Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the testing personnel and the laboratory director failed to sign two of five PT attestation statements reviewed from 2025 and 2026. The findings include: 1. A review of the laboratory's API PT records revealed that the laboratory testing personnel (TP) and the laboratory director did not sign the attestation statements for the following events: -2025 Hematology /Coagulation Event 3 -2026 Hematology/Coagulation Event 1 2. The Laboratory Technician (TP1) confirmed the survey findings during an interview on 08/26/2026 at 11:20 a.m. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the laboratory failed to review and evaluate PT results for four of five testing events reviewed from 2025 and 2026. The findings include: 1. A review of the laboratory's API PT records revealed no 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 -- documented evaluation or review for the following events: - 2025 Hematology /Coagulation Event 1 - 2025 Hematology/Coagulation Event 2 - 2025 Hematology /Coagulation Event 3 - 2026 Hematology/Coagulation Event 1 2. The Laboratory Technician (TP1) confirmed the survey findings during an interview on 08/26/2026 at 11:20 a.m. -- 2 of 2 --