ML21319A203

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10-28-2021 Minnesota Impep Questionnaire
ML21319A203
Person / Time
Issue date: 10/28/2021
From:
Office of Nuclear Material Safety and Safeguards
To:
Ford M
References
Download: ML21319A203 (25)
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Text

I. Technical Staffing and Training

2. Attached are organization charts for the MDH Radiation Control Program
3. The following is a summary of the Radioactive Materials Unit's current staffing level.

Radioactive Materials Staffing Plan Name Position Area of Effort FTE%

Administration 70 Sherrie Flaherty Supervisor Materials Licensing and Compliance 20 Emergency Response 10 Administration (Rules) 10 Brandon Juran Industrial Hygienist 3 Materials Licensing and Compliance 75 Emergency Response 10 Administration (Env Monitoring & 20 GLs)

Lynn Fortier Industrial Hygienist 2 Materials Licensing and Compliance 50 Emergency Response 8 Administration 15 Tyler Kruse Industrial Hygienist 3 Materials Licensing and Compliance 60 Emergency Response 8 Administration (Instruments)

Vacant (2020) Industrial Hygienist 1 Materials Licensing and Compliance Emergency Response Administration Vacant (2017) Industrial Hygienist 1 Materials Licensing and Compliance Emergency Response Administration 1.15 Totals (FTE) Materials Licensing and Compliance 2.05 Emergency Response 0.36

4. During this review period Minnesota hired one staff member for the Radioactive Materials Program. August of 2018, Bridget Bobick was hired as an Industrial Hygienist I. She has a Bachelor of Science in Environmental Science. Ms. Bobicks work experience includes working with a consulting company and performing site assessments.
5. All technical staff are fully qualified for inspection and license review.
6. During the review period no changes to the MDH qualification and training procedures were made.
7. During the review period the following MDH staff members have left the Radioactive Materials Unit:

Matt Duff March 2017 Martha Steinhart June 2018 Bridget Bobick August 2020

8. There are two vacancies in the program at this time. One position has been open since March 2017, the other August 2020.

The program has been unable to post an open position due to a lack of revenue.

Statutory changes approved in 2021 have provided an increase in fees and appropriations to the program. In addition, during the public health emergency, the state imposed a hiring freeze and only positions related to COVID-19 response were posted. The program plans to post a position when state hiring freeze is lifted and management approves posting the position, estimated to be spring of 2022.

9. MDH has no oversight board or committee.

II. Status of Material Inspection Program

10. All MDH Radioactive Materials licenses are being inspected at the frequency listed in IMC 2800 except for reciprocity inspections. In 2019, the Program implemented a process for identifying reciprocity candidates. The process assigns a score to each reciprocity licensee based on risk factors including program code, inspection history, recent incidents or allegations, new/unique technology use, and others. Licensees with a score above the threshold set by the program are considered a candidate for inspection within the calendar year.
11. The following is a summary of the 2017-2021 inspections:

2017: Routine Inspections Priority 1 14 Priority 2 5 Priority 3 12 Priority 5 13 TOTAL 44 Initial Inspections*

Priority 1 0 Priority 2 0 Priority 3 0 Priority 5 0 TOTAL 0 2018: Routine Inspections Priority 1 8 Priority 2 14 Priority 3 8 Priority 5 22 TOTAL 52 Initial Inspections*

Priority 1 1 Priority 2 0 Priority 3 0 Priority 5 1 TOTAL 2

  • All new licenses are inspected within 12 months.

2019: Routine Inspections

Priority 1 13 Priority 2 3 Priority 3 8 Priority 5 22 TOTAL 46 Initial Inspections*

Priority 1 0 Priority 2 0 Priority 3 0 Priority 5 2 TOTAL 2

  • All new licenses are inspected within 12 months.

2020: Routine Inspections Priority 1 4 Priority 2 4 Priority 3 2 Priority 5 6 TOTAL 16 Initial Inspections*

Priority 1 0 Priority 2 0 Priority 3 0 Priority 5 2 TOTAL 2

  • All new licenses are inspected within 12 months.

