Archived Information
-
IAC Releases Updates to Nuclear/PET Standards - New Standards Effective March 15, 2017 –updated September 15, 2016.
As an accreditation organization, IAC Nuclear/PET is committed to maintaining a program that balances the changing needs of both the nuclear cardiology, nuclear medicine and PET community and the general public by influencing the quality of patient care provided. The IAC Standards and Guidelines for Nuclear/PET Accreditation are the most important component of that commitment. Composed by physicians and technologists from the IAC sponsoring organizations, the Standards are reviewed periodically by the Board of Directors and revised as needed. As a component of the accreditation process, the IAC Nuclear/PET Board of Directors preliminarily approved the proposed Standards which were posted to the IAC Nuclear/PET website for a 60-day public comment period from April 1 to June 1, 2016. Following careful review and consideration of the comments received, the Board of Directors voted final approval of the Standards.
Download: The IAC Standards and Guidelines for Nuclear/PET Accreditation
Standards that are highlighted are major content changes that were made as part of the September 15, 2016 revision. These Standards will become effective on March 15, 2017. Facilities applying for accreditation after March 15, 2017 must comply with these new highlighted Standards.Key Revisions to the IAC Standards for Nuclear/PET
Some of the changes made are a clarification or explanation of the previous Standards, however, in several instances, the requirements have been modified. Key modifications include:- Technical Staff - The Standard previously titled nuclear medicine technologist(s) is now technical staff in all references.
- General Protocol Guidelines - A substantial change to the IAC Nuclear/PET Standards regarding the required administered radiopharmaceutical dose ranges and corresponding radiation effective doses for myocardial perfusion imaging was made. To read the background on this change, please visit intersocietal.org/nuclear/main/dose.htm.
- Part D: Therapy Procedures - The majority of the new Part D section already existed in the previous Standards, however, these requirements were moved to a new section for Therapy Protocols and Performance only.
-
WA Proposed Rule for Computed Tomography (CT) - update September 6, 2016
The State of Washington has published a proposed rule for CT. Comments will be accepted through September 7, 2016. These changes do not apply to registrants exclusively using low power CT X-ray systems (5 kW or less) or cone-beam CT X-ray systems or CT simulators exclusively for treatment planning purposes in conjunction with a megavoltage radiation therapy or brachytherapy.
AAPM files comments September 6, 2016.
A Public Hearing will be held September 7, 2016, 10:00 a.m.
Washington State Department of Health
Town Center 3, Room 224
111 Israel Road Southeast
Tumwater, Washington 98504The WA Department of Health worked with an advisory committee to develop rules for the safe use of CT X-ray systems for diagnostic purposes. The use of CT X-ray systems has grown in recent years in number of units, frequency of prescribed scans and, most importantly, the amount of radiation used. The proposed rules are intended to reduce occupational and patient radiation exposure, and help prevent overexposure. If you have questions about this rulemaking, contact Dan Van Gent, X-Ray Section Manager, at 360-236-3231.
- Preliminary Significant Analysis (PDF)
- Preliminary Small Business Economic Impact Statement (PDF)
- CR-101 Preproposal Statement of Inquiry (PDF)
- CT Advisory Committee
-
MN Announces Intent to revise x-ray regulations - updated August 18, 2016
The State of Minnesota has announced their intent to revise the state's x-ray regulations. Attached for your information is the announcement from the July 18th State Federal Register and the excerpted relevant text. The state is requesting comments by September 17, 2016 on what the proposed rule should look like.
The latest version of the Council of Radiation Control Program Directors (CRCPD's) Suggested State Regulation - Part F and the rationale which were revised in 2015. SSR-F may give you some insight as to what x-ray regulations should look like.
Questions should be directed to Richard Martin, Government Relations Program Manager at richard@aapm.org or 571.298.1227.
-
Department of Veterans Affairs Issued Advanced Practice Nurses Proposed Rule - update June 21, 2016
The Department of Veterans Affairs(VA) is seeking comments on a proposed rule that would amend its medical regulations to permit full practice authority of all VA advanced practice registered nurses (APRNs) when they are acting within the scope of their VA employment. Purpose is to increase veterans' access to VA health care by expanding the pool of qualified health care professionals who are authorized to provide primary health care and other related health services consistent with their education, training and certification. If passed, the APRN may practice without the clinical supervision or mandatory collaboration of physicians. This will also take precedence over state regulations. In the proposed rule, the VA stated that this would help to ensure a consistent continuum of health care across Veterans Health Administration by decreasing the variability in APRN practice that currently exits due to variability of state practice regulations.
AAPM represents diagnostic medical physicists who work side-by- side with both radiologic technologists and radiologists; medical physicists are involved in training both groups, and in optimizing protocols which impact both the acquisition and interpretation of medical imaging. Medical physicists have no financial stake in the VA proposal, and this commentary represents our significant experience working in the diagnostic radiology environment and our commitment to patient safety. Based upon the experience of medical physicists, there is absolutely no possibility that our respected advanced practice registered nurse colleagues, who lack the experience of radiologic technologists for acquisition and radiologists for interpretation of medical images, could deliver accurate radiologic diagnostic images and interpretation. Allowing this proposal to go forward would produce substandard care and be an egregious disservice to veterans who have honorably served our nation.
Written comments may be submitted through regulations.gov; no later than July 25, 2016 at regulations.gov/docket?D=VA-2016-VHA-0011 .
AAPM files comments June 21, 2016
ACR Press Release - This link is no longer available
ASRT Statement - This link is no longer available
If you have questions ichard Martin, Government Relations Program Manager at richard@aapm.org or 571.298.1227
-
NRC Requests Comments on Proposed Agreement State Policy Statement - updated June 13, 2016
The U.S. Nuclear Regulatory Commission (NRC) has revised and consolidated two policy statements on NRC’s Agreement State Programs: the ‘‘Policy Statement on Adequacy and Compatibility of Agreement State Programs’’ and the ‘‘Statement of Principles and Policy for the Agreement State Program.’’ The resulting proposed single policy statement has been revised to add that public health and safety includes physical protection of agreement material. Comments must be submitted to NRC by August 16, 2016.
The Commission’s proposed consolidated policy removes details on the Integrated Materials Performance Evaluation Program (IMPEP) and the ‘‘Principles of Good Regulation.’’ The NRC added a description of the National Materials Program (NMP).
Of note is the change to the definition of Levels of Compatibility especially Compatibility Category B. Based on comments received, the NRC staff noted that there is a wide variation on the interpretation of the description of Compatibility Category B and of the definition of significant transboundary implication. In light of this, the Commission is proposing a new description of Compatibility Category B to eliminate the phrase ‘‘significant transboundary implication.’’
NRC stated that:
- “An ‘‘adequate’’ program includes those program elements of a radiation control regulatory program necessary to maintain an acceptable level of protection of public health and safety within an Agreement State. An Agreement State’s radiation control program is adequate to protect public health and safety if administration of the program provides reasonable assurance of protection of public health and safety in regulating the use of agreement material. The level of protection afforded by the program elements of the NRC’s materials regulatory program is presumed to be adequate to provide a reasonable assurance of protection of public health and safety. Therefore, the overall level of protection of public health and safety provided by a State program should be equivalent to, or greater than, the level provided by the NRC program.”
- “A ‘‘compatible’’ program consists of those program elements necessary to sustain an orderly pattern of regulation of radiation protection. An Agreement State has the flexibility to adopt and implement program elements within the State’s jurisdiction that are not addressed by the NRC, or program elements not required for compatibility (i.e., those NRC program elements not assigned to Compatibility Category A, B, or C). However, such program elements of an Agreement State relating to agreement material shall (1) be compatible with those of the NRC (i.e., should not create conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis); (2) not preclude a practice authorized by the AEA and in the national interest; and (3) not preclude the ability of the Commission to evaluate the effectiveness of the NRC and Agreement State programs for agreement material with respect to protection of public health and safety. For purposes of compatibility, the State shall adopt program elements assigned Compatibility Categories A, B, and C.”
