IR 05000202/2010001: Difference between revisions

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{{Adams
{{Adams
| number = ML21025A017
| number = ML23024A024
| issue date = 01/22/2021
| issue date = 01/24/2023
| 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 = Hospital of Central Connecticut NRC Inspection Report 03001250/2021001 and Notice of Violation
| author name = Craffrey R
| author name = Lorson R
| author affiliation = NRC/RGN-III/DNMS
| author affiliation = NRC/RGN-I/ORA
| addressee name = Kritzman S
| addressee name = Edwards J
| addressee affiliation = Internal Medicine Associates of Mt. Clemens, PC
| addressee affiliation = Hospital of Central Connecticut
| docket = 03033050
| docket = 03001250
| license number = 21-26470-01
| license number = 06-02388-01
| contact person =  
| contact person =  
| case reference number = EA-22-050
| document report number = IR 2021001
| document report number = IR 2021001
| document type = Inspection Report, Safety and Compliance Inspection Record, NRC Form 591
| document type = Letter
| page count = 1
| page count = 4
}}
}}


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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:January 24, 2023
2.Docket    Number(s)
3.License Internal Me Associates ofMt. Clemens 030-33050    21-26470-01 4.Report Number(s):    5.Date(s) ofInspection:
2021-001      January 22,2021 6.inspector(s):    7.Program Code(s): 8.Priority:9.inspection Guidance Used:
RyanCraffey    02201  5 IP87130 10.Licensee ContactName(s): 11.Licensee Address:
E-mail  12.LicenseeTelephone Number(s):
Shelli Kritzman, MS RSO
  -
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.
==SUBJECT:==
NOTICE OF VIOLATION - THE HOSPITAL OF CENTRAL CONNECTICUT -
NRC INSPECTION REPORT NO. 03001250/2021001


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.
==Dear Jeanette Edwards:==
This letter refers to the routine inspection conducted on March 5, 2021, with on-site inspection from March 21-23, 2021, and with continued in-office review through August 19, 2022, of activities performed under the U.S. Nuclear Regulatory Commission (NRC) license issued to the Hospital of Central Connecticut (HOCC). The purpose of the inspection was to examine the HOCCs licensed activities as they relate to radiation safety, compliance with the NRCs regulations, and the conditions in the license. Based on the results of the inspection, the NRC staff identified apparent violations (AVs) of NRC requirements. NRC staff discussed the AVs with you during a telephonic exit meeting on [[Exit meeting date::August 19, 2022]], and described the AVs in the NRC inspection report sent to you in a letter dated September 15, 2022 (ML22258A099). 1 The inspection report, and the AVs described therein, concern Security-Related Information in accordance with 10 CFR 2.390(d)(1), and disclosure to unauthorized individuals could present a security vulnerability. Therefore, the inspection report enclosed with the September 15, 2022, letter was not publicly available, and details regarding the AVs were provided in a non-public enclosure.


Noviolations ofNRCrequirements wereidentified asa result ofthis inspection.
In the letter transmitting the inspection report, we informed you that the AVs identified in the report were being considered for escalated enforcement action. In a telephone conversation on September 22, 2022, Anne DeFrancisco of my staff informed you that we had sufficient information regarding the AVs and your corrective actions to make an enforcement decision without the need for a pre-decisional enforcement conference or a written response from you.


NRCForm592M(10-2020)       Page1of1
Enclosure transmitted herewith contains Sensitive, Unclassified, Non-Safeguards Information. When separated from the Enclosure, the transmittal document is decontrolled.
 
Designation in parentheses refers to an Agency-wide Documents Access and Management System (ADAMS) accession number. Unless otherwise noted, documents referenced in this letter are publicly-available using the accession number in ADAMS. In a letter dated October 21, 2022 (ML22336A183; non-public), you provided a response to the AVs in which you provide further detail about the violations and the HOCCs corrective actions.
 
A summary of your response, the NRC staffs assessment of the AVs, and the actions taken by the HOCC to correct and prevent reoccurrence of these issues is provided in the non-public Enclosure 1.
 
