1521 Gull Kalarnazoo. MI 49048MEDICAL MPC PHYSICS CONSULTANTS, INC. January 6,201 1 Deb Hall Diagnostics Manager HEART CENTER FOR EXCELLENCE 1722 Shaffer Street Kalamazoo, MI 49001

1521 Gull Road Kalarnazoo. MI 49048 (269) 226.7000

April 29, 2011

UNITED STATES NUCLEAR REGULATORY COMMISSION Region 111, Materials Licensing Section 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352

BORGESS Medical Center

Re: Termination of license number 21-18912-01, Heart Center for Excellence.

Please note that this termination is being sent in conjunction with an amendment to add the radioactive use areas at Heart Center for Excellence to Borgess Medical Center. Please terminate license number 21-18912-01 at the same time you approve the amendment to add the new address of use onto the Borgess Medical Center license to avoid any interruption of patient services.

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As of January 1, 2011, Borgess Medical Center acquired the Heart Center for Excellence, license number 21-18912-01. This license is now owned and managed by Borgess Medical Center.

Upon approval, Borgess Medical Center will add Heart Center for Excellence onto its NRC license and we will continue to provide patient services. There will be no changes in the location of radioactive materials and use areas. All equipment will remain as is, but will now be owned by Borgess Medical Center. Radioactive sealed sources will remain at Heart Center for Excellence, but will now be owned by Borgess Medical Center. Authorized users on the Heart Center for Excellence license are also authorized users at Borgess Medical Center and our licensed program will continue to operate with no interruption in patient services.

All required records regarding the use and possession of licensed materials will be current at the time of the transfer. The status of compliance will be maintained before, during and after the transfer of ownership. The surveillance program is current and documented and all records are kept at the address of use. The surveillance program will continue to be up to date at the time of the transfer of control. There are no open inspection items related to materials license number 21-1 8912-01.

All parties involved with the transfer are aware and agree to the planned transfer of ownership.

If you have any questions regarding this termination please contact Tom Mushett, Radiology Director at 269-226-4833 or Paul Jursinic, Ph.D., RSO at Borgess Medical Center, at 269-373-7407.

Linda Lawton, Vice President of Operations Borgess Medical Center Borgess Heart Center of Excellence

NRC FORM 314 (4-2008) 10 CFR 30 36(~)(1). 40 42QKl). 70 3@jKl). and 72 54kX5KlXl)

U.S. NUCLEAR REGULATORY COMMISSION

CERTIFICATE OF DISPOSITION OF MATERIALS

LICENSEE NAME AND ADDRESS

APPROVED BY OMB: NO. 3150-0028 EXPIRES: 08I3112t

Estimated burden per response to amp+ with this mandatwy collection request: 30 minu This submittal is used by NRC as part of the basis for its determination that the facilii released for unrestricted use. Send comments regarding burden estimate to the Records FOlAlPrivacy Services Branch (T-5 F52), US. Nuclear Regulatory Commission, Washing DC 205554001. or by internet e-mdl to [email protected], and to the Desk O h . Ofk Information and Regulatory Affairs, NEOB-10202, (3150-0028). Office of Management Budget. Washington, DC 20503. If a means used to impose an information collection does display a currently valid OM6 control number, the NRC may not conduct or sponsor, ar person is not required to respond to, the infomation co!kAm.

LICENSE NUMBER j DOCKET NUMBER

Heart Center For Excellence 1722 Shaffer Street, Suite 1 Kalamazoo, MI 49048

1 This license has expired.

6. DISPOSAL OF RADIOACTIVE MATERIAL (Check the appropriate boxes and complete as necessary. If additional space is needed, provide attachments) The licensee, or any individual executing this certificate on behalf of the licensee, certifies that:

A. LICENSE STATUS (Check th This license has not yet expired; please terminate it.

03017349 _ _

21-18912-01 I t- ~ -

LICENSE EXPIRA~ON DATE

05/31/2011

appropriate box)

j_ ] 1. No radioactive materials have ever been procured or possessed by the licensee utder this license.

