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 the demonstration of performance specifications and an interview with the laboratory director at 9:35 AM on 2/27/2018, the laboratory failed to demonstrate the reportable range for a new hematology instrument. Findings are: 1. Review of the validation of performance specifications for a new instrument used for complete blood counts (CBC's) (patient testing started on 12/15/2017), revealed no checks for reportable ranges had been included in the instrument validation. 2. Interview with the laboratory director confirmed a linearity or reportable range study had not been performed prior to patient testing. 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 --