radiological Health Spec.
Thomas Caruolo        Radiological      Emergency Response; Licensing  0.70 Health Spec.      (Reciprocity) & Inspection Maria Barnes          Radiological      Inspection & Licensing          0.51 Health Spec.
William Dundulis      Risk              Licensing; Regulations & Policy 0.56 Assessment        Development Toxicologist
: 4. Please provide a listing of all new professional personnel hired into your radioactive materials program since the last review, indicate the date of hire; the degree(s) they received, if applicable; additional training; and years of experience in health physics or other disciplines, as appropriate.
Maria Barnes joined the Radiation Control Program as a Radiological Health Specialist on 3 April 2017.
Austin Olson joined the Radiation Control Program as a Supervising Radiological Health Specialist on 23 September 2019.
Alexander Hamm joined the Radiation Control Program as a Supervising Radiological Health Specialist on 11 April 2021.
: 5. Please list all professional staff who have not yet met the qualification requirements for a radioactive materials license reviewer or inspector. For each, list the courses or equivalent training/experience they need and a tentative schedule for completion of these requirements.
Maria Barnes has completed the NRC license reviewer training course and is fully qualified to review limited-scope medical, portable gauge and industrial radiography licenses. It is anticipated that she will be qualified to review additional license categories when appropriate renewal applications are submitted to Rhode Island. She has submitted applications for H-122 (Fundamental Health Physics I and II) and G-205 (Root Cause/
Incident Investigation Workshop). She also needs to complete H-201 (Advanced Health Physics).
Alexander Hamm has completed NRC inspector training course. He has submitted an application to attend the NRC license reviewer course. He is currently waiting on acceptance to this and other required training courses.
: 6. Identify any changes to your qualification and training procedure that occurred during the review period.
Rhode Island has adopted an inspector and materials license reviewer qualification program that is comparable to the most recent revision to IMC1248.
2 Total of 2.89 FTE based on time reported for July-September 2021. Average for SFY 2021 was 2.30 FTE.
Actual FTE utilized will vary slightly from quarter to quarter.
Page 2 of 17
 
ML21279A319
: 7. Please identify the technical staff that left your radioactive materials program during the review period and indicate the date they left.
Charma Waring (Supervising Radiological Health Specialist) resigned from the Radiation Control Program on 16 March 2019.
Austin Olson (Supervising Radiological Health Specialist) resigned from the Radiation Control Program on 14 March 2020.
: 8. List any vacant positions in your radioactive materials program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.
Not applicable.
: 9. For Agreement States, does your program have an oversight board or committee which provides direction to the program and is composed of licensees and/or members of the public?
If so, please describe the procedures used to avoid any potential conflict of interest.
RI Gen. Laws § 23-1.3 Radiation advisory commission. - There is created an advisory commission to be known as the state radiation advisory commission, which shall consist of eleven (11) members.
The Commission was intended to function as an advisory group with the Agency having the discretion to accept or reject direction from the Commission. However, the Commission has not met during the current IMPEP cycle.
II. Status of Materials Inspection Program
: 10. Please identify individual licensees or categories of licensees the State is inspecting less frequently than called for in NRCs Inspection Manual Chapter (IMC) 2800 and explain the reason for the difference. The list only needs to include the following information: license category or licensee name and license number, your inspection interval, and rationale for the difference.
None of the Radiation Control Programs radioactive materials licenses are being inspected less frequently than called for in NRCs IMC 2800.
: 11. Please provide the number of routine inspections of Priority 1, 2, and 3 licensees, as defined in IMC 2800 and the number of initial inspections that were completed during each year of the review period.
See Appendix C: Initial/Routine Inspections - 2016-2021
: 12. Please submit a table, or a computer printout, that identifies inspections of Priority 1, 2, and 3 licensees and initial inspections that were conducted overdue.
Newport Hospital was conducted overdue on 28 April 2021. However, this inspection had been delayed because it was specifically requested to be one of the inspections included with the inspector field audit portion of this IMPEP.
: 13. Please submit a table or computer printout that identifies any Priority 1, 2, and 3 licensees and initial inspections that are currently overdue, per IMC 2800. At a minimum, the list should include the same information for each overdue inspection provided for Question 12 plus your action plan for completing the inspection. Also include your plan for completing the overdue inspections.
There are no overdue inspections per IMC 2800 as of 1 October 2021.
: 14. Please provide the number of reciprocity licensees that were candidates for inspection per year as described in IMC 2800 and indicate the number of reciprocity inspections of candidate licensees that were completed each year during the review period.
Page 3 of 17
 
ML21279A319 See Appendix D: Reciprocity Inspections - 2016-2021 In general, any Category A or Category B approvals would be a candidate for inspection, if they actually entered the state (i.e., some companies maintain a reciprocity approval just in case they need to provide short notice services for existing clients). Category C approvals are generally not candidates for inspection. However, they are reviewed on an individual basis (e.g., scope of work, client, past compliance history, etc.) to determine if they should be scheduled for a reciprocity inspection.
III. Technical Quality of Inspections
: 15. What, if any, changes were made to your written inspection procedures during the reporting period?
The Inspection Manual had several interim/draft revisions during the current IMPEP cycle.
The most current revision was completed in July 2021 and is compatible with IMC-2800 dated 2 March 2020.
See 2021 Rhode Island IMPEP Criteria Document Status for additional details.
: 16. Prepare a table showing the number and types of supervisory accompaniments made during the review period.
See Appendix E: Accompaniments - 2016-2020
: 17. Describe or provide an update on your instrumentation, methods of calibration, and laboratory capabilities. Are all instruments properly calibrated at the present time? Were there sufficient calibrated instruments available throughout the review period?
The Radiation Control Program has updated survey equipment used to conduct field inspections and respond to incidents.
Instrument calibration is provided by equipment manufacturer and/or outside vendors. All field instruments are calibrated on at least an annual frequency and rotated such that sufficient quantities of instruments will be available for use during calibration periods.
Laboratory capabilities are limited-the State laboratory no longer has the capabilities to provide assistance with evaluating wipes or other field samples. The Radiation Control Program has an understanding with two broad scope licensees to provide limited laboratory assistance on an as-needed basis.
IV. Technical Quality of Licensing Actions
: 18. How many specific radioactive material licenses does your program regulate at this time?
See Appendix F: Current Licenses [42 specific licensees].
: 19. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification, or renewed in this period.
Rhode Island Hospital is our most complex licensee and had requested a number of significant license amendments during the period of this review.
While other licenses have been issued, renewed, terminated, or decommissioned during the period of this review, none of them would be considered complex or unusual licensing actions that required a disproportionate amount of staff effort for review. However, it should be noted that licensing certain new technologies (e.g., PET and PET/CT), where regulatory jurisdiction is shared with other Health Department agencies, does require a high degree of coordination (and some additional meetings) to ensure that no regulatory approvals are granted until all agencies are ready to proceed with licensing.
With the exception of the corporate reorganization (not technically a bankruptcy but did go Page 4 of 17
 
