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Undated memo forwarding documents to be placed in PDR & Central Files re Regulatory History AC65-1 of proposed rule 10CFR35, "Basic QA in Radiation Therapy."
Accession Number: ML20235F951
Date Released: Wednesday, October 23, 2024
Package Contents
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- ML20236T464 - Undated memo forwarding documents to be placed in PDR & Central Files re Regulatory History AC65-1 of proposed rule 10CFR35, "Basic QA in Radiation Therapy." (3 page(s), 12/1/1987)
- ML20236U630 - Comments on AEOD rept cover sheet.Redrafting of paragraghs re AEOD rept to included stated info,including description of time period for NRC program requested. (1 page(s), 11/14/1986)
- ML20236U303 - Recommends initiation of NRC rulemaking, "QA & Penalties for Negligence." Change of title of rulemaking to "QA & Penalties to Reduce Misadministration of Radiation Therapy" suggested. (5 page(s), 11/21/1986)
- ML20244E471 - Staff requirements memo re "AEOD Case Study Rept on Rupture of I-125 Brachytherapy Source at Univ of Cincinnati Medical Ctr," in response to 860926 request. (5 page(s), 11/28/1986)
- ML20236U691 - Requests info re NMSS actions to be taken to implement Recommendation 1 & date completion of actions expected concerning AEOD Case Study Rept AEOD/C505, "Therapy Misadministrations Reported to NRC Per 10CFR35.42." (3 page(s), 9/3/1986)
- ML20236T826 - Expresses appreciation for visit to observe implementation of NRC regulations re use of radiopharms. (1 page(s), 1/15/1987)
- ML20236T744 - Submits notes from 870130 briefing of V Stello.Mention of previous requests for budget resources & ref of other matls requests noted. (1 page(s), 1/30/1987)
- ML20236U839 - Forwards draft reply prepared in response to anticipated staff requirements memo endorsing actions proposed by Commissioner Bernthal re medical misadministrations on radiation therapy. (8 page(s), 4/4/1986)
- ML20236U385 - Concurs w/sending of advance notice of proposed rulemaking, "Radiation Therapy QA & Penalties for Negligence" to Commission for approval.Specific comments discussed by telephone. (1 page(s), 12/10/1986)
- ML20236T823 - Submits comments & concurrence on Commission paper, "QA & Penalties for Negligence," per 861224 request for concurrence.Editorial comments encl.W/o stated encl. (2 page(s), 1/9/1987)
- ML20236T485 - Advises of Commission approval of proposed rule & advanced notice of proposed rulemaking re SECY-87-29A concerning misadministrations subj to stated recommendations & encl mods.Dates requested for return of rules stated. (66 page(s), 9/2/1987)
- ML20236U317 - Suggests that staff be directed to prepare comprehensive discussion & list of recommendations for improvements in administering NRC 10CFR35 regulations re medical misadministrations for Commission review within 60 days. (1 page(s), 11/26/1986)
- ML20236U763 - "Misadministration Rule Action Plan." (17 page(s), 7/29/1986)
- ML20236T476 - Requests publication of encl notices, "Comprehensive QA in Medical Use & Std of Care" for 90-day comment period & "Basic QA in Radiation Therapy" for 60-day comment period. Staff requirements memo & related info encl.W/o memo. (3 page(s), 9/22/1987)
- ML20236U288 - Submits notes from 861204 meeting between NL McElroy & B Pineles. (1 page(s), 12/4/1986)
- ML20236T567 - Responds to 860520 request for views re enforcement policy & physicians in circumstances such as set forth in SECY-86-130.Enforcement policy permits removal of individuals if circumstances warrant such action. (2 page(s), 6/9/1986)
- ML20236U368 - Concurs w/intent of advance notice of proposed rulemaking, "Radiation Therapy QA & Penalties for Negligence." No significant comments offered. (1 page(s), 12/18/1986)
- ML20236U483 - Supports need for advance notice of proposed rule re radiation therapy QA & penalties for negligence.Development of simple prohibition of therapy misadministrations within 10CFR35 coupled w/enforcement sanction encouraged. (1 page(s), 12/8/1986)