2021: Routine Inspections Completed through October 27, 2021 Priority 1 5 Priority 2 1 Priority 3 2 Priority 5 5 TOTAL 13 Initial Inspections*

Priority 1 1 Priority 2 0 Priority 3 0 Priority 5 1 TOTAL 2

  • All new licenses are inspected within 12 months.
12. During this review period no inspections of Priority 1, 2, or 3 were performed overdue prior to the COVID-19 public health emergency.

In April of 2020, all inspections activities were suspended because of the COVID-19 pandemic and statewide restrictions. In addition, MDH staff were being reassigned to COVID-19 response activities for the agency and unavailable for routine duties, like inspections. As a result 16 inspections were performed overdue and currently there are 9 inspections overdue.

Policies and procedures were developed within the agency to ensure public health, safety, and security while protecting staff. A Temporary Inspection Policy was developed in September of 2020, and updated in March of 2021, to address inconsistencies with IMC 2800. The Unit acknowledges that some inspections will go overdue due to the pandemic. The policy is designed to assist the Unit in getting caught up on overdue inspections in a timely process.

The following Priority 1, 2, and 3 inspections were performed overdue:

  • Fairview Southdale Hospital (1039) o Priority 2 o Inspection due date 3/14/2020 o Overdue date 3/14/2021 o Inspection performed 9/8/2021 o Overdue days 178 o Inspection findings issued 9/29/2021 - minor violations
  • St. Josephs Medical Center (1061) o Priority 3 o Inspection due date 3/7/2020 o Overdue date 3/7/2021 o Inspection performed 7/14/2021 o Overdue days 129 o Inspection findings issued 7/20/2021 no violations
  • Ridgewater College (1076) o Priority 1 o Inspection due date 3/13/2020 o Overdue date 9/13/2020 o Inspection performed 6/1/2021 o Overdue days 281 o Inspection findings issued 7/14/2021 - minor violations
  • T.A. Schifsky & Sons (1241) o Priority 5 o Initial Inspection due date 6/27/2020 o Overdue date 6/27/2020 o Inspection performed 3/11/2021

o Overdue days 257 o Inspection findings issued 5/27/2021 - minor violations

  • Mistras Group (1242) o Priority 1 o Initial Inspection due date 7/29/2020 o Overdue date 7/29/2020 o Inspection performed 4/8/2021 o Overdue days 253 o Inspection findings issued 5/10/2021 - minor violations
  • Chart Industries (1075) o Priority 1 o Inspection due date 11/4/2020 o Overdue date 5/4/2021 o Inspection performed 8/12/2021 o Overdue days 101 o Inspection findings issued 8/26/2021 - no violations
  • American Engineering Testing, Inc (1089) o Priority 1 o Inspection due date 5/29/2020 o Overdue date 11/29/2020 o Inspection performed 6/30/2021 o Overdue days 217 o Inspection findings issued 7/14/2021 - no violations
  • Lake Region Healthcare o Priority 3 o Inspection due date 3/8/2020 o Overdue date 3/8/2021 o Inspection performed 7/13/2021 o Overdue days 127 o Inspection findings issued 7/28/2021 - minor violations
  • Braun Intertec Corporation o Priority 1 o Inspection due date 8/2/2020 o Overdue date 2/2/2021 o Inspection performed 7/30/2021 o Overdue days 182 o Inspection findings issued 8/23/2021 - minor violations
  • Hennepin County Medical Center (1164) o Priority 2 o Inspection due date 4/18/2020 o Overdue date 4/18/2021 o Inspection performed 9/23/2021 o Overdue days 157

