IR 015000034/2020001
| ML20311A163 | |
| Person / Time | |
|---|---|
| Site: | 15000034, 015000034 |
| Issue date: | 10/17/2020 |
| From: | Folch L NRC/RGN-III |
| To: | Konerth S ViewRay Technologies |
| References | |
| IR 2020001 | |
| Download: ML20311A163 (2) | |
Text
U.S. NUCLEAR REGULATORY COMMISSION SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION NRC FORM 591M PART 1 (07-2012)
10 CFR 2.201 REPORT NUMBER(S) LICENSEE/LOCATION INSPECTED:
2. NRC/REGIONAL OFFICE 3. DOCKET NUMBER(S)
4. LICENSE NUMBER(S)
5. DATE(S) OF INSPECTION 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 licens The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the inspecto 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.
4.
Non-cited violation(s) were discussed involving the following requirement(s):
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 identifie 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 NRC FORM 591M PART 1 (07-2012)
BRANCH CHIEF ViewRay Technologies, In Thermo Fisher Way Oakwood, Village, Ohio 44146 2020001 Region III U. S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 150-00034 OH-03225180074 October 17, 2020
Luis Nieves Folch Michael Kunowski Michael A. Kunowski Digitally signed by Michael A. Kunowski Date: 2020.11.05 12:16:56 -06'00'
Luis A. Nieves Folch Digitally signed by Luis A. Nieves Folch Date: 2020.11.06 06:44:43 -06'00'
U.S. NUCLEAR REGULATORY COMMISSION NRC FORM 591M PART 3 (07-2012)
10 CFR 2.201 Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION LICENSEE/LOCATION INSPECTED:
2. NRC/REGIONAL OFFICE REPORT NUMBER(S)
3. DOCKET NUMBER(S)
4. LICENSE NUMBER(S)
5. DATE(S) OF INSPECTION SUPPLEMENTAL INSPECTION INFORMATION 1. PROGRAM CODE(S)
2. PRIORITY 3. LICENSEE CONTACT 4. TELEPHONE NUMBER Main Office Inspection Next Inspection Date:
Field Office Inspection Temporary Job Site Inspection PROGRAM SCOPE 6. INSPECTION PROCEDURES USED 7. INSPECTION FOCUS AREAS NRC FORM 591M PART 3 (07-2012)
Region III U. S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 2020001 150-00034 OH-03225180074 ViewRay Technologies, In Thermo Fisher Way Oakwood, Village, Ohio 44146 This was an announced, non-routine, inspection of a service provider that was decommissioning a ViewRay teletherapy unit at Washinton University in St. Louis, Missour This inspection was performed concurrently with inspections of Washington University in St. Louis, NRC License No. 24-00167-11, and Best Theratronics, NRC License N. ViewRay and Best Theratronics performed the decommissioning of the unit and the shipping of the sources and D ViewRay, a State of Ohio licensee, filed for reciprocity under 10 CFR 150.20 to perform this work and provided an updated NRC Form 241 when the schedule change PERFORMANCE OBSERVATIONS The inspector observed how the licensee removed the sources and DU container of the teletherapy unit while practicing ALAR Also the inspector observed the preparation, packaging, and measurement of the DU for shippin The inspector conducted independent and confirmatory surveys, and found no residual contamination or exposures to members of the public in excess of regulatory limit No violations of NRC requirements were identified as a result of this inspection.
87125 All 03225 N/A Sandy Konerth - ViewRay coordinator (410) 610-8976
Washington University in St. Louis October 17, 2020