Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of reference ranges stated in the I-Stat laboratory procedure manual, one of one selected test reports and interview with the technical consultant, the laboratory failed to ensure test reports included pertinent normal values (reference ranges) as determined by the laboratory. Ten of eleven reference ranges listed on the laboratory information system (LIS) test report differed from those stated in the approved procedure manual. Findings: 1. Review of patient test report # 006823 generated from the LIS system revealed reference ranges for ten analytes did not match those stated in the procedure manual. LIS patient test report Procedure Manual Sodium 136-145 Sodium 138-146 Potassium 3.5-5.1 Potassium 3.5-4.9 i Calcium 1.12-1.30 i Calcium 1.12-132 Glucose 60-100 Glucose 70-105 Hematocrit 37-47 Hematocrit 38-51 Hemoglobin 12.8-16.0 Hemoglobin 12-17 Venous blood gases pH 7.310-7.45 pH 7.31-7.41 pO2 40-45 pO2 none stated TCO2 22-26 TCO2 24-29 HCO3 22-28 HCO3 23-28 2. Interview with the technical consultant on December 17, 2024 at 11:55 AM confirmed the laboratory failed to ensure pertinent reference ranges stated in the procedure manual were included for LIS generated patient test reports. The technical consultant was unable to determine the source of reference ranges stated in the LIS and available for interpretation of 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 --