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 ITEMS ITEM DATE STATUS 1
NRC staff should issue an (IN), which describes errors previously made and provides examples of best practices with regards units of AKS vs.
Closed apparent activity (mCi) for brachytherapy sources. The IN should be done 6/12/07 Accepted 9/9/09 in collaboration with the American Association of Physicists in Medicine (AAPM) and coordinated with Agreement States.
2 NRC staff should remove the attestation requirement for board certified individuals and rewrite the attestation requirement for individuals seeking Closed authorization under the alternate pathway. The rewritten attestation 6/12/07 Accepted 3/7/18 should not include the word competency but should instead read has met the training and experience requirements.
3 NRC staff should revise the regulations so that board certified individuals, who were certified prior to the effective date of recognition or were Closed 6/12/07 Accepted certified by previously recognized boards listed in Subpart J of the 3/7/18 previous editions of Part 35, are grandfathered.
4 NRC 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 6/12/07 Not accepted Closed alternate pathway in 10 CFR 35.390.
5 NRC staff should not change the current definition for a RSO. 6/13/07 Accepted Closed 6
NRC staff should add the words or equivalent so it is clear that Closed information included in a letter is the same as that which would have been 6/13/07 Accepted 3/7/18 submitted in NRC Form 313A (35.12(c))
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2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 7
NRC 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 Closed use of byproduct material. Additionally, the AU, AMP, or ANP must have 6/13/07 Accepted 3/7/18 experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking RSO authorization.
8 NRC staff should remove the attestation requirement from 10 CFR 35.50(d) for AUs, AMPs, and ANPs seeking RSO status, if the AU, AMP, Closed 6/13/07 Accepted or ANP seeking RSO status will have responsibilities for similar types of 3/7/18 uses for which the individual is authorized.
9 ACMUI tabled the following issue until the next full ACMUI meeting: Moved to Oct 6/13/07 Closed 35.57(a), 35.75, 35.491(b)(2), 35.400, 35.500, and 35.600. Agenda 10 a) NRC staff should allow more than one RSO on a license with a designation of one RSO as the individual in charge. b) NRC should create a) Closed a) Accepted a Regulatory Issue Summary (RIS) to inform the regulated community of 6/13/07 3/7/18 b) Accepted NRCs interpretation. The RIS should be sent to ACMUI and the b) Closed Agreement States for review and comment.
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2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 11 NRC staff should include the three-case work experience requirement for individuals seeking authorization for Y-90 microsphere use; however, the Partially three cases do not have to be with the particular type of microsphere for accepted, which the individual is seeking authorization. Furthermore, ACMUI Revised 6/13/07 Closed recommends the training and experience does not have to be performed guidance under the supervision of an AU, and NRC staff should replace the published proposed supervision paragraph with the existing language from 10 CFR 09/07 35.690(c).
12 Accepted, NRC staff should delete the attestation requirement for Y-90 Revised microspheres users and incorporate a requirement in the second 6/13/07 guidance Closed paragraph of the guidance for individuals seeking authorization to provide published and retain documentation of the completion of training.
09/07 13 Accepted, NRC staff should incorporate the proposed wording for the team Revised approach section of the Y-90 microspheres guidance with one exception:
6/13/07 guidance Closed ACMUI recommends the word oncology be replaced by cancer published management.
09/07 14 Moved to For 10 CFR 35.1000 guidance documents, NRC staff should incorporate 10/07 the proposed wording that notification under 10 CFR 35.14 does not apply 6/13/07 Closed agenda for for specific medical use licensees.
clairification 15 Moved to ACMUI tabled the absorbed dose vs. activity issue for Y-90 microspheres 6/13/07 10/07 Closed until the next full ACMUI meeting.
agenda 3
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 16 NRC staff should revise the current guidance to conclude that the surgical Closed removal of the sentinel lymph node is an independent procedure and 6/13/07 Accepted 1/9/09 should not be regulated by NRC.
