ML18198A394
| ML18198A394 | |
| Person / Time | |
|---|---|
| Site: | 03037587 |
| Issue date: | 06/25/2018 |
| From: | Strohmeyer D C NRC/RGN-III |
| To: | Keith Miller, Siddiqui J Metro Cardiovascular Diagnostics |
| References | |
| 602295 | |
| Download: ML18198A394 (3) | |
Text
NRC FORM 699 /"-.., .. (03-2013) f~ i u_s. NUCLEAR REGULATORY COMMISSION
~/ CONVERSATION RECORD ...... NAME OF PERSON(S)
CONTACTED OR IN CONTACT WITH YOU Jawed Siddiqui, M.D. and Kevin Miller E-MAIL ADDRESS '.jhsiddiqui@aol.com';
'Kevin Miller' <kevkenl3@hotmail.com>
ORGANIZATION Metro Cardio Vascular LICENSE NUMBER(S) 24-32636-01 SUBJECT DOCKET NUMBER(S) 030-37587 CONTROL NUMBER(S) 602295 Email and phone call to discuss deficiencies on the renewal application.
SUMMARY
DATE OF CONTACT 06/25/2018 TELEPHONE NUMBER (314) 915-1983 DATE OF SIGNATURE TYPE OF CONVERSATION 0 E-MAIL D TELEPHONE D INCOMING D OUTGOING Email ( copied on second page and attached separately) was sent to the licensee on 6/25/18 to assist in phone discussion that was to take place at 6/25/18 at 1300 to discuss error in the documentation submitted for the renewal application for the license. Continue on Page 2 ACTION REQUIRED (IF ANY) The licensee committed to provided all update documentation to the NRC by COB 6/28/18. Additional information is provided below and in the attached email. Continue on Page 3 NAME OF PERSON DOCUMENTING CONVERSATION p.-N \ Q.._ IL-~/e-1\.. , NRC FORM 699 (03-2013)
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NRC FORM 699 (03-2013)
U.S. NUCLEAR REGULATORY COMMISSION CONVERSATION RECORD (continued)
SUMMARY
- (Continued from page 1) Good Morning, Please see the information below in reference to the documents that have been received by the NRC up to this date. This will be discussed in more detail during our meeting today, 6/25/18 at 100 PM, and any additional questions may be asked at that time. I have included the submitted Appendix C Checklist as well. Us the following phone number and passcode for the call: Dial in numbers: 888-282-9628 Participant Passcodes/Pin codes: 62741 Renewal Application Deficiencies:
Item 1: License Number incorrect Item 2: Additional suite number Item 3: Suite number different than on current license, why the change? Item 4: No issues. Item 5 & 6: See Checklist C Item 7 & 8: None of the information provided is necessary or would be deemed unacceptable based on dates of the documents.
Since the individual is currently the RSO, only the license number and name needs to be provided in addition to the MOU. Since the RSO is also the only AU, again that should be stated on the document and/or checklist.
There is no mention of who is proposed as being AU on the additional information.
The checklist C that was provided there is a box checked with no name or license number. There is also many boxes check that are not authorized to perform, nor is it being requested to add these uses. An example is training for 35.690, this license is not authorized for this use, the AU is not qualified for such uses, and there is no documentation showing otherwise.
Item 9: Facility diagram provided.
However, no information about the instrumentation is provided.
Also no mention of dose calibrator in previous information, but is included on the App C checklist.
No alpha emitting nuclides are authorized, but it is checked on the App C checklist.
Item 10: Therapy devices is checked, including an individual not on the license, but none of these types of uses are authorized on this license. This is 35.200 use license only. Item 11: Waste incinerator box is check, which is not authorized for, nor is any of the information requesting to be provided is. In order for the NRC to continue to process the renewal request these issues would have to be solved immediately.
The licensee needs to provide all correct information by 6/29/18. Respectfully, Daniel C. Strohmeyer, CHP Health Physicist
-Reviewer Materials Licensing Branch U.S. NRC, Region III 630.829.9689 (0) 630.515.1078 (F) NRC FORM 699 (03-2013)
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ACTION REQUIRED (Continued from page 1) Gentlemen, U.S. NUCLEAR REGULATORY COMMISSION CONVERSATION RECORD (continued)
Thank you for taking the time speak to with me today regarding your renewal application dated January 24, 2018. I want to reiterate the commitments made by Dr. Siddiqui being the CEO, RSO and sole Authorized User of Metro Cardiovascular Diagnostics.
In regards to our telephone discussion, please provide the following information that will be required to continue the review of you application in a timely manner. The items below are the outcome of our discussion on June 25, 2018: 1) A complete revision of the renewal application in its entirety provided to the NRC by 6/28/18. 2) Since Mr. Miller is not associated with the license, Dr. Siddiqui will be the reviewing and responsible for completing the documents necessary for the renewal application.
- 3) Based on our conversation, it is my understanding that you will review of the guidance (NUREG-1556, Vol. 9, Rev. 2, and associated checklists) to ensure all commitments being made in all documents submitted are full understood.
- 4) Reviewing the map of you facility, and since there is no dedicated hot lab, commitments need to be made that ensure at no time will sources be unsecured, and that patients will at no time have access to unsecured radioactive material.
Also, additional details about the cabinet being used to store source material needs to be provided.
If you have any questions please let me know at your convenience.
Respectfully, Daniel C. Strohmeyer, CHP Health Physicist
-Reviewer Materials Licensing Branch U.S. NRC, Region III 630.829.9689 (0) 630.515.1078 (F) NRC FORM 699 (03-2013)
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