ML21279A319 through the Federal Bankruptcy Court) of Genesis/21st Century Oncology, there were no bankruptcy notifications submitted for RAM licensees during the period of this review.
: 20. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.
No significant variances or exemptions were issued during the period of this review.
However, several licensees requested, and were granted, COVID-19-related variances in accordance with established NRC criteria.
: 21. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
Revised licensing checklists have been prepared for reviewer use. In addition, RI-specific regulatory guides (comparable to NUREG 1556 series) have been developed for a number of areas.
See 2021 Rhode Island IMPEP Criteria Document Status for additional details.
: 22. Identify by licensee name and license number any renewal applications that have been pending for one year or more. Please indicate why these reviews have been delayed and describe your action plan to reduce the backlog.
See Appendix G: Renewals Issued - 2016-2021.
There are currently no renewal applications pending in-house. However, at least one license will be due for renewal between the time this questionnaire is submitted to NRC and the IMPEP site visit is conducted.
With the exception of Rhode Island Hospital and Landmark Medical Center, review for the last of the backlogged renewal applications was completed in August 2017. With the exception of RI Emergency Management Agency (RIEMA), review of all renewal applications received during the current IMPEP cycle was completed well within a year of receipt.
Rhode Island Hospitals original renewal application had been submitted on 30 July 2002 and was not initially reviewed. A file audit conducted in August 2007 determined that formal review of renewal had not been initiated but that the licensee had submitted 20 amendment requests in the proceeding 5 year period. On 7 August 2007 the licensee was requested to review all amendment requests and submit a revised renewal application.
Apparently RIH did not respond to this inquiry and the renewal per-se was never reviewed, although a number of subsequent license amendments were reviewed and processed. A revised renewal request was subsequently submitted by the new RSO on 6 July 2015.
Review had been initiated when Rhode Island was approached by the licensee about merging the existing Gamma Knife license into the broad scope license during the renewal process. After a series of back and forth discussions about what would be required to merge the licenses, the licensee ultimately decided to keep the licenses separate. Review of the renewal request was resumed, and the renewal was ultimately issued on 9 April 2018. In addition to the renewal review and license merger discussions Rhode Island also processed a total of 5 amendments to the license from 6 July 2015-9 April 2018.
Landmarks original renewal application had been submitted on 28 August 2014. An additional information letter was generated on 14 October 2014. The response dated 6 January 2015 did not resolve all outstanding issues. The matter became further complicated when Landmarks corporate parent announced its intent to convert the hospital from a not-for-profit to a for-profit facility. Because this action required review and approval from other agencies within the RI Department of Health, the renewal was placed on-hold pending the outcome of this review. No further action was taken until January 2018 when the RCP Page 5 of 17
 
ML21279A319 was notified that other agencies within the Department had approved the previously requested change in status but that a new petition had been received to return Landmark to a not-for-profit status. An additional information letter was sent on 6 January 2018 requesting clarification of status. However, a response was not received until 21 August 2018. At this point, the renewal clock was reset, and another round of additional information letter and reply was necessary until the renewal was actually issued on 19 October 2018.
RIEMAs 30 May 2016 submittal to renew license 8A-009-01 also included a request to consolidate (and subsequently terminate) RAM covered under license 8A-009-02.
Additional review of the renewal application was put on-hold pending action to combine all RAM possessed by RIEMA onto the 8A-009-01 license and termination of 8A-009-02 license. An amendment to terminate 8A-009-02 was issued on 8 March 2017. Several rounds of additional information letters and licensee responses were necessary before a renewal could be issued for 8A-009-01 on 19 December 2017. Although the total time to complete the renewal process was 557 days, the actual renewal review (after consolidation and termination) was completed in 286 days.
V. Technical Quality of Incident and Allegation Activities
: 23. For Agreement States, please provide a list of any reportable incidents not previously submitted to NRC (See Procedure SA-300, Reporting Material Events, for additional guidance, OMB clearance number 3150-0178).
All reportable events have been previously submitted to NMED
: 24. Identify any changes to your procedures for responding to incidents and allegations that occurred during the period of this review.
No changes to our protocols for handling incidents or allegations were implemented during the period of this review. However, all of the Radiation Control Program staff attended a SA-300 workshop conducted by NRC which provided a greater understanding of how to handle incidents and allegations.
C. NON-COMMON PERFORMANCE INDICATORS I. Compatibility Requirements
: 25. Please list all currently effective legislation that affects the radiation control program. Denote any legislation that was enacted or amended during the review period.
All specific enabling authority for Radiation Control Program is pursuant to RI Gen. Laws Chapter 23-1.3 - Radiation Control. [http://www.rilin.state.ri.us/Statutes/TITLE23/23-1.3/
INDEX.HTM]. There have been no changes to our enabling legislation during the period of this review.
: 26. Are your regulations subject to a "Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
The Radiation Control Programs regulations are subject to sunset requirements. The RCP must refile their regulations every five years. The Program last completed a refiling in January 2017. The next refiling is scheduled for 2022.
: 27. Please review and verify that the information in the enclosed State Regulation Status (SRS) sheet is correct. For those regulations that have not been adopted by the State, explain why they were not adopted, and discuss actions being taken to adopt them. If legally binding requirements were used in lieu of regulations and they have not been reviewed by NRC for compatibility, please describe their use.
Page 6 of 17
 
ML21279A319 Rhode Island verifies that the information contained in the State Regulation Status sheet is correct. Rhode Island has adopted all changes through RATS 2015-5.
: 28. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.
No amendments are beyond the three year timeline at this time.
RATS 2018-1, 2018-2, 2018-3, 2019-1, 2019-2, 2020-1, 2020-2, 2020-3 and 2021-1 are anticipated to be adopted prior to their effective dates. Amendments addressing RATS 2018-1, 2018-2, 2018-3, 2019-1, 2019-2, 2020-1, 2020-2 and 2020-3 were to have been included in a rulemaking package that was delayed due to a hold that was placed on all non-emergency rulemaking during the COVID-19 crises. The rulemaking package has recently been submitted to the Departments Rules Coordinator to initiate promulgation. Projected timeline is unknown at this time, but it is anticipated that rules could be in effect by the end of calendar 2021. No additional actions will be required to implement RATS 2021-1. The majority of the amendments involve changes to sections that Rhode Island has incorporated by reference, and the one remaining change has already been addressed in the pending rulemaking package.
II. Sealed Source and Device (SS&D) Evaluation Program NOT APPLICABLE FOR RHODE ISLAND
: 29. Prepare a table listing new and amended (including transfers to inactive status) SS&D registrations of sources and devices issued during the review period.
: 30. Please include information on the following questions in Section A, as they apply to the SS&D Program:
Technical Staffing and Training - Questions 2-9 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24 III. Low-level Radioactive Waste Disposal Program NOT APPLICABLE FOR RHODE ISLAND
: 31. Please include information on the following questions in Section A, as they apply to the Low-Level Radioactive Waste Disposal Program:
Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24 IV. Uranium Recovery Program NOT APPLICABLE FOR RHODE ISLAND
: 32. Please include information on the following questions in Section A, as they apply to the Uranium Recovery Program:
Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Page 7 of 17
 
ML21279A319 Technical Quality of Incident and Allegation Activities - Questions 23-24 Page 8 of 17
 
ML21279A319 Appendix C Radiation Control Program - Initial/Routine Inspections 2016-2021 License #                Licensee                  NRC License Type Date of Inspection  Priority 3B-114-01  Cardinal Health                                02500                10/26/2018    2 3B-114-01  Cardinal Health                                02500                04/29/2021    2 3D-005-01  Electric Boat Corporation                      03320                10/14/2016    1 3D-005-01  Electric Boat Corporation                      03320                12/18/2017    1 3D-005-01  Electric Boat Corporation                      03320                01/22/2019    1 3D-005-01  Electric Boat Corporation                      03320                12/03/2019    1 3D-005-01  Electric Boat Corporation                      03320                12/05/2020    1 3D-005-01  Electric Boat Corporation                      03320                04/27/2021    1 3D-065-01  Thielsch Engineering                            03320                06/02/2017    1 3D-065-01  Thielsch Engineering                            03320                08/22/2018    1 3D-065-01  Thielsch Engineering                            03320                09/10/2019    1 3D-065-01  Thielsch Engineering                            03320                08/14/2020    1 3D-065-01  Thielsch Engineering                            03320                08/31/2021    1 3D-117-02  OST Services                                    03320                11/21/2017    1 3D-117-02  OST Services                                    03320                12/11/2018    1 3D-117-02  OST Services                                    03320                11/01/2019    1 3D-117-02  OST Services                                    03320                04/30/2021    1 3D-149-01  Sky Testing                                    03320                10/26/2020    1 3D-150-01  National Inspection Consultants                03320                12/04/2020    1 3E-100-01  Rhode Island Blood Center                      03510                09/28/2020    5 3K-036-01  Brown University                                01100                09/12/2017    3 3K-036-01  Brown University                                01100                07/15/2021    3 3K-040-01  University of Rhode Island                      01100                05/17/2017    3 3K-040-01  University of Rhode Island                      01100                09/10/2019    3 3K-040-01  University of Rhode Island                      01100                05/17/2021    3 Page 9 of 17
 