o Inspection findings issued 9/29/2021 - minor violations

  • Ridgeview Medical Center (1063) o Priority 3 o Inspection due date 5/17/2020 o Overdue date 5/17/2021 o Inspection performed 10/14/2021 o Overdue days 150 o Inspection findings not issued as of 10/27/2021
  • Jubilant Draximage, Inc (1023) o Priority 2 o Inspection due date 5/31/202 o Overdue date 5/31/2021 o Inspection performed 9/14/2021 o Overdue days 106 o Inspection findings issued 9/27/2021 - no violations
  • PETNET Solutions, Inc (1017) o Priority 2 o Inspection due date 7/11/2020 o Overdue date 7/11/2021 o Inspection performed 10/18/2021 o Overdue days 99 o Inspection findings not issued as of 10/27/2021
  • PETENT Solutions, Inc (1228) o Priority 2 o Inspection due date 7/11/2020 o Overdue date 7/11/2021 o Inspection performed 10/18/2021 o Overdue days 99 o Inspection findings not issued as of 10/27/2021
  • Mayo Clinic (1047) o Priority 2 o Inspection due date 10/22/2020 o Overdue date 10/22/2021 o Inspection performed 10/26/2021 o Overdue days 4 o Inspection findings not issued as of 10/27/2021
  • Mayo Clinic (1229) o Priority 2 o Inspection due date 10/22/2020 o Overdue date 10/22/2021 o Inspection performed 10/26/2021 o Overdue days 4 o Inspection findings not issued as of 10/27/2021
13. The following Priority 1, 2, and 3 inspections are currently overdue:
  • Suburban Imaging (1068) o Priority 3 o Inspection due date 2/1/2020 o Overdue date 2/1/2021 o Scheduled for inspection 11/4/2021
  • Cleveland-Cliffs Minorca Mine, Inc (1088) o Priority 2 o Inspection due date 6/5/2020 o Overdue date 6/5/2021
  • Acuren Inspection (1191) o Priority 1 o Inspection due date 1/6/2021 o Overdue date 7/6/2021
  • Minnesota Oncology-Hematology Professional Associates (1016) o Priority 2 o Inspection due date 8/8/2020 o Overdue date 8/8/2021
  • Central Minnesota Diagnostic, Inc (1046) o Priority 3 o Inspection due date 8/21/2020 o Overdue date 8/21/2021
  • Park Nicollet Methodist Hospital (1052) o Priority 2 o Inspection due date 8/22/2020 o Overdue date 8/22/2021
  • Team Industrial Services, Inc (1192) o Priority 1 o Inspection due date 3/9/2021 o Overdue date 9/9/2021
  • Cardinal Health 414, LLC (1045) o Priority 2 o Inspection due date 10/9/2020 o Overdue date 10/9/2021
  • Element Materials Technology (1231) o Priority 1 o Inspection due date 10/24/2020 o Overdue date 4/24/2021 o Scheduled for inspection 11/5/2021
14. Reciprocity Inspections

2017 Reciprocity Reciprocity Licensees Entering Minnesota Priority 1, 2, and 3 13 Priority 5 26 TOTAL 39 Reciprocity Inspections Priority 1, 2, and 3 6 (46.1%)

Priority 5 5 (19.2%)

TOTAL 11 (28.2%)

2018 Reciprocity Reciprocity Licensees Entering Minnesota Priority 1, 2, and 3 11 Priority 5 26 TOTAL 37 Reciprocity Inspections Priority 1, 2, and 3 5 (45.5%)

Priority 5 1 (3.8%)

TOTAL 6 (16.2%)

2019 Reciprocity Reciprocity Licensees Entering Minnesota Priority 1, 2, and 3 11 Priority 5 21 TOTAL 32 Reciprocity Inspections Priority 1, 2, and 3 5 (45.5%)

Priority 5 0 (0%)

TOTAL 5 (15.6%)

In accordance with the 2020 changes to IMC 2800, the unit implemented a new procedure for identifying which reciprocity licensees were considered candidates for inspection. The new procedure was implemented in 2020.

2020 Reciprocity Reciprocity Candidates Identified 22 Reciprocity Candidate Inspections 2 (9%)

2021 Reciprocity as of October 27, 2021 Reciprocity Candidates Identified 20 Reciprocity Candidate Inspections 1 (5%)

RADIOACTIVE MATERIALS UNIT Evaluate the licensees remote capabilities (Skype, Teams, ability to scan and email documents, sending Remote Inspection encrypted documents, any access restrictions for the onsite portion of Process the inspection, etc.)

Develop a plan with the licensee for the inspection. Determine what can Process for minimizing MDH inspectors on- be done remotely and what will site inspection of radioactive materials likely need to be done on-site.

licensees. Consider setting up remote Inspection Prep interviews with other members Review necessary documents of the licensees program (ROs, License RSOs, users, technologists, Previous inspection report physicists, etc.)

