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Hello Andrew, Please see my responses below. Thank you for providing the link to QC technical support. I will submit any future concerns through that portal. Field Required Customer Entry Customer Identification Number (CID) 021415 Contact Name Katherine Wesson Contact Email katherine.s.wesson@kp.org Sales Order # (or) Lot# (or) Part# *Two of the three are required Sales Order # 54934 Lot # D5369 Product # 88119 What happened? (e.g., Part number 1234 was shipped) Degradation of analyte in quality control material. Although a steady downward trend is observed in the four analytes monitored in this control (methanol, ethanol, acetone, isopropanol), acetone displays a significant degradation after only 4.5 months of use. What should have happened? (e.g., part number XYZ should have been shipped) Normally, once established, the QC range for the volatiles control requires no adjustment for the life of the lot. Additional Comments (e.g., steps already taken to troubleshoot, additional notes, or preferred resolutions) Three calibrator lots have been in use since the QC material was implemented in production. Only one instrument runs this assay; maintenance is up to date, a PM was done recently on 08/25/25 - FSE did not find anything. CAP survey material was repeated, and the repeat results were comparable to the original results, which indicates to us there is no issue with instrument performance, further supporting our suspicion that the QC material is degrading. Samples of the QC material were sent out to Quest for comparison, and their data also showed values in the range similar to what we are recovering. Regards, Katherine Wesson Toxicology QA/QC Supervisor Kaiser Regional Laboratory 914 Marina Way S Richmond, CA 94804 Office Phone: 510-231-5172 Email: katherine.s.wesson@kp.org ________________________________________ From: Andrew Hartmann <ahartmann@utak.com> Sent: Thursday, September 18, 2025 9:15 AM To: Katherine S Wesson <Katherine.S.Wesson@kp.org>; Kevin Kopp <kevin@utak.com> Cc: Christine M Mulakken <Christine.M.Giang@kp.org>; Sarah B Shugarts <Sarah.B.Shugarts@kp.org>; Jay L Salas <Jay.Salas@kp.org>; Julie Cruz <Julie.Cruz@kp.org>; Melinda K. Wade <Melinda.K.Wade@kp.org> Subject: RE: Volatiles Control - Lot D5369 Caution: This email came from outside Kaiser Permanente. Do not open attachments or click on links if you do not recognize the sender. ________________________________________ Hello Katherine, Thank you for reaching out to UTAK. We’re here to help and want to resolve this quickly. For the most expedient support (or troubleshooting guides), you may submit your request here: UTAK QC Tech Support. Could you please share the following details so we can properly log and investigate your concern? Field Required Customer Entry Customer Identification Number (CID) Contact Name Contact Email Sales Order # (or) Lot# (or) Part# *Two of the three are required What happened? (e.g., Part number 1234 was shipped) What should have happened? (e.g., part number XYZ should have been shipped) Additional Comments (e.g., steps already taken to troubleshoot, additional notes, or preferred resolutions) Once we have this information, we can move forward quickly with next steps. We appreciate your partnership and look forward to resolving this promptly. Best regards, Andrew Hartmann Business Development Manager – 25020 Avenue Tibbitts Valencia, CA 91355 – D +1.661.567.0667 P +1.888.UTAK.LAB F +1.661.294.9272 – Book a Meeting with Me https://calendly.com/ahartmann-utak/30min utak.com From: Katherine S Wesson <Katherine.S.Wesson@kp.org> Sent: Wednesday, September 17, 2025 6:05 PM To: Support@UTAK <support@utak.com> Cc: Christine M Mulakken <Christine.M.Giang@kp.org>; Sarah B Shugarts <Sarah.B.Shugarts@kp.org>; Jay L Salas <Jay.Salas@kp.org>; Julie Cruz <Julie.Cruz@kp.org>; Melinda K. Wade <Melinda.K.Wade@kp.org> Subject: Volatiles Control - Lot D5369 Importance: High Hello UTAK, The stability of Volatiles Control Lot D5369 has not been comparable to previous lots. All analytes have been treding down, most especially acetone. This lot has been in use since 04/28/25 and we have observed a steady drift in recovery over time. The verified value for this lot is 75 mg/dL, but our current set mean is 64.5 mg/dL. The calibrator material has been replaced multiple times since this control started. The instrument has been PM'd and verified as acceptable by the vendor's engineer. We store this material at the recommended refrigerator temperature, stored at 2-8 oC, and the refrigerator is montired 24/7 with no recorded outliers. The control is reconstituted per insert instructions. Have any customers contacted UTAK about this material? Would it be possible to review the manufacturing records for this control material? Is the storage condition of 2-8oC still correct? Regards, Katherine Wesson Toxicology QA/QC Supervisor