schneider regional medical center, amendment request ... · schneider regional medical center is...

SCHNEIDER REGIONAL MEDICAL CENTER

ROY LESTER SCHNEIDER! MYRAH KEATING SMITH !CHARLOTTE KIMELMAN HOSPITAL COMMUNITY HEALTH CENTER CANCER INSTITUTE

December 24, 2014

Licensing Assistance Section

Medical Branch

U. S. Nuclear Regulatory Commission

/3~>. I

Region 1, Division of Nuclear Materials Safety, Region 1

2100 Renaissance Blvd

King of Prussia, PA.19406-2713 fJ!J.}-/3 7 ~i

Reference: NRC License Number 55-17986-01, Addition of an Authorized User

Dear Sir/ Madam,

I·

' l.' .. l

Schneider Regional Medical Center is requesting the addition of Joy A. Johnson, MD to our radioactive

materials license referenced above for the uses CFR 35.100, 35.200 and 35.300.

Joy A. Johnson, MD, is an Experienced Authorized User for CFR 35.100, 35.200 and 35.300, and has been

listed on the following Radioactive Materials Licenses:

• NRC Materials License No. 24-12699-01 in the state of Missouri

• State of Kansas Radioactive Materials License No. 19-B374-01

• State of Kansas Radioactive Materials License No. 19-B383-01

(Copies of each are attached for your information).

Thank you in advance for your assistance.

Bernard A Wheatley, DBA, FACHE

Chief Executive Officer

SI-'MI I )IC ;\I ( I N I I I.C < H-'C,

PH: qo.77h.B II I FX: 140.714.(, ll B I 904B Sugar Estatt•, St. I homas, USVI OOB02

Kenneth L. Andrews Radiation Safety Officer Capital Region Medical Center Nuclear Medicine Department 1125 Madison P.O. Box 1128 Jefferson City, MO 65102-1128

Dear Mr. Andrews:

UNITED STATES NUCLEAR REGULATORY COMMISSION

REGION Ill 2443 WARRENVILLE ROAC, SUITS 210

LISLE, ILLINOIS GOS32·4M2

JUL I 6 2008

Enclosed is Amendment No. 63 to your NRC Material License No. 24-12699-01 in accordance with your request. Please note that the changes made to your license are printed in bold font.

Please review the enclosed document carefully and be sure that you understand all conditions. If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region Ill office at (630) 829-9887 so that we can provide appropriate corrections and answers.

You will be periodically inspected by NRC. Failure to conduct your program in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in enforcement action against you. This could include issuance of a notice of violation, or imposition of a civil penalty, or an order suspending, modifying or revoking your license as specified in the General Statement of Policy and Procedure for NRC Enforcement Actions. Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement action will be taken when dealing with licensees who do not achieve the necessary meticulous attention to detail and the high standard of compliance which NRC expects of its licensees.

In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be available electronically in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). The NRC's document system is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).

License No. 24-12699-01 Docket No. 030-02375

Enclosure: Amendment No. 63

Sincerely,

~d~/J..dt./ Loren':(' Hueter Materials Licensing Branch

··!IIRC FORM 37 4

U.S. NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSE

PAGE 1 OF _3_PAGES

Amendment No. 63

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose(s) and at the place(s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemf'd to contain the conditions specifiecj in Section 183 oftne Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory COmmission now or hereafter in effect and to any conditions specified below. c.:~~· ;~-"~ -~ l'J ;; " .•. .... .

Licensee ;;,i>r''"

~- '. ~~ 1. Capital Region Medical Center

Nuclear Medicine De.partment 2. 1125 Madison ·

P.O. Box 1128

Je.fferson City, MO 65102

In accordance with letter dated April 25, 2008, 3. License number 24-12699-01 is amended in its entirety to read as follows:

4. Expiration date June 30, 2015

5. Docket No. 030-02375 Reference No.

6. Byproduct, source, and/or special .. 7. Chemical and/or physical form 8. Maximum amount that licensee may possess at any one time under this license

nuclear material ·

A. Any byproduct materi~l . permitted by 1 0 CFR 35.1 00

B. Any byproduct material permitted by 1 0 CFR 35.200

C. Any byproduct material permitted by 10 CFR 35.3QO

A. Any

B. Any

C. Any

D. Any byproduct material ,,, '· .. ,2

• D. "Sealed Sources permitted by 10 Cf!3i;3..5AOO -·· .... "(Theragenics Corporation 1-

... '~- . Seed Modei125.S06;-Bard :srachytherapy Inc. ,Mpdel

. , -;', .; sT_~).;~~~1,_:~I~~J?~eniC5 . . ..

