ML22094A092
| ML22094A092 | |
| Person / Time | |
|---|---|
| Site: | 03002271, 03038167 |
| Issue date: | 03/07/2022 |
| From: | Geoffrey Warren NRC/RGN-III |
| To: | Amurao M Washington Univ in St. Louis |
| References | |
| IR 2022001 | |
| Download: ML22094A092 (3) | |
See also: IR 07100202/2020001
Text
NRC FORM 591M PART 1
U.S. NUCLEAR REGULATORY COMMISSION
(07-2012)
1ocFR 2.201
SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
1. LICENSEE/LOCATION INSPECTED:
Washington University in St. Louis
Campus Box 8053
660 S. Euclid A venue
St. Louis, Missouri 63110-1093
REPORT NUMBER(S) 2022001
3. DOCKET NUMBER{S)
030-02271, 030-38167
LICENSEE:
2. NRG/REGIONAL OFFICE
Region III
U.S. Nuclear Regulatory Commission
2443 Warrenville Road, Suite 210
Lisle, IL 60532-4352
4. LICENSE NUMBER{S)
24-00167-11,24-00167-14
5. DATE(S) OF INSPECTION
Zo2.-Z.
March 7-10 ,~
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 identified.
Previous violation(s) closed.
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 satisfied.
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 19.11.
(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 requested.
TITLE
PRINTED NAME
SIGNATURE
DATE
LICENSEE'S
REPRESENTATIVE
NRC INSPECTOR
BRANCH CHIEF
Geoffrey Warren / Luis Nieves Folch
NRC: FORM 591M PART 1 /07-2012\\
/
M*1chael A Kunowsk"1 DigitallysignedbyMichaelA.Kunowski
Date: 2022.04.01 09:41 :13 -05'00'
U.S. NUCLEAR REGULA TORY COMMISSION
Materials Inspection Record
1. Licensee Name:
2. Docket Number(s):
3. License Number(s)
Washington University in St. Louis
030-02271, 030-38167
24-00167-11 , 24-00167-14
4. Report Number(s):
5. Date(s) of Inspection:
030-02271/2022001 , 030-38167/2022001
March 7-10, 2022
6. lnspector(s):
7. Program Code(s):
8. Priority:
9. Inspection Guidance Used:
Geoffrey Warren, Sr. HP; Luis Nieves Felch, HP
02210,03210
2 (both)
87126,87127,87134
10. Licensee Contact Name(s):
11. Licensee E-mail Address:
12. Licensee Telephone Number(s):
Maxwell Amurao, Ph.D, RSO
maxwell.amurao@wustl.edu
314-362-2988
13. Inspection Type:
[Z] Routine
D Initial
[Z] Announced
D Unannounced
14. Locations Inspected:
[Z]
Main Office
15. Next Inspection Date (MM/DD/YYYY):
D Non-Routine
16. Scope and Observations:
D Temporary Job Site
[Z]
Field Office
D Remote
03/07/2024
[Z]
Normal D
D Reduced D
Extended
No change
This was an announced routine inspection of operations under Washington University in St. Louis's two NRC
licenses: (1) NRC License No. 24-00167-11, a Type A medical and research broad scope license and (2) NRC
License No. 24-00167-14 authorizing cyclotron production of licensed materials. Facilities inspected during this
inspection included the main medical campus and surrounding facilities, the Danforth campus, and Barnes-Jewish
West County Hospital.
The Type A medical broad scope licensee used a large variety of isotopes in medical and research applications. The
radiation safety committee had approved radiation users under approximately 250 medical and research permits, of
which around 150 were active permits, and oversaw around 1200 trained radiation workers. Research laboratories
used predominantly microcurie quantities of carbon-14, tritium, iodine-125, phosphorus-32, and sulfur-35. In
addition, the licensee possessed blood and research irradiators as described on the license. Research included
both animal and human (medical) research. The radiation safety office included eleven full-time technical staff
including the radiation safety officer as well as five part-time administrative staff.
The licensee operated multiple nuclear medicine areas, including Barnes-Jewish North and South areas, Children's
Hospital, and West County and South County cardiology facilities. At these facilities, nuclear medicine technologists
performed a wide variety of diagnostic procedures using technetium-99m, fluorine-18, xenon-133 and other isotopes.
In addition, nuclear medicine staff performed hyperthyroidism treatments and whole-body scans using iodine-131 in
capsule form. All areas received unit doses from licensed pharmacies or from the licensee's cyclotron operations.
The radiation oncology department performed therapy procedures using: (1) a Leksell Gamma Knife Icon gamma
stereotactic radiosurgery (GSR) unit, (2) two high dose rate remote afterloader (HOR) units, (3) brachytherapy
sealed sources (eye plaques and permanent prostate implants), (4) yttrium-90 microspheres procedures for liver
cancer, and (5) a variety of radiopharmaceutical materials, including iodine-131, lutetium-177, and radium-223. The
oncology department was staffed with multiple authorized user oncologists, authorized medical physicists,
dosimetrists, and radiation therapists. The licensee had authorized around 70 authorized medical users, including
authorized user physicians, authorized medical physicists, and authorized nuclear pharmacists.
Under the cyclotron license, the licensee operated one Siemens RDS Eclipse (11 MeV protons), one TR-19 (19 MeV
protons), and one CS-15 (15 MeV protons) for the production of materials for transfer to its broad scope license.
These materials included fluorine-18, carbon-11, oxygen-15, nitrogen-13, copper-64, and zirconium-89. The
licensee considered materials to be transferred to the broad scope license when they were transferred from the
NRG Form 592M (10-2020)
Page 1 of 2
(10-2020)
Materials Inspection Record (Continued)
U.S. NUCLEAR REGULA TORY COMMISSION
cyclotron, so all chemical processing ot cyclotron-produced materials was performed under the broad scope license.
These materials were used for medical or research purposes under the broad scope license or distributed to client
facilities in multiple states. In addition, the licensee possessed a JSW Model 168 cyclotron.
Performance Observations: The inspectors toured a variety of facilities and observed audits of research
laboratories, including leak tests, inventory, surveys, and interviews; an HOR source replacement by contractor
personnel; an yttrium-90 microspheres procedure; a radium-223 radiopharmaceutical therapy procedure; several
diagnostic procedures including dose preparation and disposal, contamination cleanup, and routine cyclotron
operations. In addition, licensee personnel described or demonstrated laboratory use of licensed materials, general
security of licensed materials, emergency procedures, a variety of therapeutic and diagnostic medical procedures
including planning and administration, patient release calculations for iodine-131 procedures, GSR and HOR daily
checks, morning nuclear medicine checks, daily and weekly contamination surveys in nuclear medicine, ordering
and receipt of laboratory materials, tracking and inventory or licensed materials, calibration of survey instruments,
waste pickup and tracking, and waste shipment for disposal. The inspectors noted no concerns with these activities.
The inspectors reviewed radiation safety committee minutes; program and laboratory audits; written directives,
treatment plans, and treatment documentation for all modalities of therapeutic procedures; inventory and tracking
records; dosimetry records; transfer of sealed sources for disposal, and other documents. Interviews with licensee
personnel indicated adequate knowledge of radiation safety concepts and procedures. Review of radiation
dosimetry records indicated no exposures of concern. Review of radiation safety committee minutes indicated good
attendance, discussion of appropriate topics. and appropriate oversight of of the radiation safety program. The
inspectors performed independent and confirmatory radiation measurements that were consistent with licensee
survey records and postings.
No violations of NRC requirements were identified as a result of this inspection.
NRC Form 592M (10-2020)
Page 2 of 2