Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of Sysmex XN2000 hematology analyzers performance specifications and interview with the technical supervisor #1, the laboratory failed to ensure verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's population. Findings: 1. Review of the Sysmex XN2000 hematology analyzers performance specifications showed no verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's population for the analytes: white blood cell, red blood cell, hemoglobin, hematocrit and platelets since the start of patient testing in July 2020. 2. Interview with the TS #1 on June 9, 2021 at 11:00 AM confirmed the laboratory failed to ensure verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's population. 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 --