Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based upon review of 2021, 2022 and 2023 API PT (Proficiency Testing) records and interview with the Laboratory Services Coordinator on 9/21/2023, the laboratory failed to test PT samples the same number of times it routinely tests patient samples during 1 of 8 PT events reviewed. Findings: Review of the Attestation Form for the First Hematology API PT Event of 2023 revealed that Testing Personnel #3 and Testing Personnel #4 both performed 5 blood cell identification samples (BCI-01, BCI-02, BCI-03, BCI-04, BCI-05) prior to the event's deadline of March 29, 2023. Patient samples are not routinely performed by two different Testing Personnel prior to the reporting of results. 1. Testing Personnel #3 performed the PT samples (BCI-01 through BCI-05) on March 23, 2023. 2. Testing Personnel #4 performed the PT samples (BCI-01 through BCI-05) on March 28, 2023. During interview at approximately 9:45 a.m., the Laboratory Services Coordinator confirmed the observation that both Testing Personnel performed testing prior to the PT event's deadline. 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 --