ML18213A067
| ML18213A067 | |
| Person / Time | |
|---|---|
| Site: | 03001265 |
| Issue date: | 07/20/2018 |
| From: | Lanzisera P A NRC Region 1 |
| To: | Mas P Stamford Hosp |
| References | |
| 609204 | |
| Download: ML18213A067 (1) | |
Text
From: Lanzisera, Penny To: pmas@stamhealth.org Cc: Janda, Donna
Subject:
Request for Additional Information Date: Friday, July 20, 2018 7:39:00 AM Licensee:
Stamford Hospital License No. 06-06697-02 Docket No. 03001265 Mail Control No. 609204 In order to continue our review of the request for microsphere use by Drs. Lazzara and Noga, please submit the following for each physician:
- 1. subspecialty certification in interventional radiology by either the American Board of Radiology or the American Osteopathic Board of Radiology or one additional year of supervised clinical experience in interventional radiology 2. commitment that each individual will complete at least the first three hands-on patient cases supervised in the physical presence of a manufacturer representative for each type of Y-90 microsphere for which authorization is sought. Additionally, confirm that you will submit documentation from the manufacturer to NRC Region 1 within 30 days of when these three patient cases have been satisfactorily completed.
In addition, please confirm that Ms. Sarah Bull is continuing to practice as an Authorized Medical Physicist at Stamford Hospital. Finally, it appears that your license may have undergone a change of control at some point over the last 2-3 decades to include an affiliation with New York - Presbyterian Healthcare System and/or Stamford Health. We have reviewed our records and have not found a notification from your facility of this change. In a separate amendment request, please describe the change of control or affiliation for both entities.
Please include the information described in Appendix E to NUREG-1556, Volume 15 found at https://www.nrc.gov/docs/ML1618/ML16181A003.pdf
. Thank you for your assistance, Penny Lanzisera Senior Health Physicist U.S. NRC, Region I