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 observation, document review, and interview with laboratory personnel, the laboratory failed to complete a reportable range verification for one of one non- waived test systems implemented by the laboratory in 2022. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Technical Supervisor 3 (TS3) during a tour of the laboratory at 10:10 a.m. on 08/21/23. 2. An Abbott i- STAT analyzer was observed as present and available for use during the tour of the laboratory. Testing using the CHEM8+ panel cartridge on this analyzer was implemented in July 2022 as indicated by Technical Supervisor 1 and confirmed in laboratory records. 3. Reportable range verification documentation for CHEM8+ testing on the i-STAT was not found during review of the laboratory's New Instrument Validation Studies for the i-STAT located in the 2023 QC Logs: i-STAT and Coagulation manual. The laboratory was unable to provide CHEM8+ reportable range verification records upon request. 4. The New Instrument Validation for the I- STAT & Hemacron Jr. Signature + and Signature Elite procedure did not include instruction to perform reportable range verification. 5. In an interview at 12:50 p.m. on 008/21/23, TS1 confirmed the above finding. . 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 --