Csl Plasma, Inc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Assistant Manager of Quality (AMQ), the laboratory failed to ensure that quality control materials (1 of 10) were not used beyond their expiration dates. Findings include: 1. During a tour of the laboratory conducted on 07/29/2025 at 9:30 AM, the surveyor observed one unopened vial of Normal Level Refractol (Lot# K305912) with an expiration date of 11/30 /2024. The expired vial was stored alongside nine unexpired vials of Normal Level Refractol (Lot# STI586N, expiration date 04/30/2026). 2. A review of the laboratory's policy titled Digital Refractometer Activities on page 3 of 3 revealed in the section titled Control Reading, "Inspect the control vial for suitability - Control is not expired ...". 3. A review of the laboratory's policy titled Reagent and Vaccine Check on page 1 of 2 revealed in the section titled Expired Reagents, Controls or Vaccines, "Discard any expired reagents and controls by placing them in a sharp's container.". 4. An interview was conducted on 07/29/2025 at 9:35 AM, with the AMQ who confirmed that an expired control was available for use to test patients. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the Quality Manager (QM), the Technical Consultant (TC), failed to evaluate and document competency at least semiannually in the first year of testing for 2 (Testing Personnel (TP) #6 and #15) of 24 testing personnel listed on the CMS-209 form. Findings include: 1. A review of personnel records revealed for 2 (TP #6 and #15) of 24 TP the following competency assessment dates: a. TP #6 - initial 6/17/2021, no assessment in 12/2021 for the 6 month b. TP #15 - initial assessment on 12/17/2019 and the annuals on 11/24/2020 and 11/16/2021 2. The surveyor requested documentation of the semiannual competency assessments in the first year for TP #6 and #15 on 1/19/2022 at 9:57 am and it was not made available. 3. An interview on 1/19/2022 at 9:57 am, the QM confirmed the laboratory did not have documentation of the semiannual competency assessment for TP #6 and #15. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --