~AR~~~VAS~U MR ASSOCIATES -OF CHARLOTTESVILLE 650 Peter Jefferson Parkway Suite 100 Charlottesville, VA 2291 1 Phone (434) 293-4072 Fax (434) 293- 4265 b.csz,rJt www cvaoc corn USNRC Region I Licensing Material Section 475 Allendale Road King of Prussia, PA 19406-141 5 March 17,2008 W 0 RE: NRC License Amendment Application NRC License #45-30876-01 To Whom It May Concern: Please accept this letter as a request to amend our Radioactive Materials License 45- 30876-01 to add Dr. Carolyn Z. Behm and Dr. Timothy Williams as authorized users for 35.200 materials. I have attached documentation of their training and experience pertaining to the safe use of diagnostic radioactive maieriais currently authorized by our license. This request was previously submitted in September 2007, however, was rejected for insufficient documentation submitted with the amendment request. 1. Dr. Carolyn Behm 1.1. The number or hours of work experience was requested in a follow-up letter dated October 22, 2007. 1.1.1. Enclosed are documentation outlining Dr. Behm’s completion of the training program to be an authorized user. In addition, a letter stating the number of hours of work experience performed is included. 2. Dr. Timothy Williams 2.1. A copy of certification from the Board of Nuclear Cardiology was requested and is enclosed. Should you have any questions regarding this application, please feel free to contact me. Sincerely, Mikol DelaCruz, CNMT enclosures
Transcript
~ A R ~ ~ ~ V A S ~ U M R ASSOCIATES - O F C H A R L O T T E S V I L L E
650 Peter Jefferson Parkway Suite 100
Charlottesville, VA 2291 1 Phone (434) 293-4072
Fax (434) 293- 4265 b . c s z , r J t www cvaoc corn
USNRC Region I Licensing Material Section 475 Allendale Road King of Prussia, PA 19406- 14 1 5
Please accept this letter as a request to amend our Radioactive Materials License 45- 30876-01 to add Dr. Carolyn Z. Behm and Dr. Timothy Williams as authorized users for 35.200 materials. I have attached documentation of their training and experience pertaining to the safe use of diagnostic radioactive maieriais currently authorized by our license. This request was previously submitted in September 2007, however, was rejected for insufficient documentation submitted with the amendment request.
1. Dr. Carolyn Behm 1.1. The number or hours of work experience was requested in a follow-up letter
dated October 22, 2007. 1.1.1. Enclosed are documentation outlining Dr. Behm’s completion of the
training program to be an authorized user. In addition, a letter stating the number of hours of work experience performed is included.
2. Dr. Timothy Williams 2.1. A copy of certification from the Board of Nuclear Cardiology was requested and
is enclosed.
Should you have any questions regarding this application, please feel free to contact me.
Sincerely,
Mikol DelaCruz, CNMT
enclosures
. Box 800662 Charlottesville, VA 22908
3/05/08
To Whom It May Concern:
RE: Carolyn Z. Behm, M.D.
Cardiovascular Fellowship Program Denny Watson, Ph.D., Director, Nuclear Cardiology Terri Ellison, M.S. Fellowship Education E-mail: tmebn@virginia. edu Phone: (434) 924-9001 Fax: (434) 244-7585
Dr. Behm accumulated 500 hours of work experience in the area of nuclear cardiology during her cardiovascular diseases fellowship at the University of Virginia between the dates of June, 2003 -June, 2007.
Dr. Carolyn Behm completed Level 2 nuclear cardiology training during her accredited cardiovascular fellowship training program, meeting the requirements for Level 2 as outlined in the ACCF/ASNC COCATS Guidelines for Training in Nuclear Cardiology, revised 2006.
The DEPARTMENT of INTERNAL MEDICINE Division of Cardiovascular Medicine
Steven W. Walter,MD Assistant Adjunot Rofe
This letter attes c ' that Carolyn Z. Behm M.D. has completed the requirements of NRC 35.290 including:
assroom and laboratory training in the following areas:
a) Radiation physics and instrumentation; b) Radiation protection; c) Mathematics pertaining to the use and measurement of radioactivity; d) Chemistry of byproduct material for medical use; e) Radiation biology f ) Generator Elution
2) Work experience which meet the requirements in 5 35.290, involving:
a) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; b) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; c) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; d) Calculating, measuring, and safely preparing patient or human research subject dosages; e) Using adrmnistrative controls to prevent a medical event involving the use of unsealed byproduct material; f ) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures; g) Administering dosages of radioactive drugs to patients or human research subjects; and h) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs
'
Dr. Behm is competent to practice independently as an authorized user.
