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 review of hematology test reports for 2018, the approved procedure manual and interview with the technical consultant, the laboratory failed to ensure pertinent reference intervals (normal values) were available for interpretation. Reference intervals included on four of four test reports differed from those stated in the approved procedure manual. Findings: 1. Review of four selected hematology test reports for 2018 revealed the following differences between reference intervals included on test reports and those stated in the approved procedure manual: Male reference intervals included on test reports February 27, 2018 and May 8, 2018; RBC 4.60 - 6.20 [10^6/uL] Hemoglobin 13.0 - 17.0 [g/dL] Hematocrit 40.0 - 50.0 [%] MCV 80 - 98 [fl] Female reference intervals included on test reports February 13, 2018 and May 1, 2018; RBC 4.20 - 5.40 [10^6/uL] Hemoglobin 12.0 - 16.0 [g/dL] Hematocrit 35.0 - 45.0 [%] Reference intervals revised /effective April 7, 2011 and stated in the approved procedure manual in use; RBC 4.20 - 6.20 [10^6/uL] Hemoglobin 12.0 - 17.0 [g/dL] Hematocrit 35 - 50 [%] MCV 79 - 100 [fl] 2. Interview with the technical consultant on May 15, 2018 at 10:00 AM confirmed reference intervals on test reports differed from those stated in the approved procedure manual effective April, 7, 2011. 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 --