Based on the information developed during the inspection, the NRC has determined that one or more violations of NRC requirements occurred and have been categorized in accordance with the NRC Enforcement Policy as Severity Level III (SL III) violations, which is escalated enforcement. The NRC Enforcement Policy can be found on the NRCs website at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violations are cited in the Notice of Violation (Notice), provided as non-public Enclosure 2, and the circumstances surrounding them are described in detail in the subject inspection report.
 
In accordance with the NRC Enforcement Policy, a base civil penalty in the amount of $8,000 is considered for a SL III violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC staff considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section 2.3.4 of the Enforcement Policy. The NRC staff determined that the HOCC took prompt and comprehensive corrective actions, and credit is, therefore, warranted. Enclosure 2 (non-public) provides an explanation of the severity level determinations and a description of the HOCCs corrective actions to address the violations. Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of the SL III violations constitutes escalated enforcement action that may subject you to increased inspection effort.
 
The NRC has concluded that information regarding: (1) the reason for the violations; (2) the corrective actions that have been taken and the results achieved; and (3) the date when full compliance was achieved is already adequately addressed on the docket in Inspection Report No. 03001250/2021001, your letter dated October 21, 2022, and this letter. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
 
Separately, in your October 21, 2022, letter, you identified an error in NRC Inspection Report No. 03001250/2021001. A corrected copy of the inspection report was provided to you with a letter dated January 23, 2023 (ML23023A111, ML23023A106; non-public).
 
In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter will be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS), accessible from the NRC Website 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 enclosure will not be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS). If you choose to respond and Security-Related Information is necessary to provide an acceptable response, please mark your entire response Security-Related Information in accordance with 10 CFR 2.390(d)(1) and follow the instructions for withholding in 10 CFR 2.390(b)(1). The NRC also includes significant enforcement actions on its Web site at http://www.nrc.gov/reading-rm/doc-collections/enforcement/actions/. If you have any questions concerning this matter, please contact Anne DeFrancisco of my staff at 610-337-5078 or Anne.DeFrancisco@nrc.gov.
 
Sincerely, Raymond Digitally signed by Raymond K. Lorson K. Lorson Date: 2023.01.24 11:01:04 -05'00'
Raymond K. Lorson Regional Administrator Docket No. 03001250 License No. 06-02388-01 Enclosures:
1. Summary of licensee response, assessment of violations and corrective actions (non-public)
2. Notice of Violation (non-public)
cc w/encl:
George Pavlonnis, Radiation Safety Officer State of Connecticut SUBJECT: NOTICE OF VIOLATION - THE HOSPITAL OF CENTRAL CONNECTICUT -
NRC INSPECTION REPORT NO. 03001250/2021001: DATED January 24, 2023 DISTRIBUTION w/encl:
ADAMS SECY    RIDSSECYMAILCENTER OEMAIL OEWEB D Dorman, EDO  RIDSEDOMAILCENTER C Haney, DEDM D Pelton, OE  RIDSOEMAILCENTER T Martinez-Navedo, OE J Peralta, OE N Hasan, OE L Sreenivas, OE J Lubinski, NMSS  RIDSNMSSOD RESOURCE R Lewis, NMSS K Williams, NMSS M Burgess, NMSS Enforcement Coordinators RII, RIII, RIV (M Kowal; D Betancourt-Roldan; J Groom)
L Baer, OGC  RIDSOGCMAILCENTER T Steinfeldt, OGC H Harrington, OPA  RIDSOPAMAILCENTER R Feitel, OIG  RIDSOIGMAILCENTER D DAbate, OCFO  RIDSOCFOMAILCENTER R Lorson, RA  R1ORAMAIL RESOURCE D Collins, DRA  R1ORAMAIL RESOURCE B Welling, DRSS, RI  R1DRSSMAILRESOURCE T Bloomer, DRSS, RI A DeFrancisco, DRSS, RI R Elliott, DRSS, RI H Ahmed, DRSS, RI D Screnci, PAO-RI / N Sheehan, PAO-RI F Gaskins, SAO-RI/ L Hanson, SAO-RI B Klukan, ORA, RI R McKinley, ORA, RI ML23024A024 Public Non-Sensitive DOCUMENT NAME: S:\Enf-allg\Enforcement\Proposed-Actions\Region1\HOCC PUBLIC NOV EA-22-050_ML22314A103.docx X Non-Sensitive  X Publicly Available X SUNSI Review/ MMM Sensitive  Non-Publicly Available OFFICE RI/ORA RI/DRSS RI/ORA RI/ORA OE NAME M McLaughlin A DeFrancisco B Klukan NLO R McKinley L Sreenivas DATE 11/10/22 12/02/22 12/05/22 12/12/22 1/09/23 OFFICE      RI/DRSS RA NAME      B Welling R Lorson DATE      1/18/23 1/24/23 OFFICIAL RECORD COPY
}}
}}