Sincerely,
Steven W. Walter, MD Assistant Adjunct Professor of Medicine Authorized UserMO NRC License Number 47-25351-01
University of Virginia Health System, 1215 Lee Street, PO Box 800662 Charlottesville, VA 22908
Department of Internal Medicine Box 800662 Charlottesville, VA 22908
Cardiovascular Fellowship Program John M. Dent, M.D., Program Director Tem EUison, M.S. Fellowship Education E-maik [email protected] Phone: (434) 924-9001 Fax: (434) 244-7585
811 3/07 Certification Board of Nuclear Cardiology 19562 Club House Road Montgomery Village, MD 20886-3002
RE: Carolyn Z. Behm, M.D.
The above-named applicant completed a minimum of 80 hours of classroom and laboratory training that meets the Nuclear Regulatory Commission (NRC) requirements as an INTEGRAL part of his/her fellowship/residency program.
The above-named applicant completed a minimum of 80 hours of classroom and laboratory training that meets the NRC requirements external to his/her fellowship program.0
The above-named applicant i s an Authorized User listed on a current Radioactive Materials Licence (RAM).O
Dr. Carolyn Behm has completed a nuclear cardiology training program that meets the requirements for Level 2 as outlined in the ACCFIASNC COCA73 Guidelines for Training in Nuclear Cardiology, revised 2006 within an accredited cardiovascular fellowship training program. Dr. Behm compieted Level 2 nuclear cardiology training between the dates of and June, 2003 -June, 2007.
I attest that Dr. Carolyn Behm is competent to independently function as an authorized user under NRC 10 CFR 35.200 uses.
Name of Preceptor: John M. Dent, M.D. Title/Relationship to Applicant: Program Director of NRCIAgreementState License Number: see attached letter from Steven W. Walter, M.D. Certified by: NIA Certification # N/A
Sincerely,
John M. Dent, M.D. Cardiovascular FeUowship Program Director
Certification Board of Nuclear Cardiology Certification Examination
2005 Administration
Number of Correct Questions on Your Exam Minimum Number of Questions Required to I’ass
Score Report
149
125
Name: Timothy Richard Williams, MI>
Content Area
I. Physics and Instrumentation
11. Radiopharmaceuticals
111. Radiation Safety
IV. Nuclear Cardiology Diagnostic Tests and Procedures/Protocols
ID: 2005341
# on exam
17
14
17
26 1
V.
VI. Risk Stratification
General Cardiology as it Relates to Image Interpretation
The table below shows the number of questions answered correctly in each of the content areas covered by the examination. This information is provided to assist you in identifying areas of strength and areas that may need improvement.
17
18
# correct
15
9
13
23
15
15
I VII. yoc car dial Perfusion Imaging I 39 35 I I VIII. Ventricular Function Imaging I l8 l6 I I E. Myocardial Viability 1 9 1 8 1
Certification Board of Nuclear Cardiology 19562 Club House Road Montgomery Village, MD 20886
We are pleased to inform you that the Board of Directors of the Certification Board of Nuclear Cardiology (CBNC) has determined that your score on the written examination of October 23, 2005 meets the standards the Board has established for certification in nuclear cardiology. Congratulations on your achievement1
A passing score of 125 questions correct was determined by an independent panel of peers, representing the disciplines involved in the practice of nuclear cardiology, drawn from both private practice and academia.
The number of questions you answered correctly was 149. The attached chart shows the number of correct answers you had for each of the content areas. Also enclosed i s a press release which you may wish to use to announce your successful completion of the 2005 exam.
Robert J. Gropler, MD
Christopher L.
Milena J. Henzlova, MD
Howard C. Lewin, MD
William A. Van Decker, MD
Frans J. Th. Wackers, MD, PhD
MD
RePresentingthe American
Kenneth A. Brown, MD
College of Cardlology
As you may recall, the application form that you completed carried the wording “List name as you wish it to appear on certificate i f you successfully pass the exam.” Therefore, we will honor your request. We anticipate that the hand calligraphed certificates will be mailed by February 1, 2006.