17 Completed, NRC staff committed to consult legal counsel to determine the feasibility added to of discussing PRM 35-20 (Ritenour/AAPM petition) with ACMUI members 6/13/07 Closed 10/07 in a closed executive session.
agenda 18 Completed, NRC staff should arrange a briefing for ACMUI members regarding the 6/13/07 8/15/07 Closed Increased Controls Orders to be issued later this year for fingerprinting.
meeting 19 Not directed by NRC staff should engage ACMUI in a discussion regarding the review of Commission; operational events and data and work towards a goal of minimizing 6/13/07 N/A NRC may therapeutic medical events, if directed by the Commission to do so.
request in future 20 NRC staff should provide detailed background information for the current Accepted,on and future presentations on the subject of potential changes to 10 CFR 6/13/07 N/A going Part 35.
21 NRC staff should email the ACMUI members a copy of the memo Accepted, 6/13/07 N/A summarizing action items and motions made during the meeting. ongoing 22 Not ACMUI supports grandfathering for individuals who had previously been accepted, 8/15/07 Closed determined to be trustworthy and reliable and granted unescorted access. Orders mailed 10/07 4
2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 23 Not ACMUI agrees to assist the NRC, if requested, to determine those levels requested, and types of material that could be of such significance to public health 8/15/07 Closed Orders and safety to warrant fingerprinting and background checks.
mailed 10/07 24 NRC staff should revise the current regulations to include Canadian Closed on 8/16/07 Accepted trained individuals who have passed the ABNM certification exam. 3/7/18 25 NRC staff should maintain Compatibility B for training and experience requirements to ensure that authorized individuals may cross state 8/16/07 Accepted Closed borders and practice throughout the U.S.
26 NRC staff should accept a preceptor statement from another AU for a non- Accepted, board certified individual if the AU who supervised the training and work 9/20/07 current NRC Closed experience is not available as a preceptor. practice 27 NRC staff should add increased complexity vs. additional benefit as an Moved to agenda item for the October ACMUI meeting, so that ACMUI may 9/20/07 October Closed continue the discussion on this topic. 2007 agenda 28 The AU should be required to place a signature on orders for radioactive Motion did 10/22/07 Closed material before the supplier can legally ship the material to an institution. not pass 29 The Elekta Perfexion should be regulated under 10 CFR 35.1000 until Open 10 CFR 35.600 is modified to be performance-based, which would allow 10/22/07 Accepted Delayed the Perfexion to be regulated under 10 CFR 35.600.
30 NRC staff should require experienced RSOs and AMPs to receive Closed additional training, if the individual is seeking authorization or 10/22/07 Accepted 3/7/18 responsibility for new uses.
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2007 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 31 NRC staff should not require experienced RSOs to obtain written Closed 10/22/07 Accepted attestation to become authorized or have responsibility for new uses. 3/7/18 32 NRC staff should not revise 10 CFR 35.75 to read 5 mSv/year (0.5 10/23/07 Not accepted Closed rem/year).
33 NRC staff should modify 10 CFR 35.491(b)(2) to specify 'superficial Open ophthalmic treatments. Additionally, NRC staff should change the title of 10/22/07 Accepted Delayed 10 CFR 35.491 to specify superficial ophthalmic treatments.
34 NRC staff should not revise 10 CFR 35.491 (intended for ophthalmologists) to include training and experience for the new Partially Open 10/22/07 intraocular device. Instead, NRC staff should regulate the new intraocular Accepted Delayed device under 10 CFR 35.490.
35 NRC staff should not require medical licensees regulated under 10 CFR Closed 35.400, 500, or 600, as applicable, to only use the sealed sources and 10/22/07 Accepted 3/7/18 devices for the principle use as approved in the SSDR.
36 NRC staff should revise 10 CFR 35.290 to allow physicians to receive Closed training and experience in the elution of generators and preparation of kits 10/22/07 Accepted 3/7/18 under the supervision of an ANP.
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