Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: **This is a repeat deficiency as cited on the CLIA inspection conducted on 05/21 /2015** Based on record review and interviews with the Technical Supervisor (TS) and the Quality Assurance Specialists (QAS), the laboratory failed to indicate the white blood cell (WBC) differential percentage (diff %) interpretive reference ranges or normal values on the final test report. This deficient practice had the potential to affect 35,464 patient white blood cell (WBC) differential (diff) tests performed in the specialty of Hematology between 08/24/2021 through 04/17/2023. Findings Include: 1. Review of the laboratory's "Sysmex XS Series Operation for CBC" policy and procedure, approved by the Laboratory Director on 07/22/2022 and provided upon request, revealed WBC diff % reference ranges established. 2. Review of five out of five of the laboratory's 2023 patient complete blood count (CBC) final test reports found the analytes tested with their result, respective reference ranges and units of measure, however, did not find WBC diff % reference ranges reported. 3. The Inspector requested the laboratory's patient final test reports with the established reference ranges for the WBC diff % results from the TS and QAS. The TS and QAS stated the laboratory did not report the established WBC diff % reference ranges due to the providers only utilizing the absolute diff values and not the WBC diff % values. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The TS and QAS confirmed the laboratory reported patient WBC diff % results, however did not report WBC diff % reference ranges on the final test report and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 04/18/2023 at 4:30 PM. -- 2 of 2 --