IR 05000202/2030001

Advanced Cardiology Associates, P.C., LLC, NRC Forms 591M and 592M, Inspection Report 03038550/2023001 (Safety)

ML23192A281
Person / Time
Site:	05000202, 03038850
Issue date:	05/10/2023
From:	Bill Lin Division of Nuclear Materials Safety III
To:	Schell Y Advanced Cardiology Associates, P C
References
IR 2023001
Download: ML23192A281 (1)

Text

NRC FORM 591M U.S. NUCLEAR REGULATORY COMMISSION (04-2022)

Materials Inspection Report 1. Licensee/Location Inspected: 2. NRC/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) 2023001 3. Docket Number(s) 4. License Number(s) 5. Date(s) of Inspection 030-38550 21-32846-01 05/10/2023 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 procedures and representative records, interviews with personnel, and observations by the inspector. The inspection findings are as follows:

1. Based on the inspection findings, no violations were identifie . Previous violation(s) close . During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements, and were assessed at Severity Level IV, in accordance with the NRC Enforcement Polic A. The violation(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self-identified, non-repetitive, corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy were satisfie (Non-cited violation(s) was/were discussed involving the following requirement(s)

B. The following violation(s) is/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 AND DATE LICENSEE'S REPRESENTATIVE NRC INSPECTOR Bill Lin Bill C. Lin Digitally signed by Bill C. Lin Date: 2023.05.18 09:41:36 -05'00'

BRANCH CHIEF Rhex Edwards Digitally signed by Rhex A. Edwards Date: 2023.05.19 13:13:17 -05'00'

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NRC FORM 592M U.S. NUCLEAR REGULATORY COMMISSION (10-04-2022)

Materials Inspection Record 1. Licensee Name: 2. Docket Number(s): 3. License Number(s)

Advanced Cardiology Associates, . Report Number(s): 5. Date(s) of Inspection:

2023001 5/10/2023 6. Inspector(s): 7. Program Code(s): 8. Priority: 9. Inspection Guidance Used:

Bill Lin 02201 5 87130 10. Licensee Contact Name(s): 11. Licensee E-mail Address: 12. Licensee Telephone Number(s):

Yolanda Schell yschell@acarochester.com 248-236-8320 13. Inspection Type: Initial 14. Locations Inspected: Hybrid 15. Next Inspection Date (MM/DD/YYYY):

Routine Announced Main Office Field Office Normal Extended 05/10/2028 Non-Routine Unannounced Temporary Job Site Remote Reduced No change 16. Location(s) Inspected List:

645 Barclay Circle Rochester Hills, MI 48307 17. Scope and Observations:

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 one full-time technologist who performed approximately 60 administrations per month in Rochester Hills (Tuesday and Wednesday 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 basis.

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 of licensee 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 audits.

No violations of NRC regulatory requirements were identified as a result of this inspection Signature and Date - Branch Chief Digitally signed by Rhex A. Edwards Date: 2023.05.19 13:12:44 -05'00'

NRC Form 592M (10-04-2022) Page 1 of 1