ML21279A319 License #                Licensee                    NRC License Type Date of Inspection  Priority 3K-045-03  Women & Infants Hospital                        03620                09/08/2017    5 3K-126-01  Ocean State Veterinary Services                02400                12/27/2017    5 3K-136-01  VeroScience                                    03620                11/17/2020    5 3K-151-01  Big River Veterinary Service                    02400                07/08/2021    5 3L-015-01  RIDOT                                          03121                07/28/2021    5 3L-050-01  Geisser Engineering                            03121                06/11/2021    5 3L-065-02  Thielsch Engineering (Gauges)                  03121                12/04/2018    5 3L-079-01  GZA GeoEnvironmenal                            03121                04/24/2018    5 3L-083-01  Briggs Engineering and Testing                  03121                12/10/2018    5 3L-119-01  Terracon Consultants                            03121                12/19/2018    5 3L-142-01  ATC Group Services                              03121                07/26/2019    5 3L-146-01  Huestis Engineering                            03220                09/01/2020    5 3L-147-01  Casali Engineering                              03121                12/20/2018    5 3L-148-01  Civil and Environmental Consultants            03121                04/02/2018    5 7A-051-02  Rhode Island Hospital (GK)                      02310                April 2016    2 7A-051-02  Rhode Island Hospital (GK)                      02310                11/15/2018    2 7B-012-01  South County Hospital                          02120                09/07/2017    3 7B-012-01  South County Hospital                          02120                07/27/2021    3 7B-016-01  Newport Hospital                                02120                03/22/2017    3 7B-016-01  Newport Hospital                                02120                04/28/2021    3 7B-019-01  Landmark Hospital                              02120                04/05/2018    3 7B-020-01  Kent Hospital                                  02120                03/25/2016    3 7B-020-01  Kent Hospital                                  02120                12/11/2019    3 7B-035-01  Westerly Hospital                              02120                06/23/2016    3 7B-035-01  Westerly Hospital                              02120                09/26/2019    3 7B-038-03  NorthMain Radiation Oncology                    02230                05/09/2016    2 7B-038-03  NorthMain Radiation Oncology                    02230                08/28/2018    2 7B-038-03  NorthMain Radiation Oncology                    02230                07/30/2021    2 Page 10 of 17
 
ML21279A319 License #                Licensee                    NRC License Type Date of Inspection  Priority 7B-053-02  SNERCC                                          02230                10/13/2016    2 7B-073-02  Richard Sanantonio, MD                          02201                08/24/2017    5 7B-120-01  John D Lowney (Medical Group of RI)              02201                12/15/2020    5 7B-125-01  Cardiovascular Associates of RI                  02201                05/17/2018    5 7B-131-01  Rhode Island P.E.T. Services                    02220                08/25/2017    2 7B-131-01  Rhode Island P.E.T. Services                    02220                08/30/2019    2 7B-134-01  Hartford Healthcare Medical Group                02201                11/21/2017    5 7B-137-01  Cardiovascular Institute of New England          02201                03/12/2018    5 7B-139-01  Roger Williams Radiation Therapy                02230                11/22/2017    2 7B-139-01  Roger Williams Radiation Therapy                02230                11/26/2019    2 7B-144-01  JNA Associates                                  02201                11/18/2020    5 7B-144-01  JNA Associates                                  02201                06/22/2021    5 7B-145-01  Ocean State Cardio and Vein Center              02201                12/02/2020    5 7D-026-01  Roger Williams Medical Center                    02110                03/07/2017    2 7D-026-01  Roger Williams Medical Center                    02110                01/31/2019    2 7D-051-01  Rhode Island Hospital                            02110                04/27/2016    2 7D-051-01  Rhode Island Hospital                            02110                12/05/2018    2 8A-009-01  RIEMA                                            03710                12/13/2018    5 Page 11 of 17
 
ML21279A319 Appendix D Reciprocity Inspections - 2016-2021 PRIORITY            2016      2017          2018    2019        2020      2021*
Category A Reciprocity        3        5            5        5          3          4 Category B Reciprocity        2        2            4        4          4          3 Total A & B Reciprocity        5        7            9        9          7          7 Authorizations Inspections Conducted      3 (60%)  3 (43%)      3 (34%)  3 (34%)        0      2 (29%)
Category C Reciprocity        1        5            4      12          13          6
                                                          *Reciprocity as of 1 October 2021 Page 12 of 17
 
ML21279A319 Appendix E Accompaniments - 2016 to 2020 INSPECTOR        REVIEWER              LICENSE CATEGORY                  DATE Maria Barnes      William Dundulis  02201 Med. Private Prac. - no WD Req. 21 Nov 2017 Maria Barnes      William Dundulis  03320 Indust. Radiography            22 Aug 2018 Charma Waring    William Dundulis  02310 Stereotactic Radiosurgery      10 Oct 2018 Maria Barnes      William Dundulis  03510 Irrad. Self-Shield < 370 TBq    5 Dec 2018 Maria Barnes      Dennis Klaczynski 02120 Med. Institution - WD Req.      11 Dec 2019 William Dundulis  Dennis Klaczynski 02230 Med. Private Prac. - WD req. 12 Dec 2019 Tom Caruolo      Dennis Klaczynski 03320 Indust. Radiography            05 Dec 2019 Dennis Klaczynski William Dundulis  03320 Indust. Radiography            30 Dec 2019 Tom Caruolo      Dennis Klaczynski 03620 R&D Limited Scope              17 Nov 2020 Maria Barnes      Dennis Klaczynski 02201 Med. Private Prac. - no WD Req. 18 Nov 2020 Page 13 of 17
 
ML21279A319 Appendix F Current List of Radioactive Materials Licensees LICENSE #            LICENSEE                            NRC LICENSE TYPE 3B-114-01  Cardinal Health                        02500 Nuclear Pharmacies 3D-005-01  Electric Boat Corporation              03320 Indust. Radiography Temp Jobsite 3D-065-01  Thielsch Engineering Inc                03320 Indust. Radiography Temp Jobsite 3D-117-02  OST Services (OSTS)                    03320 Indust. Radiography Temp Jobsite 3D-149-01  Sky Testing Services Inc                03320 Indust. Radiography Temp Jobsite 3D-150-01  National Inspection & Consultants      03320 Indust. Radiography Temp Jobsite 3E-100-01  Rhode Island Blood Center              03510 Irrad. Self-Shield < 370 TBq 3K-036-01  Brown University                        01100 Academic Type A Broad 3K-040-01  University Of Rhode Island              01100 Academic Type A Broad 3K-045-03  Women And Infants Hospital              03620 Research/Development Other 3K-126-01  Ocean State Veterinary Specialists      02400 Veterinary Nonhuman 3K-136-01  Vero Science LLC                        03620 Research/Development Other 3K-151-01  Big River Veterinary Service            02400 Veterinary Nonhuman 3L-015-01  RI Dept of Transportation              03121 Meas Sys Port Gauge inc Lixiscop 3L-050-01  Geisser Engineering Corporation        03121 Meas Sys Port Gauge inc Lixiscop 3L-065-02  Thielsch Engineering Inc                03121 Meas Sys Port Gauge inc Lixiscop 3L-079-01  GZA Geoenvironmental Inc                03121 Meas Sys Port Gauge inc Lixiscop 3L-083-01  PK Associates                          03121 Meas Sys Port Gauge inc Lixiscop 3L-096-01  Professional Service Industries Inc    03121 Meas Sys Port Gauge inc Lixiscop 3L-119-01  Terracon Consultants Inc                03121 Meas Sys Port Gauge inc Lixiscop 3L-142-01  ATC Associates Incorporated            03121 Meas Sys Port Gauge inc Lixiscop 3L-146-01  Huestis Machine Corporation            03220 Leak Test Services Only 3L-147-01  Joe Casali Engineering Inc              03121 Meas Sys Port Gauge inc Lixiscop 3L-148-01  Civil & Environmental Consultants      03121 Meas Sys Port Gauge inc Lixiscop 7A-051-02  Rhode Island Hospital                  02310 Stereotactic Radiosurgery 7B-012-01  South County Hospital                  02121Med. Institution - no WD Req.
7B-016-01  Newport Hospital                        02120 Med. Institution - WD Req.
7B-019-01  Landmark Medical Center                02121 Med. Institution - no WD Req.
7B-020-01  Kent Hospital                          02120 Med. Institution - WD Req.
7B-035-01  Westerly Hospital                      02121 Med. Institution - no WD Req.
7B-038-03  NorthMain Radiation Oncology            02230 High-Med-Pulsed Dose Afterload 7B-073-02  Richard P Sanantonio MD                02201 Med. Private Prac. - no WD Req.
7B-120-01  John D Lowney DO                        02201 Med. Private Prac. - no WD Req.
7B-125-01  Cardiovascular Associates of Rhode      02201 Med. Private Prac. - no WD Req.
Island 7B-131-01  Rhode Island P.E.T. Services LLC        02220 Mobile Nuclear Medicine Serv.
7B-134-01  Hartford Healthcare Medical Group      02201 Med. Private Prac. - no WD Req.
7B-137-01  Cardiovascular Institute of New        02201 Med. Private Prac. - no WD Req.
England PC 7B-139-01  Roger Williams Radiation Therapy        02230 High-Med-Pulsed Dose Afterload LLC Page 14 of 17
 
