INGHAM R E G I O N A L

MEDICAL CENTER

February 8,2008

United States Nuclear Regulatory Commission Region Ill, Materials Licensing 2443 Warrendale Road Suite 210 Lisle, IL 60532-4352

RE: Amendment to NRC License No. 21-04073-01 lngham Regional Medical Center

Dear SirlMadam:

We would like to amend our current NRC license to reflect the following changes.

Item #1 Please add the following individual to our NRC license:

Jeffrey G. Richmond, M.D. 35.300, 35.400, and Iridium-I92 in a remote afterloading brachytherapy device.

Dr Richmond is listed as an authorized user on the included Arizona Radiation Regulatory Agency license #7-161 , amendment number 61. Dr Richmond is also listed as an authorized user on the included Arizona Radiation Regulatory Agency license #7-271, amendment number 67.

If you have any questions or require additional information, please contact Bryan Tollenaar, M.S. at 51 7-367-5070.

lngham Regional Medical Center

401 W. Greenlawn Avenue Lansing, Michigan 48910-2819 (517) 334-2121

RECElVEO FEB 2 6 2008. An Affiliate of McLAREN HEALTH C A R E CORPORATION

ARRA-3 August 2007

Page I of 7

ARIZONA RADIATION REGULATORY AGENCY

. R A D I O A C T I V E M A T E R I A L L I C E N S E Putsum1 IO Chapfcr 4. Tide 30, Anmna Rcviscd Swum. and Title 12. chapla 1 of the Arizow Adminimtiw Code. and in reliana on memenu and reprerenutions made lo the Agency by h e liansn. a liccrrre is hutby issued authorizing the acquisition. reception. possession. use and mrfu of h e radioacuve'marcrial listed in this licerue for h e purports and at the places specified. This license is subject to n l applicable d e s and Agency wdcn now or hcrcetkr in effgt and to thc conditions spaificd. In accordance with kllcr dmtd A m y i t 20.2001. signed by Krvin Rogers, License tiumber 7-161 b bereby amended io iu cnlirc@ to rend as falbwr: ALL CHAKCES ARE IN BOLD

LICENSEE I .

Arizona Oncology Services 3. a. LICEWE XUXlBER 7 - 161 b. AMENDMENTNO.: 61

1. NAME:

4. EXPIRATION DATE: October31,2010 I 2. ADDRESS: 8994 East Desert Cove Drive .

Scottsdale, Arizona 85260 5. CATEGORY: 83(4) - MEDICAL MATERIALS TYPE B

. . 6. Radioactive material 7. Cbemical or physical form 8. Maximum quantity licensee may

(element and mass number) possess at any time

A.

B.

C.

D.

E.

F.

Strontium-90

Iridium-I 92

Depleted Uranium

Iodine- 125

Palladium-I 03

Samarium- I53

A. Sealed Source (NEN, ' Model NB- I \

A. 4.44 GBq (No single source to exceed 120 millicuries)

B. 8 sources, no single source to exceed 444 GBq (1 2 curies), total not to exceed 22 Curies (814 GBq) at any addresses authorized for storage and use under

' Condition 10(B)

C. 400 Ibs.

D. 185 GBq (SO00 mi II icuries)

E. 185 GBq (5000 millicuries)

F. 18.5 GBq (500 millicuries)

G. Strontium-89 G. Strontium Chloride G. 1.48 GBq (40 millicuries)

H. Technetium-99m H. Tc-99 H. 1 . I 1 GBq (30 millicuries)

1. Indium-I 11 . ' I . Zevalin Ibritumomab 1. 925 MBq (25 millicuries) tiwetan

J.

K.

Yttrium-90

Cesium- 13 1

J: Zevalin lbritumomab '

tiuxetan

K. Sealed Source (IsoRay Model CS-I seed)

ARRA-3 (Cant.) August 2007

ARIZONA RADIATION REGULATORY AGENCY

Page 2 of 7

. RADIOACTIVE MATERIAL LICENSE . SUPPLEME.NTARY SllEET License Number 7.161

Amendment No. 61

9. Authorized Use:

'A. . .

