ML18099A220
| ML18099A220 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18099A220 (6) | |
Text
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 1NRC staff should issue an (IN), which describes errors previously made and provides examples of best practices with regards units of AKS vs.
apparent activity (mCi) for brachytherapy sources. The IN should be done in collaboration with the American Association of Physicists in Medicine (AAPM) and coordinated with Agreement States.6/12/07Accepted Closed 9/9/09 2NRC staff should remove the attestation requirement for board certified individuals and rewrite the attestation requirement for individuals seeking authorization under the alternate pathway. The rewritten attestation should not include the word "competency" but should instead read "has met the training and experience requirements."6/12/07Accepted Closed 3/7/18 3NRC staff should revise the regulations so that board certified individuals, who were certified prior to the effective date of recognition or were certified by previously recognized boards listed in Subpart J of the previous editions of Part 35, are grandfathered.6/12/07Accepted Closed 3/7/18 4NRC staff should reduce the 200-hour radiation safety training requirement to 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> for individuals seeking authorization under the
alternate pathwa y in 10 CFR 35.390.6/12/07Not acceptedClosed 5NRC staff should not change the current definition for a RSO.6/13/07AcceptedClosed 6NRC staff should add the words "or equivalent" so it is clear that information included in a letter is the same as that which would have been
submitted in NRC Form 313A (35.12(c))6/13/07Accepted Closed 3/7/18STATUS 1 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 7NRC staff should revise 10 CFR 35.50(c)(2) to include AUs, AMPs, or ANPs identified on any license or permit that authorizes similar types of use of byproduct material. Additionally, the AU, AMP, or ANP must have experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking RSO authorization.6/13/07Accepted Closed 3/7/18 8NRC staff should remove the attestation requirement from 10 CFR 35.50(d) for AUs, AMPs, and ANPs seeking RSO status, if the AU, AMP, or ANP seeking RSO status will have responsibilities for similar types of uses for which the individual is authorized.6/13/07Accepted Closed 3/7/18 9ACMUI tabled the following issue until the next full ACMUI meeting:
35.57(a), 35.75, 35.491(b)(2), 35.400, 35.500, and 35.600.
6/13/07Moved to Oct Agenda Closed 10a)NRC staff should allow more than one RSO on a license wi th a designation of one RSO as the indiv i dual in charge. b) NRC should create a Regulatory Issue Summary (RIS) to inform the regulated community of NRC's interpretation. The RIS should be sent to ACMU I and the Agreement States for review and comment.
6/13/07a)Accepted b)Accepteda)Closed 3/7/18b)Closed 2 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 11NRC staff should include the three-case work experience requirement for individuals seeking authorization for Y-90 microsphere use; however, the three cases do not have to be with the particular type of microsphere for which the individual is seeking authorization. Furthermore, ACMUI recommends the training and experience does not have to be performed under the supervision of an AU, and NRC staff should replace the proposed supervision paragraph with the existing language from 10 CFR
35.690 (c).6/13/07Partially accepted, Revised guidance published 09/07 Closed 12NRC staff should delete the attestation requirement for Y-90 microspheres users and incorporate a requirement in the second paragraph of the guidance for individuals seeking authorization to provide and retain documentation of the completion of training.
6/13/07 Accepted, Revised guidance published 09/07 Closed 13NRC staff should incorporate the proposed wording for the team approach section of the Y-90 microspheres guidance with one exception:
ACMUI recommends the word "oncology" be replaced by "cancer management."
6/13/07 Accepted, Revised guidance published 09/07 Closed 14 For 10 CFR 35.1000 guidance documents, NRC staff should incorporate the proposed wording that notification under 10 CFR 35.14 does not apply for specific medical use licensees.
6/13/07Moved to 10/07 agenda for clairification Closed 15ACMUI tabled the absorbed dose vs. activity issue for Y-90 microspheres until the next full ACMUI meeting.