“The proposed new definition of levels of compatibility are:
- Category A—Basic Radiation Protection Standards. This category includes basic radiation protection standards that encompass dose limits, concentration and release limits related to radiation protection in part 20 of title 10 of the Code of Federal Regulations (10 CFR), that are generally applicable, and the dose limits for land disposal of radioactive waste in 10 CFR 61.41.7 Also included in this category are a limited number of definitions, signs, labels, and scientific terms that are necessary for a common understanding of radiation protection principles among licensees, regulatory agencies, and members of the public. Such State standards should be essentially identical to those of the NRC, unless Federal statutes provide the State authority to adopt different standards. Basic radiation protection standards do not include constraints or other limits below the level associated with ‘‘adequate protection’’ that take into account considerations such as economic cost and other factors.
- Category B—Cross Jurisdictional Program Elements. This category pertains to a small number of program elements that cross jurisdictional boundaries and that should be addressed to ensure uniformity of regulation on a nationwide basis. Examples include, but are not limited to, sealed source and device registration certificates, transportation regulations, and radiography certification. Agreement State program elements shall be essentially identical to those of the NRC. Because program elements used in the Agreement State Program are necessary to maintain an acceptable level of protection of public health and safety, economic factors 8 should not be considered.
- Category C—Other NRC Program Elements. These are other NRC program elements that are important for an Agreement State to implement in order to avoid conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. Such Agreement State program elements should embody the essential objective of the corresponding NRC program elements. Agreement State program elements may be more restrictive than NRC program elements; however, they should not be so restrictive as to prohibit a practice authorized by the AEA and in the national interest without an adequate public health and safety or environmental basis related to radiation protection.
- Category D—Program Elements Not Required for Compatibility. These are program elements that do not meet any of the criteria listed in Compatibility Category A, B, or C above and are not required to be adopted for purposes of compatibility.
- Category NRC—Areas of Exclusive NRC Regulatory Authority. These are program elements over which the NRC cannot discontinue its regulatory authority pursuant to the AEA or provisions of title 10 of the Code of Federal Regulations. However, an Agreement State may inform its licensees of these NRC requirements through an appropriate mechanism under the State’s administrative procedure laws as long as the State adopts these provisions solely for the purposes of notification, and does not exercise any regulatory authority as a result.”
Individual comments may be submitted to NRC by August 16, 2016 by any of the following methods:
- Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC–2016–0094.
- Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN 12–H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001.
If you would like AAPM to consider any comments on this draft policy statement, please email them to Richard Martin, Government Relations Program Manager at richard@aapm.org no later than August 1, 2016 in order that the comments can be consolidated and approved for submittal to NRC by August 16, 2016.
New Version of DICOM Standard Available - Replaces the 2016b release.
- The 2016c release of the DICOM standard is now available from the DICOM home page or from dicom.nema.org/medical/dicom/current/. It is also indexed from Editor’s status page at: www.dclunie.com/dicom-status/status.html
- Release notes are at: dicom.nema.org/medical/dicom/current/output/pdf/releasenotes_2016c.pdf
- The changes from the 2016b release are shown highlighted in PDF files; note that changes to figures are not detected and some changed figures are not rendered in the diff files: www.dclunie.com/dicom-status/status.html#DiffsStandard2016b2016c .
-
IAEA Publishes Nuclear Medicine Handbook - updated June 13, 2016
The International Atomic Energy Agency (IAEA) recently published theNuclear Medicine Physics Handbook. The handbook, intended for teachers, students and residents involved in medical physics programs, provides a comprehensive overview of the knowledge required in physics, instrumentation and data processing for the practice of medical physics in modern nuclear medicine. A set of teaching slides were also developed to assist in presenting the material in each chapter. You can download a PDF version of the slides or register with the IAEA to obtain the Power Point version.
In addition, the IAEA has made available the IAEA Radiotracer Biodistribution Template (IAEA-RaBiT)– a free resource for (organ level) radionuclide dosimetry research and applications for those involved with internal dosimetry. The IAEA-RaBiT is a standard-format template that can be used to organize biodistribution information within a center, reporting it in publications, and support high throughput dosimetry protocols. It is freely available for download/use, created as a community resource.
Finally, for those interested in Quality Assurance and Quality Controls of SPECT systems, IAEA has also developed an e-learning module for SPECT systemsand tutorial videoson the IAEAHuman Health Campus. -
NEMA Publishes NEMA XR 31-2016 Standard Attibutes on X-ray Equipment for Interventional Procedures- updated June 1, 2016
The National Electrical Manufacturers Association (NEMA) published NEMA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional Procedures. The Medical Imaging and Technology Alliance (MITA), a division of NEMA, developed this new standard using MITA Smart Dose Interventional technology. This standard offers healthcare providers a reference to identify key features which contribute to enhanced patient care and to help manage patient radiation dose delivery, while still enabling the system to provide sufficient image quality needed by the physician.
NEMA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional Procedures describes eight features that should be taken into consideration when performing risk management evaluations on existing stationary x-ray interventional equipment. These key features were introduced over the course of the past decade and are now considered state of the art: dosimetric indications- added filters
- range of air kerma rates in fluoroscopy
- last-image-hold
- virtual collimation
- stored fluoroscopy
- variable pulsed fluoroscopy
- digital x-ray imaging device
-
Proposed Changes to IAC Nuclear/PET Standards - Now Open for Public Comment - updated April 1, 2016
The Intersocietal Accreditation Commission (IAC) has announced a substantial change to the IAC Nuclear/PET Standards regarding the required radiopharmaceutical activities and their corresponding radiation effective doses is proposed.Details on the changes can be found at: intersocietal.org/nuclear/main/dose.htm. Comment period closes June 1st, 2016. In order to provide comments, the IAC Comment Form must be completed and submitted electronically by the provided deadline.
The Standards are reviewed periodically by the IAC Nuclear/PET Board of Directors and revised as needed. As a component to the accreditation process, proposed Standards that have been approved by the Board of Directors are then posted to the IAC website for a 60-day public comment period. These proposed Standards include changes to the current Standards, the removal of current Standards and/or the addition of new Standards.To Submit a Comment on ProposedStandards
- Visit the IAC website at intersocietal.org/iac/comment_period.htm#nuclear;
- Select the proposed Nuclear/PET Standard on which to comment;
- A window will expand with the description of the Standard and the proposed change on the left;
- On the right, fill in your name and comment in the boxes provided;
- Hit Submit.
At the close of the comment period, the IAC Nuclear/PET Board of Directors will review any submitted comments, consider modifications as needed and vote for final approval of the Standards. Facilities are notified of changes to the published Standards, and the most current version of the Standards can be viewed or printed from the IAC Nuclear/PET website at intersocietal.org/nuclear/main/nuclear_standards.htm.
-
AAPM Submits Comments to the Joint Commission in response to the Proposed New National Patient Safety Goal on Pediatric Computed Tomography (CT) Imaging
The Joint Commission was seeking input on a proposed new National Patient Safety Goal (NPSG) on Pediatric Computed Tomography (CT) Imaging. Published data about the frequency of pediatric CT imaging varies. Despite evidence that use of CT may have stabilized or is declining after a period of increased use, there is an opportunity to further prevent unnecessary radiation exposure for children. An NPSG would spotlight this issue, and would motivate accredited organizations to use evidence-based practices for determining when CT examinations are necessary.
-
NRC Program Review of 10 CFR Part 37 - Updated March 28, 2016
The NRC has initiated a program review of requirements in 10 CFR Part 37 to evaluate the clarity of the rule language and licensee experience with implementing the rule. As part of this review, the NRC sought input from various stakeholders, including licensees. Several licensees provided voluntary assistance by completing a questionnaire about Part 37 regulatory requirements and guidance, as well as participated in interview sessions as follow-up to the questionnaires.
As part of the continuing program review, the NRC has issued a Federal Register Notice (FRN) on March 14, 2016, and plans to hold a series of public meetings to discuss the topics identified in the FRN and facilitate public participation in the Part 37 assessment that is being performed by the NRC.
The staff will publicly notice the official dates and times of these meetings, but they are tentatively scheduled as webinars on March 31, April 7, April 12, and April 19, and a public meeting to be held at the NRC Headquarters on May 5, 2016. The webinars will be focused on specific audiences – e.g., March 31 and April 7 – Materials Licensees; April 12 – Agreement States; and April 19 – Reactor or Part 50 Licensees. The American Association of Physicists in Medicine is welcome to participate in any meeting that suits its availability. Please consult the NRC public meeting schedule, which can be accessed at: meetings.nrc.gov/pmns/mtg.