B. . c. D., E. and K. F. and G.

H. I .

For use in an eye applicator for treatment of eye disease. For use in Nucletron-HDR after-loading system. To be used as shielding material in a Varian Associates Model Clinic 6-100 Linear Accelerator. For,use as brachytherapy implant sources for treatment of.human disease. For 'palliation of bone pain associated with metastatic disease (Sm-153 may be obtained in vial

For use in diagnosis of metastic breast disease. Tumor localization as a n adjunct to the therapy authorized in Item 9(J) below.

form).

J. Radioimmunotherapy .of non-Hodgkin's lymphoma.

C O N D I T J O N S

IO. A. 1 . Radioactive material listed under subitem A of items 6, 7, and 8 may be used at:

Baptist Oncology Center I 9 16 W. Bethany Home, Ste. IO0 Mesa, AZ 85206

. Arrowhead Cancer Center 6525 W. Sack Dr.; Ste. 105 Glendale, A2 85308

Paradise Valley Oncology I 6620 N. 40th St., Ste. C Phoenix, AZ 850

, .

2. Radioactive material listed under subitem A may be stored and also used at:

Yuma Cancer Center I501 W. 24th St., Ste. C Yuma, A2 85364 Apache Junction Cancer,Ctr. 2080 W. Southern Apache Junction, AZ 85220

Mesa Radiation Services 500 W. 10th PI., Ste. 9 Mesa, A 2 85201 East Valley Oncology 6424 E. Broadway, Ste. 105 Mesa, A 2 85206

Scottsdale Oncology 8994 E. Desert Cove Dr., Ste. 100 Scottsdale, AZ 85260

B. Radioactive material listed under subitem B of Items 6, 7, and 8 may be stored and also used at: . .

Scottsdale Oncology Paradise Valley Oncology 8994 E. Desert Cove Dr., Ste. 100 Scottsdale, AZ 85260

' I6620 N. 40th Street, Suite C I Phoenix, AZ 85032

6525 W. Sack Drive, Glendale, AZ 85308

, . East Valley Oncology . I Arrowhead Cancer 6424 E. Broadway Road, Suite 105 Mesa, AZ 85206

. I I .

. .

. .

. .. Page 3 of 7 A m - 3 (Cent.)

AugUSl2007 ARIZONA RADIATION REGULATORY AGENCY

RADIOACTIVE MATERIAL LICENSE SUPPLEMENTARY SHEET License Number 7- 16 I

Amendment No. 61

C. . Radioactive material.listed under subitem C of Items 6, 7, and 8 maybe stored and also used at: Baptist Oncology Center 1916 W. Bethany Home, Ste. 100 Phoenix, AZ 850 15

Mesa Radiation Services 500 W. 10th PI., Ste. 9 Phoenix, AZ 85201

D. Radioactive material listed under subitems D, E, F, G, H and K.of Items 6, 7, and 8 may be stored and usedat:

' Scottsdale Oncology 8994 E. Desert Cove Dr., Ste. 100 Scottsdale, AZ 85260

E. 1. Radioactive material listed under subitems F and G of 6,7, and 8 may be used at: Paradise Valley Oncology I6620 N. 40th St., Ste. C 1 Phoenix, AZ 85032 Apache Junction Cancer Center 2080 W. Southern Apache Junction, AZ 85220 '

Arrowhead Cancer Center 6525 W. Sack Dr., Ste. 105 Glendale, AZ 85308

2. Radioactive material listed under subitems F and G of 6,7, and 8 may be used and stored at .

East Valley Oncology 6424 E. Broadway Road, ## 105 Mesa, A 2 85206

,

1 I .

12.