Amendments since the last Remote Inspection inspection Per the plan in the previous step, gather Any WBL attachments in the draft all possible information to complete the inspection page inspection report remotely. Examples:

Fill out the Cover and Pre Cover and Scope tabs on the Inspection tabs of the report Inspection Report Initial Phone Call Video tour the facility and storage Call the licensee contact Interview other licensee personnel Identify yourself and the purpose of The licensee may scan and email the call records for the inspector. Avoid Emphasize MDHs desire to conduct receiving records with personal, the inspection with as little on-site sensitive, or security information via contact as possible email without encryption.

Assess the licensed facilitys COVID- Note: RAM unit staff will destroy 19 risk to the inspector using the any records submitted by the Pre-Inspection Screening Form Step licensee after they have been 1 reviewed and are no longer If the licensee does not meet the needed for the inspection.

screening criteria, save the Review with the licensee the items of document to WBL as Attempt the inspection you were unable to 1 complete remotely and develop a plan After 14 days, a 2nd attempt to efficiently cover those items during should be made an on-site visit.

After 3 failed attempts, contact Schedule an On-site Visit/Field the Unit Supervisor for guidance.

Layout the scope of the inspection Inspection to the licensee Review with the licensee what to expect regarding social distancing and personal

REMOTE INSPECTIONS PROCEDURES protective equipment (PPE) from MDH when on-site Inspector COVID Evaluation Inspectors will not perform an onsite Inspector(s) will be wearing a mask inspection if; while on-site They are experiencing COVID-19 There will be no unnecessary related symptoms such as; reference physical contact (handshakes, etc.)

CDC website.

Review with the licensee what MDH They have had close contact with a expects from the licensee, regarding lab confirmed COVID 19 case within social distancing and PPE while on-site the last 14 days.

Ask to see the licensees Workplace Anyone in their household is Covid-19 Plan experiencing COVID-19 related Keeping physical distance symptoms such as; reference CDC No unnecessary physical contact website.

(handshakes, etc.)

If an inspector begins to feel unwell Entrance and exit briefings should during the inspection, they will leave have no more than 10 people in a immediately.

room. Meetings should be held in rooms large enough to allow for Onsite Protocol social distancing. Whenever possible, the inspector will Assess the licensees ability to provide maintain a minimum physical distance an appropriate environment that meets of 6-feet from others MDH and CDC guidelines for limiting the The inspector will wear a cloth face spread of disease. covering Reserving a private workspace for The inspector will not participate in any MDH inspectors that allows social unnecessary physical contact distancing from other personnel (handshakes, etc.)

Having unessential personnel The inspector will avoid unnecessarily temporarily vacate areas in which touching of surfaces. For example:

the inspector requires access The licensee should handle all paper Complete Health Screening records and files The licensee should handle any Form equipment (survey meters, licensed Prior to the inspection (no more than 24 devices, etc.)

hours), contact the licensee to complete The inspector will abide by any Step 3 of the Pre-Inspection Screening additional precautions enacted by the Form. licensee If the licensee fails Step 3, cancel the Meetings with licensee personnel will on-site inspection and save the form be limited to 10 people or less. Multiple to WBL as Attempt number 1, 2, or meetings can be held if necessary to

3. accommodate for larger groups.

Contact the licensee at least 14 days Exit briefings may be held remotely later, and restart the pre-inspection (via skype or teams) after the on-site screening on a new form. review is complete.

2 July 15, 2020

RADIOACTIVE MATERIALS UNIT Radioactive Materials Unit COVID-19 Pre-Inspection Screening Form MDH inspectors conducting on-site inspection or field work, must complete this questionnaire before initiating an inspection. This form must be completed and signed by the inspector and uploaded to WBL under the Attachments Tab for the corresponding Inspection ID prior to initiating an inspection. Inspectors must contact the Licensee to complete Step 1 and Step 2 of the form to determine the intended inspection date. No more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> before the on-site visit, the inspector must complete Steps 3 and 4 of the form.