ML21279A319 LICENSE #            LICENSEE                          NRC LICENSE TYPE 7B-145-01  Ocean State Cardiovascular & Vein    02201 Med. Private Prac. - no WD Req.
Center 7D-026-01  Roger Williams Medical Center        02110 Med. Institution Broad 7D-051-01  Rhode Island Hospital                02110 Med. Institution Broad 8A-009-01  RI Emergency Management Agency        03710 Civil Defense Page 15 of 17
 
ML21279A319 Appendix G:
Renewals Issued - 2016-2021 DATE              DATE        REVIEW LICENSE #                        LICENSEE                                NRC LICENSE TYPE                  RECEIVED          APPROVED          DAYS 7B-043-01      Memorial Hospital of Rhode Island                  02120 Med. Institution - WD Req.        30 Mar 2012        06 Oct 2016            1651 3D-005-01      Electric Boat Corporation                          03320 Indust. Radiography Temp          31 May 2012        29 Nov 2016            1643 7D-045-02      Women and Infants Hospital3                        02110 Med. Institution Broad            25 Oct 2012        05 May 2017            1653 3L-065-02      Thielsch Engineering, Inc.                        03121 Meas Sys Port Gauge inc            21 May 2013        28 Aug 2017            1560 7B-131-01      Rhode Island P.E.T. Services, LLC                  02220 Mobile Nuclear Medicine            20 Mar 2014        21 Jun 2017            1189 Serv.
3L-107-01      Paul B Aldinger & Associates Inc                  03121 Meas Sys Port Gauge inc            19 Aug 2014        31 July 2017          1077 3L-096-01      Professional Service Industries, Inc.              03121 Meas Sys Port Gauge inc            26 Feb 2015        28 Feb 2017            733 7D-051-01      Rhode Island Hospital                              02110 Med. Institution Broad            6 Jul 2015        9 Apr 2018            1008 3E-100-01      Rhode Island Blood Center                          03510 Irrad. Self-Shield < 370          20 Jan 2016        20 Jan 2017            366 7B-035-01      LMW Healthcare Inc dba The Westerly                02120 Med. Institution - WD Req.        7 Jun 2016        13 Oct 2016            128 Hospital 8A-009-01      RI Emergency Management Agency                    03710 Civil Defense                      10 Jun 2016        19 Dec 2017            557 3L-050-01      Geisser Engineering Corporation                    03121 Meas Sys Port Gauge inc            13 Jun 2016        07 Feb 2017            239 3L-119-01      Terracon Consultants Inc                          03121 Meas Sys Port Gauge inc            22 Jun 2016        26 May 2017            338 3K-036-01      Brown University                                  01100 Academic Type A Broad              23 Jun 2016        12 Dec 2016              55 3K-126-01      Ocean State Veterinary Specialists                02400 Veterinary Nonhuman                24 Aug 2016        20 Sep 2016              27 7B-137-01      Cardiovascular Institute of New England PC        02201 Med. Private Prac. - no            28 Nov 2016        23 Mar 2017            115 WD Req.
3K-040-01      University of Rhode Island                        01100 Academic Type A Broad              21 Feb 2017        3 May 2017              71 7B-134-01      Hartford HealthCare Medical Group                  02201 Med. Private Prac. - no            23 Feb 2017        1 Jun 2017              98 WD Req.
3K-136-01      Vero Science LLC                                  03620 Research/Development              25 Jul 2017        3 Aug 2017                9 Other 3D-065-01      Thielsch Engineering, Inc.                        03320 Indust. Radiography Temp          8 Aug 2017        19 Sep 2017              42 Jobsite 3
Women & Infants license 7D-045-02 was terminated as part of the renewal process due to a decrease in the scope of activity to be conducted under the license. A new license 3K-045-03 [license type 03620] was issued in lieu of a renewal.
Page 16 of 17
 
ML21279A319 DATE        DATE        REVIEW LICENSE #                LICENSEE              NRC LICENSE TYPE            RECEIVED    APPROVED        DAYS 7B-125-01 Cardiovascular Associates of RI  02201 Med. Private Prac. - no    30 Apr 2018 27 Jul 2018          88 WD Req.
7B-139-01 Roger Williams Radiation Therapy 02230 High-Med-Pulsed Dose      7 Aug 2018  05 Nov 2018          90 3L-083-01 PK Associates                    03121 Meas Sys Port Gauge inc    9 Aug 2018  25 Sep 2018          47 Lixiscop 7B-073-02 Richard Sanantonio, MD          02201 Med. Private Prac. - no    10 Aug 2018 16 Oct 2018          67 WD Req.
7B-019-01 Landmark Medical Center          02120 Med. Institution - WD Req. 21 Aug 2018 19 Oct 2018          29 7B-016-01 Newport Hospital                02120 Med. Institution - WD Req. 1 Mar 2019  24 Apr 2019          55 7B-012-01 South County Hospital            02120 Med. Institution - WD Req. 23 Apr 2019 23 May 2019          30 7B-020-01 Kent Hospital                    02120 Med. Institution - WD Req. 31 Dec 2019 16 Sep 2020        260 3B-114-01 Cardinal Health                  02500 Nuclear Pharmacies        10 Feb 2020 17 Apr 2020          67 3L-015-01 RI Dept of Transportation        03121 Meas Sys Port Gauge inc    20 Jul 2020 26 Oct 2020          98 Lixiscop 3L-142-01 ATC Associates Incorporated      03121 Meas Sys Port Gauge inc    31 Mar 2021 23 Jul 2021        114 Lixiscop Page 17 of 17}}

Latest revision as of 14:53, 18 January 2022

10-10-2021 Rhode Island Impep Questionnaire
ML21279A319
Person / Time
Issue date: 10/04/2021
From:
Office of Nuclear Material Safety and Safeguards
To:
Ford M
References
Download: ML21279A319 (17)


Text

ML21279A319 Approved by OMB1 Control No.: 3150-0183 Expires: 02/28/2023 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Rhode Island Agreement State Program Reporting Period: March 11, 2016 through October 22, 2021.

Note: If there has been no change in the response to a specific question since the last IMPEP questionnaire, the State or Region may copy the previous answer, if appropriate.

