American Osteopathic Board Of Radiology

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IAmerican OsteopathicBoard of RadiologyPamela A. Smith119 East Second Street * Milan, MO 63556-1331(660) 2654011 0 (800) 258-2627 * PAX (660) 265-3494Executive DirectorE-mail address: aobr nemr.netJanuary 25, 2006U.S. Nuclear Regulatory CommissionATTN: Mr. Thomas H. Essig, ChiefMaterials Safety and Inspection Branch (MS T8F3)11545 Rockville PikeRockville, MD 20852Dear Mr. EssigI am writing in response to your e-mail of December 8, 2005, requesting further input from theAmerican Osteopathic Board of Radiology (AOBR) regarding its application seeking recognitionof its certification processes by the U.S. Nuclear Regulatory Commission (NRC). The AOBR isseeking recognition in the following sections in the specialties as indicated:Subpart D--Unsealed Byproduct Material--Written Directive Not Required§ 35.190 Training for uptake, dilution, and excretion studies. (Diagnostic Radiologyand Radiology)§ 35.290 Training for imaging and localization studies. (Diagnostic Radiology andRadiology)Subpart E--Unsealed Byproduct Material--Written Directive Required§ 35.390 Training for use of unsealed byproduct material for which a written directiveis required. (Diagnostic Radiology, Radiology & Radiation Oncology)§ 35.392 Training for the oral administration of sodium iodide I-13 1 requiring a writtendirective in quantities less than or equal to 1.22 gigabecquerels (33millicuries). (Diagnostic Radiology, Radiology & Radiation Oncology)§ 35.394 Training for the oral administration of sodium iodide I-131 requiring a writtendirective in quantities greater than 1.22 gigabecquerels (33 millicuries).(Diagnostic Radiology, Radiology & Radiation Oncology)Subpart F-Manual Brachytherapy§ 35.490 Training for use of manual brachytherapy sources.Subpart G--Sealed Sources for Diagnosis§ 35.590 Training for use of sealed sources for diagnosis.Radiology and Radiation Oncology)(Radiation Oncology)(Diagnostic Radiology,Subpart H-Photon Remitting Remote Afterloader Units, Teletherapy Units, and GammaStereotactic Radiosurgery Units§ 3 5.690 Training for use of remote afterloader units, teletherapy units, and gammastereotactic radiosurgery units. (Radiation Oncology)We have addressed each issue of your e-mail of December 8, 2005, below:No. 1The AOBR website states the training and experience requirements for 10 CFR 35.190 and 10CFR 35.290 including required topics.

Mr. Thomas H. Essig, ChiefJanuary 25, 2006Page 2No.2The training and experience required for 10 CFR 35.390 has been revised to remove reference toa minimum number of hours of classroom and laboratory training.No.3The AOBR website states the training and experience requirements for 10 CFR 3 5.390 includingrequired topics.No. 4The Basic Standards for Residency Training in Diagnostic Radiology and the Basic Standardsfor Residency Training in Radiation Oncology, approved by the American Osteopathic Collegeof Radiology and the American Osteopathic Association, (copy attached) requires trainingprograms to meet the current Nuclear Regulatory Commission licensure requirements.The NRC requires 700 hours which averages 43.75 hours per week for 16 weeks. Duty hours aremonitored by the American Osteopathic Association (AOA). Although a required minimumnumber of hours per week is not specifically addressed, the standards state that a resident shallnot be assigned to work physically on duty in excess of eighty hours (80) per week averagedover a four (4) week period, inclusive of in-house night call. In addition, residents study outsidethe duty hours described above. Residents work on an average of 60 to 80 hours per week andwill more than fulfill 700 hours of training in Nuclear Radiology in a 4 month period.No. 5Candidates seeking certification from the American Osteopathic Board of Radiology forthe following medical uses must meet the specific training and experience requirements asstated below:10 CFR 35.392 Training for oral administration of sodium iodide 1-131 requiring a writtendirective in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) (10 CFR35.392 (c)(1) and (c)(2)).1. Has successfully completed eighty (80) hours of classroom and laboratory training,applicable to the medical use of sodium iodide 1-13 1 for procedures requiring awritten directive. The training must include:a. Radiation physics and instrumentationb. Radiation protectionc. Mathematics pertaining to the use and measurement of radioactivityd.Chemistry of byproduct material for medical usee. Radiation biology; and2. Work experience, under the supervision of an authorized user, who meets therequirements in 35.390(a), 35.390(b), 35.392, 35.394, or before October 24, 2005,35.930, 35.932, or 35.934, or equivalent Agreement State requirements. Asupervising authorized user, who meets the requirements in 35.390(b) must also haveexperience in administering dosages as specified in 35.390(b)(1)(ii)(G)(1) or 2).The work experience must involve a.Ordering, receiving, and unpacking radioactive materials safely and performingthe related radiation surveysb. Performing quality control procedures on instruments used to determine theactivity of dosages and performing checks for proper operation of survey metersc. Calculating, measuring and safely preparing patient or human research subjectdosagesd. Using administrative controls to prevent a medical event involving the use ofbyproduct material

