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: Review of records and discussion with the staff revealed that the final test report did not include the reference values or normal values established by the laboratory for the following analytes. White Blood Cell Count, Red Blood Cell Count, Hemoglobin, Hematocrit, Platelets and Cell differentials. Findings include: 1. Review of a Complete Blood Count (CBC) test report revealed that the normal or reference ranges were not included in the final test report. 2. The laboratory's hematology standard operating procedure for complete blood count did not have a list of reference ranges or normal values. 3. Discussion with the testing personnel confirmed these findings on 04/18/2022 @ 14:30 PM. 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 --