It i s important for future mailings that you keep the CBNC headquarters office informed of any address changes and so that the information in our online verification database is corred. The names of the successful 2005 examinees will be posted on CBNC’s Website by January 1, 2006.
Dawn M. Edgerton Executive Director
On behalf of the Board of Directors, I wish to thank you for your participation in the CBNC examination.
Sincerely,
H-V 7 w Manuel D. Cerqueira, M.D. President
Enclosures
PERSONAL INFORMATION WAS REMOVED BY NRC. NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC.
Representing the American Society of Nuclear Cardiology
James A Arrighi, MD
Manuel D Cerqueira, MD
Robert J. Gropler, MD
Christopher L Hansen, MD
TIMOTHY RICHARD WILLIAMS, MR ACHIEVES BOARD CERTIFICATION IN NUCLEAR CARDIOLOGY
Montgomery Village, Maryland, USA - The Certification Board of Nuclear Cardiology (CBNC), a not-for-profit corporation established to develop and administer practice- related examinations in the field of Nuclear Cardiology, i s pleased to announce that Timothy Richard Williams, MD, of University Heights, OH passed the certification examination on October 23, 2005. Dr. Williams i s now entitled to designate him1 herself as “Diplomate of the Certification Board of Nuclear Cardiology”.
<< Diplomate to add hislher biographical information here >>
The purposes of the CBNC Certification Program are to establish the domain of the practice of Nuclear Cardiology for certification; to assess the level of knowledge demonstrated by Nuclear Cardiology specialists in a valid manner; to encourage professional growth in, and enhance the quality of, the practice of Nuclear Cardiology; to recognize formally individuals who meet the requirements set by CBNC; and to serve the public by encouraging quality patient care in the practice of Nuclear Cardiology.
CBNC has been recoenized by the Nuclear Regulatory Commission (NRC) as meeting
Milena J Henzlova, MD
Howard C Lewin, MD
William A Van Decker, MD
Frans J Th Wackers, MD, PhD
Representing the American College of Cardiology -.
Kenneth A. Brown. MD the requirements fo; the specialty board certification pathway under 10 CFR Part 35, Section 35.290.
About CBNC Dawn M. Edgerton Executive Director
The Certification Board of Nuclear Cardiology, a not-for-profit corporation established in 1996, is a fully autonomous entity, independent of any other association, society, or academy. This independence allows the CBNC to maintain integrity concerning policy matters related to certification. Since 2003, CBNC has collaborated with the Certification Council of Nuclear Cardiology (ECNC) to offer the examination in a European venue. ECNC has representation on the CBNC’s Examination Committee.
To date, 4,315 physicians have been certified in nuclear cardiology.
For further information contact:
Dawn M. Edgerton Executive Director Certification Board of Nuclear Cardiology 19562 Club House Road Montgomery Village, MD 20886 USA Tel: +240.631.8151 Fax: +240.631.8152 www. cbnc. ore; edPerton@cbnc. org
0 2005 Certification Board of Nuclear Cardiology. All rights reserved. The CBNC and CBNC logo are trademarks registered in the United States.
This document is to certify that Timothy Williams, M.D. has successfully completed training and experience in nuclear imaging studies under the supervision of authorized users at the Cleveland Clinic Foundation, Cleveland, OH for the months September 2002, August 2003, and January 2005. During that time, the following numbers of procedures were performed: 1598 thallium/sestamibi stress imagingbunction procedures, 338 rubidium-82 PET perfusion studies and F-18-FDG metabolic imaging PET studies, and 71 ejection fraction calculation procedures. This training satisfies requirements for authorized users status according to the U.S. Nuclear Regulatory Commission (NRC) and Agreement States, and is equivalent to Level 2 training in Nuclear Cardiology as recommended in the American College of Cardiology training guidelines. Dr. Williams meets the requirements as outlined in the ACC/ASNC COCATS Guidelines shown on page 13 of the Candidate Bulletin. Dr. Williams has achieved a level of competence sufficient to function independently as an authorized user for the medical uses authorized under NRC Part 35.1 00 and 35.200. The training includes the following:
Seven hundred hours of work experience (after appropriate radiation safety training) in the hot lab under the direction of Gopal Saha, Ph.D. and Kanak Amin, senior nuclear chemist, covering:
1.