· ··: · <-Cbrpor_§Jr2.~~.~odel 2.00;"3M 7 '

Health'Ptiys1cs·Serv1ces .· • ModeL6T11 ;·BE BIG Gmbh Modei 12S.S06;"Best lndustn"es:fv1oCl~l Nos. 2301 and 2335;"implant Sciences Corp., Model3500; International Brachytherapy, Inc. Model Nos. lntersource 1251L and 1032P; lsoAid, Llc ModeiiAI--125A; Mills Biopharmaceuticals, Inc. Model Nos. 125SL and 125SH; North American Scientific, Model Nos. Med 3631 and 3633.)

A. As needed

B. As needed

C. As needed (not to exceed 1 curie of iodine-131)

D. 2 curies of palladium-103, .2 curies of iodine-125, 4 . curies total.

l .z· .. , -·

NRC F.ORM 374A U.S. NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSE SUPPLEMENTARY SHEET

9. Authorized use:

License Number 24-12699-01 Docket or Reference Number

030-02375

Amendment No. 63

A. Any uptake, dilution and excretion study permitted by 10 CFR 35.100.

B. Any imaging.and localization study permitted by)O CFR35.200 . . i ,·

C. Any diagnostic study or therapy procedure permitted by 10 CFR 35.300 ..

D. Any manual brachytherapy procedure permitted by 10 CFR 35.400.

CONDITIONS

PAGE 2 of 3 PAGES

10. Licensed material may be used or stored only at the licensee's facilities located at 1125 Madison, Jefferson City, Missouri.

11. The Radiation Safety Officer for this license is Kenneth L. Andrews, M.S., DABR.

12. Licensed material is only authorized for use by, or under the supervision of:

A. Individuals permitted to work as an authorized userin accordance with 10 CFR 35.13 and 35.14.

B. The following individuals are authorized users for medical use as indicated:

Authorized Users

D. J. Hawes-Davis, D.O.

~·.

H. Jerry Murreii,0-;0.

S. J. Westgate,· M.D.

Conrad Balcer, D.O ..

Mark Phillip Bryer, M.D.

William L Schlegel, D.O.

' Rodney Adkison, D.O.

Joseph M. Bean, M.D.

James Russell Allen, M.D.

Patrick J. Morello, M.D.

Joy A. Johnson, M.D.

. Material and Use,;~:\. ~- . --~ ·-··. ,. ~-

1 0 CFR 35.100, 35.~200·and.35.300 (Any diagnostic study or oral administratiortofsocHum iodide-_13.1 ~in quantities less than or equal

··- . to 33 millicuries.). ·· :, · . ,. __ ·}·: ,1 -

:--,.,~~1 ,.' ._.i J 10 CFR 35.400.

10 CFR 35.400.

10 CFR 35.1pg_aJfd'35.200.

10 CFR 35.100,35.200 and 35.300.

10 CFR 35.300 and 10 CFR 35.400. . . . ~--

' .: • ~'· • ''-1.-_ -~~· ~ ·•• •

10 CFR 35.300 'iimd 35.400.

1 0 CFR 35.1 00 and 35.200.

10 CFR 35.100, 35.200 and 35.300.

, NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 3 of 3 PAGES

MATERIALS LICENSE SUPPLEMENTARY SHEET

License Number

24-12699-01 Docket or Reference Number

030-02375

Amendment No. 63

13. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 30.35(d) for establishing decommissioning financial assurance.

14. The licensee is authorized to transport licensed material in,'atcordance with the provisions of 10 CFR Part 71, "Packaging and Transportation of RadioaCtive Material."

15. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. This license condition applies only to those procedures that are required to be submitted in accordance with the regulations. Additionally, this lic~nse condition does not limit the licensee's ability to make changes to the radiation protection program as provided for in 10 CFR 35.26. The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Application dated December 6, 2004; and

B. Facsimile letters dated May 26, 2005, June 6 and 7, 2005 and March 8, 2006.

·." ...

Date JUL 1 G 20Q8

r~:

FOR THEU.S. NUCLEAR REGULATORY COMMISSION

~~eh~utu Materials Licensing Branch Region Ill

.: . CAPjTAl REGION ·M'EDICAL CENTER . . CHECKLIST OF CLINICAL PRIVILEGES FOR

Joy A. Johnson, M.D. Privileges good through: 12/17/2010

PLEASE INDICATE BY CHECK MARK IF YOU WISH TO ADD OR DELETE A CURRENT PRIVILEGE.

CURRENT PRIVILEGES ARE INDICATED BY DOUBLE ASTERISKS(''-") ON THE FORM.

PRIV. PRIVILEGE NO. DESCRIPTION

NUCLEAR MEDICINE CRITERIA:

1. Basic Education: M.D. or D.O.

2. Minimal Formal Training: 2. A. Completion of an approved residency training program which included specific training in nuclear medicine, or 2. B. Completion of an approved residency training program with further training in nuclear medicine that allows the applicant to meet the criteria for becoming a licensed user of diagnostic radioisotopes.