Latest revision as of 15:28, 7 February 2023

Hospital of Central Connecticut NRC Inspection Report 03001250/2021001 and Notice of Violation
ML23024A024
Person / Time
Site: 03001250, 05000202
Issue date: 01/24/2023
From: Ray Lorson
Region 1 Administrator
To: Edwards J
Hospital of Central Connecticut
References
EA-22-050 IR 2021001
Download: ML23024A024 (4)


Text

January 24, 2023

SUBJECT:

NOTICE OF VIOLATION - THE HOSPITAL OF CENTRAL CONNECTICUT -

NRC INSPECTION REPORT NO. 03001250/2021001

Dear Jeanette Edwards:

This letter refers to the routine inspection conducted on March 5, 2021, with on-site inspection from March 21-23, 2021, and with continued in-office review through August 19, 2022, of activities performed under the U.S. Nuclear Regulatory Commission (NRC) license issued to the Hospital of Central Connecticut (HOCC). The purpose of the inspection was to examine the HOCCs licensed activities as they relate to radiation safety, compliance with the NRCs regulations, and the conditions in the license. Based on the results of the inspection, the NRC staff identified apparent violations (AVs) of NRC requirements. NRC staff discussed the AVs with you during a telephonic exit meeting on August 19, 2022, and described the AVs in the NRC inspection report sent to you in a letter dated September 15, 2022 (ML22258A099). 1 The inspection report, and the AVs described therein, concern Security-Related Information in accordance with 10 CFR 2.390(d)(1), and disclosure to unauthorized individuals could present a security vulnerability. Therefore, the inspection report enclosed with the September 15, 2022, letter was not publicly available, and details regarding the AVs were provided in a non-public enclosure.

In the letter transmitting the inspection report, we informed you that the AVs identified in the report were being considered for escalated enforcement action. In a telephone conversation on September 22, 2022, Anne DeFrancisco of my staff informed you that we had sufficient information regarding the AVs and your corrective actions to make an enforcement decision without the need for a pre-decisional enforcement conference or a written response from you.

Enclosure transmitted herewith contains Sensitive, Unclassified, Non-Safeguards Information. When separated from the Enclosure, the transmittal document is decontrolled.

Designation in parentheses refers to an Agency-wide Documents Access and Management System (ADAMS) accession number. Unless otherwise noted, documents referenced in this letter are publicly-available using the accession number in ADAMS. In a letter dated October 21, 2022 (ML22336A183; non-public), you provided a response to the AVs in which you provide further detail about the violations and the HOCCs corrective actions.

A summary of your response, the NRC staffs assessment of the AVs, and the actions taken by the HOCC to correct and prevent reoccurrence of these issues is provided in the non-public Enclosure 1.

Based on the information developed during the inspection, the NRC has determined that one or more violations of NRC requirements occurred and have been categorized in accordance with the NRC Enforcement Policy as Severity Level III (SL III) violations, which is escalated enforcement. The NRC Enforcement Policy can be found on the NRCs website at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violations are cited in the Notice of Violation (Notice), provided as non-public Enclosure 2, and the circumstances surrounding them are described in detail in the subject inspection report.

