'(iJ McLaren LAPEER REGION

1375 North Main St. Lapeer, Michigan 48446-1350

tel (810) 667-5500

mclaren.org

United States Nuclear Regulatory Commission Region Ill, Materials Licensing Section 2443 Warrenville Road, Ste 210 Lisle, IL 60532-4352

Close-out location for license# 21-11553-01, Mclaren Lapeer Region, Lake Orion Cardiology site

1. A close-out survey was performed on 07/25/13 of our Lake Orion Cardiology, 720 N. Lapeer Rd, Lake Orion, Ml 48362 address and is enclosed for your review. We have also enclosed a map of all areas wipe tested.

2. We did not dispose of radioactive materials by release to sewers or incineration. In addition, there were no spills or leaking sources of any long-lived radioactive material or on-site burials of radioactive materials. A leak test is enclosed for your viewing.

3. Any further correspondence may be sent to Mclaren Lapeer Region, 1375 N. Main St., Lapeer, Ml 48446.

4. We have enclosed confirmation of the sealed sources received at Mclaren Lapeer Region, 1375 N. Main St., Lapeer, Ml 48446 from the Lake Orion closed-out site.

Cordially,

Barton Buxton, CEO Mclaren Lapeer Region

Lake Orion Cardiology 2

Close-out July 2013

RECEIVED AUG 0 2 2013

~JMcLaren LAPEER REGION

1375 North Main St. Lapeer, Michigan 48446-1350

tel (810) 667-5500

mclaren.org

Nuclide Type CalibrationActivity Calibration Date Model Number

Co-57 Flood 10 mCi 4/1/2012

Ba-133 Vial 265 uCi 3/2/2012

Cs-137 Vial 198.5 uCi 5/1/2006

These sources were received by Mclaren Lapeer Region on 07/25/13

from Lake Orion Cardiology, 720 N. Lapeer Rd., Lake Orion, Ml 48362

IPL

BM06E

IPL

SeriaiNumber

1584-181

BM06133E 1205

1145-61-19

Close-out Survey

Date Performed: 07/25/13

Performed By: Laura Luna, Physics Consultant

~?MPC / ~ " MEDICAL. PHYSICS "-'"..-' '"..~ c:.ONSUI. l"AN"T S. lNG

Wipe tests analyzed with a CRC-15W well counter. Efficiency for Co-57 is 83%. MDA is 21 dpm.

\

Survey performed with Atomic Product survey meter modei14C with end window probe, S/N 85232, calibrated on 12/19/12 with a check source reading of 0.9 mR/hr. Range used was 0.1 mR/hr.

All sealed radioactive sources were transported to Mclaren Lapeer Region, 1375 N. Main St., Lapeer, Ml 48446. There is no history of any leaking sources. Documentation of received sources and a current leak test is enclosed.

History of Radionuclides Used

Tc-99m was last used 07/22/13. No other isotopes, except sealed sources: Cs-137, Ba-133 and Co-57, were used at this facility.

Visual Check

The area was checked to ensure that all radioactive waste had been removed. No radioactive material was located.

Radiation Level Survey

No area within the department demonstrated radiation levels in excess of the background reading of 0.02 mR/hr.

Lake Orion Cardiology Close-out July 2013 3

Removable Contamination

1 minute counts of a wipe sample covering at least a1 00 square centimeter area

Area Results(dpm) 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 10 0 11 0 12 0 13 0 14 0 15 0 16 0 17 0 18 0 19 0

Area 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38

Results(dpm) 0 8 8 8 8 8 0 0 0 0 0 12 12 12 12 12 0 0 0

Maximum removable contamination: 12 net dpm/100 cm2

Conclusion

As of 07/25/12 all radioactive materials were removed from the site and no removable contamination was present.

Lake Orion Cardiology Close-out July 20 13 4

~1MPC t~~ MEDICAL Pi<YSICS CONSUL "T AN·r S, lNG

Lake Orion cardiology 720 N. Lapeer Rd. Lake Orion, Ml 48362

Outside

12'9" 6

18 14 10

Staff 23 11 7 19 15

Lounge Imaging Room

12'10" 20 12 8 16

22 21 13 9 17 Outside

2 5 Hallway Hot Lab 6'4"

1 3 4

8'0"

38 37 36 35 34

32 31 Echo Room 33 Stress Room 30 29

10'0'

28 27 26 25 24

12'9" Office

Lake Orion Cardiology Close-out July 2013 5

. ( \

April19, 2013

Carissa Wessel, R.T. Manager of Diagnostic Imaging Lapeer Regional Medical Center 1375 North Main Lapeer, Michigan 48446

Dear Carissa:

MEDICAL PHYSICS CONSULTANTS, INC .

