Summary:
Summary Statement of Deficiencies D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) (d)(6) Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the reagent log, review of quality control records, and staff interview, the laboratory failed to perform quality control (QC) after changing reagents on the Sysmex XS-1000i complete blood count (CBC) analyzer in October 2023 and May 2025. The findings include: 1. Observation of the laboratory on 06.04.2025 at 9:00 a.m. revealed a Sysmex XS-1000i (Serial Number 70754) hematology analyzer used for complete blood count (CBC) patient testing. 2. A review of the Sysmex XS-1000i reagent log revealed that the laboratory changed reagents on the analyzer on 10.06.2023 at 4:45 p.m. and 05.14.2025 at 1:24 p.m. 3. A review of the Sysmex XS-1000i quality control records revealed no documentation that the laboratory ran QC after changing reagents on 10.06.2023 (QC lot 3261) and 05.14.2025 (QC lot 5090). 4. An interview with the technical consultant on 06.04.2025 at 12:30 p.m. confirmed the above survey findings. D5781