Please find the direct link below to register for Webinar 1:
Webinar 1 – Program Review of Part 37 of Title 10 of the Code of Federal Regulations
Join us for a webinar on Mar 31, 2016 at 2:00 PM EDT. Register now!
After registering, you will receive a confirmation email containing information about joining the webinar.
Comments on the FRN are due by May 13, 2016. Please feel free to send any written comments on the FRN or any other comments or items you would like to share, to Part37Assessment@nrc.gov. If you have any questions about the webinars and public meeting or any other questions, please feel free to call George Smith at 301-415-7201 or email George.smith@nrc.gov; or Carrie Crawford at 301-415-4132< or email carrie.crawford@nrc.gov.
The Intersocietal Accreditation Commissionl (IAC) releases A Year in Review - updated March 22, 2016
For the first time in its 25 year history, the IAC has published a review of its history.
-
MITA sends letter to CMS re: XR-29 - updated March 21, 2016
The Medical Imaging and Technology Alliance (MITA) sent a letter to the Centers for Medicare & Medicaid Services (CMS) on January 20, 2016 with questions on the process that CMS will use to determine compliance. On March 4, 2016, CMS responded to MITA's questions.
-
FDA Approves ACR's Digital Mammography Manual - updated March 11, 2106
This alternative standard was approved and became effective on February 17, 2016. It has no time limit. The alternative standard allows for the use by mammography facilities of the ACR Digital Mammography Quality Control Manualas an alternative to the quality assurance program recommended by the image receptor manufacturer. The FDA has determined that the ACR's quality control manual is, as required in § 900.18(a)(1): Alternative Requirements, “at least as effective in assuring quality mammography” as following the manufacturers’ QC manuals. For the most recent FDA assistance, please visit Frequently Asked Questions about DBT and MQSA Training Requirements. If there are additional questions, contact the FDA Mammography Facility Hotline at 1-800-838-7715 orMQSAhotline@hcmsllc.com.
NOTE from ACR: The ACR manual is currently undergoing preparation for publication and should be available this spring. ACR-accredited mammography facilities and those applying for accreditation will be invited to download the PDF manual at no charge; medical physicists associated with ACR-accredited facilities will also be allowed to download the manual at no charge.
-
NRC Issues Update to Yttrium-90 Microspheres Licensing Guidance added March 1, 2016
On February 17, 2016, the U.S. Nuclear Regulatory Commission (NRC), in conjunction with the Agreement States through a joint working group, issued revision 9 to the licensing guidance for Yttrium-90 (Y-90) Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®.
The licensing guidance for Y-90 microsphere brachytherapy was initially published in October 2002 and subsequently revised in 2004, 2007, 2008, 2011, and 2012. Based on recommendations from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) (ADAMS Accession No.ML14300A138), the joint working group revised this licensing guidance. This current licensing guidance revision has three major changes based on these ACMUI recommendations.These changes (1) remove specifications for gastrointestinal tract and lung dose/activity in the written directive and exclude reporting dose/activity to an organ or tissue other than the treatment site as a medical event when the dose/activity is caused by shunting when the shunting was evaluated prior to treatment in accordance with manufacturer’s procedures, (2) specifically exclude reporting of events due to stasis or emergent patient conditions, and (3) allow for interventional radiologists certified by the American Osteopathic Board of Radiology to become Authorized Users.The licensing guidance may also be found on the NRC Medical Uses Licensee Toolkit at www.nrc.gov/materials/miau/med-use-toolkit.html#et.
If you have questions regarding the Y-90 Licensing Guidance, please contact Katie Tapp at (301) 415-0236 or Katherine.Tapp@nrc.gov.
If you have questions about the ACMUI meeting notice, please contact Sophie Holiday at (301) 415-7865 or Sophie.Holiday@nrc.gov.
-
NRC Updates Medical Uses Licensee Toolkit - added February 2016
NRC recently updated the Medical Uses Licensee Toolkit to include the Purpose of Medical Event Reporting. Immediately beneath this section, you will find the Medical Event Presentations from the 2015 Advisory Committee on Medical Uses of Isotopes (ACMUI) Meetings. Additional presentations will be posted when available. If you have any questions related to the “Purpose of Medical Event Reporting”, please contact Said.Daibes@nrc.gov. If you have any questions related to the “Medical Event Presentations”, please contact Sophie.Holiday@nrc.gov.
-
Draft ICRP report “Diagnostic Reference Levels in Medical Imaging Available for Comment - added February 2016
The International Commission on Radiological Protection (ICRP) first introduced the term ‘diagnostic reference level’ (DRL) in Publication 73 (1996). The concept was subsequently developed further, and practical guidance was provided in 2001. DRLs have been proven to be an effective tool that aids in optimization of protection in the medical exposure of patients for diagnostic and interventional procedures. However, with time it has become evident that additional advice is needed. There are issues related to definitions of the terms used in previous guidance, determination of the values for DRLs, the appropriate interval for re-evaluating and updating these values, appropriate use of DRLs in clinical practice, methods for practical application of this tool, and application of the DRL concept to newer imaging technologies. This report is intended as a further source of information and guidance on these issues. Some terminology has been clarified. In addition, the report recommends quantities for use as DRLs for various imaging modalities, and provides information on use of DRLs for interventional procedures and in pediatric imaging. It suggests modifications in the conduct of DRL surveys that take advantage of automated reporting of radiation dose related quantities, and points out the importance of including information on DRLs in training programs for health care workers. The target audience for this report is national, regional and local authorities, professional societies, facilities where ionizing radiation is used for medical purposes, and responsible staff within these facilities. A full set of the Commission’s recommendations is provided.
Please send your comments on the attached Excel spreadsheet no later than April 1st, so that they can be consolidated as AAPM comments. Please be sure to include page and line number as the ICRP did not do continuous line numbering.
-
NCRP Requests Comments on Draft Lens of the Eye Commentary
The draft NCRP commentary prepared by SC 1-23 on “Guidance on Radiation Dose Limits for the Lens of the Eye” is now ready for review.This Commentary has been prepared in order to provide guidance on whether existing 3 dose limits to the lens of the eye should be changed in the United States. The guidance is based on a detailed evaluation of recent studies on the radiation dose response for the development of 5 cataracts.
Please focus your comments on substantive (e.g., technical errors, references that are not included and incomplete or incorrect interpretation of data) rather than editorial problems in the draft commentary. If you have suggestions for changes or additions to the text, please indicate clearly how your recommendations should be addressed by the committee in preparing the final revision of the commentary.
If you would like to have AAPM consider your comments, please send your comments on the attached excel spreadsheet by March 1st in order that I can consolidate them for AAPM's submittal. NCRP comment period closes March 9th.
-
NRC Requests for Information Regarding I-131 Patient Release.
On December 14, 2015, NRC Issued Regulatory Issue Summary 2015-18 Sodium Iodide-131 (I-1310 Patient Release Information Collection
The NRC is interested in obtaining input from as many stakeholders as possible, including the physicians, the NRC and Agreement State medical use licensees, and NRC MML medical use permittees that administer I-131 under the provisions of Title 10 of the Code of Federal Regulations Part 35 (10 CFR 35.300) or equivalent Agreement State requirements. The NRC is also interested in obtaining input from Agreement States. In addition to the recipients of this RIS, the NRC will also be seeking input from patients, patient advocacy groups, professional organizations, and other interested individuals. The focus of this information-gathering effort is to obtain: information that patients believe will help them understand the I-131 (also referred to as Radioactive Iodine (RAI)) treatment procedures, the physician’s or licensee’s/permittee’s best practices when making informed decisions on releasing RAI treatment patients, and information provided to patients on how to reduce radiation doses to others. The NRC is also interested in learning if patient advocacy groups, medical professional organizations, licensees, or other individuals have brochures that already contain the information requested.
