ML18229A250
| ML18229A250 | |
| Person / Time | |
|---|---|
| Site: | 03036295 |
| Issue date: | 07/12/2018 |
| From: | Ryan Craffey NRC/RGN-III |
| To: | Botti J Cardiology Consultants of Michigan |
| References | |
| IR 2018001 | |
| Download: ML18229A250 (2) | |
Text
NRC FORM 591M PART 1 U.S. NUCLEAR REGULATORY COMMISSION (07-2012) 10CFR2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
Cardiology Consultants of Michigan 3535 West 13 Mile Road Royal Oak, MI 48073 REPORT NUMBER(S) 2018001 3. DOCKET NUMBER(S) 030-36295 LICENSEE:
- 2. NRCIREGIONAL OFFICE Region III U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352
- 4. LICENSE NUMBER(S) 21-32460-01
- 5. DATE(S) OF INSPECTION 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: M 1. Based on the inspection findings, no violations were identified.
! : 2. Previous violation(s) closed. I I 3* The violations(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self..4dentified, non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, to exercise discretion, were satisfied.
Non-cited violation(s) were discussed involving the following requirement(s):
- 4. 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 19.11. (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 requested.
TITLE PRINTED NAME SIGNATURE DATE LICENSEE'S REPRESENTATIVE NRC INSPECTOR BRANCH CHIEF Ryan Craffey Aaron Mccraw NRC FORM 591M PART 1 (07-20121 ,JI . C l-~ *
- I NRC FORM 591 M PART 3 (07-2012) 10CFR2.201 U.S. NUCLEAR REGULA TORY COMMISSION Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
Cardiology Consultants of Michigan 3535 West 13 Mile Road Royal Oak, MI 48073 REPORT NUMBER(S) 2018001 3 DOCKET NUMBER(S) 030-36295 6 INSPECTION PROCEDURES USED 87130 2 NRC/REGIONAL OFFICE 4 LICENSE NUMBER(S) 21-32460-0 l Region III U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352
- 5. DATE(S) OF INSPECTION July 12, 2018 7. INSPECTION FOCUS AREAS All SUPPLEMENTAL INSPECTION INFORMATION
- 1. PROGRAM CODE(S) 02201 2 PRIORITY 5 [{] Main Office Inspection J Field Office Inspection I Temporary Job Site Inspection
- 3. LICENSEE CONTACT James Botti, MS -RSO Next Inspection Date: PROGRAM SCOPE 4 TELEPHONE NUMBER (734) 662-3197 07/12/2023 This was an unannounced routine inspection of a cardiology practice authorized to use byproduct material for diagnostic medical purposes at its clinic on the premises of the Beaumont campus in Royal Oak, Michigan.
At the time of the inspection, one nuclear medicine technologist performed around seven cardiac stress tests per week, starting on Wednesday and continuing on Thursday if necessary.
The licensee used only unit doses ofradiopharmaceuticals, and retained the services of a consulting medical physicist who audited the radiation safety program quarterly.
PERFORMANCE OBSERVATIONS The inspector toured the clinic in Royal Oak to evaluate the licensee's measures for materials security, hazard communication, and exposure control. The inspector conducted independent surveys of the facility, and observed the licensee's conduct of area surveys, including the response to a small area of minor contamination identified within the restricted area. The inspector also observed the preparation of one unit dose for a cardiac stress test; however, the licensee did not administer this dose, as the patient was unable to complete the test for medical reasons. The inspector
- also observed the preparation of packages containing limited quantities of licensed material for return to the radiopharmacy, and the handling ofradioactive waste. The inspector interviewed the licensee's staff to discuss a variety ofradiation safety topics, and found the staff to be knowledgeable of licensee procedures and regulatory requirements.
The inspector also reviewed a selection of records, including consultant audits, documentation of various radiation surveys and instrument quality assurance checks, sealed source inventories and leak tests results, decay-in-storage waste disposal logs, hazmat refresher training materials, and personnel dosimetry reports, which indicated that occupational exposures to staff since the last inspection had been well below regulatory limits. No violations ofNRC requirements were identified as a result of this inspection.
NRC FORM 591 M PART 3 (07-2012)