2.
3. 4. 5.
6.
7.
8.
Ordering, receiving, and unpacking radioactive material safely and performing the related radiation surveys. Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters. Calculating and safely preparing patient dosages. Using administrative controls to prevent misadministration of radioactive material. Using emergency procedures to contain spilled radioactive material safely and using proper decontamination procedures. Properly handling storage and disposal of radioactive waste, and maintain appropriate hot lab background and surface radioactivity levels by performing surveys and wipe tests. Eluting technetium-99m from generator systems assaying and testing the eluate for molybdenum-99 and alumina contamination, processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals, including sestamibi, DTPA, MAA, MDP, sulfur colloid, and choletec, and using chromatography and microscopy to perform quality control of the radiopharmaceuticals. Labeling of WBCs and RBCs for localization and wall motion studies.
Five hundred hours of clinical experience under direct supervision of authorized users including: 9500 Euclid Avenue, Cleveland, Ohio 44195
D I V I S I O N O F R A D I O L O G Y Department of Diagnostic Radiology (Hospital and Clinic)
Department of Nuclear Medicine rn Department of Radiation Therapy
Examining patients and reviewing their case histories to determine their suitability for radionuclide diagnosis, limitations and contradictions. Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages. Administering dosages to patients using syringe radiation shields. Collaborating with the authorized user in the calibration and set-up of gamma cameras and interpretation of cardiac radionuclide test results of more than 500 cases, of which at least 30 had angiographic correlation. Patient follow-up.
Richard C. Brunken, M.D. Director of Nuclear Cardiology
Irmk
Name: Timothy R. Williams, MD
Training in Nuclear Lab/ Dept of Molecular & Functional Imaging /CCF
Dept: Nuclear Medicine
Month: January 2005
Kit Preparation Oualitv Control of Kits Doses Drawn
Tc-Cardiolite
Tc-Myoview
99m
991n
2
3
10
10
2
3
10
10
8
8
140
120
Moly 99 Generator elution 2
A1 ion Check -- 2
Moly assay 2
Maximum amount of Radioactive handled during Hot lab rotation.
Tc-99m T1-2 10 22 mCi
1 150 mCi ( Mo/Tc99m generator elution)
Other Training include: Weekly wipe test Daily area survey Waste Disposal and storage Spill Decontamination Opening and loggmg of radioactive packages Ordering of radioactive pharmaceutical from vendors Labeling of WBC cells DOT for return shipment of radioactive packages
C LEVE LAN D C LI N I C/N U CLEAR M E 0 IC I N E RESIDENT'S TRAINING IN THE NUCLEAR PHARMACY LABORATORY
ACTIVITY DATE DISCUSSED (D) OR PARTICIPATED (P)
1. NRC and State Licenses
2. Handling of radioactivity
3. Ordering and logging doses
4. Receiving and opening of packages
. -
jcL1\ o s- Q
\, ? \ P
0 5. Measurement of activity in the dose calibrator
6. Daily check of dose calibrator with 13'Cs source
8. Moly assay
9. Aluminum assay
10. Preparation of kits
h
S
' 0
11. Q. C. of radiopharmaceuticals I I I V i
13. Dispensing of doses
14. Measurement of activities in the well counter
15. Survey of areas
16. Wipe tests
17. Radioactive spill
-l8. Labeling of WBCs
\
Q 0
/
r> n
22. 1-131 treatment (out-patient)
23. 1-131 treatment (in-patient)
T Q X L ~ ~
Rev. 2/96 3.5disc:Res-trng.lab
This is to acknowledge the receipt of your lelter/application dated
7// 7 / M , and to infcsrm you that the initial processing which includes an administrative review has been performed.
-d ,. &'r- 30% 76 -d a T h e r e were no administrative omissions. Your application was assigned to a
technical reviewer. Please note that the technical review may identify additional omissions or require additional information.
0 Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.
Your action has been assigned Mail Control Number /f+&pp ,
When calling to inquire about this action, please refer to this control number. You may call us on (61 0) 337-5398, or 337-5260,