The NRC published the “Sodium Iodide I-131 Patient Release Information Collection” FRN to reach as many stakeholders as possible. In the FRN, the NRC staff requested that stakeholders provide the NRC with information that they already possess concerning: (1) Web sites that provide potential patients with information on RAI treatment procedures so that patients will understand the reason for the procedures, the process, and how to reduce radiation exposure to others; (2) patient/licensee acknowledgement forms and best practices that focus on the dialog used by physicians/licensees and patients that ultimately results in the informed decision, based on radiation exposure considerations, on when the patient should be released; (3) guidance for released patients that helps to reduce the variability of instructions provided to patients and to eliminate some of the uncertainty regarding the type of information that is provided to the patient; and (4) an existing brochure for nationwide use that licensees and Agreement States believe provides clear guidance on the release of patients treated with I-131.
To aid all stakeholders, in the FRN NRC staff provided suggested topics or questions related to the information the stakeholders will submit on the Web site, in the patient/licensee acknowledgement forms, in guidance for released patients, and in a brochure for nationwide use. Because these topics and questions are probably incomplete, the NRC staff also requested that stakeholders, based on their personnel experience, identify any additional topics and questions that they believe should be included in these lists and any that they believe should be omitted from these lists. The NRC is not requesting the development of new information or that individuals research any of the topics presented in the FRN. Greater detail on the information requested and how to submit it is provided in the FRN. The NRC is also requesting that Agreement State and NRC medical use licensees, as well as NRC MML medical use permittees, voluntarily share the FRN with their staff associated with the administration of sodium iodine I-131. As noted in the FRN, this information should be submitted by February 16, 2016. The FRN is enclosed or can be accessed on the electronic Federal Register page.
AAPM submitted comments in response to the above request.
-
NRC Requests Comments on Petitions to change basis of Radiation Protection Regulations
On June 23, 2015, NRC published in the Federal Register, (link: federalregister.gov/a/2015-15441) a request for comment on three petitions from Drs. Carol Marcus, Mark L. Miller, and Mohan Doss for rulemaking (PRM) (Docket Nos.: PRM-20-28, PRM-20-29, PRM-20-30) requesting that NRC amend its “Standards for Protection Against Radiation” regulations and change the basis of those regulations from the Linear No-Threshold model of radiation protection to the radiation hormesis model. See the attached file for the Notice titled, ‘‘Linear No-Threshold Model and Standards for Protection Against Radiation.”
Full details of the Petitions can be accessed at: www.regulations.gov/#!docketDetail;D=NRC-2015-0057.
Comments specific to the Petitions for Rulemaking should be submitted by September 08, 2015. Comments received after these dates will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date. If you have any comments that AAPM should consider in a response, please send them no later than August 25, 2015.
-
Proposed Changes to IAC MRI Standards - Now Open for Public Comment
Comments May Be Submitted to IAC Now Through July 5th, 2015In keeping with the IAC's continued commitment to streamlining and simplifying the accreditation process, we are pleased to announce that the public now has the opportunity to comment on proposed changes to the IAC Standards and Guidelines for MRI Accreditation.
The Standards are reviewed periodically by the IAC MRI Board of Directors and revised as needed. As a new component to the accreditation process, proposed Standards that have been approved by the Board of Directors are then posted to the IAC website for a 60-day public comment period. These proposed Standards include changes to the current Standards, the removal of current Standards and/or the addition of new Standards.
Beginning May 5th, 2015, the public may visit the IAC website at intersocietal.org/iac/comment_period.htm to comment on any of the proposed Standards until July 5th, 2015.
In order to provide comments, the IAC Comment Form must be completed and submitted electronically by the provided deadline.
To Submit a Comment on Proposed Standards:
- Visit the IAC website at intersocietal.org/iac/comment_period.htm;
- Scroll down to the section for MRI Standards Available for Comment;
- Select the proposed Standard on which to comment;
- A window will expand with the description of the Standard and the proposed change on the left;
- On the right, fill in your name and comment in the boxes provided;
- Hit Submit.
- At the close of the comment period, the IAC MRI Board of Directors will review any submitted comments, consider modifications as needed and vote for final approval of the Standards. Facilities are notified of changes to the published Standards, and the most current version of the Standards can be viewed or printed from the IAC MRI website at intersocietal.org/mri/main/mri_standards.htm.
-
NRC Extends Comment Period for ANPR for 10 CFR Part 20 Standards for Protection Against Radiation
On November 20, 2014,NRC published in theFederal Register,an extension for the comment period for advance notice of the 10 CFR Part 20 proposed rulemaking by 120 days. Comments should be filed no later than June 22, 2015 (80 FR 14033).
NRC issued the Advance Notice for Proposed Rulemaking (ANPR) for 10 CFR Part 20 Standards for Protection Against Radiation was published in the Federal Register on July 25, 2014 (79 FR 43284). In addition to the ANPR, NRC also published 6 Issue Papers as well. This information is contained on the NRC website:
- Advance Notice of Proposed Rulemaking: Potential Changes to Radiation Protection Regulations
- Issue Paper 1: Update 10 CFR Part 20 to Align with International Commission on Radiological Protection Publication 103 Methodology and Terminology.
- Issue Paper 2: Occupational Dose Limit for the Lens of the Eye.
- Issue Paper 3: Dose Limit for the Embryo/Fetus of a Declared Pregnant Occupational Worker.
- Issue Paper 4: Individual Protection - ALARA Planning.
- Issue Paper 5: Metrication - Units of Radiation Exposure and Dose.
- Issue Paper 6: Reporting of Occupational Exposure.
Additional background information on NRC's Options to Revise Radiation Protection Regulations and Guidance can be found here.
Please send any comments for AAPM’s consideration.
-
FDA - MQSA National Statistics Updated
The national statistics can be found here.
-
NRC to Hold Public Meeting Proposed 10 CFR Part 35 Rule and Guidance
The NRC is hosting a public meeting on October 8, 2014, to discuss the proposed rule and associated regulatory guidance. The purpose of the meeting is to promote understanding and provide clarifications of the proposed amendments and to provide guidance on how to submit comments. This meeting is tentatively scheduled for October 8, 2014, from 9:00 a.m. to 4:00 p.m. (EDT), at the NRC White Flint Complex, 11555 Rockville Pike, Rockville, MD. You will also be able to participate via webinar and teleconference. The meeting will be posted on the NRC’s public meeting Web site at least 10 calendar days before the meeting. Once posted, you may also monitor the NRC’s public meeting Web site for additional information about the meeting: http://www.nrc.gov/public-involve/public-meetings/index.cfm.
NRC Issues Proposed Revision to 10 CFR Part 35 and Associated Guidance Document.
On the July 21, 2014 issue of the Federal Register, NRC published a notice of proposed rulemaking. The proposed rule would amend the Commission's medical use regulations in part 35. First, this rule proposes amendments to the reporting and notification requirements for a medical event for permanent implant brachytherapy. Second, the rule proposes changes to the training and experience (T&E) requirements for authorized users, medical physicists, Radiation Safety Officers, and nuclear pharmacists; to the requirements for measuring molybdenum (Mo) contamination andreporting of failed technetium and rubidium generators; and to allow Associate Radiation Safety Officers to be named on a medical license. Third, the rule proposes changes to address a request filed in a petition for rulemaking (PRM), PRM-35-20, to exempt certain board- certified individuals from certain T&E requirements (i.e., “grandfather” these individuals) so they may be identified on a license or permit for materials and uses that they performed on or before October 24, 2005, the expiration date of the prior T&E requirements.
Comments for both the proposed rule and its guidance to the NRC are due on November 18, 2014, however if you have comments that you want AAPM to consider, I will need all comments by October 1st for AAPM reviews and finalization of AAPM’s comment letter. Please send any comments for AAPM’s consideration to Lynne Fairobent, Senior Manager for Government Relations at lynne@aapm.org.
-
AAPM Working To Preserve Medical Physics Licensure in Texas (June 17, 2014)
The American Association of Physicists in Medicine (AAPM) is joining other organizations June 24-25, 2014 in Austin, Texas, to urge the Sunset Advisory Commission of the Texas Legislature to maintain licensing standards for medical physicists and radiologic technologists in Texas. Learn more.
-
CRCPD is pleased to announce the publication of the Nationwide Evaluation of X-Ray Trends trifold on computed tomography for 2005-06. update 8/7/2012.
Each survey cycle, the Nationwide Evaluation of X-ray Trends (NEXT) program selects a particular radiological examination for study. A NEXT survey captures radiation exposure data from a nationally representative sample of U.S. clinical facilities. Facilities are randomly selected for voluntary participation, and site visits are performed by trained surveyors from the participating states’ radiation control agencies.
