ML25132A199
| ML25132A199 | |
| Person / Time | |
|---|---|
| Site: | 03039271 |
| Issue date: | 05/20/2025 |
| From: | Farrah Gaskins NRC Region 1 |
| To: | Marquez-Veglio G Cardiovascular Radiology Institute |
| References | |
| IR 2025001 | |
| Download: ML25132A199 (1) | |
See also: IR 07100202/1950001
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
REGION I
475 ALLENDALE ROAD - SUITE 102
KING OF PRUSSIA, PA 19406-1415
May 20, 2025
Gerardo Marquez-Veglio, President
Cardiovascular Radiology Institute, Inc.
P.O. Box 9101
San Juan, PR 00908-9101
SUBJECT:
CARDIOVASCULAR RADIOLOGY INSTITUTE, INC. - NRC INSPECTION NO.
030-39271/2025001 AND NOTICE OF VIOLATION
Dear Gerardo Marquez-Veglio:
This letter refers to the inspection conducted on February 5, 2025, at your Coto Laurel, PR
facility with continued in-office review through May 8, 2025. This inspection examined activities
conducted under your license as they relate to public health and safety, and to confirm
compliance with the Commissions rules and regulations and with the conditions of your license.
Within these areas, the inspection consisted of selected examinations of procedures and
representative records, observations of activities, and interviews with personnel. An exit meeting
was held by phone on May 8, 2025, with Lynes Matos Rodriguez.
Based on the results of this inspection, the NRC has determined that two Severity Level IV
violations of NRC requirements occurred. These violations were evaluated in accordance with
the NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs website
at https://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violations are
cited in the enclosed Notice of Violation (Notice) because the violations were identified by the
NRC.
With respect to violation A, the NRC has concluded that information regarding: (1) the reason
for the violation; (2) the corrective actions that have been taken and the results achieved; and
(3) the date when full compliance was achieved is already adequately addressed on the docket
and include: necessary dose calibrator calibrations were performed on February 10, 2025, and
the procedure for performing dose calibrator geometry testing was updated. Therefore, you are
not required to respond to this letter for this violation unless the description herein does not
accurately reflect your corrective actions or your position. In that case, or if you choose to
provide additional information, you should follow the instructions specified in the enclosed
Notice.
With respect to violation B, you are required to respond to this letter and should follow the
instructions specified in the enclosed Notice when preparing your response. If you have
additional information that you believe the NRC should consider, you may provide it in your
response to the Notice. The NRC review of your response to the Notice will also determine
whether further enforcement action is necessary to ensure compliance with regulatory
requirements.
In accordance with 10 CFR 2.390 of the NRCs Agency Rules of Practice and Procedure, a
copy of this letter and your response will be made available electronically for public inspection in
G. Marquez-Veglio
2
the NRC Public Document Room (PDR) or from the NRC document system (ADAMS),
accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. To the extent
possible, your response should not include any personal privacy, proprietary, or safeguards
information so that it can be made available to the public without redaction.
If you have any questions regarding this matter, please contact Jonathan Pfingsten of my staff
at 630-829-9853 or via electronic mail at Jonathan.Pfingsten@nrc.gov.
Thank you for your cooperation.
Sincerely,
Farrah C. Gaskins, Acting Chief
Medical and Licensing Assistance Branch
Division of Radiological Safety and Security
Region I
License No. 52-35636-01
Docket No. 030-39271
Enclosure:
cc w/ enclosure
Lynes Matos Rodriguez,
Radiation Safety Officer
FARRAH
GASKINS
Digitally signed by
Date: 2025.05.20
14:46:27 -04'00'
G. Marquez-Veglio
3
SUBJECT:
CARDIOVASCULAR RADIOLOGY INSTITUTE, INC. - NRC INSPECTION NO.
030-39271/2025001 AND NOTICE OF VIOLATION DATED MAY 20, 2025
ADAMS ACCESSION NO. ML25132A199
x
SUNSI Review
x
Non-Sensitive
Sensitive
x
Publicly Available
Non-Publicly Available
OFFICE
RI/DRSS
RI/DRSS
NAME
JPfingsten
FGaskins
DATE
05/13/2025
05/15/2025
OFFICIAL RECORD COPY
Cardiovascular Radiology Institute, Inc.
Docket No. 030-39271
Coto Laurel, PR
License No. 52-35636-01
During an NRC inspection conducted on February 5, 2025, with continued in-office review
through May 8, 2025, two violations of NRC requirements were identified. In accordance with
the NRC Enforcement Policy, the violations are listed below:
A. 10 CFR 35.60(b) requires that a licensee shall calibrate the instrumentation possessed
and used to measure the activity of unsealed byproduct material before it is administered
to each patient or human research subject in accordance with nationally recognized
standards or the manufacturers instructions.
