Summary:
Summary Statement of Deficiencies 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 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 a review of Proficiency Testing (PT) records from 2023 and interview with the Technical Consultant (TC-1), the laboratory failed to participate in the second testing event of 2023 for Hematology resulting in unsatisfactory performance and a score of 0 for the testing event, and the laboratory failed to suspend patient testing during that time period. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing on patients under the specialty of Hematology with an annual reported test volume of 2,262. 2. The laboratory reported a PT sample issue to the PT provider, American Proficiency Institute (API), for Hematology samples received by the laboratory for the second testing event of 2023. 3. The laboratory failed to participate in the second testing event of 2023 for Hematology, resulting in unsatisfactory performance and a score of 0 for that testing event. 4. The laboratory failed to suspend patient testing during the time frame allotted for testing and reporting proficiency testing results during the second testing event of 2023 for Hematology. 5. The TC-1 interviewed on 1/30/2024 at 10:00 AM confirmed the 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 -- laboratory failed to participate in the second testing event of 2023 for Hematology resulting in unsatisfactory performance and a score of 0 for that testing event, and failed to suspend patient testing during that timeframe. -- 2 of 2 --