[Intl_DxMedPhys] QC on Dedicated Cardiac PET/CT (IAC, TJC)

Fri Jan 23 12:34:42 EST 2026

Hi all,

The following NRC document may be helpful. Basically, since you can’t assay the dose prior to administration, the Bracco unit can’t meet the 35.60/35.63 requirements. The NRC knows this and somewhat ignores it if you meet the following requirements (I’ve not heard of anyone getting a violation on this, but I also haven’t looked very hard). Page 2 of the document (page 10 on the PDF), copied below.

RUBIDIUM-82 GENERATORS, EMERGING TECHNOLOGIES, AND OTHER MEDICAL USE OF BYPRODUCT MATERIAL https://urldefense.com/v3/__https://www.nrc.gov/docs/ML2312/ML23122A356.pdf__;!!KGKeukY!w58s9dayeIk23wnCijZ_-rVCdBo_bV2St4IUWxVywd1RbxZz7dmcn5bg_t49YEmqE-kdtHs8U8b0XkgFPKtArZlRuFELCacuA9z_qeYxitR8L6KD$ 

“Because licensees cannot meet the requirements of 10 CFR 35.60 and 10 CFR 35.63, the NRC
may exercise enforcement discretion in certain circumstances according to Enforcement Guidance
Memorandum (EGM) 13-003, “Enforcement Guidance Memorandum—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 Dosages,” dated April 18, 2013 (ML13101A318). Enforcement discretion may be used if all
three of the following criteria are met:

(1) The licensee must have written test procedures to ensure that the infusion pump flow rate
is consistent and accurate, and that the radiation detector meets the manufacturer’s
specifications. The licensee must perform the tests, at least every 12 months (and repeated
after repair or replacement), and maintain records documenting the performance of and
results of these tests. The radiation detector specifications are compared to the values
obtained during tests of the detector’s electronics and the response to a radiation source in
the static mode. The licensee may use documentation of the infusion cart maintenance
performed by the manufacturer to document the completion and results of the infusion rate
and radiation detector test.
(2) All authorized users (AUs) for medical applications under 10 CFR 35.200 who are using
Rb-82 chloride, as well as the radiation safety officer (RSO) for that facility, must have
successfully completed training specific to the manufacturer and model of generator and
infusion cart being used.
Such training must include (1) elution and quality control procedures needed to determine
Rb-82 activity and the strontium (Sr)-82 and Sr-85 breakthrough levels, (2) dose calibrator
calibration procedures, and (3) safety procedures for the clinical use of Rb-82 chloride.
Until the generator manufacturer develops static or dynamic calibration procedures for
calibrating the radiation detector in the infusion cart, the quality control procedures must
include (1) performance of the Rb-82 activity constancy check comparison with Rb-82
measured in a calibrated dose calibrator, (2) how to adjust the infusion cart readout setting,
and (3) when the manufacturer requires these tests.
This training requirement is met by satisfactory completion of a training program, which
addresses all of these required topics, provided by the manufacturer. The licensee must
maintain documentation that all AUs using Rb-82 and the RSO have satisfactorily
completed such training.
(3) The licensee records the activity of each dosage administered, as provided by the infusion
cart.

As discussed in section 3, enforcement discretion is not intended to be a long-term solution to
regulatory compliance issues. The alternatives evaluated in this regulatory basis involve
exemptions or rulemaking to resolve the calibration and dosage measurement compliance issues
for Rb-82 generators.

Best,

Michael

T. Michael Martin PhD, DABSNM, DABHP, LMP  |  Sr. Health Physicist and Assistant RSO
Environmental Health & Safety | Texas A&M University
4472 TAMU | College Station, TX 77843-4472

ph: 979.458.0365  |   michael.martin at tamu.edu<mailto:michael.martin at tamu.edu>
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From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu> On Behalf Of Scott Fuller via Intl_dxmedphys_wd_osu_list
Sent: Friday, January 23, 2026 10:47 AM
To: Nicole Ranger <nicoletranger at yahoo.com>
Cc: DxMedPhys List <intl_dxmedphys_wd_osu_list at lists.osu.edu>
Subject: Re: [Intl_DxMedPhys] QC on Dedicated Cardiac PET/CT (IAC, TJC)

Thank you, all, for the great feedback. I’m not internal for this organization and was provided the plans last week so I had some concerns/questions. The site shared that the vendor rep was fine with their proposed setup, but it certainly seems
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Thank you, all, for the great feedback. I’m not internal for this organization and was provided the plans last week so I had some concerns/questions. The site shared that the vendor rep was fine with their proposed setup, but it certainly seems
Thank you, all, for the great feedback.  I’m not internal for this organization and was provided the plans last week so I had some concerns/questions.  The site shared that the vendor rep was fine with their proposed setup, but it certainly seems like there are a few items that should be considered more thoroughly before proceeding.  There are likely some short-sited visions (at the facility) of what the suite will provide that don’t account for changes/adaptation down the road.

This is my first experience with a facility that is 100% dedicated to cardiac imaging with their PET/CT so there were a few items that are new to me. I appreciate the community responses and experiences shared.