During 2005 and through 2006, a NEXT survey was conducted of facilities that perform computed tomography (CT). The survey captured data regarding aspects of clinical practice, CT scanner characteristics, equipment features, and scanner radiation output measurements for estimation of patient dose. Surveyed facilities were also asked to complete a questionnaire detailing their CT scanning protocols for a number of routinely done examinations.
This brochure provides a summary of findings for a subset of surveyed facilities. The link to the document is: http://www.crcpd.org/Pubs/
NextTrifolds/NEXT_2005-06CT_T. pdf. You also can click on the graphic of the front cover of the trifold that is on the left. Should you have any difficulties opening the file, contact lcarigan@cerpd.org. -
Senate Enzi Introduce S. 338 - CARE Act June 25, 2012
Senators Enzi and Harkin introduced the CARE bill in the Senate on Monday as S.3338
There are some differences in format between the House and Senate versions, but substantively the bills are the same and get us to the same end goal of minimum standards for imaging and therapy personnel. The main differences you will see are revised effective dates and that the criteria for deeming a certification organization has been streamlined to incorporate the criteria the Secretary would use to deem accreditation organizations for the certification boards into the same section.
AAPM respondes to request by Senator Harkin for letter of support prior to introducing S. 3338.
updated July 20, 2012
-
Update on CA law related to CT dose
View SB1237 that was signed into law September 30, 2010 by Governor Arnold Schwarzenegger, paving the way for implementation of the first state law in the U.S. aimed at protecting patients from excessive radiation exposure received during CT scans and radiation therapy procedures. SB 1237, which the governor signed without comment along with scores of other bills, will impose strict new procedures and reporting requirements to protect patients from medical radiation overdoses when it becomes effective July 1, 2012. The bill also provides an accreditation mandate for CT scanners that will take effect January 1, 2013, six months after the other provisions.
The bill requires that radiation dose be recorded on the scanned image and in a patient's health records, and that radiation overdoses be reported to patients, treating physicians, and the state Department of Public Health (DPH). It requires the same level of monitoring for therapeutic radiation used to treat cancer.
NEW - Posted June 22, 2012 - The University of California Health Care System has developed recommendations for complying with California Senate Bill 1237 and related legislation.
-
June 8, 2012
The House Energy and Commerce Committee's Subcommittee on Health holds hearing on the Consistency, Accuracy, Responsibility and Excellence (CARE) in Medical Imaging and Radiation Therapy bill, H.R. 2104
The hearing, titled "Examining the Appropriateness of Standards for Medical Imaging and Radiation Therapy Technologists." This is a key step in moving H.R. 2104 forward this session.
AAPM's statement supporting the CARE legislation submitted to Subcommittee on Health
The hearing will be broadcast live at www.energycommerce.house.gov.
-
MN Governor Signs Bill Requiring Accreditation of Advanced Diagnostic Imaging Services Operating in the State
On April 23, 2012 Minnesota Governor Mark Dayton signed into law Chapter 228, House File 2276, clarifying accreditation requirements for advanced diagnostic imaging services providers. This bill passed with unanimous support.
This bill requires effective August 1, 2013 that: advanced diagnostic imaging services (as defined in United States Code, title 42, section 1395M, except that it does not include x-ray, ultrasound, or fluoroscopy) eligible for reimbursement from any source, including, but not limited to, the individual receiving such services and any individual or group insurance contract, plan, or policy delivered in this state, including, but not limited to, private health insurance plans, workers' compensation insurance, motor vehicle insurance, the State Employee Group Insurance Program (SEGIP), and other state health care programs, shall be reimbursed only if the facility at which the service has been conducted and processed is accredited by one of the following entities:
(i) American College of Radiology (ACR);
(ii) Intersocietal Accreditation Commission (IAC);
(iii) the Joint Commission; or
(iv) other relevant accreditation organization designated by the secretary of the
United States Department of Health and Human Services pursuant to United States Code, title 42, section 1395M. -
MA Call to Action
We have never before imposed on our members in this fashion but this is a critical juncture for the profession in Massachusetts and the nation and we need your help. Our professional licensure legislation is close to a vote out of the Joint Committee and we ask that you help give it the push it needs to reach the floor.
On October 25, 2011 the Massachusetts Joint Committee on Public Health (“Joint Committee”) heard testimony in support of House Bill 3515 (“H. 3515”), An Act Relative to the Practice of Medical Physics, from Fred Fahey, Martin Fraser, and Per Halvorsen. Copies of the written testimony, the bill language and the hearing summary are available on the AAPM website.
The Joint Committee will be voting on the H. 3515 in January or early February and your assistance is needed to assure that the medical physics licensure bill is reported favorably out of the Joint Committee. A favorable recommendation is needed for the bill to move forward in the legislative process and your letter of support is necessary to make that happen.
A letter of support from you to the legislator(s) has been drafted for you and is available on the AAPM website. It is best that you personalize the letter with your own words and space has been provided for you to do so. All areas that need to be personalized in the letter have been highlighted in red.
You will send your letter to the members of the Joint Committee. This can be done via hard copy or email and all of those addresses have been provided for you. Please review the list of legislators that serve on the Joint Committee and identify those that represent districts where you live and/or work. If you live and/or work in a particular legislator’s district, please direct your letter to him and/or her. If you do not live or work in the district of a Joint Committee member, you may choose to direct your letter to the chairs of the Joint Committee as a resident of Massachusetts and a medical physicist in support of licensure of the profession. If you live AND work in two separate legislators districts, please send one letter to each. Institution letterhead for the letters is encouraged, if you have the permission to use it. Please have your letters to the legislators as soon as you are able but NO LATER THAN FRIDAY, JANUARY 27th. All legislative business *must* be completed by the legislature by March 21st so time is of the essence in showing your support for H. 3515.
On January 20th, 2012 there will be a meeting of the New England Chapter of the AAPM. AAPM Massachusetts State Committee members will be available at the chapter meeting to address any concerns that you may have and there will be resources available to assist in your participation. We have also created an open forum on the AAPM BBS (this is an AAPM member-only forum so you must be logged in to view and/or post to the BBS) to post questions or comments regarding licensure of the medical physics profession in Massachusetts. Every effort will be made to address each post individually.
Again - Please have your letters to the legislators as soon as possible, and no later than Friday, January 27th.
-
[10-25-2011] MA Licensure Hearing
AAPM Members provide testimony before MA Joint Committee on Public Health on Licensure (MA House Bill - H. 3515)
The MA Joint Committee on Public Health held a hearing on October 25, 2011 to discuss House Bill H. 3515, An Act Relative to the Practice of Medical Physics. Testifying were: Per Halvorsen, Martin Fraser and Fred Fahey. After the oral statements were presented, the co-chairs of the committee then proceeded to ask LOTS of questions, all of them relevant and intelligent (e.g., what exactly is a medical physicist, what's our role on the clinical team, scope of practice differentiation from physicians and technicians, "why now - why wasn't this important years ago", can we cite specific cases of patients in Massachusetts being harmed as a direct result of poor medical physics support and how would licensure prevent that, etc). This resulted in a very educational and beneficial discussion between the committee members and us.
The one area where Chairman Sanchez seemed skeptical about the bill was on the subject of cost, and how this fits into the bigger picture of health-care reform and cost reduction. We explained the revenue-neutral approach, of course, but his contention was that the cost ultimately transfers through to the cost of the patient care. We focused on the fact that medical management of mistakes (recurrent disease, treatment complications) is much more expensive than the cost of getting it right the first time.
Other medical physicists present were Herbert Mower and Lindsay Lavoie. Amanda Potter, AAPM staff was also in attendance.