Enclosed, please find the report on the evaluation at LAKE ORION CARDIOLOGY for the 2"d quarter visit of 2013. I have listed my comments and recommendations concerning licensed activities at your facility below:

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

2. Nuclear Medicine personnel exposures for the first quarter of 2013 (through 03/19/13) were below the ALARA Levell limits of 125 mrem/quarterforthe whole body, 1250 mrem/quarter for the extremity and skin, and 375 mrem for the lens of eye.

3. During my visit, I was able to perform both an auto calibration and an energy test on the well counter. The results were within the range of expected values.

4. There were no reported radioactive spills or accidental administrations since the previous visit.

5. As a reminder, your survey meter (SN #226161) is being located after being sent to the previous owners address. MPC has supplied a loaner meter for the interim.

6. The documentation for the daily surveys, weekly wipe tests, dose calibrator constancy, waste disposal and package logs were well maintained and on file since my previous visit.

2 14 E. Huron Street Ann Arbor, Ml48104 (734) 662-9224 Fax (734) 662-3197

'\'·1-, <Y:. 70 E. 9lst Street, Suite 106

Indianapolis, IN 46240 (317) 581-1931 Fax (317) 581-!911

t-.1 '1 r;>~ / Li\ 4806 Mile Iligh Drive .:;y~

Salt Lake City, trr 84124 (80 I) 272-2952 Office & Fax

www.mpcphysics.com

N7375 Crystal Ridge Drive Beavc,· Dam, Wl53916 (920) 885-9872 Fax (920) 885-9870

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McLaren Lake Orion Cardiology 2nd qtr. 2013 2

7. The Philips SPECT camera NEMA numbers, COR values and bar (resolution) tests are being done according to manufacturer's specifications and are acceptable.

8. Worker instruction is due for stress and clerical personnel.

It has been a pleasure to be of service to you. If you have any questions concerning this report, please feel free to contact me at 734-662-3197 or email me at lluna@mpcphysics.com ..

Sincerely,

'f~~.L Laura M. Luna, B.S. Medical Physics Consultant

Kenneth Tarr, Radiation Safety Officer: fr...:..;/};..;" .:...__" _, -~....,t:." -----­Carissa Wessel, Management: Co A." J \.A.)~ b };.~Q

"'"'"' Jenny Jenuwine, Technologist:._,"-+··tfC1/W.!....

1

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Date: 04/19/13

Location: Mclaren Lapeer Region-Lake Orion Cardiology ~7MJ:~s mCONSULTANTS.INC

NUCLEAR MEDICINE AUDIT

IDENTIFICATION

Licensee: Mclaren Lapeer Region-Lake Orion Cardiology

License Number: 21-11553-01

42

Expiration Date: 12/31/2013

11/16/2011 Latest Amend Number Amendment Date:

Authorized User(s): AS LISTED ON AMENDMENT #43

Actions Filed: REMOVING DR. KOTLAROV

Radiation Safety Officer Kenneth P. Tarr, D.O.

RSO - Brachytherapy:

Most Recent State Inspection: Most Recent Inspection- NRC:

State Registration Number: Registration Date

Accreditation Expiration Date:

Reporting Physicist: LML

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?

ManagemenURSO "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?

NM 2003 (C) MPC 02/11 Page 1

10CFR19.11

10CFR19.11

10CFR19.11

10CFR19.11

10 GFR 35.24(a)

1 0 CFR 35.24(b )(g)

10 CFR 35.24(e)

YES

YES

YES

YES

N/A

YES

YES

N/A

N/A

N/A

N/A

N/A

Date: 04/19/13

Location: Mclaren Lapeer Region-Lake Orion Cardiology

POSTING AND LABELING

Doors and/or Rooms - Properly Posted?

Areas - Properly Posted?

Sealed Source Area/Rm. Exemption <5 mR/hr@ 30 em?

Containers - Properly Labeled?

Syringes or Syringe Shields -Properly Labeled?

10 CFR 20.1902 YES

10CFR20.1902 YES

10CFR20.1903(c) N/A

10 CFR 20.1904(a) and 35.69 YES

10 CFR 35.69 YES

AUTHORIZED RADIONUCLIDE USE AND POSSESSION

NRC Authorized Radionuclides

10CFR35.100

1 OCFR35.200

Xenon Excluded

Generators Excluded 10CFR35.300

Thyroid CA Tx Excluded

1 OCFR35.400

10CFR35.500

1 OCFR35.600

1 OCFR35.1 000

10CFR31.11

Phosphorus-32

Strontium -90

Cesium-137

Gadolinium-153

lridium-192

Uranium-238 depleted

Possession Limits

AS NEEDED

AS NEEDED

NO

NO

UNDER 1 Cu

YES

1000 mCi

State Registered Radionuclides

Fluorine-18

Cobalt-57

Sealed

Unsealed

Gallium-67

lndium-111

lodine-123

Thallium-201

Palladium-1 03

Possession Limits

AS NEEDED

AS NEEDED

Radioactivity in possession within allowed limits?

