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 observation of the laboratory, a review of the laboratory Quality Assurance (QA) Policy, one electronic medical record (EMR) patient test report, and staff interviews, the laboratory failed to include reference ranges for 4 of 6 capillary blood gas results for one of one patient reviewed in 2025, with one patient test performed since testing began on 03/26/2026. The findings include: 1. Observation of the laboratory on 03/30/2026 at 10:00 a.m. revealed an Abbott iSTAT analyzer serial number (SN)- (21)333002 using CG4+ cartridges (Lot 217W260240243) for patient blood gas testing. The six reported blood gas analytes are: Measured: - pH - PO2- partial pressure of oxygen - PCO2- partial pressure of carbon dioxide Calculated: - HCO3- bicarbonate - BE- base excess - sO2- oxygen saturation 2. A review of the laboratory QA policy revealed the following requirement: "Reference ranges are included with each patient report." 3. A review of one patient's test report in the EMR revealed no reference ranges for the following analytes: pH, PO2, PCO2, HCO3 4. An interview with the Respiratory Technician and the consulting Medical Technologist on 03/30/2026 at 12:00 p.m. confirmed the survey findings. 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 --