Licensee: License Number:

Inspector:

Statement for Inspectors to Licensees: MDH is implementing precautionary measures to ensure the health, safety and well-being of our inspectors and the regulated community. We have established pre-inspection screening procedures to analyze and document current health conditions to protect the licensee, its employees, and our inspectors. MDH inspectors will attempt to conduct a remote inspection as much as possible; however, most inspections will require a brief on-site component. While on-site, MDH inspectors will: wear a cloth mask, and attempt to maintain a minimum distance of 6-feet. The inspector will not: participate in any unnecessary physical contact such as handshaking, and touch surfaces, equipment, or documents within the licensed facility, if it is not necessary. Should a licensee have more stringent procedures, inspectors will follow those measures while on-site conducting the inspection.

The following questions are being used to establish current health conditions and to establish an agreed upon inspection date. No more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> prior to the day of the inspection, the current health conditions of the licensee & inspector will be reassessed and documented.

Step 1: Licensee Pre-Screening Interview Licensee Representative Name/Title:

Date: Yes No Is your business currently shutdown due to the COVID-19 pandemic?

Have you or any personnel tested positive for COVID-19 at your facility in the past 14 days?

To the best of your knowledge, have you or any personnel been in close contact (within 6-feet for at least 15-minutes) with a lab confirmed COVID-19 case?

To the best of your knowledge, have you or any personnel had COVID-19 related symptoms such as; reference CDC website in the past 14 days?

What precautionary measures has your facility implemented in response to COVID-19? What Personal Protective Equipment (PPE) is required?

If no precautionary measures are being taken or PPE is not being used, are you or the personnel MDH plans to be in contact with during the on-site inspection willing to wear a face mask and maintain social distancing?

Based on the answers given and conversation to this point, is the inspection able to be scheduled? If no, record inspection attempt below and call back in 14 days from the pre-screening interview.

Step 2: Inspection Date Schedule Agreed upon inspection Date(s):

Step 3: Inspector & Licensee Questionnaire This portion of the form is to be completed by the inspector less than 24 Hours PRIOR to conducting the inspection.

MDH Inspector Health Screening Yes No Have you or anyone in your household tested positive for COVID-19 in the last 14 days?

Have you or anyone in your household had COVID-19 related symptoms such as; reference CDC website in the last 24-hours?

To the best of your knowledge, have you been in close contact (within 6-feet for at least 15-minutes) with an individual that has had COVID-19 related symptoms such as; reference CDC website, or tested positive for COVID-19 within the last 14 days?

Licensee Health Screening Yes No Have you or any personnel received a positive test result for COVID-19 at your facility in the last 14 days?

To the best of your knowledge, have you or any personnel been in close contact (within 6-feet for at least 15 mintures) with an individual that has had COVID-19 related symptoms such as; reference CDC website in the last 14 days?

Based on the answers given and conversation to this point, is it necessary to postpone the inspection to a later time?

If any of the answers to the inspector or licensee health screening questions are "yes," the inspector shall reschedule the inspection and begin over with Step 1.

Step 4: When Steps 1 through 3 are complete, convert to PDF, date and sign below.

Inspector: _____________________________________________Date Complete:______________

Signature:

Step 5: Upload this form to WBL under the Attachments Tab for the corresponding Inspection ID.

III. Technical Quality of Inspections

15. Inspection procedures were modified for the use of remote inspections during the public health emergency. These procedures included the addition of a health screening for both the inspector and licensee. See the attached Remote Inspection Process and Health Screening Form
16. The following table summarizes the supervisory accompaniments during the review period. No inspector accompaniments were performed in 2020 due to the temporary suspension of inspections and limited staff availability during the public health emergency.

Supervisory Accompaniments License Supervisor Type of Inspection Date Number Brandon Juran 1036 Sherrie Flaherty Medical- Diagnostic & Therapeutic 11/28/17 1045 Sherrie Flaherty Cyclotron 10/9/18 1084 Sherrie Flaherty Blood Irradiator - Security 10/29/19 1074 Sherrie Flaherty Industrial Radiography Scheduled for 11/16/21 Lynn Fortier 1026 Sherrie Flaherty Medical - Therapy HDR 12/1/16 1171 Sherrie Flaherty R&D Other 11/29/17 1075 Sherrie Flaherty Industrial Radiography 10/18/18 1231 Sherrie Flaherty Industrial Radiography 10/24/19 1063 Sherrie Flaherty Medical Diagnostic & Therapeutic 10/14/21 Tyler Kruse 1042 Sherrie Flaherty Medical - Diagnostic & Therapeutic 10/11/16 1037 Sherrie Flaherty Nuclear Pharmacy 11/2/17 1231 Sherrie Flaherty Industrial Radiography 8/28/18 1075 Sherrie Flaherty Industrial Radiography 11/4/19 1228 & Sherrie Flaherty Cyclotron & Nuclear Pharmacy 10/19/21 1017