3. Additional Required Criteria: Must meet the current Nuclear Regulatory Commission (NRC) required criteria.

CORE PRIVILEGES:

NOTE: Mark through those privileges listed in the core section that you do not utilize.

11525 Core privileges include consultation, performance, and interpretation of all routine and non-routine nuclear medicine procedures to make diagnostic evaluations of the anatomic or physiologic conditions of the body by both in vivo and in vitro (non-imaging) techniques with radioactive sources.

11535

Core privileges include the privilege to perform and document a complete medical history and physicial.

SPECIAL PRIVILEGES:

(Applicants must meet core privileges requirements and must demonstrate successful completion of an approved, recognized course when such exists, or acceptable supervised training in residency, fellowship or other acceptable experience. If additional criteria is required, this will be outlined below the privilege requiring additional information):

Radioisotope Therapy - Dosing and Administering

** Privilege is on file for Applicant

CURR PRIV

**

Page 1 of 4

DEL ADD CHAIR APPROVAL



CURRENT PRIVILEGES ARE INDICATED BY DOUBLE ASTERISKS("**") ON THE FORM.

Applicant's Signature: Date:


Page 2 of 4

CA~ITAL REGION .MEDICAL CENTER CHECKLIST OF CLINICAL PRIVILEGES FOR



CURRENT PRIVILEGES ARE INDICATED BY DOUBLE ASTERISKS("**") ON THE FORM.

PRIV. PRIVILEGE NO. DESCRIPTION

RADIOLOGY SERVICES CRITERIA:

1. Basic Education: M.D. or D.O.

2. Minimal Formal Training: Successful completion of an approved residency in radiology.

CORE PRIVILEGES:

NOTE: Mark through those privileges lsited in the core section that you do not utilize.

32600 Core Privileges include general diagnostic radiology (supervision and interpretation), diagnostic and vascular ultrasound, diagnostic and therapeutic nuclear medicine studies, diagnostic invasive and therapeutic procedures and consulting and otupatient admitting privileges for diagnostic and interventional, radiological and therapeutic procedures.

Core privileges include the privilege to perform and document a complete medical history and physical.

Core privileges include OMT for Osteopathic physicians.

SPECIAL PRIVILEGES:

(Applicants must meet core privileges requirements and must demonstrate successful completion of an approved, recognized course when such exists, or acceptable supervised training in residency, fellowship or other acceptable experience. If additional criteria is required, this will be outlined below the privilege requiring additional information):

32615 Angiography Minimum Criteria for Initial Appointment: Performed or assisted in 150 selective viseral or peripheral arteriograms, as primary opreator.


CURR PRIV

**

Page 3 of 4

DEL ADD CHAIR APPROVAL

11U.UU..J

·-- ·~ --. -· --·· -

Page 1 of 5 Pages STATE OF KANSAS

RAD10ACTIVE MATERIALS LICENSE

Pursuant to the Nuclear Development and Radiation Con1Tol Act (L. I 963, Ch, 290) and Kansas Annotated Regulations numbers 28-35-133 through 28· 35-363 inclusive, and in. reliance on statements and representations made to this agency bythe licensee designated. below, a license is hereby issued authorizing the licensee to transfer, receive; p-ossess, and use the radioactive material or materials listed below; and to use such materials at the place or places listed below~ and to use the material for the purpose or purposes listed below. This license is subject to all applicable rules, regulations, and orders now in effect or placed in effect by the Department of Health and Environment and any conditions specified below.

Licensee

1. Name Saint John Hospital

2. Address 3 500 South Fourth Street

Leavenworth KS 66048

Amendment No. 26

3. License number

19-B383-01

4. Expiration date

September 30, 2006

5. Reference number

6. Radioactive materials (element and mass number)

7. Chemical and/or physical fonn 8. Maximum quantity licensee may possess at any one time

See Page No. 2 See Page No. 2 See Page No. 2

CO~TIITIONS

9 Authorized use. (Unless otherwise specified, the authorized place of use is the licensee's address stated in Item 2 above.)

A. Any diagnostic procedure listedinGroupsiandll, ScheduleD, Regulation28-35-199aofthe Kansas Radiation Protection Regulations.

B. Any therapeutic procedure listed in Group N, ScheduleD, Regulation 28-35-199a of the Kansas Radiation Protection Regulations.

C. through H. To be used for instrument calibration and quality control.

1 0. Radioactive materials shall only be used at 3500 South Fourth Street, Leavenworth, KS.

11. The radiation safety officer in this program shall be Joy A. Johnson, M.D.

12. Radioactive material shall be used by, orunderthe supervision of, Jeffrey L. Borders, M.D., John M. Bramble, M.D., Joy A. Johnson, M.D., Caprice M. Olamon, M.D., and John McMillan, M.D.

