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The following information was received fro … The following information was received from the Minnesota Department of Health (MDH) via email:</br>We (MDH) received an initial report on 6/15/22 at 1515 CDT of a reportable medical event. The event occurred at the University of Minnesota, license number 1049, in Minneapolis on 6/14/22. The event involved a treatment with Y-90 SirSpheres where 2.2 GBq was ordered but a 5.1 GBq unit dose was delivered and administered. The licensee is working through dose calculations. No additional details are available at this time. Follow up information will be sent when it becomes available.</br>A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.</br>* * * UPDATE ON 7/6/22 AT 1013 EDT FROM SHERRIE FLAHERTY TO ERNIE WEST * * *</br>The normal procedure for this therapy is to order a dose from the manufacturer a couple of weeks prior to the treatment so the radiopharmacy has the material on hand. The dosage ordered from the manufacturer is limited to few vial activities (want to make sure there will be enough for the therapy), and the actual dose to administer to the patient is drawn up by the pharmacy the day of the procedure. The pharmacy delivers the patient dose to the nuclear medicine department. Nuclear Medicine will check the activity compared to the shipping paper to make sure it is within range. They will also do the pre-measurements for determining the residual after the treatment. They will write the activity on the top of the Nalgene jar and bring it to interventional radiology. Interventional radiology will verify the dose on the lid and perform the administration. The residual is determined from the waste in the Nalgene jar per the standard microsphere procedure. The written directive is signed by the authorized user once the residual and actual dose given is determined.</br>In the case on June 14, 2022, there was a communication error between the radiopharmacy (Jubilant) and the person ordering the dose. The pharmacy verified and the person who ordered the dose confirmed the dose was 5.6 GBq (the entire vial amount from the manufacturer). After drawing the dose, the activity in the vial the pharmacy sent was 5.1 GBq (they are not able to draw 100% of the material). Once received in nuclear medicine, the nuclear medicine technologist did their process, including comparing the dose in the vial with the shipping papers from the pharmacy (not the dose prescribed). The dose was brought to interventional radiology for the administration. The interventional radiologist did not see the activity on the Nalgene jar and was unaware that the activity was on the label. Without verifying the activity the interventional radiologist administered the dose. After the procedure the residual was calculated and it was determined that 5.1 GBq was administered (139 mCi prescribed and 137 mCi administered). The Authorized User signed the written directive after the procedure with the 139 mCi prescribed and 137 mCi administered activity. The prescribing physician (interventional radiologist) realized the error the next day when reading the post report.</br>The State performed an on-site investigation and is pursuing enforcement actions. The event is still open. Minnesota will continue to keep NRC informed of the status of the investigation.</br>Notified R3DO (Lafranzo) and NMSS (Rivera-Cappella)R3DO (Lafranzo) and NMSS (Rivera-Cappella)
05:00:00, 14 June 2022 +
55,947 +
10:19:00, 16 June 2022 +
05:00:00, 14 June 2022 +
The following information was received fro … The following information was received from the Minnesota Department of Health (MDH) via email:</br>We (MDH) received an initial report on 6/15/22 at 1515 CDT of a reportable medical event. The event occurred at the University of Minnesota, license number 1049, in Minneapolis on 6/14/22. The event involved a treatment with Y-90 SirSpheres where 2.2 GBq was ordered but a 5.1 GBq unit dose was delivered and administered. The licensee is working through dose calculations. No additional details are available at this time. Follow up information will be sent when it becomes available.</br>A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.</br>* * * UPDATE ON 7/6/22 AT 1013 EDT FROM SHERRIE FLAHERTY TO ERNIE WEST * * *</br>The normal procedure for this therapy is to order a dose from the manufacturer a couple of weeks prior to the treatment so the radiopharmacy has the material on hand. The dosage ordered from the manufacturer is limited to few vial activities (want to make sure there will be enough for the therapy), and the actual dose to administer to the patient is drawn up by the pharmacy the day of the procedure. The pharmacy delivers the patient dose to the nuclear medicine department. Nuclear Medicine will check the activity compared to the shipping paper to make sure it is within range. They will also do the pre-measurements for determining the residual after the treatment. They will write the activity on the top of the Nalgene jar and bring it to interventional radiology. Interventional radiology will verify the dose on the lid and perform the administration. The residual is determined from the waste in the Nalgene jar per the standard microsphere procedure. The written directive is signed by the authorized user once the residual and actual dose given is determined.</br>In the case on June 14, 2022, there was a communication error between the radiopharmacy (Jubilant) and the person ordering the dose. The pharmacy verified and the person who ordered the dose confirmed the dose was 5.6 GBq (the entire vial amount from the manufacturer). After drawing the dose, the activity in the vial the pharmacy sent was 5.1 GBq (they are not able to draw 100% of the material). Once received in nuclear medicine, the nuclear medicine technologist did their process, including comparing the dose in the vial with the shipping papers from the pharmacy (not the dose prescribed). The dose was brought to interventional radiology for the administration. The interventional radiologist did not see the activity on the Nalgene jar and was unaware that the activity was on the label. Without verifying the activity the interventional radiologist administered the dose. After the procedure the residual was calculated and it was determined that 5.1 GBq was administered (139 mCi prescribed and 137 mCi administered). The Authorized User signed the written directive after the procedure with the 139 mCi prescribed and 137 mCi administered activity. The prescribing physician (interventional radiologist) realized the error the next day when reading the post report.</br>The State performed an on-site investigation and is pursuing enforcement actions. The event is still open. Minnesota will continue to keep NRC informed of the status of the investigation.</br>Notified R3DO (Lafranzo) and NMSS (Rivera-Cappella)R3DO (Lafranzo) and NMSS (Rivera-Cappella)
Has query"Has query" is a predefined property that represents meta information (in form of a <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Subobject">subobject</a>) about individual queries and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
00:00:00, 6 July 2022 +
1049 +
Modification date"Modification date" is a predefined property that corresponds to the date of the last modification of a subject and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
11:30:06, 7 July 2022 +
10:19:00, 16 June 2022 +
2.222 d (53.32 hours, 0.317 weeks, 0.073 months) +
05:00:00, 14 June 2022 +
URL"URL" is a <a href="/Special:Types/URL" title="Special:Types/URL">type</a> and predefined property provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a> to represent URI/URL values.