Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of 2024 and 2025 American Proficiency Institute (API) Proficiency Testing (PT) records, and interview with Testing Personnel (TP #7) 11/24/25, the laboratory failed to ensure all TP who performed Complete Blood Count (CBC) testing participated in PT. Findings: Review of "Standard Operating Procedures (SOPS)" revealed, "...Test proficiency samples... using a staff member who routinely performs hematology testing. Rotate PT duties amongst all personnel who test samples..." Review of API 2024 and 2025 PT records revealed: 1. API 2024 - 2 of 8 TP participated in events 1-3: TP #1 tested all samples in events 1 and 3. TP #6 tested all samples in event 2. 2. API 2025 - 3 of 7 TP participated in events 1-3: TP #1 tested all samples in event 2. TP #2 tested all samples in event 3. TP #5 tested all samples in event 1. Interview at approximately 1: 45 p.m. TP #7 confirmed all TP did not participate in PT. 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 --