The standards utilized by the licensee require that the test for geometry independence
will be conducted using syringes that are representative of the entire range of size,
shape, and constructions normally used for injections or administrations.
Contrary to the above, prior to February 10, 2025, the licensee did not calibrate the
instrumentation possessed and used to measure the activity of unsealed byproduct
material before it was administered to each patient or human research subject in
accordance with nationally recognized standards or the manufacturers instructions.
Specifically, the licensee did not test for geometry independence using syringes that
were representative of the entire range of size, shape, and constructions normally used
for injections or administrations. The licensee utilized 5 CC syringes for some of their
studies but had not performed geometry independence for this size syringe. Following
the NRCs identification of the issue, the licensee performed geometry testing for the
5 CC syringes to address the violation and preemptively performed geometry testing for
10 CC syringes; the tests were performed with satisfactory results. The licensees
procedures were revised to reflect the need to perform geometry testing for syringes that
are representative of the entire range of size, shape, and constructions normally used for
injections or administrations.
This is a Severity Level IV violation (Enforcement Policy Section 6.7.d).
B. 10 CFR 35.63(d) requires that, unless otherwise directed by the authorized user, a
licensee may not use a dosage if the dosage does not fall within the prescribed dosage
range or if the dosage differs from the prescribed dosage by more than 20 percent.
Contrary to the above, prior to the inspection on February 5, 2025, without otherwise
being directed by the authorized user, the licensee used dosages that did not fall within
the prescribed dosage range, or the dosage differed from the prescribed dosage by
more than 20 percent. Specifically, for administrations of fluorodeoxyglucose (FDG), the
licensee utilizes a mass-based dosage prescription; for administrations of pylarify,
the licensee utilizes a prescribed dosage range of 8-10 mCi. Examples of FDG
administrations outside of the approved range included administering 15.1 mCi with a
prescribed dosage of 11.7 mCi on October 10, 2024, 14.9 mCi with a prescribed dosage
of 10 mCi on August 30, 2024, 16.5 mCi with a prescribed dosage of 8.4 mCi on
March 27, 2024, and 6.7 mCi with a prescribed dosage of 11.1 mCi on February 2, 2024.
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Cardiovascular Radiology Institute, Inc.
Examples of pylarify administrations outside of the approved range include
administrations of 10.7 mCi on October 7 and October 10, 2024, 11.4 mCi on
December 18, 2023, and and 6.8 mCi on November 3, 2023.
This is a Severity Level IV violation (Enforcement Policy Section 6.3.d).
The NRC has concluded that information regarding the reason for violation A, the corrective
actions taken and planned to correct the violation and prevent recurrence and the date when full
compliance will be achieved is already adequately addressed on the docket. However, you are
required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the
description therein does not accurately reflect your corrective actions or your position. In that
case, or if you choose to respond, clearly mark your response as a Reply to a Notice of
Violation, and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control
Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region I, within 30
days of the date of the letter transmitting this Notice of Violation (Notice).
Pursuant to the provisions of 10 CFR 2.201, Cardiovascular Radiology Institute, Inc. is hereby
required to submit a written statement or explanation to the U.S. Nuclear Regulatory
Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the
Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice
of Violation (Notice). This reply should be clearly marked as a Reply to a Notice of Violation
and should include for violation B: (1) the reason for the violation, or, if contested, the basis for
disputing the violation, (2) the corrective steps that have been taken and the results achieved,
(3) the corrective steps that will be taken to avoid further violations, and (4) the date when full
compliance will be achieved. Your response may reference or include previous docketed
correspondence, if the correspondence adequately addresses the required response. If an
adequate reply is not received within the time specified in this Notice, an order or a Demand for
Information may be issued as to why the license should not be modified, suspended, or
revoked, or why such other action as may be proper should not be taken. Where good cause is
shown, consideration will be given to extending the response time.
If you contest this enforcement action, you should also provide a copy of your response to the
Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington,
DC 20555-0001. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, any response
which contests an enforcement action shall be submitted under oath or affirmation.
Your response will be placed in the NRC Public Document Room (PDR) and on the NRC
website. To the extent possible, it should, therefore, not include any personal privacy,
proprietary, or safeguards information so that it can be made publicly available without
redaction. However, if you find it necessary to include such information, you should clearly
indicate the specific information that you desire not to be placed in the PDR and provide the
legal basis to support your request for withholding the information from the public.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working
days of receipt.
Dated 20th day of May 2025.