Mr. Thomas H. Essig, Chiefe.fJanuary 25, 2006Page 3Using procedures to contain spilled byproduct material safely and using properdecontamination proceduresAdministering dosages to patients or human research subjects, that includes atleast three (3) cases involving the oral administration of less than or equal to1.22 gigabecquerels (33 millicuries) of sodium iodide I-131.10 CFR 35.394 Training for oral administration of sodium iodide 1-131 requiring a writtendirective in quantities greater than 1.22 gigabecquerels (33 millicuries) (10 CFR 35.394(c)(1) and (c)(2)).1. Has successfully completed eighty (80) hours of classroom and laboratory training,applicable to the medical use of sodium iodide 1-131 for procedures requiring awritten directive. The training must include:a.Radiation physics and instrumentationb.Radiation protectionc. Mathematics pertaining to the use and measurement of radioactivityd. Chemistry of byproduct material for medical usee. Radiation biology; and2. Work experience, under the supervision of an authorized user, who meets therequirements in 35.390(a), 35.390(b), 35.394, or before October 24, 2005, 35.930, or35.934, or equivalent Agreement State requirements. A supervising authorized user,who meets the requirements in 35.390(b) must also have experience in administeringdosages as specified in 35.390(b)(1)(ii)(G)(2). The work experience must involve -a.b.c.d.e.f.Ordering, receiving, and unpacking radioactive materials safely and performingthe related radiation surveysPerforming quality control procedures on instruments used to determine theactivity of dosages and performing checks for proper operation of survey metersCalculating, measuring and safely preparing patient or human research subjectdosagesUsing administrative controls to prevent a medical event involving the use ofbyproduct materialUsing procedures to contain spilled byproduct material safely and using properdecontamination proceduresAdministering dosages to patients or human research subjects, that includes atleast three (3) cases involving the oral administration of greater than 1.22gigabecquerels (33 millicuries) of sodium iodide I-131.No. 6The AOBR website states the training and experience requirements for 10 CFR 35.590 includingrequired topics.No. 7The AOBR has revised the training and experience in response to 10 CFR 35.490 and 10 CFR35.690 to remove a breakdown of the minimum number of hours candidates must spend in astructured educational program, work experience and clinical experience. The website includesthe corrected training and experience as stated below:35.490 Training for the use of manual brachytherapy sources (10 CFR 35.490 (b)(1) and(b)(2)).1. Complete a structured educational program in basic radionuclide handling techniquesapplicable to the use of manual brachytherapy sources.2.Complete 3 years of supervised clinical experience in radiation oncology, under anauthorized user who meets the requirement in 35.490, or before October 24, 2005,35.940, or equivalent Agreement State requirements, as part of a formal trainingprogram approved by Program and Trainee Review Committee of the AmericanOsteopathic Association.

Mr. Thomas H Essig, ChiefJanuary 25, 2006Page 435.690 Training for use of remote afterloader units (10 CFR 35.690 (b)(1) and (b)(2)).1. Complete a structured educational program in basic radionuclide techniquesapplicable to the use of a sealed source in a therapeutic medical unit.2.Complete 3 years of supervised clinical experience in radiation therapy, under anauthorized user who meets the requirement in 35.690, or before October 24, 2005,35.960, or equivalent Agreement State requirements, as part of a formal trainingprogram approved by Program and Trainee Review Committee of the AmericanOsteopathic Association.No. 8In accordance with 10 CFR 35.190(a)(2) and 35.290(a)(2), and 35.390(a)(2) the DiagnosticRadiology certification examination will assess knowledge and competence in the followingexamination areas:* Radiological Physics (radiation production and interaction with matter)* Radiation Biology (health effects)* Radiation Safety and Protection* Nuclear Medicine* Radionuclide handling* Quality control.* Clinical use of unsealed byproduct material for which a written directive is requiredNo. 9In accordance with 10 CFR 35.490(a)(2) and 35.690(a)(2) the Radiation Oncology certificationexamination will assess knowledge and competence in the following examination areas: Radiological Physics (radiation production and interaction with matter)* Radiation Biology (health effects)* Radiation Safety and Protection*Nuclear Medicine* Radionuclide Handling* Quality Assurance* Treatment Planning* Clinical use of the following:a Manual Brachytherapyo Stereotactic Radiosurgeryo Remote Afterloaderso External Beam TherapyNo. 10The American Osteopathic Board of Radiology will not require a written attestation as arequirement for examination or certification.No. 11In the osteopathic profession, the American Osteopathic Board of Radiology reviews andapproves the eligibility of candidates whose training has been reviewed and approved by theAmerican Osteopathic College of Radiology (AOCR). In 1982, the AOCR training standards fordiagnostic radiology and radiology were revised to require 6 months training in nuclear medicineto comply with licensing requirements of the NRC. AOCR Basic Standards for Residency

