Avera Marshall Regional Medical Center

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 ensure one of four reportable ranges obtained during one of five performance verification (PV) activities completed in 2021 was adopted by the laboratory. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 08:10 a. m. on 08/25/22. 2. A Stago STA Compact Max hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification (PV) activities on the STA Compact Max for Prothrombin Time (PT), Activated Partial Thromboplastin Time, Fibrinogen, and D-Dimer were completed in May 2021 as indicated in laboratory records found in the STA Compact Max Method Verification Manual. 4. The upper PT reportable range limit adopted by the laboratory did not reflect the actual PT reportable range value obtained by the laboratory during the PV as indicated in the reportable range verification documents. See below. Analyte PV Adopted PT 10.0-109.2 10-120 5. The upper and lower PT reportable range limits indicated in the Prothrombin Time (PT) procedure found in the electronic procedure software PolicyStat did not reflect the actual PT reportable range values Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- obtained by the laboratory during the PV. See below. Analyte PV Procedure PT 10.0- 109.2 0.0-120 6. In an interview at 3:00 p.m. on 08/25/22, GS1 confirmed the above finding. -- 2 of 2 --

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 ensure the reportable range obtained during performance verification of two new Chemistry analytes was adopted by the laboratory. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/23/20, at 8:15 a.m. 2. A Beckman Coulter Access 2 chemistry analyzer was observed as present and available for use during the tour of the laboratory. 3. The laboratory completed performance verification (PV) activities for Free Triiodothyronine (FT3) and Prostate-Specific Antigen (PSA) analytes and began testing patient specimens using this analyzer in July 2020 as indicated by the GS during the tour and confirmed via laboratory records. 3. The reportable ranges found in procedures located in the online procedure program Policystat did not reflect the actual reportable range values obtained by the laboratory during the PV. See below. Procedure titles Free T3 - Access 2 PSA - Hybridtech for Access 2 Analyte PV Procedure FT3 1.31-30.0 0.88-30 PSA 0.07- 147.65 0.01-142.0 4. In an interview at 2:55 p.m. on 10/23/20, the GS confirmed the above finding and indicated the laboratory had adopted the manufacturer's analytical measurement range as the reportable range for the analytes. 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 --