-
[7-15-2011] The U.S. Food and Drug Administration (FDA) is alerting the public; in particular, the medical imaging community; about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82 (manufactured by Bracco Diagnostics, Inc.). A CardioGen-82 PET scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate the heart. Full details can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm263112.htm
-
H.R. 2104 Introduced June 6, 2011 – CARE Act
Representative Ed Whitfield (R-KY) introduced the Consistency, Accuracy, Responsibility, and Excellence (CARE) in Medical Imaging and Radiation Therapy Act of 2011 in the House of Representatives (H.R. 2104). The CARE Act takes an important step in ensuring upmost safety for patients receiving potentially life-saving radiation therapy procedures by setting minimum certification and educational standards for non-physician technical personnel performing medical imaging and administering radiation therapy to patients. The CARE bill, which as of June 22nd already has 33 cosponsors in addition to its chief sponsor, Rep. Whitfield, would set federal minimum education and certification standards in the Medicare program for the technical personnel providing, planning and delivering all medical imaging examinations and radiation therapy treatments. Following the introduction of the bill, it was immediately referred to the House Energy and Commerce Committee and House Committee on Ways and Means for review. Although this bill has been introduced in past Congressional sessions there are positive signs for the CARE bill in 2011. The full text of H.R. 2401 can be found at: http://www.gpo.gov/fdsys/pkg/BILLS-112hr2104ih/pdf/BILLS-112hr2104ih.pdf.
Recently there have been a number of inquiries regarding the effect of the CARE bill on those who perform treatment planning tasks. There is concern that if the CARE bill passes, only certified medical dosimetrists could perform treatment planning. This is false. The bill does not directly address scope of practice issues. Although it is likely that, under regulations promulgated subsequent to the CARE bill passage non-certified or non-licensed medical dosimetrists will not be able to perform treatment planning, it is incorrect to imply that only certified medical dosimetrists will be able to perform treatment planning. Qualified medical physicists who are licensed to practice therapy medical physics and medical physicists who are board certified in therapy medical physics will also be able, under the CARE Act and its subsequent regulations (as envisioned by the Alliance) to perform treatment planning. Physicians are not restricted in their activity by the CARE bill. The intent of the CARE Bill is to establish minimum certification and educational standards for non-physician technical personnel performing medical imaging and planning or administering radiation therapy to patients.
The CARE bill does not limit the performance of procedures. Section 3 of HR 2104 states:
`(2) QUALIFICATIONS- Individuals qualified to perform or plan the technical component of medical imaging examinations or radiation therapy procedures shall--
`(A)possess current certification in the medical imaging or radiation therapy modality or service they plan or performfrom a certification organization designated by the Secretary pursuant to subsection (c);or
`(B) possess current State licensure or certification, where--
`(i)such services and modalities are within the scope of practice as defined by the State for such profession; and
`(ii) the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary pursuant to this section.
Further in Section 3:
`(3) MINIMUM STANDARDS-Minimum standards established under this subsection shall reflect the unique or specialized nature of the technical services provided, and shall represent expert consensus from those practicing in each of the covered imaging modalities and radiation therapy procedures as to what constitutes excellence in practice and be appropriate to the particular scope of care involved.
Thus, the CARE bill does not limit scope of practice. Note, however, that states would retain the right to limit scope of practice.For example, CARE sets minimum standards for the performance of magnetic resonance imaging (MRI) but it does not limit the performance of MRI to only magnetic resonance imaging technologists (since radiographers can perform MRI in the majority of states). Consequently, it will be very important for the AAPM to work with each state as they determine how to implement the CARE Act.
It is the goal of the AAPM and ACMP to maintain the role of defining the Scope of Practice for Medical Physicists. The AAPM Professional Policy 17 (PP-17) Scope of Practice of Medical Physics (http://www.aapm.org/org/policies/details.asp?id=225&type=PP#rd) states as part of the scope of practice for Therapeutic Radiological Physics: “Development and/or evaluation, with the medical practioners, of the dosimetric component of patients’ treatment plans”.
We are also actively working on the drafting of the implementing standards for consideration by the Secretary of Health and Human Services once H.R. 2104 is enacted. Your support of the CARE Bill is vital to its success. We encourage you to contact your representative and ask them to join the 33 cosponsors of HR 2104 (Note: there were 33 co-sponsors as of June 22, 2011 - to see if your representative is a co-sponsor go to: http://thomas.loc.gov/cgi-bin/bdquery/D?d112:1:./temp/~bdIF5E:@@@P|/home/LegislativeData.php|). The CARE Act is an important step in ensuring upmost safety for patients receiving potentially life-saving radiation therapy procedures by setting minimum certification and educational standards for non-physician technical personnel performing medical imaging and planning and administering radiation therapy to patients. You are also encouraged to directly contact Lynne Fairobent at lynne@aapm.org with any questions concerning the CARE bill and help us to prevent the dissemination of erroneous information concerning this important legislation.
- AAPM receives letters of support from ACR, ACRO, ASTRO and AAHP for licensure of medical physicists
-
Pennsylvania House Bill 1559 on Licensing Medical Physicists Introduced
In mid-May, the medical physics licensure bill was introduced in the Pennsylvania (PA) General Assembly as House Bill 1559. The next step for HB 1559 is to be scheduled for public hearing, which is an opportunity for any member of the public to speak for or against the bill. One or more of the members of the Pennsylvania State Committee will be speaking in favor of HB 1559 at the hearing. Concurrently, the PA Sunrise Evaluation will continue its review process. As you may recall, the Sunrise Evaluation was instituted in PA by former Governor Ed Rendell (D) to assist the Commonwealth in determining the need and feasibility for instituting a new professional licensure law and the process is continuing through the current administration under Governor Tom Corbett (R). While it is not necessary for the medical physics licensure Sunrise Evaluation to have a positive report to move forward in the legislative process, a positive report will be critical to secure Republican co-sponsors. The PA Republicans are not likely to support a concept that the current administration does not support. Grassroots efforts to educate the legislative body on the profession and to encourage bill sponsorship are ongoing.
- The NRC addresses the issue of having one RSO per license and the availability of RSOs to serve as preceptors
-
NRC Issues Regulatory Guide 8.35 Revision 1: Planned Special Exposures (75FR52999) Regulatory Guide 8.35 provides guidance on the conditions and prerequisites for permitting planned special exposure(s) (PSE(s)), as allowed by Title 10 of the Code of Federal Regulations (10 CFR) Part 20, “Standards for Protection against Radiation” (Ref. 1), the associated specific monitoring and reporting requirements, and examples of acceptable means of satisfying these requirements. This was issued with a temporary identification as Draft Regulatory Guide, DG–8032. The full text of Regulatory Guide 8.35 Revision 1 can be found at: http://www.nrc.gov/reading-rm/doc-collections/reg-guides/occupational-health/rg/.
-
NRC Notice of issuance and availability of Draft Regulatory Guide, DG–8035, ‘‘Administrative Practices in Radiation Surveys and Monitoring. ’’ (75FR52996)
On August 30, 2010, NRC announced the availability of Draft Regulatory Guide DG-8035. DG–8035 is proposed Revision 1 of Regulatory Guide 8.2, dated August 1973. This guide provides general guidance that the staff of the NRC considers acceptable for the administrative practices associated with surveys and monitoring of ionizing radiation in licensed institutions, intended primarily for administrative and management personnel in organizations that are involved in, or are planning to initiate, activities involving the handling of radioactive materials or radiation.
The administrative requirements for radiation monitoring are mainly specified in Title 10 of the Code of Federal Regulations, part 20, ‘‘Standards for Protection against Radiation’’ (10 CFR part 20), and are applicable to all NRC-licensed activities. This part requires surveys in order to evaluate the significance of radiation levels that may be present. In addition, it requires radiation monitoring in order to obtain measurements for the evaluation of potential exposures and doses. Comments are due October 29, 2010.
- NRC cites the VA for problems with prostate brachytherapy programs at additional VA facilities
-
NRC Issues Proposed Rule – Part 37 (75 FR 33901)Physical Protection of Byproduct Material; Proposed Rule
On June 15th, NRC issued a proposed rule 10 CFR Part 37, Physical Protection of Byproduct Material; Proposed Rule in the Federal Register.
The purpose is to amend NRC regulations to establish security requirements for the use and transport of category 1 and category 2 quantities of radioactive material, which the NRC considers to be risk-significant and therefore to warrant additional protection. Category 1 and category 2 thresholds are based on those established in the International Atomic Energy Agency (IAEA) Code of Conduct on the Safety and Security of Radioactive Sources, which NRC endorses. The objective of this proposed rule is to provide reasonable assurance of preventing the theft or diversion of category 1 and category 2 quantities of radioactive material. The proposed regulations would also include security requirements for the transportation of irradiated reactor fuel that weighs 100 grams or less in net weight of irradiated fuel. The proposed rule would affect any licensee that is authorized to possess category 1 or category 2 quantities of radioactive material, any licensee that transports these materials using ground transportation, and any licensee that transports small quantities of irradiated reactor fuel.
