ML22059A014

Northstar Medical Technologies, LLC - NRC Form 592 - IR 15000048/2022001(DNMS)

ML22059A014
Person / Time
Site:	15000048
Issue date:	01/31/2022
From:	Ryan Craffey NRC/RGN-III
To:	Granberg R Northstar Medical Technologies
References
IR 2022001
Download: ML22059A014 (1)

See also: IR 015000048/2022001

Text

NRC FORM 592M U.S. NUCLEAR REGULA TORY COMMISSION

(10-2020) <>"'"'"*<<

(.) Materials Inspection Record

• • 11*"'

1. Licensee Name: 2. Docket Number(s): 3. License Number(s)

Northstar Medical Technologies, LLC 150-00048 Wl-025-2038-02

4. Report Number(s): 5. Date(s) of Inspection:

2022-001 January 24, 2022; exit on January 31 , 2022

6. lnspector(s): 7. Program Code(s): 8. Priority: 9. Inspection Guidance Used:

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 recurrence.

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