_;'

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- ··---r--- ·- -- ··-

STATE OF KANSAS Page 2 of 5 Pages

RADIOACTIVE MATERIALS LICENSE ..__.

Supplementary Sheet License number: 19-8383-01

6. Radioactive materials 7. Chemical and/or physical fonn 8. Maximum quantity licensee (element and mass number) may possess at any one time

A. Any radioactive material A. Any radiopharmaceutical A. As necessary for uses listed in Groups I a11d IT, listed in Groups I and II, authorized in Subitem ScheduleD, Regu_lation Schedule D, Regulation 9.A 28-35-199aofthe 28-3S-199a of the Kansas Kansas Radiation Radiation Protection Protection Regulations. Regulations.

B. Any radioactive material B. Any radiopharmaceutical B. 100 millicuries of each listed in Group IV, listed in Group N, radioactive material ScheduleD, Regulation Schedule D, Regulation authorized in Subitem 28-35-199a of the 28-35-199a of the Kansas 6.B. Kansas Radiation Radiation Protection Protection Regulations. Regulations.

C. Cobalt-57 c. Sealed source (DuPont c. No single source to

·J ~S-206, ~S-391, exceed 25 millicuries NES-392, NES-8012, NES-8300, NES-8400, NES-8450; Amersham CTR-Ql series; North American Scientific MED3550, MED3700-3749; Isotope Products FL series, NES series, RV-057; International lsotopes BM-01 series, BM-02 series, BM-04 series, BM -05 series, BM-06 series, BM-09 series)

D. Cesium-137 D. Sealed source (DuPont D. No single source to NES-356; Arnersham exceed 250 microcuries CDC.VI)

E. Barium-133 E. Sealed source (DuPont E. No single source to I NES-358; Amersham exceed 250 microcuries

-...../ BDC.VI)

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RADIOACTIVE MATERIALS LICENSE

Supplementary Sheet License number: 19-B383-01



13.

F. Cobalt-60 F. Sealed source (DuPont NES-354)

F. No single source to exceed 100 microcuries

A. (1) Eachsealedsourcecontainingradioactivematerial, other thanHydrogen-3, with a half-life greater than thirty(30) days and in any fonn other than gas shall be tested for leakage and/or contamination at intervals not to exceed six (6) months. In the absence of a certificate from a transferor indicating that a test has been made within six ( 6) months prior to the transfer, a sealed source received from another person shall not be put into use until tested.

(2) Notwithstanding the periodic leak test required by this condition, anyradioactivesealed source is exempt from such leak tests when the source contains 100 microcuries or less ofbetaandlor gamma emitting material or 10 microcuries or less of alpha emitting material.

(3) The periodic leak test required by this condition does not apply to sealed sources that are stored and not being used. The sources excepted from this test shall be testedfor leakage prior to any useor1ransferto another person tmless they have been leak tested within six ( 6) months prior to the date of use or transfer. Sources in storage shall be physically inventoried every six months and listed in the radioactive materials inventory.

B. The test shall be capable of detecting the presence of0.005 microcurie of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is permanentlym.ountedor stored on which one might expect contamination to accumulate. Records ofleak test results shall be kept in units of microcurie and maintained for inspection by the Department.

C. Ifthe test reveals the presence of0.005 microcurie or more of removable contamination, the licensee shall immediatelywithdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with Department regulations. A report shall be filed within five (5) days of the test with the Radiation Control Program, Bureau of Air and Radiation, Kansas Department ofHealth and Environment, Topeka, Kansas, describing the equipment involved, the test results and the corrective action taken.

D. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically authorized by the Department, the United States Nuclear Regulatory Commission, or an Agreement State to perform such services.

14. The use of radioactive material in or on humans shall be by a physician.

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STATE OF KANSAS Page 4 of S Pages



15. Sealed sources containing radioactive material shall not be opened.

16. A. Radiopharmaceuticals dispensed and/or distributed for human use shall be either:

(1) Repackaged from preparedradiopharmaceuticals that are the subject of an FDA-approved "New Drug Application" (NDA) or for which FDA has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND), or

(2) Prepared from generators and reagent kits that are the subject of an FDA -approved NDA or for which FDA has accepted an IND.

B. Prepared radiopbannaceuticals for which FDA has accepted an IND and radiophannaceuticals prepared from generators or reagent kits for which FDA has accepted an IND shall be dispensed and/or distributed:

(I) In accordance with the directions provided by the sponsor of the IND, and

{2) Onlyto physicians who have been accepted by the sponsor of the IND to participate in clinical evaluation of the dmg.

The licensee shall inform, in writing, each physician who participates in an IND evaluation, that the physician is responsible to the sponsor ofthe ft\.o"'D for use ofthe drug in accordance with protocols established by the sponsor and for reporting to the sponsor the clinical information obtained through use ofthe drug.