Unit doses properly measured and documented? 10 CFR 35.63(a)(b) and 35.2063 YES

Non-unit doses properly measured and documented? 10 CFR 35.63(c) and 35.2063 N/A

Prescribed dosage list or dosage range available/posted and followed? 10 cFR 35.63(d) YES

Accidental administrations properly documented? N/A

Mo-99 and or Sr-82/Sr-85 assays properly recorded? 10 CFR 35.204 N/A

IND protocols properly managed and documented?

SECURITY OF RADIOACTIVE MATERIAL

Rooms/Areas containing Stored RAM actively secured?

Stored RAM, i.e., Sharps Containers, actively secured from removal?

Control and constant surveillance maintained over RAM NOT in storage?

NM 2003 Ccl MPC 02/11 Page2

10 CFR 20.1801 YES

10CFR20.1801 YES

10 CFR 20.1802 YES

Date: 04/19/13

Location: Mclaren Lapeer Region-Lake Orion Cardiology ~7 MJ:~~s ~CONSULTANTS, INC

RADIATION PROTECTION PROGRAM

Radiation Protection Program (RPP) Developed and Implemented? 10 cFR 20.11o1(a) YES

RPP Procedures Documented and Available for Review? 10 CFR2o.21o2 YES

RPP Reflects Current Operations? YES

Annual Review of Written RPP Documented? 10 CFR 20.1101(c) and 20.2102(aX1) YES

Annual Review Date: 12/31/13

Annual Review of Operational RPP Documented? 10 CFR 20.1101 and 1 OCFR 35.24 YES

Annual Review Date: 12/31/13

Audits of Radiation Protection Program Documented? 10 CFR 20.2102(a)(2) YES

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)?

Last Radiation Safety Committee meeting:

Procedures and Engineering Controls for ALARA?

Periodic Performance Reviews of ALARA?

Environmental Airborne Emissions TEDE <10 mrem/yr?

OPERATING PROCEDURES

Radiation Safety Regulations - Posted?

Emergency Liquid Spill Prodecures - Posted?

Emergency Xenon-133 Spill Procedures and Clearance Times/Posted?

Aerosol Precautions - Current and Followed?

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?

10 CFR 20. 1101(b) YES

10 CFR20.1101(b) YES

10 CFR 20.1101(d)

YES

YES

10 CFR 20.1101(d) N/A

10 CFR 20.1101(d) N/A

N/A

10 CFR 20.1906(a) YES

10 CFR 20.1906(e) YES

10 CFR 20.2001 YES

PERFORMANCE AND DOCUMENTATION OF REQUIRED PROCEDURES

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

Hands and clothing monitoring (mR/hr)?

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 (CJ MPC 02/11 Page 3

01/11/13

07/18/12

01/11/13

07/18/12

10 CFR 20.1501(a)(2) YES

NUREG 1556.V9 YES

10 CFR 35.70(a) YES

10 CFR 35.67(a) YES

04/19/13 YES

10/18/12

04/19/13 YES

10/18/12

Date: 04/19/13

Location: Mclaren Lapeer Region-Lake Orion Cardiology

'"·-~ERSONNEL MONITORING

Whole body badges?

Extremity TLD's Available and Worn Appropriately?

External Occupational Exposure Levels Reviewed?

~ZMJ::Cs t)"'-.JCONSULTANTS, INC

1 0 CFR 20. 1201 YES

ALARA I ALARA II Reportable:

Fetal Exposure to Declared Pregnancies?

Annual reports provided to supervised staff?

Previous Occupational Dose - Records Available?

Internal Occupational Dose Monitoring Required or Performed?

Sum of External and Internal Dose Required?

Records of compliance with TEDE to Public (100 mrem)?

TRAINING PROGRAM

10CFR20.1208 N/A

10CFR 19 N/A

10 CFR 20.1201(f) and 2104 YES

10CFR20.1502(b) N/A

10 CFR 20.1202 N/A

10 CFR 20.2107 N/A

Supervised staff familiar with operating procedures and license conditions?

Supervised staff familiar with emergency spill procedures?

10 CFR 35.27 YES

10 CFR 35.27 YES

10 CFR 35.27 YES

10 CFR 35.27 N/ A

10 CFR 19.12 YES

10CFR19.12 YES

Supervised staff familiar with radiation protection procedures?