2. All activities authorized by this license have ceased, and all radioactive materials procured and/or possessed by the licensee under this license number cited above have been disposed of in the following mwner.

j J: a. Transfer of radioactive materials to the licensee listed below:

1 c3 Borgess Medical Center license 21-12275-02

~ b. Disposal of radioactive materials:

[ 1 2. By licensed disposal site:

I__ 1 3. By waste contractor:

1 c. All radioactive materials have been removed such that any remaining residud radioactivity is within the limits of 10 CFR Part 20. Subpart E. and is ALARA.

C. SURVEYS PERFORMED AND REPORTED [i/ 1. A radiation survey was conducted by the licensee. The survey confirms:

1 1 a. the absence of licensed radioactive materials

[ JJ b. that any remaining residual radioactivity is within the limits of 10 CFR 20, Subpart E, and is ALARA.

171 2. A copy of the radiation survey results: - ,J] a. is attached; or rj b. is not attached (Provide explanation); of-] c. was forwarded to NRC on:

i 3. A radiation survey is not required as only sealed sources were ever possessed under this license, and

E] a. The results of the latest leak test are attached; and/or

Dale 1-

[I b. No leaking sources have ever been identified.

D NAME AND TITLE

NRC FORM 314 (4-2008) PRINTED ON RECYCLED PAPER

MEDICAL MPC PHYSICS

CONSULTANTS, INC.

January 6,201 1

Deb Hall Diagnostics Manager HEART CENTER FOR EXCELLENCE 1722 Shaffer Street Kalamazoo, MI 49001

Dear Ms Hall:

Enclosed please find the Nuclear Medicine inspection report for the first quarter of 201 I. This inspection was performed on January 6, 201 1. I have listed my comments and recommendations concerning your licensed activities below:

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The following documentation is enclosed for Dr. King to review and sign: the dose calibrator accuracy test, linearity test, sealed source inventory, leak test and this letter.

.The sealed source inventory was verified and leak tested. The results of the leak tests were acceptable.

Please note that your NRC license expires on May 31 , 201 1. The NRC must receive the license renewal 30 days prior to the expiration date. The NRC renewal application and the required documentation for the transfer of ownership were emailed to Autumn on January 11 , 201 1.

All available Nuclear medicine personnel exposure reports were reviewed. The following Nuclear Medicine personnel exposures were above ALARA level I limits of 125 mremlquarter for the whole body, 1250 mredquarter for the extremity and skin, and 375 mrem for the lens of eye.

A. Karis: 142 mrem (Whole Body) 3‘ quarter 2010

There was one spill of radioactive material recorded since my last visit. Nudear Medicine personnel appropriately followed spill pmcedures and decontaminated the area with no spread of contamination. All required papennrork has been filled out and filed appropriately.

No accidental administrations of radioactive material were recorded since my last visit.

During my visit, I tested the CAPRAC well counter and found it to be operating properly.

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2309 Shelby Avenue 70 E. 91st Street, Suite 106 :,#< 4806 Mile High Drive N7375 Crystal Ridge Drive A m Arbor, MI48103 Indianapolis IN 46240 Salt Lake City, 84 124 b v e r Dam. WI 53916 (734) 662-9224 F ~ x (317) 581-1931 F ~ x (801) 272-2952 Office & Fax (920) 885-9872 F ~ x (734) 662-3 197 (317) 581-1911 (920) 885-9870

www.mpcphysics.com

Heart Center fbr Excellence First Quarter, 201 1 2

8. At the time of my visit, I was able to review the camera QC uniformity and resolution images. Review of the uniformity images and resolution images from Camera A and B reveal no significant non-uniformities and the resolution is within the range of expected values.

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9. I have taken the Ludlum survey meter (sln 148569) for annual calibration.