Mr. Thomas H. Essig ChiefJanuary 25, 2006Page 5Training in Diagnostic Radiology and the Basic Standards for Residency Training in Radiology(last certification in Radiology was approved in 1990) have met or exceeded NRC requirementssince that date. The NRC approved the application from the AOBR to be a recognized board in1982. Therefore, the AOBR requests an effective date of 1982 for recognition of its certificationexaminations in Radiology and Diagnostic Radiology.In 1993, the Basic Standards for Residency Training in Radiation Oncology were revised toinclude the requirement that the training must comply with any current Nuclear RegulatoryCommission requirements for training. Therefore, the AOBR requests an effective date of 1993for recognition of its certification examination in Radiation Oncology.The nuclear medicine requirements for candidates approved for examination by the AmericanOsteopathic Board of Radiology appears on our website at l and www.aocr.org/certification/radiation oncology.html. A copy of therequirements as they appear on the website is also enclosed with this letter.Thank you for the opportunity to submit this additional information in support of AOBR'sapplication for recognition by the Nuclear Regulatory Commission. Please do not hesitate tocontact me if additional information is required.SincerelyPamela A. SmithExecutive DirectorENCccKenneth P. Tarr, DO, ChairMark S. Finkelstein, DO, Vice ChairRoy M. Teng, DO, Secretary-TreasurerPaul J. Chase, DO, Nuclear Medicine Section ChairThomas M. Anderson, DO, Radiation Oncology Section Chair

Page I of 2Aroerican Osteopatfiic College of RadiologySchedule ofExaminationsDIAGNOSTIC C RADIOLOGY is that branch of radiology which deals withthe utilzation of all modalities of radiant energy in medical diagnosis andtherapeutic procedures utilizing radiologic guidance. This includes, but isnot restricted to, imaging techniques and methodologies utilizingradiations emitted by x-ray tubes, radionuclides, ultrasonographicdevices, and radiofrequency electromagnetic radiation emitted by ificationQualifications of Applicants for Examination* The applicant must be a graduate of an AOA accredited college ofosteopathic medicine. All training must be completed in the UnitedStates.* The applicant must be licensed to practice in the state wherehis/her practice is conducted.* The applicant must be able to show evidence of conformity to thestandards set forth in the Code of Ethics of the AmericanOsteopathic Association.* The applicant is required to be a member in good standing of theAmerican Osteopathic Association or the Canadian OsteopathicAssociation for the two (2) years immediately prior to the date ofcertification.* The applicant must have satisfactorily completed a one-year AOAapproved internship.* The applicant beginning their residency training on July 1, 1989,and thereafter is required to have four (4) or more years of AOAapproved training in diagnostic radiology.* The applicant beginning their residency training prior to July 1,1989, is required to have three (3) or more years of AOA-approvedtraining in radiology or diagnostic radiology.* The applicant must have AOCR approval of all completed training.* The resident is expected to remain in one program for all years oftraining. If a transfer to another program is necessary or desired,that transfer must be prospectively approved by the AOCR andnotification sent to the AOBR.http://www.aocr.org/certification/diagnostic radiology.htinl1/30/2006

