Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) (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 a patient test report for the EPOC analyzer and interview with the laboratory director (LD) and testing personnel (TP), the laboratory failed to ensure the test report had normal values available to the authorized person who ordered the test. Findings include: 1. Review of patient test report for EPOC analytes, revealed no normal ranges were available. a. Analytes included are pH, pCO2, pO2, Sodium, Potassium, ionized calcium, chloride, hematocrit, glucose, lactate, creatinine, blood urea nitrogen and total carbon dioxide. 2. Interview with the LD and TP #1 at 11: 45am on 04/16/2026 confirmed there were no normal ranges on the test report. 3. The laboratory performs 12,000 EPOC test panels annually. 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 --