F. Radioactive material listed under subitems H of 6, 7, and 8 may be used at: Breastnet 8994 E. Desert Cove Dr., 200 Scottsdale, AZ 85260

G . Radioactive material listed under subitems I and J of 6,7, and 8 may be used and stored at: East Valley Oncology 6424 E. Broadway Road, # 105 Mesa, AZ 85206

Arrowhead Cancer Center 6525 W. Sack Drive, Suite 105 Glendale, AZ 85308

Scottsdale Radiation Oncology 8994 E. Desert Cove Dr., 100 Scottsdale, AZ 85260,

I Yuma Cancer Center I50 1 W. 24th Street, Suite C Yuma, A 2 85364

The licensee shall comply with the provisions of Title 12, Chapter 1 , Arizona Administrative Code; Article 3, "Licensing of Radioactive Materials"; Article 4, "Standards for Protection Against Radiation"; Article 7, "Medical Uses of Radibactive Material"; and Article IO, "Notices, Instructions, and Reports to Ionizing Radiation Workers; Inspections".

A. Radioactive material listed under subitems A through E, and K of Items 6,7, and 8 shall be used by, or under the supervision of ttie following individuals:

Kent J. Rossman, M.D. David C. Beyer, M.D. Burton L. Speiser, M.D. John A. Shaw, M.D. Thomas P. Canty, M.D.

Irene Taw, M.D.

John J. Kresl, M.D. Farley E. Yang, M.D. Gregory A. Maggass, M.D. Jeffrey G. Richmond, M.D. David M. Steinway, D.O.

. Coral Quiet, M.D. Robert Kuske, M.D.

. A m - 3 (Coni.) August2007 .

Page 4 of 7

ARIZONA RADIATION REGULATORY AGENCY '

RADIOACTIVE MATERIAL LICENSE SUPPLEMLVTARY SHEET License Number 7-1 6 I

Amendment No. 61

13.

1

B.

C.

D.

E.

F.

G .

H.

4,

B.

Radioactive material listed under subitems F and G of Items 6,7, and 8 shall be used by, or under the supervision of the following individuals:

' Kent J . Rossman, M.D. John J. Kresl, M.D. David C. Beyer, M.D. Farley E. Yang, M.D. John A. Shaw, M.D. Gregory A. Maggass, M.D. Thomas P. Canty, M.D. . Jeffrey G. Richmond, M.D. Luci Mengchun Chen, M.D. Coral Quiet, M.D. David M. Steinway, D.O. Irene Taw, M.D.

Emily J. Grade, M.D. Diane Recine, M.D. Burton L. Speiser, M.D.

Radioactive material listed under subitems I and J of Items 6,7, and 8 shall be used by, or under the supervision of the following individuals:

Irene Taw, M.D. Gregory A. Maggass, M.D. John Shaw, M.D. Luci M.:Chen, M.D. Emily J. Grade, M.D. Farley E. Yang, M.D. David Beyer, M.D. Thomas P. Canty, M.D.

Jeffrey G. Richmond, M.D,

John J. Kresl, M.D.

Radioactive materials listed under subitems H of Items 6, 7, and 8 shall be used by, or under the supervision o f : Belinda Barclay-White, M.D.

Radioactive material listed under subitems B thru E and K of ltems 6,7, and 8 shall be used by or under the supervision of: Daniel Reed, D.O. and Jonathan Ashman, M.D., Ph.D.

Radioactive materials listed under subitems B, D, E, and K of Items 6,7, and 8 shall be used by or under the supervision of: Lauren D. Stegiman, M.D.

The authorized medical physicist for this license shall be: Erdal Gurgoze, Ph.D. Kevin Rogers, M.S. John Stovall, M.S. Salih Gurdalli, Ph.D. Abdur Rahim, M.S. Victor Howard, M.S. 1

Lisa Depies, M.S. Mustafa Ozer, M.S.

1 . The Radiation Safety Officer for this license shall be Erdal Mehmet Gurgoze, Ph.D. 2. The Alternate Radiation Safety Officer shall be Kevin Lane Rogers, M.S and '

Melvin Gregory Chaney. The Alternate Radiation Safety Officer shall administer the Radiation Safety Program under the policy and procedure guidance of.the Radiation Safety Officer. '

.

