Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780. 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 review of the proficiency testing records and interview, the laboratory failed to attain an acceptable score of 80% or higher for the CBC (Complete Blood Count) indices Red Blood Cells (RBC) in the 2nd event of 2021 resulting in unsatisfactory analyte performance. Findings follow. A. Review of the American Proficiency Institute (API) proficiency testing records from the 1st event of 2023, the 1st, 2nd, and 3rd events of 2022, and 2nd and 3rd events of 2021 showed in the 2021 Hematology 2nd Event the laboratory obtained a score of 60% for RBC. B. Interview with the Technical Consultant on July 20, 2023 at 1100 hours confirmed the failure. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, COLA letter, verification of performance specifications records, patient testing records and interview, the laboratory failed to participate in the 2022 3rd Event resulting in a test score of 0% in for WBC, WBC differential, Granulocytes %, Lymphocytes %, Monocytes/Mid%, RBC, HCT, HGB, MCH, MCHC, MCV and PLT in the specialty of Hematology for one of six events reviewed. Findings follow. A. Review of the American Proficiency Institute (API) Hematology proficiency testing records from the 1st event of 2023, the 1st, 2nd, and 3rd events of 2022, and the 2nd and 3rd event of 2021 showed scores of 0% in the 3rd Event of 2022 for WBC, WBC differential, Granulocytes %, Lymphocytes %, Monocytes/Mid%, RBC, HCT, HGB, MCH, MCHC, MCV and PLT. B. Review of the letter from COLA dated 02/07/2023 stated, "The laboratory was recently sent a letter requesting that you send documentation of