ML23088A209
| ML23088A209 | |
| Person / Time | |
|---|---|
| Site: | 03011072 |
| Issue date: | 03/01/2023 |
| From: | Zahid Sulaiman NRC/RGN-III |
| To: | Breeden W Union Hospital |
| References | |
| IR 2023001 | |
| Download: ML23088A209 (1) | |
See also: IR 07200202/2030001
Text
NRC FORM 591M U.S. NUCLEAR REGULATORY COMMISSION
(04-2022)
Materials Inspection Report
1. Licensee/Location Inspected: 2. NRC/Regional Office
Union Hospital, Inc. Region III
1606 N. 7th St U. S. Nuclear Regulatory Commission
Terre Haute, IN 47804 2443 Warrenville Road, Suite 210
Lisle, IL 60532-4352
Report Number(s) 2023001
3. Docket Number(s) 4. License Number(s) 5. Date(s) of Inspection
030-11072 13-16457-01 March 1-2, 2023
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:
1. Based on the inspection findings, no violations were identified.
2. Previous violation(s) closed.
3. During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements, and
were assessed at Severity Level IV, in accordance with the NRC Enforcement Policy.
A. The violation(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self-
identified, non-repetitive, corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy
were satisfied.
(Non-cited violation(s) was/were discussed involving the following requirement(s)
B. The following violation(s) is/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 AND DATE
LICENSEE'S
REPRESENTATIVE
NRC INSPECTOR Zahid Sulaiman, Health Physicist Zahid M. Sulaiman Digitally signed by Zahid M. Sulaiman Date: 2023.03.17 16:49:43 -05'00'
BRANCH CHIEF Rhex Edwards, Chief, MIB Digitally signed by Rhex A. Edwards
Date: 2023.03.24 09:20:53 -05'00'
Add Continuation Page Page 1 of 1
NRC FORM 592M U.S. NUCLEAR REGULATORY COMMISSION
(10-04-2022)
Materials Inspection Record
1. Licensee Name: 2. Docket Number(s): 3. License Number(s)
Union Hospital, Inc. 030-11072 13-16457-01
4. Report Number(s): 5. Date(s) of Inspection:
2023001 March 1-2, 2023
6. Inspector(s): 7. Program Code(s): 8. Priority:9. Inspection Guidance Used:
Zahid Sulaiman, Health Physicist 02240 2 87131 & 87132
10. Licensee Contact Name(s): 11. Licensee E-mail Address: 12. Licensee Telephone Number(s):
William Breeden, RSO wbreeden@amphysics.com Cell: 317-223-3022
Gale Wilson, Dir of Radiology gwilson@uhhg.org Work: 812-238-7590
13. Inspection Type: Initial 14. Locations Inspected:Hybrid 15. Next Inspection Date (MM/DD/YYYY):
Routine Announced Main Office Field Office 03/01/2025 Normal Extended
Non-Routine Unannounced Temporary Job Site Remote Reduced No change
16. Location(s) Inspected List:
Main Hospital: 1606 N. 7th St, Terre Haute, IN 47804
Oncology Department: 1711 N. 6 1/2 St., Terre Haute, IN 47807
Union Hospital-Clinton: 801 S. Main St, Clinton, IN 47842
17. Scope and Observations:
This was an unannounced routine inspection of a large medical institution authorized to use licensed material
permitted by 10 CFR 35.100, 35.200 (including PET), 35.300, 35.400, and 35.1000 (yittrium-90 (Y-90) SIR-Spheres
microspheres). The licensee operated two areas of use for its nuclear medicine activities (main hospital nuclear
medicine & PET, and Heart Institute). The main hospital nuclear medicine department was staffed with four full-time
technologists (NMTs) and a PRN, who performed approximately 8-10 diagnostic procedures daily and approximately
6-7 PET using FDG daily. The licensee administered a full spectrum of diagnostic studies. The department also
administered approximately15-20 iodine-131 (I-131) dosages (capsules only) for whole body follow up studies,
hyperthyroid, and cancer ablation treatments annually. The department also administered 1-2 Ra-223 Xofigo
treatments annually. The licensee also performed approximately seven Y-90 SIR-Spheres permanent manual
brachytherapy procedures since September of 2022.
