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 survey review of a patient's basic metabolic panel (BMP) test report and laboratory reference ranges and interview with the laboratory lead, staff A, the reference range shown on the patient report was not the same as the approved reference ranges for a BMP performed on the Abbott I-Stat chemistry analyzer. Findings include: 1. Review of the reference range of the BMP test report performed on the Abbott I-Stat from February 16, 2023, in the electronic medical record (EMR) for patient one (a 19-year-old male) showed the following reference ranges: Analyte /Reference Range Sodium(NA)/136-145 mmol/L Potassium(K)/3.5-5.1 mmol/L Chloride(CL)/100-110 mmol/L Glucose/74-99 mg/dL Blood Urea Nitrogen(BUN)/7- 26 mg/dL Creatinine/0.70-1.30 mg/dL 2. Review of the "I-Stat Normal Range, Linearity and Critical Values: Eastern Section of Ascension Northern Region Lab" reference range list showed the following reference ranges: Analyte/Reference Range NA/138-146 mmol/L K/3.5-4.9 mmol/L CL/98-109 mmol/L Glucose/70-105 mg/dL BUN/8-26 mg/dL Creatinine/0.6-1.3 mg/dL 3. Interview with staff A on February 16, 2023, at 1:05 PM confirmed the reference ranges in the EMR was not consistent with the approved reference ranges for testing performed on the Abbott I-Stat chemistry analyzer. 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 --