This rulemaking will codify the requirements in effect via specific orders issued to licensees with category 1 and category 2 sources.
Category 1 Threshold
Category 2 Threshold
Radioactive Material
Terabequerals
Curies
Terabequerals
Curies
(TBq)
(CI)
(TBq)
(CI)
Americium-241
60
1,620
0.6
16.2
Americium-241/Beryllium
60
1,620
0.6
16.2
Californium-252
20
540
0.2
5.40
Curium-244
50
1,350
0.5
13.5
Cobalt-60
30
810
0.3
8.10
Cesium-137
100
2,700
1
27.0
Gaolinium-153
1,000
27,000
10.0
270
Iridium-192
80
2,160
0.8
21.6
Plutonium-238
60
1,620
0.6
16.2
Plutonium-239/Beryllium
60
1,620
0.6
16.2
Promethium-147
40,000
1,080,000
400
10,800
Radium-226
40
1,080
0.4
10.8
Selenium-75
200
5,400
2.0
54.0
Strontium-90 (Yttrium-90)
1,000
27,000
10.0
270
Thulium-170
20,000
540,000
200
5,400
Ytterbium-169
300
8,100
3.0
81.0
The proposed rule and additional information can be found at www.regulations.gov at NRC 2008-0120. Comments are due to NRC October 15, 2010. Comments specific to the information collection aspects of this proposed rule are due to NRC July 15, 2010.
In addition to the proposed rule, NRC has posted the following documents at www.regulations.gov NRC 2010-0194: Draft Implementation Guidance, Draft Regulatory Analysis, and Draft EA and FONSI for review and comment.
NRC plans to hold two public meetings or workshops on the rule and guidance. These are tentatively scheduled for September 1 in Austin TX and September 20 in Rockville.
If you have any questions, please contact Lynne Fairobent, AAPM’s Manager of Legislative and Regulatory Affairs at lynne@aapm.org.
-
NRC Commissioners Direct Staff to Rework Reproposed Rule: Medical Use of Byproduct Material – Amendments/Medical Event Definitions (RIN 3150-AI26)
The NRC Commissioners disapproved the staff’s recommendation to publish the reproposed amendments to Part 35 in the Federal Register. The Commissioners stated that:
- The staff should work closely with the Advisory Committee on the Medical Uses of Isotopes and the broader medical and stakeholder community to develop event definitions that will protect the interests of patients, allow physicians the flexibility to take actions that they deem medically necessary, while continuing to enable the agency to detect failures in process, procedure, and training as well as any misapplication of byproduct materials by authorized users.
- The staff should hold a series of stakeholder workshops to discuss issues associated with the medical event definition. Areas for discussion should include, but not limited to, methods for defining medical events which continue to ensure the safe use of radioactive materials while providing flexibility to account for medically necessary adjustments and the terms and thresholds for reporting medical events to the NRC and patients.
- Given the recent Commission vote, the current regulation will remain effective until the staff completes the additional outreach to stakeholders.
-
In the August 6, 2008 Federal Register (73 FR 45635) NRC initially proposed a rule to amend 10 CFR Part 35 related to reporting and notification of medical events and to clarify requirements for permanent implant brachytherapy. NRC received a total of 57 comment letters. Many of the comments were form letters with identical language. Most of the comments were from medical universities, hospitals, private physicians, and professional organizations representing the medical community. The comments were primarily not supportive of parts of the rulemaking.
NRC has had the final rule on hold due to the substantial number of medical events that were reported to the NRC during late summer and early fall of 2008. NRC staff has been reviewing and analyzing the circumstances of, and data from, these events. Based on its evaluation of this information, including an independent analysis by an NRC medical consultant, the NRC staff believes that a number of medical events that were reported in 2008 would not be categorized as medical events under the proposed rule published on August 6, 2008. NRC staff believes this is inconsistent with the original regulatory intent, which was to clarify the requirements for permanent implant brachytherapy so that licensees would be able to identify medical events more easily and in a more timely manner. An unintended effect of the proposed rule would have been that some significant events would not be identified, categorized, and reported as medical events. Additionally, the evaluation of the circumstances and data from the substantial number of medical events reported in 2008 prompted the staff to reevaluate the regulations related to training requirements and time frames for licensees to assess the dose to the treatment site for permanent implant brachytherapy. Therefore, the proposed rule language and rationale have been modified to reflect this new information and the NRC staff is recommending that the Commission publish the revised proposed rule for public comment.
The reproposed rule would amend the current regulations by:
(1) adding activity-based criteria for defining some medical events for permanent implant brachytherapy;
(2) adding a requirement to report, as a medical event, any administration requiring a written directive (WD) if a WD is required and not prepared, and documentation in medical records or licensees’ standard written procedures that existed prior to the administration is insufficient to determine if a medical event has occurred;
(3) clarifying requirements for WDs for permanent implant brachytherapy;
(4) adding a requirement that licensees provide and document training to their staff on the requirements of § 35.3045;
(5) adding a requirement that licensees must assess the dose to the treatment site no later than 60 days from the date that the patient leaves the post-treatment recovery area; and
(6) making certain administrative and clarification changes.
The reproposed rule would facilitate the ability of medical licensees to recognize some medical events in permanent implant brachytherapy earlier and, therefore, be able to take corrective actions sooner than under current regulations. These changes to the regulations are based in part on recommendations from the ACMUI as well as the staff’s evaluation of the circumstances of, and data from, the substantial number of medical events reported in 2008.
SECY-10-0062 provides the staff’s recommendations to the Commission. Included in the draft staff paper are: the comments received on the proposed rule published on August 6, 2008, and the changes made to the proposed rule as a result of the evaluation of the circumstances of and data from the substantial number of medical events reported in 2008, are discussed in detail in the draft Federal Register Notice. Additionally, per SRM-COMSECY-09-0026, “Request For Rebaselining of Medical Event Definition Rulemaking to Reflect Recent Veterans Administration Experience” changes made to the proposed rule language published on August 6, 2008, are highlighted in Rule Language Changes.
The Commission has scheduled a hearing on July 8th to discuss the staff’s recommendations and to hear input from the stakeholder community. AAPM has been invited to testify. After the Commission briefing, the Commissioners will vote on issuing the reproposed rule.
If you have any questions, please contact Lynne Fairobent, AAPM’s Manager of Legislative and Regulatory Affairs at lynne@aapm.org.
- AAPM testifies before Congress on Radiation use in Medicine
-
FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site
Mon, 19 Apr 2010
The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.
-
House Passes H.R. 3672 - American Medical Isotopes Production Act of 2009
Posted 12-10-2009
Representative Markey (MA-7) introduced H.R. 3276 on July 21, 2009. The purpose of this legislation is to help patients who rely on medical imaging for the treatment and diagnosis of many common cancers by authorizing funding and providing a clear road map to create a domestic supply of Mo-99 while also allowing a responsible time line and safeguards for the transfer of HEU to low enriched uranium (LEU). AAPM supports this legislation and continues to work with the Senate on passage. AAPM correspondence related to this:
1. July 15, 2009 AAPM Letter to Rep. Markey
-
NRC REQUESTS COMMENTS ON DRAFT SAFETY CULTURE POLICY STATEMENT
Posted 12-10-2009
In the November 6, 2009 Federal Register (74 FR 57525) [http://edocket.access.gpo.gov/2009/pdf/E9-26816.pdf], the Nuclear Regulatory Commission (NRC) requested comments on a draft Safety Culture Policy Statement. Comments are due February 5, 2010 (90 days after publication). The NRC is issuing a draft policy statement that sets forth the Commission’s expectation that all licensees and certificate holders establish and maintain a positive safety culture that protects public health and safety and the common defense and security when carrying out licensed activities. The Commission defines safety culture as that assembly of characteristics, attitudes, and behaviors in organizations and individuals which establishes that as an overriding priority, nuclear safety and security issues receive the attention warranted by their significance. Background information related to NRC Safety Culture can be found at: http://www.nrc.gov/about-nrc/regulatory/enforcement/safety-culture.html.
