Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifiers #3 and #4 (refer to the Laboratory Personnel Report) at 10:15 am on 08/30/2023, the laboratory director failed to attest to the routine integration of PT samples into the patient workload for four out of five PT events from 01/01/2022 - 08 /30/2023. The findings include: 1. For 2022 event 2, the laboratory director did not sign the following PT attestation statements: immunology/immunohematology and microbiology. 2. For 2022 event 3, the laboratory director did not sign the following PT attestation statement: microbiology. 3. For 2023 event 1, the laboratory director did not sign the following PT attestation statements: immunology /immunohematology, core chemistry, miscellaneous chemistry, hematology /coagulation, and microbiology. 4. For 2023 event 2, the laboratory director did not sign the following PT attestation statements: core chemistry, hematology/coagulation, and microbiology. 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 --