Matt Duff 1089 Sherrie Flaherty Industrial Radiography 1/10/17 1230 Sherrie Flaherty Industrial Radiography 2/15/17 1202 Sherrie Flaherty Medical - Diagnostic 3/1/17 Martha Steinhart 1074 Sherrie Flaherty Industrial Radiography 11/1/17 Bridget Bobick 1204 Sherrie Flaherty Medical - Diagnostic 4/30/19 1115 Sherrie Flaherty Portable Gauge 7/23/19

17. MDH maintains a sufficient number of detectors and dosimeters to meet the normal activities of the Unit as well as any potential emergency response requirements. Included in the inventory are a neutron detector, two alpha detectors, and two 2" NaI scintillation detectors. MDH has two instruments capable of identification, an InSpector 1000 and a FLIR - identiFINDER2. During this review period MDH purchased four PED Blue units to be used as alarming rate meters and direct reading dosimeters. These will replace the separate alarming rate meters and electronic dosimeters.

MDH has implemented a program that provides Emergency Response Kits to state responders. The loan program ensures that the MnDOT Hazardous Materials Inspectors and the State Patrol Commercial Vehicle Inspection Section staff have up-to-date equipment to assess radiological hazards. Included in the Response Kits are a Ludlum 2241-2 scaler, a pancake probe, and a 1" NaI scintillation detector.

The following table summarizes the Radioactive Materials Unit's instrumentation.

Serial # Status Make Model Instrument Last Calibratio Assignme Type Name Calibration n Due nt Date Date 31896 Calibration SE Radiation Survey 5/12/2021 5/12/202 equip Internatio Alert 3 room nal Monitor 4/4EC

9124781 InService Dosimeter 611 Dosimetry 10/19/2020 10/19/20 Corp 21 9124783 InService Dosimeter 611 Dosimetry 10/19/2020 10/19/20 Corp 21 4010818 InService Dosimeter 862 Dosimetry 10/19/2020 10/19/20 Corp 21 4010820 InService Dosimeter 862 Dosimetry 10/19/2020 10/19/20 Corp 21 4010831 InService Dosimeter 862 Dosimetry 10/19/2020 10/19/20 Corp 21 1850670 InService Tracerco PED Blue Dosimetry 2/1/2021 2/1/2022 1850671 InService Tracerco PED Blue Dosimetry 2/1/2021 2/1/2022 1850672 InService Tracerco PED Blue Dosimetry 2/1/2021 2/1/2022 1850674 InService Tracerco PED Blue Dosimetry 2/1/2021 2/1/2022 1106399 InService Canberra InSpector Identifier 11/27/2019 11/27/20 0 1000 20 910383- InService FLIR identiFIND Identifier 5/1/2015 5/1/2023 1481 ER2 232688 InService Ludlum 2241-2 Neutron 10/30/2019 10/30/20 Detector 21 217896 InService Ludlum 2241-2 Survey 5/11/2021 5/11/202 equip 2 room 232708 InService Ludlum 2241-2 Survey 5/11/2021 5/11/202 equip 2 room 228418 InService Ludlum 2241-2 Survey 5/11/2021 5/11/202 equip 2 room 220176 InService Ludlum 2241-3 Survey 5/10/2021 5/10/202 equip 2 room 228295 InService Ludlum 2241-2 Survey 11/17/2020 11/17/20 21 217853 InService Ludlum 2241-2 Survey 11/17/2020 11/17/20 21 220152 InService Ludlum 2241-3 Survey 11/16/2020 11/16/20 lynn 21 220193 InService Ludlum 2241-3 Survey 11/13/2020 11/13/20 Tyler 21 Kruse 217822 InService Ludlum 2241-2 Survey 1/29/2021 1/29/202 Randy 2 Kudzia (DOT) 241180 InService Ludlum 2241-2 Survey 2/1/2021 2/1/2022 Eric Sundby -