Scott

On Jan 23, 2026, at 9:06 AM, Nicole Ranger <nicoletranger at yahoo.com<mailto:nicoletranger at yahoo.com>> wrote:

I concur with Erin.  Even though my most recent affiliation used unit doses, we committed to assaying doses prior to admin as a best practice.  We had at some point discovered a discrepancy in regional radiopharmacy dose assays which was addressed so it is important to have a secondary verification.  All of the above is relevant to SPECT and some PET applications where the half-life is long enough that a dose assay in the dose calibrator is feasible.  There are however, many applications where the half-life is short enough that you lose viable activity with any delays and there automatic injection and dose assaying within the automatic administration system becomes important.  Over and above whatever the manufacturer’s requirements are, I would write up a policy and procedure on how you will ensure the system is operating correctly and run this by your licensing agency.  We oftentimes have to spell out these details when renewing a license and the magnitude of the chan. ge you are describing is sufficient that you would want to either notify your regulators to get feedback on your plan and/or seek a license amendment that describes the operational change with the installation of this new system and any changes to you “Authorized Use” areas should you in fact decommission your hot lab (which I would not recommend).  There are stringent survey requirements
for doing so and as Erin pointed out, having a Hot Lab “just in case” is helpful and not overly burdensome because it is just one more location for surveying and conducting wipe tests.  Also, keep in mind that the Hot Lab is also oftentimes the location where sealed sources and radiopharnaceuticals are stored in inventory either temporarily or long-term.  It is also a convenient drop-off location for commercial radiopharmacy drivers or FEDEX.

Sent from my iPhone

On Jan 23, 2026, at 8:30 AM, Erin Niven via Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>> wrote:

I would think you would need at least a mini hot lab, with at least a shielded well counter, contamination monitor, spills kit, and waste container?

As for QC, I would expect the need to receive and use F-18 for acceptance testing if undergoing accreditation.  And has the PET/CT vendor said you never need F-18?

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On Friday, January 23, 2026 at 12:20:28 a.m. NST, Scott Fuller via Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>> wrote:

Yes, this is a Bracco system and it operates exactly as Michael has explained…the clinical dose assay occurs as the rubidium is injected into the patient.  Sounds like I need to ask a few more questions about the daily QC process to advise if the facility will want to keep its current dose calibrator (they are transitioning from SPECT to the PET/CT system).  To make room for the scanner, however, the hope is to be able to get rid of the hot lab.  I’ll ask a few more questions of everyone involved.

That still leaves me with the question of any sites who might be completing QC at a facility that does not routinely receive/handle F-18?  If anyone has that experience I would be appreciative of understanding what TJC/IAC expects.  Otherwise, my current advice to the facility is that they will need to set up an agreement to receive F-18 from a pharmacy (with whom they don’t currently have an agreement) to receive QC doses and perform ACR prescribed QC.

Thanks for the responses.

Scott

On Jan 22, 2026, at 7:00 PM, Michael Masiar via Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>> wrote:

The Rubidium generator I've seen (Bracco), has a built in scintillation detector that measures the dose as it leaves the generator. The patient gets hooked up to the generator device and it automatically gives the prescribed dose. You don't assay the dose in a dose calibrator prior to injection to the patient.

The system has a daily QC and calibration procedure though... The daily QC involves putting a dose into a vial and measuring with your dose calibrator...

So you don't assay the patient doses in a dose calibrator, but you do a QC procedure every morning that does go in the dose calibrator. I'm not sure how this could be done without one.

Michael Masiar MS DABR
Certified Medical Physicist
Therapy Physics, Inc.
2501 Cherry Ave., Suite 270
Signal Hill, CA 90755
email: mmasiar at gmail.com<mailto:mmasiar at gmail.com>
cell: 310-625-9906
office: 562-317-0650

On Thu, Jan 22, 2026 at 5:50 PM William Sensakovic via Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>> wrote:
Thinking of 10cfr35.63

William F. Sensakovic, PhD, MRSC(MRSE), FAAPM
Chair and Assoc. Prof., Mayo Clinic (Arizona)
Founder, Telerad Physics Teaching, LLC
________________________________
From: William Sensakovic <wfsensak at outlook.com<mailto:wfsensak at outlook.com>>
Sent: Thursday, January 22, 2026 5:20:21 PM
To: DxMedPhys List <intl_dxmedphys_wd_osu_list at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>>
Subject: Re: [Intl_DxMedPhys] QC on Dedicated Cardiac PET/CT (IAC, TJC)

I did not think that would be allowed. If they are drawing from a generator themselves (instead of getting unit doses from the radiopharmacy) I thought they are required to assay dose before injection. I thought you can avoid dose assay only if you use a unit dose.
Am I mistaken?

William F. Sensakovic, PhD, MRSC(MRSE), FAAPM
Chair and Assoc. Prof., Mayo Clinic (Arizona)
Founder, Telerad Physics Teaching, LLC
________________________________
From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces+wfsensak=outlook.com at lists.osu.edu<mailto:outlook.com at lists.osu.edu>> on behalf of Scott Fuller via Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>>
Sent: Wednesday, January 21, 2026 1:52:36 PM
To: DxMedPhys List <intl_dxmedphys_wd_osu_list at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>>
Subject: [Intl_DxMedPhys] QC on Dedicated Cardiac PET/CT (IAC, TJC)

I’m working with a facility that intends to install a Rubidium dedicated PET/CT system.  They would like to do so without installing any sort of a hot lab or dose measuring equipment as there is no intention of using anything other than Rb-82 (seems ok from a clinical perspective and all vendors involved have supported this).

My question is, does anyone have experience providing QC support for a setup such as this?  A dedication Rubidium unit that is not able to order, prepare, or store longer lived isotopes such as F-18?  I’m unsure how one would go about supporting an image quality assessment and program without, at minimum, scanning a filled phantom.

For accreditation purposes, the facility is under the umbrella of IAC and Joint Commission.  It looks like IAC provides some flexibility and will want the facility to follow manufacturer requirements.  Joint Commission provides me with a bit more confusion as to how the facility would meet the expectations.

Thanks, in advance, for any prior experiences or insights shared.

Scott

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