A. GENERAL

1. Please prepare a summary of the status of the State's or Region's actions taken in response to each of the open recommendations from previous IMPEP reviews.

B. COMMON PERFORMANCE INDICATORS I. Technical Staffing and Training

2. Please provide the following organization charts, including names and positions:

(a) A chart showing positions from the Governor down to the Radiation Control Program Director.

See Appendix A: Radiation Control Program Hierarchy Chart (b) A chart showing positions of the radiation control program, including management; and See Appendix B: RI Department of Health Organizational Structure Chart (c) Equivalent charts for sealed source and device evaluation, low-level radioactive waste, and uranium recovery programs, if applicable.

Not applicable for Rhode Island

3. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) full-time equivalents (FTE) applied to the radioactive materials program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, low-level radioactive waste, uranium recovery, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program.

If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts.

1 Estimated burden per response to comply with this voluntary collection request: 53 hours6.134259e-4 days <br />0.0147 hours <br />8.763227e-5 weeks <br />2.01665e-5 months <br />. Forward comments regarding burden estimate to the Records Management Branch (T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

Page 1 of 17

ML21279A319 NAME POSITION AREA OF EFFORT FTE2 Alexander Hamm Supervising Program Management & Policy 0.66 Radiological Review Health Spec.

Dennis Senior Inspection 0.44 Klaczynski Radiological Health Spec.

Thomas Caruolo Radiological Emergency Response; Licensing 0.70 Health Spec. (Reciprocity) & Inspection Maria Barnes Radiological Inspection & Licensing 0.51 Health Spec.

William Dundulis Risk Licensing; Regulations & Policy 0.56 Assessment Development Toxicologist

4. Please provide a listing of all new professional personnel hired into your radioactive materials program since the last review, indicate the date of hire; the degree(s) they received, if applicable; additional training; and years of experience in health physics or other disciplines, as appropriate.

Maria Barnes joined the Radiation Control Program as a Radiological Health Specialist on 3 April 2017.

Austin Olson joined the Radiation Control Program as a Supervising Radiological Health Specialist on 23 September 2019.

Alexander Hamm joined the Radiation Control Program as a Supervising Radiological Health Specialist on 11 April 2021.

5. Please list all professional staff who have not yet met the qualification requirements for a radioactive materials license reviewer or inspector. For each, list the courses or equivalent training/experience they need and a tentative schedule for completion of these requirements.

Maria Barnes has completed the NRC license reviewer training course and is fully qualified to review limited-scope medical, portable gauge and industrial radiography licenses. It is anticipated that she will be qualified to review additional license categories when appropriate renewal applications are submitted to Rhode Island. She has submitted applications for H-122 (Fundamental Health Physics I and II) and G-205 (Root Cause/

Incident Investigation Workshop). She also needs to complete H-201 (Advanced Health Physics).

Alexander Hamm has completed NRC inspector training course. He has submitted an application to attend the NRC license reviewer course. He is currently waiting on acceptance to this and other required training courses.

6. Identify any changes to your qualification and training procedure that occurred during the review period.

Rhode Island has adopted an inspector and materials license reviewer qualification program that is comparable to the most recent revision to IMC1248.

2 Total of 2.89 FTE based on time reported for July-September 2021. Average for SFY 2021 was 2.30 FTE.

Actual FTE utilized will vary slightly from quarter to quarter.

Page 2 of 17

ML21279A319

7. Please identify the technical staff that left your radioactive materials program during the review period and indicate the date they left.

Charma Waring (Supervising Radiological Health Specialist) resigned from the Radiation Control Program on 16 March 2019.

Austin Olson (Supervising Radiological Health Specialist) resigned from the Radiation Control Program on 14 March 2020.

8. List any vacant positions in your radioactive materials program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

Not applicable.

9. For Agreement States, does your program have an oversight board or committee which provides direction to the program and is composed of licensees and/or members of the public?

If so, please describe the procedures used to avoid any potential conflict of interest.

RI Gen. Laws § 23-1.3 Radiation advisory commission. - There is created an advisory commission to be known as the state radiation advisory commission, which shall consist of eleven (11) members.

The Commission was intended to function as an advisory group with the Agency having the discretion to accept or reject direction from the Commission. However, the Commission has not met during the current IMPEP cycle.

II. Status of Materials Inspection Program

10. Please identify individual licensees or categories of licensees the State is inspecting less frequently than called for in NRCs Inspection Manual Chapter (IMC) 2800 and explain the reason for the difference. The list only needs to include the following information: license category or licensee name and license number, your inspection interval, and rationale for the difference.

None of the Radiation Control Programs radioactive materials licenses are being inspected less frequently than called for in NRCs IMC 2800.

11. Please provide the number of routine inspections of Priority 1, 2, and 3 licensees, as defined in IMC 2800 and the number of initial inspections that were completed during each year of the review period.

See Appendix C: Initial/Routine Inspections - 2016-2021

12. Please submit a table, or a computer printout, that identifies inspections of Priority 1, 2, and 3 licensees and initial inspections that were conducted overdue.

Newport Hospital was conducted overdue on 28 April 2021. However, this inspection had been delayed because it was specifically requested to be one of the inspections included with the inspector field audit portion of this IMPEP.

13. Please submit a table or computer printout that identifies any Priority 1, 2, and 3 licensees and initial inspections that are currently overdue, per IMC 2800. At a minimum, the list should include the same information for each overdue inspection provided for Question 12 plus your action plan for completing the inspection. Also include your plan for completing the overdue inspections.

There are no overdue inspections per IMC 2800 as of 1 October 2021.

14. Please provide the number of reciprocity licensees that were candidates for inspection per year as described in IMC 2800 and indicate the number of reciprocity inspections of candidate licensees that were completed each year during the review period.

Page 3 of 17

ML21279A319 See Appendix D: Reciprocity Inspections - 2016-2021 In general, any Category A or Category B approvals would be a candidate for inspection, if they actually entered the state (i.e., some companies maintain a reciprocity approval just in case they need to provide short notice services for existing clients). Category C approvals are generally not candidates for inspection. However, they are reviewed on an individual basis (e.g., scope of work, client, past compliance history, etc.) to determine if they should be scheduled for a reciprocity inspection.

III. Technical Quality of Inspections

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

The Inspection Manual had several interim/draft revisions during the current IMPEP cycle.

The most current revision was completed in July 2021 and is compatible with IMC-2800 dated 2 March 2020.

See 2021 Rhode Island IMPEP Criteria Document Status for additional details.

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

See Appendix E: Accompaniments - 2016-2020

17. Describe or provide an update on your instrumentation, methods of calibration, and laboratory capabilities. Are all instruments properly calibrated at the present time? Were there sufficient calibrated instruments available throughout the review period?

The Radiation Control Program has updated survey equipment used to conduct field inspections and respond to incidents.

Instrument calibration is provided by equipment manufacturer and/or outside vendors. All field instruments are calibrated on at least an annual frequency and rotated such that sufficient quantities of instruments will be available for use during calibration periods.

Laboratory capabilities are limited-the State laboratory no longer has the capabilities to provide assistance with evaluating wipes or other field samples. The Radiation Control Program has an understanding with two broad scope licensees to provide limited laboratory assistance on an as-needed basis.

IV. Technical Quality of Licensing Actions

18. How many specific radioactive material licenses does your program regulate at this time?

See Appendix F: Current Licenses [42 specific licensees].

19. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification, or renewed in this period.

Rhode Island Hospital is our most complex licensee and had requested a number of significant license amendments during the period of this review.

While other licenses have been issued, renewed, terminated, or decommissioned during the period of this review, none of them would be considered complex or unusual licensing actions that required a disproportionate amount of staff effort for review. However, it should be noted that licensing certain new technologies (e.g., PET and PET/CT), where regulatory jurisdiction is shared with other Health Department agencies, does require a high degree of coordination (and some additional meetings) to ensure that no regulatory approvals are granted until all agencies are ready to proceed with licensing.