Supervised staff familiar with written directive procedures?

New supervised staff instructed?

Workers likely to receive >1 00 mrem/year instructed?

Technical Staff: Annual: 01/13 Hazmat: 03/12 Written Directive: N/A

Stress: DUE

Clerical: DUE

GENERAL HEALTH PHYSICS

Supervised staff practice safe handling techniques, i.e. tongs?

Supervised staff wear buttoned lab coats or other protective clothing?

Supervised staff wear gloves as appropriate?

Supervised staff use syringe shields as appropriate?

Work areas appropriate for radiation safety purposes?

Storage areas appropriate for radiation safety purposes?

Refrigerator Available?

Fume Hood Available and Operational?

Consolidated "Spill Kit" available?

Area Shielding Available and Appropriate:

Lead Bricks NO

Syringe Shields YES

Lead Vial Containers

Lead Syringe Carriers

NUREG-1556 Vol. 9

NUREG-1556 Vol. 9

NUREG-1556 Vol. 9

10CFR20.1406

10 CFR 20.1406

Lead-Glass Face Shield Leaded Waste Containers

NO

YES

YES

NM 2003 Ccl MPC02/11 Page4

YES

YES

YES

YES

YES

YES

NO

N/A

Date: 04/19/13

Location: McLaren Lapeer Region-Lake Orion Cardiology ~ 7MJ:~s tNcoNSULTANTS,oNc

RADIOACTIVE MATERIAL PACKAGE RECEIPT

Visual Inspection?

Radiation Level surveys (mR/hr) with Trigger Levels:

One (1) meter or Three (3) feet?

Radioactive Contamination Monitoring (dpm/300 cmA2) with Trigger Levels

Wipe test 300 cmA2 external package surface< 22 dpm/cmA2?

WASTE DISPOSAL

Return to supplier used?

Survey external package surface appropriate for DOT labeling?

Wipe test 300 cmA2 external package surface <22 dpm/cmA2?

Confirmation of sealed source return from supplier?

Transfer of Radioactive Material to Authorized Recipient used?

Manifest Tracking System Available?

49 CFR 173.441 YES

49 CFR 173.443 YES

YES

10 CFR 71 YES

49 CFR 173.443 YES

YES

10 CFR 20.2001(aX1) YES

10 CFR 20.2006(aX2) NO

Disposal by Decay in Storage used? 10 CFR 20.2001(aX2) and 35.92

Waste Tracking System Available?

Waste Segregated by half-life?

Radiation levels at background at final disposal? 10 CFR 35.92(aX1)

Release in Effluents used? 10 CFR 20.2001(aX3)

Effluent Cone. (uCi/ml) below Table2, Appendix B 10 CFR 20?

Documented DAC calculations for Xe-133, Tc-99m DTPA aero. and 1-131 available?

Last Ventillation Evaluation:

Xenon trap monitoring (uCi)?

Release into Sanitary Sewerage used?

Average monthly volume of water released is known?

Sewer Cone. (uCi/ml/month) below Table 3, Appendix B 10 CFR 20?

<5 Ci of H-3 and <1 Ci of C-14 and < 1 Ci all other released?

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

Appropriate documentation to confirm deregulated status available?

10CFR20.1101(d) N/A

10 CFR 20.2003 NO 10 CFR 20.2003 N/A

N/A

10 CFR 20.2003(aX4) N/A

1 0 CFR 20.2005 N/ A

N/A

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

BREAST -FEEDING

Breast feeding release criteria known to staff and/or posted?

Breast-feeding instructions provided and release records on file?

FACILITY DECOMMISSIONING

Recordkeeping requirements of Decommissioning on file?

NM 2003 (Cl MPC 02/11 Page 5

YES

10 CFR 35.75(d) N/A

10 CFR 30.35(gXi-iv) N/A

/ '

~7MJ~Cs tNcoNSULTANTS.INC

Licensee: Mclaren Lapeer Region-Lake Orion Cardiology Date: 04/19/13

Model #: CRC-15W

Serial #: 171588

Instrument ID:

Installation Date: 02/27/12

Calibration in accordance with manufacturers recommendation

Constancy checks on all commonly used settings

Linearity tests acceptable (required quarterly)?

First quarter: 01 /11/13

Third quarter: 07/18/12

Accuracy tests acceptable?

Geometrical variation test acceptable?

Second quarter:

Fourth quarter:

04/19/13

02/27/12

Dose Calibrator Instrument Evaluation 1

10 CFR 35.60(b) YES

YES

YES

04/19/13

10/18/12

YES

YES