17. The licensee is authorized to hold radioactive material with a physical half-life ofless than 65 days for decay-instorage before disposal in ordinary trash provided:

A. Radioactive waste to be disposed ofin this manner shall beheld for decay a minimum of 10 half-lives.

B. Before disposal as normal waste, radioactive waste shall be surveyed to determine that its radioactivity cannot be distinguished from background. All radiation labels shall be removed or obliterated.

18. The licensee maytransportradioactivematerial or deliverradioactivematerial to a carrier for transport, in accordance with the provisions of Kansas Radiation Protection Regulations 28-35 -196a, "Preparation of Radioactive Material for Transport".

, 9. The licensee shall comply with the provisions ofKansas Radiation Protection Regulations, Part 4, "Standards J for Protection Against Radiation" and Part 10, "Notices, Instructions and Reports to Workers; Inspections."

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20. The licensee shall possess and use radioactive material described in Items 6, 7 and 8 ofthis license according to the most restrictive of; the Kansas Radiation Protection Regulations, this license or statements, representations, and procedures contained in the following documents:

~/

J Date

(a) The letter dated September 24, 1998, signed by Greg Fitts, with attachlnents.

(b) Facsimile dated November 17, 1998, signed by David Buller.

(c) Curriculum vi ate, training and experience documentation for Jeffrey L. Borders, M.D., Caprice M. Olomon, M.D., John M. Bramble, M.D., Joy A. Johnson, M.D., received on January 15, 1999.

(d) Facsimile dated February-2, 1998 and received February 2, 1999, signed by Dave Buller, with attachments.

(e) The letter dated April 19, 2001, signed by Mary Jo McLear.

(f) The letter dated June l8, 2002, signed by Mary Jo McLear.

(g) The letter dated Aprill, 2003, signed by Joy A. Johnson, MD, with attachments.

(h) The letter dated March 23, 2004, signed by Laurie Mcintosh.

(i) The Jetter dated August 31,2004, signed by J. A. Johnson, MD.

----------------Thomas A. Conley,

Radiation Control P

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Page 1 of 5 Pages

STATE OF KANSAS


Pursuant to the Nuclear Development and Radiation Control Act (L. 1963, Ch. 290) and Kansas Annotated Regulations numbers 28-35-133 through 2 8-3 5-363 inclusive, and in reliance on statements and representations made to this agency by the licensee designated below, a license is hereby issued authorizing the licensee to transfer, receive, possess, and use the radioactive material or materials listed below; and to use such materials at the place or plates listed below; and to use the material for the purpose or purposes listed below. This license is subject to all applicable rules, r~gulations, and orders now in effect or placed in effect by the Depa:1mer:t of Health and Environment and any conditions specified below.

Amendment No. lS

1. Name

Licensee

Saint John Hospital

3. License number

19-B383-0l

2. Address 3500 South Fourth Street

Leavenworth KS 66048

4. Expiration date

September 30, 2004

5. Reference number


7. Chemical and/or physical form 8. Maximum qwmtity licensee may possess at any one time

See Page No. 2 See Page No. 2 See Page No. 2

CONDITIONS

9. Authorized use. (Unless otherwise specified. the authorized place of use is the llcensee's address stated in Item 2 above.)

10.

II.

12.

A. Any diagnostic procedure listed in Groups I and IT, ScheduleD, Regulation 28-35-199a ofthe Kansas Radiation Protection Regulations.

B. Any therapeutic procedure listed in Group N, ScheduleD, Regulation 28-35-199a of the Kansas Radiation Protection Regulations.

C. through H. To be used for instrument calibration and quality control.

Radioactive materials shall onl} be used at 3500 South Fourth Street, Leavenworth, KS.

The radiation safety officer in this program shall be Joy A. Johnson, M.D.

Radioactive material shall be used by, or under the supervision of. Jeffrey L. Borders, M.D., John M. Bramble, M.D., Joy A. Johnson, M.D., Caprice M. Olamon, M.D., and John McMillan, M.D.

___ /

I~U. OO:J



Supplementary Sheet


A. Any radioactive material listed in Groups I:and II, Schedule D; Regulaticm 28-35-199a of~ Kansas Radiation .. Protection Regulations.

B. Any radioactive material listed in Group IV, ScheduleD, Regulation 28-35-199aofthe Kansas. Radiation Protection Regulations.

C. Cobalt-57

D. Cesium-13 7

E. Barium-133

License number: 19-8383-01

7. Chemical and/or physical form 8. Maximwn quantity licensee may possess at any one time

A. Any radiopharmaceutical listed in Groups I and IT, ScheduleD, Regulation 28-35-199a ofthe Kansas Radiation Protection Regulations.

B. Any radiopharmaceutical listed in Group N, Schedule D, Regulation 28-35-199a of the Kansas Radiation Protection Regulations.