With the exception of the corporate reorganization (not technically a bankruptcy but did go Page 4 of 17

ML21279A319 through the Federal Bankruptcy Court) of Genesis/21st Century Oncology, there were no bankruptcy notifications submitted for RAM licensees during the period of this review.

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

No significant variances or exemptions were issued during the period of this review.

However, several licensees requested, and were granted, COVID-19-related variances in accordance with established NRC criteria.

21. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

Revised licensing checklists have been prepared for reviewer use. In addition, RI-specific regulatory guides (comparable to NUREG 1556 series) have been developed for a number of areas.

See 2021 Rhode Island IMPEP Criteria Document Status for additional details.

22. Identify by licensee name and license number any renewal applications that have been pending for one year or more. Please indicate why these reviews have been delayed and describe your action plan to reduce the backlog.

See Appendix G: Renewals Issued - 2016-2021.

There are currently no renewal applications pending in-house. However, at least one license will be due for renewal between the time this questionnaire is submitted to NRC and the IMPEP site visit is conducted.

With the exception of Rhode Island Hospital and Landmark Medical Center, review for the last of the backlogged renewal applications was completed in August 2017. With the exception of RI Emergency Management Agency (RIEMA), review of all renewal applications received during the current IMPEP cycle was completed well within a year of receipt.

Rhode Island Hospitals original renewal application had been submitted on 30 July 2002 and was not initially reviewed. A file audit conducted in August 2007 determined that formal review of renewal had not been initiated but that the licensee had submitted 20 amendment requests in the proceeding 5 year period. On 7 August 2007 the licensee was requested to review all amendment requests and submit a revised renewal application.

Apparently RIH did not respond to this inquiry and the renewal per-se was never reviewed, although a number of subsequent license amendments were reviewed and processed. A revised renewal request was subsequently submitted by the new RSO on 6 July 2015.

Review had been initiated when Rhode Island was approached by the licensee about merging the existing Gamma Knife license into the broad scope license during the renewal process. After a series of back and forth discussions about what would be required to merge the licenses, the licensee ultimately decided to keep the licenses separate. Review of the renewal request was resumed, and the renewal was ultimately issued on 9 April 2018. In addition to the renewal review and license merger discussions Rhode Island also processed a total of 5 amendments to the license from 6 July 2015-9 April 2018.

Landmarks original renewal application had been submitted on 28 August 2014. An additional information letter was generated on 14 October 2014. The response dated 6 January 2015 did not resolve all outstanding issues. The matter became further complicated when Landmarks corporate parent announced its intent to convert the hospital from a not-for-profit to a for-profit facility. Because this action required review and approval from other agencies within the RI Department of Health, the renewal was placed on-hold pending the outcome of this review. No further action was taken until January 2018 when the RCP Page 5 of 17

ML21279A319 was notified that other agencies within the Department had approved the previously requested change in status but that a new petition had been received to return Landmark to a not-for-profit status. An additional information letter was sent on 6 January 2018 requesting clarification of status. However, a response was not received until 21 August 2018. At this point, the renewal clock was reset, and another round of additional information letter and reply was necessary until the renewal was actually issued on 19 October 2018.

RIEMAs 30 May 2016 submittal to renew license 8A-009-01 also included a request to consolidate (and subsequently terminate) RAM covered under license 8A-009-02.

Additional review of the renewal application was put on-hold pending action to combine all RAM possessed by RIEMA onto the 8A-009-01 license and termination of 8A-009-02 license. An amendment to terminate 8A-009-02 was issued on 8 March 2017. Several rounds of additional information letters and licensee responses were necessary before a renewal could be issued for 8A-009-01 on 19 December 2017. Although the total time to complete the renewal process was 557 days, the actual renewal review (after consolidation and termination) was completed in 286 days.

V. Technical Quality of Incident and Allegation Activities

23. For Agreement States, please provide a list of any reportable incidents not previously submitted to NRC (See Procedure SA-300, Reporting Material Events, for additional guidance, OMB clearance number 3150-0178).

All reportable events have been previously submitted to NMED

24. Identify any changes to your procedures for responding to incidents and allegations that occurred during the period of this review.

No changes to our protocols for handling incidents or allegations were implemented during the period of this review. However, all of the Radiation Control Program staff attended a SA-300 workshop conducted by NRC which provided a greater understanding of how to handle incidents and allegations.

C. NON-COMMON PERFORMANCE INDICATORS I. Compatibility Requirements

25. Please list all currently effective legislation that affects the radiation control program. Denote any legislation that was enacted or amended during the review period.

All specific enabling authority for Radiation Control Program is pursuant to RI Gen. Laws Chapter 23-1.3 - Radiation Control. [http://www.rilin.state.ri.us/Statutes/TITLE23/23-1.3/

INDEX.HTM]. There have been no changes to our enabling legislation during the period of this review.

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

The Radiation Control Programs regulations are subject to sunset requirements. The RCP must refile their regulations every five years. The Program last completed a refiling in January 2017. The next refiling is scheduled for 2022.

27. Please review and verify that the information in the enclosed State Regulation Status (SRS) sheet is correct. For those regulations that have not been adopted by the State, explain why they were not adopted, and discuss actions being taken to adopt them. If legally binding requirements were used in lieu of regulations and they have not been reviewed by NRC for compatibility, please describe their use.

Page 6 of 17

ML21279A319 Rhode Island verifies that the information contained in the State Regulation Status sheet is correct. Rhode Island has adopted all changes through RATS 2015-5.

28. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.

No amendments are beyond the three year timeline at this time.

RATS 2018-1, 2018-2, 2018-3, 2019-1, 2019-2, 2020-1, 2020-2, 2020-3 and 2021-1 are anticipated to be adopted prior to their effective dates. Amendments addressing RATS 2018-1, 2018-2, 2018-3, 2019-1, 2019-2, 2020-1, 2020-2 and 2020-3 were to have been included in a rulemaking package that was delayed due to a hold that was placed on all non-emergency rulemaking during the COVID-19 crises. The rulemaking package has recently been submitted to the Departments Rules Coordinator to initiate promulgation. Projected timeline is unknown at this time, but it is anticipated that rules could be in effect by the end of calendar 2021. No additional actions will be required to implement RATS 2021-1. The majority of the amendments involve changes to sections that Rhode Island has incorporated by reference, and the one remaining change has already been addressed in the pending rulemaking package.

II. Sealed Source and Device (SS&D) Evaluation Program NOT APPLICABLE FOR RHODE ISLAND

29. Prepare a table listing new and amended (including transfers to inactive status) SS&D registrations of sources and devices issued during the review period.
30. Please include information on the following questions in Section A, as they apply to the SS&D Program:

Technical Staffing and Training - Questions 2-9 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24 III. Low-level Radioactive Waste Disposal Program NOT APPLICABLE FOR RHODE ISLAND

31. Please include information on the following questions in Section A, as they apply to the Low-Level Radioactive Waste Disposal Program:

Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24 IV. Uranium Recovery Program NOT APPLICABLE FOR RHODE ISLAND

32. Please include information on the following questions in Section A, as they apply to the Uranium Recovery Program:

Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Page 7 of 17

ML21279A319 Technical Quality of Incident and Allegation Activities - Questions 23-24 Page 8 of 17

