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 surveyor review of performance verification records for the pocH-100i hematology analyzer and interview with the technical consultant, the laboratory did not verify the reference intervals for this test system prior to performing patient testing. Findings include: 1. Review of performance verification records for the pocH- 100i show no evidence that the reference ranges were evaluated prior to testing patient samples. 2. Interview with the technical consultant on September 27, 2018 at 10:15 AM confirmed that the reference ranges were not evaluated prior to testing patient samples. 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 --