State Patrol 228391 InService Ludlum 2241-2 Survey 4/22/2021 4/22/202 2

228168 InService Ludlum 2241-3 Survey 1/21/2021 1/21/202 2

267949 InService Ludlum 78 Survey 1/7/2020 1/7/2022 217821 InService Ludlum 2241-2 Survey 11/18/2020 11/18/20 Jim Fox, 21 DOT 232681 InService Ludlum 2241-2 Survey 11/18/2020 11/18/20

21 232667 InService Ludlum 2241-2 Survey 11/11/2020 11/11/20 21 228381 InService Ludlum 2241-2 Survey 10/21/2020 10/21/20 21 220224 InService Ludlum 2241-3 Survey 11/12/2020 11/12/20 Brandon 21 Juran 55873 InService NDS ND-2200 Survey 10/16/2020 10/16/20 out for cal Products 21 55872 InService NDS ND-2200 Survey 10/16/2020 10/16/20 out for cal Products 21 31663 InService SE Radiation Survey 4/4/2018 4/4/2020 Sherrie Internatio Alert Flaherty nal Monitor 4/4EC 38564 InService SE Radiation Survey 4/4/2018 4/4/2020 Brandon Internatio Alert Juran nal Monitor 4/4EC 31784 InService SE Radiation Survey 5/12/2021 5/12/202 Lynn Internatio Alert 3 Fortier nal Monitor 4/4EC 02561 InService SE Radiation Survey 5/12/2021 5/12/202 equip Internatio Alert 3 room nal Monitor 5 5588 InService SE Radiation Survey 10/19/2020 10/19/20 Internatio Alert 21 nal Inspector 2378 InService Victoreen 450P Survey 4/2/2020 4/2/2021 1029 InService Victoreen 450P Survey 10/16/2020 10/16/20 21 107367 InService Victoreen 190 Survey 2/3/2021 2/3/2022 Lynn Fortier

IV. Technical Quality of Licensing Actions

18. At the time of this review, the Radiation Control Unit has 148 active specific licenses.
19. During the review period, MDH has issued approximately 8 new licenses (license numbers 1239-1247); six portable gauges, one veterinary medicine, and one medical.

Approximately 21 licenses have been terminated during the review period.

The Unit has not performed any major decommissioning or complex license reviews during this review period.

20. MDH has issued two variances during this review period. One issued to a radiography training college allows changing personnel monitoring frequency to six-month intervals. The other is a renewal allowing non-accredited nuclear medicine technologists to function as nuclear medicine technologists under specific circumstances.
21. During the review period MDH made no changes to the written licensing procedures.
22. MDH has no license renewals that have been pending for one year or more.

During the review period three license renewals were issued greater than one year due to lack of response and availability of the licensees.

23. All events reportable under SA-300 occurring during the review period have been submitted to NRC.
24. During the review period the Radioactive Materials Unit has not made any changes to the procedures for responding to incidents or allegations.
25. Below is a list of statutes that affect the radiation control program. Authority for Minnesotas Agreement State activities is primarily found in Minnesota Statutes, Sections 144.12-144.1205, and in the Minnesota Rules Chapter 4731.

Minnesotas statutes and rules are accessible on the Internet at:

https://www.revisor.mn.gov/statutes/

Statute Subject 13.02 Collection, security and dissemination of records; definitions.

13.39 Civil investigation. Covers the requirements the Commissioner follows in a pending civil legal action.

13.41 Licensing data. Covers the requirements that the Commissioner must follow to ensure that data collected for licenses is kept within the statutory guidelines of data privacy.

144.05 General duties of Commissioner; reports.

144.12 Regulations, enforcement, licenses, fees. Overall commissioner authority to regulate, adopt rules, enforce, license and collect fees.

144.1201 Definitions. For agreement state program. Provides clarification for 144.1202.

144.1202 U.S. NRC agreement. Gives the responsibility and authority for an agreement state program to the Department of Health.

144.1203 Training; rulemaking. Authority given to the Commissioner to adopt rules to ensure that individuals handling or utilizing radioactive materials are properly trained and have the qualifications to do so.

