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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure two reference intervals were consistent between a Hematology procedure and a patient test report. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 12:45 p.m. on 11/13/19. 2. An Abbott Cell-Dyn Emerald hematology analyzer was observed as present and available for use during the tour. 3. The Absolute Mid Cells (Mid Abs) and Red Blood Cell Distribution Width (RDW) reference intervals listed in the electronic procedure Hematology Normal Values were not consistent with those included on a patient test report reviewed on date of survey as indicated below. Patient #00750565 - adult female tested on 11/12 /19 Analyte* Procedure Report Mid Abs 0.0-1.8 0.3-1.4 RDW 10-15 10-17 4. In an interview at 3:10 p.m. on 11/13/19, the LD confirmed the above finding. 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 --