IR 015000020/2021001
| ML21148A287 | |
| Person / Time | |
|---|---|
| Site: | 15000020, 015000020 |
| Issue date: | 05/11/2021 |
| From: | Nieves L Division of Nuclear Materials Safety III |
| To: | MikRon |
| References | |
| IR 2021001 | |
| Download: ML21148A287 (3) | |
Text
NRC FORM 591M PART 1 U.S. NUCLEAR REGULATORY COMMISSION (07-2012)
10 CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED: 2. NRC/REGIONAL OFFICE MikRon, Inc. Region III 35 Village Road, Suite 103 U. S. Nuclear Regulatory Commission Middleton, Massachusetts 01949 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 2021001 3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION 150-00020 MA 56-0673 May 11, 2021 LICENSEE:
The inspection was an examination of the activities conducted under your license as they relate to radiation safety and to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your license. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the inspector. The inspection findings are as follows:
1. Based on the inspection findings, no violations were identified.
2. Previous violation(s) closed.
3. The violations(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self-identified, non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, to exercise discretion, were satisfied.
Non-cited violation(s) were discussed involving the following requirement(s):
4. During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements and are being cited in accordance with NRC Enforcement Policy. This form is a NOTICE OF VIOLATION, which may be subject to posting in accordance with 10 CFR 19.11.
(Violations and Corrective Actions)
Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the violations identified. This statement of corrective actions is made in accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken, date when full compliance will be achieved). I understand that no further written response to NRC will be required, unless specifically requested.
TITLE PRINTED NAME SIGNATURE DATE LICENSEE'S REPRESENTATIVE NRC INSPECTOR Luis Nieves Luis A. Nieves Folch Digitally signed by Luis A. Nieves Folch Date: 2021.05.24 14:12:48 -05'00'
BRANCH CHIEF Michael Kunowski Michael A. Kunowski Digitally signed by Michael A. Kunowski Date: 2021.05.24 14:57:15 -05'00'
NRC FORM 591M PART 1 (07-2012)
NRC FORM 592M U.S. NUCLEAR REGULATORY COMMISSION (10-2020)
Materials Inspection Record 1. Licensee Name: 2. Docket Number(s): 3. License Number(s)
Mikron Inc. 15000020 MA 56-0673 4. Report Number(s): 5. Date(s) of Inspection:
2021001 May 11, 2021 6. Inspector(s): 7. Program Code(s): 8. Priority: 9. Inspection Guidance Used:
Luis Nieves 03226 2 87126 10. Licensee Contact Name(s): 11. Licensee E-mail Address: 12. Licensee Telephone Number(s):
Mike Thomson, RSO info@mikroninc.com 508-589-3102 13. Inspection Type: Initial 14. Locations Inspected: 15. Next Inspection Date (MM/DD/YYYY):
Routine Announced Main Office Field Office Normal Extended N/A Non-Routine Unannounced Temporary Job Site Remote Reduced No change 16. Scope and Observations:
This was an announced, non-routine, inspection of a service provider that was decommissioning a Pharmalucence, Inc. Model IBL-437C self-shielded irradiator device at SSM Health Cardinal Glennon Children's Hospital in St. Louis, Missouri. Mikron performed the decommissioning of the unit and DOE the shipping of the sources.
PERFORMANCE OBSERVATIONS The inspector observed the licensee disassemble the blood irradiator to prep it for shipping while practicing ALARA.
Also the inspector observed the preparation, packaging, and measurement of the device for shipping utilizing calibrated instruments. The inspector conducted independent and confirmatory surveys, and found no residual contamination or exposures to members of the public in excess of regulatory limits.
No violations of NRC requirements were identified as a result of this inspection.
NRC Form 592M (10-2020) Page 1 of 1
From: Nieves Folch, Luis To: info@mikroninc.com Subject: FW: Mikron NRC 591M Date: Friday, May 28, 2021 9:06:00 AM Attachments: Mikron NRC 591M (2)MK.pdf Dear Mr. Thomson Attach is the clear 591 report for the inspection conducted on May 11, 2021. At this point there is no further actions on your part.
In accordance with Title 10 of the Code of Federal Regulations 2.390 of the NRCs Rules of Practice, a copy of this message will be available electronically for public inspection in the NRCs Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRCs website at http://www.nrc.gov/reading-rm/adams.html.
Please feel free to contact me if you have any questions regarding this correspondence.
Thank you, Luis Nieves Health Physicist U.S. Nuclear Regulatory Commission Division of Nuclear Materials Safety Office: (630) 829-9571 Fax: (630) 515-1259