144.1204 Surety requirement. Gives the Commissioner authority to require financial assurance for radioactive materials licensees.

144.1205 Radioactive material; source and special nuclear material; fees; inspection. Gives the Commissioner authority to collect fees and penalties, and to conduct inspections.

144.121 X-ray machine and facilities using other sources of ionizing radiation.

Indicates that machines and materials must be registered and that the Commissioner can collect fees and perform inspections.

144.989 Title; citation. This legislation is the title for the enforcement. Parts 144.989 to 144.993 are referred to as the Health Enforcement Consolidation Act of 1993.

144.99 Enforcement. Outlines the authority that the Commissioner has to access information and issue correction orders, administrative penalty orders, injunctive relief, cease and desist orders, suspension or revocation of permits, licenses, registration or certificates. Allows for hearing, misdemeanor penalties, and the authority to impound radioactive materials and associate shielding.

144.991 Administrative penalty order procedure. Outlines the administrative penalty order procedure that must be followed.

144.992 False information. Asserts that a person cannot make false material statements, representation or certification in any of the commissioners areas or they are subject to actions listed in section 144.99, subdivision 1.

144.993 Recovery of litigation costs and expenses. Allows the Commissioner to recover any costs brought on my any litigation.

181.931 Definitions. Definitions used in the sections 181.931 to 181.935. This section covers employee rights.

181.932 Disclosure of information by employees. Actions prohibited by an employer whose employee files a complaint against the employer.

181.933 Notice of termination. Addresses employee who has been involuntarily terminated, and that any defamation action is prohibited.

181.934 Employee notice. The Department of Labor and Industry will have rules for the notification of employees by employers of an employees rights.

181.935 Individual remedies; penalty. Refers to the ability of the employee to bring civil action to recover costs and damages caused by violation of 181.932.

26. No, our regulations are not subject to a Sunset or equivalent law.
27. The information in the State Regulation Status (SRS) sheet is correct.
28. The following rules went into effect on August 26, 2019.

RATS ID 2013-1 [Only comments dated 10/15/2015 - Originally due for state adoption 3/19/2016, adopted 8/17/2015]

RATS ID 2015-1 Due for state adoption 01/26/2018 RATS ID 2015-2 Due for state adoption 01/28/2018 RATS ID 2015-3 Due for state adoption 08/15/2020 (07/13/2018 initial due date)

RATS ID 2015-4 Due for state adoption 09/02/2018 RATS ID 2015-5 Due for state adoption 12/31/2018 The following changes were made in the rules that were not adopted on time during the review period.

RATS ID 2013-1 Addressed comments dated 10/15/2015 - clarified the reporting requirements in 37.71(a), changing notification to the state from NRC in 37.77(d), and adds the address for the American National Standards Institute in 34.20(a)(1), and corrects NRC addresses and telephone numbers.

RATS ID 2015-1 Removed reporting requirements required under 10 CFR 70.74 and part 70, appendix A, if applicable. (NRC only)

RATS ID 2015-2 Changes were to exempt commercial vehicle drivers for category 1 quantities of radioactive material from needing a background investigation and requires protection of advance notification information for individuals receiving it (MDH and other state officials).

RATS ID 2015-4 No changes to MN rules were required.

RATS ID 2015-5 Changes were to change the office name to Office of the Chief Information Officer, capitalizing the words Tribe, Tribes, and Tribal, correcting a Web site address, and updates on where to find contact information of governors designees and Tribal officials designees.

The following rules are in process with an anticipated effective date in November or December 2021. The proposed rules were submitted for NRC review on May 17, 2021, with the review completed on July 1, 2021, with no comments.

RATS ID 2018-1 Due for state adoption 01/14/2022 RATS ID 2018-2 Due for state adoption 12/21/2021 RATS ID 2018-3 Due for state adoption 07/30/2022

RATS ID 2019-1 Due for state adoption 12/18/2022 RATS ID 2019-2 Due for state adoption 12/30/2022 RATS ID 2020-1 Due for state adoption 06/16/2023 RATS ID 2020-2 Due for state adoption 08/17/2023 RATS ID 2020-3 Due for state adoption 11/16/2023

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