10. All other NRC records appear to be in good operating order.

If you have any questions concerning this report, please contact me at 734-662-3197 or by email at [email protected].

Sincerely,

Sharon Updike, MHP Medical Physics Consultant

Radiation Safety Officer

Dia&tics Manager

\ Nuclear Medicine

i

Date

\I a r l l l Date

Date: 01/06/11

Location: Heart Center for Excellence . - . .. .-____

MEDICAL MPC Pnystcs CONSULTANTS, INC.

/

NUCLEAR MEDICINE AUDIT

IDENTIFICATION

Licensee: Heart Center for Excellence

License Number: 2 1 -1 891 2-0 1

Latest Amend Number:

Authorized User(s): AS LISTED ON LICENSE

Expiration Date: 05/31/2011

Amendment Date: 07/14/2009

Actions Filed: Transfer of controlllicense Renewal

Radiation Safety Officer RSO - Brachytherapy:

Most Recent State Inspection: 08/07/08 Last ICANL inspection:

State Registration Number: 783-1 Registration Date: 0411 1/07

Reporting Physicist: SAU Most Recent Inspection - NRC: 05/25/07

Anthony Kina, M.D.

I - L a . r d F F"%

DOCUMENTS AND NOTICES

- NRC 10 CFR 19, 20 and 35 - Current, Posted or Referenced and on file?

License + Application and Amendments - Posted or Referenced and on file?

"Notice of Violation", Proposed Civil Penalty or "order" - Posted?

'Notice to Employees' form NRC-3 - Current and Posted?

Management agreement(s) for amend, renewals, AU's and RPP changes?

ManagemenffRSO "Letter of Understanding: - Available?

Statement of RSO Authority, Duties and Responsibilities - Available?

STATE Operating Procedures - Posted or Referenced and on file? Radioactive Materials Registration Certificate - Current and on file?

Ionizing Radiation Rules - Posted or Referenced and on file?

'Notice of Violation', Proposed Civil Penalty or 'Order' - Posted?

State 'Notice to Employees' form - Posted?

10CFR19.11 YES 10CFR19.11 YES 10CFRl9.11 N/A 10CFRl9.11 YES

10 CFR 35.24(a) YES 10 CFR 35.24(b)(g) YES

10 CFR 35.24(e) YES

- N/A - N/A

- N/A

- NIA

- N/A

MPC Date: 01/06/11

Location: Heart Center for Excellence MEDICAL PHYSICS CONSULTANTS. INC __

i POSTING AND LABELING Doors andlor Rooms - Properly Posted?

Areas - Properly Posted?

Sealed Source AreaIRrn Exemption e5 rnR1hr @ 30 cm?

Containers - Properly Labeled? Syringes or Syringe Shields - Properly Labeled?

10 CFR 20.1902 YES 10CFR20.1902 YES

10 CFR 20.1903(c) N/A

YES 10CFR35.69 YES

10 CFR 20 1904(a) and 35.69

- ___

AUTHORIZED RADIONUCLIDE USE AND POSSESSION

NRC Authorized Radionuclides

1 OCFR35.100 1 OCFR35.200

Xenon Excluded Generators Excluded 1 OCFR35.300

Thyroid CA Tx Excluded 1 OCFR35.400 1 OCFR35.500 1 OCFR35.600

1 OCFR35.1000 10CFR31.11

Phosphorus-32 Strontium-90 Cesium-I 37 Gadolinium-1 53 Iridium-I 92 Uranium-238 depleted

Possession Limits -

AS NEEDED AS NEEDED - YES - NIA - NIA - N/A - NIA - NIA - NIA - NIA

- NIA - N/A - N/A - N/A - NIA - NIA

N/A+.,. -

State Redstered Possession Radionuclides Limits Fluorine-1 8

Cobalt-57

Sealed *As needed Unsealed - NIA

Gallium-67 - NIA Indium-1 11 - NIA Iodine-123 - NIA

Thallium-201 "As needed Palladium-1 03

*NRC regulated eY& ' , .- . '

Radioactivity in possession within allowed limits?