-
NEW CARE Bill: H.R. 3652 – Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009
Posted 12-10-2009
The CARE Bill (stands for the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009) has been introduced in the House [H.R. 3652] by Rep. John Barrow (D – GA) [http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.3652:]. As of December 10, 2009,this Bill had 11 co-sponsors [Rep. Marsha Blackburn (TN-7); Rep. Michael Castle, (DE); Bob Etheridge (NC-2); Tom Latham,(IA-4), Edward j. Markey (MA-7), Patrick Tiberi (OH-12), Bruce Braley (IA-1), Stephanie Herseth Sandlin (SD), Randy J. Forbes (VA-4), Russ Carnahan (MO-3), and Jim Moran (VA-8), ]. The House Bill, with one exception, is identical to that introduced in the 110th Congress. The exception is the inclusion [Page 12, lines 8-10] recognizing the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) Bill passed in the 110th Congress. The MIPPA Bill only applies to advanced imaging procedures (PET, CT, MR and nuclear medicine) performed in free standing clinics. Work is under way identifying a sponsor and introduction of a parallel bill in the Senate.
-
NRC Announces Enforcement Conference for VA Medical Center, Philadelphia, Pennsylvania
Posted 12-10-2009
On December 17, 2009, NRC will hold an enforcement conference to discuss the Commission’s finding related to the Philadelphia Veteran’s Affairs (VA) event. The conference will be held in Rockville, MD and be available via toll free audio cast.... [Read More]
-
NRC Announces Enforcement Conference for VA Medical Center, Philadelphia, Pennsylvania
Posted 12-10-2009
On December 17, 2009, NRC will hold an enforcement conference to discuss the Commission’s finding related to the Philadelphia Veteran’s Affairs (VA) event. The conference will be held in Rockville, MD and be available via toll free audio cast.... [Read More]
-
NRC Releases Guidance on Microsphere Brachytherapy Sources and Devices
Posted 9-04-08
NRC staff evaluated Yttrium-90 (Y-90) microspheres which are regulated under 10 CFR 35.1000 "Other Medical Uses of Byproduct Material or Radiation for Byproduct Material" and in August 2008 issued a revised guidance document including additional specific training and experience requirements.
-
FDA Issues Public Health Notification
Posted 7-15-08
FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ElectronicMedical
AAPM comments on the draft FDA public health notification posted 04-08
-
House, Senate Override President's Veto Of Medicare Bill
Posted July 16, 2008
The House voted 383-41 Tuesday afternoon to override President Bush's veto earlier in the day of Medicare legislation, and the Senate followed suit with a 70-26 vote. President Bush vetoed the Medicare bill, as senior administration officials vowed yesterday he would do, railing against provisions cutting Medicare Advantage and reforming Part D. The bill earlier passed both chambers by veto-proof margins.
-
NRC Issues Revision to Regulatory Guides 6.1 and 10.2
Posted July 14, 2008
Regulatory Guide 6.1 Leak Testing Radioactive Brachytherapy Sources: This regulatory guide endorses the method described in Volumes 3 and 9 of NUREG-1556 as a process that the NRC has found to be acceptable for meeting the regulatory requirements for leak testing of radioactive brachytherapy sources. Link to NUREG-1556: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/
Regulatory Guide 10.2 Guidance to Academic institutions Applying for Licences of Limited Scope: This regulatory guide endorses the methods and procedures for limited scope byproduct material licensing contained in the current revision of NUREG-1556, Volume 7, “Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Academic, Research, and Development, and Other Licenses of Limited Scope” (Ref. 4), as a process that the NRC staff has found acceptable for meeting the regulatory requirements. Link: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v7/
-
Senate Passes Medicare Bill 7-10-08
Posted July 14, 2008
The Senate has passed the Medicare bill (H.R. 6331) which averts the 10.6% decrease tothe conversion factor effective July 1st and mandates an additional 1.1% increase in the (January 1, 2008-June 30, 2008) conversion factor for 2009. In essence, theestimated 16% across the board reduction to physician and freestandingclinic payments effective January 1, 2009 has now become a slight 1.1% increase to payments implemented on January 1, 2008.The White House reports that the President will veto the bill, however, the legislation passed both the House and Senate by a large margin to likely secure a veto-proof physician payment fix package.
-
Senate Health, Education, Labor and Pensions (HELP) Committee passes S. 1042 CARE legislation out of committee
Posted March 15, 2008
On Thursday, March 13, 2008, the Senate HELP committee voted to move forward the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy bill, or CARE bill (S. 1042) out of committee. Thank you to all AAPM members that called their Senators and Representatives to date on this legislation. In the next couple of weeks, members of Congress will be in their home districts for Easter recess, please contact their offices and ask that they support the passing of S. 1042 and H.R. 583 as soon as possible upon return from the spring recess. If you have not done so, it is not too late go to: http://capwiz.com/aapm/home/ and follow the instructions for calling or emailing your members. If you have contacted your members, please follow up and ask what action have they taken based on your request.
If you have questions, please contact, Lynne Fairobent, AAPM's manager of Legislative and Regulatory Affairs at lynne@aapm.org.
-
Action Alert: CARE Legislation - Senate HELP committee key members
Posted: February 13, 2008
The Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy (CARE) legislation (S.1042) is scheduled for mark up by the Senate Health, Education, Labor & Pension (HELP) committee. As such it is especially vital the AAPM members that reside in states where the members of the Senate HELP committee are from, call their Senator and ask that the bill be moved forward without additional amemdment. Key Senators that we are targeting are: Senator Harkin (Iowa), Mikulski (Maryland), Murray (Washington), Reed (Rhode Island), Clinton (New York), Obama (Illinois), Brown (Ohio), Gregg (New Hampshire), Alexander (Tennessee), Murkowski (Alaska), Roberts (Kansas), Allard (Colorado) and Coburn (Oklahoma).
To show you CARE about quality care and health care costs, please visit the Legislative Action Center and use the supplied communication tools to quickly and easily contact your legislators.
-
“Source Collection and Threat Reduction” (SCATR) Program -
The Conference of Radiation Control Program Directors (CRCPD) and the Department of Energy have initiated a rare opportunity for radioactive material licensees to have financial assistance in properly disposing of unwanted sealed sources. The program is entitled “Source Collection and Threat Reduction” or “SCATR.” The AAPM endorses the SCATR program and encourages AAPM members to have their licensees register and take advantage of this opportunity. For additional information and to register your sources click here CRCPD SCATR.
- NRC Publishes Notice of a Petition for Rulemaking from AAPM - PRM-35-20 Requesting a Change to 10 CFR Part 35.57
- Scottish Executive's report into the 'Glasgow incident'
- AAPM Files Petition for Rulemaking with the U.S. Nuclear Regulatory Commission to amend 10 CFR § 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
- GAO Issues Report Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations - GAO-06-724
- 2007 Health Policy Reimbursement Proposed Rules
(Members only) - NRC publishes new web page on Risks Associated with Medical Events
- NRC Issues Proposed Rule on Expanded Definition of Byproduct Material
- July 18, 2006 House Energy and Commerce Subcommittee on Health hearing "Use of Imaging Services: Providing Appropriate Care for Medicare Beneficiaries."
- NRC Creates New Office of National Materials Program, Reorganizes Office of Nuclear Materials Safety and Safeguards
- NRC Grants Recognized Status to ABR for 10 CFR 35.50 and 35.51
- NRC republished USNRC Order EA-05-090, with a new compliance date of June 2, 2006
- FDA Issues new version of MQSA inspection procedures released
- CORAR Notice to Medical Community Regarding Molybdenum-99 (Mo-99) Shortage
- NRC Releases Early draft of the Proposed Rule: Requirements for Expanded Definition of Byproduct Material (SECY-06-0069)
- Opinion Letter on Obtaining Provider Status (Direct Billing)
- NRC issues three new Regulatory Issues Summaries
- Medical Facilities Asked To Register Sealed Radioactive Sources in Database
- NRC issues three new Regulatory Issues Summaries
- Mallinckrodt Issues Voluntary Recall of Technetium Tc-99m Generators (updated 12/21/05)
- NRC Considering Request by Minnesota to be an "Agreement State"
- Health Policy Update