IR 05000201/1970001

Advanced Cardiology Associates, P.C. - NRC Form 591M Parts 1 & 3, Inspection Report 03038550/2017001 (DNMS)

ML18060A262
Person / Time
Site:	West Valley Demonstration Project, 03038550
Issue date:	12/19/2017
From:	Tehrani N NRC/RGN-III
To:	Kritzman M Advanced Cardiology Associates, P C
References
IR 2017001
Download: ML18060A262 (2)

Text

NRC FORM 591M PART 1 U.S. NUCLEAR REGULATORY COMMISSION (07-2012)

ocFR SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED 2. NRG/REGIONAL OFFICE Advanced Cardiology Associates, Region Ill 645 Barclay Circle U.S. Nuclear Regulatory Commission Rochester Hills, MI 48307 REPORT NUMBER(S)

3. DOCKET NUMBER(S)

2017001 4. LICENSE NUMBER(S)

2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 5. DATE(S) OF INSPECTION I

030-38550 21-32846-0 I December l"f 2017 LICENSEE:

The inspection was an examination of the activities conducted under your license as they relate to radiation safety and to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your license. The inspection consisted of selective examinations of pro~~res and representative records, interviews with personnel. and observations by the inspector. The inspection findings are as follows:

~ Based on the inspection findings, no violations were identifie . Previous violation(s) close . The violations(s), specifically described to you by the inspector as non-cited violations. are not being cited because they were self-identified, non-repetitive. and corrective action was or is being taken. and the remaining criteria in the NRC Enforcement Policy. to exercise discretion, were satisfie Non-cited violation(s) were discussed involving the following requirement(s): During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements and are being cited in accordance with NRC Enforcement Policy. This form is a NOTICE OF VIOLATION, which may be subject to posting in accordance with 10 CFR 19.1 (Violations and Corrective Actions)

Statement of Corrective Actions I hereby state that. within 30 days, the actions described by me to the Inspector will be taken to correct the violations identified. This statement of corrective actions is made in accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken, date when full compliance will be achieved). I understand that no further written response to NRC will be required, unless specifically requeste TITLE PRINTED NAME SIGNATURE DATE LICENSEE'S REPRESENTATIVE ./

NRC INSPECTOR BRANCH CHIEF Navid Tehrani Aaron Mccraw

)./ -=- I 1 02/28/2018 NRC FORM 591M PART 1 (07-2012)

• 1 NRC FORM 591M PART 3 U.S. NUCLEAR REGULATORY COMMISSION (07-2012)

10 CFR 2.201 Docket File Information SAFETY INSPE.CTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED: 2. NRG/REGIONAL OFFICE Advanced Cardiology Associates, Region III 645 Barclay Circle U.S. Nuclear Regulatory Commission Rochester Hills, MI 48307 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 2017001 3. DOCKET NUMBER{S) 4. LICENSE NUMBER(S) 5. DATE{S) OF INSPECTION 030-38550 21-32846-0 I December 19, 2017 6. INSPECTION PROCEDURES USED 7. INSPECTION FOCUS AREAS 87130 All SUPPLEMENTAL INSPECTION INFORMATION 1. PROGRAM CODE(S) 2. PRIORITY 3. LICENSEE CONTACT 4. TELEPHONE NUMBER 02201 5 Michelle Kritzman - Consultant (734) 662-3197

[{] Main Office Inspection Next Inspection Date: 12/19/2022 D Field Office Inspection D Temporary Job Site Inspection PROGRAM SCOPE This was an unannounced, routine inspection of a private cardiology practice authorized to use byproduct material for diagnostic medical purposes at clinics in Rochester Hills and Oxford, Michigan. At the time of the inspection, the licensee employed two full-time technologists who performed approximately 70 administrations per month in Rochester Hills (Tuesdays and Thursdays only, starting at 8 am) and 25 per month in Oxford (Mondays and Thursdays only, starting at 9 am). The licensee received unit doses from a local radiopharmacy, and retained the services of a consulting physicist who audited the radiation safety program on a quarterly basi PERFORMANCE OBSERVATIONS This inspection consisted of interviews with licensee personnel, a review of selected records, a tour of the nuclear medicine department in Rochester Hills, and independent measurements. The inspector observed the administration of two unit doses for a cardiac stress test, and discussed with staff the implementation oflicensee procedures for dose calibrator quality control, receipt of packages containing radioactive material, and area surveys. The inspector also reviewed documentation of dose administrations, area surveys, personnel dosimetry reports, and quarterly consultant audit No violations ofNRC regulatory requirements were identified as a result of this inspection.

NRG FORM 591M PART 3 (07-2012)