C. Sealed source (DuPont NES-206, NES-391, NES-392, NES-8012, NES-8300, NES-8400, NES-8450; Am.ersham CTR-Ql series; North American Scientific MED35SO, MED3700-3749; Isotope Products FL series, NES series, RV-057; International Isotopes BM-01 series, BM-02 series, BM-04 series, BM -OS series, DM-06 series, BM-09

series)

D. Sealed source (DuPont NES-356; Amersham CDC.Vl)

E. Sealed source (DuPont NES-358; Amersham BDC.VI)

A. As necessary for uses authorized in Subitem 9.A

B. 100 millicuries of each radioactive material authorized in Subitem 6.B.

C. No single source to exceed 25 millicaries

D. No single source to exceed 250 microcuries

E. No single source to exceed 250 microcuries

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Supplementary Sheet License number: 19-8383-01



13.

14.

F. Cobalt-60 F. Sealed source (DuPont NES-354)

F. No single source to exceed 100 microcuries

A (1) Each sealed source containing radioactive material, other than Hydrogen-3, with a half-life greaterthan thirty (30) days and in any fonn other than gas shall be tested for leakage and/or contatniriationat intervals not to exceed six (6) months. In the absence of a certificate from a transferor indicating that a test has been made within six ( 6) months prior to the transfer, a sealed source received from another person shall not be put into use until tested.

{2) Notwithstanding the periodic leak test required by this condition, anyradioactive sealed source is exempt from such leak tests when the source contains 100 microcuries or less ofbetaandlor gamma emitting material or l 0 microcuries or less of alpha emitting material.

(3) The periodic leak test required by this condition does not apply to sealed sources that are stored and not being used. The sources excepted from this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six (6) months prior to the date of use or transfer. Sources in storage shall be physically inventoried every six months and listed in the radioactive materials inventory.

B. The test shall be capable of detecting the presence of0.005 microcurie of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is pennanentlymmmted or stored on which one might expect contamination to accumulate. Records ofleak test results shall be kept in units of microcurie and maintained for inspection by the Department.

c. If the test reveals the presence of0.005 microcurie or more of removable contamination, the licensee shall immediatelywithdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed ofin accordance with Department regulations. A report shall be filed within five ( 5) days of the test with the Radiation Control Program, Bureau of Air and Radiation, Kansas Department ofHealth and Environment, Topeka, Kansas, describing the equipment involved, the test results and the corrective action taken.

D. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically authorized by the Deparbnent, the United States Nuclear Regulatory Commission, or an Agreement State to perform such services.

The use of radioactive material in or on humans shall be by a physician.

l NU.bl:i:J lA1':::1 ·-- -·---- ·----·----



Supplementary Sheet License number: I 9-B383-0l

15. Sealed sources containing radioactive material shall not be opened.

16. A. Radiophannaceuticals dispensed and/or distributed for human use shall be either:

( l) Repackaged from preparedradiopharmaceuticals that are the subject of an FDA-approved "New Drug Application" (NDA) or for which FDA has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND), or

{2) Preparedfromgeneratorsandreagentkits thatarethesubject of an FDA-approved NDA or for which FDA has accepted an IND.

B. Prepared radiophannaceuticals for which FDA has accepted an IND and radiophannaceuticals prepared from generators or reagent kits for which FDA has accepted an IND shall be dispensed and/or distributed:

(1) In accordance with the directions provided by the sponsor of the IND, and

(2) Only to physicians who have been accepted by the sponsor of the IND to participate in clinical evaluation of the drug.

The licensee shall inform, in writing, each physician who participates in an IND evaluation, that the physician is responsible to the sponsor of the IND for use of the drug in accordan.ce with protocols established by the sponsor and for reporting to the sponsor the clinical information obtained through use of the drug.

17. Th.e licensee is authorized to hold radioactive material with a physical half-life ofless than 65 days for decay-instorage before disposal in ordinary trash provided:

A. Radioactive waste to be disposed of in this manner shall beheld for decay a minimum of 10 half-lives.

B. Before disposal as normal waste, radioactive waste shall be surveyed to detennine that its radioactivity cannot be distinguished from backgrolllld. All radiation labels shaH be removed or obliterated.

18. The licensee may transport radioactive material or deliver radioactive material to a carrier for transport, in accordance with the provisions of Kansas Radiation Protection Regulations 28-35-196a, "Preparation of Radioactive Material for Transport".

19. The licensee shall complywith the provisions ofKansasRadiationProtectionRegulations, Part 4, "Standards for Protection Against Radiation" and Part 10, "Notices, Instructions and Reports to Workers; fnspections."

20. The licensee shall possess and use radioactive material described in Items 6, 7 and 8 ofthis license according

..,___/

..... -' Date

NU.b85



Supplementary Sheet License nu."llber: 19-8383-01

to the most restrictive of; the Kansas Radiation Protection Regulations, this license or statements, representations, and procedures contained in the following documents:

(a) The letter dated September 24, 1998, signed by Greg Fitts, with attaclunents.

