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 patient final test reports, review of laboratory's standard operating procedure (SOP) reference ranges for each analytes, and interview with the laboratory director, the laboratory failed to ensure that the printed final patients reports reference ranges matches the laboratory's standard operating procedure reference ranges for each analytes. Findings Include: 1. Review of patient final report, order # 129601, 36 year old male, date of service 09/08/2024, complete metabolic panel revealed the following. Analyte results Final Report Lab SOP a) Total Bilribin 0.0 -1.2 mg/dL 0.2 - 1.2 mg/dL b) Calcium 8.6 - 10.0 g/dL 8.6 - 10.2 g/dL c) Albumin 3.4 - 5.4 g/dL 3.4 - 5.0 g/dL 2. Interview with the laboratory director on 03/28/2025 at 11:50 AM confirmed these findings. 3. The laboratory performs 82,000 chemistry testing 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 --