IR 015000048/2022001: Difference between revisions

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{{Adams
{{Adams
| number = ML22059A014
| number = ML22094A038
| issue date = 01/31/2022
| issue date = 03/21/2022
| title = Northstar Medical Technologies, LLC - NRC Form 592 - IR 15000048/2022001(DNMS)
| title = RAM Services, Inc., NRC Form 591M Part 1, Inspection Report No. 15000048/2022001
| author name = Craffey R
| author name = Vonehr J
| author affiliation = NRC/RGN-III
| author affiliation = NRC/RGN-I
| addressee name = Granberg R
| addressee name =  
| addressee affiliation = Northstar Medical Technologies
| addressee affiliation = RAM Services, Inc
| docket = 15000048
| docket = 15000048
| license number = WI-025-2038-02
| license number = WI-071-1234-01
| contact person =  
| contact person =  
| document report number = IR 2022001
| document report number = IR 2022001
Line 18: Line 18:


=Text=
=Text=
{{#Wiki_filter:NRC FORM 592M      U.S. NUCLEAR REGULA TORY COMMISSION (10-2020) <>"'"'"*<<
{{#Wiki_filter:NRC FORM 591 PART 1      U.S. NUCLEAR REGULATORY COMMISSION (05-2012)
(.)  Materials Inspection Record
10 CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED:   2. NRC/REGIONAL OFFICE RAM Services, In Region I Temporary Job Site at 4550 Wrangle Hill Road,   U. S. Nuclear Regulatory Commission Delaware City, DE 19706 (LRN 461000)   2100 Renaissance Boulevard, Suite 100 King of Prussia, PA 19406-2713 REPORT NUMBER(S) 150-00048 / 2022-002 3. DOCKET NUMBER(S)    4. LICENSE NUMBER(S)  5. DATE(S) OF INSPECTION 150-00048    WI-071-1234-01 (GL under 10 CFR 150.20) 03/21/2022 LICENSEE:
  **11*"'
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: Based on the inspection findings, no violations were identifie . Previous violation(s) close . The violations(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): 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 19.1 (Violations and Corrective Actions)
1. Licensee Name:   2. Docket Number(s):   3. License 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 LICENSEE'S REPRESENTATIVE NRC INSPECTOR Jason vonEhr  Jason E. VonEhr Digitally signed by Jason E. VonEhr Date: 2022.03.22 12:29:57 -04'00'
Northstar Medical Technologies, LLC  150-00048   Wl-025-2038-02 4. Report Number(s):   5. Date(s) of Inspection:
BRANCH CHIEF Christopher Cahill  Christopher G. Cahill  Digitally signed by Christopher G. Cahill Date: 2022.03.22 13:37:36 -04'00'
2022-001      January 24, 2022; exit on January 31 , 2022 6. lnspector(s):    7. Program Code(s): 8. Priority: 9. Inspection Guidance Used:
NRC FORM 591 PART 1 (05-2012)
Ryan Craffey    03226   2 IP 87126 10. Licensee Contact Name(s):  11. Licensee E-mail Address :  12. Licensee Telephone Number(s):
Richard Granberg - RSO  rgrandberg@northstarnm .com  269-998-2712
 
13. Inspection Type: Initial 14. Locations Inspected: 15. Next Inspection Date (MM/DD/YYYY) :
Routine [Z] Announced Main Office Field Office TBD  D Normal D Extended 0 Non-Routine Unannounced 0 Temporary Job Site Remote    D Reduced [Z] No change 16. Scope and Observations:
Northstar Medical Technologies was authorized by the State of Wisconsin to perform a variety of licensed activities incident to the manufacture of radiochemicals with the RadioGenix system at its facility in Beloit, Wisconsin, and to perform service activities at temporary job sites in State jurisdiction. The company performed service activities at temporary job sites in NRC jurisdiction under the terms of a reciprocity request filed in December 2021 for calendar year 2022. The scope of this inspection was limited to an evaluation of service activities (investigating a report of elevated dose rates and restoring a RadioGenix system to normal operations) at the Purdue University's College of Pharmacy in West Lafayette, Indiana.
 
The inspector accompanied the licensee's service personnel to the University and observe troubleshooting and restoration activities. The personnel were knowledgeable of the RadioGenix system and associated radiation hazards, wore adequate dosimetry and PPE and used calibrated and operable survey instruments throughout. The personnel confirmed that elevated dose rates measured by a pharmacy student the week prior were due to the student leaving a cap on the needle used to fill the product vial. Rather than piercing the vial's septum, the capped needle forced the entire septum into the vial, plugging it and forcing the 700-800 mCi of Tc-99m expected in 5 ml of product solution into the space between the vial and its tungsten shield. A small amount of dried product was also found on the plastic tray on which the shield stood upon disassembly by service personnel.
 
After determining this spilled product to be the cause of the elevated dose rates and restoring the system to normal operation, the inspector interviewed the service personnel to discuss the scope of their work, extremity monitoring results (the inspector reviewed a selection of them in-office following the visit), as well as other instances of this and other abnormal conditions caused by user error (such as attempting to remove product early) and the licensee's ongoing initiatives to address the potential for their recurrenc No violations of NRC requirements were identified as a result of this inspection. The inspector held an exit meeting with the licensee's RSO by telephone on January 31, 2022.
 
NRG Form 592M (10-2020)         Page 1 of 1
}}
}}

Latest revision as of 03:00, 11 May 2022

RAM Services, Inc., NRC Form 591M Part 1, Inspection Report No. 15000048/2022001
ML22094A038
Person / Time
Site: 15000048, 015000048
Issue date: 03/21/2022
From: Jason Vonehr
NRC Region 1
To:
RAM Services
References
IR 2022001
Download: ML22094A038 (1)
v • d • e


Text

NRC FORM 591 PART 1 U.S. NUCLEAR REGULATORY COMMISSION (05-2012)

10 CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED: 2. NRC/REGIONAL OFFICE RAM Services, In Region I Temporary Job Site at 4550 Wrangle Hill Road, U. S. Nuclear Regulatory Commission Delaware City, DE 19706 (LRN 461000) 2100 Renaissance Boulevard, Suite 100 King of Prussia, PA 19406-2713 REPORT NUMBER(S) 150-00048 / 2022-002 3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION 150-00048 WI-071-1234-01 (GL under 10 CFR 150.20) 03/21/2022 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: Based on the inspection findings, no violations were identifie . Previous violation(s) close . The violations(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): 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 19.1 (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 DATE LICENSEE'S REPRESENTATIVE NRC INSPECTOR Jason vonEhr Jason E. VonEhr Digitally signed by Jason E. VonEhr Date: 2022.03.22 12:29:57 -04'00'

BRANCH CHIEF Christopher Cahill Christopher G. Cahill Digitally signed by Christopher G. Cahill Date: 2022.03.22 13:37:36 -04'00'

NRC FORM 591 PART 1 (05-2012)

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