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To best represent medical physics, the AAPM has worked to establish a close and cooperative working relationship with numerous government bodies and organizations including the Congress, federal and state agencies, related professional societies and a range of medical providers, corporations and suppliers.

For additional information related to AAPM’s government relations efforts, contact Lynne Fairobent, Senior Manager of Government Relations at lynne@aapm.org or 301-209-3364.


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.

Read more »


NRC Issues ANPR for 10 CFR Part 20 Standards for Protection Against Radiation

NRC issues 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. In addition to the ANPR, NRC also published 6 Issue Papers as well. This information is contained on the NRC website:

NRC will also be holding a series of public meetings specific to the six issues identified in the ANPR, however the dates and locations of these meetings has not been announced. NRC states that information on the meetings will be noticed on the NRC’s public meeting Web site at least 10 calendar days before the meeting. They suggest that stakeholders should monitor the NRC’s public meeting Web site for additional information about the public meetings.

Additional background information on NRC's Options to Revise Radiation Protection Regulations and Guidance can be found here.

Comments to the NRC are due on November 24, 2014, however if you have comments that you want AAPM to consider, I will need all comments by October 10th for AAPM reviews and finalization of AAPM’s comment letter. I look forward to hearing from all of you about this very important topic that will affect your Radiation Protection Programs in the years to come and I thank you in advance for your assistance!

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)

Updated August 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.

Recommendations of the California Clinical and Academic Medical Physicists (C-CAMP) regarding the Reporting Guidelines

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.

MA Member Letter to Edit

MA Joint Committee on Public Health Roster


[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.


FDA Drug Safety Communication: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans

[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


AAPM comments to FDA on Therapeutic Device Improvements

AAPM filed comments in response to FDA's request for comments related to device improvements to reduce the number of under- doses, over-doses and misaligned exposures from therapeutic radiation.

Click here to review the comments


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:


NRC Releases SECY-10-0062: Reproposed Rule: Medical Use of Byproduct Material – Amendments/Medical Event Definitions (RIN 3150-AI26)

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

2. December 2, 2009 AAPM Letter Senate Energy Subcommittee

3. Coalition paper on medical isotope supply


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.


NRC CONSIDERING REVISING RADIATION PROTECTION REGULATIONS

Posted 12-10-2009

The U.S. Nuclear Regulatory Commission (NRC) is seeking public comment on potential changes to the NRC’s current radiation protection regulations to achieve greater alignment between the regulations and the 2007 recommendations of the International Commission on Radiological Protection (ICRP) contained in ICRP Publication 103. The Nuclear Regulatory Commission is looking at implementing ICRP Report 103, which includes a reduction in the annual personnel exposure limit from 50 Sv to 20 Sv. These limits would apply beyond Nuclear Medicine departments and include Cardiology and Interventional Radiology workers. AAPM is responding to NRC on this issue, but individual comments are welcome. Please see http://www.nrc.gov/about-nrc/regulatory/rulemaking/opt-revise.html for more information. The Federal Register notice can be found at: http://edocket.access.gpo.gov/2009/pdf/E9-15950.pdf. If you have input that AAPM should consider in drafting its response, please send your comments to Lynne Fairobent, Manager of Legislative and Regulatory Affairs at lynne@aapm.org by February 1, 2010.

AAPM comments on draft ICRP Report 103


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 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.


AAPM Recent Comments to Federal Agencies

updated 1-28-09

2009 Comments

AAPM comments at the Federal Coordinating Council for Comparative Effectiveness Research Listening Session on May 13, 2009.

AAPM Provides Comments to the Nuclear Science Advisory Committee Isotope Subcommittee. 1-13-09 Additional information related to the NSACI is posted on the GRAC website.

AAPM comments to Centers for Medicare and Medicaid and Services, Current Health Policy Coding information.

2008 Comments

AAPM Provides Comments to the NRC on CsCl Sources 10-15-08

AAPM Submits Nominations for the NRC's Advisory Committee on Medical uses of Isotopes

AAPM Sends Letter to NRC chairman Klein re: Petition Determination on 10 CFR Part 35 T&E 9-22-08

AAPM Submits Comments on NRDC Petition re: HEU

AAPM Provides Comments to the Office of Management and Budget on NRC Proposed Rule re: Expanding the National Source Tracking System

AAPM Provides Comments to NRC on the Proposed Rule to Expand the National Source Tracking System.


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 http://www.asrt.org/media/images/govrel/alliance07_logo.jpg

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.


Federal Agency Issues

The responsibility for ensuring the safe use of radioactive materials and radiation-producing machines is shared by a number of federal agencies and states. Key federal agencies are the Nuclear Regulatory Commission (NRC), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Environmental Protection Agency (EPA).


Comments filed by the AAPM

Archived Information