IR 05000202/2030001: Difference between revisions

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{{Adams
{{Adams
| number = ML23192A281
| number = ML23229A501
| issue date = 05/10/2023
| issue date = 08/18/2023
| title = Advanced Cardiology Associates, P.C., LLC, NRC Forms 591M and 592M, Inspection Report 03038550/2023001 (Safety)
| title = (Cover Letter Only) Rndt, Inc. - NRC Inspection Report No. 03038850/2023001 and Notice of Violation
| author name = Lin B
| author name = Cahill C
| author affiliation = NRC/RGN-III/DNMS
| author affiliation = NRC/RGN-I/DRSS
| addressee name = Schell Y
| addressee name = Korenoski E
| addressee affiliation = Advanced Cardiology Associates, P C
| addressee affiliation = RNDT, Inc
| docket = 03038550
| docket = 03038850
| license number = 21-32846-01
| license number = 37-30942-02
| contact person =  
| contact person =  
| document report number = IR 2023001
| document report number = IR 2023001
| document type = Inspection Report, Materials Inspection Record, NRC Form 592M
| document type = Letter
| page count = 1
| page count = 1
}}
}}
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=Text=
=Text=
{{#Wiki_filter:NRC FORM 591M      U.S. NUCLEAR REGULATORY COMMISSION (04-2022)
{{#Wiki_filter:August 18, 2023
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'
Add Continuation Page          Page 1 of 1


NRC FORM 592M      U.S. NUCLEAR REGULATORY COMMISSION (10-04-2022)
==SUBJECT:==
Materials Inspection Record 1. Licensee Name:  2. Docket Number(s):   3. License Number(s)
RNDT, INC. - NRC INSPECTION REPORT NO. 03038850/2023001 AND NOTICE OF VIOLATION
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.
==Dear Eric Korenoski:==
This letter refers to the inspection conducted on June 7, 2023, at your Johnstown, PA office and at a temporary job site located in Pennsboro, WV. The inspection was continued in-office until August 14, 2023. This inspection examined activities conducted under your license as they relate to public health and safety, and to confirm compliance with the Commissions rules and regulations and with the conditions of your license. Within these areas, the inspection consisted of selected examination of procedures and representative records, observations of activities, and interviews with personnel. We shared the results of the inspection with Brian Low of your staff during an inspection exit telephone call on August 14, 2023.


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'
Based on the results of this inspection, the NRC has determined that one Severity Level IV violation of NRC requirements occurred. The violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs Web site at https://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violation is cited in the enclosed Notice of Violation (Notice) because the violation was identified by the NRC.
NRC Form 592M (10-04-2022)        Page 1 of 1
 
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. If you have additional information that you believe the NRC should consider, you may provide it in your response to the Notice. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. The NRC review of your response to the Notice will also determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
 
In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, a copy of this letter and your response will be made available electronically for public inspection in the NRC Public Document Room located at NRC Headquarters in Rockville, MD, and from the NRCs document system, the Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. However, the material enclosed herewith contains Security-Related Information as described above. Therefore, the material in the enclosures will not be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS). Similarly, your response will also be made publicly available electronically for public inspection in the NRC Public Document The enclosure(s) contains Sensitive Unclassified Non-Safeguards Information Upon separation, this cover letter is DECONTROLLED. Room or from the NRC document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html, unless it contains Security-Related Information.
 
If you have any questions regarding this matter, please contact Randolph Ragland of my staff at 610-337-5083 or via electronic mail at 610-337-5083.
 
Thank you for your cooperation.
 
Sincerely, Digitally signed by Christopher Christopher G. Cahill Date: 2023.08.18 G. Cahill 11:47:51 -04'00'
Chris G. Cahill, Chief Commercial, Industrial, R&D and Academic Branch Division of Radiological Safety and Security Region I Docket No. 03038850 License No. 37-30942-02 Enclosure:
Non-public Notice of Violation cc with enclosure:
1. Brian Low, Radiation Safety Officer 2. Commonwealth of Pennsylvania
}}
}}

Revision as of 12:58, 1 September 2023

(Cover Letter Only) Rndt, Inc. - NRC Inspection Report No. 03038850/2023001 and Notice of Violation
ML23229A501
Person / Time
Site: 05000202, 03038850
Issue date: 08/18/2023
From: Christopher Cahill
Decommissioning, ISFSI, and Reactor Health Physics Branch
To: Korenoski E
RNDT
References
IR 2023001
Download: ML23229A501 (1)
v • d • e


Text

August 18, 2023

SUBJECT:

RNDT, INC. - NRC INSPECTION REPORT NO. 03038850/2023001 AND NOTICE OF VIOLATION

Dear Eric Korenoski:

This letter refers to the inspection conducted on June 7, 2023, at your Johnstown, PA office and at a temporary job site located in Pennsboro, WV. The inspection was continued in-office until August 14, 2023. This inspection examined activities conducted under your license as they relate to public health and safety, and to confirm compliance with the Commissions rules and regulations and with the conditions of your license. Within these areas, the inspection consisted of selected examination of procedures and representative records, observations of activities, and interviews with personnel. We shared the results of the inspection with Brian Low of your staff during an inspection exit telephone call on August 14, 2023.

Based on the results of this inspection, the NRC has determined that one Severity Level IV violation of NRC requirements occurred. The violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs Web site at https://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violation is cited in the enclosed Notice of Violation (Notice) because the violation was identified by the NRC.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. If you have additional information that you believe the NRC should consider, you may provide it in your response to the Notice. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. The NRC review of your response to the Notice will also determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, a copy of this letter and your response will be made available electronically for public inspection in the NRC Public Document Room located at NRC Headquarters in Rockville, MD, and from the NRCs document system, the Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. However, the material enclosed herewith contains Security-Related Information as described above. Therefore, the material in the enclosures will not be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS). Similarly, your response will also be made publicly available electronically for public inspection in the NRC Public Document The enclosure(s) contains Sensitive Unclassified Non-Safeguards Information Upon separation, this cover letter is DECONTROLLED. Room or from the NRC document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html, unless it contains Security-Related Information.

If you have any questions regarding this matter, please contact Randolph Ragland of my staff at 610-337-5083 or via electronic mail at 610-337-5083.

Thank you for your cooperation.

Sincerely, Digitally signed by Christopher Christopher G. Cahill Date: 2023.08.18 G. Cahill 11:47:51 -04'00'

Chris G. Cahill, Chief Commercial, Industrial, R&D and Academic Branch Division of Radiological Safety and Security Region I Docket No. 03038850 License No. 37-30942-02 Enclosure:

Non-public Notice of Violation cc with enclosure:

1. Brian Low, Radiation Safety Officer 2. Commonwealth of Pennsylvania

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