IR 05000202/2010001: Difference between revisions

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{{Adams
{{Adams
| number = ML21025A017
| number = ML21048A253
| issue date = 01/22/2021
| issue date = 02/11/2021
| title = Internal Medicine Associates of Mt. Clemens, P.C. - NRC Form 592M, Inspection Report 03033050/2021001(DNMS); License: 21-26470-01 / Docket: 030-33050 / Planner: 20203502687
| title = Halco Lighting Technologies, LLC, NRC Form 591M Part 1, Inspection Report No. 03038350/2021001
| author name = Craffrey R
| author name = Shaffer S
| author affiliation = NRC/RGN-III/DNMS
| author affiliation = NRC/RGN-I/DNMS
| addressee name = Kritzman S
| addressee name = Weaver J
| addressee affiliation = Internal Medicine Associates of Mt. Clemens, PC
| addressee affiliation = Halco Lighting Technologies
| docket = 03033050
| docket = 03038350
| license number = 21-26470-01
| license number = 10-23990-01E
| contact person =  
| contact person =  
| document report number = IR 2021001
| document report number = IR 2021001
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=Text=
=Text=
{{#Wiki_filter:NRC FORM 592M     U.S.NUCLEAR REGULATORY COMMISSION (10-2020) w (  Materials Inspection Record 1.Licensee Name:   Number(s):
{{#Wiki_filter:NRC FORM 591M PART 1     U.S. NUCLEAR REGULATORY COMMISSION (07-2012)*
2.Docket    Number(s)
10 CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED:   2. NRC/REGIONAL OFFICE Halco Lighting Technologies, LLC 2940 Pacific Drive    U.S. Nuclear Regulatory Commission Norcross, GA, 30071    Region I, 2100 Renaissance Blvd, Suite 100 King of Prussia, Pennsylvania 19406-2713 REPORT NUMBER(S) 2021-001 3. DOCKET NUMBER(S)  4. LICENSE NUMBER(S)   5. DATE(S) OF INSPECTION 030-38350  10-23990-01E  February 3 - 11, 2021 LICENSEE:
3.License Internal Me Associates ofMt. Clemens 030-33050    21-26470-01 4.Report Number(s):    5.Date(s) ofInspection:
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:
2021-001      January 22,2021 6.inspector(s):   7.Program Code(s): 8.Priority:9.inspection Guidance Used:
X 1. Based on the inspection findings, no violations were identifie . Previous violation(s) close . 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, 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) and corrective action(s):
RyanCraffey    02201  5 IP87130 10.Licensee ContactName(s): 11.Licensee Address:
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 the 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)
E-mail  12.LicenseeTelephone Number(s):
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 LICENSEES REPRESENTATIVE  Jay Weaver NRC INSPECTOR    Steven Digitally signed by Steven /11/21 Shaffer Steve Shaffer  Shaffer  Date: 2021.02.11 10:13:40-05'00'
Shelli Kritzman, MS RSO
BRANCH CHIEF  Christopher Cahill  Christopher G. Cahill Digitally  signed by Christopher G. Cahill Date: 2021.02.11 16:20:52 -05'00'
  -
*NRC FORM 591M PART 1 (07-2012) (RI Rev. 09/12/2013)   G:\Reference\Blank Forms\591M-Part1-Public.doc SUNSI Review Completed By:  Steve Shaffer  X Public X Non-Sensitive This document becomes an NRC Official Agency Record once it is signed by the Branch Chief
mkritzman@mpcphysics.com  734-662-3197 13.Inspection Type: O Initial14.Locations Inspected:  15.Next Inspection Date(MM/DD/YYYY):
2 Routine 2 Announced 2 MainOffice O  Field Office gppqg  2 Normal Q Extended Q Non-RoutineQ UnannouncedQ Temporary JobSite2 Remote Q ReducedO Nochange 16.ScopeandObservations:
This wasanannounced routineinspection, conducted remotely,of a privately-owned cardiology practice authorized tousebyproduct material fordiagnostic medical purposes atitsfacility in Mount Clemens, Michiga Atthe time of theinspection, onepart-time nuclear medicine technologist performed up tofive procedures per day(cardiac stress tests andonrare occasion a MUGAstudy) onMondays andTuesdays,and every other Thursda Thelicensee used only unit doses ofradiopharmaceuticals andretained theservices ofa consulting medical physicist tofulfillthe duties ofRSO,calibrate its survey instruments, andaudit theradiation safetyprogram quarterly.
 