- ML20236U620 - Concurs w/package presenting advance notice of proposed rulemaking, "Radiation Therapy:QA & Penalties for Negligence." Marked-up package presenting editorial & format changes encl. (1 page(s), 12/4/1986)
- ML20236T777 - Concurs w/Commission paper, "QA & Penalties for Negligence," per 861224 request.Approach of Region II 861208 memo that misadministration would be violation of regulatory requirements requiring QA programs employment expressed. (1 page(s), 1/6/1987)
- ML20236U366 - Requests comments & concurrence on encl advance notice of proposed rulemaking, "Radiation Therapy QA & Penalties for Negligence," by 861205.W/o stated encl. (2 page(s), 11/24/1986)
- ML20236T735 - Requests permission for Chairman Zech & assistant Dunn-Lee, Glenn & author to visit radiation therapy & nuclear medicine clinics on 870501,based on previous conversations.Visit to assist in exam of NRC regulations re medical use of matl. (1 page(s), 3/12/1987)
- ML20236U640 - PNO-III-86-135B:on 861006-08,radiation therapy misadministration occurred.Caused by miscalculation of exposure time for each of six planned treatment.Special NRC medical advisory board formed to evaluate case. (2 page(s), 11/21/1986)
- ML20236T519 - Responds to three questions in 870624 ltr re brachytherapy patients treated at Univ of NM during 1986.Revised estimates of delivered doses probably correct. (2 page(s), 6/30/1987)
- ML20236T797 - Submits analysis & recommendation to Question 2 dealing w/ improved insp techniques,per Commission 861216 request re medical misadministrations concerning need for improved oversight. (3 page(s), 12/31/1986)
- ML20236T482 - Advises of NRC intention to publish in FR encl notices re QA in medical use of byproduct matl.Notices will be mailed to licensees & other interested individuals for comment. (58 page(s), 12/1/1987)
- ML20236U166 - Forwards draft advance notice of proposed rulemaking & draft final rule re misadministrations,for comments by telephone within next few days. (49 page(s), 1/2/1987)
- ML20236T535 - Suggests that recipient interact w/J Taylor & begin review of enforcement philosophy against reactor licensees vis-a-vis philosophy against nonreactor licensees.Discussion wk of 870609 requested. (1 page(s), 5/30/1986)
- ML20236U213 - Discusses items of interest for Commission re Commission paper concerning radiation therapy misadministrations due on 870414.Paper will include advance notice of proposed rulemaking & will be submitted in late Jan 1987. (1 page(s), 12/11/1986)
- ML20236T496 - Staff requirements memo re 870729 Commission briefing in Washington,DC re medical use of isotopes & medical misadministration rule.Staff committed to brief Commission of rule following analysis of comments.Related info encl. (5 page(s), 8/10/1987)
- ML20236T518 - Confirms understanding of recipient agreement to provide technical assistance to State of NM re dose calculations for six brachytherapy patients.Completion of review & response to stated questions by 870701 requested. (2 page(s), 6/24/1987)
- ML20236U818 - Expresses belief that Commission should direct staff to review authority currently possessed by Commission in area of medical misadministrations of radiation therapy. (2 page(s), 3/14/1986)
- ML20236U825 - Advises of strong support for efforts to improve existing situation re medical misadministrations. (2 page(s), 4/3/1986)
- ML20236T788 - Concurs w/intent of Commission paper, "QA & Penalties for Negligence" & agrees that specific issue dealing w/topic of negligence be handled as suggested in document. (2 page(s), 1/8/1987)
- ML20236U626 - Comments on advance notice of proposed rulemaking, "Radiation Therapy QA & Penalties for Negligence." Ofc has no position re whether subj document should be advance notice or proposed rule. (1 page(s), 12/5/1986)
- ML20236T779 - Provides comments on Commission paper re QA in radiation therapy & penalties for negligence.Comments of Agreement States on rulemaking package requested by 870109 & will be forwarded when received. (2 page(s), 1/7/1987)
- ML20236U907 - Forwards comments on advance notice of proposed rulemaking & draft final rule on misadministrations.Craddick Qa sys may be of interest.JD Bell may be contacted for first hand experience. (7 page(s), 1/6/1987)