ML21279A319 Appendix C Radiation Control Program - Initial/Routine Inspections 2016-2021 License # Licensee NRC License Type Date of Inspection Priority 3B-114-01 Cardinal Health 02500 10/26/2018 2 3B-114-01 Cardinal Health 02500 04/29/2021 2 3D-005-01 Electric Boat Corporation 03320 10/14/2016 1 3D-005-01 Electric Boat Corporation 03320 12/18/2017 1 3D-005-01 Electric Boat Corporation 03320 01/22/2019 1 3D-005-01 Electric Boat Corporation 03320 12/03/2019 1 3D-005-01 Electric Boat Corporation 03320 12/05/2020 1 3D-005-01 Electric Boat Corporation 03320 04/27/2021 1 3D-065-01 Thielsch Engineering 03320 06/02/2017 1 3D-065-01 Thielsch Engineering 03320 08/22/2018 1 3D-065-01 Thielsch Engineering 03320 09/10/2019 1 3D-065-01 Thielsch Engineering 03320 08/14/2020 1 3D-065-01 Thielsch Engineering 03320 08/31/2021 1 3D-117-02 OST Services 03320 11/21/2017 1 3D-117-02 OST Services 03320 12/11/2018 1 3D-117-02 OST Services 03320 11/01/2019 1 3D-117-02 OST Services 03320 04/30/2021 1 3D-149-01 Sky Testing 03320 10/26/2020 1 3D-150-01 National Inspection Consultants 03320 12/04/2020 1 3E-100-01 Rhode Island Blood Center 03510 09/28/2020 5 3K-036-01 Brown University 01100 09/12/2017 3 3K-036-01 Brown University 01100 07/15/2021 3 3K-040-01 University of Rhode Island 01100 05/17/2017 3 3K-040-01 University of Rhode Island 01100 09/10/2019 3 3K-040-01 University of Rhode Island 01100 05/17/2021 3 Page 9 of 17

ML21279A319 License # Licensee NRC License Type Date of Inspection Priority 3K-045-03 Women & Infants Hospital 03620 09/08/2017 5 3K-126-01 Ocean State Veterinary Services 02400 12/27/2017 5 3K-136-01 VeroScience 03620 11/17/2020 5 3K-151-01 Big River Veterinary Service 02400 07/08/2021 5 3L-015-01 RIDOT 03121 07/28/2021 5 3L-050-01 Geisser Engineering 03121 06/11/2021 5 3L-065-02 Thielsch Engineering (Gauges) 03121 12/04/2018 5 3L-079-01 GZA GeoEnvironmenal 03121 04/24/2018 5 3L-083-01 Briggs Engineering and Testing 03121 12/10/2018 5 3L-119-01 Terracon Consultants 03121 12/19/2018 5 3L-142-01 ATC Group Services 03121 07/26/2019 5 3L-146-01 Huestis Engineering 03220 09/01/2020 5 3L-147-01 Casali Engineering 03121 12/20/2018 5 3L-148-01 Civil and Environmental Consultants 03121 04/02/2018 5 7A-051-02 Rhode Island Hospital (GK) 02310 April 2016 2 7A-051-02 Rhode Island Hospital (GK) 02310 11/15/2018 2 7B-012-01 South County Hospital 02120 09/07/2017 3 7B-012-01 South County Hospital 02120 07/27/2021 3 7B-016-01 Newport Hospital 02120 03/22/2017 3 7B-016-01 Newport Hospital 02120 04/28/2021 3 7B-019-01 Landmark Hospital 02120 04/05/2018 3 7B-020-01 Kent Hospital 02120 03/25/2016 3 7B-020-01 Kent Hospital 02120 12/11/2019 3 7B-035-01 Westerly Hospital 02120 06/23/2016 3 7B-035-01 Westerly Hospital 02120 09/26/2019 3 7B-038-03 NorthMain Radiation Oncology 02230 05/09/2016 2 7B-038-03 NorthMain Radiation Oncology 02230 08/28/2018 2 7B-038-03 NorthMain Radiation Oncology 02230 07/30/2021 2 Page 10 of 17

ML21279A319 License # Licensee NRC License Type Date of Inspection Priority 7B-053-02 SNERCC 02230 10/13/2016 2 7B-073-02 Richard Sanantonio, MD 02201 08/24/2017 5 7B-120-01 John D Lowney (Medical Group of RI) 02201 12/15/2020 5 7B-125-01 Cardiovascular Associates of RI 02201 05/17/2018 5 7B-131-01 Rhode Island P.E.T. Services 02220 08/25/2017 2 7B-131-01 Rhode Island P.E.T. Services 02220 08/30/2019 2 7B-134-01 Hartford Healthcare Medical Group 02201 11/21/2017 5 7B-137-01 Cardiovascular Institute of New England 02201 03/12/2018 5 7B-139-01 Roger Williams Radiation Therapy 02230 11/22/2017 2 7B-139-01 Roger Williams Radiation Therapy 02230 11/26/2019 2 7B-144-01 JNA Associates 02201 11/18/2020 5 7B-144-01 JNA Associates 02201 06/22/2021 5 7B-145-01 Ocean State Cardio and Vein Center 02201 12/02/2020 5 7D-026-01 Roger Williams Medical Center 02110 03/07/2017 2 7D-026-01 Roger Williams Medical Center 02110 01/31/2019 2 7D-051-01 Rhode Island Hospital 02110 04/27/2016 2 7D-051-01 Rhode Island Hospital 02110 12/05/2018 2 8A-009-01 RIEMA 03710 12/13/2018 5 Page 11 of 17

ML21279A319 Appendix D Reciprocity Inspections - 2016-2021 PRIORITY 2016 2017 2018 2019 2020 2021*

Category A Reciprocity 3 5 5 5 3 4 Category B Reciprocity 2 2 4 4 4 3 Total A & B Reciprocity 5 7 9 9 7 7 Authorizations Inspections Conducted 3 (60%) 3 (43%) 3 (34%) 3 (34%) 0 2 (29%)

Category C Reciprocity 1 5 4 12 13 6

  • Reciprocity as of 1 October 2021 Page 12 of 17

ML21279A319 Appendix E Accompaniments - 2016 to 2020 INSPECTOR REVIEWER LICENSE CATEGORY DATE Maria Barnes William Dundulis 02201 Med. Private Prac. - no WD Req. 21 Nov 2017 Maria Barnes William Dundulis 03320 Indust. Radiography 22 Aug 2018 Charma Waring William Dundulis 02310 Stereotactic Radiosurgery 10 Oct 2018 Maria Barnes William Dundulis 03510 Irrad. Self-Shield < 370 TBq 5 Dec 2018 Maria Barnes Dennis Klaczynski 02120 Med. Institution - WD Req. 11 Dec 2019 William Dundulis Dennis Klaczynski 02230 Med. Private Prac. - WD req. 12 Dec 2019 Tom Caruolo Dennis Klaczynski 03320 Indust. Radiography 05 Dec 2019 Dennis Klaczynski William Dundulis 03320 Indust. Radiography 30 Dec 2019 Tom Caruolo Dennis Klaczynski 03620 R&D Limited Scope 17 Nov 2020 Maria Barnes Dennis Klaczynski 02201 Med. Private Prac. - no WD Req. 18 Nov 2020 Page 13 of 17

