Summary:
Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing (PT) records from the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB- MLE) and interview with the technical consultant (TC), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Hematology specialty on the first event of 2023 (Q1-2023). The findings include: 1. Based on review of the AAB-MLE records, an unacceptable score of 60 percent was obtained for the specialty of Hematology for Q1-2023 for Hematocrit (Hct) analyte. PT sample ID Reported Acceptable ---------------------------------------------------------- HEM-01 42.7 * 36.7 - 41.4 HEM-02 18.2 16.4 - 18.5 HEM-03 41.2 36.5 - 41.2 HEM- 04 56.0 * 49.1 - 55.4 HEM-05 18.3 16.2 - 18.3 2. The TC confirmed by interview on October 17, 2024, at approximately 11:00 a.m. that the laboratory received the proficiency testing score of 60 percent as described in statement #1. 3. Based on the laboratory's annual testing declaration submitted on the day of the survey on October 17, 2024, the laboratory analyzed and reported approximately 23,460 Hematology test samples during the time the laboratory had unsatisfactory proficiency testing results for Hct. 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 --