ML25133A075
| ML25133A075 | |
| Person / Time | |
|---|---|
| Site: | 03011072 |
| Issue date: | 05/14/2025 |
| From: | Rhex Edwards NRC/RGN-III/DRSS/MIB |
| To: | Howe K Union Hospital |
| References | |
| EAF-RIII-2025-0098 IR 2025001 | |
| Download: ML25133A075 (1) | |
See also: IR 07200202/1950001
Text
EAF-RIII-2025-0098
Kristi Howe
Supervisor Nuclear Cardiology
Union Hospital, Inc.
1606 N 7th St.
Terre Haute, IN 47804
SUBJECT:
NRC ROUTINE INSPECTION REPORT NO. 03011072/2025001(DRSS) AND
EXERCISE OF ENFORCEMENT DISCRETION - UNION HOSPITAL, INC.
Dear Kristi Howe:
This letter refers to a routine inspection conducted on April 1, 2025, by an inspector from the
U.S. Nuclear Regulatory Commission (NRC) at your facility in Terre Haute, with continued in-
office review through April 22, 2025. The purpose of the inspection was to review activities
performed under your NRC license to ensure that these activities were being performed in
accordance with NRC requirements. The purpose of the in-office review was to evaluate
additional information not available during the on-site inspection. Luis Nieves Folch of my staff
conducted a final exit meeting with you on April 22, 2025, to discuss the inspection findings.
This letter presents the results of the inspection.
During this inspection, the NRC staff examined activities conducted under your license related
to public health and safety. Additionally, the staff examined your compliance with the NRCs
rules and regulations as well as the conditions of your license. Within these areas, the
inspection consisted of selected examination of procedures and representative records,
observations of activities, and interviews with personnel.
Based on the results of this inspection, the NRC has determined that a violation of Title 10 of
the Code of Federal Regulations (10 CFR) 35.60 and 10 CFR 35.63 was identified during this
inspection. In accordance with the Enforcement Policy, this violation would normally be
categorized at Severity Level IV. However, in accordance with NRC Enforcement Guidance
Memorandum (EGM)13-003, issued April 18, 2013, the NRC is exercising enforcement
discretion and not pursuing any enforcement action for this violation.
Title 10 CFR 35.60 requires, in part, that licensees calibrate the instrument used to measure the
activity of the dosage before it is administered to each patient or human research subject. This
calibration may either be performed in accordance with nationally recognized standards or
calibration instructions provided by the manufacturer. However, the NRC determined that Union
Hospital Inc. was unable to calibrate the Rb-82 generator system in accordance with the
regulations because there are currently neither nationally recognized standards nor specific
calibration procedures for calibrating detectors in a dynamic mode (i.e., while liquids are flowing
past the detector). Until such standards or procedures are developed, compliance with 10 CFR
35.60 is not possible. Additionally, 10 CFR 35.63 requires, in part, that a licensee determines
May 14, 2025
K. Howe
2
the activity of each dosage administered before medical use. However, the NRC concluded that,
due to the 76-second half-life of Rb-82 and direct infusion of the Rb-82 into the patient, users of
this generator system are unable to measure patient dosages of Rb-82 prior to administration.
Although violations of 10 CFR 35.60 and 35.63 were identified, which, in accordance with the
NRC Enforcement Policy would normally be categorized at Severity Level IV, you met all of the
criteria in NRC Enforcement Guidance Memorandum (EGM) 13-003, Interim Guidance for
Dispositioning Violations involving 10 CFR 35.60 and 10 CFR 35.63 for the Calibration of
Instrumentation to Measure the Activity of Rubidium-82 and the Determination of Rubidium-82
Patient Doses, dated April 18, 2013. Therefore, the NRC is exercising enforcement discretion
and not pursuing any enforcement action for these violations.
The NRCs decision is based on the criteria listed in EGM 13-003. Specifically: (1) you have
written test procedures to ensure that the infusion pump flow rate is consistent and accurate,
and that the radiation detector meets the manufacturers specifications; (2) you have confirmed
that the required infusion rate and radiation detector tests were performed within the last twelve
months and have maintained records documenting the performance and results of these tests;
(3) all authorized users for medical uses under 10 CFR 35.200 who are using the Rb-82
generator and infusion cart, as well as the Radiation Safety Officer, have successfully
completed training specific to the manufacturer and model of generator and infusion cart being
used, and documentation of satisfactory completion of such training has been maintained; and
(4) you have recorded the activity of each dosage administered, as provided by the infusion
cart. No further action or response is required on your part with regards to these issues.
In accordance with the NRCs Agency Rules of Practice and Procedure in 10 CFR 2.390, a
copy of this letter, its enclosure and any response you provide will be made available
electronically for public inspection in the NRCs Public Document Room or from the NRCs
Agencywide Documents Access and Management System (ADAMS), accessible at
http://www.nrc.gov/reading-rm/adams.html. To the extent possible, any response you provide
should not include personal privacy, proprietary, or security-related information so that it can be
made publicly available without redaction.
Please feel free to contact Luis Nieves Folch of my staff if you have any questions regarding this
inspection. Luis can be reached at 630-829-9571 or Luis.NievesFolch@nrc.gov.
Sincerely,
Rhex Edwards, Chief
Materials Inspection Branch
Division of Radiological Safety and Security
Docket No. 030-11072
License No. 13-16457-01
cc :
State of Indiana
Signed by Edwards, Rhex
on 05/14/25
K. Howe
3
Letter to K. Howe from R. Edwards, dated May 14, 2025.
SUBJECT:
NRC ROUTINE INSPECTION REPORT NO. 03011072/2025001(DRSS) AND
NOTICE OF VIOLATION - UNION HOSPITAL, INC.
DISTRIBUTION:
MIB Inspectors
ADAMS Accession Number: ML25133A075
OFFICE
RIII-DRSS
RIII-EICS
RIII-DRSS
NAME
LNieves:mh
DBetancourt-Roldan
REdwards
DATE
5/13/2025
5/13/2025
5/14/2025
OFFICIAL RECORD COPY