An individual who has been administered 13 millicuries of In-l I I , 7 millicuries of 1-13 I , 140 millicuries of Sm- 153, or 19 millicuries of Au-198, or implanted with 2 millicurie of 1-1 25 or 8 millicuries Pd-103; or if the exposure rate at 1 meter from the patient is less than or equal to: 4 mremhr for In-I l l , 2 mremhr for 1-131, 6 mrem/hr for Sm-153, 4 mrern/hr for Au-198, 0.2 mrem/hr for 1-125, or 0.7 mremkr for Pd-103, may be released without restriction.

An individual who has been administered radiopharmaceuticals or permanent implants in excess of the levels specified in Part A may be released in accordance With R12-1-719. (NRC Reg Guide 8.39, dared April 1997, shall be used when calculating the dose to the general public) If the dose to a breast-feeding infant or child could exceed 1 millisievert (0.1 rem) assuming there were no interruption of breast- feeding, the instructions given shall +fclude: 1. 2.

Guidance on the interruption or discontinuation of breast-feeding and Information on the consequences of failure to follow the guidance.

t

, . .

ARRA-3 (Cant) Page 5 of 7 August 2007

, ARIZONA RADIATION REGULATORY AGENCY

RADIOACTIVE MATERIAL. LICENSE SUPPLEMENTARY SHEET License Number 7- 16 1

Amendment No. 61

14.

i 5.

16.

, .

C.

D.

A.’

B.

A.

B. .

C.

D.

A.

B.

Should an individual be released under Part By the licensee shall maintain a record of the basis for authorizing the release in accordan’ce with R12- 1-71 9. If applicable, the record maintained for Agency inspection shall include instructions provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem).

The licensee shall m.ake the radiation measurement required in Part A when treating patients with Cs-I3 I’to determine an exposure level that will be used to ensure members ofthe public and family ’ are not exposed to radiation in excess of &he allowable exposure levels in NRC Reg Guide 8.39, dated April I99 7.

The licensee is not required to use a dose calibrator to check a unit dosage of a therapeutic radio pharmaceutical used under Item 9 ( F ) and (G) that is received From a nuclear pharmacy or from the manufacturer.

The licensee is authorized to check the dosage taken from a stock vial of therapeutic radio pharmaceutical authorized under Item 9(G) in accordance with procedures in e-mail to the Agency dated January 20,2005.

The licensee shall administer Yttrium-90 Zevalin in accordance with the manufacturer’s procedures and recommendations,

The Yttrium-90 Zevalin patient dosages shall be measured in a radioactivity calibration device that has been calibrated with:

.. F

1 . 2.

A NIST traceable source; and The calibration source must be contained in a vial or syringe having the same geometric configuration as the vial or syringe, while calibrating the patient’s therapeutic dosage.

The licensee may use the calibration procedure described in letter dated April 22,2002 provided: 1. A decay correction is made for the time of patient administration; and 2. The administration of the patient dosage, if outside of the dosage range prescribed by the

authorized user or if the dosage differs from the prescribed dosage by greater than 20 percent, is directed by the authorized user.

Prior to the administration of Indium-I I Zevalin, the licensee shall have made accommodations for the imaging of the patient after the administration.

The licensee shall not administer to a person; radioactive material in an unsealed form that has not had its radioactivity determined.

For unit dosages, the determination may be made by: I . 2.

Direct reading of the radioactivity in a dose calibrator; or Decay correction based on the radioactivity or radioactivity concentration determined by a properly licensed: a.” Manufacturer, or ’

.b. Nuclear pharmacy

i .

ARRA-3 (Cont.1 Pegc 6 of 7 August 2007

ARIZONA RADlATION REGULATORY AGENCY

RADIOACTIVE MATERIAL LICENSE' SUPPLEMENTARY SHEET License Number 7- 16 I

Amendment No 61

C. Foi other than unit dosages, the determination shall be made by

17. . .

18.