(b) Facsimile dated November 17, 1998, signed by David Buller.

(c) Curriculum vi ate, training and experience documentation for Jeffrey L. Borders, M.D., Caprice M. Olomon, M.D., Jolm M. Bramble, M.D., Joy A. Johnson, M.D., received on January 15, 1999.

(d) Facsimile dated February 2, 1998 and received February 2, 1999, signed by Dave Buller, with attachments.

(e) The letter dated April19, 2001, signed by Mary Jo McLear.

(f) The letter dated June 18, 2002, signed by Mary Jo McLear.

(g) The letter dated April 1, 2003, signed by Joy A. Johnson, MD, with attaclunents.

{h) The letter dated Marcb 23, 2004, signed by Laurie Mcintosh •

--------

of 4 Pages STATE OF KANSAS


Pur$Ua.ot to the Nucle.v Development ~d Radiation ~trol Ac:t (L 1963,_Ch. 290) ~Kansas A.nnotan;d Re~lations 28:"35-133 et ~··.and in reliance on statements acd represcutstions made to this agency by rhe hcen.llee dengnated below, a hcenslis hereby 1ssued authonzmg the licensee to tn~nsfer, receive. possess, IID.d use the radioactive material or materials listed below; end ro use su!=]t materials at the -place Dr places listed below; and to use the matenal for the purpose or purposes listed below. This license .is subject to all; ap-plicable rules, Jegulations, and orders now in effect {1( placed in effect by tbe Department of Health and Environment and any conditions speci~ed below.

A~endment No. 24

Licensee 3. License number 1. Name Cushing Memorial Hospital 19-B374-01

1:

i 2. Address 711 Marshall Street

Leavenwortb.1 KS 66048 4. Expiration date

March 31, 2011 i I

5. Reference number i, l

6. Radioactive materials 7. Chemjcal and/or physical form 8. ~imum quantity licensee mry possess at any one time

9.

10.

11.

12.

(element and mass number)

See Page No. 2 See Page No. 2

CONDITIONS

I i See Page No. 2

;· I

Authorized use. (Unless otherwise specified, the authorized place of use' is the licensee's address stated in Item 2 above.) .

1•

A

B.

C.

Any diagnostic procedure listed in Groups I and II, KA.R. 28-35-13$g.

Any therapeutic procedure listed in Group IV, K.A.R. 2S·35-135g. ~ To be used in the preparation of reagent kits for the detection an~ imaging of ovarian and colorectal cancers. ·

I. D. To be used for calibration, transmission, reference and quality controL

I Radioactive materials shall only be used at 711 Marshall Street, Leavenwo1i , KS

The radiation safety officer in this program shall be Jeff Borders, M.D. •

Radioactive materials shall be used by or under the supervision of JeffBord~s. M.D.; John Bramble, M.D.; Joy Jolmson, M.D.; Caprice Olomon, M.D. or Jolu1 H. McMillan, M.D.

of 4 Pages STATE OF KANSAS

i·

RADIOACTIVE MATERIALS LICENSE !

Supplementary Sheet License number: ~2-B374-0I I

6. Radioactive materials 7 .. Chemical and/or physical form 8. f:um quantity licensee (element and mass number) m

1 y possess at any one time

i A. Any radioactive A. Any radiopharmaceutical A .I As necessary for uses

material listed in listed in Groups I and IT. authorized in Subitem Groups I and II, K.A.R. 28~35-lJSg. ').A. K.A.R. 28-35-13Sg.

I B. Any radioactive B. Any radiophannaceutical B.\ 100 millicuries of each

material listed in listed in Group IV, I

radioactive material Group IV, K.A.R. 28- KA.R 28-35-135g. authorized in Subitem

I 35-135g. I 6.B

I

l· c. Indium-111 c .. Chloride c., 20 millicuries

D. Any radioactive D. Any sealed source D. \ 50 mill.icuries of each material authorized by 10 CFR

I radionuclide, no

35.65 or equivalent single source to agreement state

I I exceed 20 millicuries

regulation.

I·

I

'

I 13. A. (1) Each sealed source containing radioactive material, other th~ Hydrogen-3, with a

half-life greater than thirty (30) days and in any form other th~ gas shall be tested for leakage and/or contamination at intervals not to exceed six (6)1months. In the absence of a certificate from a transferor indicating that' a test has been made within six (6) months prior to the transfer, a sealed source received from anoUter person shall not be put into use until tested.

