ML18099A265
| ML18099A265 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18099A265 (4) | |
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2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE 1
ACMUI endorsed the draft response to NRC comments, as reflected in the meeting handout (ML110600249). ACMUI agreed if NRC believes the release criteria should be changed from a per release criteria to an annual criteria, this change would require new rulemaking, as stated in Regulatory Issue Summary (RIS) 2008-07. ACMUI recommended rulemaking to clarify that the release under 10 CFR 35.75 is per release and not per year 1/5/11 Pending Closed 3/7/18 2
ACMUI recommended NRC staff maintain the current reporting structure for the Committee; however, the motion was tabled for further discussion at the January 12, 2011 ACMUI Teleconference 1/5/11 ACMUI Action Closed 1/12/11 3
ACMUI endorsed the draft comments on proposed 10 CFR Part 37, as reflected in the meeting handout (ML110600261) 1/5/11 Accepted Closed 1/5/11 4
ACMUI endorsed the Draft Final Safety Culture Policy Statement 1/5/11 Accepted Closed 1/26/11 5
ACMUI recommended NRC staff maintain the current reporting structure for the ACMUI with enhancements in communication as described in FSME Policy and Procedure 2-5 and increased technical and administrative support staff.
1/12/11 Accepted Closed 4/1/11 6
ACMUI created an action item to reevaluate its satisfaction with the reporting structure annually.
1/12/11 ACMUI Action Open indefinitely 7
Dr. Malmud will serve as a reviewer to screen I-131 cases for the ACMUI Medical Event Subcommittee 4/11/11 No NRC Action Closed 8
ACMUI recommended to reserve some time at the Fall ACMUI Meeting for Public Stakeholders to discuss items for the Part 35 Public Workshops 4/11/11 ACMUI Action Did not pass 9
ACMUI recommended a 3 month (minimum) notice for future Public Stakeholder Workshop Meetings.
4/11/11 Accepted Closed 10 ACMUI recommends NRC Staff hold the second Public Stakeholder Workshop in August in order to accommodate all public stakeholders, with the caveat that the ACMUI Permanent Implant Brachytherapy Subcommittee Report be finalized by the Fall ACMUI Meeting.
4/11/11 Accepted Closed 2/7/12 STATUS 1
2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 11 (1) ACMUI feels ASTRO's approach to Permanent Implant Brachytherapy (handout) is correct approach for patient welfare (2) ACMUI recommends that the NRC require Post-Implant dosimetry following brachytherapy treatment (3)
ACMUI believes that prostate brachytherapy is a unique subset of brachytherapy and should therefore require a separate set of rules from non-prostate brachytherapy.
4/11/11 Partially Accepted Closed 3/7/18 12 ACMUI has planned to hold the Fall 2011 ACMUI Meeting on September 22 -
23, 2011. The back-up date is October 27 - 28, 2011. The alternate back-up date is October 31 -November 1, 2011 4/11/11 Accepted Closed 9/22/11 13 ACMUI recommends to eliminate the written attestation for board certification pathway, regardless of date of certification 4/12/11 Accepted Closed 3/7/18 14 ACMUI recommends the attestation to be revised to say has received the requisite training and experience in order to fulfill the radiation safety duties required by the licensee 4/12/11 Accepted Closed 3/7/18 15 ACMUI supports the statement that residency program directors can sign attestation letters, representing consensus of residency program faculties, if at least one member of the faculty is an AU in the same category as that designated by the applicant seeking authorized status, and that AU did not disagree with the approval.
4/12/11 Accepted Closed 3/7/18 16 ACMUI continues to assert that the current regulations are based on a per release limit. ACMUI does not recommend any change to the regulation and does not recommend the NRC consider this topic during the current rulemaking process, as there is no clinical advantage or advantage to members of the public for using an annual limit.
4/12/11 Pending Closed 3/7/18 17 Dr. Welsh asked NRC Staff if ACRS Members are considered SGE's. If so, given the number of their committee and subcommittee meetings, how many days and hours do they work a year?
9/22/11 NRC action Closed 2
2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 18 Dr. Welsh asked that NRC Staff provide the ACMUI with the NRC's response to Congressman Markey regarding patient release.
9/22/11 NRC action Closed 19 Steve Mattmuller asked that NRC Staff add ACMUI to the organizational chart on the FSME website.
9/22/11 Accepted Closed 20 Dr. Langhorst requested that NRC staff 1) place historical documents on the ACMUI website that would give everyone a better understanding of the ACMUI organization and how it got to where it is today and 2) NRC add past ACMUI membership information on the ACMUI Website.
9/22/11 Accepted Closed 21 Dr. Malmud created a subcommittee to address electronic signatures for documents licenees are required to retain in accordance with 10 CFR Part 35.
Subcommittee members include: Dr. Bruce Thomadsen (chair), Dr. John Suh, Dr. Christopher Palestro, and Dr. James Welsh 9/22/11 ACMUI Action Closed 4/16/12 22 ACMUI recommends to table the discussion on changes to the AO criteria 9/23/11 ACMUI Action Closed 12/15/11 23 Dr. Leon Malmud added Dr. John Suh to the Permanent Implant Brachytherapy Subcommittee. Existing subcommittee members include: Dr. James Welsh (chair), Dr. Susan Langhorst, Dr. Orhan Suleiman, and Dr. Bruce Thomadsen 9/23/11 ACMUI Action Closed 4/16/12 24 The Permanent Implant Brachytherapy Subcommittee will revise the subcommittee report and distribute to the full committee for review by October 7, 2011.
09/23/2011 ACMUI Action Closed 10/18/11 25 The ACMUI planned a teleconference for October 18, 2011, 12:00pm - 2:00pm EDT to discuss and finalize the Permanent Implant Brachytherapy Subcommitee Report.
09/23/2011 ACMUI Action Closed 10/18/11 26 NRC staff will provide an advanced copy of the Permanent Implant Brachytherapy Subcommitte report to the Agreement States prior to the ACMUI teleconference call and will invite the States to participate in the call.
09/23/2011 Accepted Closed 10/18/11 3
2011 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 27 ACMUI has planned to hold the Spring 2012 ACMUI Meeting on April 16-17, 2012. Back-up dates are April 26-27, 2012.
9/23/11 ACMUI Action Closed 4/16/12 28 ACMUI recommends the language in item A1B of the PIBS Report to read as, "Within a timeframe to be determined by the Authorized User consistent with prevailing practice, but not to exceed 60 days unless accompanied by written justification."
10/18/11 ACMUI Action Closed 10/18/11 29 ACMUI recomments to insert the following phrase into item 3B of the PIBS Report "using the wrong radionuclides or wrong activity or source strength (+/-
20%)" and moving the rest of the items down (from 3B to 3C and so forth) 10/18/11 ACMUI Action Closed 10/18/11 30 Dr. Zelac suggested to change the verbage in the PIB Report, Section A number 1(a)(i) from, "greater than 20 percent of the sources fall out of the intended locations." to "20 percent or more of the sources as called for in the Written Directive".
10/18/11 ACMUI Action Closed 10/18/11 31 Dr. Zelac suggested to change "Terminology," and specify the definition of D-90 to read as "the minimum dose to 90 percent of the CTV" in the PIBS Report.
10/18/11 ACMUI Action Closed 10/18/11 32 ACMUI reaffirms the 2008 AO Criteria as stated in the handout with the amendment that (s) be added to the end of physician, to read "consultant physician(s)"
12/15/11 Accepted Closed 4