ML21279A319 Appendix F Current List of Radioactive Materials Licensees LICENSE # LICENSEE NRC LICENSE TYPE 3B-114-01 Cardinal Health 02500 Nuclear Pharmacies 3D-005-01 Electric Boat Corporation 03320 Indust. Radiography Temp Jobsite 3D-065-01 Thielsch Engineering Inc 03320 Indust. Radiography Temp Jobsite 3D-117-02 OST Services (OSTS) 03320 Indust. Radiography Temp Jobsite 3D-149-01 Sky Testing Services Inc 03320 Indust. Radiography Temp Jobsite 3D-150-01 National Inspection & Consultants 03320 Indust. Radiography Temp Jobsite 3E-100-01 Rhode Island Blood Center 03510 Irrad. Self-Shield < 370 TBq 3K-036-01 Brown University 01100 Academic Type A Broad 3K-040-01 University Of Rhode Island 01100 Academic Type A Broad 3K-045-03 Women And Infants Hospital 03620 Research/Development Other 3K-126-01 Ocean State Veterinary Specialists 02400 Veterinary Nonhuman 3K-136-01 Vero Science LLC 03620 Research/Development Other 3K-151-01 Big River Veterinary Service 02400 Veterinary Nonhuman 3L-015-01 RI Dept of Transportation 03121 Meas Sys Port Gauge inc Lixiscop 3L-050-01 Geisser Engineering Corporation 03121 Meas Sys Port Gauge inc Lixiscop 3L-065-02 Thielsch Engineering Inc 03121 Meas Sys Port Gauge inc Lixiscop 3L-079-01 GZA Geoenvironmental Inc 03121 Meas Sys Port Gauge inc Lixiscop 3L-083-01 PK Associates 03121 Meas Sys Port Gauge inc Lixiscop 3L-096-01 Professional Service Industries Inc 03121 Meas Sys Port Gauge inc Lixiscop 3L-119-01 Terracon Consultants Inc 03121 Meas Sys Port Gauge inc Lixiscop 3L-142-01 ATC Associates Incorporated 03121 Meas Sys Port Gauge inc Lixiscop 3L-146-01 Huestis Machine Corporation 03220 Leak Test Services Only 3L-147-01 Joe Casali Engineering Inc 03121 Meas Sys Port Gauge inc Lixiscop 3L-148-01 Civil & Environmental Consultants 03121 Meas Sys Port Gauge inc Lixiscop 7A-051-02 Rhode Island Hospital 02310 Stereotactic Radiosurgery 7B-012-01 South County Hospital 02121Med. Institution - no WD Req.

7B-016-01 Newport Hospital 02120 Med. Institution - WD Req.

7B-019-01 Landmark Medical Center 02121 Med. Institution - no WD Req.

7B-020-01 Kent Hospital 02120 Med. Institution - WD Req.

7B-035-01 Westerly Hospital 02121 Med. Institution - no WD Req.

7B-038-03 NorthMain Radiation Oncology 02230 High-Med-Pulsed Dose Afterload 7B-073-02 Richard P Sanantonio MD 02201 Med. Private Prac. - no WD Req.

7B-120-01 John D Lowney DO 02201 Med. Private Prac. - no WD Req.

7B-125-01 Cardiovascular Associates of Rhode 02201 Med. Private Prac. - no WD Req.

Island 7B-131-01 Rhode Island P.E.T. Services LLC 02220 Mobile Nuclear Medicine Serv.

7B-134-01 Hartford Healthcare Medical Group 02201 Med. Private Prac. - no WD Req.

7B-137-01 Cardiovascular Institute of New 02201 Med. Private Prac. - no WD Req.

England PC 7B-139-01 Roger Williams Radiation Therapy 02230 High-Med-Pulsed Dose Afterload LLC Page 14 of 17

ML21279A319 LICENSE # LICENSEE NRC LICENSE TYPE 7B-145-01 Ocean State Cardiovascular & Vein 02201 Med. Private Prac. - no WD Req.

Center 7D-026-01 Roger Williams Medical Center 02110 Med. Institution Broad 7D-051-01 Rhode Island Hospital 02110 Med. Institution Broad 8A-009-01 RI Emergency Management Agency 03710 Civil Defense Page 15 of 17

ML21279A319 Appendix G:

Renewals Issued - 2016-2021 DATE DATE REVIEW LICENSE # LICENSEE NRC LICENSE TYPE RECEIVED APPROVED DAYS 7B-043-01 Memorial Hospital of Rhode Island 02120 Med. Institution - WD Req. 30 Mar 2012 06 Oct 2016 1651 3D-005-01 Electric Boat Corporation 03320 Indust. Radiography Temp 31 May 2012 29 Nov 2016 1643 7D-045-02 Women and Infants Hospital3 02110 Med. Institution Broad 25 Oct 2012 05 May 2017 1653 3L-065-02 Thielsch Engineering, Inc. 03121 Meas Sys Port Gauge inc 21 May 2013 28 Aug 2017 1560 7B-131-01 Rhode Island P.E.T. Services, LLC 02220 Mobile Nuclear Medicine 20 Mar 2014 21 Jun 2017 1189 Serv.

3L-107-01 Paul B Aldinger & Associates Inc 03121 Meas Sys Port Gauge inc 19 Aug 2014 31 July 2017 1077 3L-096-01 Professional Service Industries, Inc. 03121 Meas Sys Port Gauge inc 26 Feb 2015 28 Feb 2017 733 7D-051-01 Rhode Island Hospital 02110 Med. Institution Broad 6 Jul 2015 9 Apr 2018 1008 3E-100-01 Rhode Island Blood Center 03510 Irrad. Self-Shield < 370 20 Jan 2016 20 Jan 2017 366 7B-035-01 LMW Healthcare Inc dba The Westerly 02120 Med. Institution - WD Req. 7 Jun 2016 13 Oct 2016 128 Hospital 8A-009-01 RI Emergency Management Agency 03710 Civil Defense 10 Jun 2016 19 Dec 2017 557 3L-050-01 Geisser Engineering Corporation 03121 Meas Sys Port Gauge inc 13 Jun 2016 07 Feb 2017 239 3L-119-01 Terracon Consultants Inc 03121 Meas Sys Port Gauge inc 22 Jun 2016 26 May 2017 338 3K-036-01 Brown University 01100 Academic Type A Broad 23 Jun 2016 12 Dec 2016 55 3K-126-01 Ocean State Veterinary Specialists 02400 Veterinary Nonhuman 24 Aug 2016 20 Sep 2016 27 7B-137-01 Cardiovascular Institute of New England PC 02201 Med. Private Prac. - no 28 Nov 2016 23 Mar 2017 115 WD Req.

3K-040-01 University of Rhode Island 01100 Academic Type A Broad 21 Feb 2017 3 May 2017 71 7B-134-01 Hartford HealthCare Medical Group 02201 Med. Private Prac. - no 23 Feb 2017 1 Jun 2017 98 WD Req.

3K-136-01 Vero Science LLC 03620 Research/Development 25 Jul 2017 3 Aug 2017 9 Other 3D-065-01 Thielsch Engineering, Inc. 03320 Indust. Radiography Temp 8 Aug 2017 19 Sep 2017 42 Jobsite 3

Women & Infants license 7D-045-02 was terminated as part of the renewal process due to a decrease in the scope of activity to be conducted under the license. A new license 3K-045-03 [license type 03620] was issued in lieu of a renewal.

Page 16 of 17

ML21279A319 DATE DATE REVIEW LICENSE # LICENSEE NRC LICENSE TYPE RECEIVED APPROVED DAYS 7B-125-01 Cardiovascular Associates of RI 02201 Med. Private Prac. - no 30 Apr 2018 27 Jul 2018 88 WD Req.

7B-139-01 Roger Williams Radiation Therapy 02230 High-Med-Pulsed Dose 7 Aug 2018 05 Nov 2018 90 3L-083-01 PK Associates 03121 Meas Sys Port Gauge inc 9 Aug 2018 25 Sep 2018 47 Lixiscop 7B-073-02 Richard Sanantonio, MD 02201 Med. Private Prac. - no 10 Aug 2018 16 Oct 2018 67 WD Req.

7B-019-01 Landmark Medical Center 02120 Med. Institution - WD Req. 21 Aug 2018 19 Oct 2018 29 7B-016-01 Newport Hospital 02120 Med. Institution - WD Req. 1 Mar 2019 24 Apr 2019 55 7B-012-01 South County Hospital 02120 Med. Institution - WD Req. 23 Apr 2019 23 May 2019 30 7B-020-01 Kent Hospital 02120 Med. Institution - WD Req. 31 Dec 2019 16 Sep 2020 260 3B-114-01 Cardinal Health 02500 Nuclear Pharmacies 10 Feb 2020 17 Apr 2020 67 3L-015-01 RI Dept of Transportation 03121 Meas Sys Port Gauge inc 20 Jul 2020 26 Oct 2020 98 Lixiscop 3L-142-01 ATC Associates Incorporated 03121 Meas Sys Port Gauge inc 31 Mar 2021 23 Jul 2021 114 Lixiscop Page 17 of 17