In accordance with the NRC Enforcement Policy, a base civil penalty in the amount of $8,000 is considered for a SL III violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC staff considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section 2.3.4 of the Enforcement Policy. The NRC staff determined that the HOCC took prompt and comprehensive corrective actions, and credit is, therefore, warranted. Enclosure 2 (non-public) provides an explanation of the severity level determinations and a description of the HOCCs corrective actions to address the violations. Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of the SL III violations constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding: (1) the reason for the violations; (2) the corrective actions that have been taken and the results achieved; and (3) the date when full compliance was achieved is already adequately addressed on the docket in Inspection Report No. 03001250/2021001, your letter dated October 21, 2022, and this letter. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

Separately, in your October 21, 2022, letter, you identified an error in NRC Inspection Report No. 03001250/2021001. A corrected copy of the inspection report was provided to you with a letter dated January 23, 2023 (ML23023A111, ML23023A106; non-public).

In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter will be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS), accessible from the NRC Website 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 enclosure will not be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS). If you choose to respond and Security-Related Information is necessary to provide an acceptable response, please mark your entire response Security-Related Information in accordance with 10 CFR 2.390(d)(1) and follow the instructions for withholding in 10 CFR 2.390(b)(1). The NRC also includes significant enforcement actions on its Web site at http://www.nrc.gov/reading-rm/doc-collections/enforcement/actions/. If you have any questions concerning this matter, please contact Anne DeFrancisco of my staff at 610-337-5078 or Anne.DeFrancisco@nrc.gov.

Sincerely, Raymond Digitally signed by Raymond K. Lorson K. Lorson Date: 2023.01.24 11:01:04 -05'00'

Raymond K. Lorson Regional Administrator Docket No. 03001250 License No. 06-02388-01 Enclosures:

1. Summary of licensee response, assessment of violations and corrective actions (non-public)

2. Notice of Violation (non-public)

cc w/encl:

George Pavlonnis, Radiation Safety Officer State of Connecticut SUBJECT: NOTICE OF VIOLATION - THE HOSPITAL OF CENTRAL CONNECTICUT -

NRC INSPECTION REPORT NO. 03001250/2021001: DATED January 24, 2023 DISTRIBUTION w/encl:

ADAMS SECY RIDSSECYMAILCENTER OEMAIL OEWEB D Dorman, EDO RIDSEDOMAILCENTER C Haney, DEDM D Pelton, OE RIDSOEMAILCENTER T Martinez-Navedo, OE J Peralta, OE N Hasan, OE L Sreenivas, OE J Lubinski, NMSS RIDSNMSSOD RESOURCE R Lewis, NMSS K Williams, NMSS M Burgess, NMSS Enforcement Coordinators RII, RIII, RIV (M Kowal; D Betancourt-Roldan; J Groom)

L Baer, OGC RIDSOGCMAILCENTER T Steinfeldt, OGC H Harrington, OPA RIDSOPAMAILCENTER R Feitel, OIG RIDSOIGMAILCENTER D DAbate, OCFO RIDSOCFOMAILCENTER R Lorson, RA R1ORAMAIL RESOURCE D Collins, DRA R1ORAMAIL RESOURCE B Welling, DRSS, RI R1DRSSMAILRESOURCE T Bloomer, DRSS, RI A DeFrancisco, DRSS, RI R Elliott, DRSS, RI H Ahmed, DRSS, RI D Screnci, PAO-RI / N Sheehan, PAO-RI F Gaskins, SAO-RI/ L Hanson, SAO-RI B Klukan, ORA, RI R McKinley, ORA, RI ML23024A024 Public Non-Sensitive DOCUMENT NAME: S:\Enf-allg\Enforcement\Proposed-Actions\Region1\HOCC PUBLIC NOV EA-22-050_ML22314A103.docx X Non-Sensitive X Publicly Available X SUNSI Review/ MMM Sensitive Non-Publicly Available OFFICE RI/ORA RI/DRSS RI/ORA RI/ORA OE NAME M McLaughlin A DeFrancisco B Klukan NLO R McKinley L Sreenivas DATE 11/10/22 12/02/22 12/05/22 12/12/22 1/09/23 OFFICE RI/DRSS RA NAME B Welling R Lorson DATE 1/18/23 1/24/23 OFFICIAL RECORD COPY