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 surveyor review of 2024 and 2025 American Proficiency Institute (API) proficiency test (PT) records, the CMS 209 Personnel document, and interview with testing personnel #1 (TP#1), the laboratory failed to rotate all testing personnel in proficiency testing. This was noted for one of fourteen testing personnel performing all twelve PT events in 2024 and 2025 for chemistry and hematology. Findings are: 1. Review of the API PT records revealed TP#1 performed all six chemistry and all six hematology PT events in 2024 and 2025. 2. Review of the CMS 209 Personnel document revealed thirteen other qualified testing personnel performing moderate complexity in chemistry and hematology. 3. Interview on 6/18/2026 at 9:15 AM, with TP#1 confirmed TP#1 was the only TP performing PT in 2024 and 2025. 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 --