ML18219A662
| ML18219A662 | |
| Person / Time | |
|---|---|
| Site: | 03010715 |
| Issue date: | 08/03/2018 |
| From: | Gryglak M R NRC/RGN-III/DNMS/MLB |
| To: | Roehrs D H Bothwell Regional Health Ctr |
| References | |
| 608593 | |
| Download: ML18219A662 (3) | |
Text
~Mieial Wee g,.1, 9eetu itJ Relataef h1Fe1 Malia* UNITED STATES NUCLEAR REGULATORY COMMISSION REGION Ill 2443 WARRENVILLE RD. SUITE 210 LISLE, IL 60532-4352 AUG O 3 2018 David H. Roehrs, M.D. Radiation Safety Officer Bothwell Regional Health Center 601 E. 14th St. Sedalia, MO 65302
Dear Dr. Roehrs:
Enclosed is Amendment No. 28 to your U.S. Nuclear Regulatory Commission (NRC) Material License No. 24-16275-01 for Bothwell Regional Health Center in accordance with your letters dated January 23, 2017 (received February 14, 2018) and June 5, 2018, pertaining to your request to authorize Feraas Jabi, M.D. for the use of materials in 10 CFR 35.300, limited to the oral administration of sodium iodide 1-131. As stated in your letter dated June 5, 2018, you are correct, his specialty board certification was _ appropriate and enabled us to approve him for this expanded medical use. In addition, we corrected Dr. Jabi's first name on the license from "Ferass" to "Feraas," as it appeared on several of his externally verified qualifying documents.
His name had also appeared as "Ferass" on other documents you submitted but we determined that the correct name was "Feraas." We apologize for these errors and for any inconvenience they may have caused. This amendment also refers to your letters dated April 24, 2018 (pertaining to the release of your former second location of use), June 25, 2018, and July 27, 2018, regarding the release for unrestricted use of your former second location of use. We approved the release of your former second location of use for unrestricted use at this time. In your letters dated April 24, 2018 (pertaining to the release of your former second location of use), June 25, 2018, and July 27, 2018, you provided the history of licensed materials use, close-out survey and wipe test results for 3700 West 10th Street, Sedalia, Missouri.
You also confirmed that all residual licensed material used at this location had been removed such that any remaining residual radioactivity is within the limits of Title 10 of the Code of Federal Regulations (CFR) Part 20, Subpart E. Based on its review of close-out survey information, the staff has concluded that all licensable radioactive material has been removed from your former second location of use and residual radioactive material attributable to licensed activities does not exceed current NRC criteria.
Based on these conclusions no further remediation or actions with respect to NRC regulated material is required.
Your facility at 3700 West 10th Street, Sedalia, Missouri is suitable for unrestricted use. Please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region Ill office at (630) 829-9887 so that we may provide appropriate corrections and answers. The enclosed document contains sensitive security-related information.
When separated from this cover letter this letter is uncontrolled.
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- 0. Roehrs We also reviewed your letters dated January 16, 2018; April 24, 2018 (pertaining to your proposed new high dose rate remote afterloading brachytherapy device (HOR)); May 2, 2018; and May 21, 2018, associated with your request to add a new HOR program. We are unable to approve your request for the new HOR program at this time, as the information provided in the letters immediately above was insufficient to complete our review. We will need additional specific information to complete our review, which is being sent to you under separate cover. When you receive our request for additional information (RFAI), please contact us to arrange a conference call to discuss this information with us to resolve all remaining issues. Please contact Colleen Carol Casey, at (630) 829-9841 and colleen.casey@nrc.gov and Magdalena Gryglak at (630) 829-9875 and Magdalena.gryglak@nrc.gov.
Please advise us directly as to which individual(s) you wish to serve as your point(s) of contact for the remaining issues with the proposed HOR program. This is because we have conflicting and incomplete information in the various letters above regarding who we should contact. This is also addressed in our RFAI letter sent under separate cover. In order for us to speak or communicate with someone on your behalf, other than the Radiation Safety Officer (RSO) or another party already designated to serve as your point of contact (POC), you must specifically authorize us to do so. Typically this is done in the original correspondence commencing a new amendment request and, sometimes, in subsequent correspondence.
This protects you and your license best. Simply having your consultant or someone not designated as your POC contact us may compromise the integrity and security of your license. You will be periodically inspected by NRC. Failure to conduct your program in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in enforcement action against you. The NRC may issue a notice of violation, imposition of a civil penalty, or an order suspending, modifying or revoking your license as specified in the General Statement of Policy and Procedure for NRC Enforcement Actions. Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement action will be taken when dealing with licensees who do not achieve the necessary meticulous attention to detail and the high standard of compliance which NRC expects of its licensees.
The NRC's Safety Culture Policy Statement became effective in June 2011. While a policy statement and not a regulation, it sets forth the agency's expectations for individuals and organizations to establish and maintain a positive safety culture. You can access the policy statement and supporting material that may benefit your organization on NRC's safety culture Web site at http://www.nrc.gov/about-nrc/regulatory/enforcemenVsafety-culture,html.
We strongly encourage you to review this material and adapt it to your particular needs in order to develop and maintain a positive safety culture as you engage in NRC-regulated activities.
NRC's Regulatory Issue Summary (RIS) 2005-31 provides criteria to identify security-related sensitive information and guidance for handling and marking of such documents.
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D. Roehrs that potentially sensitive information is not made publicly available through ADAMS, the NRC's electronic document system. Pursuant to NRC's RIS 2005-31 and in accordance with 10 CFR Section 2.390, the enclosed license document is exempt from public disclosure because its disclosure to unauthorized individuals could present a security vulnerability.
The RIS may be located on the NRC Web site at:
collections/gen-comm/reg-issues/2005/ri200531.pdf and the link for frequently asked questions regarding protection of security-related*
sensitive information may be located at: http://www.nrc.gov/reading-rm/sensitive-info/faq.html.
A copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from ADAMS, accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.
License No. 24-16275-01 Docket No. 030-10715
Enclosure:
Amendment No. 28 Sincerely, ~~?tft Magdalena R. Gryglak Health Physicist Materials Licensing Branch effieial I.fee Ori)
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