IR 05000048/2018001

Northstar Medical Radioisotopes, LLC - NRC Form 591M Parts 1 & 3, Inspection Report 15000048/2018001 (DNMS)

ML18215A206
Person / Time
Site:	15000048, 015000048
Issue date:	07/16/2018
From:	Folch L NRC/RGN-III
To:	Mohaupt T NorthStar Medical Radioisotopes
References
IR 2018001
Download: ML18215A206 (3)

Text

NRC FORM 591M PART 1 U.S. NUCLEAR REGULATORY COMMISSION (07-2012)

10CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED: 2. NRG/REGIONAL OFFICE NorthStar Medical Radioisotopes, LLC Region III 1800 Gateway Blvd. U.S. Nuclear Regulatory Commission Beloit, WI 53511 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 2018001 3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION 150-00048 WI-025-2038-02 July 16, 2018 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:

0 1. Based on the inspection findings, no violations were identified.

D 2. Previous violation(s) closed.

D 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):

D 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 1O 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 Folch BRANCH CHIEF Aaron T. Mccraw NRC FORM 591M PART 1 (07-2012) V

NRC FORM 591 M PART 3 U.S. NUCLEAR REGULA TORY COMMISSION (07-2012)

10 CFR 2.201 Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED: 2. NRC/REGIONAL OFFICE NorthStar Medical Radioisotopes, LLC Region III 1800 Gateway Blvd. U. S. Nuclear Regulatory Commission Beloit, WI 535 I 1 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 2018001 3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION 150-00048 WI-025-2038-02 July 16, 2018 6. INSPECTION PROCEDURES USED 7. INSPECTION FOCUS AREAS 87136 03.01-03.08 SUPPLEMENTAL INSPECTION INFORMATION 1. PROGRAM CODE(S) 2. PRIORITY 3. LICENSEE CONTACT 4. TELEPHONE NUMBER 03226 Tom Mohaupt (608) 313-8235 D Main Office Inspection Next Inspection Date:

D Field Office Inspection

[l] Temporary Job Site Inspection Purdue University, IN PROGRAM SCOPE This was an unannounced field inspection of a nuclear medicine company authorized by the State of Wisconsin to use and possess Molybdenum-99 incident to performing commercial services on, training on, testing of, or incident to the manufacture of radiochemicals by RadioGenix system at a facility in Beloit, Wisconsin, and at temporary job sites within the State. The licensee conducted these activities in NRC jurisdiction under a reciprocity request filed in July 2018. The scope of this inspection was limited to the dismantling of the old RadioGenix unit located at Purdue University and the installation of a new unit.

PERFORMANCE OBSERVATIONS The inspector visited the temporary job site on the premises of Purdue University to evaluate NorthStar's measures for materials security, hazard communication, and exposure control. At the time of the inspection the licensee had already taken apart the old RadioGenix unit and removed two waste containers from the unit that were used in the elution process of the machine. The inspector confirmed that all radioactive material was kept secured from unauthorized removal. The inspector also conducted independent surveys in the vicinity, and found no exposures to members of the public in excess of regulatory limits. The inspector was able to observe licensed activities as they kept dismantling the RadioGenix unit. Through these observations and discussions, the inspector found the users to be knowledgeable of radiation protection principles and licensee procedures.

No violations ofNRC requirements were identified during this inspection.

NRC FORM 591M PART 3 (07-2012)

Nieves Folch, Luis From: Nieves Folch, Luis Sent: Friday, August 03, 2018 8:49 AM To: 'Tom Mohaupt'

Subject: NRC 591 clear report Attachments: SKM_C45818080309390.pdf

Dear Mr. Mohaupt,

Attach is the clear 591 report for the inspection conducted on July 16, 2018. There is no further actions on your part.

In accordance with Title 10 of the Code of Federal Regulations 2.390 of the NRC's "Rules of Practice," a copy of this message will be available electronically for public inspection in the NRC's Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC's 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 1