(2) Notwithstanding the periodic leak test required by this con~tion, any .radioactive sealed source is exempt from such leak tests when the source cc,tntains 100 microcuries or less of beta and/or gamma emitting material or 10 microburies or less of alpha emitting material J

I

(3) The periodic leak test required by this condition does not apply to sealed sow-ces ihat are stored and not being used. The sources excepted from this; test shall be tested for leakage prior to any use or transfer to another person unless the~ have been leak tested within six (6) months prior to the date of use or transfer. Sowfces in storage shall be physically inventoried every six: months and listed in the: radioactive materials inventory.

0 14.

15.

16.

B.

C.

D.

I I I Page 3 of 4 Pages

STATE OF KANSAS


Supplementary Sheet License number: I9-B374-0l

The test shall be capable of detecting the presence oro:oos microcJe of radioactive material on the test sample. The test sample shall be taken from the sealed sob.rce or from the surfaces of the device in which the sealed source is permanently mounted !or stored on which one . might expect contamination to accumulate. Records of leak test r~ts shall be kept in units of microcurie and inaintained for inspection by the Radiation Contro~ Program, Bureau of Air and Radiation, Kansas Department of Health and Environment. j

! I

If the test reveals tbe presence of 0.005 microcurie or more of remoyable contamination, the licensee shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance \with Radiation Control Program, Bureau of Air and RAdiation, Kansas Departluent of Health and Envi.romnent regulations. A report shall be filed within five (5) days of the test with the Radiation Control Program, Bureau of Air and Radiation1 Kansas Department of Hbalth and Environment, describing the equipment involved, the test results and the corrective ftion taken.

Tests for leakage and/or contamination shall be performed by the liceree or by other persons specifically authorized by the Radiation Control Program, Bureau! of Air and Radiation, Kansas Department of Health and Environment, the United States Nuclear Regulatory Commission, or an Agreement State to perform such services. \

The use of radioactive material in or on humans shall be by a physician. 1,

I

\

I Sealed sources containing radioactive material shall not be opened.

A.

B.

Radiopharmaceuticals dispensed and/or distributed for human use shalD be either:

(1)

(2)

I

Repackaged from prepared radiophannaceuticals that are th~ subject of an FDAapproved "New Drug Application" (NDA) or for which FDA ltas accepted a "Notice of Claimed fuvestigatioual Exemption for a New Drug" (IND), or

. I Prepared from generators and reagent kits that are the subjec1 of an FDA-approved l\lDA or for which FDA has accepted an IND. 1 ·

Prepared radiopharmaceuticals for which FDA has accepted an IND an1 radiopharmaceuticals prepared from generators or reagent kits for which FDA bas accegted an IND shall be dispensed and/or distributed: I (1) In accordance with the directions provided by the sponsor of the :IND. and

(2) Only to physicians who have been accepted by the sponsor of th~ IND to participate in clinical evaluation of the drug. ·

17.

18.

19 ..

STATE OF KANS"AS

RADIOACTIVE ·MATERIALS LICENSE i I

I I·

i I

Page 4 of 4 Pages

Supplementary Sheet · License number: 119-B374-0l I

The licensee shall inform, in writing. each physician who participates in ani IND evaluation, that the physician is responsible to the sponsor of the IND for use of the drug in a.Ccordance with protocols established by the sponsor and for reporting to the sponsor the clinical infonnatioo. obtained through use ofthe drug. \

I

The licensee may transport radioactive material or deliver radioactive material to a carrier for transport, in accordance with the provisions of Kansas Radiation Protection ~egulations 28-35-196a, nPreparation of Radioactive Material for Transport''. \ .

The licensee shall comply with the provisions of Kansas Radiation Protec~on Regulations, Part 4, "Standards for Protection Against Radiation'' and Part 10, "Notices, Inst:fuctions and Reports to Workers; Inspections." · I

I

The licensee shall possess and use radioactive material described in Items 6p 7 and 8 of this license according to the most restrictive of; the Kansas Radiation Protection RegJliations. this license or statements, representations, and procedu.res contained in the following docum~ts:.

! (a) The letter dated February 24, 2004, signed by Linda Woods-Gillespie,! with attaclunent.

I.

(b) The Jetter- received September 9, 2004, signed by Sondra Fausett.

(c) The facsimile dated March 27,2006, from Sondra Fausett.

'--6ate APR 1 8 ZUD6

l' I

This is to a7knowledg~ the receipt of you~i}application dated

/ 0{ /'P, i/JLJ J Jj , and to infonn you that the initial processing which inCludes an administrative review has been perfor~e .

· .· ~G~ /'7'/J't;--~oJ tln vdrJtPn lt"J There wece no adm;n;,tmtive om;,bm. Your ppHoatio~a' ,,;gned to a z:t} technical reviewer. Please note that the technical review may identify additional omissions or require additional information.

O 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 actio~ has been assigned Mail Control Number '- ,rf:j.-IJI7 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.

NRC FORM 532 (RI)

(6-96)

Sincerely, , Licensing Assistance Team Leader.

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