Amefican Osteopathic college ot Kadiologyrage z oi z* The applicant must complete the requirements of training andexperience as stated in the Basic Standards for Residency Trainingin Diagnostic Radiology which includes 700 hours of nuclearmedicine training as defined here.Eligibility for Examination* Candidates will be considered for the Physics portion of the writtenexaminations only when they are in their second year of training.Successful candidates will be eligible to sit for the DiagnoslicImaging written examination during their third year of training.* If the candidate has not already passed the Physics examination,he/she may take both the written Physics and Diagnostic Imagingexaminations together during their third or fourth year of training orat any examination following training.* A second opportunity to pass the written Physics examination isoffered to candidates who fail the Physics examination in the fall.The exam is scheduled prior to the oral examinations and isoffered to any candidate who failed the Physics examination at theprevious sitting.* Candidates who have passed the written examinations are eligibleto take the oral examinations during their fourth year of training orat any examination following training.Who We Are I CME I Membership j Residency I Job ListingsCertification I Resources I Calendar I Foundation I Contact Us119 East Second St I Milan, MO 63556660-265-4011 1Fax: fication/diagnostic radiology.hatml1/30/2006

Candidates seeking certification from the American Osteopathic Board of Radiology musthave completed the training and experience requirements for NRC licensure as statedbelow:Training for update, dilution and excretion studies (10 CFR 35.190 (a)(1), (c)(1), (c)(1)(i) and(c)(1)(ii)).1.Complete 60 hours of training and experience including a minimum of eight (8) hoursof classroom and laboratory training, in basic radionuclide handling techniques andradiation safety applicable to the medical use of unsealed byproduct material foruptake, dilution, and excretion studies that includes the topics listed below:a.Classroom and laboratory training in the following areas:i. Radiation physics and instrumentationii.b.Radiation protectioniii. Mathematics pertaining to the use and measurement of radioactivityiv.Chemistry of byproduct material for medical use; andv. Radiation biologyWork experience, under the supervision of an authorized user who meets therequirements in 35.190, 35,290, 35.390, or before October 24, 2005 - 35.910,35.920, or 35.930 or equivalent Agreement State requirements, involving i. Ordering, receiving, and unpacking radioactive materials safely andperforming the related radiation surveysii. Performing quality control procedures on instruments used to determinethe activity of dosages and performing checks for proper operation ofsurvey metersCalculating, measuring, and safely preparing patient or human researchiii.subject dosagesiv. Using administrative controls to prevent a medical event involving theuse of unsealed byproduct materialv. Using procedures to contain spilled byproduct material safely and usingproper decontamination procedures; andvi.Administering dosages of radioactive drugs to patients or humanresearch subjectsTraining for imaging and localization studies (10 CFR 35.290 (a)(1), (cXl)(i) and (c)(1)(ii)).1. Complete 700 hours of training and experience, including a minimum of 80 hours ofclassroom and laboratory training, in basic radionuclide handling techniquesapplicable to the medical use of unsealed byproduct material for imaging andlocalization studies. The training and experience must include, at a minimum:a.Classroom and laboratory training in the following areas:i. Radiation physics and instrumentationii. Radiation protectioniii. Mathematics pertaining to the use and measurement of radioactivityiv.Chemistry of byproduct material for medical usev.Radiation biology

b.Work experience, under the supervision of an authorized user, who meets therequirements in 35.290, or 35.290(c)(1)(ii)(G) and 35.390, or before October24, 2005, 35.920, or equivalent Agreement State requirements, involving i. Ordering, receiving, and unpacking radioactive materials safely andperforming the related radiation surveysii. Performing quality control procedures on instruments used to determinethe activity of dosages and performing checks for proper operation ofsurvey metersiii. Calculating, measuring and safely preparing patient or human researchsubject dosagesiv. Using administrative controls to prevent a medical event involving theuse of unsealed byproduct materialv. Using procedures to safely contain spilled radioactive material and usingproper decontamination proceduresAdministering dosages of radioactive drugs to patients or humanvi.research subjects; andEluting generator systems appropriate for preparation of radioactivevii.drugs for imaging and localization studies, measuring and testing theeluate for radionuclidic purity, and processing the eluate with reagentkits to prepare labeled radioactive drugsTraining for use of unsealed byproduct material for which a written directive is required(10 CFR 35.390 (b)(l)Xi) and (b)(l)(ii)).1. Complete 700 hours of training and experience in basic radionuclide handlingtechniques applicable to the medical use of unsealed byproduct material requiring awritten directive. The training and experience must includea. Classroom and laboratory training in the following areas:i. Radiation physics and instrumentati

The American Osteopathic Board of Radiology will not require a written attestation as a requirement for examination or certification. No. 11 In the osteopathic profession, the American Osteopathic Board of Radiology reviews and approves the eligibility of candidates whose training has been reviewed and approved by the American Osteopathic College of Radiology (AOCR). In 1982, the AOCR training .

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