6/13/07Moved to 10/07 a g enda Closed 3 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 16NRC staff should revise the current guidance to conclude that the surgical removal of the sentinel lymph node is an independent procedure and should not be regulated by NRC.6/13/07Accepted Closed 1/9/09 17 NRC staff committed to consult legal counsel to determine the feasibility of discussing PRM 35-20 (Ritenour/AAPM petition) with ACMUI members in a closed executive session.
6/13/07Completed, added to 10/07 a g enda Closed 18NRC staff should arrange a briefing for ACMUI members regarding the Increased Controls Orders to be issued later this year for fingerprinting.
6/13/07Completed, 8/15/07 meetin g Closed 19NRC staff should engage ACMUI in a discussion regarding the review of operational events and data and work towards a goal of minimizing therapeutic medical events, if directed by the Commission to do so.
6/13/07 Not directed by Commission; NRC may request in future N/A 20NRC staff should provide detailed background information for the current and future presentations on the subject of potential changes to 10 CFR
Part 35.6/13/07 Accepted,on going N/A 21NRC staff should email the ACMUI members a copy of the memo summarizin g action items and motions made durin g the meetin g.6/13/07 Accepted, on g oin g N/A 22ACMUI supports grandfathering for individuals who had previously been determined to be trustworthy and reliable and granted unescorted access.
8/15/07 Not accepted, Orders mailed 10/07 Closed 4 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 23ACMUI agrees to assist the NRC, if requested, to determine those levels and types of material that could be of such significance to public health and safety to warrant fingerprinting and background checks.
8/15/07 Not requested, Orders mailed 10/07 Closed 24NRC staff should revise the current regulations to include Canadian trained individuals who have passed the ABNM certification exam.8/16/07Accepted Closed on 3/7/18 25NRC staff should maintain Compatibility B for training and experience requirements to ensure that authorized individuals may cross state
borders and p ractice throu g hout the U.S.8/16/07AcceptedClosed 26 NRC staff should accept a preceptor statement from another AU for a non
-board certified individual if the AU who supervised the training and work ex perience is not available as a p rece p tor.9/20/07 Accepted, current NRC p ractice Closed 27NRC staff should add 'increased complexity vs. additional benefit' as an agenda item for the October ACMUI meeting, so that ACMUI may
continue the discussion on this topic.
9/20/07Moved to October 2007 agenda Closed 28The AU should be required to place a signature on orders for radioactive material before the supplier can legally ship the material to an institution.
10/22/07Motion did not pass Closed 29The Elekta Perfexion should be regulated under 10 CFR 35.1000 until 10 CFR 35.600 is modified to be performance-based, which would allow the Perfexion to be regulated under 10 CFR 35.600.10/22/07Accepted Open Delayed 30NRC staff should require experienced RSOs and AMPs to receive additional training, if the individual is seeking authorization or responsibility for new uses.10/22/07Accepted Closed 3/7/18 5 2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATESTATUS 31NRC staff should not require experienced RSOs to obtain written attestation to become authorized or have responsibility for new uses.10/22/07Accepted Closed 3/7/18 32 NRC staff should not revise 10 CFR 35.75 to read "5 mSv/year (0.5 rem/year)."10/23/07Not acceptedClosed 33NRC staff should modify 10 CFR 35.491(b)(2) to specify 'superficial' ophthalmic treatments. Additionally, NRC staff should change the title of 10 CFR 35.491 to specify 'superficial' ophthalmic treatments.10/22/07Accepted Open Delayed 34NRC staff should not revise 10 CFR 35.491 (intended for ophthalmologists) to include training and experience for the new intraocular device. Instead, NRC staff should regulate the new intraocular device under 10 CFR 35.490.
10/22/07Partially AcceptedOpen Delayed 35 NRC staff should not require medical licensees regulated under 10 CFR 35.400, 500, or 600, as applicable, to only use the sealed sources and devices for the principle use as approved in the SSDR.10/22/07Accepted Closed 3/7/18 36NRC staff should revise 10 CFR 35.290 to allow physicians to receive training and experience in the elution of generators and preparation of kits under the supervision of an ANP.10/22/07Accepted Closed 3/7/18 6