- ML20236T804 - Submits comments on Commission paper, "QA & Penalties for Negligence," per 861224 request.Proposed regulation does not address misadministrations involving failure to independently verify correct source loading or implanting. (2 page(s), 1/7/1987)
- ML20244E510 - Comments on proposed Commission paper re misadministration of radiation therapy.Disagrees w/statement on bottom of Page 5 of proposed FR notice that simply measuring radioactivity of dosages satisfies need for QA program. (3 page(s), 12/5/1986)
- ML20236U224 - Advises that D Pistenmaa & J Deye would be available to provide consultative assistance re NRC efforts concerning radiation therapy misadministrations.Luncheon suggested. Marked-up agenda encl. (28 page(s), 10/29/1986)
- ML20244D912 - Discusses insps on 860110 & 0210-11 & forwards notice of violation & proposed imposition of civil penalty in amount of $5,000 & confirmatory order modifying License 08-03604-04. (3 page(s), 5/29/1986)
- ML20235F945 - Recommends Commission approve direct publication of advance notice of proposed rulemaking on comprehensive QA in medical use & std of care & notice of proposed rulemaking re basic QA in radiation therapy for public comment. (132 page(s), 6/18/1987)
- ML20244E557 - Comments on draft Commission paper, "QA & Penalties for Negligence (Medical Programs)." Refs to mod to enforcement policy should be deleted throughout package. (7 page(s), 1/9/1987)
- ML20236U637 - Ltr to all medical licensees forwarding rept analyzing radiation therapy misadministration events reported to NRC from Nov 1980 - Jul 1984.Rept includes recommendations but does not impose requirements on licensees. (1 page(s), 11/19/1986)
- ML20236T794 - Concurs w/Commission paper, "QA & Penalties for Negligence" subj to inclusion of statement similar to that provided re other AEOD work in progress. (2 page(s), 1/6/1987)
- ML20236U743 - Forwards paper requesting permission to initiate rulemaking project, "QA & Penalties for Negligence," to meet Commission 860414 request.Action plan describing directive & corollary issues within NRC & medical community also encl. (2 page(s), 8/1/1986)
- ML20236U737 - Expresses appreciation for opportunity to visit clinic.Visit informative & will have beneficial effect on NRC rulemakings re medical use of byproduct matl. (1 page(s), 8/27/1986)
- ML20236U872 - Discusses errors in Encl 2 of draft advance notice & draft final rule,which would be amends to 10CFR35 re misadministrations,provided w/870102 memo. (8 page(s), 1/6/1987)
- ML20236U738 - Requests permission to visit clinic to receive overview of science & technology of teletherapy & brachytherapy,based on informal conversations w/recipient & Wessels.Requests that Wessels call author to schedule visit,if approved. (2 page(s), 6/4/1986)
- ML20236T800 - Concurs w/Commission paper, "QA & Penalties for Negligence," per 861224 request.Issuance of immediate effective order to all medical licensees per Region III 861205 memo preferred. Comments on responses proposed in Encl 3 encl. (3 page(s), 1/7/1987)
- ML20236T756 - Forwards article summarizing rept, "Therapy Misadministrations Reported to NRC Pursuant to 10CFR35.42," for review & comments by 860926.Article to be published in American College of Radiology monthly newsletter. (5 page(s), 9/11/1986)
- ML20236U190 - Requests that advanced notice of proposed rulemaking re need for improved oversight of medical misadministration be provided for Commission review by 870131.Analysis & recommendations re 10CFR35 administration also requested. (3 page(s), 12/16/1986)
- ML20236U770 - Advises of Commission request for staff review of Commission authority in area of medical licensee regulation concerning medical misadministration of radiation therapy. (1 page(s), 4/14/1986)
- ML20236T646 - Discusses Commissioner Bernthal public comments at Baltimore-Washington Health Physics meeting on 870422 re use of byproduct matl & related matters.Record of 870408 telcon encl.Copyrighted MDDI Repts publication not filmed. (4 page(s), 4/23/1987)
