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 the patient test report, approved reference ranges in the laboratory procedure manual, and interview with the testing personnel #1 , the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. 11 of the 13 routine chemistry parameters listed on the laboratory information system (LIS) report differed from those in the approved procedure manual. Findings: 1. Review of the patient report from the LIS system revealed 11 of the 13 parameters for routine chemistry testing did not correctly match those reference ranges in the procedure manual. LIS patient report Procedure manual pO2 75-100 mmHg 83-100 mmHg BE -2.0-2.0 mEq/L no value HCO3 22.0-26.0 mEq/L no value hematocrit-male 38-51% 39-49% sodium 138-146 mmol/L 136-146 mmol/L potassium 3.5-4.9 mmol/L 3.5-5.1 mmol/L chloride 98-109 mmol/L 98-106 mmol/L glucose 70-105 mmol/L 70-110 mmol/L ionized calcium 1.12-1.32 mmol/L 1.09-1.30 mmol/L hemoglobin 12.0-17.0 g/dl no value TCO2 24-29 mmol/L no value 2. Interview with the testing personnel #1 on April 3, 2019 at 11:00 AM confirmed the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. 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 --