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 a record review and an interview with the center manager, the laboratory failed to verify the performance of the Reichert Refractometer serial number 08648- 0215 before reporting patient protein test results in August 2017. Findings: 1. A record review of calibration verification reports for eight refractometers in use for protein testing revealed the laboratory failed to perform and document the calibration verification and control activities for serial number 08648-0215 that was put into service on August 5, 2017. 2. An interview on May 7, 2018 at 9:45 AM, with the center manager, confirmed the laboratory failed to perform the verification of performance activities prior to reporting patient protein test results. 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 --