-'.19.

20.

21.

1 . Direct measurement of the radioactivity in a dose calibrator; 2. Combination of . . subsection (C)( I ) and mathematical calculations; or 3. Combination of volumetric measurement and mathematical calculation based on a radioactivity

measurement determined by a supplier listed in subsection (B)(2)(a) or (B)(2)(b).

A dosage determination shall not be Lised unless it falls within the authorized user's prescribed dosage range, or unless it is within 20% of the prescribed dosage.

The dosage determination in subsection (A) shall be made and recorded before medical use.

D.

E.

The licensee shall provide to the Agency an installation survey, for the HDR installed at the Paradise Valley facility, prior to initiating any patient therapies.

A. Before the first medical use of a brachytherapy source, not to include low dose-rate remote afterloader sources, a licensee shall:

1 . Determine the source output or activity using a dosimetry system that is calibrated using a system or source that is: a. Traceable to the National Institute of Science and Technology (NIST), and protocols

accepted by a nationally recognized body; or b. The calibration may be performed by acuirently recognized laboratory accredited by

the American Association of Physicists in Medicine (AAPM); and c. The calibration shall have been performed within the previous 2 years and after any

servicing that may have affected system calibration, or the system shall have been calibrated within the last 4 years, with an intercomparison performed 18 to 30 months after the calibration, using another dosimetry system that was calibrated within the last 24 months by NIST or by a calibration laboratory accredited by the AAPM. The brachytherapy source shall not be used until a calibration has been completed as required above, if the intercomparison indicates that the original calibration factor has changed by more than 2%.

Determine the source positioning accuracy within applicators, using currently recognized protocols meeting the standards of this rule. Mathematically correct the output or source activity for physical decay at intervals consistent with 1% physical decay.

-

2.

3.

B. ,

Notwithstanding the'sealed source inventory frequency in R12-1-712, the licensee may perform the required inventory on a 6 month basis in accordance with RI 2- 1-450.

The licensee may receive samarium-1 53 for instrument calibration purposes in accordance with the authorization specified in A.A.C. RI 2- 1-7 1 l(2).

Maintain records of each calibration for 3 years after the last use of each source.

b

For' purposes of ending the principal.activities authorized under this

A. The license stays in effect beyond the expiration date, unt i l the

The licensee shall ensure the timeliness of decommissioning of facilities ' are conducted under this license in accordance with Agency requirements.

writing that the license i s terminated.

B.

Page 7 of 7

1 .

ARRA-3 (Conr August 2007

AIUZONA RADIATION REGULATORY AGENCY

RADIOACTIVE MATERIAL LICENSE SUPPLEMENTARY SHEET License Number, 7- I6 1

r . Amendment No. 61

C. The licensee shall continue to control public access into restricted areas and pay the annual licensing fee until the license is terminated.

22.

23.

24.

25.

26.

The licensee is authorized to transport Iodine- 125 and Palladium- 103 therapy seeds in accordance with procedures described in letter dated July 18,2007.

The licensee shall have a Radiation Safety Committee that reviews the radiation safety program on an annual basis.

'

For purposes of increased control the license may not possess more than 22 Curies of Iridium-] 92 at any authorized location in Condition 10 of this license.

Each licensee who uses a HDR unit or a gamma stereotactic radiosurgery unit to treat human disease shall ensure that its use is supervised in accordance with R 12-1 732(F).

Except as specifically provided otherwise by this license, the licensee shall possess and use the radioactive material described in Items 6,7 and 8 ofthis license in accordance with the statements, representations and procedures contained in:

1. 2.

3. 4. 5. 6. 7. 8. 9. 10.