Unit doses properly measured and documented?

Non-unit doses properly measured and documented?

- YES

YES YES

10 CFR 35.63(a)(b) and 35.2063

10 CFR 35 63(c) and 35.2063

Prescribed dosage list or dosage range availablelposted and followed? 10 CFR 35.63(d) YES Accidental administrations properly documented? - NIA

Molybdenum-99 assays properly recorded? 10CFR35.204 YES IND protocols properly managed and documented? - NIA

- --___.

SECURITY OF RADIOACTIVE MATERIAL

Roorns/Areas containing Stored RAM actively secured? 10 CFR 20.1801 YES Stored RAM, I e . Sharps Containers, actively secured from removal? Control and constant surveillance maintained over RAM NOT in storage?

\ 10 CFR 2O.1801 10 CFR 20.1802 YES

.- .. . - - NM 2003 (c) MPC 07/09 Page 2

Date 01/06/11

Location Heart Center for Excellence . - __

POSTING AND LABELING

MEDICAL PHYSICS CONOULTANTS. INC

Doors andlor Rooms - Properly Posted? 10 CFR 20.1902 YES Areas - Properly Posted? 10 CFR 20.1902 YES Sealed Source AreaIRm. Exemption 4 mWhr @ 30 cm?

Containers - Properly Labeled?

Syringes or Syringe Shields - Properly Labeled? lOCFR3569 YES

10 CFR 20 1903(c) N/A

10 CFR 20 1904(a) and 35.69

_ _

AUTHORIZED RADIONUCLIDE USE AND POSSESSION

NRC Authorized Rad ion ucl ides

1 OCFR35.100 1 OCFR35.200

_ _

Xenon Excluded Generators Excluded 1 OCFR35.300

Thyroid CA Tx Excluded 1 OCFR35 400 1 OCFR35 500

1 OCFR35.600 1OCFR35.1000

10GER31.11 *,

Phosphorus-32 Strontium-90 Cesium-I 37 Gadolinium-I 53 Iridium-I 92 Uranium-238 depleted

Possession Limits

AS NEEDED AS NEEDED - YES - NIA - NIA - N/A - N/A - NIA - NIA - NIA - NIA - NIA - NIA - NIA - NIA - NIA - NIA

State Registered Possession Radionuclides Limits Fluorine-I 8

Cobalt-57

Sealed *As needed Unsealed - NIA

Gallium-67 - NIA Indium-I 11 - NIA Iodine-1 23 - NIA

Thallium-201 *As needed Palladium-I 03

hb- 'NRC regulated

Radioactivity in possession within allowed limits?

Unit doses properly measured and documented?

Non-unit doses properly measured and documented?

- YES

YES YES

10 CFR 35.63(a)(b) and 35.2063

10 CFR 35.63(c) and 35.2063

Prescribed dosage list or dosage range availablelposted and followed? 10 CFR 35 63(d) YES Accidental administrations properly documented? - NIA

Molybdenum-99 assays properly recorded? 10CFR35.204 YES IND protocols properly managed and documented? - NIA

. - - - - _- SECURITY OF RADIOACTIVE MATERIAL

RoomslAreas containing Stored RAM actively secured? 10 CFR 20.1801 YES Stored RAM, Le., Sharps Containers, actively secured from removal? 10CFR20.1801 YES Control and constant surveillance maintained over RAM NOT in storage? 10 CFR 20 1002 YES

i

.. - NM 2003 (c) MPC 07/09 Page 2

Date: 01/06/11 Location: Heart Center for Excellence MEDICAL MPC PHYSICS

CONSULTANTS. INC

i RADIATION PROTECTION PROGRAM

Radiation Protection Program (RPP) Developed and Implemented? 10 CFR 20.11Ol(a) YES RPP Procedures Documented and Available for Review? 10 CFR 20.2102 YES RPP Reflects Current Operations? - YES

Annual Review of Written RPP Documented? 10 CFR 20.1101(c) and 20.2102(a)(l)

Annual Review Date: 0811 011 0

Annual Review of Operational RPP Documented? 10CFR20.1101 and 10CFR35.24 YES Annual Review Date: 0511 811 0

Audits of Radiation Protection Program Documented?