The heart and vascular institute nuclear medicine department was staffed with five full-time NMTs and a PRD, who
performed approximately 3-5 cardiac PET using a Sr-82/Ru-82 generator (cardiogen-82 infusion system, Model
1700) and approximately 15 cardiac stress test daily.
The radiation oncology department was staffed with an oncologist, two authorized medical physicists (AMP), and
two resident physicists. The licensee performed approximately six temporary implant brachytherapy procedures
using cesium-137 (Cs-137) sealed sources, primarily for gynecological cancer treatment, and approximately 2-3
iodine-125 (I-125) permanent prostate seed implants annually. The licensee is planning to add the high-dose rate
remote afterloader modality by the end of 2023.
At Union-Clinton facility, the nuclear medicine department was staffed with a part-time NMT who performed
approximately 10 diagnostic procedures weekly (Monday, Tuesday, & Thursdays).
PERFORMANCE OBSERVATIONS
NRC Form 592M (10-04-2022) Page 1 of 2
NRC FORM 592M U.S. NUCLEAR REGULATORY COMMISSION
(10-04-2022)
Materials Inspection Record (Continued)
The inspection consisted of interviews with select licensee personnel; review of select records; and tours of the main
hospital nuclear medicine, PET/CT clinic, heart institute, oncology department, and Union Hospital-Clinton. The
inspector observed several administrations of Tc-99m doses to a patient for a cardiac stress test and FDG for PET
scan. The inspector: (1) observed the NMT conduct a physical inventory of sealed sources, and all sources were
accounted for; (2) had the NMT demonstrate the implementation of Y-90 SIR-spheres microspheres procedures as
well as the preparation, administration of microspheres, and area surveys; (3) had the NMT demonstrate package
receipt surveys and wipes procedure, the dose calibrator constancy check, the end of the day daily area surveys and
weekly wipe tests, and proper handling of radioactive waste and disposal procedures. The inspector had the NMT
demonstrate the Sr/Rb generator's daily QC and every 2 weeks calibration processes. The inspector observed the
appropriate saline solution was connected to the generator, and reviewed the Strontitum breakthrough level; no
issues were noted. The inspector had the AMP conduct physical inventory of Cs-137 temporary implant sealed
sources and the I-125 seeds; all sources were accounted for. The inspector conducted independent and
confirmatory surveys and found no residual contamination or exposures to members of the public in excess of
regulatory limits. Through these observations, demonstrations, and other discussions, the inspector found that the
licensee personnel were knowledgeable of radiation protection principles, licensee procedures, and regulatory
requirements.
The inspector reviewed selected Cs-137 temporary implants, I-125 prostate seed implants, I-131 hyperthyroid and
thyroid ablation, Y-90 SIR-spheres microshperes, and Ra-223 Xofigo written directives and pre- and post-treatment
plans. The inspector reviewed the licensee's calculations for compliance with patient release requirements in
10 CFR 35.75. The inspector reviewed the following records: annual audits, radiation safety committee minutes,
quarterly program audits, package receipts, waste disposal records, DOT Hazmat training, linearity and accuracy of
the dose calibrator, daily area surveys and weekly wipe tests, and sealed source leak tests. The inspector reviewed
the dosimetry records for 2021 through November 30, 2022 indicating the maximum annual dose to be 589 mrem -
No violations of NRC requirements were identified as a result of this inspection.
Signature and Date - Branch Chief
Digitally signed by Rhex A. Edwards
Date: 2023.03.24 10:38:44 -05'00'
NRC Form 592M (10-04-2022) Page 2 of 2