Application dated September 29,2005, signed by Erdal M. Gurgoze. Letter, with control systems attachments, dated March 1 , 1999, signed by Erdal M. Gurgoze, Ph.D. Letter, with attachments, dated April 22,2002, signed by Erdal Gurgoze, Ph.D. Letter, with attachments, dated October I8,2004, signed by Erdal Gurgoze, Ph.D. Letter dated July 12, 2005, with attachment, signed by Kevin Rogers. Letter, with attachments, dated July 12, 2005, signed by Kevin Rogers. Letter, undated with attachments, received March 13,2006, signed by Kevin Rogers. Letter, with attachments, dated July 25,2006, signed by Erdal Gurgoze. Letter, with attachment, dated August I , 2006, signed by Kevin Rogers. Letter with attachments, dated July 18,2007 and August 8,2007, signed by Kevin Rogers.

The most recent statements, representations, and procedures shall govern iithey conflict with previously submitted documents, unless otherwise specified by a license condition; and the Agency's rules shall govern the licensee's statements in applications or letters.

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PAGE 07 /07

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4116 $ 8 2006

Arizona Adminishafive Register / Secretary of Staie Notices of Final Rulemaking

B;

Volume 13, Issue 14 Page 1260 April 6,2007

Arizona Administrative Register / Secretary of State Notices of Final Rulemaking

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GmadQQ Included is the use of any unsealed radioactive material for use in uutake, dilution, or excretion studies and not reauiring a written directive: The radioactive material in this erouu shall be:

Obtained from a manufacturer or ureparer licensed under R12- 1-703(C)(2)(a). or eauivalent NRC or Apreement State reauirements: or Prepared bv an authorized nuclear pharmacist who meets the reauirements in R12-1-712. a uhvsician who is an authorized user and who meets the reauirements suecified in R12-1-721 or R12-1-723. or an individual under the supervision of either as specified in R12-1-706; And if a research urotocol: - a.

- 1.

- 2.

- 3. Obtained from and preuared bv an Agreement State or NRC licensee for use in basic research in accordance with a Radioactive Drug Research Committee-apuroved urotocol or an Investigational New Drug (IND) protocol acceuted bv FDA; or PreDared bv the licensee for use in basic research in accordance with a Radioactive Drug Research Committee- approved application or an Investipational New Drug (IND) urotocol accepted bv FDA.

b.

l2LtuLm Included is the use of anv unsealed radioactive material for use in imaging and localization not reauinng a written directive. PET radioDharmaceuticals may be used if the licensee meets the reauirements in R12- 1-7 16. The radioactive material in this

Obtained from a manufacturer or preparer licensed under R12-1-703 (CM2)(a), or eauivalent NRC or Agreement State reauirements; or Prepared bv an authorized nuclear pharmacist who meets the reauirements in R12-1-712. a phvsician who is an authorized user and who meets the reauirements specified in R12-1-721 or R12-1-723, or an individual under the suuervision of either as specified in R12- 1-706; And if a research protocol: - a.

p U D Shall be : - 1.

- 2.

- 3. Obtained from and ureuared bv an Agreement State or NRC licensee for use in basic research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol acceDted bv FDA; or PreDared bv the licensee for use in basic research in accordance with a Radioactive Drug Research Committee- aDDroVed aDulication or an Investigational New Drug (IND) urotocol accepted by FDA.

- b.

Gu?umQ Included is the use of anv unsealed radioactive material for medical use (radioDhamceutica1) for which a written directive is reauired. The radioactive material in this grouu shall be:

Obtained from a manufacturer or ureuarer licensed under R12-1-703(CM2Ma) or eauivalent NRC or Agreement State reauirements; or Prepared by an authorized nuclear pharmacist who meets the reauirements in R12-1-712, a physician who is an authorized user and who meets the requirements specified in R12-1-721 or R12-1-723, or an individual under the supervision of either as suecified in R12-1-706: or And if a research Drotocol: - a.

b. G r o w 40Q

- 1.

- 2.

- 3. Obtained from and prepared bv an Agreement State or NRC licensee for use in an Investigational New Drug (IND) Drotocol acceuted bv FDA; or Preuared bv the licensee for use in basic research in accordance with an Investigational New Drug (IND) proto- col acceuted bv FDA.

April 6,2007 Page 1261 Volume 13, Issue 14

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