- ML20236T765 - Summarizes comments received from Advisory Committee on Medical Uses of Isotopes on Misadministrations package. Comments made in ref to 870102 mailing. (1 page(s), 7/15/1987)
- ML20236T550 - Requests view on enforcement policy as described in SECY-86-130 in which NRC has proposed not to take any enforcement action against Washington Hosp Ctr which would affect physician. (1 page(s), 5/20/1986)
- ML20236U683 - Updates NMSS plans to notify licensees of info in AEOD Case Study Rept AEOD/C505, "Therapy Misadministrations Reported to NRC Per 10CFR35.42," per 860903 request.Publication of news article on subj in major newsletter planned. (1 page(s), 9/10/1986)
- ML20236T752 - Forwards marked-up draft Commission paper, "Misadministrations of Radiation Therapy." Paper responds to Staff Requirements Memos COMFB-86-3,COMFB-86-8 & COMLZ-86-25.Misadministration chronology also encl. (66 page(s), 1/21/1987)
- ML20236T783 - Concurs w/package presenting advance notice of proposed rulemaking & proposed or final rule for Commission consideration re misadministrations of radiation therapy & QA & penalties for negligence. (2 page(s), 1/6/1987)
- ML20244D920 - Confirmatory order modifying License 08-03604-04 to incorporate commitments documented in Region II 860211 confirmatory action ltr.Authorized physician user must review every patient chart & confirm teletherapy request. (5 page(s), 5/29/1986)
- ML20236T511 - Requests special study on teletherapy misadministrations as noted in encl preliminary notification of event or unusual occurrence.Determination if notice of proposed rule & advanced notice of proposed rulemaking sufficient requested. (1 page(s), 8/26/1987)
- ML20244D916 - Notice of violation & proposed imposition of civil penalty in amount of $5,000.Violation noted:teletherapy machine control not locked in off condition while interlock sys malfunctioning. (2 page(s), 5/29/1986)
- ML20236U617 - Concurs w/issuance of advance notice of proposed rulemaking, "Radiation Therapy QA & Penalties for Negligence," per 861124 request. (1 page(s), 12/5/1986)
- ML20236U382 - Comments on advance notice of proposed rulemaking, "Radiation Therapy QA & Penalties for Negligence" distributed on 861124.NRC efforts to establish QA programs for brachytherapy & teletherapy supported. (4 page(s), 12/5/1986)
- ML20236U206 - Annotated memo re 861216 discussion on misadministration rule.Approach will be modified to give Commission option on processing.Marked-up comments on advanced notice of proposed rulemaking & notice of briefing encl. (4 page(s), 12/17/1986)
- ML20236U293 - Advises that if current wording of advance notice of proposed rulemaking on QA & penalties for negligence retained,personal discussions between ofc directors may be needed. (1 page(s), 12/3/1986)
- ML20236U272 - Responds to inquiry from discussions during wk of 861201 concerning imposing immediately effective requirements for medical licensees to prevent misadministrations.Certain QA requirements can be imposed as immediate final rule. (3 page(s), 12/10/1986)
- ML20236T837 - Requests concurrences on encl Commission paper, "QA & Penalties for Negligence" by 870107.Commission directed that advance notice of proposed rulemaking be submitted by 870131. (2 page(s), 12/24/1986)
- ML20236U338 - Agrees that Commission must take hard look at way oversight of medical use of radioisotopes conducted.Direction of staff to expedite preparation of required rulemaking package due 870415 suggested. (1 page(s), 12/2/1986)
- ML20236T825 - Expresses appreciation for visit to observe implementation of current NRC regulations re administration of radiation therapy. (1 page(s), 1/15/1987)
- ML20236U309 - Recommends that NMSS proceed w/new rulemaking, "QA & Penalties for Negligence." Draft regulatory agenda entry addressing issue encl.W/o stated encl. (1 page(s), 8/8/1986)
- ML20245A088 - Recommends Commission direct publication of quick-turnaround proposed rule that would require licensees to implement certain basic QA steps & advanced notice of proposed rulemaking re scope of QA program rule. (72 page(s), 2/5/1987)