Radiation Safety Committee established as per requirements of 10 CFR 35.24(f)?

Radiation Safety Committee membership in accordance with 10 CFR 35.24(f)?

10 CFR 20.2102(a)(2)

- N/A

- N/A

Last Radiation Safety Committee meeting:

Procedures and Engineering Controls for ALARA? lOCFR2O.llOl(b) YES

Periodic Performance Reviews of ALARA? lOCFR20.1101(b) YES Environmental Airborne Emissions TEDE e1 0 mrem/yr? lOCFR20.1101(d) N/A

- . . . . _.- ____-_-

’! ~- OPERATING PROCEDURES i . *$

Radiation Safety Regulations - Posted? YES - YES Emergency Liquid Spill Prodecures - Posted?

Emergency Xenon- 133 Spill Procedures and Clearance Times/Posted? 10 CFR 20.1101(d) N/A Aerosol Precautions - Current and Followed? lOCFR20,llOl(d) N/A Documentation of Radioactive Spills?

Radioactive material order and delivery procedures available?

Opening Packages of Radioactive Material - Current and Followed?

Radioactive Waste Disposal - Current and Followed?

7 YES

10 CFR 20.1906(a) YES 10 CFR 20.1906(e) YES

10CFRM.2001

PERFORMANCE AND DOCUMENTATION OF REQUIRED PROCEDURES

Survey and monitoring reasonable to evaluate levels, conc. and hazards?

Hands and clothing monitoring (mR/hr)?

10 CFR20.1501(a)(2) YES NUREG 1558.V9

10 CFR 35.70(a) N/A 10 CFR 35.67(a) YES

0 1/06/11 04/06/10 YES 07/08/10 10/05/10

01 10611 1 04/06/10 YES 07/08/10 10/05/10

Daily surveys writtn directive prep and admin areas with surveyor name?

Sealed source safety and handling instructions available and followed?

Semiannual sealed source leak test with RSO signature? 10 CFR 35.67(b)

Semiannual inventory of sealed sources with RSO signature? 10 CFR 35.67(g)

NM 2003 (c) MPC 07/09 Page 3

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Date: 01/06/11

Location: Heart Center for Excellence R M P C CONSULTANTS. MEDICAL PIIYSICS INC

PERSONNEL MONITORING

Whole body badges?

Extremity TLD's Available and Worn Appropriately?

External Occupational Exposure Levels Reviewed? 10 CFR 20.1201

ALARAI 1 ALARA II Reportable:

Fetal Exposure to Declared Pregnancies?

Annual reports provided to supervised staff?

Previous Occupational Dose - Records Available7

Internal Occupational Dose Monitoring Required or Performed?

Sum of External and Internal Dose Required?

Records of compliance with TEDE to Public (1 00 mrem)?

10 CFR 20.1208

10 CFR 19

10 CFR 20 1201(f) and 2104

10 CFR 20 1502(b)

10 CFR 20.1202

10 CFR 20 2107

- - - ._ - __ TRAINING PROGRAM

- YES

- YES

- YES

- YES

- YES

- YES

- N/A

- N/A

- YES

Supervised staff familiar with operating procedures and license conditions? 10CFR35.27 YES Supervised staff familiar with emergency spill procedures?

Supervised staff familiar with radiation protection procedures?

10CFR35.27 YES 10CFR35.27 YES

Supervised staff familiar with written directive procedures? 10CFR35.27 N/A New supervised staff instructed? 10CFR18.12

Workers likely to receive >lo0 mremlyear in%-ucted? lOCFR~9?12 YES c F h? -.

