IR 07100202/2020001
| ML22094A092 | |
| Person / Time | |
|---|---|
| Site: | 07100202, 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) | |
Text
NRC FORM 591M PART 1 NUCLEAR REGULATORY COMMISSION (07-2012)
1ocFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION LICENSEE/LOCATION INSPECTED: 2. NRG/REGIONAL OFFICE Washington University in S Louis Region III Campus Box 8053 Nuclear Regulatory Commission 660 Euclid A venue 2443 Warrenville Road, Suite 210 S Louis, Missouri 63110-1093 Lisle, IL 60532-4352
REPORT NUMBER(S) 2022001 DOCKET NUMBER{S) 4. LICENSE NUMBER{S) 5. DATE(S) OF INSPECTION Zo2.-, 030-38167 24-00167-11,24-00167-14 March 7-10,~
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 licens The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the inspecto The inspection findings are as follows:
Based on the inspection findings, no violations were identifie 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 disc retion, 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, wh ich 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 desc ribed 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 Geoffrey Warren / Luis Nieves Folch
BRANCH CHIEF Michael Kunowski M*1chael A Kunowsk "* Date: 2022.04.01 09:41 :13 -05'00' 1 Digita llysignedbyM ichaelA.Kunow ski
NRC: FORM 591M PART 1 /07-2012\\ NUCLEAR REGULA TORY COMMISSION
Materials Inspection Record Licensee Name : Docket Number(s) : License Number(s)
Washington University in St. Louis 030-02271, 030-38167 24-00167-11, 24-00167-14 Report Number(s) : Date(s) of Inspection :
030-02271/2022001, 030-38167/2022001 March 7-10, 2022 lnspector(s) : Program Code(s) : Priority: Inspection Guidance Used :
Geoffrey Warren, Sr. HP ; Luis Nieves Felch, HP 02210,03210 2 (both) 87126,87127,87134
1 Licensee Contact Name(s) : 1 Licensee E-mail Address : 1 Licensee Telephone Number(s) :
Maxwell Amurao, Ph.D, RSO maxwell.amurao@wustl.edu 314-362-2988
1 Inspection Type : D Initial 1 Locations Inspected : 1 Next Inspection Date (MM/DD/YYYY) :
[Z] Routine [Z] Announced [Z] Main Office [Z] Field Office 03/07/2024 [Z] Normal D Extended D Non-Routine D Unannounced D Temporary Job Site D Remote D Reduced D No change
1 Scope and Observations :
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 N authorizing cyclotron production of licensed material Facilities inspected during this inspection included the main medical campus and surrounding facilities, the Danforth campus, and Barnes-Jewish West County Hospita 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 worker Research laboratories used predominantly microcurie quantities of carbon-14, tritium, iodine-125, phosphorus-32, and sulfur-3 In addition, the licensee possessed blood and research irradiators as described on the licens Research included both animal and human (medical) researc The radiation safety office included eleven full-time technical staff including the radiation safety officer as well as five part-time administrative staf 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 isotope In addition, nuclear medicine staff performed hyperthyroidism treatments and whole-body scans using iodine-131 in capsule for All areas received unit doses from licensed pharmacies or from the licensee's cyclotron operation 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-22 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 licens These materials included fluorine-18, carbon-11, oxygen-15, nitrogen-13, copper-64, and zirconium-8 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 NRC FORM 592M NUCLEAR REGULA TORY COMMISSION (10-2020)
Materials Inspection Record (Continued)
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 state In addition, the licensee possessed a JSW Model 168 cyclotro 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 operation 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 disposa The inspectors noted no concerns with these activitie 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 document Interviews with licensee personnel indicated adequate knowledge of radiation safety concepts and procedure Review of radiation dosimetry records indicated no exposures of concer Review of radiation safety committee minutes indicated good attendance, discussion of appropriate topics. and appropriate oversight of of the radiation safety progra The inspectors performed independent and confirmatory radiation measurements that were consistent with licensee survey records and posting No violations of NRC requirements were identified as a result of this inspectio NRC Form 592M (10-2020) Page 2 of 2