PERFORMANCE OBSERVATIONS Using a video teleconference platform, thelicensee's RSOprovided theinspector witha walk-through ofthe clinic at 133South Main Street inMount Clemens, including a review ofequipment andlicensed material presen The facility appeared tobeadequately posted andall material appeared tobeadequately secured. The inspector observed theRSOperform survey instrument checks, dose calibrator qualitycontrol checks, andsealed source leak testin Theinspector alsoobserved thelicensee's nuclear medicine technologist perform demonstrations of package receipt, dose preparation,radioactive waste handling, andarea survey Atthe direction ofthe inspector, thetechnologist performed additional surveys inrestricted andunrestricted areas ofthefacilit Noevidence of residual contamination or exposures tomembers ofthe public inexcess ofregulatory limits werenoted from any of these survey Theinspector alsointerviewed theRSO,technologist, andthelicensee's office manager todiscuss thestatus oftheprogram anda variety ofradiation safety topics. Through these discussions andthe aforementioned observations, thelicensee's staffdemonstrated proficiency inALARApractices anda thorough understanding oflicensee procedures, regulatory limits andother NRCrequirements.
 
Theinspector also reviewed a selection ofrecords, including quarterly consultant audits,documentation ofvarious surveys andinstrument qualityassurance sealed checks, source inventories andleak test results, dose administration records, andpersonnel dosimetry reports.
 
Noviolations ofNRCrequirements wereidentified asa result ofthis inspection.
 
NRCForm592M(10-2020)       Page1of1
}}
}}

Revision as of 12:24, 2 March 2021

Halco Lighting Technologies, LLC, NRC Form 591M Part 1, Inspection Report No. 03038350/2021001
ML21048A253
Person / Time
Site: 03001250, 05000202
Issue date: 02/11/2021
From: Sarah Shaffer
Division of Nuclear Materials Safety I
To: Judith Weaver
Halco Lighting Technologies
References
IR 2021001
Download: ML21048A253 (1)


Text

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

10 CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED: 2. NRC/REGIONAL OFFICE Halco Lighting Technologies, LLC 2940 Pacific Drive U.S. Nuclear Regulatory Commission Norcross, GA, 30071 Region I, 2100 Renaissance Blvd, Suite 100 King of Prussia, Pennsylvania 19406-2713 REPORT NUMBER(S) 2021-001 3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION 030-38350 10-23990-01E February 3 - 11, 2021 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:

X 1. Based on the inspection findings, no violations were identifie . Previous violation(s) close . 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, 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) and corrective action(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 the 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 requeste Title Printed Name Signature Date LICENSEES REPRESENTATIVE Jay Weaver NRC INSPECTOR Steven Digitally signed by Steven /11/21 Shaffer Steve Shaffer Shaffer Date: 2021.02.11 10:13:40-05'00'

BRANCH CHIEF Christopher Cahill Christopher G. Cahill Digitally signed by Christopher G. Cahill Date: 2021.02.11 16:20:52 -05'00'

  • NRC FORM 591M PART 1 (07-2012) (RI Rev. 09/12/2013) G:\Reference\Blank Forms\591M-Part1-Public.doc SUNSI Review Completed By: Steve Shaffer X Public X Non-Sensitive This document becomes an NRC Official Agency Record once it is signed by the Branch Chief