Technical Staff: Annual: 06/10 Hazmat: 10108 Written Directive:

Ancillary: 06/10

Stress: 0611 0

. - .. __ -

GENERAL HEALTH PHYSICS

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Supervised staff practice safe handling techniques, Le. tongs? Supervised staff wear buttoned lab coats or other protective clothing? NUREG1556 Vol. 8

Supervised staff wear gloves as appropriate? NUREG1556 Vol. 9

Supervised staff use syringe shields as appropriate? NUREG1556 Vol. 9 YES Work areas appropriate for radiation safety purposes? 10CFR20.1408 YES Storage areas appropriate for radiation safety purposes? 10CFR20.1408 YES

- YES

Refrigerator Available? - NIA Fume Hood Available and Operational? - NIA

Area Shielding Available and Appropriate: Consolidated "Spill Kit" available? YES

Lead Bricks - YES Lead Vial Containers - YES

Syringe Shields YES Lead Syringe Carriers - YES Lead-Glass Face Shield YES Leaded Waste Containers YES

. . - - . - _- - N M 2003 (c) MPC 07/09 Page 4

Date: 01/06/11

Location: Heart Center for Excellence MEDICAL MPC Pnvsics OONSULTANTB. INC

i RADIOACTIVE MATERIAL PACKAGE RECEIPT

Visual Inspection? - YES

Radiation Level surveys (m Whr) with Trigger Levels:

Radioactive Contamination Monitoring (dpm1300 cmA2) with Trigger Levels:

One ( I ) meter or Three (3) feet? 49 CFR 173.441 YES

Wipe test 300 cm*2 external package surface c 22 dpmIcmY? 49CFR173.443 YES - -

WASTE DISPOSAL Return to supplier used?

Survey external package surface appropriate for DOT labeling? Wipe test 300 cmA2 external package surface <22 dpm/cmA2?

10 CFR 71

49 CFR 173.443

Confirmation of sealed source return from supplier?

Transfer of Radioactive Material to Authorized Recipient used? 10 CFR 20.200l(a)(l)

10 CFR 20.2006(a)(2)

10 CFR 20.2001(a)(2) and 35.92

Manifest Tracking System Available?

Disposal by Decay in Storage used? Waste Tracking System Available? Waste Segregated by half-life?

Radiation levels at background at final disposal? 10 CFR 35 92(a)(l)

b Release in Effluents used7 10 CFR 20.2001(a)(3)

Effluent Conc. (uCilml) below Table2, Appendix B 10 CFR 20? Documented DAC calculations for Xe-133, Tc-99m DTPA aero. and 1-131 available?

Xenon trap monitoring (uCi)? lOCFR20.1101(d)

10 CFR 20.2003

10 CFR 20.2003

Release into Sanitary Sewerage used? Average monthly volume of water released is known? Sewer Conc. (uCi/ml/month) below Table 3, Appendix B 10 CFR 20? <5 Ci of H-3 and < I Ci of C-14 and < 1 Ci all other released? 10 CFR 20.2003(a)(4)

Disposal of H-3 and C-14 as "Deregulated Waste"? 10 CFR 20.2005

Appropriate documentation to confirm deregulated status available?

Labels Defaced or Removed Prior to Disposal? 10 CFR 20.1904(b) and 35.92(b)

- YES

- YES - YES

YES

- YES

- YES

- YES - YES

- YES

YES - NIA - NIA - NIA

- NIA

- NIA - NIA - NIA - NIA

- NIA

- NIA

- YES

BREAST-FEEDING

Breast feeding release criteria known to staff andlor posted? Breast-feeding instructions provided and release records on file?

- YES

10 CFR 35 75(d) YES .. . ._ .

FACILITY DECOMMISSIONIdG

Recordkeeping requirements of Decommissioning on file? IO CFR ~ . 3 5 ( g ~ i i v ) NIA

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N%%O3 (c) MPC 07/09 Page 5

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