Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation record review, and interview with the laboratory director, the laboratory failed to document monthly maintenance for the Sysmex XP-300 Analyzer for 2 (October 2025, November 2025) of 4 months reviewed. Findings include: 1. On 1 /28/2026 at 2:00 p.m., during a tour of the laboratory, the surveyor observed that the Sysmex XP-300 Analyzer was not present in the laboratory. 2. A review of the laboratory's maintenance records revealed that required maintenance for the Sysmex XP-300 Analyzer was not documented for October 2025 and November 2025. 3. An interview conducted on 1/28/2026 at 3:15 p.m. with the Laboratory Director confirmed that the Sysmex XP-300 Analyzer was picked up by the manufacturer on December 17, 2025, and that the laboratory did not document required maintenance for the analyzer for October 2025 and November 2025. 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 --